Abstract: Congress needs to take action to constrain the burgeoning
regulations and closed-door, secretive rulemaking of the growing administrative
state. To do that, Congress needs to restore formal rulemaking, with oral
hearings presided over by an administrative law judge. It also needs to
strengthen congressional control and oversight of rulemaking and establish a
Congressional Office of Regulatory Review, which, among its other duties, would
estimate the cost of major regulations.
Americans feel that they are increasingly being governed by administrators, not
legislators. They are right; the rule of law is being supplanted by the rules
and regulations that accompany government statutes.
On crucial issues that affect their daily lives, ranging from running their
businesses to choosing their health care, Americans are becoming the subjects of
an administrative state rather than citizens of a constitutional republic. Not
only is administrative rulemaking expansive, but the process whereby rules are
developed and the reasons behind many decisions are arbitrary, murky, secretive,
and often highly political. It is time for Congress to confront and roll back
this burgeoning administrative state.
In 1996, Congress tried to constrain excessive regulation through the
Congressional Review Act, but the act has been invoked only rarely, and
government agencies have ignored its reporting requirements. Meanwhile,
Americans have been subjected to:
- An explosion of red tape. In 2009 alone, the Obama Administration
published a record-breaking 163,333 pages of rules in the Code of Federal
Regulations. In 2010, the Administration continued to issue many
thousands of pages of rules—carrying the force of law—on topics ranging from
energy and greenhouse gases to financial reform and food safety to health care.
- Massive economic costs. The Small Business Administration (SBA) recently
estimated that under the Obama Administration, the annual cost of federal
regulation amounts to a staggering $1.75 trillion—almost twice the amount
collected in individual federal income taxes in 2009.
- Politicized and inequitable rules. The rigid design and subjective
application of rules makes the process even worse. So far, more than 900
companies and organizations, including unions, have received waivers from
insurance rules mandating insurance coverage levels in the Patient Protection
and Affordable Care Act (PPACA) that apply to millions of Americans. Meanwhile,
Administration officials clumsily tried to sneak through a rule including a
controversial provision for “end of life” counseling that Congress explicitly
stripped from the PPACA last year.
Congress should do its job under the first section of Article I of the
Constitution, which declares that “all legislative powers herein granted shall
be vested in a Congress of the United States, which shall consist of a Senate
and House of Representatives.” Certainly, Congress needs to write clear and
coherent statutes, but it must also end the excessive delegation of vast
lawmaking authority to unelected federal officials and make the rulemaking
process transparent and more in line with congressional intent. This can be done
by returning to formal rulemaking, with open hearings under a presiding
administrative law judge, rather than continuing to rely on the informal process
of “notice and comment” that governs federal rulemaking today.
Congress must end the excessive delegation of vast lawmaking authority to
unelected federal officials and make the rulemaking process transparent and more
in line with congressional intent. To this end, there are several immediate
steps that Congress can take to get the bureaucracy under control. For example:
- Restore transparent, formal rulemaking and end secretive regulation. By
applying the Administrative Procedures Act of 1946, Congress can restore
the formal rulemaking process that was the norm until the 1970s. That
requires formal and public evidence gathering, with an oral hearing presided
over by an administrative law judge. It prohibits ex parte communications
with the judge or other federal officials designated to preside over the
hearing, making it much harder for special interests or politics to influence
final rules. Contending parties would have the right to present evidence and
cross-examine witnesses, and the record of the proceedings would have to be the
basis of the regulatory decision.
To trigger formal rulemaking, Congress would
have to include the requirement in a statute creating a program. But by
including it in an amendment to, say, last year’s health reform legislation, it
could require formal rulemaking for all pending regulations for the entire act.
- Beef up congressional control of existing regulations. To reform the
process, Representative Geoff Davis (R–KY) and Senator Jim DeMint (R–SC) are
sponsoring the Regulations from the Executive in Need of Scrutiny (REINS) Act.
The REINS Act (H.R. 3765/S. 3826) would reverse the existing burden of action.
Today Congress has to stop a rule; otherwise, it goes into effect. Under their
bill, the House and Senate would have to affirmatively enact a bill embodying a
major rule before it could be enforced.
- Strengthen congressional oversight of informal rulemaking. For the bulk
of federal rules, currently made through the informal process of notice and
comment before final publication, tough congressional oversight into each
agency’s rulemaking process would be a major constraint on bureaucratic power.
