GUIDANCE IN THE RULEMAKING
PROCESS: EVALUATING PREAMBLES,
REGULATORY TEXT, AND
FREESTANDING DOCUMENTS AS
VEHICLES FOR REGULATORY
GUIDANCE

Kevin M. Stack
Professor of Law and Associate Dean for Research
Vanderbilt University Law School

FINAL REPORT
May 16, 2014
*This report was prepared for the consideration of the Administrative Conference of the United States. The views
expressed are those of the author and do not necessarily reflect those of the members of the Conference or its
committees.

ADMINISTRATIVE CONFERENCE
OF THE UNITED STATES

Contents
Contents .................................................................................................................................................................. ii
Introduction ............................................................................................................................................................. 1
I.

Definition of Guidance and Scope of Inquiry .......................................................................................... 4
A.

Definition and Dimensions of Guidance...................................................................................................4

B.

Scope of Inquiry and Methodology ..........................................................................................................6

II.

Guidance and Rulemaking: A Brief Overview ........................................................................................ 7
A.

The APA’s Vision: The Dual Role of the Statement of Basis and Purpose -- Justification and
Guidance ...................................................................................................................................................7

B.

The Expanding Preamble, Ossification, and Separately Issued Guidance ...............................................9

III.

The Law Governing Contemporaneous Guidance ................................................................................. 13

A.

Process Requirements for Issuing Contemporaneous Guidance ............................................................14

B.

Process Requirements for Revising Contemporaneous Guidance: The Impact of Alaska
Professional Hunters ..............................................................................................................................16

C.

When Is Contemporaneous Guidance Subject to OIRA Review? ..........................................................18

D.

What Contemporaneous Guidance is Required? ....................................................................................19

E.

What May Not Be Included in Contemporaneous Guidance? ................................................................22

F.

Reviewability of Contemporaneous Guidance .......................................................................................25

G.

Standard of Judicial Review ...................................................................................................................27

H.

Summary Table .......................................................................................................................................30

IV.

Agency Practices for Providing Contemporaneous Guidance ............................................................... 31

B.

Preambles as a Vehicle for Guidance .....................................................................................................34

C.

Guidance in Regulatory Text and Appendices .......................................................................................41

D.

Separately Issued Contemporaneous Guidance ......................................................................................46

V.

Recommendations to Federal Agencies ................................................................................................. 47

ii

Introduction
In the past two decades, the use of guidance—nonbinding statements of
interpretation, policy, and advice about implementation—by administrative agencies has
prompted considerable interest from executive branch officials, committees in Congress,
agency officials, and commentators. Most of this attention has been directed toward
“guidance documents,”1 freestanding, nonbinding policy and interpretive statements issued
by agencies. Policymakers and commentators have expressed concern that agencies are
relying on guidance documents in ways that circumvent the notice-and-comment
rulemaking process; in particular, the worry is that with the increased analytical and
justificatory burdens of notice-and-comment rulemakings, agencies have turned to
guidance as a way to establish norms without the participation benefits and explanatory
burdens of the notice-and-comment process.2

1

OFFICE OF MANAGEMENT AND BUDGET, FINAL BULLETIN FOR AGENCY GOOD GUIDANCE PRACTICES, 72
FED. REG. 3432, 3439 (Jan. 25, 2007) (defining a “guidance document” as “an agency statement of general
applicability and future effect, other than a regulatory action . . . that sets forth a policy on a statutory,
regulatory or technical issue or an interpretation of a statutory or regulatory issue.”) [hereinafter OMB’s
Good Guidance Bulletin].
2
For instance, in 1992, the Administrative Conference of the United States (ACUS) recommended that
agencies provide affected persons an opportunity to challenge the wisdom of a guidance document or policy
statement before the statement is applied to persons affected. Admin. Conf. of the United States, Agency
Policy Statements, Recommendation 92-2, 57 Fed. Reg. 30,103 (June 18, 1992).
The ACUS
Recommendation commented, “The Conference is concerned . . . about situations in where agencies issue
policy statements which they treat or which are reasonably regarded by the public as binding . . . .[but these
pronouncements do] not offer the opportunity for public comment . . .”). In 2007, President Bush issued an
executive order which subjected significant guidance documents to regulatory review based on similar
concerns. See Exec. Order No. 13,422, 3 C.F.R. § 191 (2008). President Obama revoked Executive Order
14,422, see Exec. Order No. 13,497, 3 C.F.R.§ 218 (2010), but as discussed below, see Memorandum from
Peter Orzag, Dir. Office of Mgmt. & Budget, to Heads and Acting Heads of Exec. Dep’ts and Agencies
(Mar.
4,
2009)
[hereinafter
“Orzag
Memorandum”]
(available
at
http://www.whitehouse.gov/sites/default/files/omb/assets/ memoranda_fy2009/m09-13.pdf),
significant
guidance is still subject to regulatory review. In 2007, OMB issued a “Final Bulletin for Agency Good
Guidance Practices” which requires agencies to provide a means for comment on certain significant guidance
documents, see OMB’s Good Guidance Bulletin, supra note 1, and this Bulletin remains in effect.
Committees in Congress have expressed concerns that agencies are inappropriately relying on guidance. See,
e.g., COMM. ON GOV’T REFORM, 106TH CONG., NON-BINDING LEGAL EFFECT OF AGENCY GUIDANCE
DOCUMENTS, H.R. REP. NO. 106-1009, at 9 (2000) (“[A]gencies have sometimes improperly used guidance
documents as a backdoor way to bypass the statutory notice-and-comment requirements for agency
rulemaking . . .”); cf. The Regulatory Accountability Act of 2013, S. 1029, 113th Cong. (2013) (Section
706(d) would overrule Auer deference to agency interpretations of their own regulations); Todd D. Rakoff,
The Choice Between Formal and Informal Modes of Administrative Regulation, 52 ADMIN. L. REV. 159, 166
(2000) (arguing that agencies are avoiding ossified rulemaking process by use of nonbinding guidance). For
a concise overview of the legal and policy debates over guidance documents, see Nina A. Mendelson,
Regulatory Beneficiaries and Informal Agency Policymaking, 92 CORNELL L. REV. 397, 397-414 (2007). As I
discuss below, recent empirical research calls into question empirical basis for the theory of strategic
substitution of guidance documents for rules. See infra Part II.B.

1

Concern about agency reliance on guidance is also evident in the Supreme Court’s
doctrines governing the standards of judicial review of agency action. Based in part on the
preference for policy formulation through rulemaking and other more formal processes, in
2001, the Supreme Court announced a general presumption that to qualify for Chevron
deference,3 agency interpretations of the statutes the agency administers must be issued
through relatively formal processes, such as notice-and-comment rulemaking.4 That 2001
decision, United States v. Mead Corp.,5 gives agencies incentives to act through noticeand-comment as opposed to guidance documents if they seek to trigger Chevron deference
in review of their actions. In addition, in the last two years, three members of the Supreme
Court have announced their interest in reconsidering the longstanding doctrine identified
with Bowles v. Seminole Rock & Sand Co.6 and Auer v. Robbins,7 under which the
reviewing courts must accept agency interpretation of their regulations unless plainly
erroneous or inconsistent with the regulation.8 In the same time period, the Supreme Court
denied deference to an agency interpretation of its own regulation that appeared in a
litigation brief.9 These decisions suggest a narrowing of deference available to agencies
when they take interpretive positions or issue guidance informally and post hoc.
This multi-decade debate about guidance and its relationship to notice-andcomment rulemaking has largely passed over the function and varieties of
contemporaneous guidance—that is, guidance that agencies provide about the meaning of
their rules in the rulemaking process. Contemporaneous guidance appears in three main
forms. First, agencies provide guidance about the meaning and application of their rules in
explanatory “statement[s] of their basis and purpose,”10 statements which constitute the
bulk of the regulatory “preambles” issued with final rules. Second, they provide guidance
about the application and interpretation of their regulations in the Code of Federal
Regulations, in notes and examples, and appendices to rules that are published in the Code
3

Chevron U.S.A. Inc. v. Natural Resources Defense Council, 467 U.S. 837, 843-44 (1984).
United States v. Mead Corp., 533 U.S. 218, 230-31 (2001) (noting that agency decisions decided in noticeand-comment qualify for review under Chevron).
5
Id.
6
325 U.S. 410 (1945).
7
519 U.S. 452 (1997). While this doctrine was traditionally associated with Seminole Rock, since 1997 the
Supreme Court and other courts have frequently attributed it to Auer, see, e.g., Talk Am., Inc. v. Mich. Bell
Tel. Co., 131 S. Ct. 2254, 2265–66 (2011) (Scalia, J., concurring) (noting that the Seminole Rock doctrine has
recently been attributed to Auer), despite the fact that Auer involved a straightforward application of
Seminole Rock, see Auer, 519 U.S. at 461 (relying on Seminole Rock with little ado).
8
Decker v. Northwest Envt’l Def. Center, 133 S. Ct. 1326 (2013); id. at 1338 (Roberts, C.J., and Alito, J.,
concurring) (noting that it “may be appropriate to reconsider” Seminole Rock/Auer in another case); id. at
1339, 1442 (Scalia, J.) (concurring in part and dissenting in part) (urging the Court to overturn Seminole
Rock/Auer).
9
See Christopher v. SmithKline Beecham Corp., 132 S. Ct. 2156, 2166–68 (2012) (concluding that “general
rule” of granting Auer deference to interpretations in litigation briefs did not apply in these circumstances of
the case in view of fair notice concerns).
10
5 U.S.C. § 553 (2012).
4

2

of Federal Regulations. Third, at the same time that agencies promulgate their regulations,
they sometimes issue freestanding guidance documents. Contemporaneous guidance has a
fundamental fair-notice benefit: It furnishes the public and regulated entities the agency’s
understanding of the regulation at the time of issuance, reducing some of the uncertainty
incident to any new regulatory change, as opposed to later in time or in the context of an
enforcement proceeding.11
The neglect of contemporaneous guidance in debates about guidance practices and
rulemaking has practical implications along four dimensions. First, and at a most basic
level, there has been little dialogue among policymakers or commentators about the best
practices for providing guidance in the rulemaking process. Agencies have adopted a
diverse set of practices. While uniformity is not necessary or a value to unreflectively
demand of a practice as diverse and wide-ranging as rulemaking, the self-conscious
choices that some agencies make about how to issue contemporaneous guidance can be a
source of information and insight to other agencies. One aim of this Report is to catalogue
the variety of agency practices, and legal regime that governs them, as a prompt to
reflection about those that best suit particular rulemaking environments.
Second, while many agencies openly embrace the guidance function of preambles,
other agencies treat their preambles as unrelated to, and performing an entirely different
function than, their “guidance documents.” But by treating preambles as occupying a
functionally and conceptually distinct silo from guidance, some agencies neglect the basic
guidance function of the “statement of [] basis and purpose,” exclude preambles from their
general policies on guidance, fail to include reference to preambles in their official
compilations of guidance, and web postings of guidance. Many agencies could also do
more to make guidance they provide in preambles easier to locate, for instance, by
organizing them to make it easier for the reader to locate the most salient discussions of
each element of the regulation, limiting the extent to which they rely on discussions of the
rule in notice of proposed rulemaking (NPRM) which can require the reader to integrate
two separate statements of the rule, and/or by including hyperlinks to the preambular
guidance on electronic versions of their regulatory texts. A second aim of this Report is to
suggest reasons why contemporaneous guidance deserves a place at the table in debates
and agency choices about guidance practices and rulemaking, and to make several specific
supporting recommendations in this regard.

11

This is not to say that a broad variety of circumstances—uncertainty about how a regulation will affect
those subject to it, changes in technological, business, environmental or other conditions, newly acquired
expertise or studies, constraints on agency staff time, etc.—all provide a justification for issuing post hoc
guidance. But if all other considerations are equal, contemporaneous guidance has a fair notice benefit.

3

Third, at the other extreme, in some cases, agencies treat the text of their preambles
and the text of their rules as functional equivalents. Thinking about preambles as a source
of guidance also prompts inquiry into the boundaries of appropriate use of the preamble.
A third aim of the Report is to identify the residual need to insist on the distinctions
between preamble and regulatory text.
Fourth, agencies have unrealized opportunities for including notes and examples in
the Code of Federal Regulations (CFR) or more extensive guidance published as
appendices to the CFR. Where the agency knows that the regulated public relies primarily
on the CFR to understand its obligations, there is a strong need for uniformity in guidance,
and that guidance does not need to be frequently amended including notes and examples in
the CFR or more extensive guidance in an appendix to the CFR can enhance the visibility
of this agency advice. The Report also seeks to identify some of those opportunities.
This Report is organized as follows. Part I defines guidance and discusses the
scope of the inquiry and methodology of the Report. Part II gives a brief overview of
notice-and-comment rulemaking and the role of guidance in the rulemaking process. Part
III describes the legal regime governing guidance in preambles, regulatory text, and
contemporaneous, separately issued documents. The summary provided in Part III
illustrates the continuities between guidance issued in a preamble, regulatory text, and
separate documents, highlighting the need for self-conscious choice by agencies about the
forms in which they issue guidance. Part IV offers a description of the varieties of
contemporaneous guidance that agencies issue. Part V makes several recommendations to
federal agencies. Given that regulations have long since outnumbered statutes,12 it is worth
examining the promise and challenges that contemporaneous guidance faces.
I.
A.

Definition of Guidance and Scope of Inquiry

Definition and Dimensions of Guidance

It is first important to define what is meant by the word “guidance” in this Report.
By “guidance” this Report refers to (i) agency statements outside of those appearing in
regulatory text that pertain to the meaning or interpretation of the agency’s regulations or
to advice about how to comply with the agency’s regulations, and (ii) agency statements

12

See CORNELIUS M. KERWIN & SCOTT P. FURLONG, RULEMAKING: HOW GOVERNMENT AGENCIES WRITE
LAW AND MAKE POLICY 13-21 (4th ed. 2011) (documenting, in both number of rules and pages of the
Federal Register devoted to federal regulations, a level of production that far exceeds comparable measures
for federal legislation).

4

appearing in regulatory text that are designed to guide the application or interpretation of
the regulation, such as examples or official commentaries.
This definition departs from the most prominent definition of guidance which
appears in the Office of Management and Budget’s Final Bulletin on Agency Good
Guidance Practices (“OMB’s Good Guidance Bulletin”)13 in two important respects.
Under OMB’s Good Guidance Bulletin, a “guidance document” is “an agency statement of
general applicability and future effect, other than a regulatory action, that sets forth a
policy on a statutory, regulatory or technical issue or an interpretation of a statutory or
regulatory issue.”14 In contrast, this Report addresses only guidance about the meaning or
application of regulations, not guidance about statutes or other sources of law. In that
respect, this Report focuses on a narrower class of guidance that falls within the Bulletin’s
definition.
Second, this Report includes statements that appear in the regulation’s text or are
published in an appendix to the regulation’s text as forms of guidance. Because some of
these statements might qualify as “regulatory action[s]” under OMB’s Good Guidance
Bulletin’s definition of guidance, they would be excluded from its scope. Because
statements that are similar in content can appear in a regulation’s preamble, text, or a
separately issued document, the broader definition used in this Report does not preclude
consideration of these forms of guidance, and agencies’ justifications for using them. But
because “guidance” is so frequently associated with documents issued outside of
rulemaking, it is worth expressly emphasizing that under the definition of “guidance” used
here, the guidance may appear in a preamble or the text of a regulation, not merely in
separately issued documents.15
With guidance so defined, guidance can be classified on three dimensions:
1.
Timing. Guidance can be provided at the time of the regulation’s issuance
or at a later time. Contemporaneous guidance would include guidance that appears in a

OMB’s Good Guidance Bulletin, supra note 1. The definition of “guidance document” adopted in OMB’s
Good Guidance Bulletin is the same as that used in President Bush’s Executive Order, Further Amendments
to Executive Order 12866 on Regulatory Planning and Review, Executive Order 13,422, 72 Fed. Reg. 2763,
2762 (Jan. 23, 2007) (inserting Section 3(g) with this definition), which President Obama revoked. See Exec.
Order No. 13,497, 3 C.F.R. § 218 (2010).
14
See OMB’s Good Guidance Bulletin, supra note 1, at § I.3.
15
It is worth also emphasizing that statements in preambles could be considered guidance documents even
under the definition of guidance in OMB’s Good Guidance Bulletin because they are “an agency statement[s]
of general applicability and future effect, other than a regulatory action, that sets forth a policy on a . . .
regulatory or technical issue or an interpretation of . . . a regulatory issue.” Id.
13

5

preamble, the regulation’s text, or documents issued at the same time as the regulation,
such as compliance guides.16 All other guidance is post hoc.
2.
Content. Guidance can take innumerable forms, including: providing (1)
general advice about the meaning of particular words or provisions, (2) answers to
frequently asked questions, (3) announcement of priorities of the agencies with regard to
the enforcement of their regulations, (4) examples of calculations required under the
regulations, and (5) examples of model forms.
3.
Location. As noted above, guidance can also appear as part of different
documents, most obviously including: (1) the regulation’s preamble, (2) portions of the
agency’s reasoning stated in a Notice of Proposed Rulemaking (NPRM) adopted in the
regulation’s preamble, (3) the regulation text, such as in notes and examples, (4) an
appendix to the regulation’s text whether published in the Code of Federal Regulations
(CFR) or not, or (5) documents issued separately from these core rulemaking documents.
B.

Scope of Inquiry and Methodology

This Report focuses on this third dimension—the location of guidance. In almost
every rulemaking, agencies face a choice regarding guidance. They can issue virtually
identical advice and text in the regulation’s preamble, the regulation’s codified text or
appendix, or in a separate document issued alongside the rule; guidance that appears in
preambles in some rulemakings appears in regulatory text or separately issued documents
in other rulemakings. The variation is not itself a cause for concern; the difference in the
content of regulations, their audience, duration, and interaction with the surrounding legal
landscape among many other factors may justify these different choices, even for a single
agency. But because these different locations can have different legal effects, different
modes of publication, and different ability to reach the regulated, it is worth examining the
constraints on the agency’s choices and the considerations that inform their best practices
with regard to issuing contemporaneous guidance. Those questions are the focus of this
Report.
The Report was conducted primarily through legal research and research on
agencies’ practices in providing contemporaneous guidance. As to agency practices, the
research had two components. First, it involved text-based word searches of rulemakings
conducted in the last five years by executive agencies that had promulgated economically
16

Small Business Regulatory Enforcement Fairness Act, Pub. L. No. 104-121, § 212(a), 110 Stat. 873,
codified at 5 U.S.C. § 601 nt. (2012).

