S^6P 9*^
A
n
%
PR <3$
/
Regulation Development
in
EPA
-------
ST4f
-------
Thursday
8:30-8:45
August 28, 1990
REGULATION DEVELOPMENT IN EPA
DRAFT COURSE AGENDA
September 6-7 1990
WASHINGTON INFORMATION CENTER (WIC) #3
INTRODUCTION TO THE COURSE
Nancy Helm
o Administrative Items
o Review of Schedule
8:45-9:15
9:15-9:45
EPA's RULEMAKING RESPONSIBILITIES
o What is a Regulation?
o Statutes CPA Administers and
Responsible Offices
o Cross Media Issues
SOURCES OF RULEMAKING
Neil Kerwin
o
o
o
o
o
o
Sources of Rulemaking
Basic Procedures For Rule-
making (APA)
Statutory Deadlines
Additional Procedural
Requirements in EPA Statutes
Court-Imposed Deadlines
Staff Determinations of the Need
for Rules Including ANPRM
Public Petitions for Rulemaking
Neil Kerwin
9:45-10:00
BREAK
10:00-11:00
REGULATION DEVELOPMENT OVERVIEW
o Purpose of Regulation Development
o Steering Committee
o The Start Action Request
o The Workgroup
o Regional Participation
o The Development Plan
o Regulatory Scoping Meetings
Paul Lapsley
-------
2
o Workgroup Reports
o Workgroup Closure
o Red Border
o OMB Review
o Federal Register
REGULATION NEGOTIATION AND CONSENSUS BUILDING
Debbie Dalton
11:00-11:45
11:45-1:00
LUNCH
1:00-2:15
WORKGROUP OPERATIONS
Panel Discussion
o
o
o
o
Purposes of Workgroup
Roles & Responsibilities of
Chairs & Members
Personal Experiences
Workgroup Reports:
Purpose, Frequency and Contents
Workgroup Closure:
How Do YoiiKnow When-Xo»F, Are Ready?
2:15-2:30
BREAK
2:30-3:10
RULES THAT REQUIRE INFORMATION
FROM THE PUBLIC
o Preparing For Your Information Needs
Harold Woodley
3:10-3:50
ENFORCEMENT
Jon Jacobs
o Points To Remember
In Writing Enforceable Rules
-------
3
Friday
8:35-8:45
8:45-9-30
9:30-10:00
Introduction to Dav Two
PUBLIC PARTICIPATION -INCORPORATING THE
PUBLIC IN REGULATORY DEVELOPMENT
o- Fonrfs of-Public Participation
o The Communication Plan/Strategy
o Public Comments & The Docket
Steve Johnson
Gerald Yamada
10:00-10:15
BREAK
10:15-11:00
HOW TO WRITE A LEGALLY DEFENSIBLE RULE
o Responding to Public Comments.,
o Using Appropriate Rulemaking Procedures
o Adequate Scientific Basis for a Rule
Jim Nelson
11:00-11:45
ECONOMIC INFORMATION
o The Use of Economic Analysis
In Regulation Development
Christine Augustyniak
11:45-12:15
THE REGULATORY FLEXIBILITY ACT
o Consideration of Small Entities In
Regulation Development
Betty Shackleford
12:15-1:15
LUNCH
1:15-2:00
SCIENTIFIC INFORMATION
How Statutes & Executive
Orders Affect the Use of
Scientific Information
Jay Benforado
2:00-2:15
BREAK
-------
4
OMB REVIEW Nicolas Garcia
2:15-3:30 o Who Reviews Rules at OMB?
o What Does ^aximiziiig^etvBenefits
to Society" Mean?
o Making OMB Review Easier?
