United States       Office of
             Environmental Protection    Solid Waste
             Agency        Washington, DC 20460
 4>EFA      Procedures for Developing
             Regulations
             and Guidance Documents
             September 1987

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          OFFICE OF SOLID WASTE





PROCEDURES FOR DEVELOPING REGULATIONS



         AND GUIDANCE DOCUMENTS
               SEPTEMBER 1987
        OSWER Policy Directive #9435.00-1

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                                              OSVER Policy Directive ,-','9435.00-1
                             TABLE OF CONTENTS
CHAPTER 1:  INTRODUCTION	    1
CHAPTER 2:  AGENCY REGULATORY DEVELOPMENT PROCEDURES	    2

    2.1  Key Milestones in the Agency Review Process	    3
    2.2  Regulatory Negotiation 	   11


CHAPTER 3:  OSW REGULATORY AND GUIDANCE DEVELOPMENT PROCEDURES	13

    3.1  Overview	   13
    3.2  Setting Priorities 	   13
    3.3  Procedures for Regulatory Development	   18
    3.4  Procedures for Developing Guidance Documents 	   27
    3.5  Running a Workgroup	33
    3.6  RCRA Information Center	36
CHAPTER 4:  PREPARING SUPPORTING ANALYSES, DOCUMENTS, AND BRIEFINGS ....   39

    4.1  Types of Analyses Needed	39
    4.2  Preparing the Background Document	 .   49
    4.3  Preparing Briefing Documents 	   50
    4.4  Preparing the Regulatory Decision Package	51
    4.5  Preparing the Federal Register Package 	   55


CHAPTER 5:  RELATIONSHIP TO OTHER OSW ACTIVITIES	57

    S.I  Management of Rulemaking Activities	57
    5.2  Budget and Planning Cycle	59


Appendix A: List of Acronyms

Appendix B: Bibliography

Appendix C: Blank Forms

Appendix D: List of Contacts

Appendix E: List of Sample Documents

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                                              OSWER Policy Directive ^9435.00-1
                                 CHAPTER ONE

                                INTRODUCTION
    This manual was prepared to guide OSW staff in developing regulations and
guidance documents.  It provides a summary of the Agency's review procedures
as well as specific direction on how to prepare the multitude of forms and
support documents required during the course of regulation development.   This
manual is unique because it consolidates guidance on procedures developed
across the Agency, e.g., OSW internal procedures, our Assistant
Administrator's procedures, the Office of Policy, Planning and Evaluation's
procedures, etc., and alleviates the burden on staff to acquire this essential
information.  This manual should minimize confusion, and increase the
efficiency of staff effort in meeting OSW's extensive regulatory commitments.

    This guidance manual provides a summary of the Agency's general procedures
for regulatory development in Chapter Two, and a more detailed discussion of
OSW's internal procedures for regulatory development in Chapter Three.
Chapter Three provides a framework for determining the priority of each
rulemaking.  It further describes how OSW staff should manage all rulemaking
activities, for instance, what forms to prepare, how many copies to submit,
signatory requirements, and how and when to get senior management involved to
resolve issues that arise during the course of the rulemaking.  Chapter Four
describes each of the supporting analyses and documents in the rulemaking
process and provides guidance on how to prepare them.  Chapter Five explains
the relationship of OSW rulemakings to the budget and planning process with an
emphasis on the RCRA Implementation Plan (RIP) which outlines priority
activities for the Regions and States each year.

    The appendices contain useful information for OSW staff assigned to
regulation development.  Appendix A contains a list of acronyms that are
commonly used throughout the regulatory development process.  Many of these
terms are used in other regulatory development guidance documents such as the
Office of the Federal Register's Document Drafting Handbook.  Appendix B is a
bibliography of all the supporting documents and memoranda used to prepare
this guidance manual.  Appendix C contains a copy of all the relevant forms
that staff must complete during the various stages of the regulatory
development process, e.g., Start Action Request and Federal Register reprint
form.  Appendix D lists the appropriate Agency and OSWER/contacts on
regulatory development issues and includes their current phone numbers.
Appendix E is a list of sample supporting analyses and documents described  in
Chapter Four.  The actual copies of these analyses and documents are  located
in the Office of Program Management and Support (OPMS).  OSW considers these
analyses and documents excellent examples and staff should use them as a guide
in drafting support documents for their regulatory initiatives.

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                                             OSWER Policy Directive #9435.00-1
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                                 CHAPTER TWO

              AGENCY REGULATORY DEVELOPMENT  PROCEDURES
    Chapter Two presents an overview of  the  Agency's procedures for developing
regulations and guidance documents.   This  chapter  focuses on the new
procedures recently established by the Agency  for  rules beginning the
regulatory development process after January 1,  1987.  Regulations underway
prior to January 1987 follow the review  procedures described in the Agency
memo entitled Review Procedures for Actions  Required Under  the RCRA
Reauthorization (December 20,  1984).

    The new Agency procedures  described  in The Regulatory Development
Process:  Change in Steering Committee Emphasis  (October  1986) provide  for
increased flexibility in the type and level  of Agency  review for each new
rule.  Unlike the procedures outlined in the 1984  memo, there will be no
predetermined classification scheme for  the  development and review of
regulations.  The Steering Committee, on a case-by-case basis, will decide  the
appropriate level of Agency review.

    These changes are designed to achieve the  following objectives:


             To use the Steering Committee  as a vehicle  to help
              plan regulatory activities and set priorities;

             To enhance the workgroup's effectiveness by ensuring
              that issues are raised and either resolved  or elevated
              early in the regulatory development  process;  and

             To set up a dynamic and flexible approach within  the
              existing development process to respond to  program
              offices' varying needs for different types  of
              regulatory actions.


In an effort to assist the Steering Committee in assigning appropriate Agency
review procedures, OSW has developed a framework specific to  its needs for
setting priorities.  This framework is presented in Chapter Three.   We
established three priority designations  high, medium,  and low.   Priority
designations consider several factors,  such as scope and cost,  risk,  and
management concerns.  Further, OSW prescribes what it believes  to be the
appropriate Agency review procedures for each of the three priority
ruleraakings.  OSW can recommend these prescribed Agency review procedures to
the OSWER Steering Committee  representative when the Start Action Request
(SAR) is submitted for approval.

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                                              OSWER Policy Directive #94.35.00-1
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    This chapter describes all of the key milestones that comprise  the  Agency
 review process.  The Steering Committee will select the appropriate procedures
 from this menu of key milestones.  OSW hopes to influence that selection  by
 advocating what it believes are reasonable and germane review procedures.   In
 addition, the final section in this chapter briefly discusses the Agency's
 regulatory negotiation project as an alternative to the traditional Agency
 rulemaking process.


 2.1  KEY MILESTONES  IN THE  AGENCY REVIEW PROCESS

    The major stages of Agency review during the development of a regulation
 are listed below.  Exhibit 2-1 illustrates these key milestones and optional
 review procedures.  Although the specific review procedures will vary
 according to Steering Committee decisions, for the most part, each  rule must
 follow similar basic steps which include:


             Submission of a Start Action Request (SAR);

             Formation of a workgroup;

             Preparation of. a Development Plan;

             Development and review of options;

             Drafting of the regulatory decision package; and

             Senior management and OMB review.


2.1.1  Steering Committee

    The Steering Committee is an Agency group with representatives  from each
Assistant Administrator and the General Counsel.  The Steering Committee  is
responsible for coordinating and integrating all of the Agency's regulatory
development activities.   Its key functions are to approve Start Action
Requests (SARs) and charter workgroups; monitor the progress of staff-level
workgroups, especially regarding cross-media or inter-office problem-solving;
and ensure, when appropriate, that significant issues are resolved or elevated
to top management.  Regions participate in Steering Committee activities
through Regional Regulatory Contacts.  These contacts coordinate reviews  in
the Regions and facilitate rule-related activities for the Regional
Administrators (RAs).

    The Steering Committee meets every other Wednesday, with additional
meetings scheduled as necessary.  Its regular format is:  discussion and
disposition of SARs; review of development plans; consideration of pending
workgroup reports; and other issues.  Upon request, the Steering Committee
chair will schedule a separate meeting to consider a proposed or final
rulemaking package, or arrange for some other form of Steering Committee

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                          OSVTER Policy Directive ?;9435.00'
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               Exhibit 2-1
REGULATORY DEVELOPMENT PROCESS
                 File SAfl
                Convene
                Workgroup
                 Submit
               Development
                  Plan
                 Options
                Selection
                Meeting (s)
         Steering Committee Review
               or Workgroup
              Closure Meeting
                Red Border
                 Review
                  OMB
                  Review
                   AX
                 Signature
                 Federal
                 Register

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                                              OSWER Policy Directive  #9435.00-1
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         fc

review.  This special review may function in lieu of workgroup closure.   Any
office may submit documents or issues for the agenda through its Steering
Committeeirepresentative.  Regional Contacts receive all Steering Committee
documents!  Typically they are not able to attend meetings, but Regions  can
send writtlen comments.  After each meeting, the Steering Committee chair
issues a closure memo that documents outstanding issues, agreements, and
action to be taken.

    In addition to their role as members of the Steering Committee, Steering
Committee representatives play an important regulatory management role within
their offices.  They direct the flow of documents into and through the
Agency's regulatory review systems (including Red Border, Options Selection,
and Federal Register activities); serve as their Assistant Administrator's
liaison with OMB, and direct their program's review of other offices'
regulatory development activities.

2.1.2  The  Start Action  Request (SAR)

    Before beginning work on a regulation, the lead office must submit a. Start
Action Request (SAR) form to the OSWER Steering Committee representative.  The
SAR is EPA Form 3720-10 and can be obtained from the Office of Planning,
Management and Support (OPMS) in OSW.  The principal purposes of the SAR are
to inform other Agency offices of the lead office's intention to develop a
rule, and to provide the Steering Committee with the opportunity to discuss
and plan for the inter-office or inter-media components of the regulation.

    The SAR is a one-page form that asks primarily for descriptive
information.  The SAR should:
              Clearly define the regulatory problem, including its
              health and environmental significance;

              Indicate the effect of this problem -- and any likely
              regulatory action to solve it -- on other environmental
              media or programs;

              Identify potential reporting or recordkeeping
              requirements;

              Identify the EPA Regions and other groups that should
              be involved; and

              Specify the kind of expertise and level of
              participation expected from workgroup members.
    The OSWER Steering Committee representative approves the SAR and submits
25 copies to the Steering Committee chair for distribution.  A Steering
Committee meeting is held, at which time the OSWER Steering Committee
representative presents OSW's rulemaking plan and surveys other program

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                                              OSWER  Policy Directive #9435.00-1
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of,fices for issues, workgroup representatives,  and an indication  of  their
leVel of interest in the proposal.

  f  In addition, the OSWER Steering Committee representative presents  OSW's
recommendation for Agency review procedures.   The full Steering Committee
considers this recommendation and assigns review procedures.

2.1.3  Formation of a Workgroup

    After the Steering Committee approves the SAR, the lead office convenes  a
formal Agency-wide workgroup with representatives from interested program
offices and the Regions.  Each workgroup member represents his Assistant or
Regional Administrator and is responsible for keeping his senior  management
informed on the status and issues surrounding the rule.  At any stage  in the
rulemaking, when issues cannot be resolved at staff level, workgroup members
are responsible for elevating the issue to their management.

    Effective workgroup participation is essential to any rule or guidance
development effort.  Although the intensity of effort may vary across  rules,
the workgroup's responsibilities include:


             Scoping out preliminary issues and options; 

             Identifying and developing the necessary analyses
              (e.g. / technical, cost, risk, economic impact analyses)
              to support consideration and selection of guidance or
              regulatory options;

             Ensuring that cross-media concerns are identified and
              addressed;

             Identifying early in the development process  the
              procedural, technical, and policy issues in need of
              resolution;

             Reaching consensus on issues or elevating them to a
              higher level for resolution;

             Preparing workgroup reports; and

             Meeting the workplan schedule outlined  in the
              development plan, leading to the preparation  of  a
              complete decision package.


Workgroup members should be selected for their ability to effectively
articulate the perspectives and interests of their office or  agency,  while  at
the same time being capable of understanding and  incorporating the
perspectives and interests of others.  Ideally, workgroup members working in
this way can synthesize a better rule or guidance by  building on  the  strengths

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                                              OSVER Policy Directive  #9435.00-1
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of each other's ideas, analyses, and approaches.  Chapter Three includes a
discussion on how to manage a quality workgroup.

2.1.4  The Development  Plan

    For most rules, the workgroup's first responsibility is to prepare a
development plan, which sets forth the basic policy and management framework
for developing the regulation, for Steering Committee review.   The development
plan presents a set of preliminary regulatory options and identifies areas
where further analysis may be required.  Briefly, the development plan:


             States the need for regulation and identifies the
              regulation's goals and objectives;

             Discusses all feasible options, including
              non-regulatory alternatives;

             Presents a workplan for developing the regulation
              that outlines, as appropriate:

                   Areas where further analyses may be required,
                   including:  health and environmental risk
                   assessments, benefits of the action, economic
                   impacts of the action, effects on small entities,
                  paperwork and recordkeeping burdens, potential for
                   fraud, waste, or mismanagement;

                   Major areas of technical uncertainty, and how the
                   lead office plans to resolve them;

                   Major tasks that will be performed and milestones
                   for each task;

                   The workgroup chairman and Agency offices,
                   including EPA Regional Offices, that will
                   participate in developing the rule;

                   Other Agencies and States that will be involved  in
                   developing the regulation, and the nature of their
                   involvement; and

                   Agency personnel and contract resources that will
                   be necessary to develop the  regulation.


2.1.5 Workgroup Reports

    Workgroup reports keep the Steering Committee informed about workgroup
progress on a regulatory action.  Reports describe:  issues and alternatives
being addressed and resolved; any issues that need to be elevated for

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                                                    Folicy Directive ?,*y. uu-i
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resolution; and the status of ongoing work and any anticipated  delays.   The
Steering Committee's discussion of workgroup reports  focuses  on cross-media  or .
other issues or alternatives not being considered by  the workgroup.   Steering
Committee concurrence with reports is designed to ensure that issues  resolved
by the workgroup are not raised again at a later date,  and that unresolved
issues are addressed in a timely way.

2.1.6  Options Selection  Process

    The first few months of rule development focus primarily  on identifying
significant issues and assessing possible options based on the  best data
available and other supporting analyses..  Regulations subject to Options
Selection undergo a formal options selection meeting  with the Administrator
and Assistant Administrators from other program offices.  The lead office
prepares and circulates an options paper at least 10  working  days prior to the
options selection meeting.  At the options selection  meeting, the lead
Assistant Administrator briefs the Administrator on the options paper and
receives input from the other participants.  OPPE documents the results of the
meeting and options rejected or selected and prepares a closure memo.  The
lead office may need to prepare for a second options  meeting  if any issues
remain unaddressed.

    On the other hand, many regulations will not be subject to formal Options
Selection with the Administrator.  For these regulations, the workgroup
selects the options to be considered in the development of the rule.
Throughout the regulatory development process, the lead office works with the
workgroup to refine and select options.  Where participating offices believe
that issues or options with merit are not being investigated, they should
persist in raising their concerns with the lead program Assistant
Administrator.  If differences remain, the office must convey its concerns to
the Steering Committee chairman who will then convene the Steering Committee
to review issues and options.

2.1.7  Workgroup Closure

    The workgroup closure meeting provides a forum for confirming that:   the
workgroup has successfully completed its job, resolving as many  issues  as
possible and clearly defining others; the rulemaking package is  ready  for
Assistant Administrator, Regional Administrator,  and Deputy Administrator
review; and Agency and external requirements have been met.  Workgroup  members
participate in the closure meeting as representatives of  their Assistant
Administrators.  Generally, participation in the  closure  meeting is  a
precondition for an office's participation in Red Border  review.

    The lead office distributes the  decision package to workgroup members at
least ten working days before the workgroup closure meeting.   The workgroup
chairman should prepare a memorandum from the OSWER Steering Committee
Representative to the Workgroup members, the Agency Steering Committee
Representatives, and Dan Fiorino, Director of  Information and  Regulation
Systems Division.  The Office of Standards and Regulations (OSR) chairs the
workgroup closure meeting in order to  facilitate  closure, not  to decide

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                                              OSWER Policy Directive  #9435.00-1
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substantive issues.  With the OSR chair presiding, the closure meeting begins
with the workgroup chair giving a brief summary of issues resolved and those
still outstanding.  The chair also describes any changes since the lead office
distributed the draft package to the workgroup.  The regulatory package at
this stage consists of the preamble, rule, and written analyses.   Other
workgroup members then offer their Assistant Administrator's position (e.g.,
concurrence, concurrence subject to revisions, concurrence subject to an issue
that will be raised for decision in Red Border review, or nonconcurrence).  If
more than one workgroup member from the same office attends the closure
meeting, then the members or the office's Steering Committee representative
should be sure to coordinate their positions before the meeting.   The OSR
chair encourages closure by clearly establishing:


             Matters that should be addressed before Red Border
              review;

             Issues (if any) to be presented in Red Border review;

             Participation in, and date for beginning, Red Border
              review; and

             Whether or not to have concurrent OMB and Red Border
              review.
    OSR will issue, within three working days of the workgroup closure
meeting, a brief summary of conclusions that certifies a package is.ready for
Red Border review or explicitly documents other conclusions.  Workgroup
members will immediately notify affected Assistant Administrators or Regional
Administrators of any disagreement with either the conclusions of the meeting
or OSR's written summation.  The lead office and affected parties resolve any
problems.