6

significant regulations in the last 15 years. The focus on the last five years was to ensure
study of current practices. The set of executive agencies that had issued an economically
significant rule in the last 15 years is drawn from David Lewis and Jennifer Selin’s
Sourcebook of the United States Executive Agencies.17 This sample was chosen because it
reflects a cross-section, at least of executive agencies, engaged in the most significant
rulemakings. Second, with the assistance of Staff Counsel at the Administrative
Conference of the United States (ACUS), I also conducted half-hour phone interviews with
counsel working on rulemaking in 12 agencies in January and February, 2014.18 The
Report includes discussion of examples of rulemakings from those agencies even if they
were not among those identified for the word searches of agency practices. On February
10, 2014, I presented an overview of the project for brown bag discussion at ACUS
headquarters attended by more than thirty other government lawyers working on
rulemaking. The experience and insight of the lawyers with whom I spoke informed the
recommendations and coverage of this Report.
II.

Guidance and Rulemaking: A Brief Overview

To assess the appropriate role of guidance in rulemaking today, it first makes sense
to begin with some background understanding of the place and prominence of guidance
within and outside of notice-and-comment rulemaking proceedings.
A.

The APA’s Vision: The Dual Role of the Statement of Basis and
Purpose -- Justification and Guidance

The Administrative Procedure Act (APA) provides a simple structure for noticeand-comment rulemaking, especially given the scope of federal lawmaking that now
emerges through this process. Section 553 of the APA sets out three basic elements of
notice-and-comment rulemaking.19 First, section 553 requires publication of a “[g]eneral
notice of proposed rulemaking” in the Federal Register, commonly referred to as an
17

DAVID E. LEWIS & JENNIFER L. SELIN, SOURCEBOOK OF UNITED STATES EXECUTIVE AGENCIES 132 (Table
20) (December 2012 First Edition). The following agencies fall in this category: USDA, DOC, DOD,
DOED, HHS, DHS, HUD, DOI, DOJ, DOL, STAT, DOT, DTRS, DVA, EPA, EEOC, OMB, OPM, RRB,
SBA, and SSA.
18
These agencies included the Board of Governors of the Federal Reserve System, Consumer Financial
Protection Bureau, Department of Education, Department of Health and Human Services, Department of the
Interior, Department of Transportation, Department of the Treasury, Equal Employment Opportunity
Commission, Merit Systems Protection Board, Occupational Health & Safety Review Commission, Social
Security Administration, and U.S. Coast Guard.
19
5 U.S.C. § 553 (2012). Section 553 provides a default process for rulemaking except in the rare case of a
statute that requires the rulemaking be conducted through the APA’s formal rulemaking procedure, see id. §
553 (noting that § 556 & § 557 apply when the rules are required by statute “to be made on the record and
after opportunity for an agency hearing”), or when a statute specifies its own rulemaking procedure.

7

“NPRM.”20 Second, after publication of that required notice, the agency “shall give
interested persons an opportunity to participate in the rule making through submission of
written data, views, or arguments.”21 Third, after consideration of these comments, “the
agency shall incorporate in the rules adopted a concise and general statement of their basis
and purpose.”22 The APA exempts from these notice and consideration requirements
“interpretative rules, general statements of policy, or rules of agency organization,
procedure, or practice,” among other exceptions, which are sometimes referred to as
nonlegislative rules or guidance documents.23
Early understandings of the APA suggest that the statement of basis and purpose,
which comprises much of what is commonly referred to as the regulation’s “preamble,”
was intended to have a dual role: not only identifying the legal and factual basis for the
rule, but also providing guidance on its meaning and import for the public and the courts.
This message comes through clearly in the Attorney General’s Manual on the
Administrative Procedure Act.24 Of the statement of basis and purpose, the Manual opines,
“[t]he required statement will be important in that the courts and the public will be
expected to use such statements in the interpretation of the agency’s rules.” 25 And the
Manual goes on, “the statement is intended to advise the public of the general basis and
purpose of the rules.”26 The APA’s legislative history also includes support for this
understanding. “The required statement of basis and purpose of rules issued,” as both the
House and Senate Judiciary Committee Reports commented on S.7 which became the
APA, “should not only relate to the date so presented but with reasonable fullness explain
the actual basis and objectives of the rule.”27
20

5 U.S.C. § 553(b) (2012).
Id. § 553(c).
22
Id.
23
Id. § 553(b)(3)(A); see Mendelson, supra note 2, at 406 (describing process applicable to guidance
documents).
24
UNITED STATES DEPARTMENT OF JUSTICE, ATTORNEY GENERAL’S MANUAL ON THE ADMINISTRATIVE
PROCEDURE ACT (1947).
25
Id. at 32.
26
Id.
27
H.R. REP. NO. 79-1980, at 259 (1946); S. REP. NO. 79-752, at 201 (1945), as available in ADMINISTRATIVE
PROCEDURE ACT, LEGISLATIVE HISTORY, 79TH CONG., S. Doc. No. 79-248, 1944-46, 225 (1944-46). The
Senate Report also contains as an appendix to the Attorney General’s 1945 report on Senate Bill 7. The
Attorney General’s report stated the following in regards to the statement of basis and purpose:
21

Section 4 (b), in requiring the publication of a concise general statement
of the basis and purpose of rules made without formal hearing, is not
intended to require an elaborate analysis of rules or of the detailed
considerations upon which they are based but is designed to enable the
public to obtain a general idea of the purpose of, and a statement of the
basic justification for, the rules. The requirement would also serve much
the same function as the whereas clauses which are now customarily
found in the preambles of Executive orders.

8

The idea that the statement of basis and purpose was meant to apprise the public of
the purpose and effect of the rule—that is, that it serve a guidance function—in addition to
disclosing the basis for the rule has sound logic. The statement of basis and purpose is
necessary for the procedural validity of the rule,28 and constitutes the agency’s
authoritative statement of the rule’s purposes and basis. Because the statement of basis
and purpose is part and parcel of the agency’s rulemaking, it makes sense these documents
would help inform the public about the meaning and application of the rules they
accompany, and that the public and courts would turn to them for those purposes.29 As this
Report documents, while many agencies rely extensively on statements of basis and
purpose to apprise the public of the application of their rules, the guidance function of
these statements has had not had prominence in policy on guidance nor received much
attention from government bodies or commentators.30
B.

The Expanding Preamble, Ossification, and Separately Issued
Guidance

Part of the explanation for the relative neglect of the guidance function of
preambles is that agencies have come to devote more and more attention in their preambles
to justifying the legal sufficiency of their rules. For some agencies, a clear legal division
of labor has taken hold: The preamble is devoted almost entirely to the legal sufficiency of
the regulation, and guidance is something the agency provides outside the rulemaking, in
separately issued documents.
This development has been conventionally understood as a consequence of
heightened judicial scrutiny review of the rationality of agency regulations that took hold
in the late 1960s and early 1970s in the form of “hard look review” and has persisted ever
since. Hard look review developed as a combination of two doctrinal elements. First, hard
look review adopts the pre-APA administrative law requirement associated with SEC v.

S. REP. NO. 752, at 225 (1945) (also available in ADMINISTRATIVE PROCEDURE ACT, LEGISLATIVE HISTORY,
79TH CONG., 2D SESS., Doc. No. 248, 1944-46, 225 (1946).
28
See Indep. U.S. Tanker Owners Comm. v. Dole, 809 F.2d 847, 852 (1987) (vacating a rule for inadequate
statement of basis and purpose).
29
See Kevin M. Stack, Interpreting Regulations, 111 Mich. L. Rev. 355 (2012) (defending reliance on
agency preambles to interpret regulations).
30
A few more comprehensive commentaries observe that agencies include statements of basis and purpose to
explain their rules, but do not give the practice focused attention. See, e.g., JEFFREY S. LUBBERS, A GUIDE TO
FEDERAL AGENCY RULEMAKING 337 (5th ed., 2012) (“Agencies often use the statement [of basis and
purpose] to advise interested persons how the rule will be applied.”); Richard J. Lazarus, Meeting the
Demands of Integration in the Evolution of Environmental Law: Reforming Environmental Criminal Law,
83 GEO. L.J. 2407, 2437 (1995) (noting that lengthy preambles are just one sources of “underground
environmental law” which also includes extensive guidance).

9

Chenery Corp.31 (known as Chenery I), which stated that a reviewing court will uphold an
agency’s action based only on “the grounds upon which the agency acted in exercising its
powers.”32 Second, hard look review embraces a relatively high standard for the quality of
the reasons provided by the agency, despite statements by courts that arbitrary and
capricious review is lenient or narrow.33 When the Chenery I requirement for a
contemporaneous statement of reasons is combined with a high standard for the quality of
those reasons, the consequences for the agency are clear: For rules to survive judicial
review, the agency must provide an extremely detailed justification of their grounds. The
place for the agency to do so is in the rule’s statement of basis and purpose.
The Supreme Court’s decision in Motor Vehicle Manufacturers Ass’n v. State Farm
Mutual Automobile Insurance Co.34 still provides the classic statement and illustration of
hard look review. In State Farm, the Court set a high standard for the agency’s level of
express justification in its statement of basis and purpose in the rule. To avoid being
arbitrary or capricious under section 706 of the APA, the agency must “examine the
relevant data and articulate a satisfactory explanation for its action, including a ‘rational
connection between the facts found and the choice made.’”35 An agency rule would
normally be arbitrary and capricious if “the agency has relied on factors which Congress
has not intended it to consider, entirely failed to consider an important aspect of the
problem, offered an explanation for its decision that runs counter to the evidence before the
agency, or is so implausible that it could not be ascribed to a difference in view or the
product of agency expertise.”36 In State Farm, the Supreme Court reversed the agency’s
decision to rescind a rule under this standard, in part because the agency provided no
consideration of one of the viable options within the ambit of the existing rule.37 Since the
State Farm decision, both the Supreme Court and the Courts of Appeals have emphasized
that the vesting of wide power for agencies “carries with it a correlative responsibility for
the agency to explain the rationale and factual basis for its decision,”38 a duty that agencies
discharge in their statements of basis and purpose. This duty not only includes evaluation
of alternatives and explanation of the basis for the regulations adopted, but also a duty to
discuss salient comments.39 As a result, the agency’s articulation of the grounds of its

31

318 U.S. 80 (1943).
Id. at 95.
33
See, e.g., Citizens to Overton Park, Inc. v. Volpe, 401 U.S. 402, 416 (1971) (describing the standard as a
“narrow” one); Muwekma Ohlone Tribe v. Salazar, 708 F.3d 209, 220 (D.C. Cir. 2013) (same).
34
463 U.S. 29 (1983).
35
Id. at 43.
36
Id.
37
Id. at 51
38
Bowen v. Am. Hosp. Ass’n, 476 U.S. 610, 627 (1986); see also, e.g., Detsel by Detsel v. Sullivan, 895
F.2d 58, 63 (2d Cir. 1990).
39
See, e.g., Am. Mining Cong. v. EPA, 965 F.2d 759, 771 (9th Cir. 1992).
32

10

action and engagement with commentators in its statement of basis and purpose is
necessary to the validity of the rule.
As these doctrines of judicial review congealed in the contemporary hard look
doctrine, the length of regulatory preambles has grown as measured by the average number
of pages per final rule published in the Federal Register. Based on a study performed by
the Congressional Research Service, the average number of Federal Register pages per
final rule in 1976, 1977, 1978 was 1.7, 2.07, 2.2 respectively, whereas the averages in
2009, 2010, and that 2011 were 5.93, 6.97, and 6.91 respectively.40 The common sense
explanation is that the prospect of stringent judicial review, which requires the agency to
“show it’s work,” has prompted agencies to devote more energy to writing elaborate
statements of the legal sufficiency of their regulations in their preambles. 41 Other analysis
requirements imposed on agencies also add to the explanatory obligations the agency must
discharge in their preambles, including the analysis requirements imposed by Executive
Order 12,866,42 the Regulatory Flexibility Act,43 the Paperwork Reduction Act of 1995,44
the National Environmental Policy Act of 1969,45 and the Unfunded Mandates Reform Act
of 1995,46 among other analysis and consultation requirements.
At the same time that the agency’s duties of explanation—and actual
explanations—of the basis for their rules in preambles has grown, the need for guidance as
to the meaning and application of agency regulations has not gone away.

40

MAEVE P. CAREY, CONG. RES. SERV. R43056, COUNTING REGULATIONS: AN OVERVIEW OF RULEMAKING,
TYPES OF FEDERAL REGULATIONS, AND PAGES IN THE FEDERAL REGISTER, 17-18 (2013) (calculations
produced by dividing the number of pages per final rule by the number of final rules, information reported in
Table 6).
41
See, e.g., Richard J. Pierce, Jr. Seven Ways to Deossify Agency Rulemaking, 47 ADMIN. L. REV. 59, 65
(1997) [hereinafter “Seven Ways”] (suggesting that the stringent judicial gloss on the APA has
“transform[ed] the simple, efficient notice and comment process into an extraordinarily lengthy, complicated,
and expensive process,” discouraging agency use of rulemaking); Thomas O. McGarity, Some Thoughts on
“Deossifying” the Rulemaking Process, 41 DUKE L.J. 1385, 1401 (1992) (attributing the “Herculean effort of
assembling the record and drafting a preamble” to heightened judicial scrutiny of rulemaking); Mark
Seidenfeld, Demystifying Deossification: Rethinking Recent Proposals to Modify Judicial Review of Notice
and Comment Rulemaking, 75 TEX. L. REV. 483, 492-98 (1997) (providing account of ways in which hard
look review has increased burdens of explanation and evidence production on agencies).
42
Exec. Order No. 12,866, 3 C.F.R 638 (1994). For a copy of this Regulatory Planning and Review
Executive Order as amended, see 5 U.S.C. § 601 nts. (2012).
43
5 U.S.C. § 604(a)(2) (2012) (requiring agencies to state changes made in rule in response to comments).
44
44 USC §§ 3501-3521 (2006) (requiring in § 3505 approval by Director of OMB that rules minimize
federal information collection burdens).
45
42 USC § 4321 et seq. (2006) (requiring in § 4332 preparation of environmental impact statement for
significantly effecting the quality of the human environment).
46
2 U.S.C. § 1532(a)(5)(A) (2012) (requiring agencies to respond to comments from state and local
governments).

11

A common suspicion is that the increased costs associated with notice-andcomment rulemaking has given agencies incentives to look for alternative, less costly ways
to establish policy or advise the public of the agency’s understanding of the law. In
particular, several commentators suggested that the high cost of notice-and-comment
rulemaking has caused agencies to rely to a greater extent on separately issued guidance
documents which need not proceed through notice-and-comment rulemaking,47 effectively
substituting guidance documents for rulemaking.48 Recent empirical investigations call
into question this suggestion that agencies rely on guidance documents to avoid the
burdens of notice-and-comment rulemaking. In a study of the Environmental Protection
Agency (EPA), Food and Drug Administration (FDA), Federal Communications
Commission (FCC), Occupational Safety and Health Administration (OHSA), and the
Internal Revenue Service (IRS), between 1996 and 2006, Connor Raso found that agencies
do not increase their issuance of guidance strategically,49 and that the body of significant
legislative rules issued still dwarfs that of significant guidance.50 In an extensive study of
the Department of the Interior, Jason and Susan Webb Yackee also found no support for
increased reliance on nonlegislative rules between 1950-1990.51 More generally, Anne
Joseph O’Connell also found that the volume of agency notice-and-comment rulemaking
remains significant, and thus does not appear to be so costly that it is no longer a viable
option for agencies.52
47

See 5 U.S.C. § 553(b) (2012) (excepting interpretative rules and general statements of policy from notice
and comment requirements).
48
See, e.g., Robert A. Anthony, Interpretive Rules, Policy Statements, Guidances, Manuals, and the Like—
Should Federal Agencies Use Them to Bind the Public?, 41 DUKE L.J. 1311, 1316-17(1992) (arguing that
with the increased cost of notice-and-comment rulemaking, agencies are increasingly willing to rely on forms
of nonlegislative rules, such as interpretative rules and general statements of policy to implement their
statutes); Pierce, Seven Ways, supra note 41, at 86 (same).
49
Connor Raso did not find evidence that agencies issued guidance documents more often as presidential
terms waned, nor more frequently during periods of divided government. See Connor N. Raso, Note,
Strategic or Sincere? Analyzing Agency Use of Guidance Documents, 119 YALE L.J. 782, 806-07 (2010).
50
See Raso, supra note 49, at 813-14 (Table 3 showing that the ratio of significant guidance documents to
significant legislative rules ranges from .00 and .01 (Defense and Energy) to .31 and .35 (Education and
Homeland Security)).
51
Jason Webb Yackee & Susan Webb Yackee, Testing the Ossification Thesis: An Empirical Examination of
Federal Regulatory Volume and Speed, 1950-1990, 80 GEO. WASH. L. REV. 1414, 1461 (2012). The
Yackees’ article includes interim final rules and guidance documents in a category on “no-comment
regulations,” drawn from searches of the Federal Register. With regard to guidance published in the Federal
Register, this methodological choice means that their findings of no increased reliance on guidance is very
conservative because they are counting interim final rules in this category. However, their study does not
capture guidance that is not published in the Federal Register, so may also understate agency reliance on it.
52
See Anne Joseph O’Connell, Political Cycles of Rulemaking: An Empirical Portrait of the Modern
Administrative State, 94 VA. L. REV. 889, 936 (2008) (suggesting that volume of agency rulemaking shows it
is not ossified). Interestingly, Anne Joseph O’Connell’s study reveals that agencies have increased issuance
of direct final rules and interim final rules. See id. Both direct final rules and interim final rules include
statements equivalent to statements of basis and purpose, but they do not undergo a pre-publication comment
period. NAT’L ARCHIVES & RECORDS ADMIN., FEDERAL REGISTER DRAFTING DOCUMENT HANDBOOK, 2-6
to 2-8 (1998) (noting that direct final rules and interim final rules should include preambles explaining the

12

These studies complicate and may undermine the view that agencies have
increasingly relied on separately issued guidance documents in response to the greater
demands on, and costs of, notice-and-comment rulemaking. But these studies do not
address the extent to which the agency preambles have been devoted to justifying the legal
sufficiency of the regulations as opposed to serving a guidance function. The increased
legal demands saddled upon the agency’s preamble have all been directed toward legal
sufficiency or analysis requirements, not their guidance function.53 To the extent those
increased justificatory and analysis requirements have had an effect on agency’s activities
in rulemaking—and the lengthening of agency preambles is a good indication that they
have an effect—they have augmented the prominence of the justificatory role of the
preamble. At the same time, even as policymakers and commentators have devoted more
attention to agencies’ use of guidance, that attention has been almost exclusively directed
to separately issued guidance documents, not guidance provided within rulemaking
documents. We need a better understanding of the guidance function these documents
do—and must—serve.
III.

