[Federal Register Volume 59, Number 89 (Tuesday, May 10, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-11166]
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[Federal Register: May 10, 1994]
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Part VI
Office of Management and Budget
_______________________________________________________________________
Report on Executive Order No. 12866, Regulatory Planning and Review;
Notice
OFFICE OF MANAGEMENT AND BUDGET
Report on Executive Order No. 12866, Regulatory Planning and Review
AGENCY: Office of Management and Budget, Executive Office of the
President.
ACTION: Publication of report to the president.
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SUMMARY: On September 30, 1993, the President signed Executive Order
No. 12866, ``Regulatory Planning and Review.'' On the same day, the
President directed the Administrator of the Office of Information and
Regulatory Affairs to monitor OIRA's review activities during the first
six months of the Executive Order and submit a report on these
activities to the President and the Vice President by May 1, 1994. The
President also directed that the report be published in the Federal
Register.
Pursuant to the President's directive, this document contains the
text of the report and an executive summary of the report, transmitted
to the President on May 1, 1994.
FOR FURTHER INFORMATION CONTACT: Don Arbuckle, Office of Information
and Regulatory Affairs, Office of Management and Budget, New Executive
Office Building, Washington, DC 20503, (202) 395-7340.
Sally Katzen,
Administrator, Office of Information and Regulatory Affairs.
May 1, 1994.
Report on Executive Order No. 12866
Executive Summary
On September 30, 1993, President Clinton signed Executive Order No.
12866, ``Regulatory Planning and Review.'' On that same day, he issued
a memorandum directing the Administrator of OMB's Office of Information
and Regulatory Affairs to ``monitor [her] review activities over the
next six months and, at the end of this period, to prepare a report on
[her] activities.'' OIRA's Report covers the implementation of
Executive Order No. 12866 from October 1, 1993, through March 31, 1994.
As set forth in greater detail in the report, implementation of the
new Executive Order is well underway. At this point, we are beginning
to see some of the changes that were envisioned in the Order. We have,
however, encountered greater delays than anticipated in implementing
some aspects of the Order. And some of the processes established by the
Order, while initiated on schedule, are still in the formative stages.
As a result, it is too early to arrive at a final judgment regarding
the success of the new system; however, the early indications are that
there is substantial improvement in the rulemaking process.
Executive Order No. 12866 clearly articulates President Clinton's
regulatory philosophy and his view of how the nation's regulatory
system should work. Most fundamentally, as the Order states in its
opening lines:
The American people deserve a regulatory system that works for
them, not against them: a regulatory system that protects and improves
their health, safety, environment, and well-being and improves the
performance of the economy without imposing unacceptable or
unreasonable costs on society; regulatory policies that recognize that
the private sector and private markets are the best engine for economic
growth; regulatory approaches that respect the role of State, local,
and tribal governments; and regulations that are effective, consistent,
sensible, and understandable.
A number of themes run through the Order. Within the Executive
Branch, it encourages cooperation and coordination among OMB and the
agencies. With respect to the public, it emphasizes openness and early
involvement by all of the interested entities, including particularly
State, local, and tribal participation in the rulemaking process.
The Order reaffirms the primacy of the agencies in the regulatory
decision-making process and sets forth principles to which they are to
adhere, to the extent permitted by law, when developing rules. At the
same time, the Order reaffirms the legitimacy of centralized review.
The process established for centralized review distinguishes between
significant and non-significant regulatory actions so as to focus
OIRA's review activities on where there will likely be the most
benefit. It also emphasizes sound and timely analysis, early and
frequent consultation, and it reduces delay and removes secrecy in the
review process by establishing time limits and disclosure requirements.
Many of the objectives of the Order have begun to be realized.
Regarding cooperation and public involvement, one of the major changes
during the six-month period is the improved relationships that have
been developed between OIRA and the agencies. While remnants of the
mistrust and hostility that often characterized relationships between
the career staffs over much of the past decade still exist, for the
most part this has been replaced with a spirit of cooperation.
Much of the credit for the improved environment goes to the newly
created Regulatory Policy Officers (RPO), high level agency officials
who represent the agency head in efforts to implement the Order and
improve the regulatory process. The RPOs work together in the
Regulatory Working Group (RWG) chaired by the OIRA Administrator and
attended by the White House Regulatory Policy Advisors--which meets
regularly to discuss regulatory issues. The RWG has proven to be a
useful forum not only for discussion of ideas and the exchange of best
practices, but also for coordinating regulatory activities that affect
more than one agency.
Regarding public participation, agencies appear to be making
efforts to engage the public earlier and more fully in the regulatory
process. For its part, OIRA has held two conferences (and is planning a
third) with representatives of State, local, and tribal governments to
improve the consultation process between them and Federal regulators.
OIRA has also taken steps to improve the participation of the small
business community in the rulemaking process. OIRA joined the Small
Business Administration (SBA) to sponsor a Small Business Forum on
Regulatory Reform in March 1994 to discuss how the regulatory process
can better address the special needs of small businesses.
With respect to the objectives of selectivity and timeliness, OIRA
received and reviewed 578 regulatory actions from October 1, 1993,
through March 31, 1994. (See Table 1.) The 578 rules received and
reviewed by OIRA for the six-month period is approximately half what it
was for comparable periods in previous years. The number of rules under
review at any given time has also shown a significant decline. For
example, on July 1, 1993 (three months before the Executive Order was
signed), 254 regulations were under review; on March 31, 1994 (six
months after the Executive Order was signed), 68 rules were under
review.
These figures reflect a longer than anticipated start-up period
during which many non-significant rules continued to be sent to OIRA
for review. This is a result of difficulties some agencies have had in
instituting internal systems to manage the listing process that is to
distinguish between significant and non-significant regulatory actions.
Where the process has been implemented it has been helpful.
In total, OIRA has received lists designating 1,624 regulatory
actions as significant or non-significant. (These rules would not all
be rules reviewed during the six-month period--and hence they all do
not appear on Appendix A--because, if they are non-significant, they
would not have been submitted for review, and even if they are
significant, they may not have been ready to be submitted for review
and reviewed during the period covered by the report.) Of the 1,624
regulatory actions, almost two-thirds were designated non-significant,
one-third significant; specifically, agencies designated (and OMB
agreed) that 1,047 (or 64%) were non-significant; 316 (or 19%) were
designated by the agency as (and OIRA agreed that they were),
significant; and the remaining 261 (or 16%), were designated
significant by OMB. Stated another way, the agency and OMB agreed with
the initial designation for 83% of the regulatory actions; in only 16%
was there a difference of view.
The definition of ``significant'' regulatory action has been the
source of much discussion both within agencies and departments and
between OIRA and the agencies (and it has been at least a partial
source of the start-up delays we have experienced). Some of the
differences may be attributable to the difference in the natural
inclinations of rule writers, who might prefer not to have another
review layer to go through, and the natural inclinations of reviewers,
who might prefer to see more, rather than fewer rules, to ensure that
everything that should be reviewed is reviewed. In any event, we have
found that the number of instances where there is an initial difference
of opinion as to significance decreases (sometimes substantially) with
the agencies' increased experience with the process. In some cases, it
is simply a function of the agencies' not knowing how much information
to provide to enable OIRA to agree that the regulation is non-
significant. In other cases, the agencies and OMB discuss the reasons
for their different judgments so that the staffs come to an
understanding and agreement on the definition of significance.
With respect to timeliness, the Executive Order establishes strict
time limits on OIRA review in most cases 90 days to balance the need
for adequate time to conduct review with the need to streamline the
regulatory process and prevent unwarranted delay. OIRA has made a
concerted effort to meet not only the letter of this requirement, but
its spirit as well, and this goal of the Order is clearly being
accomplished. Of the 578 rules received and reviewed between October
and March, only three were extended beyond the 90-day limit. Each of
these rules was extended at the request of the regulating agency to
permit completion of interagency reviews that were in fact concluded in
less than three weeks after the extension was requested.
In addition, the Order establishes disclosure requirements for both
OIRA and the agencies to increase openness, accessibility, and
accountability. On July 1, 1993, as one of her first actions, the OIRA
Administrator began making available a daily list of draft agency
regulations under review at OIRA. This was done in order to remove the
stigma of secrecy that had previously characterized regulatory review,
and to make the review process more transparent. In addition, lists and
statistics related to regulatory review for each month are compiled and
made available by early the following month. Meetings and telephone
calls with persons outside the Executive Branch on regulations under
review are now logged, and these logs are made publicly available. And
other material related to regulatory review is kept in a public file,
forwarded to the agencies, or made available upon request, in
accordance with the Order. These various disclosure procedures are
working well and have helped restore the integrity of the regulatory
review process.
Two aspects of the Executive Order--the regulatory planning
mechanism and review of existing regulations--are not covered in detail
in the report, because although both are underway and on schedule, it
is too early to judge their success. The regulatory planning process
began with an agencies policy meeting held in early April and guidance
on the process issued by the OIRA Administrator immediately after the
meeting. This began the planning cycle that will result in the
publication of the Regulatory Plan in October 1994. Regarding review of
existing regulations, agencies submitted to OIRA in late December their
plans for review of existing regulations. Several of the agencies have
published notices requesting the public to suggest candidates for
review. These and other approaches to reviewing existing regulations
are being discussed within the RWG, and further action is planned.
In the memorandum from the President, we were asked to identify any
provisions of the Executive Order that should be changed. As noted
above, it is premature to make specific recommendations. We have,
however, identified a number of issues that warrant further
consideration and that ultimately may require changes to the Executive
Order, its implementation by OIRA, or both.
The importance of regulations in our society makes it imperative
that the process by which they are developed and reviewed be
characterized by integrity and accountability. During the first six
months of Executive Order No. 12866, we have made major strides toward
these goals. We have moved the regulatory process from one criticized
for delay, favoritism, and secrecy to one that is principled,
professional, and productive. Much remains to be done, but we have made
a strong beginning.
Report on Executive Order No. 12866
May 1, 1994.
On September 30, 1993, President Clinton signed Executive Order No.
12866, ``Regulatory Planning and Review'' (attached). On that same day,
he issued a memorandum directing the Administrator of OMB's Office of
Information and Regulatory Affairs (OIRA) to ``monitor [her] review
activities over the next six months and, at the end of this period, to
prepare a report on [her] activities'' (attached). The President also
directed that ``[t]he report . . . identify any provisions of the order
that, based on [her] experience or on comments from interested persons,
warrant reconsideration so that the purposes and objectives of this
order can be better achieved.'' He directed that this report be
submitted to the Vice President and the President by May 1, 1994, and
be published in the Federal Register.
This report will describe and comment on what has occurred during
the first six months of implementation of Executive Order No. 12866
(from October 1, 1993, through March 31, 1994), and will identify
issues that could lead to suggested changes in the future. Although six
months is a short time to bring about the fundamental changes in the
Government's regulatory process envisioned by the Executive Order, the
outlines of the new system have clearly begun to emerge. In some cases,
we can point to unqualified successes; in others, we have encountered
unexpected difficulties in implementing the system. To a large degree,
it is too early to assess the success of the new system.
This report consists of four chapters. The first section introduces
the subject with a brief history of the major regulatory programs of
the U.S. Government and a general discussion of the nature of
regulation. The second chapter describes the Clinton Administration's
regulatory philosophy and the objectives of Executive Order No. 12866.
The third section describes the implementation of the Executive Order
during the first six months. The fourth section comments generally on
issues raised as a result of our experience or from comments received
from agencies and members of the public.
I. History of the Regulatory Programs of the U.S. Government
The Federal Government affects the lives of its citizens in a
variety of ways through taxation, spending, grants and loans, and
through regulation. Over time, regulation has become increasingly
prevalent in our society, and the importance of our regulatory
activities cannot now be overstated.
The History of Major Regulatory Programs
Federal regulation as we know it began in the late 19th century
with the creation of the Interstate Commerce Commission, which was
charged with protecting the public against excessive and discriminatory
railroad rates. The regulation was economic in nature, setting rates
and regulating the provision of railroad services. Having achieved some
success, this administrative model of an independent, bipartisan
commission, reaching decisions through an adjudicatory approach, was
used for the Federal Trade Commission (1914), the Water Power
Commission (1920) (later the Federal Power Commission), and the Federal
Radio Commission (1927) (later the Federal Communications Commission).
In addition, during the early 20th century, Congress created several
other agencies to regulate commercial and financial systems--including
the Federal Reserve Board (1913), the Tariff Commission (1916), the
Packers and Stockyards Administration (1916), and the Commodities
Exchange Authority (1922)--and to ensure the purity of certain foods
and drugs, the Food and Drug Administration (1931).
Federal regulation began in earnest in the 1930s with the
implementation of wide-ranging New Deal regulatory programs.
Some of the New Deal economic regulatory programs were implemented
by the Federal Home Loan Bank Board (1932), the Federal Deposit
Insurance Corporation (1933), the Commodity Credit Corporation (1933),
the Farm Credit Administration (1933), the Securities and Exchange
Commission (1934), and the National Labor Relations Board (1935). In
addition, the jurisdiction of both the Federal Communications
Commission and the Interstate Commerce Commission were expanded to
regulate other forms of communications (e.g., telephone and telegraph)
and other forms of transport (e.g., trucking). In 1938, the role of the
Food and Drug Administration was expanded to include prevention of harm
to consumers in addition to corrective action. The New Deal also called
for the establishment of the Employment Standards Administration
(1933), and of Social Security (1933) and related programs.