2.1.8  The Decision  Package

    After the workgroup completes its evaluation of issues and options
associated with both proposed and final rules, the lead office prepares a
decision package for the rule.  The decision package is a set of documents
which presents the Agency's rationale for the standards being proposed or
promulgated.  In general, the decision package contains the following
documents which are discussed further in Chapter Four:


             Transmittal Memo;

             Action Memorandum;

             Preamble and Rule;

             Communication Strategy;

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                                              OSWER Policy  Directive #9435.00-1
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             Request for OMB review and the Information Collection
              Request (ICR) (SF-83) associated with the rule;  and

             Supporting analyses, e.g., the RIA.


While developing the decision package, the lead office should  make sure that
the package clearly presents, as appropriate, the estimated costs, risks and
benefits of the options considered.  The package should also discuss the
action's cost-effectiveness compared to similar regulatory actions.  The
action memorandum in the decision package for a final rule -reflects the level
and extent of public comment received concerning the proposed  rule.  In
addition, the final rule action memorandum reports on the Agency's response to
major public comments and notes whether the Agency changed the proposed rule
after considering public comment.  Chapter Four explains how the Agency
responds to written public comments.

    In addition, the decision package must meet the requirements of Executive
Order 122S1, the Paperwork Reduction Act, the Regulatory Flexibility Act, and
EPA's "functional equivalency" requirements for compliance with the National
Environmental Policy Act.  The lead office must also prepare the decision
package in accordance with Federal Register requirements concerning format and
vocabulary.  Chapter Four discusses these requirements in more detail.

2.1.9  Red Border/OMB  Review        .                         .              .

    Red Border is the formal review mechanism by which senior management
reviews and approves regulatory packages.  The workgroup, with Steering
Committee oversight, should already have defined all significant  issues and
resolved all or most of them, so that no new issues or problems arise during
Red Border review.  Generally, Assistant Administrators and Regional
Administrators may participate if they have identified issues or  concerns over
the course of the rulemaking from review of the SAR through workgroup
closure.  The normal period for Red Border review is three weeks.

    Executive Order 12291 requires that all proposed and final  rules be sent
to the Office of Management and Budget  (OMB) for review under the Order.  The
purpose of OMB review is to assure that, within the constraints of their
statutes, Agencies choose among the various alternatives by considering the
costs and benefits of each.  The Order defines two categories of  rules: major
and non-major.  Under the Excecutive Order, a major rule is any regulation
that is likely to result in:


         (1)  An annual effect on the economy of $100 million or  more;

         (2)  A major increase in costs or prices for consumers,
              individual industries, Federal, State, or  local
              government agencies, or geographic regions;  or

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                                              OSWER Policy Directive /;9435.00-1
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         (3)  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.


    Executive Order 12291 requires all major rules to be accompanied by a
Regulatory Impact Analysis (RIA).  Chapter Four fully describes the components
of an RIA.  Major rules and the-RIAs are submitted to OMB for a 60-day review
at proposal and 30 days at final promulgation.  Proposed and final non-major
rules have a 10-day review.  The Steering Committee may decide that a high
priority rule should undergo a concurrent Red Border/OMB review provided that
no significant unresolved issues remain.  Normally, however, the OMB review
occurs after the Red Border review.  Regulatory packages cannot go forward for
final signature until the lead office addresses OMB concerns and resolves
outstanding issues.

    After Red Border and OMB review are completed and the lead program office
has considered and responded to all comments, it prepares the package for the
Administrator's signature.  Obtaining the Adminstrator's approval usually
takes a week to ten days.  The decision package is formally transmitted to AX
for signature.   AX is the Administrator's executive correspondence control.
Depending on the type of rule, the complete process from submittal of the SAR
to final promulgation takes up to, and sometimes more than, two years.
Chapter Three contains sample timelines (Exhibits 3-2, 3-3, and 3-4) for high,
medium, and low priority rules.


2.2  REGULATORY NEGOTIATION

    In 1983, EPA began a project to study the usefulness of interested party
negotiations as a supplement to the current regulatory development system.
The project's specific purpose is to investigate:


             The value of developing regulations by negotiation;

             The types of regulations that are most appropriate
              for this process; and

             The procedures and circumstances that best foster.
              negotiations.


    Regulatory negotiation involves bringing a balanced mix of parties and
interests together, face-to-face, to negotiate at the pre-proposal stage.  The
goal of each negotiation is to reach consensus on which to base a Notice of
Proposed Rulemaking (NPRM).  EPA is committed to use any consensus -- within
its statutory authority -- as the basis of the proposal.

    All negotiations are conducted under Federally-chartered Advisory
Committees.  Once proposed, all Administrative Procedures Act and other

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                                              OSWER Policy  Directive  #9435.00-1
                                     -12-
procedural requirements apply.   A senior official selected by the office
responsible for developing the  rule acts as EPA's chief negotiator and
party-at-interest for EPA.  Individuals representing definable interests in
the regulated community, environmental groups, enforcement officials, and
other interested parties negotiate on behalf of their constituencies.  A
neutral third-party "facilitator" chairs the negotiations, keeps the process
moving smoothly, and assists in resolving disputes.

    Regulatory negotiation offers an innovative opportunity to explore how to
use the Agency's time and resources and those of interested parties more
effectively, involves the public more fully and openly, produces better
regulations, and reduces litigation and uncertainty.  Regulatory negotiation
may also foster more effective  two-way communication between EPA and affected
parties and interests.

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                                              OSWER  Policy Directive #9435.00-1
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                                 CHAPTER THREE

       OSW REGULATORY AND GUIDANCE DEVELOPMENT PROCEDURES
3.1  OVERVIEW

    This chapter serves five purposes.   First,  Section 3.2  outlines  criteria
for assigning priorities among the many rules and guidance  documents under
development in OSW.  OSW classifies all rules and guidance  into  three
categories: high, medium, and low, based on a combination of three sets  of
criteria.  Second, Section 3.3 identifies the procedures  that OSW can
recommend to the Steering Committee for the formal Agency-wide review of its
rules.  The OSWER Steering Committee representative can present  these
recommended procedures to the full Steering Committee and determine  the
appropriateness of the recommended approach.  The criteria  are designed  to
categorize rules such that a rule defined as a "high" priority by OSW will  be
assigned comprehensive Agency review procedures that are  suitable for that
priority.  Because the Agency recently eliminated its rulemaking
classification system, OSW hopes that the criteria it has internally developed
will assist the Steer-ing Committee in reaching agreement  on the  appropriate
review procedures for OSW rules.  Section 3.3 also identifies internal OSW
review procedures that OSW staff should follow to ensure  that quality
documents are submitted into the Agency-wide review process established  by  the
Steering Committee.  These internal procedures correspond directly to the
three OSW rulemaking priorities regardless of what Agency review procedures
are assigned by the Steering Committee.  Section 3.4 provides direction  for
developing guidance documents.  Section 3.5 describes elements of a  quality
workgroup.  Finally, Section 3.6 describes how to establish the  RCRA docket
for rulemakings and how to distribute guidance and other  OSW policy  directives.


3.2  SETTING PRIORITIES

    OSW Division Directors establish priorities for each  of the rules and
guidance documents they are responsible for developing.  Priorities  are
established in order to define resource needs,  focus management attention on
critical issues as rules and guidance documents are developed, and manage the
large workload brought on by the passage of the Hazardous and Solid  Waste
Amendments (HSWA) of 1984.  This section describes three  criteria that
Division Directors should use to set priorities.  These criteria should
promote consistency across the Office and are provided as guidelines for OSW
decision-makers in setting priorities for rulemaking and guidance
development.   The criteria include:


             Scope and cost of rule -- considers the size  of the
              regulated community, the extent of control  over
              regulated community activities, the cost to comply

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                                             OSWER Policy Directive #9435.00-1
                                     -14-
              with the rule,  and the cost  to  the  Regions  and  States
              to implement the rule or guidance.

             Environmental results -- includes consideration of
              the environmental benefits of promulgating  a  particular
              rule or guidance.  An evaluation should  include
              estimates of the identity and quantity of contaminants
              released into the environment,  a description  of how
              these contaminants travel through the  environment, and
              an estimate of the exposure  potential.

             Management Concerns -- this  factor  attempts to  define
              why OSW is developing a particular  rule.  Who are the
              interested parties, what political  or  economic  pressures
              are driving the development  of  the  rule,  and what are
              the potential impacts if the Agency does  not develop the
              rule now but chooses to defer or postpone development?


    These criteria are not. dramatically different from those the Agency uses
to evaluate various rules and guidance documents.  For example, OPPE  has
developed a form for reporting risk assessment and risk management information
to the Steering Committee, and Executive Order 12291 requires the  Agency to
address the level of costs imposed by regulations..  However,  in the past,
these factors were haphazardly considered because there was no mechanism to
balance all of the various analytic components of a rulemaking and impose a
consistent framework for evaluation.  This manual is intended to serve this
function.  This chapter brings these  ideas together and provides some guidance^!
on how to consider these factors in decision-making.

    Exhibit 3-1 contains OSW checklists for three criteria:  scope and cost;
risk; and management concerns.  Staff responsible for developing rules should
rank each rule or guidance against the three checklists  and determine the
general score for each criterion.  Decision-makers should then review the
information and ultimately recommend  a classification (high, medium, or  low)
for each rule or guidance document.

    In order to evaluate all rules or guidance documents against the criteria
and determine the relative priority of each, decision-makers at the Division
level should review each checklist, evaluate the three individual rankings,
and assign a composite score.  The composite score  represents  a subjective
judgment by the decision-maker as  to  the  relative importance of each
criterion, thus allowing small or  simple  rules to be high  priority if  they
address a key problem.  The  last page of  Exhibit 3-1 contains  the composite
score table.  The composite  score  is  then used to assign the rule or guidance
4 high, medium or low  priority for OSW.   As  the  priorities checklist  is
completed and a determination  is made that the rule is a high  or  a medium OSW
priority  rule, it is  likely  that the  rule will be considered to be major under
Executive Order  12291, as  described  in Chapter Two.  This  is because  a rule
that receives a composite  OSW  score  that  classifies it as  high or medium
priority  is  likely to  have a significant  impact  on  the regulated  community in
terms of  scope and cost.   Thus the rule will be  considered major  by  OMB

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                                           OSWER Policy Directive ,V19435.00-1
                                   -15-
                                EXHIBIT 3-1

                     OSW CLASSIFICATION  CHECKLISTS
Scope and Cost Criteria Checklist

                  Criteria
                                             Ranking Factors
1.

2.
3.
4.
5.
6.
7.
8.
9.
What is the size of the regulated community?

How many industries are affected by the
rulemaking?
Does the rule or guidance affect current
hazardous waste management operations?
Does the rule impose design and operating
standards rather than only notification
requirements or technical fixes?
0 - 500
500 - 5000
5000 plus
more than 1
2-10
less than 10
Yes
No
Yes
No
How much will 'the rule cost the regulated- more than 100
community? Do costs exceed $100 million? less than 100
Does the rule have an impact on small businesses?
Does the rule impose a significant
information burden on the regulated community?
Will the rule require a signifi- many Annual
cant amount of compliance moni- few Annual
coring and enforcement activities?
Does the rule require industry to
obtain a permit or modify existing
permits?
Yes
No
Yes
No
inspections
inspections
Yes
No
1 a
2 a
3 a
1 a
2 a
3 a
2 a
1 a
2 a
1 a
2 o
1 a
2 a
1 a
2 o
1 a
1 a
2 a
2 a
1 a
SCORE
Large Scope & Cost
       18  20
Medium Scope  & Cost
       12 - 17
Small Scope  & Cost
     9 - 11

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                                     -16-
                                              OSWER Policy  Directive  ?;9435.00-1
Risk Criteria  Checklist

                   Criteria
                           Ranking Factors
1.
2.

3.
U.


5.
6.

7.
8.
What is the quantity of less
waste produced? 1001 -
more than
Are the constituents of the waste
highly toxic?
Does the existing management technology
allow major releases of waste to the
environment?
Which media are affected by releases?


Are the wastes managed in densely
populated areas?

Do the constituents have taste and
odor thresholds?
If ground-water exposures are expected,
are water supplies within close proximity?
Are wastes managed in areas of special
environmental concern (e.g., wetlands,
coastal waters, karst, flood plains)?
than lOOOkg/mo
1 million kg/mo
1 million kg/mo
Yes
No
Yes
No
Air
Surface Water
Ground Water
Urban
Rural
Yes
No
more than 1 mile
less than 1 mile
Yes
No
1 a
2 a
3 a
2 a
1 o
2 a
1 a
3 a
2 a
1 a
2 a
1 a
1 a
2 a
1 a
2 a
2 a
1 a
        High  Risk  Potential
SCORE         16  18
Medium Risk Potential
       11  - 15
Small  Risk Potential
        8 -  10

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                                              OSWER  Policy Directive /;9435 .00-1
                                     -17-
Management Criteria  Checklist

	Criteria	Ranking  Factors

1.  Who are the interested parties?

    -- Congress                                               High   2 a
                                                               Low   1 a

    -- OMB                                                    High   2 a
                                                               Low   1 a

    -- State Agencies                                         High   2 a
                                                               Low   1 a

    - Environmental Groups                                   High   2 a
                                                               Low   1 a

    -- Citizen Groups                                         High   2 a
                                                               Low   1 a

    -- Industry Associations                                  High   2 a
                                                               Low   1 a

2.  Is there a statutory hammer for this rule?                 Yes   2 a
                                                                No   1 a

3.  Is there a statutory deadline for this rule?               Yes   2 a
                                                                No   1 a

4.  Is there a. court ordered deadline for this rule?           Yes   2 a
                                                                No   1 a

5.  Does this rule increase EPA's flexibility                 Yes     2 a
    in implementing other regulatory                           No     1 o
    requirements?

6.  Is this a technical amendment to the existing             Yes     2 a
    regulations?                                               No     1 a

7.  Has OSW committed to developing this                      Yes     2 a
    rule at some point in the past?                            No     la


      Significant Mgt.  Concern     Medium Mgt.  Concern     Limited Mgt. Concern
SCORE           20 -  24                 12-19                   7 -11

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                                             OSWER Policy Directive #9435.00-1
                                     -18-
Composite  Scores

      The composite score determines whether the  rule  is considered a high, medium
or low priority by OSW.
                            High    Medium    Low
Scope & Cost
Risk
Management
COMPOSITE SCORE        HIGH            MEDIUM             LOW
standards, and require a Regula.tory Impact Analysis.   However,  in  some  cases,
OSW may consider a particular rule a high priority in terms  of  its schedule
for promulgation (e.g., fast-track rules to provide more  flexibility  in permit
modification requirements) yet this rule may be classified as  low  priority to
assign minimal Agency-wide review procedures.


3.3  PROCEDURES FOR REGULATORY  DEVELOPMENT

    As explained in Chapter Two,  under  the new Agency rulemaking process, the
Steering Committee determines the specific Agency-wide review  procedures for
all rules on a case-by-case basis.  This section recommends  the Agency-wide
review procedures that OSW believes correspond to their high,  medium,  and low
priorities.  OSW staff should recommend these procedures  to  the OSWER Steering
Committee representative.   These recommendations should be submitted  in a memo
from the Director of OSW to the OSWER Steering Committee representative.
Staff should also send a copy of this memo to OSW's Office of  Program
Management and Support (OPMS).

    The procedures described below are graphically displayed in Exhibits 3-2,
3-3, and 3-4 for high, medium, and low priority rules, respectively.   These
exhibits display optimum timelines which may not be typical  for most  rules.
The exhibits show both Agency (noted inside boxes) and OSW (noted by  bullet
points) procedures over the life of a rulemaking.  The Agency  procedures
displayed in the exhibits are those procedures that OSW recommends for each
rule classification.  As described in Chapter Two, the Steering Committee is
responsible for reviewing OSWER recommendations and assigning  the procedures
that a particular rulemaking will undergo.  The Steering Committee generally
relies on information brought to its attention by the lead office's Steering
Committee representative.  The representative suggests procedures to the full
Committee based on the lead office's assessment of the significance of a
rulemaking.  OSW has chosen to proceed further by prescribing specific Agency

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                                             19-
                                                              Policy Directive 9-33
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-------
                                              OSWER  Policy Directive #9435.00-1
                                     -20-
review procedures for the OSWER Steering Committee representative  to present
to the full Steering Committee.

    The procedures noted in the exhibits are displayed along a timeline.   The
timelines reflect OSW's estimate of the amount of time it  takes to produce a
rule beginning with subraittal of the SAR and culminating with promulgation of
the final rule.  In general, high and medium priority rules, because of  their
similarity in the procedures leading to promulgation, will take longer to
produce than will low priority rules.  Because OSW requires significantly
fewer procedures for low priority rules, the promulgation  process  is
relatively streamlined compared to high and medium priority rules.

3.3.1  High  Priority Rules

    High priority rules generally have major multi-media impacts and
significant costs associated with compliance.  In addition, high priority
rules are subject to Options Selection by the Administrator.  For this reason,
high priority rules receive the most attention during the  Agency-wide  review
process.  OSW recommends the following-Agency-wide review procedures be
applied to all high priority  rules.   (As described in Chapter Two, the
following procedures are recommended based on OSW's assessment of Agency
procedures that are suitable for a high priority rulemaking.)


