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National Research Council (US) Institute for Laboratory Animal Research. The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington (DC): National Academies Press (US); 2004.

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The Development of Science-based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop.

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Regulatory Authority of the US Department of Agriculture Animal and Plant Health Inspection Service

Chester A. Gipson

Congress passes, and the President signs, all legislation authorizing activities of the Animal and Plant Health Inspection Service (APHIS) of the US Department of Agriculture (USDA). The laws authorize or direct the Secretary of Agriculture to take certain actions, which may include issuing regulations. The Secretary delegates authority to the Under Secretary of Marketing and Regulatory Programs (MRP), who then delegates authority to the Administrator of APHIS. The Administrator of APHIS delegates authority to the APHIS Associate Administrator and Deputy Administrators/Directors. The Animal Care (AC) program of APHIS receives its regulatory authority from the Animal Welfare Act (7 U.S.C. 2131-2159) and the Horse Protection Act (15 U.S.C.1821-1831).

ADMINISTRATIVE PROCEDURE ACT

The Administrative Procedure Act (APA) contains the basic requirements for federal rulemaking. For most rulemaking, the APA requires the following:

  • Publication in the Federal Register of a proposed rule, including either the terms or substance of the proposed rule;
  • Opportunity for public participation in rulemaking through submission of written comments on the proposed rule;
  • Publication in the Federal Register of a final rule, with an explanation of any changes that the agency has made and a response to the public comments; and
  • An effective date for the final rule that is at least 30 days after publication in the Federal Register, unless the rule relieves restrictions, grants an exemption, or there is other good cause for making an exception. This kind of rulemaking is called “informal” or “notice and comment” rulemaking.

Publication of a rule in the Federal Register has certain legal effects. The rule provides official notice of the existence and content of a document. Publication indicates that the document was issued properly. Finally, publishing the rule provides evidence that it is judicially noticed by a court of law. Regulations that are not published in the Federal Register in accordance with the Administrative Procedure Act may not be upheld in a court of law. Therefore, any rules that an agency wishes to enforce should be published in the Federal Register.

OTHER ACTS AND EXECUTIVE ORDERS

Although the APA sets forth the basic requirements for federal rulemaking, other acts and executive orders also apply and include the following: (1) Executive Order 12866, which provides for review of federal rules by the Office of Management and Budget (OMB) (part of the Office of the President) and which requires the preparation of cost-benefit analyses for some rules; and (2) the Regulatory Flexibility Act, which requires analyses by agencies of the potential economic effects of their rules on small entities (small businesses, nonprofits, and small governmental jurisdictions).

TYPES OF RULES

Among the several types of rules are a proposed rule, a final rule, an interim rule, an advance notice of proposed rulemaking, and a direct final rule. Each type is described briefly below.

Proposed Rule

Most rulemaking in APHIS begins with a proposed rule. This document must contain a preamble that includes the following, at a minimum: 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); and the proposed rule itself, as it would appear in the Code of Federal Regulations.

Final Rule

Most rulemaking in APHIS concludes with a final rule. This document must contain a preamble that includes the following, at a minimum: a response to the issues raised by the public comments; an analysis of the anticipated economic effects of the final rule; a statement concerning any information collection requirements contained in the rule; and an effective date for the rule. The effective date must be at least 30 days after publication, unless the final rule relieves restrictions or there is other good cause for making the rule effective sooner. The final rule document must also contain the rule text that will appear in the Code of Federal Regulations.

Interim Rule

An interim rule may be issued instead of a proposed rule when there is good cause for making a rule effective before the public has an opportunity to comment upon 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, which could contain changes to the interim rule based on public comments. If the final rule does not make any changes to the interim rule, APHIS calls the final rule an affirmation of the interim rule. An interim rule contains a preamble that must include the following, at a minimum: an explanation of the rule; an effective date (usually upon publication); a description of any information collection requirements and the emergency approval number from the OMB necessary for implementing them; and an invitation to the public to submit comments by a specified date.

