Guidelines for Writing
Rulemaking Documents
EPA-AA-CD-91-01
Certification Division
Office of Mobile Source Air Pollution Control
U.S. Environmental Protection Agency
March 1991
Revisions August 1991
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Guidelines for Writing
Rulemaking Documents
Kathy E. Carter
March 1991
Revisions August 1991
vvEPA
EPA-AA-CD-91-01
Certification Division
Office of Mobile Source Air Pollution Control
U.S. Environmental Protection Agency
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Table of Contents
Section 1. Background and Planning 1
General Background 1
What about public participation 1
Some steps to writing and recognizing clear, coherent text
Some things to remember about the Federal Register 3
Some planning steps 4
Section 2. Notice of Proposed Rulemaking 6
What to include in the preamble to the NPRM 6
Table of Contents (TOC) 8
Summary 8
Authority 8
Background 8
Requirements 10
Discussion of Issues 10
Other Topical Headings 12
Environmental and Health Benefits 12
Economic Impact 12
Cost Effectiveness 12
Public Participation 12
Administrative Requirements 14
Section 3. Response to Comments 19
Federal Guidance on Writing a Response to Comments 19
What to include in the Response to Comments on the NPRM 19
Executive Summary of Comments 20
Discussion of Comments by Issue 20
Section 4. Notice of Final Rulemaking 25
What to include in the preamble to the Final Rule
Table of Contents (TOC) 26
Authority 26
Requirements 26
Summary of Changes 26
Background 28
Discussion 28
Administrative Requirements 28
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11
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Preface
This document was originally written and designed for the staff of the
Certification Division in the Office of Mobile Sources. It was developed as a
means to make regulatory documents easier to write and easier to review.
Many people aided in the writing process, but special thanks goes to the OBD
project team and the Cold Temperature CO project team for helping me learn
the" real" way things get done.
Kathy E. Carter
About This Guide
This guide is to help in writing and organizing three documents, the preamble to
a Notice of Proposed Rulemaking, a Response to Comments on the
NPRM, and the preamble to a Final Rulemaking. It provides
information about what should be included in each document and a structure to
follow in organizing it. You may not be writing the entire document, but only one
section. By following these guidelines and structuring your section as indicated,
the editing and review process will be simplified.
Note this is a "guide," not a set of rules. It gives you a starting point, something
to put on that blank sheet of paper. However, you will find each rule will require
changes and adaptions to the outline provided. Make those changes or
adaptions, but remember to follow the basic tenets of this document—keep it
simple and keep it logical to the reader.
To help you find Information, read this overview of what Is In each section.
You will find the information divided into several sections. The first section has
some general information related to writing rulemaking documents. Then there
is a special section for the NPRM, the Response to Comments, and the Final
Rule.
In the three special sections, the information is set up so that the right-hand
page contains an example of the text of the document. The left-hand page
contains an explanation and tips for writing that portion of the text.
Throughout the guide you will see references to the Document Drafting
Handbook. This means the Federal Register Document Drafting Handbook,
revised April 1986 (the version with the blue cover). Additional copies may be
obtained by calling the Office of the Federal Register at 523-5240.
The example text is available on floppy disk or on the LNS network at MVEL in
Microsoft Word™, WordPerfect™, and OfficeWriter™ formats. It can be accessed
via the network from zone "Cert # 2" on CD38-Carter (Macintosh-MS Word
format).
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Section 1. Background and Planning
General Background
Before writing the preamble, you will have done research and collected
information. You will have decided what type of rule you are writing:
• substantive (legislative)—issued by an agency pursuant to statutory
authority to implement the statute...has the force of law
• interpretive—rules or statements advising the public of the agency's
construction of the statutes and rules which it administers
• statements of policy—issued by an agency to advise the public
prospectively of the manner in which it proposes to exercise
discretionary power
You will also have decided the classification of the rule as major, significant, or
minor. A major rule is one which is likely to result in
• an annual effect on the economy of $100 million or more; and/or
• a major increase in costs or price for consumers, individual industries,
Federal, States or local government agencies or geographic regions;
and/or
• significant adverse effects on competition, employment, investment,
productivity, innovation, or on the ability of United States-based
enterprises to compete with foreign-based enterprises in domestic or
export markets.
A significant rule is one that does not meet criteria for major rules, but may
• have significant adverse impact on the public, or
• raise important health or intermedia issues, or
• have broad geographic effects
A minor rule is one that does not meet criteria of major or significant rules.
What about public participation
An important part of the rulemaking process is public participation. The
Administrative Procedures Act states that for any Federal rulemaking, the public
must be informed, the opinion of the public must be sought, and the issuing
agency is accountable for insuring public participation. Public participation
should not wait until after the rule has been proposed, but should begin during
the research and information gathering stage. Early participation can garner full
public and private sector support, making acceptance of the rule easier and
stronger. This involves designing a rule around what the public tells the
agency. Public participation can be sought through a variety of methods:
• advanced notice of proposed rulemaking (ANPRM)
• public hearings
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2 Background and Planning
• request for information (in Federal Register)
• letters to interested parties (up to 9 requests for information do not
need prior OMB approval)
• meetings with affected parties prior to the NPRM
• articles in trade/professional publications delineating information
needs
• meetings with public interest groups prior to the NPRM
• public comment period
• consultants
Once all the information is gathered and the research is done, you will start
making decisions about what is to be proposed in the rule. As you begin
writing, you should remember your goal is writing clearly, in plain English, and
to present your information succinctly and coherently.
