United States Regulation and Information June 1984
Environmental Protection Management Division
Agency Office of Standards & Regs.
Washington.DC 20460
Regulation
Management Series
A Decision System For
Regulatory Development
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A DECISION SYSTEM FOR REGULATORY DEVELOPMENT
INTRODUCTION
Over the last several months, we have adopted a number of
innovations in our internal procedures for developing and review-
ing regulations and other policy documents. We adopted these
changes with several objectives in mind—to improve the oppor-
tunity for top management to direct Agency policy, promote more
systematic assessment of policy options, establish standards
for decision documents and support analyses, and use the Agency's
management and analytic resources more efficiently.
I have approved three principal documents that establish
these changes: '
1. The Options Selection/Rejection Process. This decision
procedure gives the Administrator, the Deputy Administrator,
Assistant Administrators, and Regional Administrators the oppor-
tunity to participate in a rulemaking before the rule's decision
package undergoes' Steering Committee Review. Under this process,
these senior Agency officials meet to consider an array of options
for the rulemaking--presented by the lead program office—early
in the development of' the' rule. These options meetings are"
chaired either by jthe Deputy' Administrator or the lead office.'s
Assistant Administrator (depending on the scope and complexity
of the rulemaking). At these meetings, the participants discuss
the options that:'are presented, and attempt to reach a consensus
of the best approach '£6''take. f Issues not resolved at the first
meeting are addressed at subsequent options meetings.
2. The Criteria and Guidelines Memorandum. This document
sets forth general criteria that all Agency rules and other policy-
setting actions must satisfy before they can be approved by the
Administrator. The Document also sets out specific substantive
guidelines for developing and reviewing a rulemaking action--
explicitly relating each guideline to a given stage'in the regu-
latory development process. Taken as a whole, the document sets
the Agency's standards for acceptable policy products.
3. The Memorandum on Procedures for Regulation Development
and Review. This document provides a comprehensive statement
of the required procedures for developing a rule, taking into
account the innovations introduced by the Options Selection/
Rejection Process and the Criteria and Guidelines memorandum.
The document also spells out the internal review processes
(Steering Committee' and Red Border reviews), and adapts them
to recent Agency organizational changes.
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Taken together, these three documents give the Agency a
comprehensive system for making decisions on regulatory poli-
cies. I urge you to become familiar with them and rely on them
in planning and carrying out your rulemaking responsibilities.
Alvin L. Aim
Deputy Administrator
JUNE 7, 1984
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
NOV 41983
OFFICE OF
THE ADMINISTRATOR
MEMORANDUM
TO: Assistant Administrators
General Counsel
FROM: Alvin L. Aim
Deputy Administrator
SUBJECT: Options Selection/Rejection Process
Attached is a description of the regulatory options
selection/rejection process which was approved at our meeting
on November 1.
As we agreed, incorporated into the description of the
Level II process are statements designed to clarify the
circumstances under which Steering Committee options meetings
would be convened.
cc: Regional Administrators
S. Schulhof
Attachment
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PROCESS FOR LEVEL I REGULATIONS
Deputy Administrator selects the rules from nominations
by the lead office AA, OPPE, OGC and other interested
parties
Purpose of the quarterly planning meetings (chaired
by DA) is to:
—Give status overview of Level I rules
—Provide advance notice of rules that will be
ripe for an options review during the quarter*
—Decide which AAs and RAs in addition to the lead
office, OPPE, OGC and ORD should participate in
options review meetings and whether DA chooses
to chair the meeting or designate the lead AA
as chairman.
Options review meetings for each regulation will occur
whenever a decision point is reached and will be sche-
duled through the quarterly planning meetings or
independently if necessary. They will be called by
the chairman on the advice of the lead office or other
affected parties. The initial meeting will be held
very early in the development process—typically as
part of the process of approving a development plan—
to serve as a guide in the basic research and analysis.
—Lead AA circulates options paper to all participants
10 days before meeting
—Lead AA briefs, with reactions from other participants
—If resolution is not reached on which options
should be retained for further analysis and which
might be rejected, each AA presents recommendations
in writing during week following options meeting
—OPPE serves as secretariat to DA, documents results
of meeting and options rejected or selected, and
issues closure memo (which will be a vehicle for
raising disagreements to the DA for resolution
when necessary).
Would cover about 20-30 rules each year
* Perhaps a specific day each month would be set aside so that
the options reviews could be slipped easily into AA's schedules.
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PROCESS FOR LEVEL II REGULATIONS
Level II covers all other rules under development, including
a large number of routine, non-controversial rules for which a
formal options selection process would not be appropriate. The
options selection review for Level II rules would normally apply
only to rules that are of sufficient importance to undergo a
Steering Committee review. Approximately 40-50 Level II rules
a year would be subject to options selection review.
o Options selection will be under the direction of the
lead program Assistant Administrator with participa-
tion of other affected program offices, Office of
Research and Development, Office of the General Counsel,
and Office of Policy, Planning and Evaluation. This
process will typically be performed through the work
group, and initial selections will be incorporated in
the development plan. Subsequent options selection
meetings, as required to further refine and limit
options for development, will also be the responsi-
bility of the lead program Assistant Administrator.
o OPPE lead analysts will be responsible for periodic
reports to the Steering Committee Chairman. These
reports will outline work group progress, including
options under consideration and those rejected.
o Each participating office will be responsible for
raising to the Steering Committee Chairman—through
its Steering Committee representative—those options
with merit which, in" its judgment, are not being
investigated, or which have been rejected wrongly
or prematurely. Before raising the issue to the
Steering Committee Chairman, reasonable attempts
should be made to resolve concerns by working with
the lead program Assistant Administrator.
o If these attempts to resolve the issue prove unsuc-
cessful, Steering Committee options meetings would
be convened at the request of Steering Committee
representatives or by decision of the Steering
Committee Chairman. The AA's representative must
be able to speak for and bind the AA when such
meetings have been called.
o In such cases, the Steering Committee determines
options for consideration; when the Steering
Committee is unable to achieve closure, it iden-
tifies disagreements to be raised to the affected
AAs and DA.
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o OSR documents results of such meetings and options
selected or rejected.
o OD/OSR signs and circulates closure memo to participants
and AA/OPPE.
o Lead office will include as part of the Steering Committee
and Red Border packages a summary of options considered
and rejected, as well as why and when each was rejected.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JAN 3 1 1984
OFFICE OF
MEMORANDUM THE ADM.NISTRATOR
SUBJECT: Criteria and Guidelines for Review of Agency Actions
FROM: Alvin L. Aim
Deputy Administrator
TO: Assistant Administrators
General Counsel
Inspector General
Associate Administrators
Regional Administrators
Agency Office Directors
To assure that Agency regulations and other policy-setting
actions are of high quality, present defensible options, and
meet the Administrator's policy goals, I have established general
criteria that regulations and other general statements of policy
must meet to be deemed acceptable for the Administrator's consid-
eration. I expect you to do your best to ensure that each of
your decision packages satisfies these criteria. For each rule-
making, I will solicit the independent advice of OPPE on whether
these criteria — and the associated guidelines — have been appropri-
ately taken into account. However, I will hold the program offices
accountable for consistency wit-h these criteria, as well as for
timeliness and policy.