              Start Action Request  (SAR)          -
              Convene Workgroup           
              Development Plan
              Workgroup Reports
              Options Selection
              Workgroup Closure .
              Red Border Review
              OMB Review


    OSW's internal procedures for  high priority rules are  designed to raise
issues for attention by  senior  management early  in the development process.
OSW staff are encouraged to present options,  identify issues and prepare  an
analysis of the risk and cost  conditions specific to the  rulemaking effort
underway to the Division Director and Office  Director as  soon  as possible.
High priority rules will require Division Director approval  at  each step  in
the process, e.g., SAR, Development Plan, Options Selection.   In addition to
Agency procedures, internal OSW procedures  include:  monthly workgroup
meetings; monthly status briefings  and  frequent  issue papers;  and  analyses and
written documents, including a Regulatory  Impact Analysis  (RIA).   As  described
in Chapter Two, the RIA is required for major rules  by Excecutive  Order 12291.
                                                                *
    Workgroups for all high priority rules  should have broad membership and
consist of individuals  from all OSWER .offices, OGC,  OECM,  OPPE, all program
offices, the Regions, and other Agencies  and  State governments as
appropriate.  The workgroup should  meet monthly  (or  as needed)  to  review

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                                              OSWER Policy Directive  #9435.00-1
                                     -21-
on-going analyses and when appropriate, draft the preamble and rule.   The
workgroup should spend the first six months preparing the development plan and
identifying options and issues regarding the rulemaking.   Workgroup members
should decide which issues to present to the Administrator and address the
remaining issues themselves.  The workgroup prepares a workgroup report to
inform the Steering Committee of its discussions regarding potential Issues
for the options paper.  Chapter Four describes how to submit the development
plan to the Steering Committee for review.

    Development of the options paper is the next step.  The options paper is
developed by the workgroup and then submitted to the OSW Office Director and
Assistant Administrator for OSWER.  Both officials also receive a briefing on
the options paper.  After the options paper and briefings have been delivered,
the workgroup holds an options selection meeting.  Chapter Four provides a
detailed discussion of how to develop an options paper and transmit it for
review.

    The options selection meeting defines the goals and objectives of the
rulemaking.  Once the overall scope of the rule is decided, the workgroup can
resolve the remaining technical issues, which generally requires about four
months.  During this time, all analytical studies.should be completed so the
workgroup can begin drafting the preamble and rule.  High priority rules will
require routine monthly status briefings to the Office Director and issue
briefings prior to Options Selection.  If necessary, issue briefings can be
delivered after Options Selection when a rule is particularly complicated, or
when issues are controversial.

    After workgroup closure, the decision package is drafted.  The decision
package should be circulated to the workgroup for review and comment.  The
analyses and written documents should include a development plan, options
paper, supporting analytical papers (RIA), and background document.

    A summary of these internal procedures and the timing of those procedures
follows.
         Workgroup

             Broad membership in workgroup including
              representatives from all OSWER offices, OGC, OPPE,
              OECM, all programs, the Regions, other Agencies and
              State governments as necessary; and

             Minimum of monthly workgroup meetings.

         Briefings and Status Reports

             Bi-monthly status reports to the Division Director
              on the rule and supporting analyses;

             Monthly status reports to the Office Director;

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                                             -22-
                                                      OSWER  Policy.Directive 9-35
UJQ
  UJ

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                                              OSWER  Policy  Directive #9435.00-1
                                     -23-
             Quarterly status reports to the Assistant
              Administrator;

             Management briefings on issues, decision package and
              analyses prior to Options Selection meeting,  workgroup
              closure, Red Border and OMB reviews;  and

             Management briefings on preamble,  rule,  dnd analyses.

         Analyses and Written Documents

             Development Plan/Options Paper/RIA/Background
              Document;

             Early review of analyses; and

             Issue papers as necessary.


3.3.2  Medium Priority Rules

    Medium priority rules are similar in significance to high priority rules,
however, the review process is not as resource intensive.  The primary
difference between medium and high priority rules is that medium priority
rules are not subject to Options Selection by the Administrator; however, the
workgroup should still conduct an informal options selection process.   OSW
recommend the following  Agency-wide review procedures  for  review  of.medium
priority  rules:


              Start Action Request (SAR)
              Convene Workgroup
              Development Plan
              Workgroup Report
              Workgroup Closure
              Red Border review
              OMB review


    OSW's  internal procedures for reviewing medium priority rules include:
conducting quarterly status briefings and issue briefings for the Office
Director as issues arise; and preparing analysis and written documents,
including an RIA.  As discussed in Section 3.2, both high and medium priority
rules, as characterized using OSW's criteria, are likely to require an RIA.
The workgroup should consist of members from all OSWER offices, OGC, OECM,
OPPE, all programs, the Regions, and other Agencies and State governments as
necessary.   The workgroup should meet quarterly (or more frequently if
appropriate) to identify options and issues and review supporting analyses
regarding the rulemaking.  The workgroup is responsible for preparing the
development plan, making decisions regarding regulatory options, and reviewing
the decision package.  If the workgroup cannot reach consensus on the options
and issues, the chairman should raise the unresolved issues to the Steering

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                                              OSVER  Policy Directive #9435.00-1
                                     -24-
Committee as quickly as possible.   The role of the Steering Committee  is
explained in Chapter Two.   One of  its roles is ensuring that,  when
appropriate, significant issues associated with a rulemaking are resolved.
When the workgroup or the lead office cannot resolve a rulemaking issue,  the
issue is elevated to the Steering  Committee.  Workgroup reports  are the
mechanism for raising issues to the Steering Committee.  Medium  priority  rules
require routine, quarterly status  briefings and issue briefings  for the Office
Director prior to any Steering Committee meetings that may be required.

    Finally, a decision package should be circulated to the workgroup  for
review and comment.  The analyses  and written documents include  a development
plan, RIA, and background document.

    A summary of these internal OSW procedures follows.


         Workgroup

             Broad membership on  workgroup including
              representatives from all OSWER Offices, OGC, OPPE,
              OECM, all programs,  the Regions, other Agencies and
              State governments as necessary; and

             Quarterly workgroup  meetings.

         Briefings and Status Reports

             Monthly status reports to the Division Director on
              the rule and supporting analyses;

             Quarterly status reports to the Office Director;

             Briefings for the Assistant Administrator as
              necessary; and

             Management briefings on issues, decision package and
              analyses prior to Steering Committee, Workgroup
              Closure, Red Border and OMB reviews.

         Analyses and Written Documents

             Development Plan/RIA/Background Document;

             Early review of analyses; and

          .  Issue papers as necessary.


3.3.3  Low Priority Rules

    Low priority rules typically  implement  generic  policies  established  in
other rules such as listings, delistings,  relistings  and  bans for specific

-------
                               -25'
                                       CSWER Policy Directive 9-35 . 33
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-------
                                              OSWER  Policy Directive #9435.00-1
                                     -26-
wastes.  OSW recommends a limited Agency-wide review of low priority  rules
because these rules are generally routine.
                                                                                i

             Start Action Request (SAR)                                         j
             Convene Workgroup                                                 "
             Red Border Review
             OMB Review


    As with high  and medium priority rules,  OSW  also has  specified internal
review procedures for  low priority rules.   Those procedures  include
quarterly status briefings and issue briefings for the Office Director  as
necessary, and preparing written analyses.   The workgroup membership is
somewhat limited but should at a minimum include  individuals from all OSWER
offices,  OPPE, OECM, OGC, and selected program offices.   The workgroup  should
meet initially to discuss the status of the rulemaking and the schedule for
completion.  The major role of the workgroup for  low priority rules is  to
review and comment on the decision package prior  to Agency concurrence  and OMB
review.

    Low priority rules require infrequent status  briefings for the Office
Director since it is assumed that fewer issues will be raised as these  rules
are developed.  Analyses and written documents for low priority rules include
a cost analysis  and background document.   Issue papers may be generated during
the regulatory development process and circulated to the workgroup for  review
as necessary.                                                                  ^

    A summary of these procedures follows.


         Workgroup

             Limited membership on workgroup including all OSWER
              offices, OPPE, OECM, OGC and selected programs; and

             Limited number of workgroup meetings.

         Briefings and Status Reports

             Quarterly status reports to the Division Director on
              the rule and supporting analysis;

             Quarterly status reports to the Office Director;  and

             Management briefings on issues and analyses prior to
              Assistant Administrator concurrence.

         Analyses and Written Documents

             Cost analysis;

             Background document; and

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                                              OSVER  Policy Directive #9435.00-1
                                     -27-
             Issue papers as necessary.
               \

    Exhibit 3-5J is a summary of OSW's internal procedures  for  rulemaking.  The
summary reflects the timing of internal procedures  for high, medium,  and  low
priority rules.'


3.4  PROCEDURES FOR GUIDANCE  DEVELOPMENT

    OSW has defined three categories of guidance documents  and established
procedures that vary for each of those categories.   The three  categories  are:
statutory/regulatory guidance; procedural and technical guidance;  and
technical resource documents.  The following sections of this  chapter describe
each of these categories in greater detail and discuss the  procedures for
developing the guidance.  Brochures, fact sheets, and periodic status reports
are not considered guidance documents.  These documents simply provide
information to the public on existing regulations and policies.   Examples of
these public information documents include:   Understanding  the Small  Quantity
Generator Hazardous Waste Rules: A Handbook for Small Business,  Asbestos  Waste
Management Guidance, and Fact Sheet on the Land Disposal Restrictions Program:
Questions and Answers.

3.4.1  Classification  of  Guidance Documents

    Statutory/Regulatory Guidance Documents.  There are four criteria that
define statutory and regulatory guidance.  A planned guidance  document may be
classified in this category if it meets any one of  the following criteria:
(1) The guidance will have a significant impact on  other EPA regulatory
programs, for example,  air emissions; (2) the guidance is  mandated by the
statute; (3) the guidance is a new policy that interprets  a specific  statutory
provision or a technical regulation; and (4) the guidance imposes a
significant economic impact on the regulated community.

    Procedural and  Technical Guidance Documents.   There are three criteria
that define procedural  and technical guidance.  A planned guidance document  is
classified in this category if it meets any one of  the following criteria:
(1) The guidance describes administrative procedures to implement and comply
with regulatory requirements; (2) the guidance describes OSW-  or Agency-
approved technologies',  and (3) the guidance addresses quality  assurance
issues, e.g., sampling  procedures or chain of custody procedures.

    Technical Resource  Documents.   Technical resource documents  provide or
describe data, information, and results of technical and scientific
experiments or studies,  including case studies.

3.4.2  Initiating Development of  Guidance Documents

    Twice a year, the Office of Program Management and Support (OPMS) requests
Division Directors to identify all guidance documents their staff plan to
begin developing over the upcoming six months.  This request coincides with
the preparation of the  Semi-Annual Regulatory Agenda.  In preparing these

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                                    -28-
                                             OSWER Policy  Directive ?;9435.00-1
                                 EXHIBIT  3-5

                       SUMMARY OF  OSW PROCEDURES
                               FOR RULEMAKINGS
OSW Procedures

Workgroup Meetings

Status Reports
 - Division Director
 - Office Director
 - Assistant Administrator

Brief Division Director,  Office
 Director, and Assistant
 Administrator prior to
Brief Division Director, Office
 Director, and Assistant
 Administrator
  High
Priority
  Rules

Monthly
Semi-monthly
Monthly
Quarterly

Options
Selection,
Workgroup
Closure, and
Red Border
Review

Workgroup
Closure,
Red Border
Revie'w
 Medium
Priority
  Rules

Quarterly
Monthly
Quarterly
As Necessary

Red Border
Review
  Low
Priority
  Rules

Limited
Quarterly
Quarterly
Red Border
Review
Steering
Committee
Red Border
Review
Agency Con-
currence

-------
                                              OSVER Policy Directive #9435.00-1
                                     -29-
 lists,  the  Division  Directors should recommend the classification of each
 document.

     The Office  Director will evaluate the list of guidance documents,
 determine if  the  recommended classifications are appropriate, and attach a
 form either approving or disapproving the project.  OPMS will then submit the
 guidance document  lists to  the Office Director for review and approval.  Upon
 completion  of this process, OPMS will send the Division Directors a copy of
 the  standard  form which indicates approval or disapproval for the development
 of the  guidance,  the document's classification, and the appropriate review
 procedures.

     Once the  Office  Director approves the development of a guidance document,
 the  Division  Directors must incorporate milestones for the project into the
 OSW  workplan  system.  The OSW workplan system is an internal version of the
 Administrator's Tracking System which is explained in Chapter Five.  The
 workplan should identify all major steps in the project, reflecting the
 different levels of  review  for each step, and include projected completion
 dates for the guidance document.

 3.4.3   Procedures for  Review of OSW Guidance  Documents

     This next section outlines the varying review procedures for each "category
 of guidance.  All statutory/regulatory guidance documents are subject  to
 Agency-wide review procedures whereas procedural and technical guidance and
.technical resource guidance documents are subject only to OSW's internal
 review  procedures.   All procedures described below apply to both proposed and
 final guidance.  Exhibit 3-6 is a summary that reflects the timing of  OSW's
 internal procedures  for reviewing guidance documents.

     Statutory/Regulatory  Guidance Documents.  Statutory/regulatory guidance
 documents are subject to Agency-wide review procedures.  Therefore, staff must
 prepare a Start Action Request (SAR) for approval by the Office Director.
 Once approved,  the SAR is submitted to the Steering Committee for  review and
 approval.   As explained in Chapter Two,- the Steering Committee determines
 appropriate Agency-wide review procedures upon receipt of the SAR.  Staff
 should  define the priority of each statutory/regulatory guidance document
 using the criteria outlined in section 3.2 of Chapter Three and recommend the
 appropriate Agency-wide review procedures as outlined in sections  3.3.1,
 3.3.2,  or 3.3.3 of Chapter Three.  Exhibit 2-1 displays the menu of potential
 Agency  review procedures.

     Because statutory/regulatory guidance documents are subject to Agency-wide
 review  procedures, OSW recommends to the Steering Committee, through the OSWER
 Steering Committee representative, the Agency review procedures that OSW
 thinks  are  appropriate for a particular guidance document.  The OSW
 recommendations are  based on an evaluation of the guidance document using OSW
 criteria checklists  covering scope and cost, risk, and management  concerns.
 These checklists are explained in Section 3.2 and blank forms are  included  in
 Appendix D.   The checklists enable OSW to assign a composite score to  the
 guidance document; the score determines whether the guidance is a  high,
 medium, or  low priority document.

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                                              OSWER  Policy Directive #9435.00-1
                                     -30-
    OSW's internal procedures for statutory/regulatory guidance  documents  are
designed to ensure that all interested offices have an opportunity  to
participate in the development of the guidance.   Workgroups  should  have  broad
membership and consist of individuals from all OSWER offices,  the Regions,
OGC, OECM, OPPE, and all .interested program offices.   The Steering  Committee
will review OSW's recommended workgroup membership to ensure adequate
representation from key offices.   Adequate representation is intended  to
provide early identification of cross-media issues that must be  resolved prior
to issuance of the guidance document.  The workgroup chairman should maintain
written minutes of workgroup meetings.  The.workgroup chairman should  make
arrangements for teleconferencing so that workgroup members  located outside of
Washington, D.C. may fully participate.

    The workgroup chairman -should conduct bi-monthly status  briefings  for
his/her Branch Chief and Division Director and monthly status briefings  for
the Office Director.  At the Office Director's request, staff should prepare
quarterly status briefings for the Assistant Administrator.   Staff  should
prepare management briefings for his/her Division and Office Directors as well
as the Assistant Administrator on significant issues before  submitting the
decision package for Red Border and OMB review.   Sections 4.3 and 4.4  provide
guidance on preparing briefings and decision packages for Red Border and OMB
review.

    Procedural and  Technical Guidance Documents.  This category of guidance
documents is issued by either the Office Director, or if. more appropriate,
Assistant Administrator.  The Office Director is responsible for making the
final decision regarding the appropriate signature .requirements  for a document

    OSW's internal procedures for this category of guidance  are  designed to
encourage broad participation in its development and alert senior managers to
significant issues early in the process.  The workgroup should include
representatives from all OSWER offices, the Regions, OGC, OPPE,  and OECM.  The
workgroup chairman should maintain written minutes of workgroup meetings.  The
workgroup chairman should make arrangements for teleconferencing so that
workgroup members located outside of Washington, D.C. may fully participate.

    The workgroup chairman should conduct quarterly status briefings for the
Branch Chief and Division Director.  At the Division Director's request, staff
should prepare quarterly status briefings for the Office Director.  Staff
should prepare management briefings  for the Division and Office Directors as
significant issues develop.  The Office Director may request that staff
prepare an issue briefing for the Assistant Administrator if unresolved  issues
are likely to result in significant  negative  reaction  to the  final  guidance
document.

    Technical Resource Documents.   This category of guidance documents is
usually issued by the Office Director  but can be  issued by  the Assistant
Administrator if appropriate.  The Office Director  is  responsible  for making
the final decision regarding the document's signature  requirements.

-------
                                                     OSVZR Policv Directive  -V9-.35 . 00 - 1
                                           -31-
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                                              OSWER  Policy Directive #9435.00-1
                                     -32-
    OSW's internal procedures for this category of guidance  are minimal,
primarily because most guidance in this category is developed  by  other
offices, such as the Office of Research and Development  (ORD).  Workgroup
membership should include all OSWER offices, and ORD if  appropriate.  The
workgroup chairman should maintain written minutes of workgroup meetings and
make arrangements for teleconferencing so that workgroup members  located
outside of Washington, D.C. may fully participate.

    The workgroup chairman should conduct quarterly status briefings  for the
Branch Chief.  Upon request by the Branch Chief, staff should  prepare
quarterly status briefings for the Division Director and/or  the Office
Director.  Staff should prepare management briefings for the Branch Chief  and
Division Director as significant issues develop.  The Division Director may
request that staff prepare an issue briefing for the Office  Director  and
possibly the Assistant Administrator if unresolved issues are  likely  to result
in significant negative reaction to the final guidance document.

