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Policy Development Process
FSIS Directive 1232.4 (Nov 20, 2001)
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FSIS Directive 1232.4, Regulations Development and Clearance, is also available in PDF format.
I. Purpose
This directive:
- Describes the process of forming docket
teams, the functions of docket teams, and the
responsibilities of members of docket teams.
- Describes the documents docket teams develop
and the laws and Executive orders governing FSIS
regulations development.
II. (Reserved)
III. (Reserved)
IV. References
See Attachment 1 for
a summary of laws and Executive orders governing
regulations development.
V. Abbreviations and Forms
- APA - Administrative Procedure Act
- ANPR - Advance Notice of Proposed Rulemaking
- NEPA - National Environmental Policy Act
- OFO - Office of Field Operations
- OGC - Office of General Counsel
- OMB - Office of Management and Budget
- OPPDE - Office of Policy, Program Development and Evaluation
- OPHS - Office of Public Health and Science
- OA - Office of the Administrator
- RDDS - Regulations and Directives Development Staff, OPPDE
- RFA - Regulatory Flexibility Act
- SBREFA - Small Business Regulatory Enforcement Fairness Act of 1996
VI. Formation of Docket Teams
- When is a docket team formed?
The Deputy Administrator or Associate Deputy
Administrator for OPPDE, the Assistant Deputy
Administrator for Policy Analysis and Formulation,
OPPDE, and the RDDS 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 or ANPR.
- There is other good cause to establish a team.
- How is a docket team created?
Once OPPDE management determines that a
docket team is necessary, RDDS prepares a call
memo for participation on the team. The memo
is sent to the OA Staff Directors, the Deputy
Administrators outside of OPPDE, and the OPPDE
Assistant Deputy Administrators. The Staff
Directors and Deputy Administrators 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 should assign staff members to
participate in docket teams in a
non-discriminatory manner. The U.S. Department
of Agriculture 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.
Each OPPDE Assistant Deputy Administrator
meets with the Directors in his or her program
and decides whether to be represented on the
team. Only staffs that have a direct and
significant involvement in the subject of the
docket that is to be developed should be
represented on the team. RDDS will be
represented on all docket teams. An OGC
representative may participate on the docket
team, when appropriate.
VII. Docket Team Meetings
- What is RDDS´ role in docket team meetings?
RDDS informs designated team members of
proposed meetings. The RDDS analyst facilitates
the work of the team, ensures that the team
completes necessary documents, and ensures that
the completed documents include required
components. The RDDS economist collects economic
data from the other team members and develops the
economic analysis. The RDDS Director manages the
docket team process, ensuring that appropriate
offices and staffs are represented on the team,
that the team works together effectively, and that
the team develops the necessary documents.
- What is the team leader's role?
During the initial docket team meetings, the
team chooses a leader who leads team meetings and
informs the OPPDE Assistant Deputy Administrator
for Policy Analysis and Formulation of the docket
team´s progress. The team leader may be the RDDS
analyst or any other member of the docket team.
- How will the responsibilities of each team member be determined?
The docket team determines 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 team
leader and RDDS analyst consult with the OPPDE
Assistant Deputy Administrator for Policy Analysis
and Formulation and the RDDS Director for guidance
on how best to address the problem.
VIII. Roles of Docket Team Members
- What is the RDDS analyst´s role in
developing the documents for which the team is
responsible?
The RDDS analyst ensures that the team
completes necessary documents and that the
completed documents include required components.
To ensure that the documents include the required
components, the RDDS 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. (See Attachment 1.)
Other docket team members assist in writing and
developing these analyses.
- What are the roles of the other
members of the team?
To help ensure that rulemaking documents
are based on the best reasonably obtainable
scientific, technical, and economic
information, other docket team members assist
in writing and developing the analyses
required in rulemaking documents and other
text in rulemaking documents. For example,
team members from OPHS 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 OFO assist in
drafting information on implementation of new
regulations or current activities of
inspection program personnel.
- In general, docket team members from
outside RDDS 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 ANPR, proposed rule,
or final rule, as needed, on a subject
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.
- Provide assistance in responding to
comments to ANPRs and proposed rules, as
needed.
- Provide input and technical assistance
in developing FSIS directives that implement
final rules. The staff members who
participate as docket team members in
developing rules would, if possible, serve
as members of the directive development
team.
IX. Clearance of Documents
- Who is responsible for circulating
documents through clearance?
When the team completes work on a document, the
RDDS analyst circulates the document through FSIS
Deputy Administrators, OA Staff Directors, other
appropriate FSIS managers, OGC, and the
Departmental and OMB clearance processes. RDDS
typically requests that FSIS management provide
comments on the document within 5 business days of
receipt of the document. The RDDS analyst ensures
that the correct version of the document
circulates through clearance.