The Law Governing Contemporaneous Guidance

Assessment of best practices for providing guidance in rulemakings—that is, best
practice for contemporaneous guidance—requires understanding the legal regime and
constraints that apply to providing guidance in regulatory preambles, the regulatory text
(including any appendices), or in separately issued documents. Despite the ubiquity of
contemporaneous guidance,54 there are few, if any, resources that draw together the legal
regime applicable to contemporaneous guidance. From the perspective of the agency and
the public, there are a host of questions about how the general law of guidance applies to
contemporaneous guidance, including:



What, if any, process requirements apply to issuing contemporaneous
guidance?
What, if any, process requirements apply to revising contemporaneous
guidance?

rule’s purpose and grounds). Agencies’ increased reliance on these forms suggests that at least the “noticeand-comment rulemaking has significant costs that the agencies want to avoid.” Joseph O’Connell, supra, at
936.
53
See, e.g., Unfunded Mandates Reform Act, 2 U.S.C. § 1523(a) (2006); Small Business Regulatory
Enforcement Fairness Act, 5 U.S.C. § 609, Pub. L. No. 104-121, 110 Stat. 857 (1996); Regulatory Flexibility
Act, 44 U.S.C. §§ 301-612 (2006); Congressional Review Act, 5 U.S.C §§ 801-08 (2006); Paperwork
Reduction Act, 44 U.S.C. §§ 3501-20 (2006); 44 U.S.C. § 3504(c) (2006).
54
See infra Part IV.

13







When is contemporaneous guidance subject to OIRA review?
What, if any, guidance must be included in a regulatory preamble or
regulatory text, or separately issued document?
What, if any, guidance may not be included in a regulatory preamble or
regulatory text?
What forms of contemporaneous guidance are reviewable?
What standards of judicial review apply?

This Part addresses these questions, and then provides a summary of the answers in
Table 1.55
A.

Process Requirements for Issuing Contemporaneous Guidance

One of the distinctive features of separately issued guidance documents is that they
are exempt from the requirements of notice-and-comment under APA § 553(b)(A).56 But
this does not mean that there are no applicable procedural requirements. The APA requires
that interpretive rules and general statements of policy be published in the Federal
Register,57 and that other forms of guidance be publically available.58 Preambles and
regulatory text obviously must meet that publication requirement.
The more involved and less explored process issue for contemporaneous guidance
arises from those agencies covered by OMB’s Good Guidance Bulletin.59 As noted at the
outset, this Bulletin defines “guidance documents” to exclude regulatory actions,60 so it
would not apply to any guidance the agency provided in the text of its regulations. But
under the definition in the Bulletin, agency preambles (as well as separately issued
documents) could qualify as guidance documents within the Bulletin because they may be
statements of “general applicability and future effect . . . that set[] forth a policy on a . . .
regulatory issue or interpretation of a . . . regulatory issue.”61 Likewise, statements in an
agency preamble could also constitute “significant guidance” which includes guidance
leading to an annual effect on the economy of more than $100 million, creating serious
55

See infra Section III(H).
5 U.S.C. § 553(b)(A) (2012).
57
See id. § 552(a)(1)(D).
58
See id. § 552(a)(2)(B) (2012).
59
OMB’s Good Guidance Bulletin, supra note 1. The Bulletin applies only to executive agencies. See id. §
I.2 (defining “agency” as agencies other than those considered to be independent regulatory agencies under
44 U.S.C. § 3205(5)).
60
Id. § I.3 (“The term ‘guidance document’ means an agency statement of general applicability and future
effect, other than a regulatory action (as defined in Executive Order 12866, as further amended by, section
3(g)), that sets forth a policy on statutory, regulatory, or technical issue or an interpretation of a statutory or
regulatory issue.”).
61
Id.
56

14

inconsistencies with another agency’s actions or planned actions, altering budget impacts
on entitlements, or raising novel legal issues arising out of legal requirements or the
president’s priorities or Executive Order 12,866.62
Accordingly, for executive agencies, to the extent any statements in an agency
preamble as well as those in separately issued documents would be considered “significant
guidance documents” or even “economically significant guidance documents” under the
Bulletin, the agency would have to comply with the procedural requirements the Bulletin
imposes.63 Most interesting for their application to preambles are the requirement that: (1)
there be a designation of the statement as “guidance” (or its equivalent), 64 (2) the agency
maintain on its web site a list of significant guidance documents,65 and (3) the agency
structure a means for the public to submit comments on significant guidance documents.66
While many agencies provide extensive guidance about the meaning and operation of their
regulations in their preambles, few agencies appear to treat their preambles as subject to
the procedural requirements of OMB’s Good Guidance Bulletin which, by its own terms,
could apply to guidance provided in preambles.
Consider in particular OMB’s Good Guidance Bulletin’s requirement that each
agency maintain on its web site a list of its current significant guidance documents in
effect, including a link to the document.67 Based on a review of the web sites of the 21
executive branch agencies that have issued an economically significant regulation in the
last 15 years,68 only the Department of Transportation’s web site on guidance mentions
preambles as a source of guidance.69
In sum, while guidance provided in agency preambles or in regulatory text clearly
meet the APA’s publication requirements, these same statements, if their effects are
significant, could require compliance with OMB’s Good Guidance Bulletin. That would
require the agency to be conscientious about how it designated those guidance portions, to
62

Id. § I.4(a)(i)-(iv).
Id. § II.2-3 (outlining basis procedures for significant guidance). The Bulletin’s imposition of procedural
requirements for issuing guidance builds upon ACUS Recommendation 92-2 on Agency Policy Statements.
That recommendation urged agencies to provide procedures to challenge the legality and wisdom of the
statements prior to these policies being applied. See Admin. Conf. of the United States, Agency Policy
Statements, Recommendation 92-2, ¶ II(B), 57 Fed. Reg. 30,103 (June 18, 1992).
64
Id. § II.2 (setting out requirement elements for significant guidance).
65
Id. § III.1 (providing for Web posting of significant guidance).
66
Id. § III.2 (setting forth requirements for public to submit comments and complaints about its guidance).
67
Id. § III.1.
68
This list of agencies is drawn from LEWIS & SELIN, supra note 17, at 132 (Table 20). It includes: USDA,
DOC, DOD, DOED, HHS, DHS, HUD, DOI, DOJ, DOL, STAT, DOT, DTRS, DVA, EPA, EEOC, OMB,
OPM, RRB, SBA, and SSA.
69
The web sites on guidance for the agencies noted did not include mention of preambles or a rule’s
statement of basis and purpose, except for DOT (websites on guidance visited March 2014).
63

15

post or mention preambles alongside other significant guidance on their web sites, and
even to provide an opportunity to comment on the significant guidance in preambles,
among other requirements.
B.

Process Requirements for Revising Contemporaneous Guidance: The
Impact of Alaska Professional Hunters

The process requirements that apply to an agency decision to revise
contemporaneously issued guidance are even clearer than those that apply to issuing
contemporaneous guidance. Clearly guidance issued as part of a regulatory text can only
be revised through a new notice-and-comment proceeding. Based on the rule adopted by
the D.C. Circuit in Alaska Prof’l Hunters Ass’n v. FAA70 and Paralyzed Veterans of
America v. D.C. Arena,71 in some cases, agencies must also proceed through notice-andcomment to revise guidance provided in their preambles.
The “Alaska Hunters” rule, also known as the “one-bite” rule,72 states that “[w]hen
an agency has given its regulation a definitive interpretation, and later significantly revises
that interpretation, the agency has in effect amended its rule, something it may not
accomplish without notice and comment.”73 As the D.C. Circuit recently clarified in
Mortgage Bankers Ass’n v. Harris,74 this rule involves two basic inquiries: whether the
interpretation is definitive (“definitiveness”), and whether there has been a significant
change in the interpretation (“significant change”), but does not require substantial and
justified reliance on the prior interpretation.75
In Paralyzed Veterans, the D.C. Circuit characterized a change in an interpretation
of a rule as an “amendment” to a regulation.76 The court then turned to APA § 551(5),
which defines “rulemaking” as including “formulating, amending, or repealing a rule.”77
On this basis, the court concluded that amendments in the form of changes to
interpretations must go through notice-and-comment.78 As commentators have pointed out,
the Paralyzed Veterans court neglected to consider that § 553, which sets forth the

70

177 F.3d 1030, 1035-36 (D.C. Cir. 1999).
117 F.3d 579, 588 (D.C. Cir. 1997).
72
Stack, supra note 29, at 415–16.
73
177 F.3d at 1034.
74
720 F.3d 966 (D.C. Cir. 2013), petition for cert. filed, Nos. 13-1041, 13A636 (Feb 28, 2014).
75
Id. at 969; Matthew P. Downer, Note, Tentative Interpretations: The Abracadabra of Administrative
Rulemaking and the End of Alaska Hunters, 67 VAND. L. REV. (forthcoming 2014) (exploring distinction
between definitive and tentative interpretations).
76
See Paralyzed Veterans, 117 F.3d at 586.
77
Id.
78
Id.; 5 U.S.C. 551(5) (2012).
71

16

requirements for notice-and-comment rulemaking, specifically exempts “interpretative
rules” from notice-and-comment.79
Alaska Hunters formalized Paralyzed Veterans into a doctrine.80 At issue in Alaska
Hunters was a thirty-year-old practice of the Federal Aviation Administration’s Alaska
regional office that uniformly advised hunting and fishing guides flying clients on Alaskan
hunting tours that they were not considered “commercial operators,” a treatment that
resulted in exempting these businesses from some FAA regulations.81 In 1997, FAA
officials in Washington, D.C. published a “Notice to Operators” announcing that it would
interpret these hunting businesses as “commercial operators” subject to commercial
operator regulations going forward.82 Relying on Paralyzed Veterans, the Alaska Hunters
court held that the “Notice to Operators” was procedurally invalid because it effectively
amended a regulation by changing a definitive interpretation without notice-andcomment.83 The prior interpretation, the court noted, had become “an authoritative
departmental interpretation, an administrative common law.”84 In subsequent decisions,
the D.C. Circuit has narrowed the scope of this rule somewhat, holding that when an
administrative interpretation includes conditional language (e.g., “may use,” “can be
used”) or did not establish an “express, direct, and uniform interpretation,”85 it is not
definitive. While roundly criticized by commentators as inconsistent with the APA §
553,86 the D.C. Circuit and several other Circuits continue to apply this doctrine.87
79

Jon Connolly, Note, Alaska Hunters and the D.C. Circuit: A Defense of Flexible Interpretive Rulemaking,
101 COLUM. L. REV. 155, 160, 165 (2001).
80
Alaska Prof’l Hunters Ass’n, 177 F.3d at 1034 (citing Paralyzed Veterans, 117 F.3d at 586) (“‘Rule
making,’ as defined in the APA, includes not only the agency’s process of formulating a rule, but also the
agency’s process of modifying a rule.”).
81
Id. at 1031-32.
82
Id. at 1033.
83
Id. at 1034.
84
Id. at 1035.
85
MetWest Inc. v. Sec’y of Labor, 560 F.3d 506, 509 (D.C. Cir. 2009) (conditional statement,
“circumstances may exist,” in guidance does not establish a definitive agency interpretation); Darrell
Andrews Trucking, Inc. v. Fed. Motor Carrier Safety Admin., 296 F.3d 1120, 1126 (D.C. Cir. 2002)
(presence of language “can be used” or “could be used” rendered guidance ambiguous and thus did mark a
definitive interpretation); Ass’n of Am. R.R.s v. Dep’t of Transp., 198 F.3d 944, 949 (D.C. Cir. 1999)
(agency interpretations not sufficiently authoritative or uniform).
86
Richard W. Murphy, Hunters for Administrative Common Law, 58 ADMIN. L. REV. 917, 918 (2006)
(“Academic commentary on [the Alaska Hunters doctrine] has been scathing.”); see also William Funk, A
Primer on Nonlegislative Rules, 53 ADMIN. L. REV. 1321, 1329 (2001) (criticizing the D.C. Circuit's
reasoning in Alaska Hunters); Pierce, Seven Ways, supra note 41, at 566 (same); Peter L. Strauss, Publication
Rules in the Rulemaking Spectrum: Assuring Proper Respect for an Essential Element, 53 ADMIN. L. REV.
803, 846 (2001) (same); Connolly, supra note 79, at 157 (same).
87
See Mortg. Bankers Ass’n v. Harris, 720 F.3d 966 (D.C. Cir. 2013) (reaffirming the Alaska Hunters
doctrine). The Third, Fifth and Sixth Circuits have adopted the Alaska Hunters doctrine. See SBC Inc. v.
FCC, 414 F.3d 486, 498 (3d Cir. 2005); Dismas Charities, Inc. v. U.S. Dept. of Justice, 401 F.3d 666, 682
(6th Cir. 2005); Shell Offshore Inc. v. Babbitt, 238 F.3d 622, 629 (5th Cir. 2001). In contrast, the First,
Seventh, and Ninth Circuits have rejected the Alaska Hunters doctrine. See Abraham Lincoln Mem’l Hosp. v.

17

The Alaska Hunters rule has clear implications for preambles. It seems clear that
guidance provided in a preamble to a regulation could be definitive under Alaska Hunters.
Guidance provided in a preamble is clearly authoritative; it is the agency as an institution
that issues it. So long as it was not conditional or ambiguous, it would qualify as a
definitive interpretation. As a result, under Alaska Hunters, for the agency to significantly
change its definitive guidance provided in a preamble would require the agency to undergo
a new notice-and-comment proceeding.
The idea that a notice-and-comment proceeding is required to change guidance
given in a preamble to a regulation may strike many as an odd result in part because it
appears to blur the distinction between rule and preamble. That blurring follows from
Alaska Hunters, but also has an important implication for agencies: For definitive
guidance, there may be less procedural difference that would initially appear between
statements in the preamble and in the regulatory text. So long as the statements in the
preamble are definitive, then they can be changed, like regulatory text, only through
notice-and-comment. So the difference in procedural requirements is only a difference in
the processes that govern their issuance: Regulatory text is subject to notice-and-comment
under the APA, whereas guidance in a preamble, like separately issued guidance, is at most
subject to the notice obligations imposed by OMB’s Good Guidance Bulletin (which in
turn involves notice and comment for economically significant guidance).
C.

When Is Contemporaneous Guidance Subject to OIRA Review?

For agencies that are not independent regulatory agencies,88 preambles to
significant final rules, the text of those rules, as well as significant guidance documents are
all subject to some oversight by the Office of Information and Regulatory Affairs under
Executive Order 12,866.89
Executive Order 12,866 defines regulatory actions as “any substantive action by an
agency (normally published in the Federal Register) that promulgates or is expected to
lead to the promulgation of a final rule or regulation . . . advanced notices of proposed
rulemaking, and notices of proposed rulemaking.”90 Preambles to final rules and
Sebelius, 698 F.3d 536 (7th Cir. 2012); Erringer v. Thompson, 371 F.3d 625 (9th Cir. 2004); Warder v.
Shalala, 149 F.3d 73 (1st Cir. 1998). The Tenth Circuit appeared to criticize the Alaska Hunters decision, but
did not either formally adopt or reject it. See United States v. Magnesium Corp. of Am., 616 F.3d 1129 (10th
Cir. 2010).
88
Exec. Order. No. 12,866 § 3(b), 3 C.F.R 638 (1994) (defining agencies, unless otherwise noted, as
excluding independent regulatory agencies as listed in 44 U.S.C. § 3502(10)).
89
Id. at § 3(e).
90
Id.

18

regulatory text are clearly “regulatory actions.” As such, under the Executive Order’s
Centralized Review provisions, for regulations that are “significant,”91 covered agencies
must provide the text of the preamble and the regulatory text to OIRA for review.92
In addition, “significant” guidance documents are also subject to OIRA review.
While President Obama revoked President Bush’s Executive Order which formally
subjected guidance documents to review,93 that did not remove significant guidance
documents from OIRA review. As former OIRA Administrator Cass Sunstein reports,
“Across multiple administrations, OIRA has long reviewed such [guidance] documents . . .
so long as they count as ‘significant.’”94 This understanding was confirmed by then-OMB
Director Peter Orzag in a March 2009 memorandum that made clear that the revocation of
President Bush’s Executive Order formally including guidance in regulatory review
restored regulatory review to the process between 1993 and 2007. 95 “During that period,”
Director Orzag wrote, “OIRA reviewed all significant proposed final agency actions,
including significant policy and guidance documents.”96
D.

What Contemporaneous Guidance is Required?