3:30-4:00
BRINGING IT ALL TOGETHER
Tom Kelly
-------
September 5, 1990
Thursday
8:30-8:45
8:45-9:15
9:15-9:45
REGULATION DEVELOPMENT IN EPA
COURSE AGENDA
September 6-7 1990
WASHINGTON INFORMATION CENTER (WIC) #3
INTRODUCTION TO THE COURSE
Nancy Helm
o Administrative Items
o Review of Schedule
EPA's RULEMAKING RESPONSIBILITIES
o What is a Regulation?
o Statutes EPA Administers and
Responsible Offices
o Cross Media Issues
SOURCES OF RULEMAKING
o Sources of Rulemaking
o Basic Procedures For Rule-
making (APA)
o Statutory Deadlines
o Additional Procedural .
Requirements in EPA Statutes
o Court-Imposed Deadlines
o Staff Determinations of the Need
for Rules Including ANPRM
o Public Petitions for Rulemaking
Neil Kerwin
Neil Kerwin
9:45-10:00
BREAK
10:00-11:00
REGULATION DEVELOPMENT OVERVIEW
o Purpose of Regulation Development
o Steering Committee
o The Start Action Request
o The Workgroup
o Regional Participation
o The Development Plan
o Regulatory Scoping Meetings
Paul Lapsley
-------
2
o Workgroup Reports
o Workgroup Closure
o Red Border
o OMB Review
o Federal Register
REGULATION NEGOTIATION AND CONSENSUS BUILDING
11:00-11:45
Debbie Dalton
11:45-1:00
LUNCH
1:00-2:15
WORKGROUP OPERATIONS
o
o
o
o
Purposes of Workgroup
Roles & Responsibilities of
Chairs & Members
Personal Experiences.
Workgroup Reports:
Purpose, Frequency and Contents
Workgroup Closure:
How Do You I^npw ^hen^You Arp Ffoady?
Panel Discussipn
2:15-2:30
BREAK
2-30-3:10
RULES THATREQlflRE INFORMATION
FROM THF PUBLIC
Preparing For Your Informatioln'i^eeds
Harold Woodley
3:10-3 JO
ENFORCEMENT
Jon Jacobs
Points To Remember
In Writing Enforceable Rules
-------
3
Friday
8:35-8:45 Introduction to Dav Two
PUBLIC PARTICIPATION -INCORPORATING THE
PUBLIC IN REGULATORY DEVELOPMENT
8:4$-9's3(M » Forms of PublicParticipation Steve Johnson
o The Communication Plan/Strategy
9:30-10:00 o Public Comments & The Docket Gerald Yamada
10:00-10:15 BREAK
10:15-11:00 HOW TO WRITE A LEGALLY DEFENSIBLE RULE
Jim Nelson
o Responding to Public Comments
o Using Appropriate Rulemaking Procedures
o Adequate Scientific Basis' for a Rinle
ECONOMIC INFORMATION
Christine Augustyniak
11:00-11:45 o The Use of Economic Analysis
In Regulation Development
11:45-12:15
THE REGUCATQflY FLEXIBILITY ACT
Betty Shackleford
Consideration of Small Entities In
Regulation Development
12:15-1:15
LUNCH
1:15-2:00
SCIENTIFIC INFORMATION
Kevin Teichman
How Statutes & Executive
Orders Affect the Use of
Scientific Information
2:00-2:15
BREAK
-------
4
OMB REVIEW Nicolas Garcia
2:15-3:30 o Who Reviews Rules at OMB? •
o What Does "Maximizing Net Benefits
to Society" Mean?
o Making OMB Review Easter?"
3:30-4:00
BRINGING IT ALL TOGETHER
Tom Kelly
-------
TABLE OF CONTENTS
REGULATION DEVELOPMENT IN EPA
REGULATION MANAGEMENT FACT SHEETS
EPA's RULEMAKING RESPONSIBILITIES
EPA's Rulemaking Responsibilities
What is a Rule?
