The Department of Justice has loosened restrictions on the use of agency guidance documents to establish violations of underlying legal requirements in enforcement actions and other litigation. According to a memorandum by Attorney General Garland, DOJ attorneys may now “rely on relevant guidance documents in any appropriate and lawful circumstances, including when a guidance document may be entitled to deference or otherwise carry persuasive weight with respect to the meaning of” statutory and regulatory requirements. Related changes to the Justice Manual that guides DOJ attorneys in their daily practice, namely JM 1-19.000 and 1-20.000, are forthcoming. Where exactly regulators and DOJ will draw the line in individual cases, between using guidance documents to effectively create legal requirements for regulated parties and merely informing their meaning, remains to be seen.
There are innumerable federal agency guidance documents in existence. For example, the Food & Drug Administration lists 2,626 documents on its website, the Federal Trade Commission maintains a database of over 124 documents, and the Alcohol and Tobacco Tax and Trade Bureau flags “many” of the dozens of documents it has prepared over the years. These documents, which can take a variety of forms, are generally meant to advise regulated parties about their legal rights and obligations. The informality by which they are published (outside of normal rulemaking requirements, for example) and their sheer volume, however, have often led to claims of unfair surprise of supposed legal requirements.
Unsurprisingly, the use of guidance documents in regulatory litigation has been the topic of much debate, particularly in recent years. Under the Trump administration, DOJ promulgated memoranda and regulations to limit what it then called “improper” reliance on guidance documents. E.g., Memorandum from the Associate Attorney General, Limiting Use of Agency Guidance Documents in Affirmative Civil Enforcement Cases (Jan. 25, 2018). The Biden administration has taken a decidedly different tact. This is perhaps captured best by Executive Order 13992, which equips federal regulators and prosecutors “with the flexibility to use robust regulatory action to address national priorities.”
Regulated parties should take note. DOJ’s implementation of E.O. 13992’s mandate will impact not only the positions that DOJ attorneys will take in litigation, but it will also inevitably affect your regulators’ understanding of compliance in the first place. Staying abreast of evolving, voluminous agency guidance documents will, therefore, have added importance for companies moving forward.