3.4.4  Guidance Document Format

    Each guidance document must be accompanied by an Executive Summary  ranging
from one to five pages in length.  The Executive Summary must  contain the
following information: (1) A brief statement on the purpose  of the guidance;
(2) a summary of the contents of the document; (3) a discussion  on the  degree
of flexibility intended for users of the document, i.e., clear explanations of
cases where the guidance is merely a suggestion and cases where  it is required
because the guidance represents the only "acceptable" method or  procedure
known to the Agency; and (4) information regarding the availability of  the
guidance document to both the regulated community and members of the  public.

3.4.5  Distribution  of Guidance Documents

    OPMS will assist staff by arranging the appropriate distribution system
for each guidance document.  There are two main distribution systems: the
OSWER Policy Directives Service, used primarily for the Regions and States;
and the National Technical Information Service  (NTIS), used primarily for the
regulated community and the public.  Occasionally, OSWER Policy Directives are
also distributed through NTIS.  NTIS charges a  fee for each document
requested.  OPMS will assign an OSWER Policy Directives Number and possibly  an
OSW publication number depending on the distribution system selected.

    In addition, each division should prepare a monthly Federal Register
notice to announce the availability of recently completed guidance documents
in their division.  If the Division originating the guidance document chooses
to solicit public comment by publishing the guidance document in the Federal
Register, that Division is responsible for  preparing the Federal Register
package.  Instructions for preparing a Federal  Register package  are  provided
in section 4.5 of Chapter Four.

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                                              OSWER Policy Directive  #9435.00-1
                                     -33-
3.5  RUNNING A WORKGROUP

    To meet its  responsibilities as described in Chapter Two, workgroups need
to function smoothly and effectively.  At the same time, workgroups are
expected to provide a forum for raising issues that may be the source of
disputes or conflicts between program offices or between EPA and other
agencies.

    The responsibilities of the workgroup chairperson are considerable.
Typically, the chairperson not only must manage the whole process for
successfully completing the workgroup's tasks, but must represent and advocate
a particular office's point of view during the process.  At the same time, the
chairperson is expected to facilitate the resolution of issues raised in
workgroup meetings and help the workgroup reach closure on the decision
package.  For high priority rules, the chairperson must also assist the
workgroup in reaching consensus on a preferred option.  The dual role of
facilitating consensus while advocating a point,of view places special demands
on the workgroup chairperson.  To meet the goal of early identification and
resolution of issues, the chairperson should be able to encourage the airing
of all workgroup members's ideas and opinions.

    The workgroup chairperson should make an effort to ensure that members are
selected from every office that has an interest in, is affected by, or can
make a contribution to the development of a rule or guidance document.
Realistically, not every office that meets one of the above criteria will
necessarily want to commit a staff person to full, or even partial,
participation in the workgroup.  If a chairperson knows that an office is
affected by a rule but unable to assign someone to the workgroup, the
chairperson will want to keep that office apprised of significant workgroup
developments and decisions so that issues can be surfaced early in the
process.  On the other hand, the chairperson should advise offices that do not
participate in the workgroup that their non-participation will significantly
undercut any objections they might raise during a Red Border review.

    To obtain the best rule or guidance possible, the workgroup chairperson
should pay careful attention to the composition of the workgroup.  Given the
workgroup's responsibilities to scope out issues and options, identify needed
analyses, and address cross-media concerns, the workgroup chairperson should
ensure adequate  representation of a diversity of perspectives.  Because rules
and guidance must be not only technically sound, but fair, practical, and
implementable, the workgroup chairperson should take into account the
technical, program, and policy background of potential workgroup members and
the depth of their "real-world" experience in ensuring the requisite diversity
of perspectives.

    The larger the workgroup, the greater the challenge for  a chairperson to
coordinate workgroup activities and forge consensus among its members.  The
concern over workgroup size, however, should not prevent adequate
representation of agencies and offices outside of EPA Headquarters  in  the
workgroup.  With ten EPA Regions and hundreds of local, State, and Federal
agencies that potentially could be interested in or affected by a rule,

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                                              OSWER Policy  Directive #9435.00-1
                                     -34-
however, it may be necessary in some cases to limit the actual  number  of
non-EPA Headquarters' participants.   Particularly with rules  of major
significance, the workgroup chairperson may need to encourage the search  for
workgroup members who are representative of perspectives held by a broader
class of interests than simply their own agency or office,  as a way of
limiting workgroup size.  If these workgroup members can be designated by
other agencies or offices as their representatives in the workgroup process,
then their participation will further enhance the value of any consensus
reached by the workgroup.  As representatives, however, it will be especially
important for them to consult frequently with the other agencies or offices
they represent.

    In addition to contributing their expertise and experience, workgroup
members are expected to convey the opinions and perspectives of the offices or
agencies they represent.  Members should also keep their offices and agencies
apprised of workgroup progress and problems in developing a rule or guidance.
The role of workgroup members as go-betweens will be particularly crucial when
workgroup decision-making requires negotiations about approaches or positions
taken by offices or agencies represented by workgroup members.   Accordingly,
workgroup members should be selected for their ability to effectively convey
the perspectives and articulate the interests of their office or agency,  while
at the same time being capable of understanding and incorporating the
perspectives and interests of others.  Ideally, workgroup members working in
this way can synthesize a better rule or guidance by building on the strengths
of each other's ideas, analyses, and approaches.

    Having a chairperson who can effectively manage group decision-making and
workgroup members who are able to represent their offices effectively as they
consider other perspectives, lays the groundwork for conflict resolution.  The
objective of surfacing conflicts early is itself a conflict  resolution tool,
because conflicts are easier to resolve before opposing viewpoints or
positions have become entrenched.  Conversely, the closer a  workgroup is to
reaching closure, the more difficult it will be for the members  to reconsider
decisions or reevaluate assumptions they adopted earlier.  It  is  inevitable,
however, that conflicts will arise.

    Once a conflict has emerged, there are several activities  a  workgroup  can
engage in to try to resolve it:


             Conflict definition;

             Issues analysis;

             Development of resolution criteria;

             Option brainsterming;  and

             Option synthesis.

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                                     N         OSVER Policy Directive  #9435.00-1
                                     -35-
    Defining a conflict is a critical but often overlooked step in resolving
conflicts.  A conflict can be rooted in the different assumptions, data, or
goals held by workgroup members.  The conflict often emerges, however, as a
disagreement over the preferred regulatory or guidance option.  To resolve
such a conflict, it is important for workgroup members to determine the basis
of the disagreement.  Until the basis of the conflict is defined, e.g., a
disagreement over data, differing objectives, problem definition, or some
other source of conflict, it will be difficult to resolve.

    Assuming a conflict has been defined, workgroups can use detailed issues
analysis as another resolution tool.  What may on the surface seem to be
mutually incompatible positions are often resolvable when broken down into
issues and analyzed separately.  By breaking a disagreement down into
component issues, workgroup members may detect additional areas of needed
technical analyses or data gaps.  Separating out issues also allows subgroups
of the workgroup to focus on resolving different issues without taking up all
of the time at general workgroup meetings.  Finally, breaking a conflict down
into component issues allows the workgroup members to-discover hidden areas of
agreement, to determine where it is possible to agree to disagree, and to
narrow the scope of issues that need to be elevated to higher management
levels for resolution.

    Having analyzed the issues that comprise a conflict and identified those
that are not easily resolved through further analysis, conflicts can sometimes
be resolved by developing resolution criteria.  The purpose of this activity
is co separate a workgroup's decision from the criteria used to make that
decision.  If the workgroup resolves an issue by simply choosing between
opposing viewpoints or options, then consensus is not achieved.  If, on the
other hand, the workgroup can achieve consensus first on what criteria should
be used to fairly judge the adequacy of any given approach or option, the
workgroup members can resolve their differences more effectively as options
are debated against those criteria instead of each other.  The issues analysis
step usually contributes immensely to the development of resolution criteria.

    Sometimes conflicts can- be resolved not by narrowing the choices but by
expanding them.  If, for example, the options development phase has not
produced a sufficiently diverse or rich field of choices, the inability of the
workgroup to select a preferred option may reflect the fact that no single
option yet developed adequately addresses the problem the regulation or
guidance document is designed to resolve.  At this point, brainsterming
additional options or approaches can provide the missing-facets of a rule or
guidance that would enable it to gain wide approval.  True brainstorming sets
aside consideration of current options and concentrates on developing novel,
innovative, untried, or unusual options.  After generating as many new options
as possible, the workgroup then evaluates the new options, and compares them
with current options.  If resolution criteria were developed previously, they
will be useful in evaluating any new options generated through brainstorming.

    In many cases, no single option, whether developed initially or developed
later in the process as a means for conflict resolution, will be clearly
superior to other options.  Option synthesis is often overlooked  in these

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                                              OSWER Policy  Directive  #9435-90-1
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situations as not only a. way of resolving a conflict but of improving the rule
or guidance itself.  Combining, incorporating,  or modifying options  to take
advantage of each other's strengths is a technique for reaching consensus
because it makes possible the inclusion of everyone's ideas and interests,
rather than choosing among them.

    If none of these methods for resolving a conflict is successful, the
workgroup needs to raise the issue to a higher management level for
resolution.  The previous efforts of the workgroup to resolve the conflict,
however, will still be extremely helpful.  Higher level managers should find
their decision-making made easier because the workgroup has already  defined
and analyzed the conflict, generated options for its resolution, and developed
criteria for evaluating those options.  For this reason, it will be  important
for adequate written documentation to be kept of workgroup discussions and
decisions so that higher level managers can share in the reasoning and
analysis behind both workgroup consensus and conflict.


3.6  RCRA INFORMATION  ClNTER

    All rules must make a record of the rulemaking available to the public.
The ruleraaking record for OSW rules is contained in the RCRA docket.  The RCRA
docket is part of the RCRA information center which is  located in LG-100 at
EPA Headquarters.  The RCRA Information Center is maintained by the Office of
Program Management and Support  (OPMS).  The Center also includes OSWER Policy
Directives; Reports to Congress; and RCRA public information.  The RCRA
Regulatory Docket and the OSWER Policy Directives System are described in
greater detail below.

    Regulatory Docket.  The Regulatory Docket contains  four types of
information regarding rulemakings.  (1) records of all  OSW rulemakings;  (2)
administrative records resulting from litigation on individual rules;  (3)
petitions from the public on OSW regulations and associated material  such  as
EPA's response to those petitions; and (4) other regulatory materials  as
appropriate.  OSW staff developing rules are responsible for providing OPMS
the appropriate information to  establish the docket for their  rule.   Specific
submittal requirements will be  addressed below in more  detail.

    Records of rulemaking include:


             Comprehensive index  of  all documents placed  in the
              Docket;

             Items to be published in the Federal Register;

             Supporting documents such  as the RIA  and Background
              Document;

             Correspondence and meeting summaries;

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                                              OSVER Policy Directive ,%'9435.00-1
                                      -37-
              Public hearing transcripts  and list  of  attendees  and
               speakers;

              Public comments;  and

              Other materials as  appropriate.


     All documents placed in the Docket  are numbered  to  correspond to  the
 Comprehensive Index.  Items to be published in  the Federal  Register  include:
 Advanced Notice of Proposed Rulemaking  (ANPRM);  Notice  of Proposed Rulemaking
 (NPRM); Notice of Intent to extend or reopen public  comment period;  Interim
 Final Rule;  Final Rule;  Notices of Availability,  e.g.,  titles  and dates of
 guidance documents, including the numbers assigned to those documents  by  the
 National Technical Information Service  (NTIS) or the  Government Printing
 Office  (GPO); and Correction Notices.   Supporting documents include  the
 Regulatory Impact Analysis  (RIA)  or other economic analyses performed;  the
 Background Document for  the rulemaking  which is  a comprehensive response  to
 all public comments; technical resource documents  or  guidance;  the Regulatory
 Flexibility Analysis;  and any relevant  contractors'  reports or  other  analyses
 used in developing the rulemaking.

     Correspondence and meeting summaries  are also an  important  part  of the
 regulatory docket.  In many cases,  staff  will either  meet with  or receive
.phone calls  from members of the public  or the regulated community that result
 in additional public comments on  the rulemaking.   It  is essential that staff
 write a memorandum to the docket  detailing those comments to ensure  that  the
 docket  contains all public  comments received on  the  rulemaking. Additional
 correspondence that staff should  submit to the  docket include:   critical
 internal memoranda of a  factual nature; lists of participants  in any external
 meetings regarding the rulemaking;  summary minutes of meetings  held;  and  trip
 reports that directly relate to the rulemaking.

     In  addition, staff may  receive phone  calls  from  interested parties outside
 the Agency regarding changes in the rule  from proposal  to final rule.   Any
 discussion of this information with outside parties  prior to promulgation of
 the final rule is considered ex parte communication  and is  prohibited under
 the Administrative Procedures Act.   If  staff have any questions regarding ex
 parte communications,  they  should contact the attorney in the Office of
 General Counsel (OGC)  assigned to their rule.

     The OPMS will acquire transcripts of  any public  hearings held on
 individual rulemakings and  include them in the  docket.   This docket  entry will
 include a list of speakers  at the hearing and the attendees.  In addition,
 OPMS receives all written public  comments submitted  on rules.   The  Docket
 Clerk will provide staff with one copy  of every public comment at the close  of
 the comment  period.  If  other arrangements are  necessary, staff should contact
 the Docket Clerk as soon as possible.

     Th'e comprehensive index, items to be  published in the Federal  Register.
 and supporting documents must be  placed in the  docket prior to publication of

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                                              OSWER  Policy Directive ?;9435.00-1
                                     -38-
the items in the Federal Register.   A hard copy of the rulemaking itself  is
acceptable but should be replaced with the Federal Register typeset  version  as
soon as it becomes available.   Correspondence,  meeting summaries, public
hearing transcripts, and public comments must be placed in the docket  within
three days of receipt.   Staff should notify the Docket Clerk one month in
advance of the projected Federal Register publication date in order  to allow
sufficient time to create the docket for that rule.  The Docket Clerk  will
enter the documents into the automated indexing system and arrange them in an
appropriate format for public viewing.

    The docket is open from 9:30 - 3:30 Monday through Friday, except  for
Federal holidays.  The public must make an appointment to review docket
materials.  The public may copy a maximum of 50 pages of material from any one
regulatory docket at no cost.   Additional copies cost $.20 per page.

    OSVER Policy Directives System.  The RCRA Information Center also
maintains a comprehensive inventory of all RCRA guidance documents.   Each of
these documents must receive an OSVER Policy Directives Number.  OPMS  is
responsible for assigning the OSWER Policy Directives Number and must  receive
a brief description of the document along with one copy when completed.  At
least two months prior to publication of the guidance document, staff  should
contact OPMS to arrange for distribution and assignment of the Policy
Directives Number.  The Policy Directives Number must appear in  the
transraittal memo, on the title page, and in the upper right hand corner of
each page of the document.  OPMS should be informed as guidance  documents are
revised or withdrawn, and when they become obsolete.

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                                              OSWER  Policy Directive #9435.00-1
                                     -39-
                                 CHAPTER FOUR

     PREPARING  SUPPORTING ANALYSES, DOCUMENTS, AND  BRIEFINGS
    This chapter describes the documents and analyses  that  are  part  of  a
rulemaking.  Each of the following sections discusses  a different document,
the purpose for creating that document,  and the format and/or elements  that
must be presented in the document.  The  information for this chapter is
primarily derived from guidance and policy memoranda published  by EPA
offices.  A bibliography of the specific memoranda used is  provided  in
Appendix B.  In addition, samples of each of the documents  discussed in this
chapter are provided in the RCRA docket.  Appendix E lists  the  specific titles
of the sample documents provided in the  docket.  Appendix E is  located  in  OPMS.


4.1  TYPES OF ANALYSES NEEDED

4.1.1  Development Plan

    The Development Plan provides the framework for developing  proposed
rules.  It explains the need for action; identifies regulatory  goals and
objectives; presents .the major regulatory issues and alternatives;  identifies
any policies,  decision criteria or other factors that  will  influence
regulatory choices; and presents the workplan for developing the  regulation.
Chapter Three explains when OSV must prepare development plans.

    The workgroup chairman is responsible for preparing the development plan.
The plan is generally prepared with assistance from the workgroup.   The
workgroup chairman should obtain concurrence on the development plan from  his
Division Director before sending 25 copies to the Steering  Committee for
review.  OSW staff will use the approved development plan to identify the
milestones for regulatory development.

    OSW should submit the development plan for Steering Committee  review
within 60 days of SAR approval.  The Steering Committee review  period is two
weeks.  Steering Committee members review the package  to ensure that it is
complete and to identify questions or issues.  OSW then briefs  the  Steering
Committee on the development plan during the Steering Committee biweekly
meeting.  The Committee agrees upon an appropriate schedule for workgroup
reports and other review steps.  The development plan for the mining waste
regulatory development effort is provided in Appendix E as  an  example.

4.1.2  Workgroup Reports

    Workgroup reports keep the Steering  Committee informed about  workgroup
progress on a regulatory action.  The reports describe issues  and alternatives
being addressed and resolved; any issues that need to be elevated for
resolution; and the status of on-going work and any anticipated delays.  OSW

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                                              OSWER Policy Directive #9435.00-1
                                     -40-
must submit 25 copies of the workgroup report to the Steering Committee within
one month following each workgroup meeting.