- How will the docket team address
comments from reviewing offices?
The RDDS analyst advises the team leader of
comments received on documents during the
clearance process. The RDDS analyst and the team
leader will work together to ensure that the
responses to the comments are developed
expeditiously, through unilaterally making
changes, contacting individual team members, or
reconvening the group. As the document is revised
in response to comments, RDDS will send the
revised versions of the document to the docket
team.
- Will members of the docket team meet
with reviewing offices during the clearance
process?
If it is necessary to meet with Agency
management, the Department, OGC, or OMB on a
docket during the clearance process, the OPPDE
Assistant Deputy Administrator for Policy Analysis
and Formulation, in consultation with the RDDS
Director, team leader, and RDDS analyst, will
decide who will attend the meeting.
X. Preliminary Documents
The docket team develops preliminary documents
before a regulation or ANPR is published.
Preliminary documents are described as follows:
- The docket team develops a Preliminary
Report as quickly as possible. RDDS sends the
report to the Deputy Administrator of OPPDE.
Once the Deputy Administrator approves the
preliminary report, it serves as the basis for
development of the workplan, the unified
regulatory agenda and regulatory plan, and the
rule or ANPR under development. The preliminary
report answers the following questions:
- What is the purpose of the action? What is
it intended to accomplish?
- What is the public health risk or other
issue (e.g., misbranding, regulations reform)
being addressed and what evidence is there
that the issue needs to be addressed?
- Who will be affected by FSIS´ proposed or
final action (e.g., which industry segments,
which consumers)?
- What are the options for addressing the
problem, and what is the evidence that each
option will be effective? For rules that
address public health risks, the report should
present a range of possible mitigation
strategies and a summary of available data on
the potential effectiveness of each mitigation
strategy.
- What are the costs and benefits of each
option (brief description)? How will they be
estimated? What are the major areas of
uncertainty in estimating costs and benefits?
What is the relative public health risk with
each option?
- Is a risk assessment needed? If so, what
type of risk assessment is needed?
- What is the timetable for producing the
workplan, other preliminary documents, and the
ANPR, proposed rule, or final rule?
- What are the resource requirements for
developing the preliminary and rulemaking
documents?
- How will FSIS enforce the approach being
proposed or adopted?
- What measures will FSIS use to assess the
success of the approach being proposed or
adopted?
- What other documents will FSIS need to
develop to implement the approach being
proposed or adopted?
- What information is needed to develop the
ANPR, proposed rule, or final rule and what
are potential sources of this information?
- The Workplan document is used to initiate a
regulatory action.
- The workplan provides a description of the
contemplated regulatory
action, including objectives, alternatives, and
expected results of the regulatory action.
- The information in the workplan is used to
determine the regulatory
classification of the regulatory action and
designate the appropriate level of oversight. Six
terms are used to classify regulatory actions with
respect to the degree of oversight that will occur
for a particular regulatory action. The terms are
NON-SIGNIFICANT; SIGNIFICANT; ECONOMICALLY
SIGNIFICANT; two definitions of Major: MAJOR as
defined by the Federal Crop Insurance Reform and
Department of Agriculture Reorganization Act of
1994 and MAJOR as defined by subtitle E of the
Small Business Regulatory Enforcement Fairness Act
of 1996; and EXEMPT.
- RDDS sends the workplan to the Deputy
Administrator of OPPDE
for review and signature and then to the Under
Secretary for Food Safety for review and
signature. The Under Secretary recommends a
regulatory classification. The Department´s Office
of Budget and Policy Analysis then sends the
workplan to OMB, and OMB provides the official
regulatory classification.
- The Unified Regulatory Agenda and Regulatory
Plan are documents that are published in the
Federal Register. Any rule that has a workplan
that OMB has approved is included in the Unified
Regulatory Agenda, which is published on a
semi-annual basis. The Unified Regulatory Agenda
includes a summary of the rule, the legal
authority for the action, and any legal deadline
for the action. Additional information on the
rules that FSIS considers to be the most
significant would be included in The Regulatory
Plan, which is published annually.
XI. Components of an ANPR
FSIS develops an ANPR when the Agency needs
additional input from the public before it can
develop a proposed rule. 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.
- Request for comment.
XII. 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" or "exempt," 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´
response to the comments.
- A risk assessment of the rule for a "major"
rule that affects human health,
human safety, or the environment.
XIII. Directives, Notices, and Compliance Guides
- How do inspection-related directives relate to
regulations?