A second burst of regulation began in the late 1960s with the
enactment of comprehensive, detailed legislation intended to protect
the consumer, improve environmental quality, enhance work place safety,
and assure adequate energy supplies. In contrast to the pattern of
economic regulation adopted before and during the New Deal, the new
social regulatory programs tended to cross many sectors of the economy
(rather than individual industries) and affect industrial processes,
product designs, and by-products (rather than entry, investment, and
pricing decisions).
The consumer protection movement led to creation in the newly
formed Department of Transportation of several agencies designed to
improve transportation safety. They included the Federal Highway
Administration (1966), which sets highway and heavy truck safety
standards; the Federal Railroad Administration (1966), which sets rail
safety standards; and the National Highway Traffic Safety
Administration (1970), which sets safety standards for automobiles and
light trucks. Regulations were also authorized pursuant to the Truth in
Lending Act, the Equal Credit Opportunity Act, the Consumer Leasing
Act, and the Fair Debt Collection Practices Act. The National Credit
Union Administration (1970) and the Consumer Product Safety Commission
(1972) were also created to protect consumer interests.
In 1970, the Environmental Protection Agency was created to
consolidate and expand environmental protection programs. Its
regulatory authority was expanded through the Clean Air Act (1970), the
Clean Water Act (1972), the Safe Drinking Water Act (1974), the Toxic
Substances Control Act (1976), and the Resource Conservation and
Recovery Act (1976). This effort to improve environmental protection
also led to the creation of the Materials Transportation Board (1975)
(now part of the Research and Special Programs Administration in the
Department of Transportation) and the Office of Surface Mining
Reclamation and Enforcement (1977) in the Department of the Interior.
The Occupational Safety and Health Administration (1970) was
established in the Department of Labor to enhance work place safety. It
was followed by the Mining Enforcement and Safety Administration
(1973), now the Mine Safety and Health Administration, also in the
Department of Labor. The Pension Benefit Guaranty Corporation was
directed to administer pension plan insurance systems in 1974.
Also in the 1970s, the Federal Government attempted to address the
problems of the dwindling supply and the rising costs of energy. In
1973, the Federal Energy Administration (FEA) was directed to manage
short-term fuel shortage. Less than a year later, the Atomic Energy
Commission was divided into the Energy Research and Development
Administration (ERDA) and an independent Nuclear Regulatory Commission.
In 1977, the FEA, ERDA, the Federal Power Commission, and a number of
other energy program responsibilities were merged into the Department
of Energy and the independent Federal Energy Regulatory Commission.
Another significant regulatory agency, the Department of
Agriculture (1862), has grown over time so that it now regulates the
price, production, import, and export of agricultural crops; the safety
of meat, poultry, and certain other food products; a wide variety of
other agricultural and farm-related activities; and broad-reaching
welfare programs. Agriculture regulatory authorities have changed over
time, but now include the U.S. Forest Service (1905), the Farmers Home
Administration (1921), the Soil Conservation Service (1935), the
Agricultural Stabilization and Conservation Service (1961), the Food
and Nutrition Service (1969), the Agricultural Marketing Service
(1972), the Federal Grain Inspection Service (1976), the Animal and
Plant Health Inspection Service (1977), the Foreign Agricultural
Service (1974), The Food Safety and Inspection Service (1981), and the
Rural Development Administration (1990).
The consequence of the long history of regulatory activities is
that Federal regulations now affect virtually all individuals,
businesses, State, local, and tribal governments, and other
organizations in virtually every aspect of their lives or operations.
Some rules are based on old statutes; others on relatively new ones.
Some regulations are critically important (such as the safety criteria
for airlines or nuclear power plants); some are relatively trivial
(such as setting the times that a draw bridge may be raised or
lowered). But each has the force and effect of law and each must be
taken seriously.
The Nature of Regulation
It is conventional wisdom that competition in the marketplace is
the most effective regulator of economic activity. Why then is there so
much regulation? The answer is that markets are not always perfect and
when that occurs, society's resources may be imperfectly or
inefficiently used. The advantage of regulation is that it can improve
resource allocation or help obtain other societal benefits. For
example, consider the following situations:
--Certain markets may not be sufficiently competitive, thus potentially
subjecting consumers to the harmful exercise of market power (such as
higher prices or artificially limited supplies). Regulation can be used
to promote competition (for example, removing barriers to entry) and to
ensure that firms engage in fair trade practices such as the sale of
dangerous substances.
--In an unregulated market, firms and individuals may impose costs on
others--including future generations that are not reflected in the
prices of the products they buy and sell. They may pollute streams,
cause health hazards, or endanger the safety of their workers or
customers. Regulation can be used to reduce these harmful effects by
prohibiting certain activities or imposing the societal costs of the
activity in question on those causing harm. One goal of regulation is
to induce private parties to act as they would if they had to bear the
full costs that they impose on others.
--Similarly, in an unregulated market, firms and individuals may not
have incentives to provide individuals with accurate or sufficient
information needed to make intelligent choices. Firms may mislead
consumers or take advantage of consumer ignorance to market unsafe or
risky products. Regulation may be needed to require disclosure of
information, such as the possible side effects of a drug, the contents
of a food or packaged good, the energy efficiency of an appliance, or
the full cost of a home mortgage.
--Even when consumers have full information, the Government may wish to
protect individuals, especially children, from their own actions.
Regulation may thus be used to restrict certain unacceptable or harmful
practices.
--Regulation can also be beneficial in achieving goals that reflect our
national values, such as equal opportunity and universal education, or
a respect for individual privacy.
There are also many potential disadvantages of regulating, to the
Government, to those regulated, and to society at large.
--The direct costs of administering, enforcing, and complying with
regulations may be substantial. Some of these costs may be borne by the
Government, while others are paid for by firms and individuals,
eventually being reflected in the form of higher prices, lower wages,
reduced output, and investment, research, and expansion foregone.
--There are also disadvantages of regulation that are difficult to
measure, such as adverse effects on flexibility and innovation, which
may impair productivity and competitiveness in the global marketplace,
and counterproductive private incentives, which may distort investment
or reduce needed supporting activities.
In short, regulations (like other instruments of government policy)
have enormous potential for both good and harm. Well-chosen and
carefully crafted regulations can protect consumers from dangerous
products and ensure they have information to make informed choices.
Such regulations can limit pollution, increase worker safety,
discourage unfair business practices, and contribute in many other ways
to a safer, healthier, more productive, and more equitable society.
Excessive or poorly designed regulations, by contrast, can cause
confusion and delay, give rise to unreasonable compliance costs in the
form of capital investments and on-going paperwork, retard innovation,
reduce productivity, and accidentally distort private incentives.
The challenge for regulators is to approach their task with an
appreciation and respect for the complexity of the problems they must
solve and the diversity of the individuals and institutions their work
affects. In doing this, they need to balance a number of conflicting
objectives, to apply sensitivity and judgment to the best available
information, and ultimately to achieve the most effective means to the
desired ends. The efforts to do this, especially in the recent past,
have not been particularly successful, and the American people have
indicated their irritation, if not anger, at the maze of inconsistent,
duplicative, and excessive rules that can cause more harm than good.
Executive Order No. 12866 was developed to bring the Government
back to the task at hand--to design sensible regulations that improve
the quality of our life without imposing unnecessary costs and to do so
in a way that is efficient, fair, and accountable to the American
people.
II. The Objectives of Executive Order No. 12866
Executive Order No. 12866 clearly articulates President Clinton's
regulatory philosophy and his view of how the nation's regulatory
system should work. Most fundamentally, as the Order states in its
opening lines:
The American people deserve a regulatory system that works for
them, not against them: a regulatory system that protects and improves
their health, safety, environment, and well-being and improves the
performance of the economy without imposing unacceptable or
unreasonable costs on society; regulatory policies that recognize that
the private sector and private markets are the best engine for economic
growth; regulatory approaches that respect the role of State, local,
and tribal governments; and regulations that are effective, consistent,
sensible, and understandable.
The Order sets out specific goals:
The objectives of this Executive Order are to enhance planning and
coordination with respect to both new and existing regulations; to
reaffirm the primacy of Federal agencies in the regulatory decision-
making process; to restore the integrity and legitimacy of regulatory
review and oversight; and to make the process more accessible and open
to the public.
In its first section, Executive Order No. 12866 sets forth the
specific philosophy and principles that are to govern regulatory
development. This is worth quoting at this point because it so
succinctly describes the philosophy that the Order is established to
implement:
Federal agencies should promulgate only such regulations as are
required by law, are necessary to interpret the law, or are made
necessary by compelling public need, such as material failures of
private markets to protect or improve the health and safety of the
public, 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 alternative 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.
Regulatory Principles
The Order then lists 12 principles of regulation (Section 1(b))
that, to the extent permitted by law, agencies are to follow when
considering and developing regulating. These principles can be viewed
as a series of questions to be raised by the agency, begins with
identifying the problem the agency is trying to solve or the situation
it is trying to change. How serious is it, compared with other problems
the agency faces? What will this proposed regulation do? How sure is
the agency that it will do it? Will the proposed regulation have any
unintended benefits? Any unintended costs? Create any counterproductive
private incentives? Is there any other approach that would achieve the
same objective better? Is there a way of modifying the proposed
regulation to achieve greater benefits for the same costs or to achieve
the same benefits for fewer costs?
Two themes emerge from these principles: the need for data and for
analysis, particularly of alternative ways to solve the problem. It is
the responsibility of regulators to obtain and rely on the best
reasonably obtainable scientific, technical, or economic data, as may
be called for in a particular instance. The data should be assembled
and analyzed objectively, without preconceived notions of the outcome.
At the same time, it is clear that as the state of scientific knowledge
advances, technology develops and changes, and economic forecasts are
revised, there may be legitimate disputes about what constitutes the
best available data. That being the case, the quest for the best should
not be the enemy of the practicable.
It is also the responsibility of regulators to be disciplined in
analyzing the benefits and costs of proposed regulations and
alternative ways of solving the problem, so that they can attest not
only that the benefits of their regulations outweigh their costs, but
also that their regulations are designed in the most cost-effective
manner possible. Such a statement of principle would not seem to be
controversial, yet the use of benefit-cost analysis has been one of the
most contentious issues in the regulatory arena during the last twelve
years.
Those who criticize benefit-cost analyses believe that it is often
difficult (or even impossible or morally improper) to quantify or place
a dollar value on such benefits as lives saved, improved air quality,
or reduced discrimination. Others believe that while it may be
difficult to quantify or place a dollar value on certain costs--such as
reduced flexibility, the loss of innovation, or counterproductive
incentives to cheat--generally costs are easier to measure than
benefits, so that undertaking a benefit-cost analysis will, they
believe, skew the decision-making process against the adoption of
needed regulations.
While there is no easy response to these concerns, the Executive
Order stresses not only that the anticipated effects of a regulation
should be quantified to the extent possible, but also that those that
cannot be quantified--whether they be benefits or costs--should
nevertheless be considered. This underscores that the decision-maker
should consider all of the anticipated effects in deciding whether, on
balance, society as a whole will benefit from the proposed regulatory
action.
Responsibilities of the Various Participants
How these objectives are to be incorporated into a regulatory
system is the subject of the rest of the Executive Order. It begins by
affirming the primacy of the regulatory agencies, the legitimacy of
centralized review, and the areas of responsibilities for each.
The process of developing regulations must begin with the agencies
to which Congress has assigned statutory regulatory authority and
responsibilities. These agencies are the repositories of significant
substantive expertise and experience in a particular field. An agency's
activities are sometimes driven by statutory mandates; there is also
frequently a substantial amount of discretion involved. In either
event, it is the agency itself that must be responsible for carefully
identifying the problem to be addressed, analyzing the source of the
problem (including whether existing regulations or other laws have
created, or contributed to, the problem and whether those regulations
or other laws can be modified to achieve the regulatory goals more
effectively), assessing the importance of that problem, and determining
the proper solution to it.
The Order assigns the task of centralized review to OMB's OIRA,
which in the words of the Executive Order, is the ``repository of
expertise concerning regulatory issues, including methodologies and
procedures that affect more than one agency, this Executive Order, and
the President's regulatory policies.'' With such expertise, OIRA's role
is to ``ensure that regulations are consistent with applicable law, the
President's priorities, and the principles set forth in this Executive
Order, and that decisions made by one agency do not conflict with the
policies or actions taken or planned by another agency.'' (Section
2(b).)
The Vice President is designated as ``the principal advisor to the
President on . . . regulatory policy, planning, and review.'' The Order
also names 12 White House regulatory policy ``Advisors'' who are to
assist the President and Vice President in specified tasks. These
include: (1) The Director of OMB; (2) the Chair (or another member) of
the Council of Economic Advisors (CEA); (3) the Assistant to the
President for Economic Policy (NEC); (4) the Assistant to the President
for Domestic Policy (DPC); (5) the Assistant to the President for
National Security Affairs (NSA); (6) the Assistant to the President for
Science and Technology (OSTP); (7) the Assistant to the President for
Intergovernmental Affairs (IGA); (8) the Assistant to the President and
Staff Secretary; (9) the Assistant to the President and Chief of Staff
to the Vice President (OVP); (10) the Assistant to the President and
Counsel to the President; (11) the Deputy Assistant to the President
and Director of the White House Office on Environmental Policy (OEP);
and (12) the Administrator of OIRA, who is to ``coordinate
communications relating to this Executive Order among the agencies,
OMB, the other Advisors, and the Office of the Vice President.''
(Section 2(c).)
Scope of the Executive Order
The scope of the Order is set forth in several different sections.