While the law does not require including particular guidance in regulatory text,97
there are minimum obligations for contemporaneous guidance to be included in regulatory
preambles as well as in separate guidance documents called “compliance guides” for rules
that have “a significant impact on a substantial number of small entities,” as required by
the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA).98

91

Id. § 3(e).
Id. § 6(a)(3)(B).
93
Exec. Order No. 13,497, 3 C.F.R. § 218 (2010), revoking Exec. Order No. 13422, 3 C.F.R. § 191 (2008)
(revoked) (subjecting guidance to regulatory review).
94
Cass R. Sunstein, The Office of Information and Regulatory Affairs: Myths and Realities, 126 HARV. L.
REV. 1838, 1853 (2013).
95
See Orzag Memorandum, supra note 2. The issuance of this memorandum, Sunstein reports, “reflects
broad support for such review within the Executive Office of the President,” notwithstanding the fact that
guidance might strictly fit within Executive Order 12,866’s definition of “regulatory action.” See Sunstein,
supra note 94, at 1853 n.60. For a description of the character of OIRA’s review of guidance documents
during that period, see Jennifer Nou, Agency Self-Insulation Under Presidential Review, 126 HARV. L. REV.
1755, 1785 (2013).
96
See Orzag Memorandum, supra note 2.
97
President Clinton’s directive on plain language, which includes plain language in final rules, remains in
effect. See Memorandum for the Heads of Executive Departments and Agencies on “Plain Language in
Government Writing” (June 1, 1998), 63 Fed. Reg. 31,885 (June 10, 1998).
98
5 U.S.C. § 601 notes, § 212 (requiring the production of compliance guides whenever the agency must
produce a regulatory flexibility analysis under 5 U.S.C. § 605(b) and quoting § 605(b)).
92

19

1.

Preambles

The near exclusive focus on the justificatory function of statements of basis and
purpose in regulatory preambles also completely occludes the question of what minimum
level of guidance preambles must provide. There are two legal sources that could be
understood to impose a minimum guidance obligation on the agency: the requirement of
APA § 553 that the agency issue a “statement of [] basis and purpose,” and the Regulatory
Flexibility Act’s requirement that agencies engaged in rulemaking under § 553 provide a
“statement of the need for, and objective of, the rule.”99
These requirements ensure that a minimum guidance function is served by the
preamble. Independent U.S. Tanker Owners Committee v. Dole100 provides the established
formulation of the necessary requirements for an agency’s statement of basis and purpose
to be procedurally valid. While the statement need not “be an exhaustive, detailed account
of every aspect of the rulemaking proceedings,” the statement “should indicate the major
issues of policy that were raised in the proceedings and explain why the agency decided to
respond as it did, particularly in light of the statutory objectives that the rule must
serve.”101 Under this standard, the Independent U.S. Tankers court concluded that the
agency’s statement did not explain how the rule furthered statutory objectives, and
accordingly vacated the rule.102
Requiring this articulation in the statement of basis and purpose clearly helps a
reviewing court assess whether the agency has taken a hard look at the problem in light of
its statutory objectives. But it just as clearly serves a guidance function. It requires the
agency to provide an independent articulation of the purpose of the rule and its place in the
implementation of the statute. The fact, as Independent Tankers held, that issuing a
statement of basis and purpose with an adequate explanation of how the rule furthers the
statute’s purposes is procedurally necessary for a notice-and-comment rulemaking103
suggests that guidance is one of the purposes—and minimum obligations imposed on—
these statements. In other words, part of what makes a statement of basis procedurally
valid is providing a minimum level of guidance that explains how the rule implements the
statute’s purpose. From this perspective, statement of basis and purpose that falls short of
this minimum requirement does not perform its necessary guidance function of stating the
rule’s purposes in light of statutory objectives.104
99

5 U.S.C. § 604(a)(1) (2012)
809 F.2d 847 (D.C. Cir. 1987).
101
Id. at 852.
102
Id.
103
Id.
104
Direct Final Rules and Interim Final rules should also include the functional equivalent of a preamble, see
FEDERAL REGISTER DRAFTING DOCUMENT HANDBOOK, supra note 52, at 2-6 to 2-8 (1998) (noting that direct
100

20

The Regulatory Flexibility Act (RFA) requires that when an agency promulgates a
final rule through notice-and-comment, the agency must provide a “regulatory flexibility
analysis” that includes “a statement of the need for, and objectives of, the rule,”105
published in the Federal Register.106 The RFA’s requirements are “[p]urely procedural”
and so “requires nothing more than that the agency file a [final regulatory flexibility
analysis] demonstrating a ‘reasonable, good-faith effort to carry out [RFA’s] mandate’.”107
Still, RFA sets out “precise, specific steps the agency must take.”108 And reviewing courts
will assess whether the agency’s analysis “addressed all of the legally mandated subject
areas.”109 Substantial compliance is not authorized.110 Accordingly, where an agency fails
to address one of those mandated subjects, a reviewing court will remand to the agency to
conduct the analysis required by RFA.111
While courts deferentially review the substance of an agency’s final regulatory
flexibility analysis for the purposes of assessing compliance with RFA, the fact remains
that the agency must state the need for and objectives of the rule. That requirement also
enforces discipline on the agency, requiring it to have a clearly stated objective and
rationale for its rules. The requirement of publication in the Federal Register suggests that
there is a minimum guidance function enforced by RFA as well.
At a minimum, both the APA and the RFA require the agency to provide a
statement of the need for the rule and the rule’s objectives in light of the authorizing
statute’s aims. Preambles that do not include those statements do not satisfy their guidance
function and thus should be procedurally invalid.
2.

Separately Issued Documents

Section 212 of SBREFA requires agencies to publish a “small entity compliance
guide” at the same time as the publication of the final rule (or as soon as possible

final rules and interim final rules should include preambles explaining the rule’s purpose and grounds);
Ronald M. Levin, Direct Final Rulemaking, 64 GEO. WASH. L. REV. 1, 16-18 (1995) (noting direct final rules
and interim final rules include functional equivalent of statement of basis and purpose), which could also be
viewed as having the same minimum guidance function.
105
5 U.S.C. § 604 (2012).
106
5 U.S.C. § 604(a)(6)(b) (2012).
107
United States Cellular Corp. v. FCC, 254 F.3d 78, 88 (D.C. Cir. 2001).
108
Nat’l Tel. Co-op. Ass’n v. FCC, 563 F.3d 536, 539-40 (D.C. Cir. 2009).
109
Id.
110
Aeronautical Repair Station Ass’n v. FAA, 494 F.3d 161, 178 (D.C. Cir. 2007) (remanding to FAA
inadequate FRFA but not staying effect of rule).
111
See id. at 177-78.

21

thereafter) and no later than when the rule becomes effective.112 These guides shall
“explain the actions a small entity is required to take to comply with a rule,”113 which
“shall include a description of actions needed to meet the requirements of a rule, to enable
a small entity to know when such requirements are met,”114 and include descriptions of
procedures that “may assist a small entity in meeting” the rule’s requirements.115 These
guides must be written “using sufficiently plain language likely to be understood by the
affected small entities.”116 These compliance guides must be easily accessible on the web
site of the agency, and distributed to known industry contacts, such as affected
associations.117
E.

What May Not Be Included in Contemporaneous Guidance?

1.

Restrictions on Guidance in the Code of Federal Regulations

Only those rules that have “general applicability and legal effect” may be codified
in the regulatory text of the Code of Federal Regulations.118 The regulations implementing
this statutory requirement define documents have “general applicability and legal effect” to
mean “any document issued under proper authority prescribing a penalty or course of
conduct, conferring a right, privilege, authority, or immunity, or imposing an
obligation.”119 Thus, the codified text of the CFR may not include guidance, though
agencies may include notes and examples with their codified text, or guidance in
appendices to codified text.120
2.

Preamble-Specific Restrictions

a.
Restriction on Preemption Statements. Perhaps the most straightforward
and recent restriction on the guidance statements that may be made in preambles is
President Obama’s Memorandum for the Heads of Executive Departments and Agencies
112

Small Business Regulatory Enforcement Fairness Act, Pub. L. No. 104-121, § 212(a), 110 Stat. 873,
codified at 5 U.S.C. § 601 nt. (2012).
113
Id. § 212(a)(4).
114
Id. § 212(a)(4)(B)(i).
115
Id. § 212(a)(4)(B)(ii).
116
Id. § 212(a)(5). The Plain Writing Act of 2010, Pub. L. No. 111, 124 Stat. 2861, codified at 5 U.S.C. §
301 nt. (Supp. V 2011), also imposes a plain writing requirement on documents that “explain[] to the public
how to comply with a requirement the Federal Government administers or enforces.” Id. § 3.
117
Id. § 212(a)(2).
118
44 U.S.C. § 1510(a) (2006); 1 C.F.R. § 8.1 (2013) (the Code of Federal Regulations shall contain each
Federal regulation of general applicability and legal effect); see also Wilderness Soc. v. Norton, 434 F.2d
584, 596 (D.C. Cir. 2006) (the CFR may contain only documents having general applicability and legal
effect).
119
1 C.F.R. § 1.1 (2013).
120
FEDERAL REGISTER DRAFTING DOCUMENT HANDBOOK, supra note 52, at 7-9 (discussing use of
appendices to clarify but not to impose substantive obligations).

22

on Preemption.121 This Memorandum directs executive agencies not to include statements
in regulatory preambles to the effect that the agency intends the regulation to preempt state
law unless preemption provisions are also codified in the regulation’s text.122
b.
Statements Without Corresponding Rules. There is some authority
supporting the principle that statements in the preamble to a final rule that do not pertain to
any aspect of the rules adopted are nullities in the sense that they are not validity issued
even as explanatory statements. This principle arose in a D.C. Circuit decision’s review of
a drafting error in an EPA rule. The D.C. Circuit was confronted with a statement in the
preamble referring to EPA’s “final rule concerning high wind events” which states that
“ambient particulate matter concentrations due to dust being raised by unusually high
winds will be treated as due to uncontrollable natural events.”123 The final regulatory text,
however, did not make any reference to high wind events or “ambient particulate matter
concentrations,”124 an oversight that EPA characterized as a drafting error. The court held
that in view of this error, “the high winds event section of the preamble is a legal
nullity.”125 While it is unclear how broad this principle is, at a minimum, the principle
appear to apply to statements that refer to rules that do not exist. Such statements are
nullities in the sense not being validly issued. It would seem a reasonable extension of
this principle to apply it to statements exceed the scope of the rules adopted, for instance,
by suggesting compliance obligations that extend beyond the scope of the rules.
2.

Restrictions Applicable to Preambles and Separately Issued Documents

a.
Subterfuge Legislative Rules. Neither a preamble nor a separately issued
guidance document may contain a legislative rule. As a matter of blackletter law, under
APA § 553, a “legislative” rule must be subject to notice-and-comment whereas
interpretative statements and general statements of policy are not.126 Thus, if a preamble or
guidance document includes a statement that is a legislative rule, the rule is procedurally
invalid under section 553. While the differences in legal effect and procedural
requirements for legislative and nonlegislative rules are straightforward, distinguishing
121

Preemption: Memorandum for the Heads of Executive Departments and Agencies, 74 Fed. Reg. 24,693,
24,693-94 (May 20, 2009), available at http://www.gpo.gov/fdsys/pkg/FR-2009-05-22/pdf/E912250.pdf#page=1.
122
Id. at ¶ 1.
123
Natural Res. Def. Council v. EPA, 559 F.3d 561, 565 (D.C. Cir. 2009) (quoting the preamble).
124
Id.
125
Id.
126
5 U.S.C. § 553(b)(3)(A); 5 U.S.C. § 553(b)(3)(A) (2012). “Legislative” or “substantive” rules are those
that “‘grant rights, impose obligations, or produce other significant effects on private interests,’ or which
‘effect a change in existing law or policy.’” Am. Tort Reform Ass’n v. OHSA, 738 F.3d 387, 395 (D.C. Cir.
2013) (citations omitted).

23

between legislative and nonlegislative rules is a notoriously difficult issue.127 Courts rely
on a collection of doctrinal factors, including the “agency’s label,”128 the practical impact
on those covered by the rule,129 and a legal effect test,130 which looks to whether the rule
imposes legal rights or obligations.131 Numerous formulations of these and other factors
are found in the courts of appeals.132
With regard to statements in preambles challenged as legislative rules, courts must
wade into those same muddy waters.
Interestingly, despite numerous challenges to
language in preambles as improper legislative rules, courts have consistently held that
statements in preambles are interpretive rules or general statements of policy, and thus
procedurally valid.133 Because of the blurry lines of the distinction between legislative and
nonlegislative rules, it is difficult to tell whether this consistent practice is a result of the
caution exercised by agencies in their preambles to avoid any mandatory or binding
statements or simply a more relaxed judicial review of statements in preambles than in
separately issued guidance documents. Given that courts frequently invalidate separately
issued guidance documents, the trend is notable.
127

See, e.g., David L. Franklin, Legislative Rules, Nonlegislative Rules, and the Perils of the Short Cut, 120
YALE L.J. 276, 278 (2010) (suggesting there is perhaps “no more vexing conundrum in the field of
administrative law than the problem of defining a workable distinction between legislative and nonlegislative
rules.”).
128
See, e.g., Warshauer v. Solis, 577 F.3d 1330, 1337 (11th Cir. 2009) (the agency’s “characterization of the
rule is relevant”).
129
Cent. Tex. Tel. Coop., Inc. v. FCC, 402 F.3d 205, 214 (D.C. Cir. 2005) (noting that court had used a
substantial impact test); see also William Funk, A Primer on Nonlegislative Rules, 53 ADMIN. L. REV. 1321,
1325 (2001) (noting strain of cases looking to substantive impact on the regulated).
130
See, e.g., Miller v. Cal. Speedway Corp., 536 F.3d 1020, 1033 (9th Cir. 2008) (legislative rules “create
rights, impose obligations, or effect a change in the law”).
131
Troy Corp. v. Browner, 120 F.3d 277, 287 (D.C. Cir. 1997).
132
See, e.g., Am. Mining Cong. v. Mine Safety & Health Admin., 995 F.2d 1106 (D.C. Cir. 1993) (listing the
following factors: “(1) whether in the absence of the rule there would not be an adequate legislative basis for
enforcement action or other agency action to confer benefits or ensure the performance of duties, (2) whether
the agency has published the rule in the Code of Federal Regulations, (3) whether the agency has explicitly
invoked its general legislative authority, or (4) whether the rule effectively amends a prior legislative rule.”).
133
See, e.g., Troy Corp. v. Browner, 120 F.3d 277, 287 (D.C. Cir. 1997) (EPA’s premabular statement
“merely informed the public that the agency would exercise its discretion by considering exposure only for
low toxicity chemicals” and thus was a general policy statement); Fertilizer Institute v. EPA, 935 F.2d 1303,
1308-09 (D.C. Cir. 1991) (holding that EPA’s rule in its preamble was interpretive because it represents “the
agency’s attempt to interpret the meaning of a statutory provision”); Barrick Goldstrike Mines, Inc. v.
Whitman, 260 F. Supp. 2d 28, 38 (D.D.C. 2003) (“In this case, the interpretation [contained within the
preamble] . . . is within the scope of the regulation”); Bd. of Trustees of Knox Cnty. Hosp. v. Shalala, 959 F.
Supp. 1026, 1031 (S. D. Ind. 1997) (“Rather than create or destroy substantive rights, the [preambular] policy
simply clarifies what the Secretary believes the regulation means and explains how the Agency will apply
it.”); OSG Bulk Ships v. United States, 921 F. Supp. 812, 824 n.11 (D.D.C. 1996) (explaining that an
interpretation within the preamble does not transform the preamble into a legislative rule); Comité de Apoyo a
los Trabajadores Agrícolas v. Solis, No. 09-240, 2010 U.S. Dist. LEXIS 90155 at 47 (E.D. Pa. Aug. 30,
2010) (holding that the preambular language was an interpretation because the language was “very closely
tied” to the definition included in the regulation and “expressly purports to be an interpretation of that
definition”).

24

b.
Consistency with Regulations and Statutes. Most obviously, statements
in preambles (as well as separately issued documents) must be consistent with the
regulations they explain and the statutes they implement. Both of these points are
illustrated in Cuomo v. Clearing House Association, LLC.134 There, the Court held that the
interpretation of a regulation in the Comptroller of the Currency’s statement of basis and
purpose was inconsistent with the regulation’s text as well as the underlying statute, and
therefore invalid. “This passage in the statement of basis and purpose,” the Court
commented, “resting upon neither the text of the regulation nor the text of the statute,
attempts to do what Congress declined to do: exempt national banks from all state banking
laws, or at least state enforcement of those laws.”135
F.