Some steps to writing and recognizing clear, coherent text:
1. Develop an outline.1 Use those provided, but fill in the specific topical
headings appropriate for your rulemaking.
2. List all the ideas you want to present (this doesn't have to be in complete
sentences and probably shouldn't be). List the ideas under the
appropriate sections in your outline.
3. Chunk the ideas into related groups. Decide if your related groups will
remain single sentences or will be expanded into paragraphs or
subsections needing headings.
4. Create your headings and subheadings and insert them into your outline.
You should not have more than three levels of headings [main headings
(I., II ), subheadings (A., B ), and sub-subheadings (1., 2 )]
5. Write 1-2 sentences for each of the headings or subheadings which
summarizes the focus of that particular chunk of the document. These
sentences should answer the questions "What's the point?" and "So
what?"
6. Decide on the tables or figures you want to use and create them, if not
already done. (You may add others later, but if you assemble the ones
you anticipate using first, it makes writing about them easier.)
7. Now, starting from the beginning of your outline, write the text. Write as
though you were talking to someone and be as clear as possible. Don't
force the reader to make inferences, spell out the facts (but this doesn't
mean giving every detail, just the basic facts.)
8. If possible, put your writing away at this point. Come back the next day
and review your original outline and your document. Delete (or
1Many people do not start the writing process with an outline and I am not implying this is the
beginning of the writing process. If you think through your ideas by writing your thoughts and
notes together, by all means continue. DON'T MAKE THE MISTAKE of using this random
collection of thoughts as your rough draft. Once your research is done, your data analyzed, and
your thoughts generated, begin writing your rough draft by developing an outline and following
the steps above.
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Background and Planning
minimize) any information unrelated to the central concepts. (You may
want to have a colleague review the document.)
Your text structure should be clear and coherent. Now it's time to look at your
sentence structure.
9. Work on individual sentences, deleting useless words and phrases,
tightening constructions, and polishing the overall text. Check spelling,
word usage, grammar questions, and any format guidelines you need to
follow.
10. Again, put your writing away. This is also another good time to get
someone else to read it, preferably someone who is not familiar with the
topic and might represent the intended reader. Can they identify the
main issues? Do they understand why EPA chose this option? Then
you've probably accomplished your objective.
Some things to remember about the Federal Register
Some things to remember about writing for the Federal Register:
Indentation: Headings and subheadings are not indented from the margin.
Instead a variety in type style is used to indicate the different
levels.
Underlining: Only underline—
• what will be in bold typeface [i.e., section headings in the
regulatory text and main headers (I., II., Ill ) in the
preamble].
• what will be in italic typeface [i.e., paragraph headings in
the regulatory text and subheadings headers (A., B., C )
in the preamble; scientific terms; ordering statements; and
court cases].
• all dates to be computed by FR staff.
DO NOT underline anything else.
Formatting: Double-space on one side of each page. See page 61 of
Document Drafting Handbook for margins and other specifics.
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Background and Planning
Some planning steps
After the NPRM is complete and sent to the Federal Register for publishing,
plans should be made for the next steps. Top often preparations are not made
until after the public hearing or comment period. Planning ahead helps to make
deadlines for the Final Rule easier to meet. Just because a deadline may be set
for the preamble, doesn't mean that is done first. Do tasks in the order that is
most efficient and will produce the best final product.
Plan who will be involved with preparing the Response to Comments and the
preamble to the Final Rule. Assemble the team and notify them of important
dates and involve them in the planning. Use the timetable provided to set your
schedule.
One of the points to note In this timetable Is that preparation of the Response
to Comments does not have to wait for the end of the comment period to begin,
especially if your team is organized and assignments are made early. Also,
changes to the regulatory language can begin to be made by team members as
soon as their analysis of comments is complete.
A second point to notice Is that the Response should be near completion as the
Preamble to the Final Rule is begun. This is a very important point. In order to
write the preamble, EPA must have decided its position and why that position is
appropriate. A great deal of discussion usually takes place in order to come to
a position. This discussion can be much more focused when all participants
have a copy of the summary of the comments on the particular issue and know
exactly what the NPRM said on the issue. Meetings can go much more
smoothly when someone has already examined the NPRM for what was said
and time does not have to be spent trying to remember what was said (and
memories might be faulty) and everyone knows what comments were made.
And once the decisions are made and the Response drafted, the Preamble can
be written in a few days. When you try to do the preamble first, most of the time
spent on the Preamble is actually time spent deciding the issues. So just
decide the issues, then write the Preamble.
