Author:Strauss, Peter L.
  1. INTRODUCTION 766 II. Is "GUIDANCE" A SINGULAR CONCEPT? 771 III. THE OBJECTION THAT NOTICE AND COMMENT PROCEDURES SHOULD 773 HAVE BEEN USED IV. REVIEWING THE MERITS OF GUIDANCE DOCUMENTS 776 A. Where an agency has relied on its guidance in formally 776 deciding a matter subject to judicial review, what standard of review applies if the guidance embodies a statutory interpretation? B. Where an agency has relied on its guidance in formally 778 deciding a matter subject to judicial review, what standard of review applies if the guidance concerns interpretation of an agency regulation? C. The possibility of reviewing on the merits guidance 782 documents not relied upon in a regulation or formal adjudicatory opinion I. INTRODUCTION

    Professor Funk learned much of his administrative law, as I did, through his important responsibilities in the general counsel's office of a government agency. And that experience has significantly informed his scholarship about the son law documents--statements of general policy and interpretive rules--that today one generally finds discussed under the rubric "guidance." (2) These are agency texts of less formality than hard law regulations adopted under the procedures of 5 U.S.C. [section] 553. They inform the public how an agency intends to administer its responsibilities, as a matter of policy or (what may seem just one instance of that) via the interpretation of its governing statutes or regulations. The Administrative Procedure Act (APA) is explicit that in adopting these texts, agencies are not required to use the notice and comment process ordinarily required for the adoption of regulations having the force of law; but it also signals that, like agency case law precedent, guidance may be relied upon to a private party's disadvantage if it has been published or come to its actual notice. (3) Guidance documents, revealing agency policy and perhaps showing the way to safe compliance, can structure the behavior of agency staff and be highly influential for the regulated; but they are not in themselves enforceable against actors in the outside world--hence, soft law. The term "guidance" is sometimes used in ways that could reach an extraordinary variety of agency documents, such as staff advice given individuals concerning possible statutory applications; (4) as used in this Essay it refers only to documents issued by central administration (although often not the agency head as such) that have the quality of "soft law" that will govern staff behavior, and are likely to influence private actions as well.

    Documents like these are common worldwide in regulatory contexts. The reason is not far to seek. One can imagine a hierarchy of law-like documents, each characterized by a certain level of generality resolving questions unaddressed by its hierarchical superior, yet itself leaving unaddressed questions of greater detail.

    Constitutions, and perhaps treaties, mark the top of this hierarchy; these are single instruments creating institutions and expressing their authority, but rarely indicating how that authority will be exercised and not, in themselves, binding on private individuals. Their creation and amendment are unusual events.

    Statutes adopted by a representative legislature or, more rarely today, directives issued by a supreme executive authority, create legal obligations of the public. An active legislature might enact hundreds annually. The imprecisions of language and the vicissitudes of legislative politics produce statutes whose meaning is not wholly determined. Often, in circumstances rendering legislative judgment difficult, statutes state only general standards, and create subordinate institutions capable of resolving the issues they address with greater expertise and flexibility. (5) Unable quickly to respond to the appearance of new drugs, whether promoting health or promoting addiction, the legislature may empower a Food and Drug Administration (FDA) or a Department of Justice to identify those that are legal (or illegal) for use, using standards and following procedures it specifies, and to enforce those judgments.

    Regulations government agencies adopt using the notice and comment procedures of 5 U.S.C. [section] 553 are a common means of using the standard-setting authority thus conferred. U.S. agencies have adopted thousands each year, signed as required by the agency head and published first in the Federal Register and then in the Code of Federal Regulations (C.F.R.). Often they convey sufficient detail to determine the matters they address. Yet agencies, too, are incapable of perfect foresight; moreover, in many contexts there is a strong preference to have regulations expressed in terms of ends to be achieved (e.g., no more than five micrograms of sulfur dioxide per cubic meter of exhaust from a coal-fired utility's smokestack, as one means of securing the cleaner air the U.S. Environmental Protection Agency (EPA) has been directed to promote) rather than particular means that must be used to attain a desired result. The idea is to promote initiative among the regulated to find the most efficient means of securing that result. But a necessary result, then, is uncertainty just what technologies will satisfy the regulatory demand.