This memorandum will set out:
o in section I, general criteria that regulatory actions
must satisfy to be considered acceptable; and
o in section II, guidelines for developing Agency
regulatory actions.
The guidelines in section II are divided into units corresponding
to the main stages in developing an Agency action. The intention
is to bring into focus those considerations that should be para-
mount for you at each stage in the regulatory development process.
I should add at the outset, that I am well aware of the enormous
differences among rulemakings, and even, for a given rule, between
its proposal and the final promulgation. In offering the criteria
and guidelines that follow, therefore, it is with the understanding
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that not all will be equally relevant or appropriate to any given
individual case. For example, in the case of minor rules, emergency
actions, or purely administrative rulemakings, many of the criteria
will apply very loosely or not at all.
I. POLICY CRITERIA FOR ACCEPTABLE AGENCY ACTIONS
The Agency's primary goal is to develop standards and regulations
that protect human health and the environment. Ultimately, the most
important criterion for evaluating any of our actions is the extent
to which they achieve this goal.
Given this responsibility, and within the limits of time,
resources, and statutory authority, any Agency standard, regulation,
or other policy-setting action should achieve high levels of environ-
mental protection and the best possible combination of the following
criteria:
A. Compared with the feasible alternative options, the
action produces the greatest net benefit to society.
B. As a means of achieving efficient outcomes, compared
with all the alternative options, the action allows
maximum flexibility in compliance with standards or
rules—for instance, where possible, specifying perfor-
mance or end-results rather than means.
C. To the extent possible, the action encourages environ-
mentally acceptable innovation in the regulated community—
for example, by encouraging the development and use of
better or more efficient control technology, or providing
incentives for the development of safer products.
D. The action is consistent with other regulatory programs—
EPA's, the States' and those of other Federal agencies—
and complements them where possible, especially when
they affect the same regulated community.
E. Consistent with meeting the other criteria, the action
places the least possible burden on the public and
: regulated parties with respect to reporting, record-
keeping, and information collection requirements.
F. The action avoids disrupting competitive markets, or
is the least disruptive of the alternative options
with similar levels of net benefits.
G. The action can be smoothly implemented and adequately
enforced by those responsible for doing so, within
likely budget/resource constraints.
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Often no one action consistent with our primary goal of
protecting the public dominates all others with respect to these
criteria. In that case, unless an explicit choice has been made
by the Administrator at a previous stage, alternatives must be
presented for his consideration accompanied by the recommendations
of all the offices that have participated in developing the action.
II. GUIDELINES FOR INTERNAL DEVELOPMENT AND REVIEW OF DECISION
PACKAGES
The process of developing a regulatory action can be divided--
in terms of work products—into four stages:
o submission of start action request (SAR),
o preparation of the development plan,
o development of options in conjunction with
the options selection process, and
o drafting of the regulatory decision package.
The guidelines for each of these stages are the following:
A. The Start Action Request (SAR)
Before you submit a SAR, you should determine that, to the
best of your knowledge:
1. The action responds to a clearly defined problem that
requires regulatory action.
2. The action will be consistent with, and adequate to,
the statutory mandate.
3. The action is not likely to duplicate or conflict with
other regulatory programs, either at EPA or at other
Federal agencies, without adequate justification.
4. The action will coordinate its approach with that of
other relevant Federal and State programs that affect
the same prospective regulated community.
5. This is the appropriate time to develop the action, and
the effort will make the best use of our resources in
view of competing priorities.
B. The Development Plan
The development plan (where required) sets forth the basic
policy and management framework for developing the regulation.
You should ensure that:
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1. The plan states the need for the regulation and
identifies its goals and objectives.
2. The plan discusses the prima facie reasonable, legal,
and technically feasible options, including;
- no action;
- alternatives to Federal regulation, including
market, judicial, or State or local regulatory
mechanisms;
- alternatives within the scope of the action's
legislative provision, including degree of
control, effective compliance dates, and
methods of ensuring compliance.
3. The plan identifies any alternatives that may be
environmentally or administratively preferable, or
more cost-effective, but that currently cannot be
considered because they are precluded under existing
law.
4. The plan specifies any generic decision rules drawn
from current or historical Agency policy that will
be used to choose among the options. (For example,
certain generic forms of regulations are compared
on the basis of the cost of pounds of pollutants
reduced.)
5. The plan presents a work plan for developing the
regulation that outlines, as appropriate;
- the areas that projected analyses will cover,
including, as applicable: health and environ-
mental risks, benefits, economic impacts,
effects on small entities, paperwork and record-
keeping burdens, potential for fraud, waste, or
mismanagement;
- the major areas of technical uncertainty, and how
we plan to resolve them;
- the major tasks that will be performed—from the
first work group meeting to the final promulgation
of the regulation—and milestones for each task;
- the Agency offices—including EPA Regional Offices-
that will participate in developing the rule, and
the choice of the work group chairperson;
- other agencies, States, and others that will be
involved in developing the regulation, and the
nature of their involvement;
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the mechanisms for communicating with participants
external to the Agency, other affected parties,
and the general public during the regulatory
development process; and
- the Agency personnel and contract resources that
will be necessary to develop the regulation.
C. The Options Selection Process
The options selection process involves the formulation of,
and selection among, feasible options, connected with one or a
series of decision points that successively narrows the range of
alternatives for the Administrator's final consideration. At each
of the decision points the process is supported by the analyses
anticipated in the development plan, performed with respect to the
options that still remain under active consideration. For each of
these options, you should ensure that to the extent possible:
1. The analyses are based on the best data available
within the constraints of the decision schedules,
taking into consideration;
uncertainties in the data;
other technically sound scientific studies
based on adequate peer review;
- anticipated requirements for further research; and
- adequate and appropriate statistical data.
2. The analyses consider all relevant health and environ-
mental impacts, including primary and secondary impacts,
cumulative impacts, .and short and long term impacts.
Especially for major rules, the analyses should consider
these impacts not only in qualitative terms, but—where
possible—in quantitative and monetized terms as well.
3. The analyses consider the relevant economic impacts,
such as;
the effect on product prices, and overall economic
output;
the impact on foreign trade and competition;
- potentially disproportionate effects on small
businesses; and
- potential effects on plant closures or employment.
4. The analyses take account of the reporting and record-
keeping burdens that the option entails.
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The analyses consider the following issues related to
implementation;
- the resources required for implementation and enforcement;
- the enforceability of the option;
- the degree to which the option allows for flexibility
in achieving compliance; and
- the potential inherent in the option for fraud, waste,
or mismanagement in practice.
The analyses assess impacts on other regulatory programs—
both within and beyond the Agency—and overall consistency
with Agency policy and regulatory strategy.
D. The Decision Package
The decision package provides the Agency's brief for the
option(s) it presents, based on the supporting analyses. You
should ensure that the package clearly presents the results of
these analyses. Specifically, you should ensure that to the
extent appropriate:
1. The package includes a neutral discussion of the
major options that were considered at the most
recent decision point in the options selection
process,including;
- the comments of any Assistant Administrators
who were involved in the decision, reflecting
their preference among the options;
- the pros and cons of each of these options.
2. The package very briefly summarizes the major
options considered and rejected at earlier decision
points, indicating (again, very briefly) the point
at which each option was rejected and why.