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Background and Planning
Proposed Timetable for Drafting Final Rule
What's Due
Date Due Description
NPRM published
Public Hearing held
Team Meets
Week 1, Day 1
Week 5, Day 30
Week 6
Transcript and Comments Week 7-8
Arrive
Public Comment Period
ends
Statement of Proposal and
Summary of Comments
Week 9, Day 60
Week 10
Statement of Proposal and Week 11
Summary of Comments
completed
Discussion of Comments and Week 12-15 (or
EPA Position longer)
Preamble Drafted—rough Week 12
draft
Reg. Lang.—draft changes Week 13
Preamble—Complete Draft Week 16
ready for internal review
Response to Comments on
NPRM complete
Reg. Lang.—finish changes Week 17
Discuss what are the major,
significant, and minor
issues/make assignments to
each member to track
Team members read as received
and prepare a list of the
comments on their assigned
topic (or other way to track the
comments)
Continue above
Team members examine NPRM
for what it says and summarize
the comments on the issues
raised
Team begins meeting to
analyze and respond to the
comments, copies of each
summary are distributed
as each issue reaches
conclusion, the position
statement is prepared
Prepare Background and
boilerplate sections of Final
Rule preamble/as issues
resolved and decisions made,
prepare appropriate discussion
sections
For their respective topics.
have team members prepare
list of changes or a draft of
Reg. Lang.
All position statements
complete in summary and all
discussion statements complete
in preamble
Change appropriate sections of
Reg. Lang, as need
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Section 2. Notice of Proposed Rulemaking
The Notice of Proposed Rulemaking (NPRM) is the first published version of the
regulations. It includes a preamble supplying the background and support for
the regulations and the regulatory language. For a detailed explanation of the
preamble and regulatory language requirements, refer to the Document
Drafting Handbook.
What to include in the preamble to the NPRM
Headings
AGENCY:
ACTION:
SUMMARY:
DATES:
ADDRESSES:
FOR FURTHER
INFORMATION CONTACT:
SUPPLEMENTARY
INFORMATION
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part xx
Subject (content of document)
Environmental Protection Agency
Notice of proposed rulemaking.
Action summary which answers three
questions:
• What action is being taken?
• Why is this action necessary?
• What is the intended effect of this
action?
Should not exceed one page (about 1-2
paragraphs). See example on next page.
Includes all dates essential to rulemaking.
Underline the notes asking Federal
Register staff to compute the date.
Includes all addresses any participant
needs to know (mailing, hand delivering,
public hearing, examining public
material).
Name and telephone number of contact
person (principal project officer).
Provides the rationale for your proposed
rule. Should not exceed 50 double-
spaced manuscript pages.
The following provides guidelines for what to include in your preamble and how
to organize it. The text is provided where the same text is always used or used
with only slight modifications. This text is available over the LNS network—MS
Word version on CD38 in Zone "Cert #2."
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NPRM
Example
SUMMARY: Today's action proposes on-board diagnostic (OBD)
system requirements for light-duty vehicles and light-duty trucks
commencing in the 1994 model year. Under the Clean Air Act
Amendments of 1990, EPA is required to promulgate final OBD rules
by May IS, 1992; this action is an initial step in that process. This
proposal will require manufacturers to install systems which will
monitor the functioning of emission control components and alert the
vehicle operator to the need for repair. In addition, when a
malfunction occurs, diagnostic information must be stored to assist
the mechanic in diagnosis and repair. Also proposed are
requirements which would make available to the repair industry
information necessary to perform repair and maintenance service on
on-board diagnostic systems and other emission-related vehicle
components.
Answers the three questions—what, why, effect—and no more.
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NPRM
Table of Contents (TOC)
• At the beginning of the preamble, provide a Table of Contents. Use your document
outline, listing the first and second level of headings. In some cases you may also
want to show the third level of heading also. (Example shows only first and second
levels.)
• On working drafts, you may want to supply page numbers.
• Oo this section after the first draft is reviewed or document organization is fairly
complete.
• Having a TOC not only makes it easier to find things in the draft, but helps readers to
understand your organization when it is published in the Federal Register.
Summary
• This section provides an executive summary of the proposal (a summary of the
preamble as opposed to a summary of the regulation). Answers the question "What
does the action involve?"
• This is different from the action summary at the beginning of the document (which is
more a summary of the regulation). DO NOT include the exact same information.
• Answers the question "What is the point?" of your whole preamble in just three to
four sentences.
• Picks up where the action summary left off: give one to two statement summary of
the proposed regulation (Section IV.A.), one sentence summary of why this option
was chosen (Section IV.B.), and one to two sentence summary of issues or other
options (Section V or VI).
• Write this section LAST or at least after most of preamble is complete.
• An executive summary helps to make sure everyone gets your main idea, and allows
them to do so without reading every word first.
Authority
• provides a complete statement of statutory authority
• mention all applicable sections and a statement of the authority provided
Background
• Answer the questions "What led to making this proposal?" and/or "What went on
before and while developing this proposal?" Include in this section any or all of the
following:
a brief statement of current procedures (if being changed)
prior research or decisions on another rule which pertains to this rule
pending Congressional actions pertaining to this rule
prior legal decisions pertaining to this rule
anticipated future needs/changes
related rulemaking documents
magnitude of pollution problem this rule affects
pollution abatement and controls already in effect
• Describes the problem for which the rule is the solution.
• This section should just state the facts, clearly and succinctly, not provide great
detail; i.e. state your point, but don't comment on it.
• For more detail, refer to supporting documents, but do not repeat detailed analysis
which appears in support documents.
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NPRM
This section can have subheadings (i.e.; Air Quality, Legislative Action, etc.) if the
topics listed previously require more than several sentences each.
