Regulations and Assessments - Rulemaking Glossary

Regulations and Assessments - Rulemaking Glossary

Final Rule
Most rulemaking in APHIS concludes with a final rule. A final rule makes changes in the Code of Federal Regulations. A final rule may differ from the preceding proposed or interim rule because the agency may have made changes based on comments received on the proposed or interim rule. Responses to commenters may mean that the changes made by the final rule are different from those proposed in the proposed rule. A final rule must contain:

  • A preamble, which includes:
    • responses to the issues raised by commenters
    • an analysis of the anticipated economic effects of the rule
    • a statement concerning any information collection requirements contained in the rule
    • an effective date
    • The effective date is usually at least 30 days after publication. A final rule that relieves restrictions may be made effective sooner. There may also be other good cause under § U.S.C. 553, explained in the final rule, for making the rule effective less than 30 days after publication.

The final additions or changes to our regulations, as they will appear in the Code of Federal Regulations.

Advance notice of proposed rulemaking 
APHIS publishes this type of rule when we want to obtain preliminary information prior to issuing a proposed rule or even, in some cases, deciding whether to issue a proposed rule. This document contains:

  1. A description of the rulemaking being considered (but usually not specific language that would appear in the Code of Federal Regulations).
  2. An invitation to the public to submit comments by a specified date (usually 60 days after publication).
  3. Specific questions or issues that we would like the public to address.


Direct Final Rule 
This type of rule can be thought of as a short cut for noncontroversial rules. It is not used for any rule that is likely to generate an adverse comment. (An adverse comment is defined as any comment that suggests that we change our rule or withdraw it.) A direct final rule contains:

  • A preamble, which includes:
    • an explanation of the rule
    • an analysis of the anticipated economic effects of the rule
    • a deadline for submitting comments (usually 30 days after publication)
    • a tentative effective date (usually 60 days after publication).
  • The actual additions or changes to our regulations, as they would appear in the Code of Federal Regulations.

If any adverse comments are received by the close of the comment period, the direct final rule must be withdrawn, and the Agency must issue a proposed rule. If no adverse comments are received by the close of the comment period, the direct final rule will become effective on the date specified.

To ensure that the public has adequate notice of whether a direct final rule will become effective as indicated, APHIS publishes a brief notice after the comment period closes, either affirming the effective date or, if we have received an adverse comment, withdrawing the direct final rule.

Economically significant 
An action that meets the first criterion for an Office of Management and Budget designation of "significant," meaning that it is likely to have 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. (More details on OMB's "significant" designation are available here.)

Proposed rule 
Most rulemaking in APHIS begins with a proposed rule. A proposed rule describes a change to the regulations APHIS feels would benefit agriculture and the public and invites public comment on the proposed change. This document contains:

  • A preamble, which includes:
    • an explanation of the proposed rule
    • an analysis of the anticipated economic effects of the proposed rule
    • a description of any information collection requirements
    • an invitation to the public to submit comments by a specified date (usually 60 days after publication).
  • The proposed additions or changes to our regulations, as they would appear in the Code of Federal Regulations.


Interim rule 
This type of rule may be used instead of a proposed rule when there is good cause for making a rule effective before the public has an opportunity to comment on it. (See "Good Cause Exception.") An agency may make changes to an interim rule in a follow-up document (e.g., a final rule). If no changes are made, APHIS refers to the follow-up as an affirmation of an interim rule. An interim rule contains:

  • A preamble, which includes:
    • an explanation of the rule
    • an effective date (usually upon publication, but sometimes earlier)
    • a description of any information collection requirements and the emergency approval number from the Office of Management and Budget necessary for implementing them in an interim rule
    • an invitation to the public to submit comments by a specified date (usually 60 days after publication)
    • an analysis of the anticipated economic effects of the rule (however, if an analysis cannot be completed before the rule is published, it may published in the follow-up final rule or affirmation, or separately).
  • The additions or changes to our regulations, as they would appear in the Code of Federal Regulations.

 

Regulatory Workplan 
This document describes a change in the regulations or a new regulation that APHIS plans to develop. The Office of Management and Budget designates a regulatory action as "significant" or "not significant" based on a review of the regulatory workplan for that action.

Significant 
An action that is likely to: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a section of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities (actions that meet this criterion are "economically significant"); (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 set forth in Executive Order 12866. Rules that the Office of Management and Budget (OMB) has determined to be significant are reviewed by OMB before publication. For further information on "significant" and "economically significant," see Executive Order 12866 of September 30, 1993.

Not significant This term has nothing to do with an action's importance or priority; it simply means that the Office of Management and Budget has decided not to review the document before publication.

Major rule (as designated by Office of Management and Budget) 
Any rule that is likely to result in: (1) An annual effect on the economy of $100 million or more; (2) a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. (Source: Congressional Review Act of 1996, also known as the Small Business Regulatory Enforcement Fairness Act.) Any rule designated by OMB as economically significant will also be considered a major rule under this act.

Major rule (as determined by Office of Risk Assessment and Cost-Benefit Analysis) 
Any regulation that the Secretary of Agriculture estimates is likely to have an annual impact on the economy of the United States of at least $100 million in 1994 dollars. Major rules whose primary purpose is to regulate issues of human health, human safety, or the environment require special risk and cost-benefit analyses and must be reviewed by USDA's Office of Risk Assessment and Cost-Benefit Analysis. (Source: The Federal Crop Insurance Reform and Department of Agriculture Reorganization Act of 1994, section 304.)

Federal Register Although the CFR is revised only once a year, new regulations and changes to existing regulations may be issued and take effect at any time. Changes, and proposed changes, to Federal regulations are published daily in the Federal Register. The Federal Register publishes a monthly list of CFR sections affected by new regulations (called the LSA). Also, every Federal Register contains a list of all CFR sections affected so far that month. Our citations of the CFR give the volume number followed by the page number; for example, 67 FR 79836-79837 refers to a document published on pages 79836 and 79837 of volume 67 of the Federal Register. The Federal Register follows sequential page numbering within volumes.

Code of Federal Regulations 
The complete Code of Federal Regulations (CFR) is divided into 50 titles. Some titles have more than one volume. The 50 titles together contain the regulations of all the various Federal agencies. Each title of the CFR is divided into chapters, subchapters, parts, subparts (in some parts), sections, and paragraphs. Each part begins with a table of contents that lists each section of the part. The legal authority for the part follows the table of contents. The first section of each part is usually a list of definitions for that part.

Parts 300-399 of title 7 of the CFR contain APHIS regulations related to plants; parts 1-199 of title 9 of the CFR contain APHIS regulations related to animals.

The CFR is revised annually, at different times of the year for different titles. The CFR volumes that contain APHIS's regulations are updated every year as of January 1, to show all changes that became effective during the previous calendar year.

Learn more at Regulations.gov

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