``Regulation'' and ``regulatory action,'' the subject of the planning
and review provisions of the Order, are defined, as are exemptions from
the definitions, such as formal rulemaking, rules pertaining to
military or foreign affairs, and rules limited to agency organization,
management, and personnel matters. (Section 3(d).) In addition, the
OIRA Administrator is given the authority to exempt any other category
of regulations. (Section 3(d)(4).) ``Regulation'' and ``regulatory
action'' are the operative terms used throughout the Order. They are
defined to include any regulatory pronouncement, regardless of form,
that has, or is expected to lead to a promulgation that has the force
and effect of law. Thus, certain guidance documents, directives,
notices of inquiry, policy statements, and the like may be included
under the Order depending on the extent to which the agency intends to
enforce their terms and conditions.
In general, the Order focusses on ``significant regulatory
actions,'' rather than all regulations or regulatory actions. This is
an important distinction between this Order and its predecessor,
Executive Order No. 12291. This Order makes clear, among other things,
that centralized review is to be focussed on the most important
regulatory actions, where OIRA's limited resources can be expected to
have maximum beneficial effect. Consistent with the spirit of the
primacy of agencies for regulatory decisions and the streamlining of
the regulatory process, the agencies themselves are solely responsible
for review of non-significant regulatory actions.
A significant regulatory action is defined to mean any regulatory
action that is likely to result in a rule that may:
(1) 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;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order. (Section 3(f).)
The Order applies as a whole to all Federal agencies, with the
exception of the independent regulatory agencies. However, the
independent regulatory agencies are requested on a voluntary basis to
adhere to the statement of regulatory philosophy and the regulatory
principles that may be pertinent to their activities. Moreover, these
independent agencies are included within the provisions relating to the
planning process. (Section 4(b) and Section 4(c).)
Planning and Coordination
The objective of the planning process is to identify significant
issues early in the course of regulatory development so that
appropriate coordination can be conducted at the beginning of the
process rather than at the end. Specifically, the purpose of the
planning and coordinating mechanisms set up by the Order is:
[T]o provide for coordination of regulations, to maximize
consultation and the resolution of potential conflicts at an early
stage, to involve the public and its State, local, and tribal officials
in regulatory planning, and to ensure that new or revised regulations
promote the President's priorities and the principles set forth in this
Executive Order. (Section 4.)
First, the Order establishes a planning cycle that begins with a
meeting, convened by the Vice President, with the regulatory policy
advisors and the heads of agencies to discuss priorities and to
coordinate regulatory efforts to be accomplished in the upcoming year
(Section 4(a)). The Order recognizes the continued utility of the
``Unified Regulatory Agenda,'' a compilation of ``all regulations under
development or review,'' to be published as specified by the
Administrator. (Section 4(b).) The Order also calls for agencies to
develop a ``Regulatory Plan'' (Section 4(c)), a description of the
``most important significant regulatory actions that the agency
reasonably expects to issue in proposed or final form in that fiscal
year or thereafter.'' Agencies' plans are to be submitted to OIRA by
June 1st of each year, and are then to be coordinated with various
affected agencies and the regulatory policy advisors. After appropriate
consultation and coordination, the Plan is to be published annually in
the October publication of the Unified Regulatory Agenda.
Another vehicle for increased coordination and cooperation
regarding regulatory affairs among agencies and between the Executive
Office of the President and the agencies is the Regulatory Working
Group (RWG). (Section 4(d).) The RWG--which is to meet at least
quarterly--is to be chaired by the OIRA Administrator, and consist of
representatives of the regulatory policy advisors and the heads of
agencies determined to have significant domestic regulatory
responsibility. The Order sets forth specific tasks for the RWG:
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 assessment in regulatory decision-making,
and (3) the development of short forms and other streamlined regulatory
approaches for small businesses and other entities.)
In order for agencies to implement the Order's philosophy regarding
accountability, planning, and coordination, it is necessary for a very
senior official with sufficient authority to be given responsibility
for these functions. The Order thus requires each agency to appoint a
Regulatory Policy Officer (RPO) (Section 6(a)(2)). The RPO is to report
to the agency head and is to oversee in the agency ``the development of
effective, innovative, and least burdensome regulations and to further
the principles set forth in this Executive Order.'' In most cases, the
RPO also serves as the agency's representative on the RWG.
To ensure improved coordination between the Government and the
public, the Order also requires the OIRA Administrator to meet
quarterly with representatives of State, local, and tribal governments,
and to convene, from time to time, conferences with representatives of
businesses, nongovernmental organizations, and the public to discuss
regulatory issues of common concern. (Section 4(e).)
Centralized Review Process
A large part of the Order is devoted to the processes for
implementing centralized regulatory review (Section 6), including a
mechanism for resolving disputes that may result from such review
(Section 7). In the most recent Administration, centralized review was
highly controversial and vigorously attacked by critics who believed
that it had been misused. Yet, few really challenge the notion that it
is appropriate for the President to provide an opportunity for an
appraisal--detached from the originating agency's legitimate focus on
its programmatic goals--as to whether the agency's regulatory
activities are consistent with and further the President's overall
objectives and regulatory philosophy. Centralized review also provides
an effective vehicle for ensuring that decisions made by one agency do
not conflict with policies or actions taken or planned by other
agencies--an increasingly important function as the decentralized
government takes on increasingly complex responsibilities. And
centralized review can be helpful in identifying a particular success
story, or a particular mistake, by an agency that can provide important
information for other agencies facing the same or similar problems.
Some of the problems with the way centralized review has been
implemented in the past can be reduced if the agency rule-writers and
the reviewer become engaged sooner rather than later in the regulatory
process. After an agency has spent years, and substantial intellectual
resources in producing a proposed regulation, it is difficult for it to
be receptive and responsive to comments questioning the fundamental
premises on which the regulation is based regardless of the merits of
those comments. Recognizing the benefits of advance planning and
coordination in identifying and more importantly resolving major issues
early in the process, Section 6 establishes a process that focusses on
selectivity and early determination of what is important, or
``significant.''
The process begins with the agency submitting to OIRA a list of
planned regulatory actions (Section 6(a)(3)(A)), indicating those the
agency believes to be ``significant regulatory actions'', as defined in
Section 3(f). OIRA then has ten working days to notify the agency that
it has determined that a listed regulation is a ``significant
regulatory action.'' Those regulatory actions that both OIRA and the
agency agree are not significant are not subject to review. Also, the
OIRA Administrator may waive review of any regulatory action designated
by the agency as significant.
For regulatory actions designated as significant, the agency is to
send the draft rule and an assessment of its costs and benefits to OIRA
for review. Additional and more extensive analysis is necessary if the
rule is ``economically significant.'' (A regulatory action is
economically significant within the meaning of the Executive Order if
it appears that it will ``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.'' (Section 3(f)(1).) For an economically
significant rule, the agency, unless it is prohibited by law, is to
submit with the rule an assessment, including the underlying analysis,
of the anticipated benefits, the anticipated costs, and of the costs
and benefits of ``potentially effective and reasonable feasible
alternatives.'' (Section 6(a)(3)(C).)
Section 6 also seeks to eliminate unwarranted delays in the
regulatory review process by establishing deadlines within which OIRA
must complete its review. (Section 6(b)(2).) For preliminary regulatory
actions prior to a Notice of Proposed Rulemaking, such as a notice of
inquiry or advance notice of proposed rulemaking, OIRA must conclude
review within 10 working days. For most submissions, OIRA must conclude
review within 90 calendar days, except that if OIRA has previously
reviewed a submission and there is no material change at its next
stage, OIRA must complete its review within 45 days. In some cases
extensions of review may be needed. The Order allows the review period
to be extended upon written approval of the Director of OMB or at the
request of the agency head. Finally, if the OIRA Administrator returns
a regulatory action to the agency for further consideration, this
action is to be done in writing and is to include an explanation for
the return, including the pertinent provision of the Order that is the
basis for the return.
Openness: Public Involvement and Disclosure
The Order speaks not only to the relationship between the
centralized reviewer and the agencies, but also to the relationship
between both of them and the public. It is essential that the public be
involved in the rulemaking process those benefitting from, those
incidentally affected by, as well as those who might be burdened by,
the proposed regulations. The public will often be able to corroborate
the information that the agency already has in its possession, or
provide additional relevant information to the agency. The public can
also provide a useful reality check on the agency's proposal.
While the Administrative Procedure Act, 5 U.S.C. Sec. 551, et seq.,
the agency's organic statute, and the agency's internal rules provide
for public input, the Order reflects the fact that more can be done to
involve the public in the rulemaking process, particularly in the early
stages (before a formal notice of proposed rulemaking is issued).
Specifically, the Order requires each agency to ``provide the public
with meaningful participation in the regulatory process,'' including
``a meaningful opportunity to comment on any proposed regulation, which
in most cases should include a comment period of not less than 60
days.'' (Section 6(a)(1).) The Order also encourages agencies ``to
explore and, where appropriate, use consensual mechanisms for
developing regulations, including negotiated rulemaking.'' (Section
6(a)(1).) An open and easily accessible process generally improves the
basis for decision-making, increases accountability on the part of the
agency, and generally enhances the prospect for acceptance of the final
product by the regulated industry.
To increase the openness and accountability of the regulatory
review process itself, the Order sets forth certain disclosure
responsibilities for both the agencies and OIRA. After a regulatory
action has been issued, the agency is to make available to the public
the material that the Order requires to have been submitted to OIRA for
review. The agency is also to identify for the public the ``substantive
changes between the draft submitted to OIRA for review and the action
subsequently announced,'' as well as identifying those changes that
were made at the suggestion or recommendation of OIRA. (Section
6(a)(3)(E).)
OIRA too is subject to a variety of disclosure procedures. (Section
6(b)(4).) Regarding regulatory actions under review at OIRA, only the
OIRA Administrator or a particular designee is to receive oral
communications from persons not employed by the Executive Branch. If
meetings are held with such persons, OIRA is to invite a representative
from the appropriate agency to be present. Within 10 working days OIRA
will forward to the agency a copy of all written communications
received from persons outside the Executive Branch, as well as the
names and dates of individuals involved in substantive oral
communications. OIRA is also to maintain a publicly available log that
includes a notation of all written communications forwarded to an
agency and the dates, names of individuals, and subject matter
discussed in substantive oral communications between OIRA and persons
outside the Executive Branch. In addition, OIRA will make available the
status of all regulatory actions under review. Finally, after
publication or issuance of a regulatory action, OIRA will make
available all documents exchanged between OIRA and the agency during
the review.
The Order also provides a dispute resolution mechanism, in the
event that the Administrator of OIRA cannot resolve a disagreement
between or among agency heads or between OMB and an agency. (Section
7). In that event, the issue will be decided by the President or the
Vice President acting at his behest. Resolution of an issue under this
section may be requested only by the Director of OMB, the head of the
issuing agency, or the head of an agency with a significant interest in
the outcome. Such review will specifically not be undertaken at the
request of any other persons.
Review of Existing Regulations
The Order establishes an ongoing process whereby agencies will
review existing regulations (Section 5). Agencies were required to
submit to OIRA by December 31, 1993, a plan under which the agency will
periodically review its existing significant regulations to determine
whether any such rules should be modified or eliminated. The
Administrator of OIRA is directed to work with the RWG and others,
State, local and tribal governments in particular, to help pursue the
review of existing regulations. The general purpose of such review is
as follows:
[T]o 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 unnecessary as a result of changed circumstances;
to confirm that regulations are both compatible with each other and not
duplicative or inappropriately burdensome in the aggregate; to ensure
that all regulations are consistent with the President's priorities and
the principles set forth in this Executive Order, within applicable
law; and to otherwise improve the effectiveness of existing
regulations. * * * (Section 5).
III. The Implementation of Executive Order No. 12866
We would prefer to report that all the regulatory problems of the
nation have either been resolved or are on their way to being resolved
by the 6-month mark of the Executive Order. It should be no surprise,
however, that this is not the case. Improving the regulatory system of
the nation is tied to reforms that are being undertaken throughout the
government, many initiated through the Vice President's National
Performance Review. While changes are underway, most are not yet
completed; this is true also for implementation of the Executive Order.
Many of the themes that run through the Order, careful planning,
cooperation and team work within the Executive Branch, sound and timely
analysis, focusing of resources, openness and accountability, are also
being instituted across other programs of the Federal Government. In
some cases, the ability of agencies to implement changes in the
regulatory system depends on changes being made in other areas. For
example, planning and priority setting depend on the existence within
departments of offices that possess the authority to resist the natural
tendency of large agencies to seek autonomy within departments. In
other cases, there may be a tension between reform in one area and
reform in another. Sound analysis, for example, requires highly skilled
personnel and budget resources, at a time when the Federal Government
is reducing personnel and constraining budgets.
To some extent, our ability to reform the regulatory process is not
wholly within our control. Regulations are often mandated by statutes,
most of which attack a single problem without recognition that other
problems, possibly more important problems, may be implicated by the
proposed solution. Many statutes also create lengthy, often highly
detailed regulatory requirements, leaving agencies with little
discretion to establish reasonable tradeoffs between requirements, and
in some cases driving agencies to scramble in response to the statutory
(or, if they miss it, the judicially imposed) deadline of the day.
Nevertheless, we believe that we have made a very good start in
implementing Executive Order No. 12866 during its first six months in
operation, with many measurable improvements. The OMB Director and OIRA
Administrator issued guidance to the heads of agencies regarding
implementation of the Order on October 12, 1993, less than two weeks
after the Order was signed. Since then, as detailed below, both OIRA
and the agencies have been energetic in implementing the Order.