4.1.3  Options Papers

    The options paper outlines the various regulatory alternatives and is the
key document used -by Agency officials to decide the structure of a proposed
rule.  Its principal audience consists of the attendees at the Options
Selection meeting (i.e., the Administrator, etc.).   Therefore, it should be as
specific and concise as possible.  This paper includes an executive summary of
the issues presented and a short history of the rulemaking that establishes
the context of the issues as they apply to the rulemaking.

    The options paper reflects the results of workgroup discussions on issues
surrounding a particular rulemaking.  The workgroup is responsible for
selecting the issues and developing regulatory options for the options paper.
First the workgroup must identify all of the potential issues regarding the
proposed regulatory action.  The workgroup then defines each issue and uses a
triage approach to identify the most significant issues for inclusion in the
options paper.  After selecting the issues for the options paper, the
workgroup develops several regulatory approaches that address each of the
issues.  The workgroup also identifies the pros and cons of each regulatory
approach and then recommends a regulatory approach to resolve each issue.
Once the workgroup agrees on the selection of issues and the recommended
approach, the workgroup chairman, often with help from the workgroup members,
develops the options paper.     '                     '

    OPPE has developed guidance that addresses a standard format for options
papers.  The issue discussion is presented first, followed by the recommended
approach.  The paper also addresses the other options applicable to that issue
that were considered, and the data that was used to evaluate the options.  For
example, any studies or analyses that are applicable to the recommended option
are discussed.  In addition, the uncertainties in the data used to evaluate
the options are candidly discussed.  A rationale for the recommendation
follows the discussion of the applicable data.  The rationale includes
background information that may be necessary to explain the recommended
option, as well as a description of the pros and cons of the  recommended
option.  The pros and cons address:  health, environmental, and economic
impacts of the option; reporting and recordkeeping burdens; implementation and
enforcement strategies; and impact on and consistency with other regulatory
programs.  For each of the options that was not selected, these pros  and cons
should also be briefly discussed.  Finally, where options can be compared
quantitatively (i.e., in terms of risk, cost, etc.), a matrix depicting  each
option is suggested.

    After the workgroup reviews the options paper, the workgroup chairman
submits the options paper to the Office Director and the  Assistant
Administrator.  The chairman then schedules a briefing for each  of those
individuals prior to the Options Selection meeting.  All  issues  and potential
conflicts should be addressed in those briefings.   In  addition,  the workgroup
chair distributes copies of the options paper to the participants  in  the
Options Selection meeting.

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                                              OSWER Policy Directive  ?;9435.00-1
                                     -41-
    The options paper for the Subtitle D municipal landfill rulemaking is
provided in Appendix E as an example.

4.1.4  Regulatory  Impact Analysis  (RIA)

    The RIA is a tool to identify the specific impacts of potential regulatory
actions.  The RIA:
             Characterizes the pre-regulated community (i.e.,
              size, financial conditions) and human health and
              environmental risks associated with the regulated
              community;

             Identifies existing State requirements covering the
              regulated community;

             Evaluates Che quantitative and qualitative costs,
              impacts, and risks of viable regulatory and
              non-regulatory options; and

             Compares the costs and risk reduction benefits of the
              rulemaking, reviews options considered, and
              systematically discusses qualitative considerations.


The RIA produces "better" regulations by ensuring that regulations have more
benefits than costs, and that regulations are as simple and as easy to
implement, enforce, and monitor as possible.

    An RIA consists of three aspects:  (1) an analysis defining the problem
being addressed through regulation, (2) an analysis of benefits and costs of
rulemaking, and (3) a rationale for selecting the preferred regulatory
approach.  Although the Office of Policy, Planning and Information (OPPI) has
the lead on RIAs, OPPI and the lead office must work closely together to
ensure that the RIA is an integral part of regulatory development.

    There are several steps OSW managers and staff can take to better utilize
RIAs in making regulatory decisions:


             Regulatory impact considerations should be fully
              explored during initial planning and should be
              tailored based on OSW's priority ranking.  Staff must
              identify key milestones in the regulatory development
              process and develop RIA milestones including issue
              papers for every rule.

             Division Directors must sign off on development
              plans and identify key milestones 'in the regulatory
              development process.

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                                              OSWER  Policy Directive #9435.00-1
                                     -42-
             The OPPI Division Director should hold monthly
              meetings with the appropriate Division Directors  to
              review progress on analyses,  and identify new issues
              requiring analysis.


    In order to enhance the timeliness 'of analyses,  OSW is adopting a  more
systematic and dynamic approach to RIA development:


             Prepare focused issue papers  that address specific
              issues and problems  as they arise.

             Provide a quick preliminary analysis of quantified
              and non-quantified risk and cost conditions specific
              to the regulatory effort underway,  and identify
              additional information needs.

             Produce focused qualitative and quantitative
              cost/economic impact and risk evaluation of options  to
              support options selection by managers.

             Provide workgroup closure report incorporating issue
              papers and analyses, and summarizing decisions.

             Formalize workgroup closure report into RIA. for Red
              Border and OMB review.


    Origin of the RIA.  A  Regulatory  Impact  Analysis  (RIA)  supports
regulatory actions by demonstrating compliance with Executive Order 12291.  In
the RIA, it is essential to explore the need for the regulatory action and
assess the consequences of various proposed options.  When Executive Order
12291 was issued, RIAs were required on all major rules  (as defined in Section
2.1.9) but recently we have adopted a more fluid approach to RIA's and OSW
staff should tailor RIA's according to our internal ranking of regulatory
actions.

    For major rules, an RIA is part of the decision package that is sent  to
OMB for review.  The RIA is submitted with the proposed  rule to OMB at least
60 days prior to publication of the proposed rule.  In addition, a final  RIA
must be transmitted with a copy of the final rule at  least  30 days prior  to
publication of the final rule in the Federal Register.

    If a rulemaking does not involve a proposed rule,  the final RIA is
transmitted to OMB accompanied by the final  rule  at least 60 days  prior to
publication of the final rule in the Federal Register.   Extensions  for
submitting an RIA are granted for any major  regulation that responds  to an
emergency situation, provided that  (1) such  regulation is reported to OMB as
soon as practicable, and (2) the Agency publishes,  in the Federal  Register, a
statement describing the reasons why  it  is impracticable for the Agency to
prepare an RIA in the time available.  The Agency must prepare  an  RIA for an

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                                              OSWER  Policy  Directive #9435.00-1
                                     -43-
eraergency rule as soon as practicable.   An exemption from preparing an  RIA
also is granted when preparation of an RIA would conflict with a statutorily-
or judicially-ordered rulemaking deadline.   Such a regulation is reported to
OMB and is accompanied by a brief explanation of the conflict.   In  addition,
the Agency publishes a statement in the Federal Register outlining  the  reasons
why an RIA is impracticable.  The Agency must,  however,  adhere to the RIA
requirements to the extent permitted by judicial or statutory deadlines.

    A summary of the requirements for RIAs sec  out in the Executive Order
follows:
    1. DEFINING THE PROBLEM

             Establish what the problem is that needs to be
              addressed.

                   identify causes

                   explore consequences of taking action

                   assess quantitative and qualitative cost/economic
                   impacts

             Examine how the proposed approach would.address the
              problem.

                   will it meet the regulatory objectives?

                   how will the market compensate?

             Consider alternative approaches.

                   what are the consequences of not taking action?

                   are there other effective control mechanisms
                   either in place or underway (e.g. state or local,
                   judicial, market) that could resolve the problem?

                   are there other regulatory mandates that share
                   jurisdiction over the problem?  If so, a
                   cross-program, and in some instances,
                   cross-Agency analysis is essential.

                   are the options proposed within the scope of
                   legislative provisions?

                   are there market-oriented approaches that could
                   resolve the environmental problem  (i.e., economic
                   incentives, fees or charges, permits or offsets,
                   insurance provisions, etc.)?

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                                         OSWER Policy Directive #9435.00-1
                                 -44-
2.  ANALYSIS OF BENEFITS  AND COSTS

     Benefits

         State the proposed beneficial  effects  of  the
          regulatory change.

         Estimate the present value  of  all potential benefits
          to society.   All favorable  effects  should be
          identified in the RIA and quantified,  as  appropriate.

         Provide a schedule of benefits,  for instance,
          showing who would derive  benefit,  in what way,  and
          when.

     Risk Assessment

         Hazard Identification--Gather  information and
          evaluate the types of health injury or disease  that
          the hazardous constituents  may produce under certain
          conditions.

         Dose-Response Evaluation--Describe  the quantitative
          relationships between the amount of exposure to a
          substance and the extent  of toxic injury  or disease.

         Human Exposure EvaluationExamine  the nature  and
          size of the population-that is potentially, currently,
          or historically exposed to  a substance, and the
          magnitude and duration of their exposure.

         Risk Characterization--Integrate and analyze  the
          previous three components in order to  determine the
          likelihood that humans will experience any of  the
          various forms of toxicity associated with a  substance.
     Costs
          Estimate the present value of all real incremental
          costs of the regulatory proposal and reasonable
          alternatives.

          Prepare a schedule of costs, showing who would bear
          costs, and when would the cost be incurred.

          State economic impacts, including reductions in
          competition, innovative activity, or productivity
          growth.

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                                              OSWER Policy Directive  #9435.00-1
                                     -45-
         Qualitative Evaluation

             Implement qualitative evaluations to help'bound a
              problem, demonstrate the range, or depict the worst
              case and best case situations.

             Incorporate qualitative analyses for problems and
              aspects of problems that are ill-suited to
              quantitative techniques.

             Structure text such that qualitative information
              (e.g., case studies, hypothetical scenarios, and
              anecdotal information) is not dominated by
              quantitative studies.

    3.  RECONCILIATION

             Compare benefits to costs in quantitative terms.

             Produce net benefit estimate, and list
              nonquantifiable costs and benefits.

             Show cost-effectiveness of viable alternative
              approaches.

    4. . RATIONALE FOR SELECTING PREFERRED REGULATORY APPROACH

             Include a summarization of considerations made in
              the RIA, including limitations on beneficial options
              (e.g., legal constraints, statutory restrictions).


    The Regulatory Impact Analysis of Proposed Standards  for the Management of
Used Oil is provided in Appendix E as a sample.

4.1.5  Regulatory  Flexibility Analysis (RFA)

    The Regulatory Flexibility Act (RFA) requires OSW to  consider the impacts
of regulatory actions on small businesses, small governmental jurisdictions,
and non-profit organizations.  In order to respond to the RFA requirement, OSW
either performs an analysis of the impacts that the regulatory  action will
have on small entities, or, alternatively, certifies that the regulatory
action will not have a significant impact on a substantial number of small
entities.  The RFA requires that if a regulatory action will have a
significant economic impact on a substantial number of small entities, OSW
must:   (1) prepare a Regulatory Flexibility Analysis for  the regulation;  (2)
identify the regulation in the Serai-Annual Regulatory Agenda; (3) periodically
review the regulation; and (4) make special efforts to involve  small entities
in the regulatory development process.  A proposed regulation that will not
have such impact includes a certification that the special analysis is
unnecessary.  These four steps are described below.

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                                              OSWER Policy Directive  #9435.00-1
                                     -46-
    (1)  Regulatory Flexibility Analysis.  The main objective of the
Regulatory Flexibility Analysis is for OSW to estimate the impacts of the
regulatory action on small entities as a group that is distinct from other
groups.  OSW also considers any alternatives that minimize the impacts but
still achieve the statutory objectives.  A separate summary of this analysis
is presented in the preamble to both the proposed and the final regulations.
The preamble statement clearly and succinctly describes to the public the
steps that OSW took to assess the effects of the rule on small entities,  and
justifies any expected adverse effects that are necessary for achieving
environmental goals.

    The following elements are included in the analysis:


             Explanation of why EPA is considering action;

             Objectives and legal basis of the rule;

             Identification of alternatives;

             Demographic analysis;

             Cost analysis;

         '   Competitive effects analysis';

             Exemptions or allowances;

             Identification of overlapping regulations;

             Summary of public comments; and

             Periodic review.
    (2)  Identify the regulation in the Semi-Annual Regulatory Agenda.  Twice
yearly, in April and October, EPA publishes its schedule of regulatory actions
in order to inform interested parties of the Agency's activities.  The
Semi-Annual Regulatory Agenda summarizes the status of regulations and briefly
describes the regulations that are under development, review, and revision.
Each regulation listed in the Semi-Annual Regulatory Agenda includes the
Agency's determination of whether the regulation will have a significant
impact on small entities. If small entities will be substantially affected by
the rulemaking, then the Agency briefly characterizes the small entities that
will be affected, and estimates the expected impacts.  Subsequent Agenda are
updated to reflect Agency decisions regarding the direction or structure of a
rule, such as reasons for revising or rescinding a rule.

    (3)  Review the regulation periodically.  The RFA requires EPA to
periodically review regulations that have a significant economic impact on
small entities.  For regulations adopted before January 1, 1981, EPA  is
required to review such regulations by January 1, 1991.  Regulations  adopted

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                                              OSWER Policy Directive  ,-,-9435 . 00-1
                                     -47-
after January 1, 1981, must be reviewed within 10 years after their
promulgation.

    When regulations are reviewed, the RFA requires the Agency to consider:


             Continued need for the regulation;

             Comments received about the regulation;

             Complexity of the regulation;

             Extent to which the regulation overlaps with other
              regulations; and

             Length of time elapsed since the regulation was last
              evaluated, or the degree to which technology, economic
              conditions, or other relevant factors have changed.


    (4)  Make special efforts to involve small entities in the regulatory
development process.  In-order to ensure involvement of small entities in the
regulatory development process, OSW can:


             Issue Advance Notice of Proposed Rulemakings (ANPRMs')
              for regulations that have significant impacts on small
              entities.  Send notice of the publication of an ANPRM
              to the Small Business Administration, trade
              associations, etc.  Solicit comments in the ANPRM on
              specific alternative definitions of small entity and on
              specified alternatives for minimizing impacts on small
              entities.

             Arrange for open conferences with affected groups,
              both before the Notice of Proposed Rulemaking (NPRM)
              and during the comment period.

             Directly notify interested small entities, trade
              associations, etc., of the publication of the NPRM.


4.1.6  Implementation Strategies

    Implementation strategies are plans for activities that support the
implementation of new rules and guidance.  Their purpose is to improve the
efficiency and cost-effectiveness of program actions by planning  for
anticipated needs.   In an ideal situation, development of  an  implementation
strategy coincides  with and complements the development of a  technical rule.
The strategies have several objectives.  First, the strategies limit  future
management problems by enabling OSW to anticipate potential problems  and thus

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                                     -48-
                                              OSWER  Policy  Directive #9435.00-1
respond to those problems before they emerge.   Second,  the  strategies  enable
OSW to implement a regulation in a manner that increases  the effectiveness  of
the regulation for protecting human health and the environment.   Third,  the
strategies increase the efficiency with which a regulation  is implemented.
Finally, by creating the implementation strategies,  OSW eases the burden on
EPA, on authorized States, and on the regulated community.

    Implementation strategies are developed as the regulatory options  are
explored for the rulemaking.   By concurrently formulating implementation
strategies during rulemaking, the workgroup performs analyses and often uses
the implementation strategies as a method of determining the best regulatory
option for a rule.  Because an implementation analysis  must be performed for
each regulatory option, the workgroup explores State requirements and other
applicable requirements that could potentially affect a rulemaking, and
determines whether certain options are workable while others may not be
feasible.

    As OSW promulgates new rules and issues new guidance documents, the office
must take steps to modify the administration of its regulatory program (or
assist in modifying the regulatory programs of authorized States) in order to
accommodate the new rules and guidance.  Activities supporting these actions
can include:
              Shifting resources';

              Providing guidance or technical training sessions; and

              Supplying public information and performing outreach
              activities to ensure understanding of and compliance
              with the regulations.
    When several regulatory actions or expansions of the regulatory program
are being made (e.g., the HSWA Amendments), it may be appropriate to develop
an overall integrated implementation strategy.  In such a situation,
independent strategies for each rule will be developed and later considered
together in order to guarantee consistency and clarity of the Agency's program.

    There are three principal phases for the development of an  implementation
strategy:

    (1)  Issue Identification.  The workgroup identifies all major
implementation issues.  The workgroup discussions  lead to the production  of  a
Phase I Report which gives a comprehensive list of issues to be addressed in
the strategy.

    (2)  Options Identification.  The Phase I report  is the basis  for
deliberations by the workgroup on various options which address each
identified issue.  The deliberations conclude with the production of a Phase
II Report which lists each option and discusses  its relative merits or
disadvantages.  The Phase II Report is also used to identify additional

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                                              OSWER Policy Directive #9435.00-1
                                     -49-
 implementacion issues that the workgroup failed to identify in earlier
 deliberations or that are secondary implementation issues (i.e.,  issues  which
 result from the pursuit of an identified option or alternative).

     (3)  Options Selection and Strategy Development.   Once consensus is
 reached by the workgroup on which of the identified options will  be pursued,  a
 draft implementation strategy document is produced.  The draft implementation
 strategies discuss only the activities selected by the workgroups;  options
 considered and discarded by the workgroup are not presented in the
 strategies.  These strategies are designed to be action plans to  ensure
 successful implementation of a rule at the Regional or State level.

    The Implementation Strategy for the Land Disposal Restrictions Rulemaking
 is provided in Appendix E as a sample.


4.2  PREPARING THE  BACKGROUND  DOCUMENT

    The background document is the reference material for the final rule.
This document provides descriptions of the prior rule if applicable, the
proposed regulatory language, the rationale for the regulatory provision, and
a response to all comments received, addressing each section of the rule, and
 final regulatory language.  The background document is developed in two
stages.   First, the Agency compiles the public comments received and
summarizes those comments.  The workgroup uses this summary of public comments
to revise the proposed rule to final form.  The background document serves as
the mechanism to respond to all public comments submitted on the rulemaking.
The second stage of the background document is a more complete description of
the issues and a detailed discussion of the Agency's rationale for rejecting
or accepting alternative rulemaking options.  In effect, the background
document is a history of the rulemaking.

