Rulemaking :Rulemaking United States Department of Agriculture


Legal Authority to Promulgate Rules :Legal Authority to Promulgate Rules ? Statutes passed by Congress, signed into law by the President, provide authority for Federal agencies to write regulations that implement the laws. ? An agency may issue rules only within the scope of its authorizing statutes.


USDA Statutes :USDA Statutes ? Animal Health Protection Act 7 U.S.C. § 8301 et seq. ? Plant Protection Act 7 U.S.C. § 7701 et seq. ? Federal Meat Inspection Act 21 U.S.C. § 601 et seq. ? Poultry Products Inspection Act 21 U.S.C. § 451 et seq.


What is a Rule? :What is a Rule? ? Must be issued in accordance with the Administrative Procedure Act. ? A rule is “an agency statement of general applicability and future effect designed to implement, interpret or prescribe law or policy or describing the organization, procedure or practice requirements of an agency…”


General Rulemaking Procedure“Notice and Comment Rulemaking” :General Rulemaking Procedure“Notice and Comment Rulemaking” ? Publish a Proposed Rule in the Federal Register. ? Provide interested parties an opportunity to submit written data, views, or opinions about the proposed rule. ? Publish a final rule in the Federal Register.


Exceptions to Notice and Comment Rulemaking :Exceptions to Notice and Comment Rulemaking ? Rules of agency Organization, Procedure or Practice ? Interpretative Rules ? Rules or statements issued by an agency to advise the public of the agency’s construction of the statutes and rules it administers. ? General Statements of Policy ? Statements issued by an agency to advise the public of the manner in which the agency proposes to exercise a discretionary power.


The “Good Cause Exception” :The “Good Cause Exception” ? Used where notice and comment rulemaking is “impracticable, unnecessary, or contrary to public interest” ? Generally, it is invoked where immediate action is necessary to reduce or avoid health hazards or other imminent harm to persons or property or inaction would lead to serious dislocation in government programs or the marketplace.


The Good Cause Exception :The Good Cause Exception ? Rules issued under the exceptions to the notice and comment requirements are effective immediately. ? The agency must explain in the rule why it is invoking the good cause exception. ? The exceptions are narrowly construed by courts in reviewing agency action. ? Usually, there is an opportunity for post-promulgation comments.


Ex Parte Communication in Rulemaking :Ex Parte Communication in Rulemaking ? What is ex parte communication? ? private communications between agency decisionmakers and other persons concerning the substance of the agency’s proposed rule ? It is USDA policy to avoid ex parte communications during rulemaking ? Once a proposed rule is published, USDA officials may: ? Answer factual questions about the rule; ? Accept written comments; ? Accept oral comments in a public hearing. ? If an ex parte communication occurs, the agency official will draft a memorandum detailing the communication and include it in the rulemaking record.


Other Laws that Affect Rulemaking :Other Laws that Affect Rulemaking ? The Regulatory Flexibility Act ? Requires agencies to assess potential economic effects of rules on small U.S. businesses, non- profit organizations, and small governmental jurisdictions


Other Laws That Affect Rulemaking :Other Laws That Affect Rulemaking ? The Paperwork Reduction Act ?Purpose is to minimize federal paperwork burden for individuals, small businesses and State and local government ? The Office of Management and Budget reviews and approves information collection requirements ? The Agency must show that the information collection requirement is the least burdensome possible, that it is not duplicative of other federal information collections, and that the collected information will have a practical use.


Other Laws That Affect Rulemaking :Other Laws That Affect Rulemaking ? National Environmental Policy Act ? Requires agencies to evaluate the potential environmental consequences of proposed actions


The Role of the Office of Management and Budget in Agency Rulemaking :The Role of the Office of Management and Budget in Agency Rulemaking Planned Regulatory Actions are designated as: ? Not significant: OMB does not review the action ? Significant: Raises novel legal or policy issues; create a serious inconsistency or interfere with an action of another agency; materially alter the budgetary impact of existing programs ? Economically significant: Likely to have an annual effect on the economy of $100 million or more or adversely affect the economy, a sector of the economy, jobs, or competition.


USDA Clearance of Regulations :USDA Clearance of Regulations ? “ Not Significant” ? Office of General Counsel ? Deputy Administrator ? Administrator ? Office of Budget and Program Analysis ? Under Secretary


USDA Clearance of Regulations :USDA Clearance of Regulations ? “Significant” or “Economically Significant” ? Office of General Counsel ? Deputy Administrator ? Office of Budget and Program Analysis ? General Counsel for USDA ? Office of Risk Assessment and Cost Benefit Analysis (for economically significant rules only) ? Assistant Secretary, Civil Rights ? Office of the Chief Economist ? Office of the Chief of Information ? Under Secretary ? Secretary ?OMB (has 90 days to review which can be extended by 30 days upon approval of the Director)


Why Does Rulemaking Take So Long? :Why Does Rulemaking Take So Long? Steps In Rulemaking: 1. Identify the Need for a Rule; 2. Draft Analyses-such as Risk assessment; Environmental Assessment and other analyses as needed; 3. Prepare Work Plan and Submit to OMB for Designation as “not significant”, “significant” or “economically significant”; 4. Draft Proposed Rule; Complete all analyses; 5. USDA clearances and OMB if “significant” or “economically significant”; 6. Publish Proposed Rule in Federal Register with a comment period (usually 60 days);


Why Does Rulemaking Take So Long? :Why Does Rulemaking Take So Long? 7. Comments are received and analyzed; 8. New work plan for final rule is prepared, reviewed and sent to OMB for designation; 9. Final Rule is drafted; 10. USDA clearances and OMB if “significant” or “economically significant”; 11. Final Rule Published in Federal Register 12. Final Rule Effective, Usually 30 days after publication


Judicial Review of Agency Rulemaking :Judicial Review of Agency Rulemaking Courts can find that a rule is unlawful and set it aside if: 1. It is arbitrary, capricious, an abuse of discretion, or not in accordance with law; 2. It is in excess of statutory authority; 3. The agency didn’t follow the proper procedure in promulgating the rule.