Advance Notice of Proposed Rule

Yet another type of rulemaking document is the advance notice of proposed rulemaking. This type of document may be used when the agency seeks to obtain preliminary information before issuing a proposed rule, or even making a decision about whether to issue a proposed rule. This document contains a description of the rulemaking being considered; an invitation to the public to submit comments by a specified date; and specific questions or issues that APHIS believes the public should address.

Direct Final Rule

The direct final rule is a type of rule that provides a shortcut for noncontroversial rules that are unlikely to generate even one negative comment. The direct final rule must include the following, at a minimum: an explanation of the rule; an analysis of anticipated economic effects of the rule; a deadline for submitting comments; a tentative effective date; and the rule itself, as it would appear in the Code of Federal Regulations. If no adverse comments are received by the close of the comment period, the direct final rule becomes effective on the date specified. If any adverse comments are received by the close of the comment period, the direct final rule must be withdrawn. If APHIS chooses to proceed with rulemaking, APHIS must issue a proposed rule. To ensure that the public receives 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 APHIS receives adverse comments, withdrawing the direct final rule.

RULEMAKING PROCESS IN APHIS

The following steps occur within APHIS before any rule is issued:

  • A need is identified.
  • A regulatory work plan is prepared, cleared within the Department of Agriculture, and designated as “significant” or “not significant” by OMB.
  • A writer on the regulatory staff of APHIS receives the assignment and works with a technical expert from the relevant APHIS program area and others to develop the rule.
  • The proposed rule is drafted and cleared within APHIS.
  • The Office of General Counsel (OGC) of USDA reviews and clears the rule for legal sufficiency, and policy officials within the department also review and clear the rule. At a minimum, the policy officials include the Deputy Administrator for Animal Care or other program involved, the Administrator of APHIS, and the Under Secretary for Marketing and Regulatory Programs. If the proposed rule has been designated “significant” by OMB, it is also reviewed by other policy officials in the Department, including the Chief Economist of USDA, the Chief Information Officer, and the Secretary.
  • The proposed rule is then also reviewed by OMB.
  • After all clearances have been obtained, the proposed rule is signed by the Administrator or the Under Secretary and published in the Federal Register.

After the rule is published in the Federal Register, comments arrive. The comments undergo evaluation and, if changes are necessary, revisions will occur. A worksheet describing the number and nature of public comments received and the agency's planned response to them is submitted through the OMB for a designation (which may or may not be the same as the designation for the proposed rule). The final rule is drafted and cleared within APHIS. It is then reviewed and cleared by OGC, policy officials within USDA, and, if “significant,” by OMB. The final rule is then signed and published in the Federal Register with a specified effective date.

TIME FRAMES

The time required for a given rulemaking varies, depending on the complexity of rule, the number and nature of comments received, the priority assigned by the agency (APHIS has an average of 150-200 actions in progress at any given time), and the designation assigned by OMB. Rules designated “significant” take longer than rules designated “not significant,” at least partly because the clearance process within the department involves more policy officials and because OMB also reviews the document. OMB normally has 90 days to complete its review. Regulations designated “significant” may take several years to complete, from initiation of the regulatory workplan to publication of a final rule.

SUMMARY

For most requirements that the agency imposes on the public, the APA requires APHIS to conduct rulemaking. Although APA contains the basic requirements for rulemaking, including publication in the Federal Register, other laws and executive orders also apply to rulemaking. Among the various types of rulemaking documents, the most typical is a proposed rule followed by a final rule. Regulations are reviewed within APHIS, by the Office of General Counsel (USDA) and other policy officials, and, if designated “significant,” by the OMB. Rules designated “significant” may take several years to complete.

ADDITIONAL INFORMATION

For more information about USDA-APHIS rulemaking, visit the APHIS website at www.aphis.usda.gov/index.html, or contact the Regulatory Analysis and Development Staff of APHIS at USDA-APHIS-RAD, 4700 River Road, Unit 118, Riverdale, MD 20737–1238, Phone: (301) 734-8682.

Copyright © 2004, National Academy of Sciences.
Bookshelf ID: NBK25398

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