Types" of Rules
Basic Elements of Regulation Development
The Regulatory Principles/Policy Guidelines
EPA Compliance with Non-EPA Statutes
SOURCES OF RULEMAKING
Legal Requirements For Rulemaking & Why EPA Does Rules
Additional Procedural Requirements
Examples of Statutory Provisions Requiring Rules
Safe Drinking Water Act: Statute Language Authorizing EPA
to write a Rule
Example of Actual "Deadline" language from a Judicial Decision
Example of an ANPRM
Example of Public Petition for Rulemaking
REGULATION DEVELOPMENT OVERV8EW
Overview Charts
Fact Sheet: Steering Committee
Flow Charts of Major, Significant & Minor Rules
Fact Sheet: Red Border Review
WORKGROUP OPERATIONS
Fact Sheet: Workgroup
Regulation Development Branch Desk Officers,
Phone Numbers & Program Areas
Practical Aspects of Workgroup Operations
-------
2
Fact Sheet Start Action Request (SAR)
Prototype: Start Action Request: Update of Oil Pollution
Prevention Regulation
Common Problems in Completing the SAR
Fact Sheet: Development Plan
Guidelines for a Development Plan
Identifying Regulation Development Issues
Example: Development Plan For Pesticide Registration,
Storage and Disposal Data Requirements
Fact Sheet: Workgroup Reports
Guidance for a Workgroup Report
Sample Workgroup Report: Domestic Sewage Study Implementation
Regulation
Workgroup Closure Outline
Fact Sheet Workgroup Closure
Sample Workgroup Closure Memo: National Primary Drinking Water
Regulation for Arsenic
INFORMATION COLLECTION
Fact Sheet: Information Collection Requests
Information Policy Branch Desk Officers,
Phone Numbers & Program Areas
Information Collection Request Handbook
REGULATORY FLEXIBILITY
Fact Sheet: The Regulatory Flexibility Act
Guidelines for Implementing the Regulatory Flexibility Act
PUBLIC PARTICIPATION
Goals & Strategies For Public Participation
Reasons For Public Participation
Forms of Public Participation
Guidance' Administrator's Communication Order of 6/24/87
Fact Sheet: Regulatory Negotiation
Regulatory Negotiation Outline
Selection Criteria For Reg. Neg.
Regulatory Negotiation Activities
Gerry Yamada-Qs & As on Recording Outside Comments
Guidance: Uniform Rulemaking Docket
Pathfinder To Major EPA Dockets
Memo: Contact with Persons Outside the Agencg
-------
3
WRITING A LEGALLY DEFENSIBLE RULE
How to Write a Legally Defensible Rule
Responding to Public Comments
SCIENTIFIC INFORMATION
The Use of Scientific Information in Rulemaking
ENFORCEMENT
Checklist for Developing Enforceable Regulations
Memo: Implementation and Enforcement Checklist
ECONOMIC INFORMATION
Outline: The Use Economic Analysis in Rulemaking
OMB REVIEW
Outline
Fact Sheet: OMB Review Under E.O. 12291
Executive Order 12291 — Basic Princples
Executive Order 12291
Executive Order 12498
FEDERAL REGISTER FYI
Fact Sheet: Rederal Register
Checklist with Page References & Answers
Federal Register Check List
Sample of Rule Submitted to the Federal Register
POLLUTION PREVENTION FYI
-------
THE STEERING COMMITTEE
Purpose: The Steering Committee is a standing group with representation from each Assistant
Administrator and the General Counsel. It is the primary mechanism for coordinating and integrating
the Agency's regulatory development activities. Its key functions are to approve Start Action
Requests (SARs); charter and 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).
Participants:
CHAIR- Thomas Kelly
382-4001
OW.
