Title 28

SECTION 50.27

50.27 Processes and procedures for issuance and use of guidance documents.

§ 50.27 Processes and procedures for issuance and use of guidance documents.

(a) Definitions - (1) Guidance document has the same meaning described in § 50.26 of this part. A guidance document does not impose new standards of conduct on persons outside the Executive Branch, except as expressly authorized by statute or as expressly incorporated into a contract.

(2) Significant guidance document means a guidance document that may reasonably be anticipated to:

(i) Lead to an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(ii) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(iii) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(iv) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles of Executive Order 12866.

(3) Pre-enforcement ruling means a formal written communication by an agency in response to an inquiry from a person concerning compliance with legal requirements that interprets the law or applies the law to a specific set of facts supplied by the person. Pre-enforcement ruling includes, but is not limited to:

(i) Informal guidance under section 213 of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121 (Title II), as amended;

(ii) Letter rulings;

(iii) Advisory opinions; and

(iv) No-action letters.

(4) Guidance Portal means the single, searchable, indexed database located at www.justice.gov/guidance that the Department has established pursuant to section 3(a) of Executive Order 13891.

(5) Contract includes, but is not limited to, a grant or cooperative agreement.

(b) Limitation on use of guidance documents in litigation. (1) Criminal and civil enforcement actions brought by the Department must be based on violations of applicable legal requirements, not mere noncompliance with guidance documents issued by federal agencies, because guidance documents cannot by themselves create binding requirements that do not already exist by statute or regulation. Thus, the Department should not treat a party's noncompliance with a guidance document as itself a violation of applicable statutes or regulations. The Department must establish a violation by reference to statutes and regulations. The Department may not bring actions based solely on allegations of noncompliance with guidance documents. Consistent with Part 1-20.000 of the Department's Justice Manual, the Department may continue to rely on agency guidance documents for purposes, including evidentiary purposes that are otherwise lawful and consistent with the Federal Rules of Evidence, that do not treat such documents as independently creating binding requirements that do not already exist by statute or regulation.

(2) The Department shall not seek deference to any guidance document issued by the Department or any component after the effective date of this rule that does not substantially comply with the requirements of paragraphs (c) and (d) of this section.

(c) Requirements for Department of Justice issuance of guidance documents - (1) Requirements for issuance of all guidance documents. (i) Guidance documents may not be used as a substitute for regulation and may not be used to impose new standards of conduct on persons outside the Executive Branch, except as expressly authorized by statute or as expressly incorporated into a contract.

(ii) Each guidance document shall clearly state that it does not bind the public, except as expressly authorized by statute or as expressly incorporated into a contract. This clear statement shall be prominent in each guidance document.

(A) The clear statement shall consist of the following: “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way. This document is intended only to provide clarity to the public regarding existing requirements under the law or Department policies.”

(B) Where a guidance document is binding because binding guidance is expressly authorized by statute or the guidance document is expressly incorporated into a contract with a specific party or parties, the clear statement described in paragraph (c)(1)(ii)(A) of this section shall be modified to reflect either of those facts.

(C) Nothing in this section shall be construed to prevent a guidance document from stating that the underlying law it discusses, as opposed to the guidance document itself, is binding.

(iii) Each guidance document shall:

(A) Include the term “guidance”;

(B) Identify the component issuing or maintaining the document;

(D) Include the date of issuance;

(E) Note if it is a revision to a previously issued guidance document and, if so, identify the guidance document that it replaces;

(F) Provide a title and unique document identification number;

(G) Include citations of the statutory provisions or regulations to which it applies or which it interprets;

(H) Include the clear statement specified in paragraph (c)(1)(ii) of this section; and

(I) Include, at the top of the document, a short summary of the subject matter covered in the document.

(2) Requirements for significant guidance documents. Unless the Department, or a component, has sought and obtained an exemption pursuant to section 4(a)(iii) of Executive Order 13891, the following requirements shall apply to a significant guidance document, except that the following requirements shall not apply to a pre-enforcement ruling:

(i) Approval and signature. Before issuance, a significant guidance document shall be approved and signed, on a non-delegable basis, by the Attorney General, by the Deputy Attorney General, or by the head of a component whose appointment to office is required to be made by the President.

(ii) Submission to the Office of Information and Regulatory Affairs (“OIRA”) of the Office of Management and Budget (“OMB”). Before issuance, a significant guidance document shall be submitted to OIRA, through the Department's Office of Legal Policy, for review under Executive Order 12866, unless the Administrator of OIRA has issued a categorical exception applicable to the guidance document through a memorandum issued pursuant to section 4(b) of Executive Order 13891. The Department will seek a determination of significance from OIRA for certain guidance documents, as appropriate, in the same manner as for rulemakings.

(iii) Notice and comment and response. (A) Before issuance, a significant guidance document shall be made available for public notice and comment for no less than 30 days, except when the Department or a component finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest. Any such finding, and a brief statement of reasons therefor, shall be incorporated into any significant guidance document that is not made available for public notice and comment.

(B) Notice that a draft significant guidance document is available for public comment shall be accomplished by publication of a notice in the Federal Register and posting of the draft significant guidance document on the Guidance Portal. The document that is published in the Federal Register shall announce the availability of a draft significant guidance document, provide a title and descriptive summary of the draft significant guidance document, and state the length of the comment period and the method or methods by which public comments may be submitted.