3. The package very briefly summarizes any legally
proscribed alternatives that were identified as
environmentally or administratively preferable, or
more cost-effective—explaining in each case the
legal restrictions that operate.
4. The package clearly presents;
- as appropriate, the comparable costs, risks and
benefits of the options considered based on com-
parable assumptions; and
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a comparison of the action's cost-effectiveness
with that of any similar regulatory actions.
5. The package adequately analyzes reporting and
recordkeeping burdens, including:
- the uses of the required information; and
effective means to control the quality of
the information and data processing.
6. The package assesses resources for implementing
the ruler including;
- plans for enforcement, implementation, and
fpllpw-up actions; and
resource needs, particularly for regional
requirements.
You should also ensure that the package satisfies the
applicable procedural requirements, specifically that:
1. The package has met the requirements of E.O. 12291,
the Paperwork Reduction Act, the Regulatory Flexibility
Act, and EPA's "functional equivalency" requirements
for compliance with the National Environmental Policy
Act, including;
analytical requirements;
public participation requirements;
OMB review requirements; and
preamble requirements for appropriate statements
and certifications.
2. The package has met Federal Register requirementsi
including vocabulary and format constraints.
3. The package complies with Agency procedures for
Steering Committee and Red Border review, and
incorporates a "communication plan" for the
the proposed action.
Finally, you should ensure that:
1. The presentation of the action is adequate, both
in internal documents and in the published rule
and preamble, and includes;
a clear statement of the problem;
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- clear conclusions flowing logically from the
basic information;
- a clear, consistent, and logical rationale for
the proposed or final Agency position;
- clear justification for any departures from the
environmentally preferable option; and
- presentation of any risk analysis information in
a clear and consistent format.
The action includes a mechanism for decision follow
through, including plans for;
- evaluating the effectiveness of the regulation;
- correcting data gaps identified during the rule
development process;
- analyzing statutory restrictions against alternatives
that may be environmentally or administratively
preferable, or more cost-effective, for possible
corrective action; and
- preventing fraud, waste, or mismanagement in
implementing the action.
The criteria and guidelines set forth in this memorandum are
necessary to establish adequate policy oversight and quality control
over the Agency's policy-setting actions. I expect you to treat
them as standards for acceptable regulatory development in your
offices. They will be the measure I will use — with the advice of
OPPE — to assess your recommendations. Of course, I expect that we
will all treat these criteria and guidelines intelligently — recog-
nizing both that not all will apply, or apply equally, in every
case, and that sometimes the press of deadlines or the limitations
on resources will dictate flexibility.
I should add that while some of the guidelines as set out in
this memorandum are rather general, more specific guidance exists
in a number of instances. Attached to this memorandum is a list
of review guidelines, along with references to relevant guidance
documents. The list includes both currently available and forth-
coming documents, as well as their estimated completion dates. I
welcome suggestions of additional areas where more detailed regula-
tory development guidance is needed.
Attachment
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GIJIDANCK FOR DEVELOPMENT AND REVIEW OF REGULATORY ACTIONS
Tlie chart below lists the questions to be addressed during the four-stage process of developing a regulatory
action, together with sources of official guidance on how to consider such issues.
A. The Start Action Request (SAR)
A Start Action Request represents the
judgment of the lead program office that a prob-
lem requires some action by the Agency.
Currently Available Guidance
Forthcoming Guidance
o Does the SAR clearly define the problem?
o Does it justify a regulatory approach to the
problem, as opposed to other approaches?
o Does the proposed action fulfill the statu-
tory mandate?
o Will the action conflict with or duplicate
other regulatory programs, particularly those
covering the same prospective regulated com-
mun ity?
o Will the proposed action make the best use
of the Agency's resources, in view of com-
peting priorities? Is this the best time to
develop the action?
Procedures for Regulation Develop-
ment and Review (Office of Stan-
dards and Regulations, OPPE, 4/82)
UNDER REVISION
Checklist of Regulatory Alternatives
(Office of Planning and Management,
7/80)
Managing the Process (Office of
Standards and Regulations,OPPE,8/82)
EPA Chemical Activities Status Re-
port (Chemical Coordination Staff,
OPTS, 6782 and CIS)
Overview of the Industry File Index
System (Chemical Coordination
Staff, OPTS, 6/83)
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R. The Development Plan
Currently Available Guidance
Forthcoming Guidance
The development plan sets forth the basic
policy and management framework for developing
the regulation by presenting a preliminary set
of options and their projected analytical needs.
o noes the plan state the need for the regula-
tion?
o Does it present all reasonable and technical-
ly feasible options, including:
o alternatives to Federal regulation, in-
ding market, judicial, or State or local
regulatory mechanisms; and
o alternatives within the scope of the ac-
tion's legislative provision, including
degree of control, effective compliance
dates, and methods of ensuring compli-
ance?
o Does the plan identify any generic Agency de-
cision rules that will dictate a choice among
the options?
o noes the plan outline projected analytical
requirements, including (as applicable):
o health and environmental risks;
o benefits;
o economic impacts;
o effects on small entities; and
o paperwork and recordkeeping burdens.
o Does the plan identify major technical un-
certainties and their possible resolution?
o Does the plan identify major tasks and pro-
vide milestones for them?
Checklist of Regulatory Alternatives
(op. cit.)
Managing the Process (op.cit.)
Procedures for Regulation Develop-
ment and Review (op. cit.)
Procedural Requirements of Executive
Order 12291(President Reagan,2/81)
Regulatory Options Selection/Rejec-
tion Process (Memo from Alvin Aim,
11/83)
Compliance with the Regulatory
Flexibility Act (Memo from Ron
Smith to Steering Committee Repre-
sentatives, 4/83)
Guidelines for Performing Regula-
tory Impact Analyses (Office of
Policy Analysis, OPPE, 11/83)
Chemical Substances Designation
(Chemical Coordination Staff,
OPTS, 12/81)
Checklist for Regional Review (Of-
fice of Standards and Regulations,
OPPE
Feasibility Study Guidance
Document (Office of Policy
and Program Management,OSWER,
1/84)
Planning and Budgeting Manual
(Office of the Comptroller,
ARM, 3/84)
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Development Plan (Continued)
Currently Available Guidance
Forthcoming Guidance
Does the plan identify participating Agency
offices and a work group chairperson?
Does the plan identify how and why other Fed-
eral and non-Federal institutions will be in-
volved?
Does the plan anticipate needed personnel
and contract resources?
Does the plan present a mechanism for commu-
nicating with participants external to the
Agency, other affected parties, and the gen-
eral public during the development of the
regulation?
Background Information for Develop-
ment of Communication Strategies
(Memo from Josephine Cooper, 8/83)
Federal Activities in Toxic Sub-
stances (Chemical Coordination
Staff, OPTS, 5/80) UNDER REVISION
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C. Options Selection Process
Currently Available Guidance
Forthcoming Guidance
The goal of the options selection process is
to present the Administrator with decision pack-
ages which clearly present and analyze realistic
alternatives. The analytical support for these
alternatives, which was anticipated in the de-
velopment plan, is further developed during the
options selection process.
Are the analyses based on the best data a-
vailable within the constraints of decision
schedules, taking into consideration:
o uncertainties in the data;
o other technically sound scientific stud-
ies based on adequate peer review;
o anticipated requirements for further re-
search; and
o adequate and appropriate statistical
data?