James Home
382-7818
OE: Winston Haylhe
475-8783
OAR. Robert Brenner
475-7717
ORD: Jay Benforado
382-7669
OARM: Robert English
382-5000
OPPE. Dan Fiorino
382-4012
OPTS: Judy Nelson
382-2890
OSWER: Elizabeth LaPointe
382-4617
OGC: Gerald Yamada
475-8064
Operation: The Steering Committee meets biweekly (every other Wednesday), with additional
meetings scheduled as necessary. Its regular format is (a) review of Development Plans (b)
consideration of pending Workgroup Reports (c) discussion and disposition of SARs, and (d) other
issues Upon request, the Chair will schedule a separate meeting to consider a proposed or final
rulemaking package, or arrange for some other form of Steering Committee review Any office may
submit documents or issues for the agenda through its Steering Committee Representative. Regional
Contacts receive all Steering Committee documents. Typically they are not able to attend meetings,
but Regions can send written comments. Due to time limitations, they may call the Regulation
Development Branch (RDB) in the Office of Regulatory Management and Evaluation with issues, so that
RDB can present these views at a meeting. After each meeting, the Committee Chair issues a closure
memo that documents outstanding issues, agreements, and action to be taken. RDB provides staff
support for the Committee.
In addition to their role as members of the Steering Committee, these 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, and Federal Register
activities); serve as their Assistant Administrator's liaison with OMB under Executive Orders 12291
and 12498; and direct their programs' review of other offices' regulatory development activities
See Also: Administrator's Memorandum, 'The Regulatory Development Process: Change in Steering
Committee Emphasis" (October 16, 1986), and 'Information Sheet to Guide New Steering Committee
Process" (November 19, 1986). Available from the Regulation Development Branch (382-5475).
Fact Sheet 1 (Rev 5/90)
Regulation Management Series
-------
START ACTION REQUESTS
Purpose: A Start Action Request (SAR) initiates work on a rule or related action and establishes the
Agency workgroup. It provides brief, descriptive information and should be prepared at the very
outset of an office's effort. Its principal purposes are to alert other Agency offices to the lead office's
intention to develop a rule, and provide the Steering Committee with the opportunity to discuss and plan
for the inter-office or inter-media aspects of the action. In addition, submitting the SAR to the
Steering Committee is the mechanism for: (a) reaching agreement on the necessary review steps (e.g.,
a Development Plan, Workgroup Reports, and an Information Collection Request), and (b) helping all
Agency programs decide at the start of the process whether to designate members to participate on the
workgroup and what skills would best contribute to the rulemaking.
Preparing the Document: The SAR is a one-page form with instructions on the reverse side. It
asks primarily for descriptive information, which should be available to the lead office when it starts
work on the regulation The most important category of information on the form is Item 4, called
"Descnption of Action." The Steering Committee uses this information to determine the significance of
the action for the Agency and for individual offices, the need for a Development Plan or other planning
documents, the composition of the workgroup, and the type of management review that is appropriate.
For these reasons, the description should give information on any likely cross-program effects, issues
or problems. The description should.
o clearly define the problem, including its health and environmental significance;
o indicate the effect of the problem and the intended regulatory action on other
environmental media or programs,
o identify the EPA Regions and other groups that should be involved;
o specify the kind of expertise and level of participation expected from workgroup
members
Operation: The lead office Steering Commitee Representative approves the SAR, catagorizes it as
either "discussion" or "nondiscussion", and submits 25 copies to the Regulation Development Branch
(RDB) for distribution. "Discussion" SARs warrant a briefing Irom the lead office to facilitate approval
and workgroup nominations "Nondiscussion" SAR's are considered automatically approved and only
require nomination of workgroup representatives at the meeting. The lead office should submit
"nondiscussion" SARs 15 days prior to the biweekly Steering Committee meeting. Steering Committee
Representatives can decide before the final agenda is set (one week before the meeting) if the SAR
needs a briefing and RDB can reschedule it as a "discussion* item. " Discussion' SARs need only be
submitted 8 days before the Steering Committee meeting for inclusion in the final agenda The
Committee approves the SAR, charters a workgroup, designates workgroup members, and determines
what further reviews are appropriate. If the SAR does not provide sufficient information for Steenng
Committee Representatives to select their workgroup members, they can give RDB the name or names
after the meeting. RDB will include these^names in the closure memo for the meeting. The lead office
then convenes the workgroup.