- Establish a Congressional Office of Regulatory Review. Congress could
create a Congressional Office of Regulatory Review (CORR) modeled after the
Congressional Budget Office (CBO). Like the CBO, the CORR would report on the
estimated costs and impact of the federal regulatory authority embodied in bills
that come before Congress. House and Senate rules could require a Regulatory
Review score similar to the CBO score.
- The Administrative State and a Free Republic: Mutually Exclusive
The Founders designed the American republic carefully and elegantly. What makes
the United States a republic is that political authority is inherently limited
and exercised as a public trust over public affairs (res publica),
not private affairs (res privata). America is at once a
democratic and a federal republic. It is democratic because political
decision-making (in most instances) is based on the principles of popular
sovereignty, political equality, and majority rule. Its federal character is
embodied in the wise division of authority between a national government
carefully confined to general concerns, and state governments that retain
plenary authority over particular concerns.
Within the framework of the national government, the U.S. Constitution provides
for three distinct and separate and independent branches of a republican
government to execute legislative, executive, and judicial functions. The
Founders’ functional division of authority is designed specifically to prevent a
consolidation of political power that would threaten Americans’ personal,
political, and economic liberty. Writing in The Federalist No. 48, James
Madison is explicit: “The accumulation of all powers, legislative, executive,
and judiciary, in the same hands, whether of one, a few, or many, and whether
hereditary, self- appointed, or elective, may justly be pronounced the very
definition of tyranny.”
Escaping Responsibility. Over the course of the 20th century, Congress
has habitually delegated legislative, or rulemaking, authority to executive
branch departments and agencies, as well as to independent agencies. Continuing into the 21st century, these delegations
often reflect Congress’s inability or unwillingness to deal directly with
demanding, often technically difficult problems of public policy or are a
convenient means to avoid taking direct responsibility for difficult and
potentially painful and unpopular decisions.
The agenda of the early Progressives, Woodrow Wilson’s New Freedom, Franklin D.
Roosevelt’s New Deal, Lyndon B. Johnson’s Great Society, and Richard Nixon’s
vast expansions of federal power, including the imposition of wage and price
controls, all contributed to the growth of federal bureaucratic power that
controls progressively larger chunks of Americans’ economic lives. Since the
1960s, this growth has been accompanied by an avalanche of federal regulation.
Since congressional delegations of legislative authority have rarely been
nullified by the federal courts as unconstitutional, the consequence has been
the creation of a “fourth branch” of the federal government: the administrative
state. Gary Lawson, professor of law at Boston University, has noted:
Many administrative agencies have authority over matters that are far removed
from any of the enumerations of the Constitution…. Many of these agencies—the
so-called independent agencies—are statutorily insulated from presidential
control. And to cap things off, the agencies perform all of the functions of
government at the same time: They promulgate rules, enforce the rules, and
adjudicate their own enforcement actions.
So the administrative state’s functionaries are powerful, their operations
subtle, yet their decisions are consequential for millions of Americans. They
are unelected, unknown, and, for all practical purposes, often unaccountable,
and their positions are protected by an impressive body of civil service laws,
rules, and regulations. As Madison warned in 1788, “There are more instances of
the abridgement of the freedom of the people by gradual and silent encroachments
of those in power than by violent and sudden usurpations.”
Concentrations of Power. With the administrative state, the laws that
govern the day-to-day activities of millions of Americans are in fact not laws,
the common products of legislative deliberation by elected representatives, but
federal rules and regulations produced by unelected administrators. These, in
turn, are routinely accompanied by federal guidelines and administrative
decisions of officials in increasingly powerful federal departments and
Today, these rules have the force of law, just like acts of Congress signed into
law by the President. Indeed, Congress has not only delegated rulemaking
authority, but also authorized new forms of judicial authority, exercised by
administrative law judges, to decide cases and controversies concerning the
application of federal rules. Moreover, Congress has authorized civil monetary
fines and penalties against violators of federal rules and regulations. In
effect, Congress has created administrative institutions that do indeed combine
executive, legislative, and judicial powers—precisely the dreadful combination
against which Madison warned Americans in 1788.