(C) The Department shall ensure that persons with disabilities are afforded an opportunity to comment during any period of public notice and comment that is equal to that afforded to other members of the public.

(D) The Department shall make comments available to the public for online review by posting them on the Guidance Portal or on another website with a direct link to the Guidance Portal.

(E) The Department or a component seeking to issue a significant guidance document need not respond to every comment or issue raised in a comment, but the Department or a component shall provide a public response to each major concern raised in comments. The Department or a component shall also provide a public explanation of the Department's or component's choices in the final guidance document, including why the Department or component did or did not agree with relevant suggestions from commenters.

(F) The public response to comments shall be incorporated into the final guidance document or into a companion document that is made available on the Guidance Portal.

(iv) The development and issuance of significant guidance documents shall comply with the applicable requirements for regulations or rules, including significant regulatory actions, set forth in Executive Orders 12866, 13563, 13609, 13771, and 13777.

(3) Contact. Components having questions regarding implementation of § 50.27(c) should contact the Department's Office of Legal Policy.

(d) Public access to all guidance documents. (1) All final guidance documents for which OMB has not issued a waiver or extension pursuant to section 3(c) of Executive Order 13891 shall be publicly available on the Guidance Portal.

(2) Except for a guidance document for which OMB has issued a waiver or extension pursuant to section 3(c) of Executive Order 13891, a guidance document shall not represent the Department's policy on a statutory, regulatory, or technical issue or represent the Department's interpretation of a statute or regulation unless and until it is publicly available on the Guidance Portal.

(e) Department's reliance on guidance documents. (1) No guidance document that has been withdrawn or superseded by modification may be cited, used, or relied upon by the Department for purposes other than to establish historical facts.

(2) Final guidance documents that are expressly incorporated into a contract with a specific party or parties may be cited, used, or relied upon by the Department with respect to that contract.

(3) Except as provided in paragraph (e)(2) of this section, of the final guidance documents for which OMB has not issued a waiver or extension pursuant to section 3(c) of Executive Order 13891, only those that are publicly available on the Guidance Portal may be cited, used, or relied upon by the Department for purposes other than to establish historical facts.

(f) Procedure to petition for withdrawal or modification of a guidance document. (1) Any member of the public may petition to withdraw or modify a guidance document.

(2) A member of the public wishing to petition for the withdrawal or modification of a guidance document shall submit a petition in writing, directed to the component that issued or maintains the guidance document, containing a statement of reasons for the petition. Upon receipt of a petition for withdrawal or modification, the receiving component shall forward a copy of the petition to the Department's Office of Legal Policy, which shall coordinate such requests.

(3) The Guidance Portal shall provide clear instructions to members of the public regarding how to submit a petition for the withdrawal or modification of a guidance document, including an email address or web portal where electronic petitions can be submitted, a mailing address where petitions can be submitted, and instructions that petitions shall:

(i) Be in writing (which may include using electronic means) and, if the petition is not in English, be accompanied by an English translation;

(ii) Be directed to the component that issued or maintains the guidance document;

(iii) Be titled as a petition for withdrawal or a petition for modification of a guidance document;

(iv) Identify the guidance document at issue; and

(v) Contain a statement of the reasons for the petition.

(4) The component that issued or maintains the guidance document shall respond to a petition in writing (which may include using electronic means) no later than 90 days after it receives the petition. The response shall state whether the petition is granted, granted in part and denied in part, denied, or provisionally denied for lack of adequate information. If the petition is provisionally denied for lack of adequate information, the response shall indicate what additional information is necessary to adjudicate the petition. Upon receipt of the necessary additional information, the receiving component shall forward the information to the Department's Office of Legal Policy, and the component that issued or maintains the guidance document shall respond to the petition in writing no later than 90 days after it receives the necessary additional information. The response shall state whether the petition is granted, granted in part and denied in part, or denied.

(5) The Department or a component may consider in a coordinated manner, or provide a coordinated response to, similar petitions for withdrawal or modification.

(g) Exclusions. (1) Notwithstanding any other provision in this section, except for the provisions of paragraph (b)(1) of this section, nothing in this rule shall apply:

(i) To any action that pertains to foreign or military affairs, or to a national security or homeland security function of the United States (other than guidance documents involving procurement or the import or export of non-defense articles and services);

(ii) To any action related to a criminal investigation or prosecution, including undercover operations, or any civil enforcement action or related investigation by the Department, including any action related to a civil investigative demand under 18 U.S.C. 1968;

(iii) To any investigation of misconduct by an agency employee or any disciplinary, corrective, or employment action taken against an agency employee;

(iv) To any document or information that is exempt from disclosure under section 552(b) of title 5, United States Code (commonly known as the Freedom of Information Act); or

(v) In any other circumstance or proceeding to which application of this rule, or any part of this rule, would, in the judgment of the Attorney General or his designee, undermine the national security.

(2) Notwithstanding any other provision in this regulation, except for the provisions of paragraph (b)(1) of this section, nothing in this regulation shall apply to categories of guidance documents made exempt from Executive Order 13891 by the Administrator of OIRA through memoranda issued pursuant to section 4(b) of Executive Order 13891.

[Order No. 4803-2020, 85 FR 63202, Oct. 7, 2020]