Considerations for Rulemaking

TABLE OF CONTENTS

OVERVIEW

2.1 What is the purpose of this chapter?

A. This chapter:

(1) Provides guidance for U.S. Fish and Wildlife Service (Service) employees who prepare rulemaking actions.

(2) Establishes the Service Handbook on Publishing Documents in the Federal Register for employees to use when they are preparing regulations and notices. The handbook provides detailed information about the process.

B. The Departmental Manual at 318 DM and the How to Prepare Regulations and Federal Register Notices Handbook (318 DM HB) also provide guidance on the requirements for drafting rules and other related documents.

2.2 What are the scope, authorities, and terms for this chapter? The scope and authorities for this chapter are in 202 FW 1. See Exhibit 1, 202 FW 1, for a glossary of terms used in Part 202 and the accompanying handbook.

CONSIDERATIONS FOR RULEMAKING

2.3 How does a program office decide if a rule is necessary or advisable? To decide whether rulemaking is necessary or advisable, first determine whether adequate authority exists for the Service to publish a rule. If we have the authority, then ask yourself the following questions:

A. Why should the Service publish this rule? Consider why we need the regulation or what problem it will solve. Some reasons for rulemaking include:

(1) A specific legislative requirement to conduct rulemaking,

(2) Program deficiencies (such as those identified in an audit) that could be improved or solved through regulatory administration and enforcement,

(3) Chronic abuses or problems that need a remedy such as new compliance and enforcement tools, or

(4) A need to demonstrate consistent program administration.

B. Are there any alternatives to rulemaking that are feasible? For the need you identified by asking the question above, consider possible alternatives to rulemaking, such as a revision to the U.S. Fish and Wildlife Service Manual or other internal policy document, and whether or not they are a feasible and preferable means to achieving the desired result.

2.4 What does a program need to do before it begins drafting a rule?

A. Before drafting Federal Register documents, you should review this Part (Part 202) of the Service Manual, the Service Handbook on Publishing Documents in the Federal Register, the Departmental Manual at 318 DM, and the related How to Prepare Regulations and Federal Register Notices Handbook. You can find additional guidance at 1 CFR parts 18, 21, 22, and 51.

B. The Division of Policy, Economics, Risk Management, and Analytics (PERMA), Policy and Regulations Branch (PRB) encourages program offices to consult with them before beginning to draft documents for publication in the Federal Register. PRB can provide guidance that can help the programs conduct an efficient rulemaking process. Contact PRB by sending an email to PRBDocs@fws.gov.

2.5 What are the principles of regulation that a program office should consider before and during rulemaking? Keep the following principles from Executive Order (E.O.) 12866 in mind before and during rulemaking:

A. Identify the problem you intend to solve through rulemaking and assess the significance of that problem.

B. Examine whether existing regulations or laws have created or contributed to the problem that you intend to correct through the new regulation and whether we should modify those regulations or seek changes to those laws to achieve the intended goal of the regulation more effectively.

C. Identify and assess available alternatives to regulation, including providing economic incentives to encourage the desired behavior, such as user fees or permits, or providing information that the public can use to make choices.

D. In setting priorities, consider the degree and nature of risks posed by various activities within our jurisdiction.

E. Design the regulation in the most cost-effective manner to achieve the regulatory objectives. Consult the PERMA Branch of Economics for assistance. In some cases, the Department’s Office of Policy Analysis may also assist. Consider:

(1) Incentives for innovation, consistency, and predictability;

(2) Enforcement and compliance costs to the Government, regulated entities, and the public;

(3) Flexibility;

(4) Distributive impacts; and

(5) Equity.

F. Assess the costs and benefits of the intended regulation. Propose the regulation only when you determine that the benefits of the intended regulation justify its cost. Consult with the Branch of Economics for help with this analysis.

G. Base regulatory decisions on the best reasonably obtainable scientific, technical, economic, and other information concerning the need for, and consequences of, the intended regulation.

H. Identify and assess alternative forms of regulation and, to the extent feasible, specify performance objectives rather than specifying the behavior or manner of compliance that regulated entities must adopt.

I. Before proposing a rule, whenever feasible, work with State, local, and Tribal governmental entities by:

(1) Seeking their views before imposing regulatory requirements that might significantly or uniquely affect them;

(2) Assessing the effects of the regulation on their governments, including the availability of resources to carry out any mandates;

(3) Minimizing the burdens that uniquely or significantly affect them, consistent with achieving regulatory objectives; and

(4) Keeping our regulatory actions consistent with related State, local, and Tribal regulatory functions.

J. Avoid regulations that are inconsistent or incompatible with, or duplicative of, other Federal regulations.

K. Tailor regulations to impose the least burden on society, including individuals, businesses of differing sizes, and other entities (including small communities and governmental entities), consistent with obtaining the regulatory objectives. Take into account, among other things and to the extent practicable, the costs of cumulative regulations.

L. Draft regulations so that they are simple and easy to understand, with the goal of minimizing the potential for uncertainty and any subsequent litigation.

2.6 Will OMB review every rule? It depends on whether or not the rule is significant. E.O. 12866 requires that we work with OMB to designate significance for rulemaking actions. Using the four parameters listed in Exhibit 1 to 202 FW 1 (see definition of significant rule), the Service recommends whether a rule is significant or not. However, OMB makes the final determination of significance.

A. OMB reviews rules that they designate as significant. If OMB designates a rule as significant, they will generally review the rule in 90 days or less, using the procedures in E.O. 12866. A frequent part of the OMB review process includes OMB circulating the draft rule to other Federal agencies for their review and comment. We cannot publish a significant rule in the Federal Register until OMB has reviewed and approved it.

B. If OMB designates the rule as not significant, they will not review the rule. The Service may submit rules that are not significant under E.O. 12866 to the Office of the Federal Register for publication following approval from the Department.

NEXT STEPS

2.7 After determining that rulemaking is necessary, what are the next steps? Once your program has determined that issuing a rulemaking document is necessary and appropriate to accomplish programmatic goals, the principal drafters of the document should consult the Service Handbook on Publishing Documents in the Federal Register for detailed information on the process.