Reviewability of Contemporaneous Guidance

Contemporaneous guidance is reviewable in court if it constitutes “final agency
action”
and satisfies the requirements of ripeness.137 Statements in regulatory text
presumably would not face distinctive reviewability issues. Likewise, the reviewability of
separately issued guidance is solely a matter of application of general principles of finality
and ripeness, for which there are existing treatments.138 But what about guidance provided
in preambles? Is preamble guidance reviewable?
136

The short answer is that guidance in preambles has been found to be both final
and ripe, and thus subject to review. Perhaps the most prominent example of a decision
concluding that language in a preamble is reviewable is the Supreme Court’s decision in
Whitman v. American Trucking Associations.139 While the statements at issue concerned
the agency’s interpretation of a statute, not its own regulations, the decision reveals clearly
that statements in regulatory preambles, just like other forms of guidance, may be
reviewable if they are final and ripe.140 After soliciting comment on an interim
134

557 U.S. 519, 129 S. Ct. 2710 (2009).
Id. at 2720; see also Home Concrete & Supply, LLC v. United States, 634 F.3d 249, 256–57 (4th Cir.
2011) (rejecting the IRS’s interpretation contained in the preamble to a regulation because it was “contrary to
the clearly and unambiguously expressed intent of Congress and must fail”); Barrick, 260 F. Supp. 2d at 36
(“Because the preamble to the 1988 rulemaking is inconsistent with the plain language of the regulation, see
Auer, 519 U.S. at 461, it is invalid. Accordingly, subject to the concentrations of toxic chemicals it contains,
Barrick’s waste rock may be eligible for the de minimis exemption.”).
136
5 U.S.C. § 704 (providing that final agency action is reviewable).
137
There are, of course, elements to the availability of review, including standing, but finality and ripeness
are the post germane to assessing reviewability of contemporaneous guidance.
138
See, e.g., Lubbers, supra note 30, at 398-402 (discussing whether guidance is “final” agency action);
Mendelson, supra note 2, at 421-24 (identifying heightened obstacles for regulatory beneficiaries to obtain
review of guidance documents).
139
531 U.S. 457 (2001).
140
See id. at 478.
135

25

implementation policy for national ambient air quality standards (NAAQS) under the
Clean Air Act, the EPA published an explanatory preamble to its final ozone NAAQS,
including a sectioned entitled “Final decision on preliminary standard.” In that section of
the preamble, the EPA stated that it had reconsidered its proposed interpretation and “now
believes that the Act should be interpreted such that the provisions of subpart 2 continue to
apply” to certain areas of the country that fall below ambient air quality standards. “As a
consequence,” the preamble stated “the provisions of subpart 2 . . . will continue to apply
as a matter of law for so long as an area is not attaining [requisite air quality standard].”141
In Whitman, the Supreme Court had no difficulty concluding that these statements
were reviewable. As to finality, the Court concluded that these statements marked “the
consummation of the agency’s decisionmaking process,” a decision bolstered by the fact
that in subsequent rulemakings, the EPA had denied requests to reconsider the issue,
explaining “to disappointed commentators that it’s earlier decision was conclusive.”142 As
to ripeness, under the standard of Abbott Laboratories v. Gardner looking to the “fitness of
the issues for judicial decision” and the “hardship to the parties of withholding court
consideration,”143 the Court concluded that the issue of statutory interpretation presented
and the hardship on states that would be imposed justified review under the Clean Air
Act’s special authorization for preenforcement review,144 and declined to opine on whether
the statement would be ripe in a case brought under APA § 704.145
The standard for final agency action under APA § 704 is well established: “A final
agency action is one that marks the consummation of the agency’s decisionmaking process
and that establishes rights and obligations or creates binding legal consequences.”146
Applying this standard to statements in preambles, the D.C. Circuit has commented that
“[w]hile preamble statements may in some unique cases constitute binding, final agency
action susceptible to judicial review, . . . that is not the norm.”147 Still, the D.C. Circuit has
141

62 Fed. Reg. 38873 (1997), discussed in Whitman, 531 U.S. at 478.
531 U.S. at 478-79.
143
Id. at 479 (quoting Abbott Labs. v. Gardner, 387 U.S. 136, 149 (1967)).
144
531 U.S. at 479.
145
Id. at 479.
146
Natural Res. Def. Council v. EPA, 559 F.3d 561, 564 (D.C. Cir. 2009) (citing Bennett v. Spear, 520 U.S.
154, 177-78 (1997)).
147
Id. (citing Kennecott Utah Copper Corp. v. Department of Interior, 88 F.3d 1191, 1222-23 (D.C. Cir.
1996); see also Natural Res. Def. Council v. EPA, 706 F.3d 428, 432 (D.C. Cir. 2013) (affirming same). For
decisions denying review of statements in preambles on finality or ripeness grounds, see, e.g., Nat’l Envtl.
Dev. Ass’ns. Clean Air Project v. EPA, 686 F.3d 803, 808-09 (D.C. Cir. 2012) (preamble not final); Natural
Res. Def. Council v. EPA, 559 F.3d 561, 565 (D.C. Cir. 2009) (preamble not ripe); Clean Air
Implementation Project v. EPA, 150 F.3d 1200, 1208 (D.C. Cir. 1998) (preamble not final nor ripe);
Kennecott Utah Copper Corp., 88 F.3d at 1222-23 (extensive discussion of preamble not being final nor
ripe); Florida Power & Light Co. v. EPA, 145 F.3d 1414, 1420 (D.C. Cir. 1998) (preamble neither final nor
ripe).
142

26

held that statements in preambles are final and ripe for review on numerous occasions,
including with regard to statements of regulatory interpretation.148 A critical factor in
making this determination is the language of the preamble. On the one hand, language that
is not definitive (such as “may,” “might” and “could”),149 hypothetical or non-specific,150
conjectural,151 or characterizes the views as preliminary,152 or promises future binding
action,153 all counsel against reviewability. On the other hand, language which is clear, not
conjectural, and not qualified, makes it “fair to infer that [the agency] intended the
statements to create binding legal consequences.”154
Thus, the appearance of the statement within a preamble does not bar review.155
Rather, the reviewability of guidance within a preamble, like the reviewability of guidance
generally, depends upon the finality and ripeness analysis, which for these purposes often
“converge.”156 Ultimately, then, it is the content of the guidance, not its regulatory
location, that determines its reviewability.
G.

Standard of Judicial Review

For many years, there was little movement in the judicial doctrine first associated
with Bowles v. Seminole Rock & Sand Co.157 and now more consistently identified with
Auer v. Robbins158 that an agency’s construction of its own regulation is “controlling
unless ‘plainly erroneous or inconsistent with the regulation.’ ”159 While Auer still
provides the general standard applicable to an agency’s interpretation of its regulations—
regardless of the document type in which those interpretations appear—the Supreme Court
has carved out an exception for post hoc interpretive positions, and several Justices have
indicated an interest in revisiting the merits of the doctrine altogether. The fact that the
148

See, e.g., Natural Res. Def. Council v. EPA, 571 F.3d 1245, 1252 n.2 (D.C. Cir. 2009) (holding that
statements in EPA’s preamble final because they represented a consummation of the agency’s process, have
binding consequences); La. Envtl. Action Network v. EPA, 172F.3d 65, 69 (D.C. Cir. 1999) (holding
language in preamble final under RCRA, 42 U.S.C. § 6976(a)(1)); Chem. Waste Mgmt. v. EPA, 869 F.2d
1526, 1533 (D.C. Cir. 1989) (holding that regulatory interpretation in preamble was final); see also Cent. &
Sw. Servs. v. EPA, 220 F.3d 683, 689 n.2 (5th Cir. 2000) (concluding EPA preamble interpreting a statute
was final action and ripe); Select Specialty Hosp.-Akron, LLC v. Sebelius, 820 F. Supp. 2d 13, 26 (D.D.C.
2011) (preamble binding and reviewable).
149
Kennecott Utah Copper, 88 F.3d at 1222.
150
Id. at 1223.
151
Nat’l Envtl. Dev., 686 F.3d at 808.
152
Natural Res. Def. Council, 706 F.3d at 433.
153
Am. Petroleum Inst. v. EPA, 684 F.3d 1342, 1354 (D.C. Cir. 2012).
154
Natural. Res. Def. Council, 571 F.3d at 1252 n.2.
155
Kennecott Utah Copper, 88 F.3d at 1223.
156
Id.
157
325 U.S. 410 (1945).
158
519 U.S. 452 (1997); see supra note 7 (discussing naming conventions for this doctrine).
159
Auer, 519 U.S. at 461.

27

recent limitations on Auer have all been directed to post hoc guidance suggests that
contemporaneous guidance—whether provided in a preamble, appendix, or separately
issued document—has a stronger footing for maintaining Auer deference.
While there has been a longstanding critique of Seminole Rock/Auer deference,160
current interest in the doctrine comes from the disjunction between the scope of application
of Auer deference and Chevron deference created by the Supreme Court’s decision in
Mead. In Mead, the Court constricted the application of Chevron deference to statutes that
grant lawmaking authority to the agency and to agency actions which exercise that
authority.161 Under Mead, notice-and-comment rulemaking is presumptively eligible for
Chevron deference, whereas guidance documents are not.162 Mead thus denies deference
to an agency’s statutory interpretation that appears in a guidance document or litigation
brief, whereas a guidance document or litigation brief interpreting an agency regulation
would still qualify for deference under Auer. This disjuncture has prompted a call for
constricting the scope of application of Auer so that it would apply only to those
documents to which Chevron would apply under Mead, that is, those produced by
relatively formal processes.163
Despite the logic that an agency’s regulatory interpretation issued informally
should not receive deference if its statutory interpretation would not, the Supreme Court
has generally accorded Seminole Rock/Auer deference to agency interpretations advanced
in litigation briefs. As recently as 2011, for instance, the Court concluded twice that
agency amicus briefs qualify for Seminole Rock/Auer deference, rejecting the argument
that under Mead and Christensen they should not.164 But, in 2012, in Christopher v.
SmithKline Beecham Corp.,165 the Court declined to grant Seminole Rock/Auer deference
to an agency’s position taken in a litigation brief based in part on the concern that doing so

160

John F. Manning, Constitutional Structure and Judicial Deference to Agency Interpretations of Agency
Rules, 96 COLUM. L. REV. 612, 618 (1996) (challenging Seminole Rock deference and proposing a model of
independent judicial evaluation of regulations that would place greater reliance on agencies’ explanatory
statements)
161
United States v. Mead Corp., 533 U.S. 218, 226-27 (2001).
162
Id. at 229.
163
Thomas W. Merrill & Kristin E. Hickman, Chevron’s Domain, 89 GEO. L.J. 833, 900 (2001) (“Seminole
Rock deference should at a minimum be subject to the same limitations that apply to the scope of Chevron
deference.”); Matthew C. Stephenson & Miri Pogoriler, Seminole Rock’s Domain, 79 GEO. WASH. L. REV.
1449, 1484-96 (2011) (arguing that Mead’s logic for constraining Chevron’s scope of application extends to
Seminole Rock).
164
See Pliva, Inc. v. Mensing, 131 S. Ct. 2567, 2575 n.3 (2011) (relying on brief of United States); Chase
Bank USA, N.A. v. McCoy, 131 S. Ct. 871, 883–84 (2011) (rejecting argument that agency amicus brief was
not entitled to deference under Auer, and according deference to the interpretation contained in the brief).
165
132 S. Ct. 2156 (2012).

28

would undermine fair notice of the regulation’s requirements.166 The Court reasoned that
reliance on Auer in these circumstances would “frustrat[e] the notice and predictability
purposes of rulemaking,” quoting Justice Scalia’s concurrence in Talk America, Inc. v.
Michigan Bell Telephone Co.,167 in which Justice Scalia first declared his interest in
reconsidering Auer. The Court’s explanation suggested that it viewed the distinction
between guidance issued ex ante and post hoc as meaningful, at least with regard to
interpretations announced in enforcement proceedings:
It is one thing to expect regulated parties to conform their conduct to an
agency’s interpretations once the agency announces them; it is quite another
to require regulated parties to divine the agency’s interpretations in advance
or else be held liable when the agency announces its interpretations for the
first time in an enforcement proceeding and demands deference.168
In March 2013, three Supreme Court Justices publically indicated an interest in
reconsidering Auer in Decker v. Northwest Environmental Defense Center.169 There, Chief
Justice Roberts and Justice Alito announced they would be receptive to reconsideration of
Auer deference in an appropriate case,170 and Justice Scalia filed an opinion concurring in
part and dissenting in part arguing for overruling Auer deference.171
But even if the Court were to revisit the doctrine, based on the reasoning in
Christopher v. SmithKline Beecham Corp., the Court appears to view guidance rendered
contemporaneously with the issuance of the rule (or even guidance offered prior to
enforcement) as standing on a different footing than post hoc interpretations produced in
litigation. If this is right, then contemporaneous guidance—especially that in a preamble,
regulatory text or appendix—stands in the strongest stead for deference under Auer: It
furnishes the agency’s authoritative interpretation at the time the rule become effective,
and thus allows parties as much fair notice as they receive about the rule itself.
It is worth noting that an assumption underlying this discussion is that Auer, not
Chevron, provides the currently governing standard of review for an agency’s statements
in its preamble to a final rule about the purpose and effect of its regulations. At least one
See id. at 2166–68 (concluding that “general rule” of granting Auer deference to interpretations in
litigation briefs did not apply in these circumstances of the case in view of fair notice concerns).
167
131 S. Ct. 2245, 2266 (2011).
168
Id.
169
133 S. Ct. 1326 (2013).
170
Id. at 1338 (Roberts, C.J., and Alito, J., concurring) (noting that it “may be appropriate to reconsider”
Seminole Rock/Auer in another case); id. at 1339, 1442 (Scalia, J., concurring in part and dissenting in part)
(arguing that the Court to overturn Seminole Rock/Auer).
171
Id.
166

29

court of appeals, however, has concluded that a statement’s about the application of its
regulations in a preamble to a final rule are entitled to receive Chevron deference under
Mead.172 If statements of this sort in a preamble receive Chevron deference just as
statements in regulatory text does, there would be little need for courts to invoke Auer as a
standard of review for statements about the meaning of regulations in preambles because
those statements would be reviewable directly under Chevron.
H.

Summary Table

Table 1 (below) provides a summary of the legal regime applicable to
contemporary guidance addressed thus far. Readers may draw different inferences from
this compilation, but one striking feature is the extent of the overlap in the requirements
applicable to contemporaneous guidance, whether it appears in a preamble, regulatory text,
or separately issued document. In Table 1, cells on each row that are identical are
highlighted; but even where the requirements are not identical, in many cases there is
significant practical overlap.
To illustrate the scope of overlap in requirements, use Table 1 to compare
economically significant guidance issued in a preamble (column 1) and in a separately
issued document (column 3). The requirements of issuance are the same (row 1); the
requirements for revision are the same (row 2); they are both subject to OIRA review (row
3); and the same standards of judicial review (rows 6 & 7); the only difference is what
content must be included or excluded.
Table 1: Summary of Legal Regime Applicable to Contemporaneous Guidance
Guidance in Preamble

1: Process Requirements
for Issuance

For covered agencies, if
“significant,” or
“economically
significant” under OMB’s
Good Guidance Bulletin,
then it must comply with
the GGP, including
notice and comment for

Guidance Published in
the Code of Federal
Regulations (in notes,
examples, or
appendices)
Notice-and-comment
required

Guidance Separately
Issued

For covered agencies, if
“significant,” or
“economically
significant” under OMB’s
Good Guidance Bulletin,
then it must comply with
the GGP, including
notice and comment for

See Tibble v. Edison Int’l, 711 F.3d 1061, 1071 (9th Cir. 2013), amended by 729 F.3d 1110 (9th Cir.
2013) (“As for Mead’s second consideration [that the agency have exercised its authority to bind with the
force of law], we do not view the fact that the interpretation appears to in a final rule’s preamble as
disqualifying it from Chevron deference.”).
172

30

2: Process Requirements
for Revision

3: Subject to OIRA
Regulatory Review?

4: What must be
included?

5: What may not be
included?

6: Is it reviewable in
court?
7: What standard of
review applies?

IV.

economically significant
guidance.
If “definitive,” then
revision must proceed
through notice-andcomment under Alaska
Prof. Hunters.
Yes, for covered agencies
for all significant
regulatory actions.
i. Under the APA, a
statement of the purpose
of the rule in light of
statutory objectives, and
ii. Under RFA, a
statement of the need for
the rule and its
objectives.
i. Statements preempting
state law without
regulatory text that
preempts.
ii. Interpretations without
corresponding regulatory
text.
iii. Statements that are
binding legislative rules
iv. Statements that
contradict the regulatory
text or statute.
Yes, if “final agency
action” and ripe for
review.
Auer deference (with a
stronger basis than post
hoc guidance)

Notice-and-comment
required

Yes, for covered
agencies for all
significant regulatory
actions.
No requirements other
than those with a
statutory basis.

economically significant
guidance.
If “definitive,” then
revision must proceed
through notice-andcomment under Alaska
Prof. Hunters.
Yes, for covered agencies
for all significant
regulatory actions.
Agency must publish
compliance guide for
rules with significant
effects on small entities
under SBREFA.

The CFR text may
contain only statements
of general applicability
and legal effect, as
defined by 1 CFR 1.1.

i. Statements that are
binding legislative rules,
or including mandatory
language
ii. Statements that
contradict the regulatory
text or statute.

Yes, pre-enforcement
review routinely
available.
Auer deference (with a
stronger basis than post
hoc guidance)

Yes, if “final agency
action” and ripe for
review.
Auer deference (with a
stronger basis than post
hoc guidance)

Agency Practices for Providing Contemporaneous Guidance

Given the significant overlap in the legal requirements governing contemporaneous
and guidance, agencies will frequently have significant discretion as to whether to include
the same statement in a preamble, regulatory text (or appendix), or in a guidance document
issued alongside the rule. How do agencies make this choice? More specifically, what
forms of contemporaneous guidance do agencies actually provide? This Part provides a
description and illustrative compilation of the ways in which agencies use each of these
31

forms of contemporaneous guidance. It first introduces, in Table 2, a menu of agency
practices with illustrative examples. These categories are relatively straightforward; the
text following Table 2 provides a narrative description of examples that fall within these
categories.
The scope of federal rulemaking is vast, and it is important to note that this Report
makes no claim to be a completely comprehensive identification of the ways in which
agencies issue contemporary guidance. Rather the Report identifies the most significant
uses of contemporaneous guidance, isolating a menu of types of contemporaneous
guidance with illustrative examples. Such a menu is sufficient to provide a means for
agencies to consider their own practices in relation to those of other agencies, and also
identify some problems and outliers in agency practices. The Report also makes no
attempt to quantitatively assess the frequency with which agencies use particular forms of
contemporaneous guidance.
Table 2: Menu of Agency Contemporary Guidance Practices
Type
Guidance in
Preamble

Location

Format

Discussion

Background
Discussion
Primarily Narrative Statement

Includes Section-by-Section Analysis

Relying Primarily on Grounds Stated
in NPRM

Purpose Stated in View of Statutory
Objectives

Purpose Statement Solely Mirroring
Statutory Language (or Otherwise
Inadequate)

32

Some agencies provide long
narrative discussions
without structuring them in
accordance with the rule’s
structure.
In addition to general
discussion, some preambles
include analysis that
matches the structure of
rule.
Some preambles incorporate
portions of the discussion in
the NPRM or other prior
notices.
Most preambles provide an
independent assessment of
the rule’s purposes in
relation to statutory
objectives
Some agencies give this
statement short shift, stating
the purpose solely by

Type

Location

Format

Discussion
parroting statutory language.

Response to
Comments
General Responses

Section-by-Section Analysis

Question-and-Answer

Detailed Examples

Preamble as Rule

Some preambles provide
general narrative discussions
of comments without much
organizational structure.
Some preambles structure
the response to comments in
section-by-section.
Some structure preambles
response to comment
questions in a Q & A
format.
Some preambles provide
detailed examples to
illustrate how the rule
applies.
Some preambles treat the
preamble and regulatory text
interchangeably.