    Although OSW has no required format for a background document, the
following format is recommended:


             Background.  This section presents the Federal
              regulatory history for the activity being addressed  in
              the new rulemaking; past implementation experience (if
              any); and statutory mandate for the regulation, if
              applicable.

             Rule.  For each rule promulgated or amended, the
              background document provides a synopsis of the previous
              regulation; summary of the proposed rule; rationale  for
              the proposed rule; comments and responses (grouped by
              subject area); and final rule.

             References.  The Agency often bases its rationale for
              promulgation of a rule on analyses.  The background
              document should list all materials that were used to
              develop the proposed and final rules.  Copies of all

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                                              OSWER  Policy Directive #9435.00-1
                                     -50-
              applicable materials should also be  included  in  the
              RCRA docket.   Chapter Three contains  procedures  for
              establishing a docket for a rulemaking.


4.3  PREPARING  BRIEFING DOCUMENTS

    This section discusses the two types of briefings  that  are part  of
ruleraakings:  status briefings, and issue briefings.  Although  there  are  no
formal requirements for the structure or format of  either of these briefings,
the subsections bel'ow provide guidance for developing  and presenting the
briefings.  In addition, Exhibit 3-4 in Chapter Three  displays the frequency
with which the briefings should be given to various senior  managers.

    Another helpful guidance document for preparing and presenting briefings
has been developed by Gene Zelazny.  The document,  "Making  the Most  of Your
Presentation," delivers succinct guidance in the following  areas:


             Define the situation: analyze your audience;  specify
              your objective; and select your approach;

             Design the presentation: structure the outline to
              match your audience; sketch the storyboard (what,
              where, who, when, how, how much); and produce the
              visuals and supporting handouts;

             Rehearse the presentation; and

             Deliver the presentation.


A copy of Gene Zelaznyfs guidance  is included in Appendix D.


4.3.1  Status Briefings

    The purpose of status briefings is to briefly summarize the progress of a
rulemaking.  Status briefings are  given to the QSW Division Director, the OSW
Office Director, and the Assistant Administrator.  Chapter Three  identifies
the frequency of status briefings  for high, medium, and  low priority rules.

    Status briefings are generally one page long and are typed in bullet
format.  The contents of a status  briefing may reference issues of  interest
currently being discussed by the workgroup, especially with regard  to the
effect that issue resolution may have on the  schedule  for  rulemaking.   The
status briefing may also include potential issues which  may affect  the  timely
development of the rule.  The briefing concludes by providing an  updated
schedule  for the rulemaking.

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                                              OSWER  Policy  Directive ?;9435.00-1
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4.3.2  Issue Briefings

    Issue briefings are substantive and informative briefings.   The purpose  of
issue briefings is to alert senior management to issues that could affect  the
outcome of a rulemaking.  These briefings present an opportunity for senior
management to express its preference or direction for the outcome of key
issues during the rulemaking.  Issue briefings should provide background
information pertinent to a rulemaking including cost, risk,  impact
evaluations, and a description of the positions of participating offices.
They are succinct, and clearly state and define each major issue that arises
during the course of the rulemaking, and alternatives or options available for
resolving the issues as well as focused analysis on the issues.   Often,  the
briefings trigger meetings and discussions about the raised issues, and  those
meetings can result in decisions about the available regulatory options.  If
issues surrounding a rulemaking are complicated, then a preliminary background
briefing is advised.  A pre-briefing is necessary when a rulemaking has  broad
policy implications, or when the rule applies to a relatively new regulatory
area (e.g., corrective action).  The briefings identify the offices in EPA
that have raised each issue, and present the level of agreement or
disagreement surrounding each issue, including whether an issue has the
potential to stall the decision package in Steering Committee or Red Border
review.  Although there is no specific format for the issue briefings, bullets
are recommended.  Visual aids should be used as necessary to display
complicated scenarios.  An outline of the contents of an issue briefing is
displayed in Exhibit 4.


4.4  PREPARING THE  REGULATORY DECISION  PACKAGE

    For both proposed and final rules, a regulatory decision package must be
prepared.  This package consists of a request for OMB review and information
collection (SF-83); a transmittal memo; a communication strategy; an action
memorandum, a preamble; and a rule.  Descriptions of each of these documents
are provided below.  A copy of the SF-83 is provided in Appendix D.  The
workgroup chairman delivers 25 copies of the decision package to OSR for Red
Border review.   The decision package for the May 2, 1986 final rule governing
Standards for Closure and Post-Closure Care of Hazardous Waste Management
Facilities is provided in the Appendix E as a sample.

4.4.1  Transmittal Memo

    The Transmittal Memo is a brief (usually less than one page) memo that
requests formal Agency review of a regulatory decision package.  The
transmittal memo generally describes the content of the attached rule,  the
reason for the rulemaking, and whether or not the attached package is a major
rule.  The memo is drafted from the OSWER Assistant Administrator and
addressed to the OPPE Assistant Administrator.  The transmittal memo serves as
a cover memo for internal Agency review of the action memorandum, preamble,
and rule.

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                                   OSWER Policy Directive #9435.00-1
                           -52-
                       EXHIBIT 4-1

            CONTENTS OF AN ISSUE  BRIEFING
I.   Statement of Issue
II.  Background  Information

          Cost

          Risk

          Impact  Evaluations

          Positions of Participating Offices
111.  Major Considerations

          Alternatives/Options

          Implications of Alternative Approaches (strengths  and
          weaknesses)

          Potential  Sources of Conflict.


IV.  Recommendations

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                                              OSWER Policy  Directive  /;9435 .00-1
                                     -53-
4.4.2  Communication Strategy                  i

    The communication strategy is generally a fi^e-page document that provides
descriptions of how the Agency plans to notify the regulated community of the
promulgation of the rule.  It includes names of key Agency personnel
responsible for the rulemaking, and outreach efforts that have been or that
will be undertaken after promulgation of the rule.  However, depending on the
specific nature of the rulemaking, the communication strategy may be
considerably more detailed.  For example, the strategy for a rule that affects
significant numbers of small businesses may entail a more detailed discussion
of the Agency's plans to communicate the new regulatory requirements (i.e.,
brochures, meetings with trade associations, teleconferencing, etc.).

4.4.3  Action Memorandum

    The purpose of the Action Memorandum is to summarize specific issues
raised over the course of the regulatory action.  The Action Memorandum
discusses the background for, provisions of, and controversy (if any) over the
rulemaking.  Although there is not a specified format, the Action Memorandum
addresses the following areas:


             Purpose "of the memo (e.g., seeking Administrator's
              approval to publish a final rule concerning Subpart G
              closure and post-closure requirements);

             Background and purpose of the rulemaking;

             Organization and content of the regulation (this
              section outlines the general principles of the
              regulation and discusses any controversial aspects of
              the rule);

             Reporting requirements imposed by the rule;

             Public participation (generally a summary of the
              nature and extent of public comment on the proposed
              rule);

             Communication strategy;

             Anticipated reaction to the rule; and

             Regulatory analysis if applicable.


Finally,the Action Memo provides a place for the Administrator to officially
approve (or disapprove) and sign a rule.

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                                              OSVER  Policy Directive #9435.00-1
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4.4.4  Preamble and Rule              ^

    Each proposed and final rule must bfc  published in the Federal  Register  and
must be accompanied by a preamble.   Thejpreamble provides a list of subjects
addressed in the rulemaking, describes in detail the reasons  for the
rulemaking, provides background information (i.e., previous Agency action in
this area) on the rulemaking, and discussess the rationale for the proposed or
the final rule.   If the action is a final or an interim final rule on which
public comments  have been received, the preamble must address those majo.r
comments as they apply to the specific decisions the Agency made concerning
the provisions of the interim final or final rule.

    The proposed or-final rule must be published in the Federal Register.  The
text of the rule,  as proposed or promulgated, follows the preamble in the
Federal Register.   The rule contains the  exact language as it will be codified
in the Code of Federal Regulations for the standards that the Agency proposes
or promulgates.   Section 4.5 addresses preparation of the Federal  Register
package.

4.4.5  Request  for  OMB  Review

    As described in Chapter Two, under Executive Order 12291 the Agency must
send each proposed and final rule to OMB  for review before the Administrator
signs it.  The SF-83 form is a simple checklist of information regarding the
scope o.f the attached rule.  To initiate review under Executive Order 12291,
OSW must submit  four copies of the decision package along with one copy of the
SF-83 form to the Regulation Management Branch in the Office of Policy,
Planning, and Evaluation (OPPE).  The SF-83 should be signed by the Director
of OSW before transmittal to OPPE.  OPPE clears and signs the SF-83 for
submittal to OMB.   For interim final rules without prior proposals, OGC must
also sign the SF-83 (before submittal to OPPE) to verify that they agree that
an interim final meets the Agency's responsibilities for notice and comment
under the Administrative Procedures Act (APA).  A copy of the SF-83 is
provided in Appendix C.

4.4.6  Information Collection Requests

    Under the Paperwork Reduction Act, the Agency must prepare an  information
collection request  (ICR) to obtain OMB clearance  for any activity  that will
involve collecting substantially the same information  from ten or  more
non-Federal respondents.  OSW may need to prepare ICRs for information
requirements included in a rule, e.g., reporting, monitoring, preparing  plans;
and other information collection activities,  conducting  surveys,  studies,
sending out application forms, etc.

    The ICR is part of the decision package  submitted  to OMB  for  review  at the
proposal stage of a rulemaking.  The SF-83 must  indicate that  an  ICR  is
attached for review.  OMB review of the ICR  generally  takes  60-90  days.   If
OMB does not approve the ICR, it must be  resubmitted when  the  final  rule is
published.  Similarly, if information requirements  change  from proposed  to
final rule, OSW must submit  a revised ICR.   For  other  activities,  the ICR

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                                              OSWER Policy Directive  ?;9435.00-1
                                     -55-
 should  be  ready to submit four months before the activity is scheduled to
 begin.   In the case of surveys, a pilot or pretest may be necessary,  and in
 some  cases,  the pilot or pretest may need its own ICR.

    An  ICR consists of an SF-83 form plus an attached justification
 statement.   The justification statement should emphasize the need for the
 information  to be collected.  In addition, the statement must calculate the
 burden  hours required of respondents and the dollar cost to the government to
 ensure  that  they are consistent with calculations of economic impact  in the
 rulemaking package.  In the case of surveys, the statement should provide a
 detailed explanation of any statistical components, including the sampling and
 analysis plans.


 4.5   PREPARING  THE  FEDERAL  REGISTER  PACKAGE
                                                      
    Publication in the Federal Register provides official notice of a
 document's existence and content; creates a rebuttable presumption that the
 text  is &  true copy of the original document; establishes that the document
 was duly issued, prescribed, or promulgated; and provides evidence that it is
 recognized by a court of law.  The Office of the Federal Register (OFR) has
 prepared the Federal Register Document Drafting Handbook to guide Agency staff
 in the  precise preparation of documents for publication in the Federal
 Register.  The handbook is available from the Agency supply store.

    The'Federal Register package must include four items:  (1-) Three originals
 with  ink signatures of the preamble and regulation; (2) the Federal Register
 Checklist; (3) typesetting request form; and (4) reprint request form, if
 desired.  A  copy of these forms is provided in Appendix C.

 4.5.1   Signed Original of the Preamble and  Rule

    The Office of the Federal Register (OFR) must have an original signed copy
 of the preamble and rule.  In addition, OFR needs three copies of the preamble
 and rule.  OSW should ensure that the signature on the originl documents is
 readable and that any charts or graphs are clear and ready for typesetting.

 4.5.2   Federal Register Checklist

    The Federal Register Checklist is designed to assist the Agency in meeting
 the requirements for publishing proposed and final rule documents in the
 Federal Register.  Each item contained on the Checklist is explained in detail
 in the Federal Register Document Drafting Handbook.  The Checklist itself is
 included in  Appendix D and is generally available from the OSWER Steering
 Committee Representative.

    The Checklist includes seven major items:  (1) billing code information;
 (2) headings, i.e., Agency name, CFR Part, and Subject; (3)  preamble
 requirements, e.g., summary of proposed action, addresses for public comment,
 and supplementary information such as the regulatory  impact analysis;  (4)
words of issuance; (5) regulatory text; (6) signature; and  (7) consecutive
 page numbers.

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                                              OSVER  Policy Directive #9435.00-1
                                     -56-
    Th e Federal Register checklist specifies  a standard format  for  all
documents.  These format requirements are described in detail  in  the  Document
Drafting Handbook.  The following items are highlighted for your  convenience:


             Bond paper or legibile photocopy --  8-1/2 x 11;

             Single-sided copies;

             Margins one inch from top, bottom,  and right sides,
              and 1-1/2 inch margin from left side;

             Double space text;

             Typed name and title of signing official, ink
              signature;

             Deliver three originals with ink signatures; the
              signature may not appear on a page  by itself;  and

             Page numbers must be consecutive and appear at  the
              bottom of the page.


4.5.3  Typesetting  Request

    The typesetting request form is EPA Form 2340-15.  This  form includes the
billing code information and the approximate cost of typesetting the attached
rulemaking package.  This form is included in Appendix D and is available from
the Office of Program Management and Support (OPMS) in OSW.   OPMS must attach
the billing code information and certify that funds are available to print the
rulemaking package.

    The Federal Register produces galleys for everything it prints.  OSW is
responsible for proofing those galleys prior to publication of the rule.
Since typesetting often produces mistakes in the galleys, it is strongly
recommended that OSV staff proofread the galleys on all rules.

4.5.4  Reprint Request Form

    The reprint request form is EPA Form 2340-1.   This form includes billing
code information and the number and approximate cost of the reprints
requested.  OSW staff are encouraged to order Federal Register reprints  for
major rules and rules that affect smaller entities so that copies  can be
widely distributed among the Regions and States in conjunction with  the
communication strategy for the rule.   It is  important to bear in mind that
once the final rule is printed in the  Code of Federal Regulations, the
preamble no longer appears with the regulation.  Federal Register  reprints are
the only way to ensure that the rule is accompanied by the preamble  which may
be very important in understanding the Agency's rationale for a  particular
standard.  The print request form is an optional part  of  the Federal Register
package.

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                                              OSWER  Policy Directive ,v9435.00-l
                                     -57-
                                 CHAPTER FIVE

                 RELATIONSHIP TO OTHER OSW ACTIVITIES
    This chapter describes the overall management of regulatory development
activities as well as their relationship to the OSW budget and planning
processes.  Generally staff develop regulations over a two- or three-year
period using a mix of in-house resources and contract dollars.   Sound
management of the regulatory development process is essential  because  of  its
length and complexity, and the variability of parties involved.   Section  5.1
briefly discusses the management activities associated with rulemakings.

    The resources required to support the Office of Solid Waste are  directly
influenced by the extent of on-going rulemaking and guidance development
activities.  This is particularly true in Headquarters where a large number of
OSW employees are involved in preparing regulations and guidance documents.
Further, regulations drafted at Headquarters are implemented by the  Regions
and authorized States and therefore rulemaking activities also directly  affect
the resources required to administer the national hazardous waste management
program.  Section 5.2 briefly describes the OSW budget cycle and indicates  how
staff can ensure that the budget accurately reflects the level of on-going  and
anticipated rulemakings.  It also describes the OSW planning process with
regard to implementation of the national program and indicates how staff  can
ensure that future implementation activities triggered by on-going rulemakings
are translated into implementation strategies and guidance documents.


5.1  MANAGEMENT  OF RULEMAKING ACTIVITIES

    There are two distinct responsibilities involved in managing regulatory
development:   managing contract resources, and monitoring progress of
regulatory documents and support analyses.

5.1.1  Contract Resources

    OSW has several major level-of-effort contracts that support its
regulatory and guidance development efforts.  These contracts  are managed by
project officers in each Division.  Project officers are responsible for all
official administrative tasks and interface with the Procurement and Contracts
Management Division (PCMD).   PCMD has prepared a manual to guide the project
officers in the execution of these tasks.  Staff may find this manual useful
in the day-to-day management of their contract resources.

    Staff managing rulemaking activities are responsible for writing a work
assignment to provide the supporting analysis required for the rulemaking.
This work assignment should be specific to the regulation under development
but at the same time, broad enough to provide all the analytical support that
may be needed on a particular rule.  In most cases, that support will include

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                                              OSVER  Policy Directive ?;9435.00-1
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infortnation gathering, computer modelling,  policy analysis,  and  economic
analysis.  The work assignment must be approved by the  work  assignment
manager's Branch Chief and by the Project Officer for the  contract.   In
additio.n to these approvals, the Project Officer must also submit  the work
assignment to PCMD, where the Contracting Officer will  determine if  the work
assignment is within the scope of the contract.

    Once PCMD approves the work assignment, staff should meet  with their
contractor to discuss the tasks that are desired and agree upon  the
required/deliverables.  After reaching agreement on the work to  be conducted,
staff should direct the contractor to prepare a work plan  that outlines the
steps required to complete the desired tasks and a schedule  for  delivering
work products.  Staff are also responsible for monitoring  monthly progress
reports on the expenditure of resources and reviewing all  deliverables
produced under their work assignments.