It is not necessary to include information which was in the action summary at the
beginning of the document. However, it is preferable to have the details in this
section and not in the action summary.
Example
I. Table of Contents
Summary of Proposal
Authority
Background of Proposed Rule
Proposed Regulations
A. Proposed Requirements
B. Rationale (or Discussion)
Discussion of Issues
A., B., etc.
Environmental and Health Benefits
A., B., etc.
Economic Impact
A., B., etc.
Cost-Effectiveness
Public Participation
A. Comments and the Public Docket
B. Public Hearing
Administrative Requirements
A. Administrative Designation
B. Reporting & Recordkeeping Requirements
C Regulatory Flexibility Act
II. Summary of Proposal
III. Authority
Authority for the actions proposed in this notice is granted
to EPA by section XXX(x) of the Clean Air Act as amended [42
U.S.C. 7521(a)]....
IV. Background of Proposed Rule
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10 NPRM
Requirements
• Discusses in detail EPA's proposed course of action.
• May have topical subheadings (but not necessary to have them).
• Include any or all of the following:
Part A.
• standards
• test procedures
• compliance procedures
• effective dates
• leadtime/phase-in
enforcement
• other topical headings
Part B.
benefits of this option
• impact of this option (usually the economic effects, but costs may be
something besides money)
• why benefits outweigh costs
• Part A should always be included. Part B might be included in VI. Discussion of
Issues instead of here.
• Part A answers the question "What do I do to obey this rule?"
• Part A explains the proposed regulation requirements in layperson's language, but
doesn't get into "why" this is being proposed.
• Make the rationale (Part B) separate from the statement of the regulations; i.e. don't
try to explain why you chose this option in the same paragraph you tell them what to
do.
• Part B answers the question "Why did EPA choose this option?"
• Part B is a succinct statement of overall benefits/costs using positive language. Save
the detailed analysis for other sections.
Discussion of Issues
• Discuss the issues or the options. Issues are more general (i.e. what temperature to
use, what level of standard, etc.). Options are the combination of decisions on issues
that present different ways to meet the goal. If you are discussing options, then you
are only discussing the ones EPA chose not to use in this rulemaking.
• If you discuss both issues and options, separate them into two sections (see VI. Other
Topical Headings)
• Should summarize, not repeat, information in support documents entered in the
public docket.
• If you find the information In this section overlapping the info in III. B. Rationale or
VI. Other Topical Headings, then cut one of these sections or combine these sections.
• State the topic, or point, of each section or subsection at the BEGINNING of the
section. The point of a section can come at either the beginning or the end, but in this
type of writing, the reader will be looking for your point at the beginning.
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NPRM 11
Example
V. Requirements of the Proposed Rule
A. Proposed Requirements
(optional subheadings)
B. Rationale (or topical headings if appropriate)
VI. Discussion of Issues (or Options)
A. Topical Subheadings (make these descriptive, not just "Option
No. 1" but "Regulatory Approach," "Technical Feasibility,"
"Enforcement," etc.)
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12 NPRM
Other Topical Headings
• If there are major headings not covered in one of the other sections, make them
separate sections. For example, if you had several alternative approaches or courses
of action and want to briefly discuss them, you might have a heading such as "Other
Actions Considered" and then describe each option.
• You will probably find everything should fit into one of the other sections. If not,
make sure this info is crucial to the preamble or could it just be presented in a
support document.
Environmental and Health Benefits
• This is an extremely important part of a proposed rule. It should receive importance
and may appear earlier in the preamble.
• Since our rules focus specifically on providing environmental benefits, go into detail
on the benefits. Provide information about specific impacts on health. This is a risk
assessment in terms of the public health and welfare, the ecological system, and
wildlife.
• Write about the anticipated benefits. Do not use numbers and data as though they
were absolute or the final word.
• Note that the optional subheadings say basically the same thing in three different
ways. Choose one version (or one of your creation) and use it as the model for
wording all your subheadings. Don't use all three versions in the same document. Be
consistent.
Economic Impact
• Should summarize, not repeat, information in support documents entered in the
public docket. This does not repeat, nor is it the same, as section XI. C. Regulatory
Flexibility Act.
• State the topic, or point, of each section or subsection at the BEGINNING of the
section. The point of a section can come at either the beginning or the end, but in this
type of writing, the reader will be looking for your point at the beginning.
Cost Effectiveness
• Benefits vs. Cost
• State the topic, or point, of each section or subsection at the BEGINNING of the
section. The point of a section can come at either the beginning or the end, but in this
type of writing, the reader will be looking for your point at the beginning.
Public Participation
• Use as written, with addition of appropriate names, dates, and addresses.
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NPRM 13
Example
VII. Other Topical Headings (Optional^
(such as: Other Actions Considered)
VIII. Environmental and Health Benefits
(optional subheadings)
A. Reduction of NOX
B. CO Emissions Benefits
C. Effect on HC Emissions
IX. Economic Impact
(optional subheadings)
A. Developmental Costs
B. Variable Costs
C. Fixed Costs
D. Cost to Government
X. Cost-Effectiveness
XI. Public Participation
A. Comments and the Public Docket
EPA welcomes comments on all aspects of this proposed
rulemaking. Commenters are especially encouraged to give
suggestions for changing any aspects of the proposal that they
find objectionable. All comments, with the exception of
proprietary information, should be directed to the EPA Air Docket
Section, Docket No. A-XX-XX (see "ADDRESSES").