Inspection-related directives are documents that
FSIS issues to provide instructions to its
personnel in carrying out FSIS functions. FSIS may
develop an inspection-related directive in
conjunction with a final rule to provide
instructions to inspection program personnel on
how to perform functions necessary to implement
new FSIS regulations. FSIS makes
inspection-related directives available to
regulated industry, but these directives are not
regulations and do not carry the force of law. The
staff members who participate as docket team
members in developing a final rule would, if
possible, serve as members of the directive
development team for the final rule. RDDS is
responsible for the clearance and issuance of
inspection-related directives.
- How does an inspection-related notice differ
from an inspection-related directive?
An inspection-related notice provides instructions
and information to FSIS personnel on
time-sensitive issues, one-time activities, and
clarification of inspection-related directives.
Notices expire one year after they are issued.
Docket teams are not typically involved in the
development of inspection-related notices. RDDS is
responsible for the clearance and issuance of
inspection-related notices.
- When does FSIS develop compliance guides?
In conjunction with proposed or final rules, FSIS
may develop compliance guides that would assist
the regulated industry´s compliance with new
requirements. For example, compliance guides may
include methods proven to be effective at meeting
pathogen reduction performance standards or other
performance standards in proposed or final
regulations. Members of the docket team assist in
developing compliance guides related to the
docket.
Attachment
- Summary of Laws and Executive Orders Governing Regulations Development
Distribution:
- Washington Offices
- District Offices
- Technical Service Center
- Field Service Laboratories
OPI:
- OPPDE
- Regulations and Directives Development Staff
Summary of Laws and Executive Orders Governing Regulations Development
- Federal Meat Inspection Act, Poultry Products
Inspection Act, and the Egg Products Inspection
Act.
These statutes direct and authorize FSIS to
carry out its inspection programs for meat,
poultry, eggs, and egg products.
- Administrative Procedure Act.
The APA requires
Federal Agencies to publish proposed rules in the
Federal Register and provide for public
participation in rulemaking. The APA also provides
that proposed rules are not required in certain
situations.
- Executive Order 12866, Regulatory Planning and
Review.
This Executive order guides all Federal
rulemaking. Importantly, it requires Agencies to
conduct cost and benefit analyses for proposed and
final regulations that are "significant"
regulatory actions.
- Executive Order 12988, Civil Justice Reform.
This Executive order instructs Agencies to adhere
to certain requirements in the development of new
and revised regulations to avoid unduly burdening
the court system.
- Unfunded Mandates Reform Act of 1995.
This Act
requires Agencies to estimate the cost of Federal
rulemaking to State, local, and tribal
governments.
- Paperwork Reduction Act of 1995.
This Act
requires Agencies to minimize the paperwork burden
for individuals or other entities resulting from
the collection of information by or for the
Federal Government. This Act requires Agencies to
assess the paperwork and reporting burden of
proposed and final rules.
- Regulatory Flexibility Act.
The RFA requires
Agencies to estimate the economic impact of their
proposed and final regulations on small businesses
and to attempt to minimize that impact.
- Small Business Regulatory Enforcement Fairness
Act of 1996 (Contains amendments to the APA and
RFA).
Among other things, SBREFA requires agencies
to publish an easily understood guide to assist
small business to comply with regulations that
undergo a required RFA analysis.
- The Federal Crop Insurance Reform and
Department of Agriculture Reorganization Act of
1994 (P.L. 103-354, Section 304).
This Act
requires that any regulation published by USDA
concerning human health, human safety or the
environment and having an annual economic impact
of at least $100 million in 1994 dollars contain a
risk assessment and cost-benefit analysis.
- Departmental Regulation 1512-1, Regulatory
Decision making Requirements.
These regulations are
intended to provide a consistent process for the
development and review of all USDA regulatory
actions.
- National Environmental Policy Act (42 U.S.C.
4321 et seq.) and
the Council for Environmental Quality Regulations
(40 CFR parts 1500-1508).
This Act and these
regulations require Federal Agencies to conduct
environmental impact analyses for regulatory
actions. FSIS has been granted a categorical
exclusion from NEPA requirements by USDA
regulation (7 CFR 1b.4), unless "the agency head
determines that an action may have a significant
environmental effect."
- Executive Order 12898, Federal Actions to
Address Environmental Justice in Minority
Populations and Low-Income Populations.
This
Executive order requires Federal Agencies to
consider the potential impact of regulations on
environmental and health conditions in low-income
and minority communities.
- Executive Order 13132, Federalism.
This
Executive order requires agencies to submit a
certification with all final rules that impose
substantial direct compliance costs on State or
local governments or that preempt state law.
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