Do the analyses consider all relevant health
and environmental impacts, not only in quali-
tative terms, but — where possible — in
quantitative and monetized terms as well?
Do the analyses consider all relevant econom-
ic impacts, including:
o the effect on product prices, output
(i.e.,demand and response);
O the impact on foreign trade (e.g., GATT);
o potentially disproportionate effects on
small businesses; and
o potential effects on plant closures or
employment
Do the analyses take account of the reporting
and recordkeeping burdens entailed by each
of the options under consideration?
Survey Management Handbook; Guide-
lines for Planning and Managing a
Statistical Survey (Office of Stan-
dards and Regulations, Vol.I,11/83)
EPA Chemical Activities Status Re-
port (op.cit.)
Interim procedures and Guidelines
for Health Risk and Economic Im-
pact Assessments of Suspected Car-
cinogens (Office of Health and En-
vironmental Assessment,ORD,5/76:
Appendix I: Interim Guideline for
Carcinogen Risk As-
sessment
Appendix II: lnterim~Guideline for
Economic Impact Ana-
lysis of Proposed Reg-
ulatory Actions to
Control Carcinogenic
Pesticides
Method for Determining the Unit Risk
Estimate for Air Pollutants DRAFT
(Office of Health and Environmental
Assessment, ORD, fi/80)
Water Quality Criteria Documents
(Criteria and Standards Division,
OW, 11/80):
Appendix A: Summary of Water Qual-
ity Criteria
Survey Management Handbook;
Guidelines for Planning and
Managing a Statistical Sur-
vey (Office of Standards and
Regulations, Vol.II, 1/84)
Quality Assurance Manual (Of-
fice of Monitoring and Qual-
ity Assurance, ORD, Chapter I,
10/84)
Procurement and Grants Data
Base (EPA Information Clear-
inghouse, ARM, 4/84)
Report of the Administrator's
Task Force on Toxics Integra-
tion;
Guidelines for Risk Assess-
ment
Guidelines for Risk Manage-
ment
Uniform Reporting Format for
Risk Management Information
Risk Assessment for RCRA Reg-
ulations (Office of Policy
Analysis, OPPE, 12/83)
Risk Evaluation and Management
Procedure Manual (office of
Policy and Program Management,
OSWER, 7/84)
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C. The Options Selection Process (Continued)
o Do the analyses consider all relevant econom-
ic impacts, including:
o the effect on product prices, output
(i.e., demand and response);
o the impact on foreign trade (e.g., GATT);
o potentially disproportionate effects on
small businesses; and
o potential effects on plant closures or
employment?
o Do the analyses take account of the reporting
and recordkeeping burdens entailed by each
of the options under consideration?
o Do the analyses assess the resources required
for implementation and enforcement, and the
degree to which the options allow for flexi-
bility in achieving compliance?
o Do the analyses assess impacts on other regu-
latory programs — both within and beyond •
the Agency — and overall consistency with
Agency policy and regulatory strategy?
Currently Available Guidance
Appendix B:
Appendix C:
Guidelines for Deriving
Water Quality Criteria
for the protection of
Aquatic Life and Its
Uses
Guidelines and Methodo-
logy Used in the Prepa-
ration of Health Effect
Assessment Chapters of
the Consent Decree Wa-
ter Criteria Documents
Proposed Guidelines for Mutagenicity
Risk Assessments (Office of Health
and Environmental Assessment, ORD,
10/80)
Assessment of Risks to Human Repro-
duction and to the Development of
the Human Conceptus from Exposure
to Environmental Substances (Office
of Health and Environmental Assess-
ment, ORD, 10/80)
Guidance for the Preparation of Ex-
posure Assessments DRAFT (Office of
Health and Environmental Assess-
ment, ORD, 9/83)
Water Quality Criteria
for the Protection of
Aquatic Life and Its~
Uses
Guidelines and Method-
Appendix C;
ology Used in the Pre-
paration of Health Ef-
fect Assessment Chap-
ters of the Consent De-
cree Water Criteria
Documents
Guidelines for Performing Regulatory
Impact Analyses (op.cit.)
Forthcoming Guidance
Risk Evaluation and Manage-
ment Procedure Manual (Of-
fice of Policy and Program
Management, OSWER, 7/84)
Draft Policy on Small Business,
(OPPE, 2/84)
Agency Guidelines for Imple-
menting the Paperwork Reduc-
tion Act Requirements (Office
of Standards and Regulations,
OPPE, /84)
Guidelines for Evaluation
Planning (Office of Standards
and Regulations, OPPE, /84)
Guidance on Meeting the Func-
tional Equivalency Require-
ments of the National Environ-
mental Policy Act (NEPA~j
(Office of Federal Activities,
OEA, 2/84)
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D. The Decision Package
Currently Available Guidance
Forthcoming Guidance
The decision package is the Agency brief for
the options it presents, and is based on the
suppporting documents. To be effective, the
package must clearly present the results of
these analyses.
o Does the package neutrally present the most
recently considered major options from the
selection process, including:
o the pros and cons of each of these op-
tions; and
o the comments of the AAs who were involved
in the decision, along with their prefer-
ence among the options?
o Does the package briefly summarize when and
why major options were rejected earlier in
the process?
o Does the package clearly present:
o the costs, risks, and benefits of the'op-
tions considered;
o comparable costs and benefits based on
comparaole assumptions (e.g., comparable
baselines, or interest and inflation
rates); and
o a comparison of the options' cost-effec-
tiveness with that of any similar regula-
tory actions?
o Does the package adequately analyze reporting
and recordkeeping burdens, including:
o the uses of required information; and
o effective means to control the quality
of the information and data processing?
o Does the package assess resources required
for implementing and enforcing the rule,
i nclucl iny :
o plans for enforcement, implementation,
and follow-up actions; and
o resource needs, particularly regional
requ i rements?
Procedures for Regulation and De-
velopment and Review (op.cit.)
Regulatory Options Selection/Rejec-
tion Process (op.cit.)
Guidelines for Performing Regulatory
Impact Analyses (op.cit.)
Survey Management Handbook, Vol.1.
(op.cit.)
Appendices to the Guidelines
for Performing Regulatory Im-
pact Analyses;
A. Analysis of Benefits
B. Analysis of Costs
C. Analysis of the Discount
Rate
D. Analysis of Economic Im-
pacts
(Office of Policy Analysis,
OPPE, 1/84)
Agency Guidelines for Imple-
menting Paperwork Reduction
Act Requirements (op.cit.)
Survey Management Handbook,
Vol.11 (op.cit.)
Quality Assurance Manual
(op.c i t.)
Guidelines for Evaluation
Planning (op.cit.)
-------
0. Decision Package (Continued)
Currently Available Guidance
Forthcoming Guidance
Has the package met the requirements of Exe-
cutive Order 12291, the Paperwork Reduction
Act, the Regulatory Flexibility Act, and
EPA's "functional equivalency" requirements
for compliance with the National Environmen-
tal policy Act (NEPA), including:
o analytical requirements;
o public participation requirements;
o OMB review requirements; and
o preamble requirements for appropriate
statements and certifications?
Has the package met Federal Register require-
ments, including vocabulary and format con-
straints?