Commenters who wish to submit proprietary information
for consideration should clearly separate such information from
other comments by
labeling proprietary information "Confidential Business
Information" and
sending proprietary information directly to the contact person
listed (see "FOR FURTHER INFORMATION CONTACT") and not to
the public docket.
This will help insure that proprietary information is not
inadvertently placed in the docket. If a commenter wants EPA to
use a submission labeled as confidential business information as
part of the basis for the final rule, then a nonconfidential version
of the document, which summarizes the key data or information,
should be sent to the docket.
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14 NPRM
Public Participation
Continuation of example text
Administrative Requirements
• Use as written, with addition of appropriate names, dates, and addresses.
Part A.
• Two first paragraphs are provided. Choose the one appropriate for the rule being
proposed. Second paragraph same in both versions.
• Pertinent info from the RIA should be included in VIII. Economic Impact. NOTE: RIA
is different from Regulatory Analysis.
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NPRM 15
Information covered by a claim of confidentiality will be
disclosed by EPA only to the extent allowed and by the
procedures set forth in 40 CFR Part 2. If no claim of
confidentiality accompanies the submission when it is received by
EPA, the submission may be made available to the public without
notifying the commenters.
B. Public Hearing
Anyone who wants to present testimony about this proposal
at the public hearing (see "DATES") should, if possible, notify the
contact person (see "FOR FURTHER INFORMATION CONTACT") at
least seven days prior to the day of the hearing. The contact
person should be given an estimate of the time required for the
presentation of testimony and notification of any need for
audio/visual equipment. A sign-up sheet will be available at the
registration table the morning of the hearing for scheduling those
who have not notified the contact earlier. This testimony will be
scheduled on a first-come, first-serve basis to follow the
previously scheduled testimony.
EPA requests that approximately SO copies of the statement
or material to be presented be brought to the hearing for
distribution to the audience. In addition, EPA would find it
helpful to receive an advance copy of any statement or material
to be presented at the hearing at least one week before the
scheduled hearing date. This is to give EPA staff adequate time to
review such material before the hearing. Such advance copies
should be submitted to the contact person listed.
The official records of the hearing will be kept open for 30
days following the hearing to allow submission of rebuttal and
supplementary testimony. All such submittals should be directed
to the Air Docket, Docket No. A-XX-XX (see "ADDRESSES").
, is hereby designated
Presiding Officer of the hearing. The hearing will be conducted
informally, and technical rules of evidence will not apply. A
written transcript of the hearing will be placed in the above
docket for review. Anyone desiring to purchase a copy of the
transcript should make individual arrangements with the court
reporter recording the proceeding.
XI. Administrative Requirements
A. Administrative Designation
Under Executive Order 12291, EPA must judge whether a
regulation is a "major" rule and, therefore, subject to the
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16 NPRM
Administrative Requirements
Part B. Always included.
Part C. If a significant impact was. found, then change the text to indicate this here, but
provide more information in IX. Economic Impact or X. Cost-Effectiveness.
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NPRM 17
requirement that a Regulatory Impact Analysis (RIA) be
prepared. Since EPA has determined that this regulation is not
major, an RIA has not been prepared.
This regulation was submitted to the Office of Management
and Budget (OMB) for review as required by Executive Order
12291. Any written comments from OMB and any EPA response
to those comments are in the public docket for this rulemaking.
OR
Under Executive Order 12291, EPA has determined that this
regulation is major. A Regulatory Impact Analysis (RIA) has been
prepared and is available from the address provided under "FOR
MORE INFORMATION CONTACT."
This regulation was submitted to the Office of Management
and Budget (OMB) for review as required by Executive Order
12291. Any written comments from OMB and any EPA response
to those comments are in the public docket for this rulemaking.
B. Reuortine & Recordkeeoine Requirement
All of the information collection requirements contained in
this proposed rule have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction
Act of 1980, 44 U.S.C. 3501 et seq.. and have been assigned OMB
Control Number XXXX-XXXX. The information collection provisions
relating to [insert reference to the data/forms to be collected]
have been submitted for approval to OMB.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act of 1980 requires federal
agencies to identify potentially adverse impacts of federal
regulations upon small entities. In instances where significant
impacts are possible on a substantial number of these entities,
agencies are required to perform a Regulatory Flexibility Analysis
(RFA).
EPA has determined that the regulations proposed today
will not have a significant impact on a substantial number of
small entities. This regulation will affect only [insert appropriate
businesses], a group which contains few small entities. [May
insert additional reasons why small entities not affected.]
Therefore, as required under section 605 of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq.. I certify that this regulation
does not have a significant impact on a substantial number of
small entities.
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18 NPRM
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Section 3. Response to Comments
Federal Guidance on Writing a Response to Comments
No formal guidelines are provided on the content or structure. Instructions
provided in the Regulatory Development Notebook indicate the following:
The law requires that the Agency provide a written response to all
significant comments. You should respond to major comments in the
preamble to the final rule. For most rules of any size, the Agency usually
prepares a Response to Comments document that presents a more
complete response to the comments received.
