Rulemaking at APHIS

Any number of factors may prompt the need for a new or revised regulation (rule). Here are a few:

• New technologies or new data on existing issues
• Recommendations from Congressional committees or Federal advisory committees
• Petitions from interest groups, corporations, or members of the public
• Studies and recommendations from other agencies or our own agency staff

We assess the possible impacts of the rule by preparing risk, environmental, or other analyses as needed. We then prepare a regulatory work plan, clear it within APHIS and USDA, and submit it to the Office of Management and Budget (OMB) so they can designate it as "significant" or "not significant" as described under Executive Order 12866.

APHIS staff work to draft a proposed rule and clear it with our technical experts, USDA attorneys, and policy officials (plus OMB if “significant”).

Our next step is to publish the proposed rule in the Federal Register. This document must have a summary that includes:

• An explanation of the proposed rule
• An analysis of its expected economic effects
• A description of any information collection requirements
• An invitation to the public to submit comments by a set date (usually 60 days after publication)
• The proposed rule itself (as it would appear in the Code of Federal Regulations)

We consider all public comments on the proposed rule and prepare responses. We make decisions on how to proceed, including any revisions needed to the rule. We prepare a regulatory worksheet for the final rule, clear it within APHIS and USDA, and submit it to OMB for designation.

We draft a final rule and clear it with our technical experts, USDA attorneys, and policy officials (plus OMB if “significant”).

We publish the final rule in the Federal Register. This document must have a summary that includes:

• A response to issues raised by the public comments
• An analysis of the expected economic effects
• A statement about any information collection requirements
• An effective date for the rule (at least 30 days after publication, in most cases)
• The final rule itself (as it will appear in the Code of Federal Regulations)

We may issue an interim rule 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. For example, APHIS may need to put immediate restrictions in place after an outbreak of an animal disease to prevent the spread of that disease.

An interim rule may be followed by a final rule; this could contain changes to the interim rule based on public comments. If the final rule doesn't make any changes to the interim rule, we call the final rule an affirmation of the interim rule.

Another type of rulemaking document is the advance notice of proposed rulemaking. We may use this type of document when APHIS needs preliminary information before issuing a proposed rule–or even deciding whether to issue a proposed rule.

This includes notices that make environmental assessments, environmental impact statements, and related documents that fall under the National Environmental Policy Act (NEPA) available to the public. Learn about NEPA compliance.

This includes notices making available a variety of documents, such as pest risk assessments, risk management documents, risk analyses, evaluations of foreign regions with regard to their status for a pest or disease of livestock, reviews of the regulatory status of certain products of genetic engineering, and evaluations of the quarantine significance of certain plant pests.

These documents vary in purpose. We may publish a notice to share information or seek input on agency actions that are of public interest, but don't have broad national impact or legal effects. Some examples include advisory committee meeting notices, administrative orders, or notice of decisions that impact specific groups.