Does the package comply with Agency procedure
for Steering Committee and Red Border review?
Does it incorporate a "communication plan"
for the action?
Is the action presented adequately, both in
internal documents and in the published rule
and preamble? Does it include:
o a clear statement of the problem;
o clear conclusions flowing logically from
the basic information;
o a clear, consistent, and logical ration-
ale for the Agency action;
o clear justification for any departures
from the environmentally preferable
option; and
o a clear and consistent presentation of
any risk analysis information?
Procedural Requirements of Execu-
tive Order 12291 (op.cit.)
Regulatory Options Selection/Rejec-
tion Process (op.cit.)
Compliance with the Regulatory
Flexibility Act (op.cit.)
Guidance on Information Clearance
Requirements (Memo from Ron Smith,
5/83)
Procedures for Regulation Develop-
ment and Review (op.cit.)
Document Development Handbook (Of-
fice of the Federal Register)
Federal Register Thesaurus Guidance
(Office of Standards and Regula-
tions, OPPE, 11/81).
Background Information for Develop-
ment of Communications Strategy
(op.cit.)
Guidance on Meeting the Func-
tional Equivalency Require-
ments of the National Environ-
mental Policy Act (NEPA)
(op.cit.)
-------
n. Decision Package (Continued)
Currently Available Guidance
Forthcoming Guidance
Does the action include a mechanism for de-
cision follow-through, including plans for:
o evaluating the effectiveness of the
action;
o correcting data gaps identified during
the rule development process;
o identifying statutory restrictions
against various actions and analyzing
these restrictions for possible correc-
tive action?
Guidelines for Evaluation
Planning (op.cit.)
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
• WASHINGTON, D.C. 20460
FEB 2 1 1984
MEMORANDUM
OFFICE OF
THE ADMINISTRATOR
SUBJECT: Procedures for Regulation Development and Review
FROM: Alvin L. Aim
Deputy Administrator
TO: Assistant Administrators
General Counsel
Inspector General
Associate Administrators
Regional Administrators
Staff Office Directors
This memorandum revises a number of the Agency's current
rulemaking procedures set out in the April 30, 1982 memorandum
on this same subject. The purposes are:
o to incorporate the options selection/rejection process
announced in my memorandum of November 4, 1983;
o to provide the mechanisms for ensuring that Agency
rulemaking conforms to the criteria and guidelines
set out in my memorandum of January 30, 1984.
o to make the rulemaking process as consistent, predic-
table, efficient, and accountable as it can be given
its inherent complexity.
This memorandum — taken together with those setting out the options
selection/rejection process, and the criteria and guidelines--
replaces the April 30, 1982 memorandum referenced above.
In presenting the revised procedures, this memorandum will:
1. Set out the classification scheme that will apply to
regulatory actions;
2. Describe the primary participants in regulatory
development and review;
3. Outline the procedures themselves; and
4. Explain the mechanisms for making the process accountable,
including the Action Tracking System (ATS) .
-------
-2-
The memorandum will devote a section to each of these, and then
append: (i) a matrix relating the classification scheme to elements
of the procedures, (ii) a matrix diagram summarizing the structure
of formal reviews associated with regulatory development, and
(iii) a table listing the specific changes that this memorandum
makes in current Agency practice.
I. Classification of Agency Regulations
The Agency must establish priorities among its regulations
that allow us to allocate our program, analytical, and management
resources efficiently. Regulations that have major program im-
plications, that involve especially significant effects on the
environment or the economy, or that are the subject of contro-
versy or widespread public concern deserve a proportionately
greater share of the Agency's time and resources. I therefore
want to continue the three-level classification scheme of major,
significant, and minor rules.
Major rules are those meeting the definition of "major" in
section one of Executive Order. 12291. A rule is significant if
it is not major but nonetheless will have important effects on
the environment, public health, or the economy, will present
intermedia issues, or will affect th£ administration or operation
of several Agency offices. Minor rules are those that are neither
major nor significant. They include the more specialized and
routine rules that affect only one program or sector of the
economy, or that simply implement established Agency policy.
This classification bears on major elements of the procedures
outlined in this memorandum, including the process for options
reviews. All major or significant regulations will be covered by
either the Level I or the Level II options review process, while
minor rules will be subject to neither. Attachment (i) summarizes
the relation between the classification scheme and elements of the
procedures.
II. Participants and Role
This section describes the Agency participants who play
important roles in preparing or reviewing the regulation packages
that reach me and the Administrator for our decision.
A. Lead Office
The lead office for a regulation initiates, and has
program responsibility for, the rulemaking. The four environ-
mental program offices—OAR, OPTS, OSWER, and OW—have lead
responsibility for nearly all of the regulations covered by
these procedures.
-------
-3-
The Assistant Administrator (AA) of the lead office and
his/her designee (the project officer) manage the development
of the regulation. The lead office organizes the Agency-wide
work group and notifies the designated representatives, and
the project officer chairs the work group sessions. The lead
office is the primary source of technical expertise, drawing
on other offices to complement its analytical resources. In
addition, the lead office sets the schedule for the rulemaking
and elicits the participation of other Agency offices and the
public.
B. Assistant Administrators and the General Counsel
1. Program Assistant Administrators
In addition to heading the lead offices for regulatory
development, the program AAs review other regulations to
offer their views and expertise, and to assure the neces-
sary integration of our programs. They are represented
in all Steering Committee reviews. In addition, they
participate in options selection reviews, and in Red
Border reviews that are of interest to them.
2. Assistant Administrator for Policy, Planning
and Evaluation
The Assistant Administrator for the Office of Policy,
Planning and Evaluation (AA/OPPE) manages the process
outlined in this memorandum, supported by his staff in
the Office of Standards and Regulations (OSR). As part
of this, he oversees the Agency's compliance with such
external requirements as Executive Order 12291, the Paper-
work Reduction Act, and the Regulatory Flexibility Act.
In addition, the AA/OPPE heads the policy review
of Agency regulations, both directing the Steering Commit-
tee process, and participating in each Red Border review.
Supported by a lead OPPE analyst assigned to each regu-
lation and work group, the AA/OPPE focuses especially
on analytical quality, program integration, cost-
effectiveness, and scientific and statistical validity.
I also rely on the AA/OPPE to promote thorough consider-
ation of options and to provide an independent assessment
of proposed rules for me and the Administrator.
3. General Counsel
The Office of General Counsel (OGC) reviews regulatory
packages to advise the Administrator, Deputy, and Assistant
Administrators on the legal aspects of each rulemaking.
OGC lawyers help draft the regulations and their preambles,
working closely with the lead offices. The General Counsel
is represented in Steering Committee reviews, and partici-
pates in all Red Border reviews.
-------
-4-
4. Other Assistant Administrators and the Regional
Administrators
The Assistant Administrators for Enforcement and
Compliance Monitoring, Research and Development, Exter-
nal Affairs, and Administration and Resources Management
have lead office responsibility for a select number of
rulemakings generated by their offices. In addition,
these AAs, and the Regional Administrators (RAs), are
represented in all Steering Committee reviews and parti-
cipate in Red Border reviews of packages that are of
specific interest to them.
C. Work Group
The lead office first convenes the work group shortly
after the SAR is approved, to draft the development plan.