No guidelines for distinguishing a major issue from a significant issue are
provided. Only major issues need be discussed in the preamble to the
final rule.
• Organize this document carefully to prevent responding to the same
comment repeatedly. Cutting up the comments and grouping them
together by issue and then writing one response often works best.
Responses should be thoughtful, reflecting that you took the comment
seriously; it should indicate whether the Agency has changed the final
rule in response, and if not, why not.
What to include in the Response to Comments on the
NPRM
The Response to Comments document presents the entire discussion of EPA's
response to comments received at a public hearing on the NPRM or during the
comment period. It should be as exhaustive as necessary to make your case. It
is not necessary to repeat all the comments or to repeat technical discussions or
analysis found in the public docket.
The document can be organized into three basic sections as described on the
following pages.
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20 Response to Comments
About This Summary
Write your introduction to the overall summary, providing information about
each chapter and how it is organized. Much of this will be boilerplate language,
which can be copied from a previous document or use the sample provided.
Successful introductions usually cannot be written until the document is
complete or near completion.
Executive Summary of Comments
This section should be written after the completion of the rest of the document.
You will then be able to summarize the comments made on significant issues
into a short paragraph or two and give EPA's position on these issues. This
section should provide an overall view of the positions without necessarily
mentioning each specific comment and commenter by name. It also does not
go into every comment or issue. Here you are summarizing what the
substantive issues were which could influence rulemaking decisions. Positions
which were unchanged do not need to be discussed in this section.
Discussion of Comments by Issue
Here is the detailed summary and analysis of comments and EPA's position for
the final rule. All significant and major comments must be addressed. Since it
is an arbitrary decision what is significant and what is major and what is neither,
err on the conservative side. It is a matter of discretion whether or not to
mention every comment made; however, there is no need to deal with every
comment. Those comments which had no impact on the decision-making
process or which repeat issues discussed in documents which proposed the
rule are not significant comments.
Favorable comments do not need a response, but a mention that they existed is
recommended, especially where they enhance our choice among options or
our position on an issue.
Group all comments by issue. Each issue should have four types of information
given:
• a concise statement of what the NPRM said on this issue. Give a 1 -2
sentence synopsis of what the proposed rule says or the position being
debated. Do not give the rationale for why the NPRM said this.
This is a key starting point from which to base all discussions of the issue.
Unless compelling reasons and evidence was provided to justify a
change, we intend to finalize what we proposed.
a summary of the comments. A summary, by definition, means to cover
the main points succinctly. This is not a list of the actual comments, but a
summary of them (remember the full text is part of the docket). Indicate
who made the comment (the entity's name, not the individual's name).
When several commenters take the same position, indicate this
agreement and who agreed. This can be done in several ways,
depending on the nature of the comment. The use of company names
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Response to Comments
21
Example
Chapter 1. About This Summary
On [give date], the Environmental Protection Agency (EPA) published
in the Federal Register a Notice of Proposed Rulemaking (NPRM) for [title-
description]. EPA also held a public hearing on this proposal on [give date]
and accepted written comments for 30 days following the conclusion of the
hearing. EPA received [give number] written statements from the public on
the NPRM. All of the written comments submitted to EPA and a transcript of
the public hearing are contained in EPA's [name of docket (docket #)]. A list
of all commenters speaking at the public hearing and writing to the public
docket is provided in the appendix to this document.
The purpose of this document is to summarize and respond to the
comments submitted by the public. Included in the document are responses
to issues raised both at the public hearing and in the written comments sent
to EPA. Comments were grouped by issue and responded to as a group. The
issues discussed in this document are [give list].
[OPTIONAL PARAGRAPH] Comments on [give list] are not addressed in
this document. The reader is referred to the final rule published in the
Federal Register for a detailed discussion of this (these) issue(s).
Chapter 2. Executive Summary contains a synopsis of the comments
received and EPA's position on each issue in order to provide a quick overall
view of the issues.
Chapter 3. Discussion of Comments by Issue is broken into sections
corresponding to the issues given above. Each section begins with a brief
description of the EPA proposal followed by a summary of the comments
received, and then EPA's response to these comments and the final position
taken.
Chapter 2. Executive Summary of Comments
Chapter 3. Discussion of Comments by Issue
3.1. First Issue
Statement of Proposal
Summary of Comments
Discussion of Comments
EPA Position
3.2. Second Issue
Statement of Proposal
Summary of Comments
Discussion of Comments
EPA Position
etc.
Appendix 1. List of Commenters
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22 Response to Comments
summary of comments continued-
should be avoided except where it makes more sense to be specific
rather than general, as when one commenter varies greatly from all the
other comments. When a large number of commenters make a similar
comment, it is not necessary to provide all of their names.
Examples: Several manufacturers indicated..., Two environmental groups agreed
that..., Only Ford and Toyota commented that..., All state and local areas said..., etc.
If opposing comments were received, indicate who was opposed and the
support for each side.
Tell what was said, the basic thrust of the comments, summarizing the
commenter's position in 1-2 sentences. Repeating large portions of
information which is in the public docket is not necessary. Careful
analysis is required to interpret the comments correctly and to state the
main point of the comments succinctly. You will find times when it is
difficult to truly understand what the commenter means, making your
interpretation all the more important.