These delegations have also undermined democratic accountability and undercut
the transparency of American government. As Judge James L. Buckley has argued:
[The administrative state] is manned by insulated and sometimes imperious
officials who wield an enormous influence over virtually every facet of American
life. As they are not elected, they are not directly responsible to the people;
and as they are protected by the civil service laws, they are virtually immune
to the discipline by a president or by Congress. We have, in short, managed to
vest these individuals with a degree of authority over others that the Founders
of the Republic went to great pains to prevent anyone from acquiring.
Ronald Pestritto, a professor of political science at Hillsdale College, has
observed similarly that:
For those who hold the Constitution of the United States in high regard and who
are concerned about the fate of its principles in our contemporary practice of
government, the modern state ought to receive significant attention. The reason
for this is that the ideas that gave rise to what is today called the
“administrative state” are fundamentally at odds with those that gave rise to
Why Americans Are Ready to Roll Back Bureaucratic Power
Particularly over the past century, these delegations of congressional authority
have become a norm of American public policy; they are taken for granted. Among
Washington’s policymakers and their allies on K Street, the well-paid agents of
a lucrative industry of special-interest lobbying, well-connected and schooled
in the arts of influence peddling, the existence and continued prosperity of the
administrative state has long been a settled question.
That norm can change. With a new, innovative, and imaginative congressional
leadership committed to the spirit and example of America’s Founders, the
administrative state, particularly its regulatory excesses, can be rolled back.
There is nothing inevitable about the growth of the administrative state, no
permanent arrangement in the correlation of political forces that govern
official Washington. As The Wall Street Journal observes:
[T]he Constitution vested Congress with the duty to make laws, not vague
suggestions about what it might be good for the law to be. And now there is a
growing movement to force Members to take responsibility for the laws they pass,
and to force Administrations to be accountable for the laws they create through
While President Barack Obama himself has recently called for a review of federal
regulation, his Administration issued 62 major rules in 2010 alone, and 191 such
rules are under development. In the area of financial regulation alone,
Americans can expect as many as 243 new regulations over the next 12 years
thanks to the Wall Street Reform and Consumer Protection Act sponsored by
Senator Chris Dodd (D–CT) and Representative Barney Frank (D–MA).
High Cost. The level of public anxiety over official Washington’s policy
initiatives, ranging from complex financial regulations to the unpopular health
care law, gives new Members of Congress an opportunity to channel the growing
public dissatisfaction with current governance into a positive agenda for
far-reaching reform. As noted, the Small Business Administration estimates the
annual cost of federal regulations at a staggering $1.75 trillion—almost twice
as much as the total amount collected in individual federal income taxes in
2009. Additionally, new rules often reflect an excessive
faith in central planning.
Even more damaging than its economic cost is the high toll that the
administrative state exacts on America’s civic life. As Judge Buckley has
Millions of Americans are being overwhelmed by events they can no longer
influence, and [realize] that voting to replace one government official with
another is an act of futility. There is no single cause for this disintegration
of confidence, but as a veteran of six years on Capitol Hill who has had to
wrestle with hundreds of constituents’ concerns, I am persuaded that a major
source of current discontent stems from the accelerating expansion of federal
authority and the way that authority is being exercised.
Federal regulations have routinely targeted discrete sectors of the economy such
as banks and financial institutions, specific areas of general concern such as
the protection of air and water quality under the Environmental Protection
Agency (EPA), or safety in the workplace, the object of the regulatory authority
of the Occupational Safety and Health Administration (OSHA). Complaints
affecting any one of these areas have thus been contained to those areas of
public policy, as has the political fallout from the exercise of arbitrary or
Health Law Excesses. As The New York Times reports, “Federal rule
makers, long neglected stepchildren of Washington bureaucrats, suddenly find
themselves at the center of power as they scramble to work out details of
hundreds of sweeping financial and health care regulations that will ultimately
affect most Americans.” In 2010, the Obama Administration issued 43 new
major regulations with a net cost of $26.5 billion to the economy; 15 of them
involve financial regulation, and five of them are attributable to the Patient
Protection and Affordable Care Act of 2010, an unprecedented and radical
federalization of health care decision-making.