5.1.2  Progress Tracking Systems

    Administrator's Tracking System (ATS).   The Agency established the
Administrator's Tracking System to monitor the development of  EPA
regulations.  The ATS is largely a tool for senior Agency  managers to focus on
key rulemakings and alert them to any problems that occur  in the regulatory
development process that may delay promulgation of a final rule.  Staff must
prepare a schedule that outlines the key steps for each rulemaking.   In
preparing the schedule, staff should consider the applicable components of  the
Agency regulatory development process, available-staff and-contractor
resources, and potential outside constraints such as data  gathering needs.
The schedule should include major milestones such as workgroup meetings,
options selection, workgroup closure, and Red Border/OMB review.

     The Office of Program Managment and Support  (OPMS) is responsible for
maintaining the ATS milestones and reporting to the Assistant  Administrator's
office on OSW's progress- toward meeting those milestones.    QSWER then reports
its progress to the Office of Management Systems  and Evaluation (OMSE) which
in turn reports directly to the Administrator on  all Agency ruleraaking
activities.  As mentioned earlier, the ATS system is a means to alert senior
Agency management to delays in the process, particularly those which may
affect a Congressionally-mandated or court-imposed deadline.

    OSW Workplan System.  OSW established  a  system for  developing and
monitoring workplans for all major Headquarters projects.   The workplan system
encompasses rulemakings, guidance documents, Reports to Congress, and other
major projects.  Staff prepare workplans and submit them  for review and
approval by their Branch Chief and Division Director.  The workplans are
similar to the ATS schedules in that they  identify key activities for each
project and specify anticipated dates for  completion of those activities.

    OPMS is responsible for maintaining the OSW workplans and reporting to the
Office Director on the Division's progress toward meeting those milestones.
The workplan system is a management tool designed to alert  senior managers in
OSW to delays in completing projects.  However, unlike ATS, since the workplan

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                                              OSWER Policy  Directive  ,->9435.00-l
                                     -59-
system focuses on all OSW activities, it provides senior management a
comprehensive overview of OSW progress.


5.2  BUDGET AND  PLANNING  CYCLE

    OPMS is directly responsible for developing resource estimates and
preparing the budget and supporting documents.  The fiscal year (FY) begins  on
October 1 of every year.  The budget for each fiscal year is prepared two
years in advance of the actual fiscal year.  For example, the budget for FY  87
was prepared in the spring of calendar year 1985.  The complex nature of the
Federal government's budget process requires EPA to begin its planning cycle
far in advance of the actual fiscal year.  As a result of this early planning
process, staff must anticipate resource needs not only for the development of
regulations but also for the implementation activities that are likely to
result in future years, commonly referred to as the "lifecycle of a
regulation."

5.2.1  The Budget  Request

    The workload analysis required to estimate resource needs- for the fiscal
year one-and-a-half year's ahead, begins in the spring of each year.  Staff
estimate Headquarters resource needs for regulatory and guidance development
in March and April and finalize those estimates with their Branch Chiefs and
Division Directors in early May.  The Division Directors present their
resource estimates to the Office Director in. late May.  At that time, the
Office Director and OPMS staff evaluate the resource estimates and determine
what level of regulatory development activities can be funded within
the/budget target.  This evaluation usually requires a ranking of all
activities within OSW.  The budget target is approximately 100 percent of the
prior year's budget, but in growth years may include a 10-15 percent increase
in resources.

    In addition to preparing estimates for regulatory development activities
in Headquarters, staff should discuss the impact of on-going rulemakings with
OPMS staff to determine what level of State and Regional resources will be
necessary to implement rules that are expected to be promulgated and in effect
during that fiscal year.  Estimates for the State and Regional workload can be
derived by developing assumptions about the type and level of implementation
activities, assigning a price for those activities, and  then using  the
workload analysis model to calculate the national costs  for program
implementation.  If an Implementation Strategy has been  developed, workload
estimates should be driven by the activities and assumptions described  in that
strategy.

5.2.2  Implementation Strategies
                                                                         *
    Section 4.1.5 in Chapter Four describes Implementation Strategies.
Developing an implementation strategy is one of the best ways to  ensure that
thorough resource estimates are prepared for the State and Regional budget
requests.   These strategies are often prepared as the rule is being developed

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                                              OSWER  Policy  Directive #9435.00-1
                                     -60-
and provide a basic understanding of the impact the rule will  have on  the
States and Regions as they implement the new regulatory requirements and
monitor industry's compliance.

    Staff responsible for developing new regulations should encourage  early
development of an implementation strategy and work closely with the individual
preparing it to ensure maximum comprehension of the regulatory options and
their anticipated effects.

5.2.3  RCRA  Implementation  Plan  (RIP)

    The RIP is a principle planning document that provides detailed direction
on program priorities and guidance for running a State or Regional hazardous
waste management program.  The document is prepared annually and is primarily
used by the Regions in negotiating specific commitments with the States for
inclusion in their grant work plans.  The RIP is used in conjunction with the
annual Agency Operating Guidance and in essence, sets the national agenda for
the RCRA program.

    The Permits and State Programs Division (PSPD) is responsible for
developing the RIP.  The development process begins in December and concludes
with issuance of the document in May.  Early development of the RIP is crucial
since it is used to establish quantitative targets for inspections,
enforcement actions, and permit issuance which are generally negotiated with
the States in late spring and incorporated in the grant workplans by early
summer.  These quantitative targets are incorporated in the Agency's Strategic
Planning and Management System (SPMS) to enable tracking of the Regions' and
States' progress toward implemnting the national agenda.

    Rulemaking staff are responsible for providing sufficient input in the
development of the RIP to ensure appropriate implementation of the new
regulatory requirements.  To a large extent, input regarding new
implementation activities should be derived directly from the Implementation
Strategies.

    Once PSPD drafts the RIP, and OSW circulates it to the Regional RCRA
Division Directors and Branch Chiefs for their  review and comment.  The draft
RIP is revised and then recirculated to the Regions.  At this time, the
Regions typically share the draft RIP with the  States to gather their  input on
the document.  By mid April, PSPD begins drafting  the final version of  the  RIP
for signature by the Assistant Administrator for OSWER.

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APPENDICES

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                                             OSWER Policy Directive .-9^35.00-1
                                     A-L
                                  APPENDIX  A

                              LIST OF ACRONYMS



ANPRM - Advance Notice of Proposed Rulemaking

APA -- Administrative Procedures Act

ATS -- Administrator's Tracking System

AX -- Administrator's Executive Correspondence Unit

CFR -- Code of Federal Regulations

NPRM -- Notice of Proposed Rulemaking

OECM -- Office of Enforcement and Compliance  Monitoring

OFR -- Office of the Federal Register

OGC -- Office of General Counsel

OMB -- Office of Management and Budget

OPMS - Office of Program Management and Support

OPPE -- Office of Policy, Planning, and Evaluation

OPPI -- Office of Policy, Planning, and Information

OSR -- Office of Standards and Regulations

PCMD -- Procurement and Contracts Management  Division

RFA -- Regulatory Flexibility Act

RIA -- Regulatory Impact Analysis

RIP -- RCRA Implementation Plan

RMB -- Regulation Management Branch

SAR -- Start Action Request

SPMS -- Strategic Planning and Management System

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                                              OSVER  Policy Directive -v'9435.00-1
                                     B-l
                                  APPENDIX B

                                BIBLIOGRAPHY
Office of the Administrator, Memorandum to Assistant Administrators, Staff
    Office Directors, and Regional Administrators.   "Briefings  for  the '
    Administrator," August 30, 1982.

Office of the Administrator (U.S. EPA).  Memorandum to Assistant, Associate,
    and Regional Administrators and Office Directors.  "EPA Implementation of
    Regulatory Flexibility Act,"  February 9,  1982.

Office of the Administrator (U.S. EPA).  Memorandum to Assistant, Associate,
    and Regional Administrators; Inspector General; and General Counsel.   "The
    Regulatory Development Process:  Steering Committee Emphasis,"  October  16,
    1986.

Office of the Administrator, Deputy Administrator (U.S. EPA).   Memorandum to
    Assistant, Associate and Regional Administrators; Inspector General;  and
    General Counsel.  "Format for Options Papers," February 9,  1984.

Office of the Administrator, Deputy Administrator (U.S. EPA).   Memorandum to
    Assistant, Associate, and Regional Administrators; Inspector General; and
    General Counsel.  "Guidance for Options Selections Meetings," March  15,
    1984.

Office of the Administrator, Deputy Administrator (U.S. EPA).   Memorandum to
    Assistant, Associate, and Regional Administrators; Inspector General; and
    General Counsel.  "Procedures for Regulatory Development and Review,"
    February 21, 1984.

Office of the Administrator, Deputy Administrator (U.S. EPA).   Memorandum to
    Assistant, Associate, and Regional Administrators; Inspector General; and
    General Counsel.  "Risk Assessment," May 21, 1984.

Office of the Administrator, Deputy Administrator  (U.S. EPA).   Memorandum to
    Assistant, Associate, and Regional Administrators; Inspector General; and
    General Counsel.  "Risk Assessment, Information Reporting Requirements,"
    May 21, 1984.

Office of Management and Budget.  "Interim Regulatory  Impact Analysis
    Guidance," June 12, 1981.

Office of Policy Planning and Evaluation, Assistant Administrator  (U.S.  EPA).
    Memorandum to Assistant Administrator for Solid Waste  and Emergency
    Resonse.  "Assignment of Responsibility within OPPE for Reviewing OSWER
    Regulations," May 7, 1984.

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                                              OSWER  Policy Directive ?r'9435.00-l
                                     B-2
Office of Policy Planning and Evaluation,  Assistant  Administrator  (U.S. EPA).
    Memorandum to Assistant Administrators and General  Counsel.  "Compliance
    with the Regulatory Flexibility Act,  Additional  Guidance,"  1984.

Office of Policy Planning and Evaluation,  Information Policy Branch,
    "Instructions for Preparation of Information Collection  Requests  (ICRs),"
    March 1987.

Office of Policy Planning and Evaluation,  Assistant  Administrator  (U.S. EPA).
    Memorandum to OPPE Management and Lead Analysts,  "Management Papers
    Prepared to Implement the OPPE Reorganization Plan," December  1,  1983.

Office of Policy Planning and Evaluation,  Assistant  Administrator  (U.S. EPA).
    Memorandum to Deputy, Assistant, Associate and Regional  Administrators;
    Inspector General; and General Counsel.   "Options Selection Meeting,  April
    16, 1984:  Closure Memo for OAR's National Ambient Air Quality Standards
    for Sulfur Oxides."

Office of Policy Planning and Evaluation,  Assistant  Admininstrator (U.S.  EPA).
    Memorandum to Assistant Administrator of OGC.  "Requirements  for Exposure-
    Related Analyses."

Office of Policy Planning and Evaluation,  Economic Analysis  Division (U.S.
    EPA).  "Guidelines for Preparing Regulatory Impact Analysis,  Appendices .B,
    C, D (Appendix A forthcoming)," July 1984.

Office of Policy and Resource Management,  Associate  Administrator (U.S.  EPA.  '
    Memorandum to Assistant Administrators and General Counsel.  "Regulatory
    Impact Analysis Guidelines," January 19, 1982.

Office of Solid Waste and Emergency Response, Policy, Budget and
    Program Management Division (U.S. EPA).  Memorandum for OSWER Office
    Directors, "Additional Guidance on Rulemakings," May 16, 1984.

Office of Solid Waste and Emergency Response, Policy, Budget and Program
    Management Division  (U.S. EPA).  Memorandum to OSWER Office Directors,
    "Substantive and Procedural Guidance on Rulemaking," March 15, 1984.

Office of Standards and Regulations, Information and Regulatory Systems
    Division (U.S. EPA).  Regulation Management Fact Sheet  Series 1-10.

United States Small Business Administration, Office of  Chief Counsel for
    Advocacy.  Better Federal Treatment for Small Entities, December 1980.

The White House, Office of the Press Secretary.  Executive  Order #12291.
    (Requirements for promulgating  regulations  and developing  legislative
    proposals),  February 17, 1981.

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                                             OSWER Policy Directive #9435.00-1
                                    C-l
                                  APPENDIX C

                                 BLANK FORMS



Forms to be included:

1.  Criteria Checklists:
        Scope and Cost
    --  Risk
        Management

2.  Federal Register Checklist

3.  Federal Register printing form

4.  Federal Register Reprint  Form

5.  SF - 83 Request for OMB  review and  information collection request

6.  Gene Zelazny Briefing Guide

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                                   C-2
                                           OSWER Policy Directive ;9*35.00-1
                     OSW CLASSIFICATION CHECKLISTS
Scope and Cost Criteria Checklist

                  Criteria
                                             Ranking Factors
1.

2.
3.
4.
5.
6.
7.
8.
9.
What is the size of the regulated community?

0 - 500
500 - 5000
5000 plus
How many industries are affected by the more than 1
rulemaking? 2-10
less than 10
Does the rule or guidance affect current
hazardous waste management operations?
Does the rule impose design and operating
standards rather than only notification
requirements or technical fixes?
Yes
No
Yes
No
How much will the rule cost the regulated more than 100
community? Do costs exceed $100 million? less than 100
Does the rule have an impact on small businesses?
Does the rule impose a significant
information burden on the regulated community?
Will the rule require a signifi- many Annual
cant amount of compliance raoni- few Annual
toring and enforcement activities?
Does the rule require industry to
obtain a permit or modify existing
permits?
Yes
No
Yes
No
inspections
inspections
Yes
No
1 a
2 a
3 3
1 a
2 a
3 a
2 a
1 a
2 a
1 a
2 a
1 a
'2 a
1 a
2 a
1 a
1 a
2 a
2 a
1 a
SCORE
Large Scope & Cost
       18 - 20
Medium  Scope & Cost
       12 - 17
Small  Scope  & Cost
      9  - 11

-------
                                     C-3
                                              OSWER Policy  Directive ;>9*35 . 00-L
Risk Criteria  Checklist

         	  Criteria
                                                          Ranking Factors
1.  What is quantity of waste
    produced?
                                             less than lOOOkg/mo
                                         1001 -  1 million kg/mo
                                       more than 1 million kg/mo
2.  Are the constituents of the waste
    highly toxic?

3.  Does the existing management technology
    allow major releases of waste to the
    environment?

4.  Which media are affected by releases?
5.  Are the wastes managed in densely
    populated areas?

6.  Do the constituents have taste and
    odor thresholds?

7.  If ground-water exposures are expected,
    are water supplies within close proximity?

&.  Are wastes managed in areas of special
    environmental concern (e.g., wetlands,
    coastal waters, karst, flood plains)?
        High Risk  Potential    Medium Risk Potential
SCORE         16  - 18                11  - 15
                                                             Yes
                                                              No

                                                             Yes
                                                              No
             Air
   Surface Water
    Ground Water

           Urban
           Rural

             Yes
              No

more than 1 mile-
less than 1 mile
                                                               Yes
                                                                No
                   1  a
                   2  3
                   3  3

                   2  3
                   1  3
 3 a
2 3
1 3

2 a
1 a

1 a
2 a

1 a
2 a

2 a
1 a
                                                        Small Risk Potential
                                                                8 - 10

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                                             OSVER Policy Directive "9^33.00-1
                                     C-4
Management Criteria Checklist

	Criteria	        Ranking Factors

1.  Who are the interested parties?

    -- Congress                                              High   2 -
                                                              Low   1 a

    " OMB                                                   High   2 a
                                                              Low   1 ~

    -- State Agencies                                         High   Z a
                                                              Low   1 a

    -- Environmental  Groups                                  High   2 a
                                                              Low   1 a

    -- Citizen Groups       '                                  High   2 a
                                                              Low   1 a

    -- Industry Associations                                 High   2 a
                                                              Low    1 a

2.  Is there a statutory hammer for this rule?                 Yes   2 a
                                                                No    1 a

3.  Is there a statutory deadline for this rule?               Yes   2 a
                                                                No    la

4.  Is there a court  ordered deadline for this  rule?          Yes    2 a
                                                                No    1 a

S.  Does this rule increase EPA's flexibility                 Yes    2 a
    in implementing other regulatory                          No    la
    requirements?

6.  Is this a technical amendment to the existing             Yes    2  a
    regulations?                                               No    1  a

7.  Has OSW committed to developing this                      Yes    2  a
    rule at some point in the past?                            No    la


      Significant Mgt.  Concern     Medium Mgt.  Concern     Limited Mgt.  Concern
SCORE          20 -  24                 12-19                    7-11

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                                             OSWER Policy Directive ;;9433 .00-1
                                    C-5
Composite Scores

      The composite  score determines whether the rule is  considered a high, medium
or low priority by OSW.
                           High    Medium    Low
Scope & Cost
Risk
Management
COMPOSITE SCORE        HIGH            MEDIUM            LOW

                         //            //             O

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                                     C-6
                                                  OSWER Policy Directive #9435
                  FEDERAL REGISTER  CHECKLIST  FOR
            NOTICES,  PROPOSED AND FINAL RULE  DOCUMENTS
                                                  *


(Attach.to all documents that are to  be published  in the Federal
Register.  Only complete the  section  that  applies  to the document
to be published.  All of these questions can  be answered through
the Federal Register  Document Drafting  Handbook  [DDH1).
SECTION ONE:  NOTICE DOCUMENTS

   (This section applies to Notice of  public hearings, meetings,
   and/or workshops, Correction Notices,  Notices  extending comment
   periods,  and Notices of Avai-lability)
                                                                 Yes   No
  1.   Is  your  document classified correctly?  If it is  rule
       related,  or a technical  amendment it may be considered
       a proposed or final rule.    (DDH 5-7)
  2.   Does  your  document include the required preamble
       elements  (optional for notices):  Agency Action;
       Summary;  Dates;  Addresses; For Further Information
       Contact;  Supplementary Information?   (DDH 51-55)


  3.   Does  your  summary answer the three required questions:
       What  you're doing, Why you're doing it, and the
     I-tendec  Effect  of your action?   (DDH 53)
  4.   Is  the  signers name and title printed below the
       signature?   (DDH 61)
  5.  Are  the pages numbered consecutively?
  6.  Are  the copies sharp, clear and legible, especially
      illustrations?