The AA for OPPE and the General Counsel always send a
representative. Almost all work groups also include repre-
sentatives of at least one RA and of the AAs for Research
and Development, Enforcement and Compliance Monitoring, and
External Affairs. Other offices participate when there are
issues involved that concern them.
The work group continues to meet throughout the
regulatory development process, until the final decision
package is submitted for Agency-wide review. These meetings
provide a forum for sharing expertise on the regulation
under development. Full work group participation helps
resolve conflicts at the start, thus enhancing the quality
of Steering Committee review. Full participation also
helps ensure that all necessary analyses are integrated
and that resources are efficiently allocated.
D. Steering Committee
The core Steering Committee membership includes a
representative for each of the nine Assistant Administra-
tors (AAs), for the General Counsel, and for each of the
Associate Administrators for Regional Operations and Inter-
national Liaison. These representatives should: {1) be
at or above the Office Director's level, (2) be located in
the immediate office of their AAs (or General Counsel) or
report directly to their AAs, and (3) have general respon-
sibilities covering the entire range of regulatory issues
within the offices that they represent. Ideally, these
representatives are either Deputy AAs or persons of similarly
senior status. They speak for their AAs or General Counsel
and are directly accountable to them. Regional Adminis-
trators are included in all Steering Committee Reviews and
are encouraged to attend meetings on regulations in which
they have sufficient interest. The Director of OSR chairs
the Steering Committee.
-------
-b-
III. Procedures for Developing a Regulatory Action
In terms of work products, the process of developing a
regulatory action can be divided into four stages:
o submission of a start action request (SAR);
o preparation of the development plan;
o review and selection of options;
o submission of the proposed/final regulatory decision
package.
For each of these stages, the procedures consist of certain
requirements that the lead program office must satisfy together
with an associated review process. The following sections describe
the requirements and review processes at each stage, and their
applicability. If you are unsure whether a particular requirement
applies in a given case, check with the Chief of the Regulation
Management Staff, in the Office of Standards and Regulations (OSR).
A. Submission of Start Action Request (SAR)
Applicability. SAR requirements apply to ail rulemaking
subject to OMB review under Executive Order 12291* — except for
approvals of State plans in the various programs (including State
Implementation Plans), pesticide tolerances, Significant New Use
Rules and other routine; high-volume categories of actions.
Requirements. Before starting work on a regulation, the lead
office must submit a Start Action Request (SAR) to OSR for the
approval of the AA/OPPE. No action can enter internal Agency
review without an approved SAR.
The SAR must:
o describe the proposed action and its purpose;
o state the statutory authority for the action and
propose its classification as either major, signi-
ficant, or minor;
o explain the reason(s) for proposing to initiate the
action, and the consequences of not doing so;
o certify that the action's relation to other relevant
programs has been investigated,- and justify any pro-
jected conflict, duplication, or failure to pursue
possibilities for integration;
o explain why developing the action now will be an
appropriate use of our time and resources.
See Attachment fi)
-------
-6-
The Review. OPPE review normally takes at most three weeks,
which includes a week for review by Steering Committee members.
An approval will bear the signature of the AA/OPPE. In reviewing
the SAR, OPPE will determine, in consultation with the lead office,
whether the action is major, significant, or minor.
B. Preparation of the Development Plan
Applicability. Development plan requirements apply to all
rulemakings that are classified as major or significant. However,
for some significant rulemakings, OPPE may waive the development
plan requirements when it approves the SAR.
The Requirements. The lead office must submit the development
plan to the Steering Committee within 60 days after OPPE approves
the SAR. Typically, the lead office prepares the plan in consul-
tation with the work group. As appropriate, the plan must cover
the points spelled out under the heading "The Development Plan" in
my Criteria and Guidelines memorandum.
It is especially important that the plan present a broad array
of options for management to co'nsider in determining the most effec-
tive way to meet our regulatory obligations. Where the rulemaking
is subject to the options selection process, the lead program office
must begin this process as a part of preparing the development plan.
Other affected programs, ORD, OGC, and OPPE all participate.
The Review. Development Plans are reviewed by the Steering
Committee; this normally takes two weeks. The Chairman of the
Steering Committee must approve all required development plans.
In the case of major regulations, the AA/OPPE must also approve
the plans. In addition, where the plan is for a Level I rule, it
will normally be reviewed by the first formal options review meeting
on that rule, which I or the lead program AA will chair.
Where there is an accompanying ANPRM, it receives Steering
Committee review together with the Development Plan. The ANPRM
must also undergo Red Border review, and normally must be signed
by the Administrator.
C. Review and Selection of Options
1. Level I Process
Applicability. All Level I rules.
The Requirements. At least 10 days before a scheduled options
review meeting, the lead office must circulate an options paper
for the rule in question. The options paper should be based on
the analyses specified under the heading "The Options Selection
Process" in my Criteria and Guidelines memorandum.
-------
-7-
The Review. The options review meetings are chaired by me
(or, if I so choose, the lead program AA). At these meetings,
the lead AA briefs the participants on the options, and the parti-
cipants attempt to agree on which options to retain for further
development and which to reject. If no agreement can be reached
on specific options, the participating AAs and RAs present their
recommendations in writing within a week after the meeting. OPPE
documents results of options review meetings, and issues closure
memos (which serve as vehicles for raising disagreements to me
for resolution when necessary).
2. Level II Process
Applicability. All Level II rules.
Requirements. Typically, the work group serves as the forum
for the Level II options selection process — beginning with its
first meeting, which is convened after the SAR is approved, to
draft the development plan. The lead program office calls this
meeting, as well as subsequent meetings at which the options are
refined and selected/rejected for further development. When it
submits the decision package for Steering Committee and Red Border
reviews, the lead office must include a summary of the options
considered and rejected, stating why and when each was rejected.
Where participating offices believe that options with merit
are not being investigated, or have been wrongly or prematurely
rejected, they must make reasonable attempts to resolve their
concerns by working with the lead program AA. If differences
persist, they must then communicate their concerns to the
Steering Committee Chairman.
The Review. The OPPE lead- analyst for the rule in question
reports periodically to the Steering Committee Chairman, outlin-
ing work group progress and the options considered and retained
or rejected.
Where work group participants are unable to resolve differences
over options with the lead program AA, Steering Committee options
meetings are convened — either at the request of the Steering
Committee representatives or by decision of the Steering Committee
Chairman. In such cases, the Steering Committee determines the
options for consideration—or, if i.t is unable to achieve closure,
it identifies disagreements to be raised to me and to the affected
AAs. OPPE documents the results of such meetings and the options
selected or rejected, the Steering Committee Chairman signing the
closure memo and circulating it to the participants and the AA/OPPE.
D. The Decision Package
Applicability. All rules, with qualifications as noted.
The Requirements. The lead office must prepare a decision
package to be submitted for Steering Committee and Red Border
reviews. The package must satisfy the applicable guidelines under
-------
-8-
the heading "The Decision Package" in my Criteria and Guidelines
memorandum. Before it is submitted for Steering Committee review
(or Red Border review, in the case of minor rules), the package
must be circulated to all members of the work group for review
and comment, and then approved by the lead program AA.