With the enactment of financial reform and the massive 2,700-page PPACA,
Americans are witnessing a record-breaking surge in federal intrusion into a
huge and highly complex sector of the American economy. From March to September
2010 alone, federal officials published more than 4,000 pages of rules
implementing the new health care law. The U.S. Departments of Health and Human
Services (HHS), Labor, and Treasury, including the IRS, have the primary
responsibility for making and enforcing rules that would compel individuals and
businesses, states, doctors, hospitals, nursing homes, home health agencies, and
insurers to follow detailed diktats that affect virtually every aspect of
their business operations or professional lives.
Special-Interest Politics. A troubling feature of the health care
rulemaking thus far is its arbitrariness. In sharp contrast to the general
public, many of the leaders of large corporations and unions strongly supported
the enactment of the national health law. James Forbes, an executive with Bank
of America Merrill Lynch, recently declared that “[r]eform is not going to be
repealed. It’s not going to happen, folks. Quite honestly, most of your private
equity firms view this as a tremendous opportunity.”
But the special benefits are clearly uneven. The law progressively reduces
coverage limits for health insurance and eliminates them entirely in 2014, for
instance. Understandably, this change in the legal status of limited-benefit
health plans undermines low-cost coverage for millions of Americans. So, in
enforcing the law last year, the Secretary of HHS approved 222 applications for
waivers from the law, covering an estimated 1.5 million workers, including
members of 45 labor organizations, such as the powerful Service Employees
International Union (SEIU). As of February 2011, the total number of such
waivers has exceeded 900, affecting as many as 2.4 million persons.
The new law also establishes a “medical loss ratio” (MLR) for health insurance
that specifies how much insurance plans must pay out in medical benefits and how
much they may retain for administrative expenses, efforts to combat fraud and
abuse, and profits. Under the terms of the law, insurance companies will be
required to spend 80 percent to 85 percent of their premium dollars on health
care benefits rather than administrative and related costs. If a plan does not
meet the MLR target, it must rebate the difference to enrollees in lower
premiums or lump-sum payments. Federal officials expect as many as 9 million
persons to be eligible for $1.4 billion in rebates in 2012.
Because the MLR regulations deal with complex technical issues, the law requires
the National Association of Insurance Commissioners to provide detailed
recommendations for the federal rule writers. During the fall of 2010, this
process engaged what are called “stakeholders,” which is another word for
special interests such as brokers, employers, and insurers. Such a bureaucratic
process always produces winners and losers. Rowen Bell, vice president of the
Health Care Service Corporation, says that “I think what we have here in the
rebate MLR rule is a new burden on the small business community.”
The law authorizes the Secretary of HHS to give states temporary relief from the
MLR rule and make an “adjustment” to the federal standards if a state can prove
to the Secretary’s satisfaction that its imposition would “destabilize” the
individual market and reduce the choice of coverage for that state’s citizens.
Because health insurance markets are radically different and Washington’s rules
will have a diverse impact, it can be expected that several states will file for
The new law also has a “grandfather clause” so that employees can keep their
existing employer health plans, yet even the authors of the PPACA regulations
concede that employers and employees will see changes in their coverage. At the
same time, there are special rules for health plans under collective bargaining
agreements (union plans), which are given flexibility in making changes denied
to other plans without losing their “grandfathered” status. Meanwhile, in a survey of American firms by
Mercer, a prominent business consulting firm, only half expected that they would
be able to keep their existing coverage in 2011.
The national health law is becoming an engine for arbitrary exercises of
bureaucratic power. As reporters for The New York Times relate:
Congress provided a road map for measures aimed broadly at getting more
Americans covered by health insurance and providing more federal safeguards
against risky financial practices. But the laws were so broad and complex that
executive-branch regulators have wide leeway in determining what the rules
should say and how they should be carried out. In all, the bills call for
drafting more than 300 separate rules on a rolling schedule by about 2014, plus
dozens of other studies and periodic reports. That may be only the beginning. A
recent report from the Congressional Research Service said the publication of
rules under the health care law could stretch for decades to come.
How Congress Can Restrain the Administrative State
The new Congress has the power to curtail and reverse the growth of the
administrative state. To this end, there are six specific steps that Members can
Step #1: Stop expanding the administrative state.
The first thing that Congress can do is to craft legislative language clearly
and concisely and stop delegating broad legislative authority to federal
agencies and departments and independent agencies. Americans expect Congress to
accept—and demand that it accept—direct responsibility for the laws it enacts
and for the impact of those laws on the personal and economic lives of ordinary
Step #2: Restore transparent, formal rulemaking as the norm.