Guidance included
in the CFR
Regulatory Text
Notes and Example Applications

Some regulatory text
includes examples to guide
application.

Official Commentary in Appendix

Some appendices include an
official interpretive
commentary
Some appendices include
example applications.
Some appendices are
structure with Q & A
Some appendices include
technical guidance.

Appendix

Examples in Appendix
Question-and-Answer Format in
Appendix
Technical Guidance in Appendix
Separately Issued,
Contemporaneous
Guidance
Compliance Guides,
FAQs, and Other
Documents

33

B.

Preambles as a Vehicle for Guidance

Agencies have long treated the preambles to their regulations, which “statements of
their basis and purpose,” as a means of providing guidance about the meaning and
application of their rules. Agencies organize their preambles—and the guidance they
provide—in different formats, many of which are familiar to agency lawyers and
practitioners of administrative and regulatory law.
1.

Background Sections

The preamble to federal rules typically appears under the Supplemental Information
heading in the Federal Register.173 Most agencies provide extensive narrative commentary
on the rule, its procedural history, factual and legal grounds and aims in subsection of the
Supplement Information entitled Background Discussion.174 This section typically
includes content that would constitute guidance, and agencies organize it in many different
ways, frequently using one or more of the following formats.
a.
Preamble Composed Primarily of Narrative Statement. One common
format of the Background Discussion section is a narrative statement. A recent preamble
produced by the Occupational Health and Safety Administration (OSHA) for a rule
adopted to conform to the United Nations’ Globally Harmonized System of Classification
and Labelling of Chemicals (GHS) reflects this structure.175 The preamble consists of
general narrative in sections entitled, for instance, “Events Leading to the Revised Hazard
Communication Standard” and “Overview of the Final Rule and Alternatives
Considered.”176 In these sections, OSHA generally explained the impact and motivation for
the rule, but did not organize its discussion in accordance with the particular sections of the
rule.177
b.
Section-By-Section Format. Agencies also organize background
discussions of preambles in a section-by-section format. While agencies also use the
section-by-section format to structure a response to comments, as discussed below, in the
background discussion, the section-by-section analysis is not explicitly responding to
comments.

173

See FEDERAL REGISTER DOCUMENT DRAFTING HANDBOOK, supra note 104, at 2-8 (directing that
extended discussion of the rule belongs in the Supplemental Information section).
174
See id. at 2-17.
175
Hazard Communication, 77 Fed. Reg. 17,574, 17,574 (March 26, 2012) (to be codified at 29 C.F.R. pts.
1910, 1915, 1926).
176
Id. at 17,577, 17,579, 17,693.
177
Id.

34

The Consumer Protection Financial Bureau (CFPB) adopted this approach in a rule
amending Regulation E, which implements the Electronic Fund Transfer Act. 178 In the
preamble, the agency provides a section-by-section analysis which is subdivided
numerically and by topic with subsections such as “Section 1005.2 Definitions” and
“Section 1005.3 Coverage.”179 In the Coverage subsection, for instance, the agency
explains changes to the regulation without engaging specific comments: “Currently, §
1005.3(a) states that Regulation E generally applies to financial institutions. Section
1005.3(a) is revised to state that the requirements of subpart B apply to remittance transfer
providers. The revision reflects the fact that the scope of the Dodd-Frank Act’s remittance
transfer provisions is not limited to financial institutions.”180
c.
Agency Reliance on Grounds Stated in NPRM. Agencies vary as to how
much they rely upon discussions in the NPRM (or other prior notices) to provide a
statement of the rule’s basis and purpose or treat the preamble to the final rule as a
freestanding document that provides a comprehensive statement of the rule’s basis and
purpose. Agencies frequently refer the readers to explanations, proposals, or studies
published in the NPRM. Agencies occasionally specifically incorporate particular aspects
of the legal reasoning or analysis provided in the NPRM.181 Agencies also rely upon
reasoning and discussions in the NPRM for a more comprehensive summary of the rule’s
basis, purposes and effects.182 In contrast, agencies also frequently treat the preamble as a
relatively comprehensive and stand-alone statement of the grounds of the rule, referring to
the NPRM only as necessary to explain how the agency’s reasoning has shifted, how the
agency has responded to comments, or to appreciate the procedural history of the rule.
178

Electronic Fund Transfers (Regulation E), 77 Fed. Reg. 6,194, 6,194 (Feb. 7, 2012) (to be codified at 12
C.F.R. pt. 1005).
179
Id. at 6,204–6,205.
180
Id. at 6,205.
181
See, e.g., Eligible Obligations, Charitable Contributions, Nonmember Deposits, Fixed Assets,
Investments, Fidelity Bonds, Incidental Powers, Member Business Loans, and Regulatory Flexibility
Program, 77 Fed. Reg. 31981 (May 31, 2012) (to be codified at 12 C.F.R. pts. 701, 703, 713, 721, 723, 742)
(“For the reasons discussed below the Board is adopting the amendments almost exactly as proposed. As
such, the Board does not restate the legal analysis it presented in the NPRM’s preamble and incorporates it
by reference here in this rulemaking.”); Crewmember Identification Documents, 74 Fed. Reg. 19135, 19139
(Apr. 28, 2000) (to be codified at 33 C.F.R. pt. 1360) (“We received no public comments that would alter our
assessment of impacts in the NPRM. We have adopted the assessment in the NPRM as final.”).
182
See, e.g., Medicare Program: Review of National Coverage Determinations and Local Coverage
Determinations, 68 Fed. Reg. 63692 (Nov. 7, 2003) (to be codified at 42 C.F.R. pts 400, 405, 426); id. at
63693 (“For further discussion of the claims appeal process please consult the proposed rule.”); id. (“For the
full discussion of NCDs please consult our proposed rule at 67 FR 54535 published on August 22, 2002.”);
id. (“The provisions described in bullets two through four above constitute coverage provisions. For further
information on LMRPs please consult our proposed rule at 67 FR 54535.); Practices and Procedures, 77

Fed. Reg. 62,350, 62,350 (Oct. 12, 2012) (to be codified at 5 C.F.R. pts. 1200, 1201, 1203, 1208,
1209) (“[r]eaders desiring a more detailed summary of the amendments proposed by the MSPB
should consult the proposed rule.”).

35

d.
Purpose Statements. Agencies typically provide a statement of the
purpose of the regulation in the Summary and/or in the Supplemental Information sections
of their preambles to their substantive rules, that is, those that have independent legal
effect. These statements vary widely in terms of their level of specificity and clarity.
Many statements clearly indicate the purpose of the regulation in light of the statute’s
objectives, the agency’s powers, and its past regulatory history.183
Rather than providing an independent assessment of the purpose of the rule in light
of the statute, some preambles state the purpose of their regulations in terms that largely
mirror statutory language. For instance, a Department of Labor rule establishing the
uniform national threshold for the employment rate for veterans included a purpose
statement that largely mirrored the statutory language requiring the agency to promulgate
the rule.184 In the preamble, the Department of Labor stated “[w]e undertook this
Rulemaking in accordance with 38 U.S.C. 4102A(c)(3)(B) (as enacted by the Jobs for
Veterans Act) which requires the Department to establish that threshold rate by
regulation.”185 Then the agency wrote “Section 4(a)(1) of the JVA amended 38 U.S.C.
4102A to require that the Secretary of Labor ‘establish, and update as appropriate, a
comprehensive performance accountability system . . . and carry out annual performance
reviews of veterans employment, training, and placement services provided through
employment service delivery systems, including through Disabled Veterans’ Outreach
Program specialists and through Local Veterans’ Employment Representatives in States
receiving grants, contracts, or awards under this chapter.”186
After the agency recited what it was required to do by statute, the agency turned to
discussing details of the rule, such as its definition of critical terms, but did not provide an
independent statement reflecting the agency’s choices about how best to implement the
statutory requirement.187
2.

Response to Comments

a.
General Responses. Agencies frequently provide guidance about the
meaning and application of their regulations in a dialogue with commenters in the
preamble. They do this in different formats. Sometimes they do this in the course of a
183

Exemption of Work Activity as a Basis for a Continuing Disability Review, 71 Fed. Reg. 66,840, 66,840
(Nov. 17, 2006) (to be codified at 20 C.F.R. pts. 404, 416).
184
Uniform National Threshold Entered Employment Rate for Veterans, 78 Fed. Reg. 15,283, 15,283 (Mar.
11, 2013) (to be codified at 20 C.F.R. pt. 1001).
185
Id. at 15,284.
186
Id.
187
Id.

36

general response to comments. For instance, in a Department of Veterans Affairs (DVA)
rule implementing the DVA’s medical foster home program, a commenter asked whether
the spouse of a married veteran could move into the medical foster home with the veteran
or if the rule forced couples to live apart.188 The DVA answered that “[n]othing in the
regulation would preclude a spouse of a veteran from living in the same medical foster
home as the veteran. Such an arrangement would be a matter of agreement between the
spouse of the veteran and the medical foster home caregiver.”189 In this preamble, the DVA
provided this and other guidance in response to comments without topical headings.
Agencies, however, often organize their general responses to comments by topic.
For example, in a Department of Treasury and U.S. Customs and Border Protection (CBP)
rule defining “members of a family” for purposes of filing a customs family declaration,
the agencies responded to commenters in topical sections.190 In the “Definition of
Resident” section, a commenter posed a question about whether the definition of “resident”
as used by CBP in this context was the same as “permanent resident” as used in the
immigration law context.191 The agencies responded that “[t]he term ‘resident’ for
purposes of this regulation is not the same as ‘lawful permanent resident’ in immigration
law. For customs purposes, pursuant to 19 CFR 148.2, persons arriving from foreign
countries are divided into two categories: (1) Residents of the United States returning from
abroad and (2) all other persons (i.e., visitors).”192
b.
Section-by-Section Analysis. Agencies also provide guidance in the
course of responding to comments through a section-by-section analysis. The Equal
Employment Opportunity Commission (EEOC) used this format in a rule implementing
Title II of the Genetic Information Nondiscrimination Act.193 The EEOC offered guidance
pertaining to numerical sections of the regulation, including “Section 1635.1 Purpose”
followed by “Section 1635.2 Definitions—General.”194 In “Section 1635.3(a) Family
Member,” the EEOC confronted a commenter’s suggestion that medical information
obtained from one employee should not be considered family medical history of a family
188

Medical Foster Homes, 77 Fed. Reg. 5,186, 5,187 (Feb. 2, 2012) (to be codified at 38 C.F.R. pt. 17); see
also State Official Notification Rule, 77 Fed. Reg. 39112 (June 29, 2012) (to be codified at 12 C.F.R. pt.
1082) (the following statement was the closest to a statement of purpose in the summary of the final rule: “In
drafting the Final Rule, the Bureau endeavored to create a process that would provide both the Bureau and,
where applicable, the prudential regulators with timely notice of pending actions and account for the
investigation and litigation needs of state regulators and law enforcement agencies.”).
189
Id.
190
Members of a Family for Purpose of Filing CBP Family Declaration, 78 Fed. Reg. 76,529, 76,529 (Dec.
18, 2013) (to be codified at 19 C.F.R. pt. 148).
191
Id. at 76,530.
192
Id.
193
Regulations Under the Genetic Information Nondiscrimination Act of 2008, 75 Fed. Reg. 68,912, 68,912
(Nov. 9, 2010) (to be codified at 29 C.F.R. pt. 1635).
194
Id. at 68,913.

37

member who also works for the same employer.195 The EEOC rejected this suggestion,
writing, “[w]e do not think Congress could have intended that an employee not be
protected from the discriminatory use or the disclosure of his or her genetic information
just because the employer obtained it from a family member who was also an
employee.”196
The Small Business Administration (SBA) also utilized the section-by-section
analysis format in a rule defining a new category of small business investment companies
(SBICs).197 Under the heading of “Section 107.50—Definitions,” the SBA responded to a
number of commenters that suggested changing the proposed definition of “Early Stage
SBIC,” by writing “SBA . . . believes the commenters’ contrasting points of view
illustrate the benefits of maintaining the flexibility that the proposed definition provided.
SBA expects that some management teams will focus exclusively on early stage
companies, while others will opt for a mixed portfolio.”198 This rule also includes a
“General Comments” section where the SBA responds to comments that impact broad
issues in the rule.199 Agencies frequently combine two formats in their rules as the SBA
did here.
c.
Question-And-Format. Another method agencies use to respond to
comments is the question and answer format. The Railroad Retirement Board (RRB) used
this approach in a rule that removes a listing of impairments from its regulations and
explains how the RRB will determine disability.200 The preamble is divided into sections
including, “What Programs Will the Final Rule Affect?” and “How Is Disability
Defined?”201 In the section, “How Does This Final Rule Address That Problem?”, the RRB
responds to commenters by stating “[t]he Board has reviewed the comments and the
amendments to section 220.178(c)(1) and agrees that the second sentence could be
confusing. We have modified that sentence to make it clear that in a continuing disability
review, the claimant's current severity will be compared to the standard that was used to
make the original, or ‘comparison point decision.’”202 Unlike the SBA rule, question and
answer format is the only format used in this preamble.

195

Id. at 68,915.
Id. at 68,916.
197
Small Business Investment Companies—Early Stage SBICs, 77 Fed. Reg. 25,042, 25,042 (April 27,
2012) (to be codified at 13 C.F.R. pt. 107).
198
Id. at 25050.
199
Id. at 25043.
200
Removal of Listing of Impairments and Related Amendments, 74 Fed. Reg. 63,598, 63,598 (Dec. 4, 2009)
(to be codified at 20 C.F.R. pt. 220).
201
Id.
202
Id. at 63,599–63,600.
196

38

A Social Security Administration (SSA) rule revising medical criteria used for
evaluating digestive disorders utilized a combination of the question and answer format,
section-by-section analysis, and general response to comments format.203 The preamble
begins with sections entitled, “Why are we revising the listings for digestive disorders?”
and “What general changes are we making that affect both the adult and childhood listings
for digestive disorders?”204 Then, within these larger sections, SSA includes subsections
with questions associated with particular regulatory text sections, such as “5.00D—How
do we evaluate chronic liver disease?”205 Next, SSA includes a “Public Comments” section
that is a general response to comments.206 Guidance appears throughout these different
formats. For instance, in the “Public Comments” section, one commenter suggested that all
individuals who require feeding through intravenous or gastrostomy tubes should be
considered not able to work under the rule, but the SSA responded that “we do not think it
appropriate to presume disability in all individuals who need such treatment; we must
evaluate most situations on a case-by-case basis.”207
d.
Detailed Examples. A fourth method that agencies use to provide
guidance in preambles while responding to comments is through the use of detailed
examples. These can be incorporated within any of the other three formats discussed
above. The Department of Education included detailed examples in a rule amending the
Direct Loan Program.208 The agency wrote “[t]he following two examples illustrate the
operation of the final regulations” and then “Example 1: Borrower A and Borrower B are
both enrolled half-time and both enrolled in the fall term only. Borrower A receives a
Direct Subsidized Loan in the amount of the annual loan limit and Borrower B receives a
loan for less than the annual loan limit.”209 Following this introduction to the example, the
Department of Education included a chart and a few paragraphs explaining how the
hypothetical borrowers would be impacted by the regulation.210
The Centers for Medicare and Medicaid Services (CMS) also used detailed
examples in the preamble to a rule establishing guidelines for Accountable Care
Organizations (ACOs).211 For instance, commenters expressed confusion over a proposed
203

Revised Medical Criteria for Evaluating Digestive Disorders, 72 Fed. Reg. 59,398, 59,398 (Oct. 19, 2007)
(to be codified at 20 C.F.R. pts. 404, 416).
204
Id.
205
Id at 59,399.
206
Id. at 59,407.
207
Id. at 59,409.
208
William H. Ford Federal Direct Loan Program, 79 Fed. Reg. 3,108, 3,108 (Jan. 17, 2014) (to be codified
at 34 C.F.R. pt. 685).
209
Id. at 3,114 – 3,115.
210
Id. at 3,115.
211
Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, 76 Fed. Reg.
67,802, 67,802 (Nov. 2, 2011) (to be codified at 42 C.F.R. pt. 425).

39

requirement that the governing bodies of ACOs at least 75% controlled by Medicareenrolled entities. CMS responded with an example: “For example, if a hospital, two
physician groups, and a health plan formed an ACO, the hospital and two physician groups
must control at least 75 percent of the ACO governing body.”212 This example is
embedded in a general response to comments section, but agencies frequently use
examples and incorporate them in various formats.
3.

Preambles the Appear to Bind

Rather than articulating the basis and purpose of the regulatory text or providing
guidance on how to comply with it, some preambles make statements that appear or
purport to have legal effect.
A complex rulemaking by the Centers for Medicare and Medicaid Services (CMS)
provides an example of the slippage that can occur between the preamble and the text of
the rule.213 In the rule, CMS revised requirements for the way in which long-term care
hospitals transfer patients to hospitals within them (“hospitals within hospitals”) or
affiliated satellite hospitals. In the preamble to its final rule, CMS noted in response to
comments that it provided a 4-year transition prior for the implementation of the new
requirements and also provide for certain hospitals to be “grandfathered,” treating the first
year as “hold harmless.”214 The preamble went on to state, “we are requiring that even for
grandfathered facilities, in the first cost reporting period, the percentage of discharges
admitted from the host hospital may not exceed the percentage of discharges admitted from
the host hospital in its FY 2004 cost reporting period.”215
The final rule, however, “omitted the limitation that grandfathered facilities in the
first year of the transition period would not be allowed to exceed the percentage of patients
admitted from the host during fiscal year 2004 cost reporting period.”216 The preamble
thus stated a requirement about the percentage of permissible admissions to hospitals
within hospitals and satellite facilities that did not appear in the rule.
On its own initiative, CMS issued a correcting amendment to the rule to conform
the rule to its preamble’s statement of the requirements applicable to grandfathered

212

Id. at 67,819–67,820.
Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005
Rates, 69 Fed. Reg. 48916 (Aug. 11, 2004) (to be codified at 42 C.F.R pts. 403, 412, 413, 418, 460, 480, 482,
483, 485, 489).
214
Id. at 49196.
215
Id.
216
Select Specialty Hosp.-Akron v. Sebelius, 820 F.Supp.2d 13, 23-24 (D.D.C 2011).
213

40

institutions,217 which correcting amendment was upheld from procedural and substantive
challenges.218
C.

