(a) This subpart governs all United States Department of Agriculture (USDA) employees and contractors involved with all phases of issuing USDA guidance documents.

(b) These procedures apply to all newly issued guidance documents and, in certain respects, guidance documents already in effect.

(c)

(1) For purposes of this subpart, the term “guidance document” is defined as in Executive Order 13891 and means an agency statement of general applicability, intended to have future effect on the behavior of regulated parties, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation.

(2) The term is not confined to formal written documents; guidance documents may come in a variety of forms, including (but not limited to) letters, memoranda, circulars, bulletins, advisories, and may include video, audio, and Web-based formats. See Office of Management and Budget's (OMB) Bulletin 07-02, “Agency Good Guidance Practices,” 72 FR 3432, 3434, 3439 (January 25, 2007) (“OMB Good Guidance Bulletin”)

(d) “Guidance document” does not include the following:

(1) Rules promulgated pursuant to notice and comment under 5 U.S.C. 553 or similar statutory provisions;

(2) Rules exempt from rulemaking requirements under 5 U.S.C. 553(a);

(3) Rules of agency organization, procedure, or practice;

(4) Decisions of agency adjudications under 5 U.S.C. 554 or similar statutory provisions;

(5) Internal guidance directed to the issuing agency or other agencies that is not intended to have substantial future effect on the behavior of regulated parties;

(6) Internal executive branch legal advice or legal opinions addressed to executive branch officials;

(7) Agency statements of specific applicability, including advisory or legal opinions directed to particular parties about circumstance-specific questions (e.g., case or investigatory letters responding to complaints, warning letters), notices regarding particular locations or facilities (e.g., guidance pertaining to the use, operation, or control of a government facility or property), and correspondence with individual persons or entities (e.g., congressional correspondence), except documents ostensibly directed to a particular party but designed to guide the conduct of the broader regulated public;

(8) Agency statements that do not set forth a policy on a statutory, regulatory, or technical issue or an interpretation of a statute or regulation, including speeches and presentations, editorials, media interviews, press materials, or congressional testimony that do not set forth for the first time a new policy or interpretation;

(9) Grant solicitations and awards; or

(10) Contract solicitations and awards.

(e) The term “significant guidance document” means a guidance document that may reasonably be anticipated to:

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

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

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

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles of E.O. 12866.

(f) The term “significant guidance document” does not include the categories of documents excluded in writing by OMB's Office of Information and Regulatory Affairs (OIRA).

(g) Significant guidance documents must be reviewed by OIRA before issuance and must demonstrate compliance with the applicable requirements for regulations or rules, including significant regulatory actions, set forth in Executive Orders 12866, 13563, 13609, 13771, and 13777.