In 1946, Congress enacted the Administrative Procedures Act (APA) as a
comprehensive effort to increase the regularity and transparency of the federal
administrative process. Several provisions of that act deal with federal
rulemaking, categorized by the statute as either formal or informal. That
categorization results in very different procedures, which in turn have
important consequences for the openness and rigor of the process of agency
In formal rulemaking, when Sections 556 and 557 of the APA apply, the act
provides for a process that requires the gathering and orderly presentation of
evidence, an oral hearing presided over by an administrative law judge with some
measure of independence from the rulemaking agency, prohibition of ex parte
communications with the presiding official, the right of contending parties to
present opposing cases, a presumptive right of cross examination of the
witnesses in the proceedings, and a requirement that the public record of the
proceedings be the exclusive basis for the regulatory decision.
Formal rulemaking, then, is conducted very much as the civil procedures of a
courtroom are conducted. Not only would the administrative law judge be
empowered to issue subpoenas, but counsel or representatives for parties on
either side of a regulatory issue would be able to make the case in this open
hearing to secure, in the language of the statute, “a full and true disclosure
of the facts.”
This formal style of rulemaking has fallen into disuse, though it was quite
commonplace until the early 1970s. In 1973, the United States Supreme Court
effectively held that Sections 556 and 557 of the APA apply only when Congress
has prescribed in specific statutes that rules be made “on the record after
opportunity for agency hearing.” Statutes authorizing agency rulemaking seldom use
that precise language. Statutes typically require agencies to make rules after
hearings or public hearings, and under the Supreme Court’s earlier
interpretation of the law, those statutes do not require formal rulemaking
Instead, almost all rulemaking today uses informal procedures, which simply
require the agency to give notice of its intention to propose a rule, receive
comments in writing from interested parties, and issue a statement of the rule’s
basis and purpose if one is issued. There is no requirement of oral proceedings
or cross-examination of witnesses, no formal presentation of evidence, no
impartial administrative law judge overseeing the proceedings, and no
requirement that the agency rule be based exclusively on publicly vetted and
adversarially tested evidence. This informal process of mere “notice and
comment” is a recipe for backroom deals and special-interest lobbying.
In the interest of transparency and public accountability, and as a way to
restore public trust in a process that is increasingly seen as arbitrary and
abusive, Congress should require the restoration of formal rulemaking as the
norm. This could be done either as an omnibus measure, applying the requirement
to all federal departments or agencies, or as an amendment to any bill governing
the activities of any agency that has federal regulatory authority. Because the
Supreme Court in 1973 purported simply to be determining the will of Congress,
Congress can clarify its intent and secure the objective of proving openness in
the agency lawmaking process by amending both existing and future statutes to
require a formal rulemaking process, referencing the language of APA section
553(c), which refers to “rules [that] are required by statute to be made on the
record after [an] opportunity for an agency hearing.”
Step #3: Reinforce congressional control of regulation.
Under the Congressional Review Act of 1996, each federal agency is required by
law to send its final rules to the Comptroller General of the United States and
to the House and Senate before the federal rules take effect. The law provides a delay of 60 days after the
final rules are published in the Federal Register or submitted to
Congress, whichever is later, before the rules take effect. During that period,
Congress may enact a joint resolution of disapproval of the rule and thus render
it null and void.
Under current law, the rules to be submitted for congressional consideration are
those that are designated as “major.” A rule fits this category if it has an
annual effect on the economy of $100 million or more; results in a major
increase in costs to consumers, individual industries or federal, state or local
agencies; or adversely affects competition, employment, investment, productivity
and innovation, undermining the ability of firms to compete in domestic or
In practice, the Congressional Review Act has been disappointing. It has been
rarely invoked, and a Congressional Research Service analysis of its enforcement
indicates that federal agencies have simply failed to submit the appropriate
rules to Congress and the Government Accountability Office in more than 1,000
The Regulations from the Executive in Need of Scrutiny (REINS) Act (H.R. 3765/S.
3826), introduced by Representative Geoff Davis (R–KY) and Senator Jim DeMint
(R–SC), would reverse the burden of action and require that the House and Senate
each affirmatively enact a bill that would embody a major rule before
it can be enforced. Like all legislation, the bill would, of course,
be signed or vetoed by the President. Thus, any issue of controversy over the
rules would become a highly visible public policy question to be settled in open
debate and in broad daylight.