Guidance in Regulatory Text and Appendices

Agencies provide guidance about the meaning and application of their regulations
in the regulatory text published in the Code of Federal Regulations (CFR) and in
appendices attached to final rules. While guidance in the regulatory text appears, by
definition, in the Code of Federal Regulations, guidance in appendices is sometimes only
published in the Federal Register and other times published in the Code of Federal
Regulations. Agencies use different formats to provide guidance in the regulatory text and
appendix, including through official commentary, examples, notes, and technical guidance.
The following sections illustrate the various ways agencies offer guidance in the regulatory
text and appendix.
1.

Guidance Published in the CFR

a.
Examples in Regulatory Text. Agencies provide guidance in material
published in the CFR, most often in the form of notes and examples. For instance, the
Department of the Treasury provided illustrative examples in a rule on mergers,
acquisitions, and takeovers by foreign persons.219 In § 800.215 (a)–(b), the regulatory text
defines a “foreign person” as “(a) Any foreign national, foreign government, or foreign
entity; or (b) Any entity over which control is exercised or exercisable by a foreign
national, foreign government, or foreign entity.”220 After this text, there are five examples

217

Id.
Id. at 27 (concluding that the agency was not required to go through another round of notice-and-comment
to issue its correcting amendment and that the amendment was not arbitrary nor capricious); see also Natural
Res. Def. Council v. EPA, 559 F.3d 561, 565 (D.C. Cir. 2009) (invalidating requirements stated in preamble
that did not correspond to or interpret a section of the rule). In some cases, agencies make statements in their
preambles that appear to be binding in part because they use mandatory language and do not make a
reference the regulatory text, even when the regulatory text provides a basis for the obligations discussed.
See, e.g., Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations, 76 Fed.
Reg. 67,802, 67,898-99 (Nov. 2, 2011) (to be codified at 42 C.F.R. pt. 425) (in a section headed “Final
Decision” the preamble stated “if an ACO [Accountable Care Organization] fails to achieve the minimum
attainment level on at least 70 percent of the measures in each domain, we will give the ACO a warning, an
opportunity to resubmit and re-evaluate the following year. If the ACO continues to underperform in the
following year, the agreement would be terminated,” without referring to 42 C.F.R. § 425.502(d)(2)(ii)). It is
preferable to for mandatory statements of this kind in preambles to cite the regulatory provisions that give
rise to those obligations.
.
219
Regulations Pertaining to Mergers, Acquisitions, and Takeovers by Foreign Persons, 73 Fed. Reg. 70,702,
70,702 (Nov. 21, 2008) (to be codified at 31 C.F.R. pt. 800).
220
Id. at 70,720.
218

41

illuminating the “foreign person” definition.221 Example 4 states that “[c]orporation A is
organized under the laws of a foreign state and is owned and controlled by a foreign
national. A branch of Corporation A engages in interstate commerce in the United States.
Corporation A (including its branch) is a foreign person. The branch is also a U.S.
business.”222 After the examples, the rule proceeds to the next regulatory provision.223
The Merit Systems Protection Board (MSPB) provided guidance through examples
in the regulatory text of a rule updating MSPB’s adjudicatory practices and processes. 224 In
its rule addressing the filing of appeals, the Board notes that “[a]n appellant is responsible
for keeping the agency informed of his or her current home address[.]”225 Following the
rule’s text, the Board provided examples “to illustrate the application of this rule.”226 The
three enumerated examples include: “Example A: An appellant who fails to pick up mail
delivered to his or her post office box may be deemed to have received the agency
decision. Example B: An appellant who did not receive his or her mail while in the hospital
may overcome the presumption of actual receipt. Example C: An appellant may be deemed
to have received an agency decision received by his or her roommate.”227
2.

Guidance in Appendices

a.
Official Commentary in Appendix. Some agencies incorporate official
commentary, official interpretations, or designated interpretive guidance into appendices.
The Equal Employment Opportunity Commission (EEOC) included official interpretations
in a rule implementing the equal employment provisions of the ADA Amendments Act of
2008.228 In the preamble to the final rule, the EEOC explained the function of the official
interpretations:
The appendix addresses the major provisions of the regulations and explains
the major concepts. The appendix as revised will be issued and published in
the Code of Federal Regulations with the final regulations. It will continue
to represent the Commission’s interpretation of the issues discussed in the

221

Id.
Id.
223
Id.
224
Practices and Procedures, 77 Fed. Reg. 62,350, 62,350 (Oct. 12, 2012) (to be codified at 5 C.F.R. pts.
1200, 1201, 1203, 1208, and 1209).
225
Id. at 62,364.
226
Id.
227
Id. (appearing in 5 C.F.R § 1201.22 (2012).
228
Regulations To Implement the Equal Employment Provisions of the Americans With Disabilities Act, as
Amended, 76 Fed. Reg. 16,978, 16,978 (March 25, 2011) (to be codified at 29 C.F.R. pt. 1630).
222

42

regulations, and the Commission will be guided by it when resolving
charges of employment discrimination under the ADA.229
The appendix entitled “Appendix to Part 1630—Interpretive Guidance on Title I of the
Americans with Disabilities Act” includes a lengthy introduction on the development of
the ADA followed by a section-by-section analysis of the provisions promulgated in the
regulation.230 For instance, in the appendix under “Section 1630.2(l) – Regarded as
Substantially Limited in a Major Life Activity”, the EEOC wrote “[c]overage under the
‘regarded as’ prong of the definition of disability should not be difficult to establish.”231
The EEOC states that these interpretations will guide it when resolving employment
discrimination charges under the ADA.232
The Consumer Financial Protection Bureau (CFPB) also included official
interpretations at the end of Regulation X, a rule implementing the Real Estate Settlement
Procedures Act (RESPA).233 After appendices with technical guidance, there is a section
entitled “Supplement I to Part 1024—Official Bureau Interpretations.”234 In this
supplement, the CFPB explains that “[t]his commentary is the primary vehicle by which
the [Bureau] issues official interpretations of Regulation X. Good faith compliance with
this commentary affords protection from liability under section 19(b) of [RESPA].”235 Like
the EEOC rule above, this supplement included section-by-section interpretations of the
regulation.236 For instance, in the supplement the CFPB interpreted the regulatory
provision § 1024.36 on investigation and response requirements. 237 Specifically, the
agency interpreted “information not available” as occurring when: “(i.) [t]he information is
not in the servicer’s control or possession, or (ii) [t]he information cannot be retrieved in
the ordinary course of business through reasonable efforts.”238
b.
Examples in Appendix. The EEOC appendix that provided interpretive
guidance on the ADA Amendments Act of 2008 also incorporated examples.239 In the
appendix, the EEOC wrote: “[f]or example, an individual who is denied a promotion
229

Id. at 16979.
Id. at 17003.
231
Id. at 17014.
232
Id. at 16978.
233
Mortgage Servicing Rules Under the Real Estate Settlement Procedures Act (Regulation X), 78 Fed. Reg.
10,696, 10,696 (Feb. 14, 2013) (to be codified at 12 C.F.R. pt. 1024).
234
Id. at 10,887.
235
Id.
236
Id.
237
Id. at 10,891.
238
Id.
239
Regulations To Implement the Equal Employment Provisions of the Americans With Disabilities Act, as
Amended, 76 Fed. Reg. 16,978, 17,016 (March 25, 2011) (to be codified at 29 C.F.R. pt. 1630).
230

43

because he has a minor back injury would be ‘regarded as’ an individual with a disability if
the back impairment lasted or was expected to last more than six months.”240 The EEOC
offered numerous examples in this appendix.
A joint rule by a group of agencies (Treasury, SSA, DVA, RRB, and OPM) on
garnishment of accounts containing federal benefit payments utilized examples in an
appendix to the final rule.241 For instance, one of the appendices entitled “Appendix C to
Part 212—Examples of the Lookback Period and Protected Amount” stated “the following
examples illustrate the definition of protected amount.”242 There are then five examples
that explain how hypothetical scenarios fit within the definition of protected amount.243
Here is an excerpt of example 4: “Since the $2,000 sum of the two benefit payments posted
to the account during the lookback period is less than the $3,000 balance in the account
when the account review is performed, the financial institution establishes the protected
amount at $2,000 and places a hold on the remaining $1,000 in the account in accordance
with State law.”244 The appendices were published in the CFR.245
c.
Question and Answer Format in Appendix. Agencies provide guidance
in appendices through the question and answer format. The Social Security Administration
promulgated a rule revising medical criteria for evaluating visual disorders in which
revisions adopted consisted almost exclusively amendments to the appendix appearing in
the CFR.246 After the preamble, the agency posed and answered a series of questions in the
appendix.247 Questions included, for instance, “How do we evaluate visual disorders?” and
“How do we define statutory blindness?”248 In response to the question “What are visual
disorders?”, the agency wrote “Visual disorders are abnormalities of the eye, the optic
nerve, the optic tracts, or the brain that may cause a loss of visual acuity or visual
fields.”249 These questions and answers in the appendix were published in the CFR.250
The Department of Education also provided guidance in an appendix through the
question and answer format in a rule implementing the Family Educational Rights and
240

Id.
Garnishment of Accounts Containing Federal Benefit Payments, 78 Fed. Reg. 32,099, 32,110 (May 29,
2013) (to be codified at 31 C.F.R. pt. 212).
242
Id. at 32,109.
243
Id. at 32,109–32,110.
244
Id. at 32,110.
245
See 31 C.F.R. § 212 app. A, B & C (2013).
246
Revised Medical Criteria for Evaluating Visual Disorders, 78 Fed. Reg. 18,837, 18,837 (March 28, 2013)
(to be codified at 20 C.F.R. pt. 404).
247
Id. at 18,839.
248
Id.
249
Id. at 18,834
250
20 C.F.R. § 404, Subpart P, app. 1 (2013).
241

44

Privacy Act (FERPA).251 After the regulatory text, the Department of Education included a
document on “Guidance for Reasonable Methods and Written Agreements” in Appendix
A.252 The Department of Education structured this guidance document as a series of
questions and answers.253 Questions included: “What is the Family Educational Rights and
Privacy Act?” and “What do I do if the terms of the written agreement are violated?”254 In
response to the latter question, the agency answered “[i]f the entity to which you have
disclosed PII from education records without consent . . . violates the terms of the written
agreement, you should evaluate your options under the penalty and termination provisions
of the agreement . . . .”255 Interestingly, before the appendices to the FERPA rule, the
Department of Education wrote “Note: The following appendices will not appear in the
Code of Federal Regulations.”256 (The agency did not further explain its choice to exclude
the appendices from the CFR.)
d.
Technical Guidance in Appendix. Agencies sometimes include technical
guidance in appendices to final rules. For instance, the CFPB utilized this approach in
Regulation X discussed above.257 After the regulatory text, the CFPB attached appendices
with model forms and sample language for use by regulated entities.258 Appendix MS-2
contained a model form of a notice of transfer of loan servicing for a servicer to provide to
a borrower.259 An excerpt of this model form read: “[Name of present servicer] is now
collecting your payments. [Name of present servicer] will stop accepting payments
received from you after [Date].”260 These model forms were published in the CFR.
The Department of Education’s rule implementing FERPA also includes technical
guidance in appendices.261 FERPA requires educational institutions to annually notify
parents and eligible students of their rights under FERPA.262 To facilitate this requirement,
Appendix B attached to the final rule includes a “Model Notification of Rights under
251

Family Educational Rights and Privacy, 76 Fed. Reg. 75,604, 75,645 (Dec. 2, 2011) (to be codified at 34
C.F.R. pt. 99).
252
Id.
253
Id.
254
Id. at 75,645, 75,653.
255
Id. at 75,653.
256
Id. at 75644. So long as the material is reasonable available, as it was in this case, this practice complies
with recommended practices on incorporation by reference. See Admin. Conf. of the United States, Agency
Policy Statements, Recommendation 2011-5, ¶ 1, 77 Fed. Reg. 2257, 2258 (Jan. 17, 2012) (recommending
that material incorporated by reference be reasonably available).
257
Mortgage Servicing Rules Under the Real Estate Settlement Procedures Act (Regulation X), 78 Fed. Reg.
10,696, 10,886 (Feb. 14, 2013) (to be codified at 12 C.F.R. pt. 1024).
258
Id.
259
Id. at 10,877.
260
Id. at 10,886.
261
Family Educational Rights and Privacy, 76 Fed. Reg. 75,604, 75,654 (Dec. 2, 2011) (to be codified at 34
C.F.R. pt. 99).
262
Id. at 75608.

45

FERPA for Elementary and Secondary Schools.”263 The model form begins with
“[FERPA] affords parents and students who are 18 years of age or older (‘eligible
students’) certain rights with respect to the student’s education records” and then the model
form enumerates those rights.264 As noted above, the appendices to the FERPA rule were
not published in the CFR.
D.

Separately Issued Contemporaneous Guidance

Agencies frequently issue guidance or draft guidance in the form of separately
issued documents at the same time that they issue their rules. This practice has the benefit
of giving regulated parties as much notice as possible at the time the rule promulgated
about the agency’s interpretation of the rule and advice about compliance with it.
The Nuclear Regulatory Commission (NRC) provides a recent example an agency
issuing detailed guidance alongside a new rule. At the time the NRC issued a rule
amending its regulations regarding the security requirements for the transportation of
radioactive material,265 it also issued an extensive guidance document to assist in the
implementation of these requirements.266 The implementation guidance provided
comprehensive treatment of the approaches and methods that the agency deemed
acceptable in complying with the regulations,267 framing this guidance in an accessible
question-and-answer format. The practice of issuing a freestanding guidance at the same
time a rule is promulgated is particular helpful where, as in the case of the NRC rule, the
preamble makes reference to (and providing links to) the accompanying guidance.268
Even when agencies choose not to issue a separately designated guidance
document, as noted above, for rules with significant impacts on small entities, SBREFA
requires agencies to issue a form of contemporaneous guidance, “small entity compliance
guidance,” before the regulation becomes effective to explain what actions are necessary
for a small entity to comply with the regulation.269

263

Id. at 75654.
Id.
265
Nuclear Regulatory Commission, Physical Protection of Byproduct Material, Final Rule, 78 Fed. Reg.
16922 (Mar. 19, 2013).
266
U.S.N.R.C., Office of Federal and State Materials and Environmental Management Programs,
Implementation of Guidance for 10 C.F.R. Part 37 “Physical Protection of Category 1 and Category 2
Quantities of Radioactive Material,” NUREG-2155 (Feb. 2013).
267
Id. at 1.
268
See Physical Protection of Byproduct Material, 78 Fed. Reg. at 16922.
269
Small Business Regulatory Enforcement Fairness Act, § 212(a)(4)(B)(i), 5 U.S.C. § 610 (2006)
264

46

In 2001, GAO issued a report concluding that many agencies were failing to fully
comply with these requirements of SBREFA.270 Based on an examination of rulemaking
in 1999 and 2000 for seven agencies (the Department Commerce, CMS, FDA, HHS, EPA,
FCC, and SEC), the GAO study concluded that agencies were applying different standards
for when a rule affected small entities triggering the obligation to prepare a guide,271 were
not designating their products as “compliance guides,”272 were failing to explain the
compliance actions required,273 and did not meet the contemporaneous deadlines set by the
Act,274 among other difficulties. Interestingly, there is no central clearinghouse for these
compliance guides or for the agency websites on which they appear.
V.

Recommendations to Federal Agencies

This Part sets forth recommendations to federal agencies with regard to the use of
contemporary guidance. Some of these recommendations apply to all rulemaking agencies
and others pertain to specific agencies and practices; some suggest relatively substantive
reforms, such as how preamble are drafted, and others pertain to how agencies can increase
the accessibility of their contemporary guidance. These recommendations are clustered
under five headings: (1) preamble drafting, (2) integrating preambles into policies on
guidance and collections of guidance, (3) electronic presentation of regulations, (4)
tailoring the location of guidance to the practices of those regulated, and (5) small entity
compliance guides.
1.

Preamble Drafting

Rec. 1.1.
The statement of “basis and purpose” produced in the preamble to
final rules should state the purpose of the rule and how it advances statutory objectives in a
way that goes beyond merely repeating statutory language.
Discussion: Recommendation 1.1 is based on the principle that an agency’s own
statement of the purposes of the rule in light of statutory objectives is a necessary element
of the “statement of [] basis and purpose” under APA § 553 and “a statement of the need
for, and objectives of, the rule” under the Regulatory Flexibility Act (RFA).275 This
principle follows from judicial interpretations of the APA and RFA discussed above
U.S. GOV’T ACCOUNTABILITY OFFICE, GAO 02-172, Compliance Guide Requirement Law Little Effect
on Agency Practices (2001).
271
Id. at 14.
272
Id. at 23.
273
Id. at 24.
274
Id. at 28.
275
5 U.S.C. § 604 (2012).
270

47

(Section III(D)(1)). At a basic level, a statement of a rule’s purpose and how it advances
statutory objectives orients all interpretation of the rule, and demonstrates the agency’s
discharge of the statutory powers with which it is vested. The vast majority of agencies
and rulemakings admirably comply with this basic requirement, but not all do.
Accordingly, it is worth highlighting this fundamental duty.
For those concerned about the burden this recommendation might place on
agencies, it is worth emphasizing three points. First, this is a fundamental requirement of
the APA and RFA, but one for which there is not active judicial enforcement for many
rules. Second, compliance with this recommendation should not be unduly burdensome.
For small and routine rulemakings, the agency could comply with this recommendation
with a sentence or two of explanation. Third, this recommendation addresses only those
rules that proceed through notice and comment. Regulations that merely restate the
language of statutes they implement need not proceed through notice and comment,276 and
therefore fall outside this recommendation (along with rules exempted from notice and
comment for other reasons).
Rec. 1.2.
Agencies generally should organize their preambles to include a
section-by-section analysis in which the organization of the preambular analysis
corresponds to the organization of the final rules to facilitate identification of the
discussion the agency has provided as to each provision of the rule.
Discussion: The increased justificatory demands on preambles, as discussed
above (Section II(B)), have contributed to the length and complexity of these documents.
Recommendation 1.2 is the organizational equivalent of a requirement for plain language
in government documents.277 It reflects the common sense idea that when the analysis in
the preamble includes a section-by-section treatment corresponding to the sections of the
rule adopted, it is easier for those reading the preamble to locate the most highly pertinent
discussion. Of course, reading a section-by-section analysis is no excuse for not reading
the entire preamble in order to understand its context and cross-cutting implications. But a
section-by-section organizational structure reduces the search costs for those seeking to
understand the operation and justification for particular aspects of an agency rule. In other
words, a well-organized preamble reduces the cost of locating its guidance.