If evidence was presented to support a comment, summarize this
evidence. If no evidence was presented, then you might indicate no
evidence was presented to support the comment. This is especially
important on a comment where commenters disagree with EPA or with
each other and the use of evidence is needed to support a position.
The summary of comments section Is vital because of the Influence your
Interpretation may have on the rationale EPA uses to make a final
decision.
• a discussion and full analysis of the comments. This is our response to
the comments made and our analysis of them. When responding,
consider whether we have new data unavailable when the NPRM was
written. Also consider whether commenters raised points inconsistent
with prior positions they have taken. Use the following questions to help
you think about our response:
How have the comments influenced our thinking?
Do the comments simply raise issues or arguments we anticipated
and refuted in the NPRM?
Is there any new data or arguments we didn't deal with in the NRPM?
Is a change from the proposal warranted? If not, why not?
If a change is warranted, what options should we consider for
changing the final rule?
Are there any new CAA requirements which require us to change or
influence us to change from the proposal? If so what options
should we consider?
Each comment must be acknowledged and treated seriously, even if the
law prescribes the action they are commenting about. When the law very
clearly prescribes an action, all that is needed is a statement that EPA is
aware of the comments made and the argument presented, but they are
not pertinent because of the law. When the law is being interpreted as
prescribing an action, then it is best to still respond to each comment so
future changes in interpretation will not necessarily change the analysis.
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Response to Comments 23
You do not need to acknowledge each individual commenter, however,
just each position taken.
References may be made to the Regulatory Support Document or other
documents in the docket, but detailed analyses from these documents do
not need to be repeated. However, where new analysis has been done,
a full explanation is needed.
Discuss the pros and cons of the options raised. Relevant comments
may be mentioned, but keep this to a minimum, since they should be in
the summary given previous to this section. The response should show
the logic EPA used to get to its final position.
• the position taken on the issue and why. Organize this section by first
stating the position EPA is taking for the final rule, followed by the
rationale or process EPA used to reach this position. This should
essentially summarize in a few sentences the detailed explanation of the
logic and process presented in the discussion and full analysis. For
example, in the case of a prescribed action, you indicate EPA is aware of
the comments, but cannot act on them because the law precludes such
action.
The language used is often of concern. For positions in the NPRM, EPA
"believes." In the Response to Comments, EPA has "determined" or "believes."
In the Final Rule, EPA has "decided." Avoid the use of the term "recommended."
Our statements are the law unless significant reason for change exists, so do
not use language which implies possible change.
Appendixes
One appendix should exist which lists all the commenters at the hearing and
from the docket. It is also suggested that this list be coded to indicate which
issues each commented on. This can be done by simply listing after the name
the issue as numbered in the discussion section. For example, after MVMA, the
numbers 3.4, 3.5, and 3.8 might appear, indicating MVMA provided comments
on those three issues.
All tables, figures, and other information should be included in text as it is
referred to. However, if the same information is referred to frequently, it may be
more advantageous to put it into an appendix at the end of the summary.
Number each appendix in the order it is referred to in the text. This means the
list of commenters should always be Appendix 1 since it is referred to in the first
paragraph of "About This Summary" at the beginning of the document.
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24 Response to Comments
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Section 4. Notice of Final Rulemaking
The Notice of Final Rulemaking is the last published version of the regulations
before going into the Code of Federal Regulations (CFR). It includes a
preamble supplying the background and support for the regulations and the
regulatory language. For a detailed explanation of the preamble requirements,
refer to the Document Drafting Handbook).
What to include in the preamble to the Final Rule:
Headings ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part xx
Subject (content of document)
AGENCY: Environmental Protection Agency
ACTION: Final rule.
SUMMARY: Action summary which answers three
questions:
• What action is being taken?
• Why is this action necessary?
• What is the intended effect of this
action?
Should not exceed one page (about 1-2
paragraphs). Can be repeated from NPRM
as appropriate.
EFFECTIVE DATE: Unless dates other than the effective date
are given, use this heading and give the
date. Underline the notes asking Federal
Register staff to compute the date.
ADDRESSES: Optional, but frequently gives the docket
address.
FOR FURTHER Name and telephone number of contact
INFORMATION CONTACT: person (principal project officer).
SUPPLEMENTARY Provides background and basis for final
INFORMATION rule. Should not exceed 50 double-
spaced manuscript pages.
The following provides guidelines for writing your preamble. The text is
provided where the same text is always used or used with only slight
modifications. This text is available over the LNS network—MS Word version
on CD38 in Zone "Cert #2."
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26 Final Rule
Table of Contents (TOC)
• At the beginning, provide your document outline using the first and second level of
headings. In some cases you may also want to show the third level of heading also.
(Example shows only first and second levels.)
• On working drafts, you may want to supply page numbers.
• Do this section after first draft is reviewed or document organization is fairly
complete.
• May start out with just the first level of headers and add subheads as text is written
and organized.
• Having a TOC helps the reader to understand your organization and to find things in
the text.
Authority
• provides a complete statement of statutory authority
• mention all applicable sections and a statement of the authority provided
• can probably take from NPRM, plus any new actions
Requirements
• Discusses and explains EPA's final requirements as will be written into code. Include
any or all of the following:
• standards
• test procedures
• compliance procedures
• effective dates
• leadtime/phase-in
• enforcement
- other topical headings
• Explain in layperson's language.