In addition to the preamble and the rule itself, the decision
package must include:
o an action memorandum signed by the lead office AA;
o for Level I and II rules, a summary of: (1) the options
considered and rejected, and (2) why and when each was
rejected;
o for Level I and II rules, the written comments of any
Assistant Administrators or Regional Administrators
who were involved in the options selection process,
reflecting their preference among the options;
o any Information Collection Requests (ICRs) associated
with the rule. This must be submitted at the time of
Steering Committee review unless the requirement is
waived. In the case of a waiver, the ICR must be sub-
mitted at the time of Red Border review; and
o any other important support documents.
The Chairman of the Steering Committee may refuse to schedule a
Steering Committee review for any package that does not satisfy
the above requirements. OPPE may correspondingly refuse to begin
Red Border review.
The Reviews. Both proposed and final decision packages
undergo the following sequence of reviews:
o Steering Committee Review. All major and significant
rules undergo Steering Committee review, which normally
requires two weeks. For major and many significant
rules, a meeting of Steering Committee representatives
is scheduled. However, some significant rules undergo
Consent Calendar review.in lieu of a meeting. In these
cases, OPPE circulates the package to the Steering Com-
mittee for comments in writing, normally due in two
weeks.
The Steering Committee determines whether the
package is ready to go on to Red Border review. This
includes identifying the issues that require resolution
by the AAs, me, or the Administrator. The Steering
Committee recommends resolutions for those of the issues
on which the representatives can reach agreement. The
-------
-9-
Steering Committee Chairman, the lead office represen-
tative, and representatives from the affected offices
then present at least the more important of the issues—
together with any Committee recommendations—to their
AAs and to me for decision. Especially where there are
disagreements arising from the Steering Committee review,
the Steering Committee Chairman must ensure that I have
the views of all the offices concerned.
OPPE prepares a summary of important issues, comments,
and agreements arising from Steering Committee review.
In addition, before the package enters Red Border review,
the lead office must prepare a summary of important changes
in the package since Steering Committee review. The lead
office summary must address Steering Committee comments.
Both the OPPE and the lead office summaries accompany
the package through Red Border review.
o Red Border Review. This is the formal senior management
review of all decision packages, normally limited to the
AA/OPPE and the General Counsel. Other non-lead AAs and
RAs may be included if they have identified issues or
concerns at the Steering Committee stage and ask to par-
ticipate in the Red Border review.
The normal period for a Red Border review is three
weeks. If a reviewing office fails to respond by the
review deadline, i may ask that the review be terminated
without their comments.
o OMB Review.
Executive Order 12291 requires that all proposed
and final rules (except those that OMB has exempted) be
sent to the Office of Management and Budget (OMB) for
review under the Order. Minor and significant rules
are submitted to OMB for a 10-day review. Proposals of
major rules and a draft regulatory impact analysis are
submitted to OMB for a 60-day review. Final major rules
and a final regulatory impact analysis are submitted
for a 30-day review prior to signature.
The AA/OPPE must approve Agency documents (except
SIPs) for transmittal to OMB before they are sent for
OMB review under the Executive Order. Normally OPPE
will grant this approval only for documents that have
completed Red Border review. However, Red Border and
OMB reviews may sometimes proceed at the same time if
OPPE determines that no significant unresolved issues
remain. OPPE will continue to have complete responsibi-
lity for managing the OMB review, including that for SIP
actions.
-------
-10-
In the course of its review, OMB may comment on the
rule, or deem it to be "inconsistent with the Executive
Order." In either of these cases, the action memo must
be revised to explain the issues involved and detail any
resulting changes to the package.
OMB also reviews any information collection requests
(ICRs) associated with a rule, under the authority of
the Paperwork Reduction Act. This review begins when
the proposed rule is sent to the Federal Register, and
generally takes 60-90 days. If OMB has problems with
an ICR, or if there are changes, the ICR may have to be
resubmitted when the final decision package is prepared.
Consult OPPE's memorandum entitled "Integrating Paperwork
Review into the Agency's Regulation Review Procedures"
for details on timing in this case.
o Administrator and Deputy Administrator Review
The Office of Standards and Regulations in OPPE
presents the decision package to the Office of the Admin-
istrator through AX once the Red Border and OMB reviews
are complete. My staff or the Administrator's staff may
raise questions or issues before the decision package is
presented for final approval and signature.
The Administrator and I will often have reviewed a
regulation before it reaches us at this stage, through
either the options selection process or special briefings
or decision memoranda. This means that—especially for
significant and major regulations—we will probably be
aware of important policy choices and issues before the
package is presented to us in the form of a final draft.
Once the Administrator signs a rule it is returned through AX
to the Office of Standards and Regulations, which arranges for
publication in the Federal Register.
IV. Scheduling and Accountability
I have established an Agency-wide Action Tracking System (ATS)
that allows me to monitor the progress of many of the rules covered
by these procedures. The biweekly ATS reports inform me regularly
of problems or delays and are designed to ensure that there is ade-
quate review time in the development process for each regulation.
Each lead AA must allow adequate time for analysis and review
of each regulation within his or her program. This must include
time for the procedures in this memorandum, including the options
selection/rejection process, and for products specified in my
Criteria and Guidelines memorandum. Lead AAs must also allow suf-
ficient time for final review by me and by the Administrator. In
turn, OPPE, OGC, and other reviewing offices have an obligation to
complete reviews in a timely manner.
-------
Attachment (i)
SAR
Development
Plan
Options
Review
Analytical
Requirements
Steering
Committee
Review
Red
Border
OMB
Review
MAJOR
SIGNIFICANT
MINOR
Yes
Yes
Yes
( unless
specifi-
cally
exempted
Yes,
with approval
by AA/OPPE
,
Yes,
with approval
by Steering
Committee
Chairman
No
1
Covered by
Level I or
Level II
process.
Covered by
Level I or
Level II
process.
Not covered
by the formal
options
process
RIA
No RIA, but
usually sub-
stantial
analytical
support.
Minimal or
generic
analytical
support.
Yes
Yes
No
Yes
Yes
Yes
(unless
specifically
delegated or
exempted )
Yes — for 60-day
(proposal) or
30-day (final)
period.
Yes — for
10-day
period.
Yes — for
10-day
period,
unless
exempt.
-------
Attachment (ii):
Required Documents and Formal Reviews at the Four Stages of Regulatory Development
Symbols "o" = review and approval required
REQUIRED
DOCUMENTS
I. Start Action Request
(SAR)* (Required for
all rulemakings and
policy documents
subject to OMB review
under Executive Order
12291)
I la. Development Plan
[Required for (a) all
major rules, (b) all
significant rules not
specifically exempted
by the AA/OPPE, and
(c) some policy
documents]
lib. Accompanying ANPRM
[Optional]
I I I. Opt ions Papers
[Require for all major
and significant rules]
IV. Proposed and Final
Decision Packages
Vtork Group
o
[all Level II
rules]
o
Steering
Committee
(SO
o
o
[approval of
chairman
required]
o
[Level II
rules, if
there are
unresolved
issues in the
work group]
o
[all major and
significant
rules]
AA/OPPE
o
o
[required for
major rules]
Deputy Adminis-
trator/AA
Options Review
Meeting .
o
[all Level I
rules]
1. In sane cases OPPE will send documents for OMB review before Red Border review fonr
2. Time periods for CMS review are: proposed major; 60 days; proposed non-major; 10 da
final non-major: 10 days.
