Regulations Development and Clearance - Revision 1
This directive sets out the process of forming docket teams, the functions of docket teams, and the responsibilities of docket team members. It also explains the documents docket teams develop and the laws and Executive Orders governing the development of FSIS regulations. FSIS is revising this directive to update program area names and to provide instructions to docket teams to ensure that documents produced by FSIS meet the USDA’s data quality guidelines.
FSIS Directive 1232.4, Regulations Development and Clearance, 11/20/01
III. FORMATION OF DOCKET TEAMS
A. The Assistant Administrator or Deputy Assistant Administrator for the Office of Policy and Program Development (OPPD) and the Regulations Development Staff (RDS) Director determine that there is a need to form a docket team when:
- Legislation requires development of a rule.
- The Administrator or other management requests development of or identifies the need for a rule.
- There is other good cause to establish a team.
B. Once OPPD management determines that a docket team is necessary, RDS is to request that Assistant Administrators outside of OPPD assign staff members to participate in docket teams or delegate to other managers the authority to assign staff members to participate in docket teams. Managers are to assign staff members to participate on docket teams in a non-discriminatory manner. The U.S. Department of Agriculture (USDA) prohibits discrimination in all its programs and activities on the basis of race, color, national origin, gender, religion, age, disability, political beliefs, sexual orientation, and marital or family status.
C. Only staffs that have a direct and significant involvement in the subject of the docket to be developed are to be represented on the team. RDS is to be represented on all docket teams.
IV. DOCKET TEAM MEETINGS
A. The RDS analyst is to inform the designated team members of proposed meetings, facilitate the work of the team, ensure that the team completes all necessary documents, and ensure that the completed documents include all required components.
B. The docket team is to determine the responsibilities of each team member for contributing to the development of preliminary and rulemaking documents. If members of the docket team are unable to commit to completing the work, the RDS analyst is to consult with the OPPD Assistant Administrator and the RDS Director for guidance on how best to address the problem.
V. ROLES OF DOCKET TEAM MEMBERS
A. The RDS analyst is to ensure that the team completes necessary documents and that the completed documents include required components. To ensure that the documents include the required components, the RDS analyst is responsible for development of or incorporation of legal analysis, risk assessment (when required), economic analysis, civil rights analysis, paperwork burden analysis. and other analyses required by the statutes and Executive Orders. Other docket team members assist in writing and developing these analyses.
B. To help ensure that rulemaking documents are based on the best reasonably obtainable scientific, technical, and economic information, other docket team members are to assist in writing and developing the analyses required in rulemaking documents and other text in rulemaking documents. For example:
- Team members from the Office of Public Health Science (OPHS) are to assist in drafting scientific information for these documents, such as information on pathogens or chemicals in foods and information on relevant epidemiology. Team members from OPHS may also be responsible for providing risk assessment information;
- Team members from the Office of Field Operations (OFO) are to assist in drafting information on implementation of new regulations or current activities of inspection program personnel;
- Team members from the Policy Analysis Staff (PAS) are to collect economic data from the other team members and develop the economic analysis; and
- Team members from the Office of Planning, Analysis and Risk Management (OPARM) are to analyze and provide data on inspection tasks.
C. In general, docket team members from outside RDS are to perform the following functions:
- Inform their management officials of the docket team's work and present the views of their office or staff. Keeping management informed of the team's activities allows for the rapid mobilization of resources, if necessary, for the development of a rule;
- Assist in the development of preliminary and rulemaking documents;
- Assist in the preparation of interim reports describing the status of the docket team activities, including the identification of potential problems in meeting projected deadlines, as needed;
- Draft text for the Federal Register document, as needed, on subjects related to the docket team member’s area of expertise.
- Provide economic, technical, or public health data on a subject related to the docket team member’s area of expertise when the data are available and the member has access to this data;
- Ensure compliance with USDA Information Quality Activities Guidelines, including data source transparency requirements;
- Provide assistance in responding to comments, as needed; and
- Provide input and technical assistance in developing FSIS directives that provide instructions for implementation. The staff members who participate as docket team members in developing rules would, if possible, serve as members of the issuance development team to develop FSIS directives or notices that provide instructions to inspection program personnel on how to perform functions necessary to implement new or revised regulations (See FSIS Directive 1230.1, FSIS Issuance System). Also, the staff members would help to develop guidance to assist the regulated industry’s compliance with new requirements, as needed.