The REINS Act holds great promise of reversing the accelerating trend toward
congressional delegation of legislative authority and limiting the powers of an
opaque administrative state. In 1983, Supreme Court Justice Stephen Breyer, then
a federal appeals court judge, indicated that such a “confirmatory” statute for
major federal rules would be a constitutionally appropriate response to the
Step #4: Strengthen congressional oversight of rulemaking.
According to the staff of Representative Davis, the federal government issued
3,482 new rules and regulations in 2009; 84 of them were major rules, as defined
under current law.
The Patient Protection and Affordable Care Act has opened the floodgates of
federal regulation, giving the Secretary of Health and Human Services sweeping
rulemaking authority as well as broad discretion in granting exemptions or
waivers to the rules. In the case of the rules governing “mini-med” plans
(inexpensive health plans with limited coverage), as of December 2010, there had
been 222 waivers, including the prominent year-long exemption given to the
McDonald’s fast food chain. Since then, as noted, the Administration has granted
The standards that govern these waivers seem to be almost infinitely flexible,
and the exact process by which some companies are exempted from the requirements
of the health law and others are not is not entirely clear. Nor is it clear
either how much political or partisan influence governs the decisions of the
Secretary of HHS or other federal officials in this process or what kinds of
communications are exchanged among officials within or outside the
Given the enormous impact of the national health care law, these matters deserve
scrutiny, and the public expects Congress to shine the light on these practices.
The purpose of congressional hearings and investigations is not to embarrass
federal officials, but to gather useful information to make substantive policy
changes through legislation. Since the bulk of federal rules are made through
the informal process of notice and comment before final publication,
congressional oversight into the process of rulemaking can be a major restraint
on the arbitrary exercise of power by the administrative state.
Step #5: Establish an internal mechanism for regulatory review.
There are two options to accomplish this objective. First, Congress could create
a Congressional Office of Regulatory Review (CORR) modeled after the
Congressional Budget Office (CBO). Like the CBO, the CORR would report on the
estimated costs and impact of the federal regulatory authority embodied in bills
that come before Congress. House and Senate rules could require the provision of
a Regulatory Review score just like the CBO score.
Alternatively, Congress could establish a Joint Committee on Regulatory Review
modeled on the Joint Committee on Taxation, whose central function would be to
monitor the regulatory activities of federal agencies and departments and
independent agencies: a body that would hold hearings, hear testimony, and
assess the impact of federal rules on business and the economy.
Step #6: Provide citizens with a right to legal self-defense and recovery
for regulatory damages.
Congress should undertake, as part of its oversight functions, a review of
actions by federal agencies that have improperly damaged persons or firms
subjected to faulty, abusive, or arbitrary applications of federal rules. Judge
Buckley suggests two remedies.
First, any accused citizen should be presumed innocent until proven
guilty before the imposition of administrative fines or penalties, and, if
successful, the citizen should also be able to recover costs of presenting his
case in an administrative or civil hearing.
Second, Congress should waive sovereign immunity for federal agencies in
certain circumscribed areas of regulatory enforcement. This means that a
business owner, for example, would be able to recover damages from abusive or
incompetent agency actions.
There is nothing inevitable about the growth of the administrative state unless
the people’s elected representatives allow it to continue. A congressional
leadership committed to promoting transparency and curbing bureaucratic power
can roll back the administrative state.
To do this, Congress must stop the practice of broad delegations of legislative
power to executive and independent agencies. It must re-establish formal
rulemaking, with its open hearings and rules of evidence, as the norm in federal
regulation, especially with major or particularly sensitive rules. Congress
should also exercise better control over the substance of federal rules, review
the costs and impact of federal rules more effectively, and provide legal
recourse for citizens damaged by regulatory abuses.
It is time for Congress to restore accountability, transparency, and the
traditional rule of law under the Constitution.
—Robert E. Moffit, Ph.D., is Senior Fellow in the Center for Policy
Innovation at The Heritage Foundation. This paper grew out of a November 18,
2010, conference sponsored by The Heritage Foundation’s B. Kenneth Simon Center
for American Studies on reforming the administrative state. The author thanks
Gary Lawson, professor of law at Boston University, for his contribution to the
research on the federal rulemaking process.