AA/OPPE, General
Counsel and other
participating AAs
("Red Border")
3 weeks max.
o
[required for
ANPRM]
o
OMB l'»,^)
10-60 days
o
Deputy
Administrator
o
[normally
required for
ANRPM]
o
[if there are
unresolved
issues in SC
or Options
Review Com-
mittee]
o
[except
delegated
actions]
Administrator
o
[normally
required for
ANRPM]
o
[except
delegated
actions]
ally ends.
ys; final major: 30 days;
.
-------
Changes from the April 30, 1983 Procedures Memorandum to the
New Procedures Memorandum
PAST
PRESENT
SAR two-week review period,
SAR three-week review period;
new SAR form (presently being
prepared) covers additional
points.
Red Border standard two-week
review.
Red Border standard three-week
review; Deputy Administrator
can terminate at deadline.
Enforcement review of all
Red Border packages as part
of OLEC.
Office of Enforcement and
Compliance Monitoring review of
selected Red Border packages with
enforcement issues.
No specific requirements on
submission of Information
Collection Requests associated
with rules.
Requirement that ICR's associated
with rules be submitted at
Steering Committee entry point.
Occurrence of OMB review after
completion of Red Border
Allowance for parallel OMB/Red
Border review under prescribed
circumstances.
Participation of the AA External
Affairs, and the Associate Admin-
strators for Regional Operations
and International Liaison in the
review process through Steering
Committee representations
and selected Red Border
reviews.
Incorporation of options
selection/rejection process.
Incorporation of Criteria and
Guidelines Document.
-------
1/9/84
PROGRAM OFFICE COMMENTS AND RESPONSES
I. Steering Committee
1. Comment; The Steering Committee should be chaired by
a disinterested party - not an advocate like OPPE. As
an alternative, the Steering Committee chair could be
rotated among the program offices.
Response: Rotating the Steering Committee chair would
badly compromise its responsibilities for managing the
ongoing process of Agency-wide review of regulatory actions,
Since the chair must reside with one office, then, OPPE
is the most appropriate choice—for at least two reasons:
First, OPPE is more likely to be detached from the
actions under review than any of the program offices, since
OPPE very rarely has lead responsibility for such actions.
This helps ensure that the independence and integrity of
the review process will be maintained. (Of course, OPPE
does also play an advocate's role.)
Second, OPPE is, after all, the office charged with
the responsibility for managing both Agency-wide review
and the regulatory development process generally.
2. Comment; Steering Committee representation should be
at a higher level, possibly including the Assistant
Administrators.
Response;
The document provides for representation by "Qeputy
Assistant Administrators or persons of similarly senior
status." Assistant Administrators are welcome to par-
ticipate in any Steering Committee activities.
3. Comment; The document should define in more detail
the role of the Steering Committee.
Response; Page 8 gives a brief explanation of the
Steering Committee's role; specific aspects of this
role are discussed elsewhere in the document. If addi-
tional description would be useful, we would welcome
specific suggestions.
4. Comment: OPPE should circulate more Steering Committee
consent calendars and conduct fewer meetings.
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-2-
Response: Currently about three=fourths of the Steering
Committee's reviews are consent calendar. We try to limit
meetings to those cases where a meeting is needed to help
resolve outstanding issues. In view of this practice,
we don't think we can make the proportion of reviews that
involve a meeting any smaller than it already is. In fact,
on previous occasions program offices have suggested that
we hold more meetings.
5. Comment: If the Steering Committee decides that the work
group has not done a thorough job, OPPE should send the
regulation back.
Response; In some cases, regulations have been sent
back to the work group for substantial revision or addi-
tional analysis. That practice would continue under the
new document.
6. Commenti OPPE should assume automatic concurrence when
the two-week Steering Committee review period is over on
routine regulations and "a reviewing office has not responded.
Response: We do assume concurrence unless we have been
informed that an office intends to submit comments.
Even in those cases, we agree that a program should not
delay its work to respond to comments submitted well
past the deadline.
II. Work Group
1. Comment; OPPE analysts should issue reports on work group
effectiveness.
Response; OPPE now assigns a lead analyst to each regu-
lation, and part of that lead analyst's responsibilities
is to report periodically on work group effectiveness.
2. Comment; Who is responsible for work group effectiveness?
Specifically what role should OPPE, OECM, and the lead
office play in regulation development?
Response; Each office is responsible for ensuring the
effectiveness of its representation on work groups. The
work group chairman from the lead office should contact
the Steering Committee representative from any other
office that does not provide effective representation.
This draft includes more detail on the work group and
on the role of various offices, including reviewing and
lead offices.
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3. Comment; Work group members should have an appropriate
policy or technical background and should be able to
represent management's viewpoint.
Response: Agreed. This is not a matter we thought should
be addressed in the document itself. However, each office
has a clear responsibility for seeing that it is appropri-
ately represented on the work group.
III. General
1. Commentt How does the options selection/rejection process
relate to or differ from the Development Plan?
Response; The development plan is the initial specifica-
tion of options that will be considered, and of analyses
the Agency will conduct to assess and compare those options.
Under the options selection/rejection process, formal options
reviews normally would begin when the development plan enters
Agency review, and would continue as necessary beyond that
point. The options process would not replace the develop-
ment plan. Pages 5-7 of" the procedures document describe
this in more detail.
2. Comment; There should be less stringent review require-
ments for minor actions.
Response; Minor rules do not require a formal development
plan, do not receive a Steering Committee review, and are
not covered by the formal options selection process. In
addition, OPPE has adopted streamlined internal procedures
for Red Border reviews of many minor rules.
3. Comment; There should be more flexibility in how the pro-
cedures are applied. There should also be clear criteria
for exceptions from standard requirements.
Response; The document provides for waivers from or excep-
tions to many requirements. In practice, exceptions to
the rules have always been available when there has been
good reason not to follow standard procedures. It is
difficult to specify criteria for exceptions, because we
cannot always anticipate the special circumstances that
make exceptions appropriate.
IV. QPPE Management
1. Comment; Delegate responsibility for signing Red Borders
to the OPPE Office Directors on more routine actions.
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Response; Agreed. OPPE has adopted this practice for
several categories of actions.
2. Comment; Prompt and high-quality Red Border reviews should
be an element of OPPE performance standards.
Response; Agreed. This is an element for most OPPE managers,
3. Comment; OPPE should streamline its review chain.
Response; OPPE has taken steps to streamline its reviews.
Several classes of regulations are delegated to office
directors for approval and formal memoranda have been
eliminated for many such actions.
4. Comment; OPPE should reallocate its assignments, taking
resources from Air and Water to sufficiently cover OSWER
and OPTS.
Response; OPPE has increased the resources available
for review of OPTS rules, and for regulation review
generally.
5. Comment; OPPE should aggressively manage the review
process. It should provide regular feedback on status
of regulations.
Response; OPPE monitors Red Border performances care-
fully, and will continue to do so. In addition, OPPE
has designated a lead analyst for each regulation under
development to provide a source of information on issues,
problems, or delays. The list of lead analysts will be
sent to program offices. By way of feedback, OPPE pre-
pares a Red Border Status Report, updated every day and
sent through electronic mail, as well as a comprehensive
monthly report on all regulations under review.
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