  7.  Are  you submitting the orginal plus 3 copies?   Do
      your copies match?  (DDH 62)
                             SIGNED

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                                    C-7
                                            OSWER policy Directive #9433.0.
                                                               Yes
  1.   Does your document include the required preamble
      elements: ^JENCY, ACTION, SUMMARY, DATES, ADDRESSES,
      FOR FURTHER  INFORMATION CONTACT, SUPPLEMENTARY
      INFORMATION?     (DDH 12-13)

  2.   Does your Summary answer the three required questions:
      What you're  doing, tftiy you're doing it, and the
      Intended Effect of your action?  (DDH 14)

  3.   Have you included your List of Subjects (Thesaurus
      Terms) at the end of Supplementary Information?
      (008 18)

  4.   Is your Amendatory language clear and correctly
      worded?    (DDH 25-26)

  5.   Is your Authority Citation your first amendment?
      (DDH 19)

  6.   Did you use  the most recent version of the CFR
     and LSA?  (DDH 26)

  7.   Have you included the Table of Contents  for each
     entire CFR part of su-bpart that you are  adding or
     amending?  Do heading in the regulatory  text match
      those in the table of contents?  (DDH 36)

  8.  Are all CFR paragraphs given a letter or  nunber in
     correct sequence?  (a), (1), (i),  (A)  (DDH 30) .

  9.   Is text of regulation displayed correctly (include
     all section headings, and place the asertrisks
     appropriately)?   (DDH 30)

10.  Are the pages numbered consecutively?

11.  Are your copies sharp/ clear and legible,
     especially illustrations?

12.   Is there a new, OMB control number?  If so,  is  it
     mentioned in the amendatory language and set  out
     correctly?   (DDH 36)

13.   Is th signer's name and title printed below  the
     signature?     (DDH 61)

14.  Are you preparing a proposed and  final rule?   They
     cannot be prepared in the  same document, they must
     be separate  documents.   (DDH 7)

15.  Are your submitting the original  plus  3  copies?  Do
     your copies match?  (DDH 62)
                               Signed

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                                                  .  c-a
                                      a  j I .   . v.  .- * -
                                     OSWER Policy  Directive
                   FEDERAL REGISTER TYPESETTING REQUEST
                                                     3 9  10  11  !2 "
                                                       ACCOUNT NO.
OBJECT  ;
CLASS  -
  1*1    I
                                                                                             AMOUNT HI
                                                                                            DOLLARS
1'J  3  4  J S  7  8  9 ''0111 I13<13|14I15|11!7 1,19 20.31 32I33I34 33 i38l37:3ll39'40'41'2|43l44i4Si.a.*74g:49iO'!l  S2 S3 V4
                      o i   , o i
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                      01   :oi   I  I  i   I
   SIGNATUE  i BEOUESTINO
                                                             . SIGNATURE. ii FEDERAL REGISTER OESIGNEE
ai DATE
                             1C) TELEPHONE NUMtER
                                                           lei DATE
                                                                                        (el TELEPHONE
3. UNO3 AR| AVAILABLE iCo*tm4limtml Otrtl

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                                                      C-9           OSWER Policy Directive  *9U35.(
  1  CONTACT ipfognf "* mii coat ntmt A orton*
                                                                 CONTROL NO
                                                                                   1377-^2
                                                                              , 3
  4 fQRM. PUBLICATION. OR ISSUANCE NO  ANO TITLE OB DESCRIPTION
 5 QUANTITY njn*i at tutitf** arotfiMr;
                             6 IS OVERTIME AUTHORIZED TO
                             MEET DESIRED DELIVERY DATE?
                                                                   a
                                                                               7 DESIRED DEL/VERY DATE
                                          COMPOSITION ANO PROOF
 8 NUMBER OF PACES SUBMITTED
 MANUSCRIPT
                                    9. TYPE
                                                  10. FACE
                                                                               U SIZE
 11. ACTUAL IMAGE SOC
                             13. PROO*
                                                    13* GALLHY
                              n,.   a.
                                                                   13h. PAGE   | 1 3c  SEND P*OOF TQ
                                          PRESSWORK ANO BINDERY
               14 NUMBER OF PIECES SUBMITTED
  CAMERA COPY
                                     ILLUSTRATIONS
                                                           . SIZE ilr*t*ni
                                                          Ti
 0 NEGATIVES
                            (11 HALFTONE
 c OVERLAYS
                            I (2) UNECUT
                             (3) OTHER
                                                          IB. RUN fCr*ct onti
                                                                     O.->-
                                                           LJ O~    Lj MM*  *^
 i a  TEXT PAPER /G/MM. cMr. n
                                    1 9 COLOR INK
                                                          20
                                                          Trim
                                                          It
 21 COVER STOCK
  Us-    U
                                    22. COLOR INK
                                                          23 PERFORATE/SCORE Ptrwm to Too/L .
                                                                                                    ^oo
2 PUNCH
                                                                    2. AOORCSSINO ANO MAIL/NO
26.   GsiMSmai    Gdnw SMCH  Qi
     G$ttSmcf  GPMW*M     -Q*
                                                                      K~   G
27 UMMerit ft*t ifn**dd tor MdRionfi toei(icjtion or rmfW
                                                                        c. OTHER MAJUNG Mrr*c/> '/ o<
28 FUNOSAAEAVAJLUU/G
3t
                                   2* AklOTMIMTNO
                                                          30. RETURN NEGATIVES. PLATES. COPY TO
                                   32. OCM NO.
33 RESTRICTIONS ON OUANTmr lCT*t* r>*
  G """>- u- o~r     G.   G
                                                                           34.
                                                                                      TO:
35. APPROVED BY
                                                         . QUANTITY
                                                                        6. AGENCY/DIVISION    ROOM
   36. I concur in ihe publication of the attached material and certify that it complies with Agency Order No. 2200 4 A
. SIGNATURE
                                                    '  6. AA/RAFOR
                                                                                          e. DATE
L_J
37 if tni* mtni i to M ton*rod te mt Cflie* o External Attairs.

     ooocv
                                         I J
                                                                o4 tr* toiiowinq aop4y:

                                                                         3
                                              31.
t. FOR THE OFFICE Of EXTERNAL AFFAIRS tS,ynvr*l
                                                                                          6 DATE
iPAFom,2340.1(4.4>
                T.0.
                                                PUBUCATJC^ REVIEW RECORD AND PRINTING REQU
                                                23*0- 1

-------

-------
  S'anCarC for-n 83
                                                    c~10             OSWER  Policy Directive #9435,

                                   Request for OMB Review
  Important
    Read instruction s Before competing form  Do not us* the same SF 83
  ro "eduest aotn an Executive Order 12291 review and approval under
  :-e Paperwork Reduction Act.
    Arjwer an Questions m  Part I. If this request a for review under .0.
  12291. comoiete Part  H  and vgn tne regulatory certification. If  this
  ecuest s 'or approval uncer the Paperwork Reduction Act and 5 CFR
  1520  sio Part n  complete Part ill and sign the paperwork certification.
                                                             Send three copies of this form, the material to oe rev>v
                                                           paperworkthree copies of the supporting statement, to.

                                                             Office of Information and Regulatory Affairs
                                                             Office of Management and Budget
                                                             Attention Docket Uorary. Room 3201
                                                             Washington. OC 20503
  PART I.Complete This Part for All Requests.
                    *na Bureau/ OHK* originating request
                                                                                                         2. *4nc coce
i se'jon no can out answer questions regarding inn rtquot
                                                                                                            "e-onon num:
 4. i ife ol >n'ormj(ion collection or ojimiinj
 S. uegai iuinonty lor >n(ormadon collection of ruw (cm Unit*} Stitn COM. Putt Lim. or Uceufnv

   	USC  	^.or
 6. Affected puOK fcfle* u tn*t ip0r)

   1  _;  individual* or neuMiOi  .
   Z  '_  State or local governments
                                  3  D
                                  4  Q 8vmne*a> or otner for-orott
                                           S Q Fofl afenciM or emp4ov3
                                           6 Q Non-profit immutKxa   ~  

                                           7 Q Small DusirteiM*
 PART II.Complete This Part Only If the Request Is for OMB Review Under Executive Order 12291

 7  'eguiation ioentiier Ngmor(RlN)

  	  	  	 	   ~~~   _    __	or. None Manned O
 8. 'yse of iuormuion icrifc* on* //> e eattfaff)
   Clfivtlcttton
   1  _: Maior

   2  L- Nonmaior
iD
2 Q rmelerntwvnnnai.wiaipnar
3Qn-
                                                                             1  Q Standard
                                                                             2  D Pwtdm
                                                                             3  Q Emergency
                                                                             *  O Statutory or judicial odHn
9. C^R section attecud
   	CFR _
 10. 3ocs tnis recuiatwn comam
    ano 5 CFR 1320?        .
                                               i trtat require OMB approve! under m Paoerwon Reduction Act
 11. tf a maiorrute. there a reprtetoiy impect)
                                  attacfMdT
                                                                        i i_i
     "No." did OM8 werve tfte er>erye
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                                                                       c-n
                                                                                             OSWER  Policy  Directive  9U35
PART III.Complete This Part Only if the Request is for Approval of a Collection
	  of Information Under the Paperwork Reduction Act and 5 CFR 1320.
13. Aosfac:3escr.ce needs, uses and affected puOiic m 50 words or less
 14. */oe ot information collection (cftee* only out)
    Intormitioa eoiltetlottt not conttln+d In rultt
    '. _ Regular juomuiion
    Iniarmttian collection! coatittt4 In rultt
    3 _J Existing regulation (no efitngt orooottti)
    4 G Not.ee of proeosed rulemafeing (NPRM)
    S v__ F
    '. _- New collection
    2 _ Revinon of a currently aooroved collection
    3 _J Ertention of tne eioiration date of a currently aooroved collection
                             4 U  Reinstatement of a previously approved collection tar wni
                                   Mas tipired
                             $ O  Citsting collection in use without an OMB control numoer
1 6. Agency report form numoer(s) (inciuOt tunatra/optionn form numotrfs))
1 7. Annual reporting or disclosure Durden
I Numoe' of respondents
2 Numoer of responses per respondent
3 Total annual responses (lint 1 tiirttt lint 2)
4 Hours per response ' ...
 Tgta' nojrs (lint 3 ttrntt lint 4)
" Annual recordkeeping Burden
1 Numoer of recordkeeoers
2 Annual nours per recordkeeper
3 Total recordkeening nours (lint 1 f;me* lint 2)
4 Beeordkecoing retention oenod
'. 9 *o:a' annual ourder
: Reouested C/me i 7-5 Oiut lint 1 8-3)
2 in current OMB inventory
3 Difference (lint I itu lint 2)
LtolMnmtioa at eVfVerertce
4 Program change
5 Adiusiment








years





20. Cerent 
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                                     C-13
i Sketching your stor/board
i
!                                                        byGcneZdozny
  An oral/visual presentation is more chan a series of facts presented one at a rime.
  A presentation is a story with a beginning, a middle, and an end in which each fact
  is meticulously orchestrated  into a cohesive whole. Each thought must be related
  to the next until che sequence of ideas builds up to a message that is clearly under-
  stood by ail members of the  audience and that leads to che desired course of action.

  The story board  approach presented here minimizes our tendency co get so  wrapped
  up in the intricacies of an exhibit that we fail to relate the chart to the total story.
  Instead it allows us to map out the flow of the presentation, to see where we have
  too many charts for a simple point and not enough for more complicated ones, to
  identify transition problems, to determine where we should summarize before
  introducing the  next thought.

  The steps that make up the story board approach are listed below and illustrated
  on the following pages.
  A.' Structure the outline of  the story

  B.  Determine what visuals are needed

  C  Sketch the story board .-
         Write an introduction: (1) stating the purpose of the presentation;
          (2) reviewing the need for action or relevance to the audience; and
          (3) giving a preview of the way you will present your message.

         Design and substantiate the visuals
              Sketch the visuals needed to convey the story  line
              Write out the message  the "so what" - of each visual

         Write  the oral transitions needed to carry you from one visual to
          the next

         Write the ending: (1) summarizing the major conclusions; (2) specifying
          the recommendations; and (3) identifying the next steps.

  For your convenience, a blank story board page appears on the back of this handout.
 Make copies and try it with your next presentation.
  Ccnc Zlunv 1979

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                                                                            C-1U
        4
 Q,  Deprninewtxat visuals ore needed
      U.S. MARKET a ATTRACTIVE FOR ENTRY BY
      }.J\ Ltd.
        A. U.S. i* the werld't ledin| economy 1~11~
        1
        ^. U.S. 3nkw(  rtturn* are mo*l attractive

        V- Barrier* to nrr emn Be overcome	
      A.  '.'.S. 3 THE WORLD'S  LEADING ECONOMY
         I. U.S. ha* Urfeet ar at wortd'i COP
        2. U.S. he mar* foreign trad* tnan uir oer country-
        ). U.S. farei(n direct invtmnt tietd> til otnrt,
           nd i* p*ci4 to rn 4rm*ucallr
       .  U.S. BANKLNC RETURNS ARC MOST ATTRACTrvg
        I.  PreliutttUty o< nvijer U.S. b4nk cornier**
           >*arDiy with (erctfn bnb

        Z.  Etc.
   U.5.: LACIEST &HAQS:
        OC \MORi_D GDP
                       .UhlTtO STMTS
                                       SO WHAT
                                        in irm o( |ra
                                        4omitic product.
                                        * (ui4 Hi* U. S.
                                        hat 4 totMr thn
                                        lOHi  ittar* al  th
                                        *rU'i COP.
                                        Thi* u mar* th*n
                                        th turn of th nvt
                                        thr* countrici.
TRANSITION-  Not only do* th* U.S. h4v* th* larfttl
tivare of in*  world's economy, it n* mor* (or*t(n
trd* lh%tt an* other country.
                                                                              /*OST
                                                                                                              SO WHAT
                                     Combuitnf im*
                                     aorta and *por,
                                     th< U.S. |*n*r-
                                     ttcd 3vr SJOO
                                     ailUon m (or*>tn
                                     trad* Ut vttf -
                                     JO". mor Uin
                                                                                                                 nt
                                                                                                                 (ortfn trdr.
                                                                         TRANSITION; IA addition, the U.S. eontrola contidra-
                                                                         at* (orvifn dtr*et unvtmnl. nd that uivitmnt n
                                                                         proi*et*4 to mera aifnilictntly.
MOR OF SAME ...
                                                        ENDING
                                                             ad
SUMMARY
                                                                         RECOM-
                                                                         MENOATION
                                                                           NcXT STEPS
                                                                                             To uflimru.  th* '. S  -narktt ioorj
                                                                                             to b* an attricuv*  frowtti ooportunitv
                                                                                             a*cauM 01 u. rttumi.  ma  riati^e
                                                                                             as* of in4 protrai-
                                                                                                                             v ee >
                                                                                             I    Identify  specific >t-?*ru
                                                                                                 that lake 4d\antag* of
                                                                                                 J.J  Ltd.'* trn,th.
                                                                                             2.  Determine  resource*  required
                                                                                             ).  Develop  action  plan for  entry
                                                                                                 i elaborate)

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                                     D-l
                                             OSVER Policy Directive ,-.'9435 .00-1
                                   APPENDIX  D

                               LIST OF CONTACTS
      NAME
Randy Bacon

Pat Blacknall

Dan Fiorino


Oonna Giovinazzo

Joan LaRock

David Levy


Vickie Reed


John Richards


Phil Schwartz

Rick Westlin
PHONE NUMBER

382-2128

382-2130

382-5480


382-4471

382-4617

382-7206


382-7204


382-2253


382-5493

382-2745
                 EXPERTISE
Print Shop

GPO-Specialized Billing for  Reprints

Agency Chairman for Workgroup Closure
Meetings

OSWER Correspondence Unit

OSWER Steering Committee Representative

Desk Officer, RMB, Special Contact with
OFR

Federal Register Officer, format and
technical requirements

Chief of Federal Register staff, teaches
course on Federal Register requirements

Desk Officer, RMB, Start Action Requests

OPPE, Information Collection Requests

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                                             OSWER Policy Directive -9435.00-L
                                     E-l
                                  APPENDIX  E

                          LIST OF SAMPLE DOCUMENTS
RCRA Subtitle D Regulatory Program for  the  Management of Mining Wastes:  Final
    Regulatory Development Plan.   USEPA,  Office  of  Solid Waste.  "March 18,
    1987.

NCP Workgroup Report Covering the Period  from  January Through February 1987.

Subtitle D Options Paper.

Regulatory Impact Analysis of Proposed  Standards for the Management of Used
    Oil. Office of Solid Waste,  Economic  Analysis Branch.  November 1985.

Regulatory Flexibility Analysis.

Implementation Strategy for the  Land Disposal  Restrictions Program.

Background Document --.Final Rule:  Closure,  Post-Closure Care,  and Financial
    Responsibility Requirements.   USEPA,  Office  of  Solid Waste.   April 1986.

Decision Package for the May 2.  1986 Final  Rule  Governing Standards for
    Closure and Post-Clousre Care of Hazardous Waste Management  Facilities.

         Transmittal Memorandum
         Action Memorandum
         Preamble and Rule
         SF-83

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