VI. CLEARANCE OF DOCUMENTS
A. When the team completes work on a document, the RDS analyst is to ensure timely clearance of the document through the OPPD Assistant Administrator, other FSIS Assistant Administrators or designees, the Office of General Counsel (OGC), the Office of the Administrator (OA), the Office of Food Safety (OFS), the USDA’s Office of Budget and Program Analysis (OBPA), and the Office of Management and Budget (OMB). RDS typically requests that FSIS management provide comments on the document within 5 business days of receipt of the document. The RDS analyst is to ensure that the correct version of the document circulates through clearance.
B. The RDS analyst is to advise the docket team of comments received on documents during the clearance process. The RDS analyst is to ensure that the responses to the comments are developed expeditiously, , contacting individual team members for assistance, if needed, or reconvening the group. As the document is revised in response to comments, RDS is to send the revised versions of the document to the docket team.
C. If it is necessary to meet with Agency management, USDA officials, OGC, or OMB on a docket during the clearance process, the RDS Director and RDS analyst, in consultation with the OPPD Assistant Administrator as necessary, are to decide who will attend the meeting.
A. Before FSIS can publish a document pursuant to rulemaking in the Federal Register, it is to submit a workplan to OMB for review and designation. Workplans are generally not required for other Federal Register notice documents.
B. The workplan provides a description of the contemplated regulatory action, including objectives, alternatives, and expected results of the regulatory action.
C. The information in the workplan is used to determine the regulatory classification of the regulatory action and designate the appropriate level of oversight. Under Executive Order 12866, OMB is responsible for determining which agency regulatory actions are "significant" and, in turn, subject to interagency review. Significant regulatory actions are defined in E.O. 12866 as those that:
- 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;
- Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
- Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
- Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866.
D. RDS is to send the workplan to the Assistant Administrator of OPPD, OGC, OA, and OFS for clearance. FSIS is to corroborate with OFS in recommending a regulatory classification (e.g., significant or non-significant). OBPA sends the workplan to OMB for the official regulatory classification.
E. After OMB approves the workplan and designates it as a significant or non significant action the rule is included in the Unified Agenda of Regulatory and Deregulatory Actions (Agenda). The Agenda is published twice a year, in the spring and fall. The fall version includes the Regulatory Plan, which identifies regulatory priorities and contains information about the most significant regulatory actions that agencies expect to take in the coming year.
VIII. COMPONENTS OF AN ADVANCED NOTICE OF PROPOSED RULEMAKING (ANPR)
A. FSIS develops an ANPR when the Agency needs additional input from the public before it can develop a proposed rule.
B. An ANPR typically includes:
- Discussion of relevant existing regulations and statutes;
- Regulatory changes FSIS is considering proposing;
- Reasons that FSIS is considering regulatory changes;
- Alternatives that FSIS is considering;
- Preliminary discussion of costs and benefits of the changes being considered; and
- Request for comment.
XI. COMPONENTS OF A PROPOSED OR FINAL RULE
A proposed or final rule typically includes:
- Preamble discussion of the provisions of the rule, and the need for and the statutory bases for the provisions;
- A regulatory impact analysis estimating the future costs and benefits of the rule and discussion of regulatory alternatives considered. If the rule is designated "non-significant," a detailed regulatory impact analysis is not required;
- A discussion of the estimated economic impact of the regulations on small businesses;
- Statements addressing relevant Executive Orders;
- Proposed regulatory provisions or final regulatory provisions that will be codified in the Code of Federal Regulations;
- A request for comment in a proposed rule, or, in a final rule, a summary of comments received to the proposed rule and FSIS’s response to issues raised in the comments; and
- A risk assessment of the rule for a "major" rule that affects human health, human safety, or the environment.
Refer questions to RDS at: email@example.com