• Answers the question "What do I do to obey this rule?"
• May have topical subheadings (but not necessary to have them).
Summary of Changes
• Provide a list of exactly what in the regulatory language has been changed from the
NPRM.
• Do not give any background or rationale for these changes, but just make reader
aware of the changes.
• Often may be giving minor changes made to accommodate procedures or new statutes
and may not be discussed anywhere.
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Final Rule 27
Example
I. Table of Contents
Authority
Requirements of Final Rule
Summary of Changes to Proposed Rule
Background and Development of Rule
Discussion of Comments and Issues
A., B., etc.
Administrative Requirements
A. Administrative Designation and RIA
B. Reporting & Recordkeeping Requirements
C Regulatory Flexibility Act
II. Authority
Authority for the actions in this notice is granted to EPA by
section XXX(x) of the Clean Air Act as amended [42 U.S.C.
III. Requirements of Final Rule
IV. Summary of Changes to Proposed Rule
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28 Final Rule
Background
• Answers the question "What lead to making this rule?* and/or "What went on before
developing this rule?" Include in this section any or all of the following:
• highlights from the background section of the NPRM (but does not repeat the
entire background section of the NPRM)
• highlights of the activities provided for public participation
• related legislative or judicial action occurring since NPRM published
• It is not necessary to include information which was in the action summary at the
beginning of the document.
• This section should just state the facts, clearly and succinctly, not provide great
detail; i.e. state your point, but don't comment on it.
• This section can have subheadings if the topics listed above require more than
several sentences each (will probably have a section for Public Participation).
Discussion
• This section should begin with a paragraph indicating a complete analysis of all
comments has been done and where it can be obtained. This section then only
describes the major issues. All significant and minor issues are dealt with only in
the Response to Comments.
• Decide which are the major issues and so must be dealt with in the preamble.
• Major issues can be identified by determining if policy hinges on these issues, if they
are so controversial we must explain our rationale, or if
the resolution of the issue affects the stringency of the standards.
• All the discussion contained in the Response to Comments on a major issue does not
need to be repeated in the preamble. Only the action to be taken, an abbreviated
summary of comments, and a summary of the discussion and analysis are needed.
(Answer the questions: What's the final outcome? What was the comment made? and
Why did or didn't we change our position?) These can be lifted from the Response to
Comments when it is completed.
• None of the discussion on significant and minor issues needs to be in the preamble. A
statement indicating what other issues were raised and what decisions were made is
sufficient for significant issues. Minor issues do not need to be mentioned.
• Organize by the issues raised in the comments, not by the commenter.
Administrative Requirements
• Use as written, with addition of appropriate names, dates, and addresses.
Part A.
• Two first paragraphs are provided. Choose the one appropriate for the rule being
proposed. Second paragraph same in both versions.
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Final Rule 29
V. Background and Development of Rule
VI. Discussion of Comments and Issues
A full discussion of all comments received is available in the
Response to Comments on the NPRM. A copy may be
obtained by contacting . A summary of the
discussion on several issues of major importance is provided
here.
A. Topical Subheadings (make these descriptive, not just "Issue
No. 1" but "Regulatory Approach," "Technical Feasiblity,"
"Enforcement," etc.)
VII. Administrative Requirements
A. Administrative Designation
Under Executive Order 12291, EPA must judge whether a
regulation is a "major" rule and, therefore, subject to the
requirement that a Regulatory Impact Analysis (RIA) be
prepared. Since EPA has determined that this regulation is not
major, an RIA has not been prepared.
This regulation was submitted to the Office of Management
and Budget (OMB) for review as required by Executive Order
12291. Any written comments from OMB and any EPA response
to those comments are in the public docket for this rulemaking.
OR
Under Executive Order 12291, EPA has determined that this
regulation is major. A Regulatory Impact Analysis (RIA) has been
prepared and is available from the address provided under "FOR
MORE INFORMATION CONTACT."
This regulation was submitted to the Office of Management
and Budget (OMB) for review as required by Executive Order
12291. Any written comments from OMB and any EPA response
to those comments are in the public docket for this rulemaking.
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30 Final Rule
Administrative Requirements
Continuation
Part B. Always included.
Part C. If a significant impact was found, then indicate this here and summarize info
from the NPRM.
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Final Rule 31
B. Reporting & Recordkeemne Requirement
All of the information collection requirements contained in
this proposed rule have been approved by the Office of
Management and Budget (OMB) under the Paperwork Reduction
Act of 1980, 44 U.S.C. 3501 et seq.. and have been assigned OMB
Control Number XXXX-XXXX.
C. Reeulatorv Flexibility Act
The Regulatory Flexibility Act of 1980 requires federal
agencies to identify potentially adverse impacts of federal
regulations upon small entities. In instances where significant
impacts are possible on a substantial number of these entities,
agencies are required to perform a Regulatory Flexibility Analysis
(RFA).
EPA has determined that the regulations proposed today
will not have a significant impact on a substantial number of
small entities. This regulation will affect only [insert appropriate
businesses], a group which contains few small entities. [May
insert additional reasons why small entities not affected.]
Therefore, as required under section 60S of the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq.. I certify that this regulation
does not have a significant impact on a substantial number of
small entities.
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