We must point out, however, that the start-up time for various
provisions of the Order has taken longer (and in some cases a lot
longer) than we anticipated. Many agencies have had to establish new
oversight mechanisms to enable them to implement provisions in the
Order. For example, the listing of significant and non-significant
rules has proven particularly troublesome for some decentralized
departments, both in terms of the internal decision-making to determine
the ``significance'' of particular rules, and in terms of clearing
those determinations with sister agencies or the Office of the
Secretary (or its equivalent).
In addition, several provisions of the Order establish processes
that will take time to implement or simply have not been used yet. The
regulatory planning process set forth in Section 4 of the Order is on
schedule, but only just now beginning. The Vice President convened the
Agencies' Policy Meeting (Section 4(a)) on April 5, 1994, and guidance
to the agencies on implementation of the Regulatory Plan (Section 4(c))
was issued by the OIRA Administrator immediately after the meeting.
Draft Regulatory Plans are not due to OIRA until June 1st, and the
first Plan will not be published until October 1994, when it will
appear with the semi-annual Regulatory Agenda.
Similarly, the review of existing regulations established by
Section 5 contemplated that agencies would submit programs under which
they would periodically review their existing significant regulations
by December 31, 1993. Several agencies, including DOT, HHS, DOE, and
DOI, included as part of their plans public notices soliciting
suggestions for regulations to be reviewed. Other approaches to
reviewing existing regulations have been discussed within the
Regulatory Working Group, and next steps are being developed.
Finally, the provision of the Order that has not yet been
implemented because it has not been used is Section 7, Resolution of
Conflicts. To date, there have been no disagreements regarding
implementation of the Order that have been raised to the President or
Vice President for resolution.
To a large extent, the first three months of the Order, October
through December 1993 were almost exclusively devoted to start-up, by
both OIRA and the agencies. During January through March 1994, the
changes created by the Order began to emerge, and now some are clearly
visible and measurable. Start-up still goes on, however, and, as will
be discussed below, it may simply be too early to tell whether the
Order is working as intended.
Cooperation and Coordination
There are a number of ways to analyze and measure the
implementation of Executive Order No. 12866. Some of the most important
changes that have been made, which nourish the spirit of the Order as
much as carrying out its letter, are intangible and difficult to
quantify. One of these is the vastly improved relationship that has
developed between OIRA and the agencies.
While remnants of the mistrust and hostility that often
characterized relationships between the career staffs over much of the
past decade still exist, for the most part this has been replaced with
a spirit of cooperation. Rule writers and rule reviewers are learning
to work together as partners rather than as adversaries. Particularly
good working relationships have evolved between OIRA and DOT, DOI, and
Education. Substantial changes are evident with DOL and EPA. In all
cases, working relationships have improved.
Differences between OMB and the agencies, including significant
disagreement on issues, continue as one would expect and as is
contemplated by the Order. But these differences, which are largely the
product of different perspectives, are functioning for the most part as
a constructive, professional tension that leads to improved
regulations.
The change toward a spirit of cooperation and teamwork has occurred
largely because it has been fostered by strong leadership within the
Administration, including that of the President and Vice President
themselves, as well as by agency heads and managers at OMB. The
Administrator of OIRA and her staff have visited many of the agencies
to meet with the senior regulatory officials and entertain comments or
answer questions about the Executive Order. More work needs to be done,
however, so the message reaches throughout the agencies. In the end,
perhaps the best antidote for any residual hostility will be several
working experiences where the career staffs work together through a
problem to produce a product that all agree is better for the effort.
Other serious efforts to improve communications, cooperation, and
coordination have now been institutionalized.
As required by the Executive Order, each agency has designated a
high level Regulatory Policy Officer (RPO) to represent directly the
agency head in efforts to implement the Order and improve the
regulatory process. (Section 6(a)(2).) Although departments have
selected different positions to perform this role, many have designated
the general counsel as the RPO. This has ensured high level agency
attention to the regulatory process and efforts to reform it.
One of the primary forums for the RPOs to work together to improve
the regulatory process is the Regulatory Working Group (RWG). The RWG
has met three times, in November, January, and March. These meetings
have been well attended by the White House advisors and the RPOs and
have served as a convenient forum for discussion of issues related to
the implementation of the Order in an organized and collegial manner.
The meetings have allowed agencies to share techniques and solutions to
common problems, and have allowed White House and agency officials to
exchange views as a group on a regular basis.
The RWG has created four sub-groups to consider specific cross-
cutting issues that affect all or many regulatory agencies: these
include benefit-cost analysis, risk assessment, streamlining the
regulatory system, and use of information technology to improve
rulemaking. The sub-groups are inclusive and any agency that is
interested has been invited to designate staff to participate. These
sub-groups have discussed informal work plans and several are in the
process of developing materials for consideration by the RWG.
An additional effort to improve working relationships between
agencies and OIRA is the Regulatory Training and Exchange Program
instituted by OIRA. Agencies have been encouraged to designate career
staff who would come to OIRA on a training detail to learn how
regulatory review is conducted and to work on RWG matters. The purpose
of the program is to provide expertise among the agency career staff in
how regulatory review is conducted so that it can be incorporated into
the working practices of the agency, as the Executive Order envisions.
This program is still in its start-up phase, but OIRA has hosted two
trainees, from USDA and DOT. Other exchange program candidates are
being sought, and are expected to undergo this training during the
summer and fall.
Openness: Public Involvement and Disclosure
Executive Order No. 12866 places special emphasis on increased
openness in the rulemaking process, particularly increased public
involvement earlier in the regulatory process. Agencies are instructed
to ``provide the public with meaningful participation in the regulatory
process * * * which in most cases should include a comment period of
not less than 60 days.'' In addition, agencies are to ``explore, and
where appropriate, use consensual mechanisms for developing
regulations, including negotiated rulemaking.'' (Section 6(a)(1).)
Agencies are also encouraged, prior to issuing notices of proposed
rulemaking, to seek the involvement of those affected by it, especially
State, local, and tribal officials.
It is difficult to know how much advance consultation is taking
place. However, with all but a few well justified exceptions, agencies
are allowing 60 days for public comment. Regarding regulatory
negotiation, on the same day that the President signed the Executive
Order, he also signed a memorandum to agency heads further encouraging
the use of consensual mechanisms and directing each agency, by December
31, 1993, to identify to OIRA at least one candidate for a regulatory
negotiation during the upcoming year, or explain why the use of such a
process would not be feasible. Agencies provided these candidates to
OIRA on time, or very shortly after the deadline, and many agencies are
currently undertaking regulatory negotiations. To assist with the
learning process, OIRA joined with the Administrative Conference of the
U.S. (ACUS) to sponsor a program for agency officials, which was held
on November 29, 1993, on how to do regulatory negotiation, using
expertise and materials that ACUS staff have assembled over the past
decade.
As noted above, OIRA has its own responsibilities to meet with
various affected entities. OIRA has held two conferences with
representatives of State, local, and tribal governments one in December
1993, the second in March 1994. The first conference, chaired by the
OIRA Administrator and attended by about 100 persons, consisted of
three panel discussions: an overview of the regulatory partnership;
regulatory burdens and how they may be reduced; and involving all
affected entities in regulatory development. The panels and audience
consisted of representatives from State, county, town, and tribal
governments; academics; association representatives, for example from
the National Association of Counties, the National Governors'
Association, the National Association of Towns and Townships, the
National Association of American Indians, and the Advisory Commission
on Intergovernmental Relations; and agency intergovernmental affairs
office representatives.
The second conference, also chaired by the OIRA Administrator, was
a working session devoted to discussion of consultations between the
Federal government and State, local, and tribal officials regarding
unfunded nonstatutory mandates. This session brought together at one
table general counsels from several major regulatory agencies and
various State, local, and tribal governmental officials to discuss how
to improve the consultative process called for in Executive Order No.
12875, ``Enhancing the Intergovernmental Partnership''.
These conferences are the beginning of a significant and continuing
effort by this Administration to ensure that more effective working
relationships among the Federal, State, local, and tribal governments
are institutionalized. A third conference is tentatively scheduled for
early June. We have asked representatives of the major State, local,
and tribal associations for suggested topics or formats for this and
other conferences to be scheduled on a regular basis.
OIRA has also taken steps to improve the participation of the small
business community in the rulemaking process. OIRA joined the Small
Business Administration (SBA) to sponsor a Small Business Forum on
Regulatory Reform in March 1994 to discuss how the regulatory process
can better address the special needs of small businesses. The Forum,
chaired by the OIRA Administrator and the Administrator of the SBA,
brought together high level officials from regulatory agencies that
significantly affect small businesses--EPA, DOT, IRS, DOL, DOJ, and
FDA--to listen to small business owners discuss their concerns
regarding Federal regulations. This Forum was followed by work session
meetings focussed on five industry sectors--chemical and metals; food
processing; transportation and trucking; restaurants; and
environmental, recycling, and waste disposal--that have been attended
by both relevant agency officials and small business representatives. A
second conference, to discuss the results of these work sessions, will
be scheduled later this summer.
While the regulatory review process conducted by OIRA cannot
displace the agencies' responsibilities to seek and accommodate public
input in rulemaking, OIRA is charged with conducting its work so as to
``ensure greater openness, accessibility, and accountability in the
regulatory review process.'' (Section 6(b)(4).) On July 1, 1993, as one
of her first actions, the OIRA Administrator began making available a
daily list of draft agency regulations under review at OIRA. This was
done in order to remove the stigma of secrecy that had previously
characterized regulatory review, and to make the review process more
transparent. Now, the fact that a rule is under review at OIRA, or
``pending,'' is public information available to anyone who seeks it.
The completion of review is also made public. On the pending list,
the date of completion of review for any regulation pending that month
is indicated. Lists and statistics for each month are compiled and made
available by the tenth day of the following month. This information
includes a list of all rules on which review was concluded the previous
month, showing agency, title, an identification number, date received,
date review completed, type of rule (e.g., proposal, final, etc.), and
OIRA action taken (e.g. found consistent with the Order without change,
with change; withdrawn; returned to agency; etc.). In addition, there
is a list of all economically significant rules reviewed. Finally, this
monthly compilation includes aggregate statistics on reviews for the
month and for the calendar year, including the number of reviews by
agency, OIRA action taken, and average review time.
As provided for in the Executive Order, meetings and telephone
calls with persons outside the Executive Branch on regulations under
review are now logged, and these logs are made publicly available.
Entries for meetings include the date, the attendees, and the subject
matter discussed. An agency representative is invited and almost always
attends such meetings. Any written materials provided by the outside
person(s) are made publicly available, and, if an agency representative
is not in attendance, are provided to the agency.
The OIRA meetings log contains 36 entries, for meetings that
occurred between July 19, 1993, and March 31, 1994. In all but two, the
OIRA Administrator chaired the meetings; in these two, other officials
in the Executive Office of the President acted as chair. An agency
representative attended all but four meetings. Usually the meetings
were with persons outside the Federal Government, but in several
instances the attendees included Congressional representatives. Most of
the meetings were devoted to EPA regulations, 30 of the 36. The other
meetings concerned a DOC/NOAA rule and several FDA and USDA food safety
regulatory actions.
Any material sent to OIRA on rules being reviewed from anyone
outside the Executive Branch is kept in a public file. In addition, if
the material is not merely a copy of documents already sent to the
agency, a copy is forwarded to the agency. Finally, documents exchanged
between OIRA and the agency during the review, including the draft rule
submitted for review and changed pages, are made available to anyone
requesting them after the rule has been issued (or, if it is not
issued, after the agency has announced its decision not to issue the
rule).
These various disclosure procedures are working well and have
helped restore the integrity of the regulatory review process.
Communications with outsiders are controlled and disclosed, but
apparently this has not had the result of discouraging such
communications. Also, the results of the review process itself are
disclosed, making OIRA clearly accountable for its actions.
Regulatory Review Statistics
The statistics maintained by OIRA of the regulatory review process
provide another means of measuring the implementation of the Executive
Order. Indeed, these statistics respond directly to most of the
questions raised in the President's September 30, 1993, memorandum to
the OIRA Administrator. In this memorandum, he directed the
Administrator:
To monitor your review activities over the next six months and, at
the end of this period, to prepare a report on your activities. This
report shall include a list of the regulatory actions reviewed by OIRA,
specifying the issuing agency; the nature of the regulatory action * *
*; whether the agency or OIRA identified the reviewed regulatory action
as ``significant,'' within the meaning of the order; and the time
dedicated to the review, including whether there were any extensions of
the time periods set forth in the order, and if so, the reason for such
extensions.
OIRA received and reviewed 578 regulatory actions from October 1,
1993, through March 31, 1994. Appendix A lists these rules, indicating
the originating department and/or agency, the review time in days, the
nature of the regulatory action (e.g., Proposed Rule, Final Rule,
etc.), the rules designated significant by the agency and those
designated by OIRA, the rules for which review was extended, and the
title of the rule. Table 1 summarizes information about these rules by
agency, including the number of rules and average review time for rules
in the ``economically significant'' and ``other than economically
significant'' categories. It also indicates the OIRA action taken by
agency.\1\
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\1\On October 1, 1993, OIRA also had 175 rules under review that
had been submitted under Executive Order 12291. Table 2 summarizes
the data on these rules. On average, these rules were reviewed in 76
days. Review was concluded on the last of these pre-Executive Order
No. 12866 rules on 1/13/94.