Gray Panthers Advocacy Cmm., 936 F.2d 1284, 1291 (1991) (“when regulations merely restate the statute
they implement, notice-and-comment procedures are unnecessary”).
277
See, e.g., Memorandum for the Heads of Executive Departments and Agencies on “Plain Language in
Government Writing” (June 1, 1998), 63 Fed. Reg. 31,885 (June 10, 1998); Plain Writing Act of 2010, Pub.
L. No. 111, 124 Stat. 2861, codified at 5 U.S.C. § 301 nt. (Supp. V 2011) (imposing plain writing
requirements on many government documents including those that explain how to comply with a
requirement the federal government administers).
276

48

Rec. 1.3.
Agencies should strive for preambles to their final rules to be
comprehensive statements of each rule’s basis and purpose. In preambles to final rules,
agencies should generally avoid relying on discussions of the basis and purpose of the rule
provided in the Notice of Proposed Rulemaking (or in other prior notices) in ways that
require the reader of the final preamble to integrate two or more discussions of the rule’s
basis and purpose.
Discussion: Recommendation 1.3 addresses the practice of incorporating
background discussions of the policy, basis, and objections provided in the Notice of
Proposed Rulemaking (and other prior notices) in the final preamble. The Government
Printing Office charges agencies per page they print in the Federal Register,278 so agencies
have some financial incentive to incorporate prior analyses in a final preamble as opposed
to restating them. Moreover, sometimes rules and their supporting analysis change very
little in the comment process. Relying on prior discussions can also save agency drafters
time. Notwithstanding these considerations, the practice of relying on discussion in
previously published notices impedes the guidance function of the final rule’s preamble.
With extensive reliance on prior statements of the rule’s basis and purpose, the final
preamble can become merely a placeholder and signpost to other discussions that need to
be integrated with the text of the final preamble. Requiring the public and regulated parties
to integrate two or more separate and partial discussions of the basis and purposes of the
rule reduces the utility of the final preamble for guidance purposes. This suggests that
agencies should, at a minimum, consider whether incorporating or relying upon prior
discussion will impede the guidance function of their preamble, and generally avoid such
incorporation when it requires a reader to integrate two or more treatments.279 At a more
general level, the guidance function of the final preamble is best served when the preamble
provides a comprehensive statement of the rule’s basis and purpose. Accordingly, when
feasible, agencies should strive for the preamble to the final rule to be a comprehensive and
free-standing explanation of the rule.
Rec. 1.4.
Agencies should not make statements of general applicability that
are intended to have legal effect, such as statements imposing binding substantive
standards or obligations, in preambles to final rules.

278

The fees for Federal Register publication in FY 2014 are as follows: MS Word submission: $477/per
page, $159/per column; Manuscript Copy: $522/per page, $174/per column; Camera Copy: $522/per page,
$174/per column. See Government Printing Office, Circular Letter No. 885 to Printing and Publishing
Officials
of
the
Federal
Government
(May
31,
2103)
(available
at
http://www.gpo.gov/pdfs/customers/cir885.pdf) (last visited March 31, 2014).
279
Fewer burdens are imposed on the reader when the agency adopts the entire previous statement of the
basis and purpose for the rule. In those cases, much less integration of two separate discussions is required.

49

Discussion: While preambles may be authoritative sources of guidance, as
discussed above, under the APA, preambles should not include legislative rules; if a
preamble were to include a legislative rule, that rule would be procedurally invalid under
APA § 553. ACUS Recommendation 92-2 states that agencies should “not issue
statements of general applicability that are intended to impose binding substantive
standards or obligations upon affected persons without using legislative rulemaking
procedures (normally notice-and-comment).”280 Recommendation 1.4 makes clear that this
general prohibition on including statements that are intended to have legal effect applies to
statements in preambles to final rules.
This recommendation also finds support in OMB’s Good Guidance Bulletin. The
Bulletin prohibits agencies from using mandatory language in guidance documents unless
“the agency is using these words to describe a statutory or regulatory requirement, or the
language is addressed to agency staff and will not foreclose consideration by the agency of
positions advanced by affected private parties.”281 The Bulletin gives “shall,” “must,” and
“requirement” as examples of prohibited mandatory language. Recommendation 1.4
highlights that the prohibition applies to all statements that purport to specify legal effects,
not just those singled out by the mandatory language identified in OMB’s Good Guidance
Bulletin.
2.

Integrating Preambles into Policies on Guidance and Collections of
Guidance

Rec. 2.1. Agencies should mention preambles to their final rules as sources of
guidance in their general compilations of guidance and on their webpages devoted to
guidance. Agencies should also develop ways to integrate the guidance content of their
preambles into their general compilations of guidance and their webpages devoted to
guidance.
Discussion: The preambles to final rules are often the most important sources of
guidance about the rule’s meaning and effects. For agencies covered by OMB’s Good
Guidance Bulletin, the Bulletin requires “each agency to maintain on its Web site . . . a
current list of its significant guidance documents in effect.”282 These pages typically
define guidance and provide a topical and/or chronological listing of the agency’s guidance
documents, with links. Based on a review of those executive agencies which have issued

280

Admin. Conf. of the United States, Agency Policy Statements, Recommendation 92-2, 57 Fed. Reg.
30,103 (June 18, 1992).
281
OMB’s Good Guidance Bulletin, supra note 1, at 3440.
282
See id. at Section III.1

50

an economically significant rule in the last 15 years,283 only the Department of
Transportation mentions preambles as sources of guidance on its webpage devoted to
guidance. Recommendation 2.1 seeks to improve the visibility of preambles as sources of
guidance by recommending that, at a minimum, agencies mention preambles to final rules
on their guidance web pages and integrate them into their general compilations of
guidance.
There is not likely to be a uniform way to integrate the guidance content of
preambles into agency’s web-based summaries of guidance. (One promising format is
providing hyperlinks from the regulatory text to guidance in preambles and other guidance
documents, a suggestion addressed in Recommendation 3.1.) Regardless of the format, by
endeavoring to integrate the guidance content of their preambles into their topical and
other treatments of guidance, the agencies will not only assist the public in identifying this
content but also will be spurned to consider how the guidance content of their preambles
relates to the guidance they later provide. This process may encourage agencies to make
self-conscious choices about the allocation of their guidance content between final
preambles and later issued guidance documents, and may help to overcome perceptions
that preambles concern only the legal sufficiency of rules and thus need not be considered
as part of the way in which the agency provides guidance about the meaning of its
regulations.
Mentioning preambles as sources of guidance and working to integrate the
guidance in preambles into presentations of agency guidance will promote the visibility of
this guidance regardless of the type of agency. Accordingly, this recommendation applies
not only to those agencies covered by OMB’s Good Guidance Bulletin but to all agencies
that provide compilations or summaries of their guidance.
Rec. 2.2.
To the extent agencies have policies on issuing guidance, those
policies should address the guidance content of preambles to their final rules.
For
agencies covered by OMB’s Good Guidance Bulletin, their policies should address
compliance with the Bulletin’s procedural requirements applicable to guidance documents
for significant and economically significant guidance included in preambles to final rules.
Discussion: As discussed above, preambles to final rules provide an important
source of guidance, and so agency policies on issuing guidance should address them.
Doing so will encourage agencies to make choices about the kind of guidance that they
provide in preambles and in other documents. It will also encourage agencies to consider
283

This list of agencies is drawn from LEWIS & SELIN, supra note 17, at 132 Table 20. The web pages for
these agencies were visited in March 2014.

51

how they envision those affected by their regulations integrating these different sources of
guidance. The recommendation does not independently suggest that agencies develop
policies on guidance, only that those with policies reassess them to address guidance
provided in preambles.
Agencies covered by OMB’s Good Guidance Bulletin must have policies for the
approval of guidance.284 As the analysis above suggests (Section II(A)), guidance that
those covered agencies provide in preambles to final rules, if significant, is subject to the
procedural requirements of the Bulletin. As a result, conscientious compliance with that
Bulletin (or careful monitoring of compliance with it by the Office of Management and
Budget) would require evaluating whether guidance provided in preambles triggers any of
the process or other requirements of the Bulletin.
3.

Electronic Presentation of Regulations

Rec. 3.1.
Working in conjunction with the Office of the Federal Register and
the Government Printing Office, agencies should develop electronic versions of their
regulations which include hyperlinks to relevant guidance in the rules’ final preambles as
well as to other relevant guidance documents.
Discussion: The electronic presentation of regulations can integrate agency
guidance with their regulations by providing hyperlinks to relevant guidance in preambles
to final rules as well as to other relevant guidance documents. This can improve the public
and regulatory entities access and understanding of agency regulations and agency
guidance.
The Consumer Financial Protection Bureau has piloted a new online tool,
“eRegulations,”285 with the aim of improving access to and understanding of final rules.286
The tool provides navigable links to defined terms, official commentary, previous and
proposed versions of the rule, as well as section-by-section analysis in regulatory
preambles.287 This tool is an important step in realizing the possibilities of the internet and
hypertext formats to improve understanding of regulations. In particular, because this tool
provides links to relevant sections of preambles to final, it clearly highlights the guidance
function of preambles and also reduces the costs associated with accessing this preamble
See OMB’s Good Guidance Bulletin, supra note 1, at 3440.
E-Regulations, http://www.consumerfinance.gov/eregulations/1005 (last visited Mar. 21, 2014).
286
See Stephanie J. Tatham, CFPB’s eRegulations tool promises to help users navigate federal regulations,
ADMINISTRATIVE FIX BLOG, (Oct. 22, 2013, 6:11 PM), http://www.acus.gov/newsroom/administrative-fixblog/cfpb%E2%80%99s-eregulations-tool-promises-help-users-navigate-federal.
287
See id.
284
285

52

guidance. This format provides a promising way of integrating the guidance content of
preambles with other guidance, and associating it with the relevant provisions of the rule.
Adoption of such hyperlink tools may also influence the way in which preambles
are drafted, in particular by giving agencies incentives to write preambles with
organizational structures (as suggested by Recommendation 1.2 above) that track the rule’s
sections so that they can support intelligible hyperlinks. Substantive knowledge of the
agency’s preambles and guidance is necessary to provide reliable links to the portions most
relevant to each provision of a rule. Accordingly, this work will require detailed
involvement and supervision by general counsel for each agency. In addition, the Office of
the Federal Register and the Government Printing Office should be encouraged to work
with agencies to make available electronic versions of agency regulations with these
hyperlinks to supplement the official versions of the Federal Register and Code of Federal
Regulations that the Office of the Federal Register maintains.
4.

Tailoring the Location of Guidance to the Practices of Those Regulated

Rec. 4.1.
Where the regulated population is (1) primarily the public and (2) is
understood to rely primarily on the codified text of the regulation to understand their
regulatory compliance obligations, agencies should consider including guidance (such as
notes and example applications) in the text of the Code of Federal Regulations or in an
appendix to the Code of Federal Regulations, as opposed to including it only in a separate
guidance document or a preamble.
Discussion: Most members of the public and many regulated parties have little
knowledge of administrative government, much less the distinction between a “regulation”
and “guidance.” Members of the public frequently and reasonably seek the simplest way
to find out what the law requires. When the agency publishes guidance in the form of
examples, technical advice, or official interpretations, it can improve the accessibility of
this content if it is published in the Code of Federal Regulations, either as a note or
example in the text or as an appendix.
Recommendation 4.1 suggests that when the public is the primary regulated
audience and the agency has reason to believe that the public relies primarily on the Code
of Federal Regulations to ascertain its obligations, the agency should consider including
that guidance in the Code of Federal Regulations (CFR). One possible downside of
publishing guidance in the CFR is that the public will take it too seriously, treating it as

53

binding (not just as authoritative guidance).288 This is a real risk, and so agencies issuing
guidance in the CFR should clearly designate that it is nonbinding.
Publishing guidance content in the CFR also imposes an additional process burden
on the agency. But, as noted above, as long as Alaska Professional Hunters remains good
law, the agency would have to proceed through notice-and-comment to revise any
authoritative guidance, so issuing it in the CFR does not increase the agency’s revision
cost, only its cost for issuance. This recommendation encourages agencies to make case
specific determinations about when the benefits of publishing guidance content in the CFR
are outweighed by the increased cost, delay, or other problems that publishing it in the
CFR can pose.
5.

Small Entity Compliance Guides

Rec. 5.1. Agencies should reassess how they display their small entity compliance
guides on their websites to ensure that these guides are in an “easily identified location”289
as required by the Small Business Regulatory Enforcement Fairness Act of 1996
(SBREFA).
Rec. 5.2. The Small Business Administration should work with agencies to
develop guidelines for posting small entity compliance guides on agency websites in ways
that make them easily identifiable.
Rec. 5.3. The Small Business Administration should maintain a webpage with
links to agency webpages that host agency’s small entity compliance guides.
Discussion of 5.1-5.3: While many agencies post the small entity compliance
guides required by SBREFA in an “easily identified location” on their websites, for many
other agencies these guides are difficult to find. Indeed, searching the websites of the 21
agencies that have issued an economically significant rule in the past 15 years,290 only four
agencies (Labor, State, Transportation, and EPA) have an identified web page devoted
288

For instance, the Department of Energy decided to delete guidance that had appeared as an appendix in
the C.F.R. and publish the same in an updated form on its web site. See Energy Conservation Program: Test
Procedures for Electronic Motors and Small Electric Motors, 77 Fed. Reg. 26608, 26623-24 (May 4, 2012)
(to be codified at 10 C.F.R. pt. 431). The Department noted that his change “does not change the legal effect
or authority of appendix A as appendix A was a ‘Policy Statement’ that merely provided users with guidance
as to DOE’s interpretation of existing statutes and regulations.” Id. Placing this content in freestanding
guidance, the Department explained will allow the Department “to respond more efficiently to questions” and
also “eliminate any potential confusion as to the legal effect of appendix A.” Id.
289
5 U.S.C. § 601 nt. § 212(a)(2(A) (2012).
290
See LEWIS & SELIN, supra note 17, at 132. Web searches of these agency websites conducted in March,
April, and May 2014.

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either to displaying these guides or acknowledging the responsibility of producing them.
It does not make sense to require agencies to produce these guides, as SBREFA does, and
not follow through on making them readily accessible. In this regard, agencies should be
encouraged to evaluate where they are posting these guides on their web sites, as provided
in Recommendation 5.1, to ensure they are easily located.
Recommendation 5.2 encourages the Small Business Administration (SBA) to take
a leadership role in coordinating among agencies and developing policies on uniform and
best practices for agencies presenting small entity compliance guides on their websites.
Because these guides are directed to small entities, the Small Business Administration is a
logical leader for this endeavor. The assistance of the Office of Management and Budget
would also be welcome in assisting SBA in coordinating among agencies on a set of
guidelines.
Recommendation 5.3 goes a step further and recommends that SBA host a
clearinghouse with links to agency webpages that contain their small entity compliance
guides. Such a clearinghouse would provide a backstop for small entities searching for
these guides; it would allow them to easily find where these guides are located for each
agency, and may also alert them to other useful guides. Because these guides are directed
to small entities, and the SBA already maintains a webpage with information about
SBREFA, the SBA is a logical home for this clearinghouse.
Maintaining this clearinghouse would also create a welcome additional incentive
for agencies to comply with the requirements of SBREFA. As noted above, GAO’s 2001
report, Compliance Guide Requirement Law Has Little Effect on Agency Practices,291
found that many agency compliance guides were not complying with all the requirements
of this provision of SBREFA. A collection of links to agency webpages with these guides
will make it easy for agencies to compare their guides to those produced by other agencies,
and may create some pressure toward greater consistency in meeting the requirements
SBREFA establishes. It will also provide an informal monitoring mechanism for
Recommendation 5.2 which urges SBA to work with agencies to enhance the visibility of
these guides.

U.S. GOV’T ACCOUNTABILITY OFFICE, GAO 02-172, COMPLIANCE GUIDE REQUIREMENT HAS HAD LAW
LITTLE EFFECT ON AGENCY PRACTICES (2001).
291

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Conclusion
Given that regulations produced through notice-and-comment account for many
more binding legal norms than statutes, the interpretation of these regulations is a critical
question for administrative governance. One critical source for understanding the meaning
and application of regulations is agency’s own guidance.
Agencies routinely provide guidance in the context of rulemaking. There is some
minimum guidance function inherent in an agency’s statement of basis and purpose in a
regulation’s preamble. But in many cases, agencies provide considerably more preamble
guidance about the meaning of the regulation in the preamble. Agencies also do so in the
regulatory text (including appendices that may be published in the CFR) and separate
documents. Despite the ubiquity of contemporaneous guidance, it has been largely
neglected in the long-running debate on the use of guidance by agencies.
This Report seeks to take some initial steps in overcoming this neglect. It does so
by pursuing three goals. First, by documenting the scope of contemporaneous guidance
and its varieties, the Report aims to provide agencies with resources for making deliberate
choices about the use of guidance in rulemaking. Second, by describing the legal regime
applicable to contemporaneous guidance the Report aims to inform and prompt evaluation
of current practices. Third, by tracing the implications of the neglect of the guidance
function of preambles and use of regulatory text for guidance, the Report teases out several
recommendations to improve the utility and accessibility of these forms of guidance.

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Acknowledgment
I would like to thank Michael Snow, Jason Sowards, and Robin Frazer for excellent
research assistance. I am also grateful to Funmi Olorunnipa and Gretchen Jacobs for
extremely helpful guidance, as well as the government lawyers who generously responded
to my inquiries.

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