    Guidance having the quality of soft law may be created by agency bureaus and staff (that is, it need not be issued or approved by the agency head); it takes many forms and is issued in a volume that dwarfs that of agency regulations. (6) One frequent use is to inform the public (the regulated especially) about specific approaches agency staff has determined will meet the standards a regulation has set. Since the regulation (not the guidance) sets the obligation, this is "soft law" and one can attempt to show compliance in other ways. Guidance may also inform the public of the interpretation the agency places on a statute or regulation whose language is susceptible of more than one meaning; again, if the agency is using guidance correctly, the legal obligation is that stated by the law or regulation and not what the guidance instrument itself may say. Guidance may also set out policy paths the agency intends to take, enforcement priorities it anticipates following, or rules of conduct it expects its staff to follow. None of this is obligatory on the public, although it may provide useful information and, if it has been included in the agency's electronic library, the agency is permitted to give it presumptive force against outside parties who might be disadvantaged by its use. (7) Within the agency, however, the agency leadership and its staff may regard it as internal law; if a regulated party has followed guidance in its actions, then the staff will not (and should not) feel free to accuse it of non-compliance; if a member of staff does not act as agency guidance directs, she might be subject to internal discipline. Perhaps surprisingly given how common guidance documents are, and how important they are in the world of regulation--to the regulated, to regulatory beneficiaries and, perhaps especially, to agency leadership seeking to coordinate the activities of its staff, and to assure their predictability, uniformity and regularity--they are not often the subject of litigation; and when they are, their treatment is contentious and confused. Unlike some among the scholars who have written on the subject, (8) Professor Funk (9) and I, (10) with others who frequently encountered it from inside government (11) believe that procedural issues should be resolved by what Professor David Franklin characterized as "the short cut;" (12) simply asking whether notice and comment procedures had been used and, if not, refusing the guidance the legal effect a regulation would have. The paragraphs that follow were informed by that experience and scholarship, and also by the appearance on the Supreme Court's docket, as this Essay was being written, of Kisor v. fVilkie, (13) inviting the Court to address a question much disputed in recent years: if an agency has used guidance to interpret one of its regulations, must a court reviewing an application of that interpretation simply accept it so long as the regulation's language is susceptible of that interpretation? In Auer v. Robbins (14) the Supreme Court ruled that a court reviewing an agency's interpretation of its own regulations should accept that interpretation so long as it is not "plainly erroneous or inconsistent with the regulation." (15) Critics (16) feared that this lenient attitude would encourage agencies to write their regulations loosely, permitting future policy changes via guidance, without the inconvenience and expense of further notice and comment proceedings. Proponents argued that the ruling supports the agency's much greater familiarity with the intricacies of its responsibilities overall and its primary incentive to regulate for the current day with as much clarity as its knowledge permits; evidence of the feared encouragement to laxity, they say, is simply missing. (17) In Kisor, with Chief Justice Roberts casting the pivotal vote, the Court reformulated the Auer proposition in ways that considerably limit its application, and instruct courts independently to assess the possibility and reasonableness of agency interpretations of its soft law--in effect, applying what has long been known as "Skidmore deference." (18) As this occurred twelve weeks after the Festschrift for which this essay was written, Kisor will not be addressed at any length here; one may confidently expect a rich literature to flourish. Nor is this Essay is a comprehensive critical review of the literature, such as others have essayed. (19) While it has points of considerable tangency with other writings on the subject, (20) it essentially continues to develop the view of the issues my earlier writings have expressed, reflecting many points of agreement with Professor Funk's extensive writings on...

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