Also, on March 31st, 68 rules that had been submitted between
October 1st and March 31st were still under review. Table 3
summarizes the pertinent data on these rules. 45 rules (or 66%), had
been under review for under 30 days; 66 (or 97%, had been under
review less than 90 days. Three (or 3%), had been under review over
90 days, and had been extended.
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Table 1 indicates that of the 578 rules reviewed, 63 (11%) were
economically significant (or ``major,'' a term from Executive Order
12291 that continued to be used until about the beginning of January).
The average review time for all the rules was 26 days, well below the
90-day limit established by Executive Order No. 12866. The 10 agencies
with the highest volume of submissions were, in order: HHS (126), USDA
(94), EPA (52), DOT (44), DOC (42), DOI (34), Education (25), HUD (25),
VA (21), and OPM (17). For about 60% of the submissions, review was
completed without change to the rule. In 30% of the cases, review was
completed with change. 4.5% of the rules were withdrawn by the agency;
2% were returned because they were sent improperly; in about 3% of the
cases, mostly EPA rules, review was not concluded but was ended because
of a statutory or judicial deadline.
These statistics are affected by the fact (discussed later) that
during the start-up period, during which many non-significant rules
continued to be sent to OIRA for review. Once the process is fully
implemented and agencies submit only significant rules to OIRA for
review, the total number of rules is likely to decrease, as will the
percentage of rules for which review is concluded without change. At
the same time, as only the more important rules become the focus of
OIRA's review, average review time is likely to increase. We will be
watching these indicators closely during the coming year.
Of the 578 individual rules listed in Appendix A, three rules were
extended beyond the 90-day limit, all at the request of the agency to
permit interagency coordination to be completed. Regarding the
designation of rules as ``significant,'' the list indicates which rules
were designated significant by the agency, and which were designated
significant by OMB. Of the 578 rules reviewed, a total of 238 or 41%
were designated significant in accordance with Section 6(a)(3)(A). Of
those designated significant, 166 or 70% were so designated by the
agency, while 72 or 30% were designated significant by OMB.
Listing Process
As Appendix A indicates, many of the rules reviewed were not
designated either ``significant'' or ``not significant.'' This is
because virtually all agencies needed the first two to three months of
the Order for start-up activities, and did not have in place their
listing processes until the second half of the six-month period under
review. The process was smoother for agencies that either already had
or created offices to perform the central management function necessary
for the listing process to succeed. DOT, for example, has had in place
for many years a central regulatory review office in its Office of the
General Counsel, whose function is to coordinate and review the DOT
sub-agencies' rulemaking on behalf of the Secretary. In other
instances, offices have been established to perform these functions by
Clinton appointees. The Secretary of the Department of the Interior,
for example, created an Office of Regulatory Affairs whose director
reports to the Secretary and Chief of Staff and whose job it is to
organize, monitor, and manage the Department's rulemaking activities.
The Department of Education also addressed the need for centralized
responsibility, assigning this function to its General Counsel, who
brought on board a Deputy specifically charged with regulatory
responsibilities. These agencies have done an excellent job instituting
the listing procedures.
In other instances, however, it has proven difficult to create a
centralized, departmental function capable of: collecting information
from agencies within the department on the status of regulations;
coordinating a departmental decision on significance; and managing the
submission of the result to OMB and the discussion with OMB to reach
agreement on the proper designation. Even now, after six months of
experience, some agencies have still been unable to submit a single
list to OIRA designating rules as significant or non-significant. These
agencies generally continue to submit all rules to OMB for review,
telling us that it is easier and quicker for them to do so than to go
through the process of designating rules as significant or non-
significant even though they know that the majority of their rules are
non-significant and would therefore not need to be reviewed.
These agencies are examples where internal agency coordination
needs to be improved. OIRA does not want to review non-significant
rules; more importantly, it is only when agencies are able to designate
rules as non-significant well in advance that the benefits of this
system in streamlining the regulatory processes will be realized. In
the meantime, OIRA is working with agencies to process all the rules
that are submitted, accommodating as much as possible the difficulties
agencies are experiencing starting up their systems.
OIRA initially envisioned that agencies would send lists
designating rules significant or non-significant every 30 or 60 days.
It is now clear that for some agencies, lists may be needed more often;
for others, less often; and for some, at irregular intervals. The
process should remain informal and flexible to respond to differences
among the agencies and to changing circumstances within some agencies.
For example, DOC's National Marine Fisheries Service must sometimes
modify Federal fishery management plans on only several weeks, and
indeed sometimes on several days, notice. Speed in the listing process
is therefore critical. Also, in some instances, agencies have preferred
to submit informal drafts of lists to OMB so that discussions can take
place and additional information be exchanged before the lists are
finalized. We do not want to discourage any opportunities for early
exchanges of information, and therefore it has worked with the agencies
to sort through the various informal lists they are able to provide.
In total, OIRA has received lists designating 1,624 rules as
significant or non-significant. (These rules would not all be listed in
Appendix A because, if non-significant, they would not have been
submitted for review, and if significant, they may or may not have been
ready to be submitted for review within the six-month period covered by
this report.) Of the 1,624 regulatory actions, agencies designated, and
OIRA agreed, that 1047, or 64% were non-significant; 316, or 19% were
designated by the agency as, and OIRA agreed they were, significant;
and the remaining 261, or 16%, were designated significant by OIRA.
Stated another way, the agency and OIRA agreed with the initial
designation for 83% of the cases; in only 16% was there a difference of
view.
These aggregate data mask the fact that for most agencies the
number of instances where there is an initial difference of opinion
between the agency and OIRA as to significance decreases as the agency
gains experience with the process. In some cases it is simply a
function of the agencies not knowing how much information to provide to
enable OIRA to agree with the agency designation. In all cases,
differences have diminished with time as the agencies and OMB discuss
the reasons for the different perspectives and develop an understanding
and agreement on the definition of significance.
OIRA's experience implementing this listing provision of the
Executive Order has provided some valuable lessons. In some cases, the
difficulties described above are symptomatic of agency processes that
are broken and need to be fixed. But it is also true that the Executive
Branch is characterized by great variety in agency structures,
cultures, statutory mandates, and missions. As a consequence, the
Executive Order must be flexible enough to accommodate such variety and
not seek to impose rigid constraints that may be counterproductive.
We believe that so far, the listing system that has been
implemented contains both discipline and flexibility. Both OIRA staff
and agency staff have worked to accommodate each other's needs. The
listing process is serving to focus OIRA efforts on significant rules,
promote streamlining in the rulemaking process, and establish
accountability in agencies, without creating unnecessary and burdensome
additional structures.
Selectivity
One of the purposes of the Executive Order was to reduce the number
of rules submitted to OIRA for review, thereby streamlining the
rulemaking process for the agencies and allowing OIRA to focus its
limited resources on the more important rules. The start-up issues
discussed above have clouded to some extent a clear measure of the
changes that have occurred in regulatory review since the Executive
Order was signed. Nevertheless, the intended reduction in the number of
rules reviewed under the Order is clearly demonstrated in the
statistics.
Part of the reduction is attributable to the implementation of
OIRA's authority to exempt both specific agencies and categories of
regulations from centralized review. In guidance issued to agencies on
October 12, 1993, the OIRA Administrator exempted 31 smaller agencies
and 35 categories of regulation so that OIRA review could be more
usefully focussed. (Lists of these exemptions are included with the
October 12, 1993, guidance from the OMB Director and OIRA Administrator
on implementation of the Order, attached. These lists have been updated
to exempt four additional agencies and approximately 30 additional
categories of regulations.)
Overall, the 578 rules received and reviewed by OIRA for the six-
month period is approximately half what it was in previous years.
Figure A indicates the clear decline in the number of rules OIRA
received for review, compared to the average monthly receipts for the
preceding nine months of 1993 (which is comparable to that of previous
years). The number of rules received for OIRA review decreased from an
average of about 180 per month from January through September 1993 (the
monthly average for the years 1989 through 1992 was 192), to well under
100 for January through March 1994. (Monthly figures will vary
depending on regulatory activity at agencies. Figure A shows a steady
decline from October 1993 through February 1994 and an increase for
March. April's figures are between those of February and March.)
The number of rules under review at any given time has also shown a
significant decline. On July 1, 1993, when OIRA began its disclosure of
rules under review, 254 regulations were listed as pending. On
September 30, when the President signed Executive Order No. 12866, 175
regulatory actions were pending review at OIRA. On March 31, 1993, 68
regulatory actions were pending. All these figures re-emphasize the
obvious, that OIRA is reviewing far fewer rules than in the past,
exactly as envisioned by the Executive Order.
Time Limits
The Executive Order establishes strict time limits on OIRA review,
in most cases 90 days. The purpose of such limits is to balance the
need for adequate time to conduct review with the need to streamline
the regulatory process and prevent unwarranted delay. OIRA has made a
concerted effort to meet not only the letter of this requirement, but
its spirit as well, and this goal of the Order is clearly being
accomplished.
As can be seen from both Table I and Appendix A, the average review
times for the rules submitted during the first six months of the Order
is only 26 days. This is a reduction in the average annual review time
for the past five years: 1989--29 days; 1990--28 days; 1991--29 days;
1992--39 days; 1993--44 days. (The average times were particularly high
during 1992 and 1993 because of, respectively, the Regulatory
Moratorium instituted by President Bush and the effect of the
transition to the Clinton Administration, when many agencies were
without political appointees for a significant portion of 1993.)
Notwithstanding OIRA's commitment to speed up the review process,
it is likely that the average review time will go up in the future. As
non-significant rules, which in the past had generally been reviewed
quickly and thus helped keep average review times down, are removed
from the review process, and only significant rules submitted and
reviewed by OIRA, the time necessary to complete such review may
increase. To some extent, however, average review time is no longer as
useful a measure as it was when there were no meaningful limits on
review. Since all rules, except the small percentage specifically
extended, must be reviewed within 90 days, it is compliance with that
deadline that is most important and is therefore discussed in detail
below. Nevertheless, average review time will continue to be a measure
carefully watched by OIRA in the coming year.
A quick look at Appendix A reveals that most reviews were completed
in under 30 days. This may be as a result of OIRA's still receiving
non-significant rules, or its receiving some rules on the eve of
statutory or judicial deadlines, or because OIRA and agency staffs have
consulted earlier in the process and few issues remain by the time for
formal submission. Of the 578, 408 or 71% were reviewed in under 30
days. 512 or 89% were reviewed in under 60 days. Review took greater
than 60 days for only 66 or 11% of the 578. The OIRA Administrator has
instituted an internal management system that flags for her attention
all rules still under review at their 60th day. This has ensured that
submissions do not languish on staff desks, but are raised to the
appropriate level well before the 90th day.
Appendix A and Table I also show how review times compare across
different agencies. For some agencies, the review time is skewed
because of lengthy reviews of only a small number of rules. For
example, the average time for review for OMB of 108 days was for a
single rule, which was extended. NSF's average of 84 days was for three
rules; FFIEC's average of 70 days was for a single rule. For the higher
volume regulatory agencies, review time averages ranged from 15 days
for DOT's 44 rules to 40 days for VA's 21 rules. Others fall in
between: HHS--27 days (for 126 rules); USDA--19 days (for 94 rules);
EPA--35 days (for 52 rules); DOC--16 days (for 42 rules); DOI--23 days
(for 34 rules); Ed--29 days (for 25 rules); HUD--33 days (for 25
rules); OPM--19 days (for 17 rules).
The Order permits the time for review to be extended at the request
of the agency head, or by the Director of OMB for 30 days. Appendix A
indicates that of the 578 rules received and reviewed between October
and March, only three were extended. These were: DOI's Wild Bird
Conservation Act rule, which was under review for 107 days; OMB's Cost
Accounting Standards Board Regulations, under review for 108 days; and
DOD's Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS) rule, under review for 99 days. Each of these rules was
extended at the request of the originating agency. Wild Birds was
extended to permit the completion of interagency coordination between
DOI, DOJ, State and USTR. Cost Accounting Standards was extended to
allow OIRA staff to meet with the Cost Accounting Standards Board at
the Board's request. DOD's CHAMPUS rule was extended to ensure
coordination of the rule with the regulatory programs of other health
care agencies. In all these cases, extension was used to permit
completion of reviews that were in fact concluded in less than three
weeks after the extension was requested.
As of March 31st, two additional rules had been extended and were
still under review: USDA's Revisions of Farmland Protection Policy Act
(received November 9, 1993), and EPA's Lender Liability for Underground
Storage Tanks (received December 20, 1993). Also, nine rules that were
submitted before the Executive Order was signed, but for which review
was concluded after October 1, 1993, were extended after they had been
under review for 90 days in an effort to comply with the spirit of the
new Order.2
---------------------------------------------------------------------------
\2\These rules were: USDA's Export Bonus Program (review
concluded 12/7/93); DOD's Prompt Payment Act (review concluded 12/
16/93); DOC's Natural Resource Damage Assessment rule (review
concluded 12/23/93); HHS's Payment of Preadmission Service, Medicare
Program (review concluded 12/23/93); HHS's Revisions to Freedom of
Information Regulations, Medicare and Medicaid (withdrawn 12/09/93);
HHS's Medicare Coverage and Payment of Clinical Psychologists
(review concluded 12/15/93); HHS's Medicare Secondary Payment
(review concluded 1/13/94); DOE's Amendment to Workplace Substance
Abuse Programs (review concluded 12/3/93); and DOE's Workplace
Substance Abuse Programs at DOE Sites (review concluded 12/3/93).
---------------------------------------------------------------------------
Overall, OIRA's experience during the first six months with the
review time limits show them to be working well.
IV. Issues for Further Consideration
In his September 30, 1993, memorandum, the President requested that
the Administrator of OIRA ``identify any provisions of the order that,
based on your experience or on comments from interested persons,
warrant reconsideration . . . .'' There are a number of provisions that
qualify, although it is too early to say whether the problems lie with
the terms of the Executive Order, with its implementation, or some
combination of the two. As discussed above, in many cases start-up
activities implementing certain provisions of the Order are still in
progress. The process of listing rules as significant or non-
significant, for example, while well underway at most agencies is
nevertheless still in its formative stages at many other agencies. As a
result, we are not now able to judge the effectiveness of this approach
in achieving the objectives of the Order.
By the same token, we do not know if agencies are giving to non-
significant regulatory actions the review and care that they deserve.
It was anticipated that, because there would be no OIRA review,
agencies themselves would have to ensure that non-significant rules, as
well as significant regulations, meet the principles of the Order. Some
agencies have told OIRA that they are fulfilling this responsibility.
OIRA has no independent basis for confirming or denying these reports.
With time, however, there should be sufficient information to enable
informed judgment on the issue. With time, OIRA should also be able to
better evaluate the effects of earlier communication between OIRA and
agency staffs and more selective review to ensure that significant
regulations adhere to the principles of the Order. And, as noted above,
additional time is needed to evaluate the planning process and the
process for review of existing regulations.
While it is premature to recommend specific revisions to the
Executive Order, we have enough experience to suggest some areas that
are likely to require further consideration.
Review Time Limits
One such issue is the 90-day review time limit (Section
6(b)(2)(B).) In general, we have found the discipline of this limit
useful and fair. Along with the disclosure procedures, the time limits
have helped remove the stigma of secrecy and delay that have
characterized regulatory review in the past. As shown in Appendix A,
only a small percentage of the rules submitted for review are extended.
There are two types of situations, however, where the balance
between adequate review and the limits on review time is problematic.
First, OIRA's experience is that interagency coordination can sometimes
be unexpectedly lengthy. In the case of the USDA Farmland Protection
rule, for example, coordination among multiple agencies, in this case
USDA, DOT, HUD, Treasury, and GSA, has required the resolution of
significant issues at the highest levels in major regulatory
departments. As a practical matter, it takes time to arrange meetings,
define and analyze issues, circulate and coordinate exchanges between
the agencies, and negotiate solutions. It has proven extremely
difficult to keep this process moving to resolution.
The second situation is where the agency and OIRA agree that
additional analysis is necessary to meet the requirements of the Order.
In some instances, where issues are highly technical--legally,
mechanically, or economically--such analysis can take months to
complete. If this is the case, the rule is technically still under
review at OIRA, although in fact no review can be conducted--either by
OIRA or the agency--until the further data and analysis are generated.
In such cases, the time limits on review serve to discourage rather
than encourage efforts to develop the most effective, minimally
burdensome regulation.
The current mechanism to deal with such circumstances is the
provision for extension of review by either the Director or the agency
head. (Section 6(b)(2)(C).) While this provision has functioned to keep
some rules under review that might otherwise have been returned to the
agency, it gives the misleading impression that OIRA is reviewing the
rule when in fact the originating agency, or an affected agency, is
engaged in further analysis or coordination or even in some cases
simply making changes that have already been agreed to in principle by
policymakers.
There is another area where the 90-day limit may not be
appropriate--namely, an economically significant regulatory action,
which may have taken several years to develop to the proposed stage and
which arrives at OIRA with several hundred pages of detailed analysis.
Even if the OIRA and agency staffs have conferred during the
developmental stages, it is very difficult to review all of the
materials presented, and particularly to consider not only what is
presented, but also what is not (which often is equally, if not more,
important), within the 90-day limit under the best of circumstances
(e.g., no intervening statutory or judicial deadlines or agency
requests for expedited consideration of high priority agency
initiatives).
At the other extreme are those instances where review is triggered
by section 3(f)(4)--that is, a rule raises novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in the Order. Here, if there has been advance
consultation as there should be, and other agencies are not affected,
OIRA may need very little, if any, time to conclude review.
By contrast, OIRA is often given a few days for review--even though
substantially more time is necessary--because there is an imminent
statutory and/or judicial deadline. Some agencies, notably EPA, but
also HHS, DOL, DOI and others, often must develop regulations under
severe time constraints set in statutes or arising from litigation
resulting from missed statutory deadlines. In such cases, the
discretion of the agency is often severely limited, both in terms of
time to conduct adequate analysis and discretion to devise flexible,
innovative, and cost-effective solutions to difficult problems. In some
of these cases, OIRA has received rules for review only days before a
deadline; in fact, in some cases, the agency managers themselves have
only a few days to deal with deadline cases.
While this is a serious problem, it may be beyond our ability to
remedy through the Executive Order. It is our view that highly
prescriptive legislation, including dictating time lines for
promulgating regulations, has contributed to a regulatory system that
is sometimes unmanageable or is driven by plaintiffs rather than by a
rational planning process that directs the government's limited
resources to the most important problems and the most cost-effective
solutions. However, the solution, if there is one, clearly invites the
Legislative Branch and extends beyond the issues covered in this
report.
A different problem, but one related to review time limits, is the
question of when the clock should start. OIRA has encouraged agencies
to consult early in the development of a regulatory action. This brings
the perspectives of both the reviewer and the agency to bear on the
rule early in the process, informing the regulatory development and
permitting early identification and resolution of any major policy
differences. Adequate front-end involvement is especially important
when statutory or judicial deadlines dictate a rapid pace in the
development of the rule. The starting of the clock with the submission
of a relatively complete formal draft does not encourage such advance
consultation. On the other hand, some have expressed concern that with
such advance consultation, the measurement of review time beginning
with the submission of a relatively formal draft does not accurately
state (indeed, may substantially understate) the time that OIRA has in
fact spent reviewing (in some sense) the regulatory action.
Definition of ``Significant''
Another area where further monitoring and additional thought is
warranted involves the term ``significant,'' which is the trigger for
determining whether or not there will be OIRA review. The definition of
``significant'' is not, apparently, self-executing, and argument over
its meaning has been at least partly responsible for the long start-up
time in implementing the listing process. In some cases, debate takes
place within the agency as to whether or not a rule is significant. In
some of those same cases, and in others, the debate takes place between
OMB and the agency, typically with OMB thinking that a regulatory
action which the agency initially thinks is non-significant is, in
OMB's view, significant.
To some extent these debates are part of the initial adjustment
period as the Order is implemented; some reflect residual mistrust from
the previous regulatory review system; and, some reflect the natural
tension between the agency responsible for the regulation and a
reviewing entity. But some may reflect the lack of precision
(deliberate at the time of drafting) in the definition set forth in the
Executive Order.
The uncertainty centers in particular around two of the four
criteria that define ``significant regulatory action''--the first and
the fourth. The first criterion defines what has become known as an
``economically significant'' rule. (Section 3(f)(1).) Although the
initial clause of the criterion--a $100 million annual effect on the
economy--is clear, the remainder is not as easily understood. What does
it mean to ``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''? Similarly, looking at the fourth criterion, what are
``novel legal or policy issues arising out of legal mandates, the
President's priorities, or the principles set forth in this Executive
Order''? Some have read it very narrowly; others have read it to
include everything. While it is too early to suggest specific changes
to the definition, we will be monitoring it to see if further
clarification is required.
Identification of Changes Made During Review
Another area that may warrant further consideration are sections
6(a)(3)(E) (ii) and (iii), which require the agency to identify the
substantive changes made in a regulatory action during OIRA review, and
to identify those changes made at the suggestion or recommendation of
OIRA. These provisions are intended to make the results of OIRA review
transparent to the public. Some agencies have told us they are
identifying such changes, and while we have not conducted a survey, we
have no reason to think that all are not complying with the terms of
the Order.
From our perspective, however, changes that result from regulatory
review are the product of collegial discussions, involving not only
OIRA and the agency, but frequently other White House Offices--such as
OVP, DPC, NEC, CEA, OEP, OSTP--and other agencies as well (including at
times, other sister agencies in the same department as the originating
agency). After an extended process, it is not clear that identifying
changes made at the suggestion of OIRA is accurate (if the only choice
is OIRA suggestions or agency proposals) or meaningful (if OIRA
suggestions are only those suggestions originating at OIRA rather than
at another agency). We expect to explore this subject with the agencies
and see if any further guidance is necessary or desirable.
Intergovernmental Relations
There are two areas that are touched on in the Executive Order
where perhaps more should be done. The first involves Executive Order
No. 12875. It provides, among other things, that Federal agencies that
impose nonstatutory, unfunded mandates on State, local, or tribal
government either: (1) assure that funds necessary to pay the costs of
compliance are provided by the Federal Government, or (2) describe the
extent of the agency's prior consultations with affected units of
government, the nature of their concerns, any written submissions from
them, and the agency's position supporting the need to issue the
regulation containing the mandate. The purpose of this provision is, in
part, to improve communications between the agencies and State, local,
and tribal officials, particularly those responsible for funding the
programs, and to establish a meaningful working relationship between
them where none may now exist. This is very much a part of the
philosophy of Executive Order No. 12866, and OMB has provided guidance
to the agencies that regulatory actions that contain an unfunded
mandate should be submitted to OIRA for review under Executive Order
No. 12866. Further clarification of OIRA's role in this regard could be
considered.
Small Business Concerns
The second area involves the burdens of regulation on small
businesses. Concerns voiced by the small business community have led to
a variety of proposals to increase the focus of regulators on the
unique problems of small businesses, and in particular the agencies'
compliance (or lack of compliance) with the Regulatory Flexibility Act.
5 U.S.C. 601. One suggestion is to have OIRA and the Small Business
Administration (SBA) coordinate review of agency rules to assure that
the agencies prepare and use high quality regulatory flexibility
analyses when it would be appropriate to do so. SBA could notify OIRA
of any concerns it has with an agency's regulatory flexibility analysis
within a certain time after publication (e.g., 20 days) of a notice of
proposed rulemaking, and OIRA could be authorized to direct the agency
to issue a supplemental notice raising regulatory flexibility analysis
concerns or announcing the intent to prepare a regulatory flexibility
analysis by a date certain. Other forms of collaboration are also
possible to encourage better interagency coordination and compliance
with existing law.
Post Hoc Evaluation of Rules
Finally, regulations are developed based on estimates of behavior
and events in the future. Even the best of such predictions can turn
out to be wrong. After a regulation has been issued, however, there is
little, if any, effort made to review estimates and analyses to see
what was right and what was wrong, both to change the current rule to
make it more effective and to learn how to do better analyses for
future rules. Agencies with increasingly limited staffs and new
mandates to meet have little incentive for such exercises, although
they could be critical to an efficient and effective rulemaking
program.
It is possible that the appropriate incentives could be provided by
requiring, at least in selected cases, that agencies manage their
regulations toward results. That is, a rule could be written with
specific goals, initial baselines against which to measure achievement
of these goals, and an evaluation plan, including comment by affected
parties with an expectation that based on such input and analysis the
rule would be modified to improve its effectiveness and efficiency. If
so, review of an existing regulation would become part of its
development rather than an after-the-fact exercise.
Conclusion
The importance of regulations in our society makes it imperative
that the process by which they are developed and reviewed be
characterized by integrity and accountability. Regrettably, this
Administration did not inherit such a process from the prior
Administration. On the contrary, that process was severely criticized
for delay, uncertainty, favoritism, and secrecy. Significant
improvements have been made with the implementation of Executive Order
No. 12866. While it is still too early to judge the effects of the new
Order, the regulatory process has been made more principled,
professional, and productive. The Executive Office of the President is
working in concert with the agencies and listening to the public in
order to solve problems, not pretending they do not exist.
The American people deserve a regulatory system that improves their
health, safety, and economic well-being without imposing unacceptable
or unreasonable costs on society. The regulatory system being
established by Executive Order No. 12866 demands quality, efficiency,
and accountability, and is well on its way to improving the functioning
of government, the economy and, most importantly, the quality of life
for the American people.
List of Attachments
1. Executive Order No. 12866 (This Executive Order does not appear in
this document. See 58 FR 51735; October 4, 1993).
2. Presidential Memorandum for the Administrator of OIRA dated
September 30, 1993. (This Presidential memorandum does not appear in
this document. Copies are available from the EOP Publications Office at
202-395-7332.)
3. Guidance from the Administrator of OIRA for Implementing E.O. 12866.
4. Appendix A--Executive Order 12866 Reviews October 1, 1993-March 31,
1994; Received Since October 1, 1993
5. Table 1--Executive Order Reviews October 1, 1993-March 31, 1994;
Received After October 1, 1993
6. Table 2--Executive Order Reviews October 1, 1993-March 31, 1994;
Received Prior to October 1, 1993
7. Table 3--Executive Order Reviews Pending on April 1, 1994
8. Figure A--Executive Order 12866 Receipts From Agencies
October 12, 1993.
Memorandum for Heads of Executive Departments and Agencies, and
Independent Regulatory Agencies
From: Sally Katzen, Administrator, Office of Information and Regulatory
Affairs
Subject: Guidance for Implementing E.O. 12866
The President issued Executive Order No. 12866, ``Regulatory
Planning and Review,'' on September 30, 1993 (58 Fed. Reg. 51735
(October 4, 1993)).\1\ It calls upon Federal agencies and the Office of
Information and Regulatory Affairs (OIRA) to carry out specific actions
designed to streamline and make more efficient the regulatory process.
This memorandum provides guidance on a number of the provisions of the
new Order. Undoubtedly, with experience, additional questions will be
raised, and we will attempt to respond promptly as they arise.
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\1\This Order replaces E.O. 12291 and E.O. 12498.
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1. Coverage
The Order as a whole applies to all Federal agencies, with the
exception of the independent regulatory agencies (Sec. 3(b)). The
independent regulatory agencies are included in provisions concerning
the ``Unified Regulatory Agenda'' (Sec. 4(b)) and ``The Regulatory
Plan'' (Sec. 4(c)). However, while the President's ``Statement of
Regulatory Philosophy and Principles'' (Sec. 1) applies by its terms
only to those agencies that are not independent, the independent
regulatory agencies are requested on a voluntary basis to adhere to the
provisions that may be pertinent to their activities.
In addition, the Order states that the OIRA Administrator may
exempt agencies otherwise covered by the Order. Appendix A is a first
cut of those agencies that have few, if any, significant rulemaking
proceedings each year; effective immediately, these agencies are exempt
from the scope of the Order.\2\ Like the independent agencies, those
agencies listed in Appendix A are requested to adhere voluntarily to
the relevant provisions of the Order, particularly the President's
``Statement of Regulatory Philosophy and Principles'' (Sec. 1).
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\2\To assure that the purposes of the Executive Order are
carried out, we may ask these agencies to review particular
significant regulatory actions of which we become aware. These
Agencies should advise OIRA if they believe that a particular rule
warrants centralized review.
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2. Designation of Regulatory Policy Officer
The Order directs each agency head to designate a Regulatory Policy
Officer ``who shall report to the agency head'' (Sec. 6(a)(2)). This
Regulatory Policy Officer is to be involved at each stage of the
regulatory process to foster the development of effective, innovative,
and least burdensome regulations. Because the Regulatory Policy Officer
will in most circumstances serve as the agency representative to the
Regulatory Working Group (see below), please provide us with the name,
mailing address, and telephone and fax numbers of your designee as soon
as possible.
3. Regulatory Working Group
The Order directs the OIRA Administrator to convene a Regulatory
Working Group consisting, in part, of the representatives of the heads
of each agency having significant domestic regulatory responsibility
(Sec. 4(d)).
Again, we have made a first cut of a list of those agencies which
should be members of the Regulatory Working Group, which is attached as
Appendix B. Some of the Departments that have separate regulatory
components may qualify for multiple representatives. Please notify us
if you believe that your Department should have more than one
representative. In suggesting additional representatives, please
identify these persons and provide us with their mailing addresses, and
telephone and fax numbers.
The Administrator is to convene the first meeting of the Regulatory
Working Group within 30 days. It is therefore essential that we have
your response as soon as possible.
4. Regulatory Planning Mechanism
The Order emphasizes planning as a way of identifying significant
issues early in the process so that whatever coordination or
collaboration is appropriate can be achieved at the beginning of the
regulatory development process rather than at the end (Sec. 4).
There are two specific planning documents discussed in the Order.
The first, the semiannual Unified Regulatory Agenda (Sec. 4(b)), is on
schedule and will be published before the end of October.
Traditionally, all agencies participate, describing briefly the
regulations under development. The Order does not call for any change
in either the scope or format of this document.
The second planning document is the annual Regulatory Plan (Sec.
4(c)), which is to be published in October as part of the Unified
Regulatory Agenda. The Regulatory Plan seeks to capture the most
important significant regulations. In advance of agencies drafting
their Regulatory Plans, the Vice President will meet with agency heads
to seek a common understanding of regulatory priorities and to
coordinate regulatory efforts to be accomplished in the upcoming year
(Sec. 4(a)). The Vice President will convene the first meeting in early
1994. Following that meeting, we will provide appropriate guidance on
the scope and structure of the submissions for the 1994 Regulatory
Plan.
As you may recall, OMB had asked in OMB Bulletin No. 93-13 (May 13,
1993) that certain agencies prepare a draft 1993 Regulatory Program
under the then applicable Executive Order No. 12498. Many agencies sent
in some or all of their proposed programs. Other agencies informed us
that they wanted to wait for the confirmation of political appointees
or the issuance of the new Executive Order. While there is now
insufficient time for all of the steps necessary to prepare a formal
regulatory plan for this year, the materials we have received will be
useful in preparing for the meeting with the Vice President and our
other coordination efforts. Those agencies that have already drafted
but not submitted materials, as well as those who wish to augment what
we have already received, are encouraged to send these materials to
OIRA.
5. Review of Existing Regulations
The Order directs each agency to create a program under which it
will periodically review its existing significant regulations to
determine whether any should be modified or eliminated to make the
agency's regulatory program more effective, less burdensome, and in
greater alignment with the President's priorities and regulatory
principles (Sec. 5). Specifically, within 90 days, agencies are to
submit to the OIRA Administrator a program establishing, consistent
with the agency's resources and regulatory priorities, the procedures
for carrying out a periodic review of existing significant regulations
and identifying any legislative mandates that may merit enactment,
amendment, or rescission (Sec. 5(a)).
We are aware that past Administrations have required agencies to
undertake similar review efforts. Some of these have been so broad in
scope that necessary analytic focus has been diffused, or needed
follow-up has not occurred. This current effort should be more
productive because it focuses only on significant regulations and the
legislation that mandates them, and because we will be looking at
groups of regulations across agencies with the help of the Vice
President and the White House Regulatory Advisers, as well as the
public.
Pursuant to the Order, we are asking each agency to send to the
OIRA Administrator within 90 days a work-plan which identifies who and
which office within the agency will be responsible for assuring that
periodic reviews take place; the criteria to be used for selecting
targets of review; the kinds of public involvement, data collection,
economic and other analysis, and follow-up evaluation that are planned;
the timetables to be applied; and, to the extent then known, the
targets selected. As the program is implemented and an agency selects
specific targets for review, please identify the specific programs,
regulations, and legislation involved. To the extent they are relevant,
we will share with you the review efforts of other agencies.
6. Centralized Review of Regulations
One of the themes in the Order is greater selectivity in the
regulations reviewed by OIRA, so that we can free up our resources to
focus on the important regulatory actions and expedite the issuance of
those that are less important. Another theme is that we are to
determine early in the process which regulations are important (the
term in the Order is--``significant''). Among other things, this will
permit agencies to conduct the needed analyses for these regulations as
part of the development process, not as an after-the-fact exercise
(Sec. 6(a)(3)(B)).
The Order defines ``significant'' regulatory actions'' as those
likely to lead to a rule (1) having an annual effect on the economy of
$100 million or more or adversely and materially affecting a sector of
the economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities; (2) creating a serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impact of entitlements, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
(Sec. 3(f)).3 This definition is not wholly susceptible to
mechanical application; rather, in many instances, it will require the
exercise of judgment. We will work with the agencies to come to a
consensus on the meaning of this term in the context of the specific
programs and characteristics of each agency.
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\3\The Order is intended to cover any policy document of general
applicability and future effect, which the agency intends to have
the force and effect of law, such as guidances, funding notices,
manuals, implementation strategies, or other public announcements,
designed to implement, interpret, or prescribe law or policy or to
describe the procedure or practice requirements of an agency. Such
documents are normally published in the Federal Register, but can
also be made available to the affected public directly.
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To begin, we ask the appropriate personnel at each agency to work
with the OIRA desk officer(s) to develop an appropriate list of
rulemakings that are under development for submission to OIRA. For each
rulemaking, please use the format below:
DEPARTMENT/REGULATORY COMPONENT. Title: ([Indicate
significance4]; Upcoming Action: [Identify]5) Planned
Submission/Publication: [date]; RIN: [number6]. Statutory/Judicial
Deadline: [date, if any].
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\4\ State one of the following: ``Not Significant'',
``Significant'', or ``Economically Significant''. A designation as
``Economically Significant'' means that the regulatory action is
likely to result in the effects listed in the first subsection--
namely, i.e., ``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.'' A regulatory action that is considered ``Economically
Significant'' must ultimately be supported by the analyses set forth
in Section 6(a)(3)(C).
\5\ Indicate whether the upcoming regulatory action is a
``Notice of Inquiry'', ``Funding Notice'', ``ANPRM'', ``NPRM'',
``Interim Final Rule'', ``Final Rule'', or what other action it may
be.
\6\ ``RIN'' is the Regulation Identifier Number published in the
Unified Regulatory Agenda. If a RIN has not been assigned, the
agency should obtain one through the normal process by contacting
the Regulatory Information Service Center.
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[Describe briefly what the agency is intending to do and why,
including whether the program is new or continuing and, if continuing,
the significant changes in program operations or award criteria.
Briefly describe issues associated with the rulemaking, as appropriate,
e.g., impacts (both benefits and costs), interagency and
intergovernmental (State and local) effects, budgetary effects (e.g.,
outlays, number of years and awards, administrative overhead), time
pressures, and why the regulatory action is important, sensitive,
controversial or precedential. For final regulatory actions, include a
brief statement of the nature and extent of public comment, and the
nature and extent of changes made in response to the public comments.]
([Name and telephone number of program official who can answer detailed
questions])
We are not looking for a lengthy or detailed description of the
issues listed above. All we need is information sufficient to confirm
the characterization of ``significant'' or ``not significant''.
Similarly, for final regulatory actions, the description of the public
comments and changes is simply to enable us to decide whether we can
expedite or waive our review of the final rule where, for example,
there are few or no public comments and little or no substantive change
from the previously reviewed NPRM.
Under the Executive Order, within 10 working days after OIRA
receives this list, we will meet with or call your office to discuss
whether or not listed regulatory actions should be submitted for
centralized review (Sec. 6(a)(3)(A)). The purpose of this meeting is to
confirm the characterization of the proposal as ``significant'' or
``not significant,'' the characterization is important because, absent
a material change in the development of the rule, those characterized
as ``not significant'' need not be submitted for OIRA review before
publication.
OIRA will also want to discuss the timing for updates that would
identify any new regulatory actions under development. OIRA implemented
this procedure with several agencies on a pilot basis while the Order
was being drafted. We are most pleased by the results. It has in some
instances taken one or two tries to develop a process that works for a
particular agency. In most instances, submission of a list once a month
has proven sufficient for our purposes.
Once it is clear that a rulemaking warrants review by OIRA, the
process will be facilitated by your advising the OIRA staff as soon as
possible on the basic concept, direction, and scope of the rulemaking.
This will enable us to identify early the issues that we are concerned
about and to inform agency personnel of the type of analyses that OIRA
will look for when it reviews the regulatory action. All of this is
designed to make the review process more efficient and avoid last
minute problems.
When an agency submits a significant regulatory action for review,
the Order sets forth certain information that each agency should
provide a description of the need for the regulatory action, how the
regulation will meet that need, and an assessment of the potential
costs and benefits of the regulatory action, together with an
explanation of how it is consistent with a statutory mandate, promotes
the President's priorities, and avoids undue interference with State,
local, and tribal governments. This should not impose additional burden
on the agency. All of the information should have been prepared as part
of the agency's deliberative process; and much, if not all, of this
information should already be set forth in the preamble of the proposal
so as to allow more informed public comment.
If the regulatory action is economically significant (as defined in
Sec. 3(f)(1)),7 the Order sets forth additional information that
an agency must provide--an assessment of benefits, costs, and of
potentially effective and reasonably feasible alternatives to the
planned regulatory action (Sec. 6(a)(3(C)). We recognize that this
material may take different forms for different agencies. We are
reviewing our current guidance to see what changes, if any, are
appropriate. Pending the conclusion of this review, agencies should
continue to adhere to the existing OMB guidance on how to estimate
benefits and costs.
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\7\See footnote 4.
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In order to assure that the public is aware of our review under the
Order and the possible effects that this review may have had, agencies
should indicate in the preamble to the regulatory action whether or not
the regulatory action was subject to review under E.O. 12866. On the
other hand, there is no requirement that an agency document (in the
preamble or in its submissions to OIRA) compliance with each principle
of regulation set forth in the beginning of the Executive Order (Sec.
1(b)); we do, however, expect agencies to adhere to these principles
and to respond to any questions that may be raised about how a
regulatory action is consistent with these provisions of the Order.
The OIRA Administrator was given the authority to exempt any
category of agency regulations from centralized review (Sec. 3(d)(4)).
To begin with, we have decided that the previously granted exemptions
should be kept in effect, except as the Order specifically includes
them.8 Several additional exemptions have been added as a result
of our ongoing discussions with agencies. A list of current exemptions
is set forth in Appendix C. We will add to this list as experience
warrants. We urge you to contact the Administrator, or have your staff
contact your OIRA desk officer, to discuss those categories you believe
may be suitable for exemption.
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\8\Section 3(d)(2) includes within the definition of
``regulation'' or ``rule'' those pertaining to ``procurement'' and
the ``import or export of non-defense articles and services.'' The
OIRA Administrator interprets the latter to include within the scope
of the Order the regulations of the Bureau of Export Administration,
and to exclude State Department regulations involving the Munitions
List.
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7. Openness and Public Accountability
To assure greater openness and accountability in the regulatory
review process, the Order sets forth certain responsibilities for OIRA
(Sec. 6(b)(4)). Among other things, OIRA is placing in its public
reading room a list of all agency regulatory actions currently
undergoing review. This list is updated daily, and identifies each
regulatory action by agency, title, date received, and date review is
completed.
The reading room also contains a list of all meetings and telephone
conversations with the public and Congress to discuss the substance of
draft regulations that OIRA is reviewing. Within OIRA, only the
Administrator (or an individual specifically designated by the
Administrator--generally the Deputy Administrator) may receive such
oral communications.
When these meetings are scheduled, we are asking those outside the
Executive branch to have communicated their concerns and supporting
facts to the issuing agency before the meeting with OIRA. To assure
that the matters discussed are known to the agency, we are inviting
policy-level officials from the issuing agency to each such meeting.
In addition, written materials received from those outside the
Executive branch will be logged in the reading room and forwarded to
the issuing agency within 10 working days. It will be up to each agency
to put these in its rulemaking docket.
After the regulation is published, OIRA is making available to the
public the documents exchanged between OIRA and the issuing agency.
These materials will also be made public even if the agency decides not
to publish the regulatory action in the Federal Register. In addition,
the Order directs that, after a regulatory action has been published in
the Federal Register or otherwise released, each agency is to make
available to the public the text submitted for review, and the required
assessments and analyses (Sec. 6(a)(3)(E)). In addition, after the
regulatory action has been published in the Federal Register or
otherwise issued to the public, each agency is to identify for the
public, in a complete, clear, and simple manner, the substantive
changes that it made to the regulatory action between the time the
draft was submitted to OIRA for review and the action was subsequently
publicly announced, indicating those changes that were made at the
suggestion or recommendation of OIRA (Sec. 6(a)(3)(E) (ii) and (iii)).
Should you have any questions about these matters, please call the
Administrator or one of your OIRA Desk Officers.
8. Time Limits for OIRA Review
The Order sets forth strict time limits for OIRA review of
regulatory actions. For any notices of inquiry, advance notice of
proposed rulemaking, or other preliminary regulatory action, OIRA is to
complete review within 10 working days (Sec. 6(b)(2)(A)). For all other
regulatory actions, OIRA has 90 calendar days, unless OIRA has
previously reviewed it and there has been no material change in the
facts and circumstances upon which the regulatory action is based, in
which case there is a limit of 45 days (Sec. 6(b)(2)(B)). Because of
these tight time limits, we must work closely together to ensure that
requests for clarification or information are responded to promptly.
Upon receipt of a regulatory action, we plan to take a quick look and
make certain that whatever analyses should be included are included,
and to get back promptly to the agency to ask for whatever is missing.
In some instances, a reason for OIRA review will be the potential
effect of a regulation on other agencies. In these circumstances, OIRA
will attempt to provide the affected agencies with copies of the draft
regulatory action as soon as possible. If you are aware that another an
agency has an interest in the draft regulatory action, please let us
know quickly.
We also want to stress the provision in the Order that calls upon
each agency, in emergency situations or when the agency is obligated by
law to act more quickly than normal review procedures allow, to notify
OIRA as soon as possible and to schedule the rulemaking proceedings so
as to permit sufficient time for OIRA to conduct an adequate review
(Sec. 6(a)(3)(D)).
9. Regulation Identifier Number (RIN)
We ask that each agency include a Regulation Identifier Number in
the heading of each regulatory action published in the Federal
Register.9 This will make it easier for the public and agency
officials to track the publication history of regulatory actions
throughout their life cycles and to link documents in the Federal
Register with corresponding entries in the Unified Agenda of Federal
Regulations (Sec. 4(b)) and the Regulatory Plan (Sec. 4(c)).
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\9\The Office of the Federal Register has issued guidance to
agencies on the placement of the RIN number in their documents. See
Document Drafting Handbook, 1991 ed., p. 9.
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* * * * *
We look forward to working with you to implement this Executive
Order. If you have any questions, please let us know. We will, of
course, provide additional guidance as experience and need dictate.
Appendix A--Agencies Exempt From E.O. 12866
Advisory Council on Historic Preservation
African Development Foundation
Alaska Natural Gas Transportation System, Office of the Federal
Inspector
American Battle Monuments Commission
Arms Control and Disarmament Agency
Board for International Broadcasting
Central Intelligence Agency
Commission of Fine Arts
Committee for Purchase from the Blind and Severely Handicapped
Export-Import Bank of the United States
Farm Credit System Assistance Board
Federal Financial Institutions Examination Council
Federal Mediation and Conciliation Service
Harry S. Truman Scholarship Foundation
Institute of Museum Services
Inter-American Foundation
International Development Corporation Agency
James Madison Memorial Fellowship Foundation
Merit Systems Protection Board
Navajo Hopi Indian Relocation Commission
National Capital Planning Commission
Office of Special Counsel
Overseas Private Investment Corporation
Panama Canal Commission
Pennsylvania Avenue Development Corporation
Peace Corps
Selective Service System
Tennessee Valley Authority
United States Metric Board
United States Information Agency
United States International Development Cooperation Agency
Appendix B--Members of the Regulatory Working Group
Department of Agriculture
Department of Commerce
Department of Defense
Department of Education
Department of Energy
Department of Health and Human Services
Department of Housing and Urban Development
Department of the Interior
Department of Justice
Department of Labor
Department of Transportation
Department of the Treasury
Department of Veterans Affairs
Environmental Protection Agency
Small Business Administration
General Services Administration
Equal Employment Opportunity Commission
Appendix C--Regulatory Actions Exempted From Centralized Regulatory
Review
Department of Agriculture
Food and Nutrition Service--Special Nutrition program notices that
revise reimbursement rates and eligibility criteria for the School
Lunch, Child Care Food, and other nutrition programs.
Food and Nutrition Service--Food Stamp program notices that set
eligibility criteria and deduction policies.
Agricultural Marketing Service--Regulations that establish
voluntary standards for grading the quality of food.
Animal and Plant Health Inspection Service--Rules and notices
concerning quarantine actions and related measures to prevent the
spread of animal and plant pests and diseases.
Animal and Plant Health Inspection Service--Rules affirming actions
taken on an emergency basis if no adverse comments were received.
Rural Electrification Administration--Rules concerning standards
and specifications for construction and materials.
Department of Commerce
National Oceanic and Atmospheric Administration--Certain time-
sensitive preseason and in season Fishery Management Plan regulatory
actions that set restrictions on fishing seasons, catch size, and
fishing gear.
Department of Education
Certain Final Rules Based on Proposed Rules--Final regulations
based on proposed regulations that OMB previously reviewed where: (1)
OMB had not previously identified issues for review in a final
regulation stage; (2) Education received no substantive public comment;
and (3) the proposed regulation is not substantively revised in the
final regulation.
Rules Directly Implementing Statute--Final regulations that only
incorporate statutory language with no interpretation.
Notices of Final Funding Priorities--Notices of final funding
priorities for which OMB has previously reviewed the proposed priority.
Department of Energy
Power Marketing Administrations--Regulations issued by various
power administrations relating to the sale of electrical power that
they produce or market.
Department of Health and Human Services
Food and Drug Administration--Agency notices of funds availability.
Food and Drug Administration--Medical device reclassifications to
less stringent categories.
Food and Drug Administration--OTC monographs, unless they may be
precedent-setting or have large adverse impacts on consumers.
Food and Drug Administration--Final rules for which no comments
were received and which do not differ from the NPRM.
Department of the Interior
Office of Surface Mining--Actions to approve, or conditionally
approve, State regulatory mining actions or amendments to such actions.
Office of Surface Mining--Approval of State mining reclamation
plans or amendments.
Office of Surface Mining--Cooperative agreements between OSM and
States.
United States Fish and Wildlife Service--Certain parts of the
annual migratory bird hunting regulations.
Department of Transportation
All Office of DOT--Amendments that postpone the compliance dates of
regulations already in effect.
Coast Guard--Regatta regulations, safety zone regulations, and
security zone regulations.
Coast Guard--Anchorage, drawbridge operations, and inland waterways
navigation regulations.
Coast Guard--Regulations specifying amount of separation required
between cargoes containing incompatible chemicals.
Federal Aviation Administration--Standard instrument approach
procedure regulations, en route altitude regulations, routine air space
actions, and airworthiness directives.
National Highway Traffic Safety Administration--Federal Motor
Vehicle Safety Standard 109 table of tire sizes.
Department of the Treasury
Internal Revenue Service, Bureau of Alcohol, Tobacco, and Firearms,
and Customs Service--Revenue rulings and procedures, Customs decisions,
legal determinations, and other similar ruling documents. Major
legislative regulations are covered fully.
Environmental Protection Agency
Office of Pesticides and Toxic Substances--Actions regarding
pesticide tolerances, temporary tolerances, tolerance exemptions, and
food additives regulations, except those that make an existing
tolerance more stringent.
Office of Pesticides and Toxic Substances--Unconditional approvals
of TSCA section 5 test marketing exemptions, and of experimental use
permits under FIFRA.
Office of Pesticides and Toxic Substances--Decision documents
defining and establishing registration standards; decision documents
and termination decisions for the RPAR process; and data call-in
requests made under section 3(c)(2)(B) of FIFRA.
Office of Air, Noise, and Radiation--Rules that unconditionally
approve revisions to State Implementation Plans.
Office of Air, Noise, and Radiation--Unconditional approvals of
equivalent methods for ambient air quality monitoring and of NSPS,
NESHAPS, and PSD delegations to States; approvals of carbon monoxide
and nitrogen oxide waivers; area designations of air quality planning
purposes; and deletions from the NSPS source categories list.
Office of Water--Unconditional approvals of State Water Standards.
Office of Water--Unconditional approval of State underground
injection control programs, delegations of NPDES authority to States;
deletions from the 307(a) list of toxic pollutants; and suspension of
Toxic Testing Requirements under NPDES.
Office of Solid Water and Emergency Response--Unconditional
approvals of State authorization under RCRA of State solid waste
management plans and of hazardous waste delisting petitions under RCRA.
Pension Benefit Guaranty Corporation
Interest Rates--Changes in interest rates on later premium payments
and delinquent employer liability payments under sections 6601 and 6621
of the Internal Revenue Code as amended by the Tax Equity and Fiscal
Responsibility Act of 1982.
BILLING CODE 3110-01-P
Appendix A
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[FR Doc. 94-11203 Filed 5-5-94; 4:10 pm]
BILLING CODE 3110-01-C
_______________________________________________________________________
Part VII
Department of Agriculture
_______________________________________________________________________
Cooperative State Research Service
_______________________________________________________________________
Small Business Innovation Research Grants Program; Notice
DEPARTMENT OF AGRICULTURE
Cooperative State Research Service
Small Business Innovation Research Grants Program for Fiscal Year
1995; Solicitation of Applications
Notice is hereby given that under the authority of the Small
Business Innovation Development Act of 1982 (Pub. L. 97-219), as
amended (15 U.S.C. 638) and section 630 of the Act making
appropriations for Agriculture, Rural Development, and Related Agencies
programs for fiscal year ending September 30, 1987, and for other
purposes, as made applicable by section 101(a) of Public Law Number 99-
591, 100 Stat. 3341, the U.S. Department of Agriculture (USDA) expects
to award project grants for certain areas of research to science-based
small business firms through Phase I of its Small Business Innovation
Research (SBIR) Grants Program. This program will be administered by
the Office of Grants and Program Systems, Cooperative State Research
Service. Firms with strong scientific research capabilities in the
topic areas listed below are encouraged to participate. Objectives of
the three-phase program include stimulating technological innovation in
the private sector, strengthening the role of small businesses in
meeting Federal research and development needs, increasing private
sector commercialization of innovations derived from USDA-supported
research and development efforts, and fostering and encouraging
participation of women-owned and socially and economically
disadvantaged small business concerns in technological innovation.
The total amount expected to be available for Phase I of the SBIR
Program in fiscal year 1995 is approximately $3,500,000. The
solicitation is being announced to allow adequate time for potential
recipients to prepare and submit applications by the closing date of
September 1, 1994. The research to be supported is in the following
topic areas:
1. Forests and Related Resources
2. Plant Production and Protection
3. Animal Production and Protection
4. Air, Water and Soils
5. Food Science and Nutrition
6. Rural and Community Development
7. Aquaculture
8. Industrial Applications
9. Marketing and Trade
The award of any grants under the provisions of this solicitation
is subject to the availability of appropriations.
This program is subject to the provisions found at 7 CFR part 3403,
as amended. These provisions set forth procedures to be followed when
submitting grant proposals, rules governing the evaluation of proposals
and the awarding of grants, and regulations relating to the post-award
administration of grant projects. In addition, USDA Uniform Federal
Assistance Regulations, as amended (7 CFR part 3015), Governmentwide
Debarment and Suspension (Non-procurement) and Governmentwide
Requirements for Drug-free Workplace (Grants) (7 CFR part 3017), New
Restrictions on Lobbying (7 CFR part 3018), and Managing Federal Credit
Programs (7 CFR part 3) apply to this program. Copies of 7 CFR part
3403, 7 CFR part 3015, 7 CFR part 3017, 7 CFR part 3018, and 7 CFR part
3 may be obtained by writing or calling the office indicated below.
The solicitation, which contains research topic descriptions and
detailed instructions on how to apply, may be obtained by writing or
calling the office indicated below. Please note that applicants who
submitted SBIR proposals for fiscal year 1994 or who have recently
requested placement on the list for fiscal year 1995 will automatically
receive a copy of the fiscal year 1995 solicitation.
Proposal Services Branch, Awards Management Division, Cooperative State
Research Service, U.S. Department of Agriculture, Ag Box 2245,
Washington, DC 20250-2245, telephone: (202) 401-5048.
Done at Washington, DC, this 4th day of May 1994.
William D. Carlson,
Associate Administrator, Cooperative State Research Service.
[FR Doc. 94-11166 Filed 5-9-94; 8:45 am]
BILLING CODE 3410-22-M