See Also: SAR forms, guidelines, and prototypes are available from Steering Committee
Representatives or from the Regulation Development Branch (382-5475)
Fact Sheet 2 (Rev 5/90)
Regulation Management Series
-------
THE WORKGROUP
Purpose: Workgroups are EPA-wide, staff-level groups formed to develop regulatory actions and
supporting materials. The workgroup's primary responsibilities are to: 1) support the lead office in
its design, technical and analytical work; 2) identify and assess principal policy issues and options,
especially those that are cross-media; 3) resolve issues or elevate them for upper management's
resolution; 4) ensure the quality and completeness of regulatory packages. Workgroup members are
expected to represent the policy positions and perspectives of their management as well as to
contribute their technical and analytic expertise.
Participants: Typically the lead office will place several people on the workgroup to support the
chair and conduct the bulk of the technical, analytical, and drafting work. OGC, OPPE, and often ORD
and OE participate; other program offices-OAR, OPTS, OSWER, and OW--often participate actively
especially when there are significant inter-media issues. OARM and Regional Offices participate less
frequently. If a Steering Committee Repreentative assigns more than one workgroup member, they
usually designate one person as lead to represent their Assistant Administrator's position and
coordinate the efforts of the other members (If workgroup progress requires that there be a single
lead from other offices, the lead program Steering Committee Representative can ask each office to
designate a lead workgroup member.) Except in special cases, it is difficult for Regions to participate
actively on workgroups. Therefore, the lead office should initiate efforts to solicit Regional office
perspectives, especially those that pertain to implementation issues.
Operation: The workgroup's formal operation begins with the approval of the Start Action Request
(SAR) and the chartering of the workgroup by the Steering Committee. The lead office chairs and
convenes workgroup meetings Other members of the workgroup are assigned by their offices'
Steering Committee Representatives. How the workgroup should operate will vary, depending on the
rulemaking. The workgroup chair should discuss and clarify members' roles and expectations early in
the process to avoid misunderstandings. The workgroup's first responsibility, for major and
significant rules, is to prepare a Development Plan, which the Steering Committee reviews. For most
rules, the Steering Committee will ask the workgroup to report on its progress through periodic
Workgroup Reports, which the workgroup chair must prepare. To ensure workgroup and Steering
Committee consensus on the agenda of issues for discussion, the workgroup chair should prepare a
comprehensive list of issues (originally part of the Development Plan for major or significant rules)
and revise it as appropriate throughout the rulemaking.
See Also: Fact Sheet #5, "Workgroup Reports", available from the Regulation Development Branch
(382-5475).
Fact Sheet 3 (Rev. 5/90)
Regulation Management Series
-------
DEVELOPMENT PLANS
Purpose: The Development Plan sets forth the framework for developing proposed major or
significant Agency rules. Its-purpose is to explain the need for the action; identify regulatory goals and
objectives; present the major regulatory issues and alternatives; identify any policies, decision
criteria or other factors that will influence regulatory choices; and present the work plan and resource
requirements for developing the regulation.
The Development Plan is prepared for Steering Committee review. This review is meant to identify the
full range of issues early in the process The Steenng Committee will: (a) raise cross-media or other
issues or alternatives not identified in the Plan; (b) inform the lead office of related activities
underway in the Agency; (c) encourage coordination of Agency resources, experience and policies; and
(d) review the work plan and schedule to decide how the various offices will participate and whether
they can meet the time and resource needs of the lead office.
Preparing the Document: The lead office prepares the document with participation from the
workgroup The document should include detail commensurate with the complexity and importance of
the rule To the extent possible -- based on previous experience and available data - the plan should
describe the environmental problem and issues, and the alternatives to be considered in addressing
them. It should also address enforcement and implementation issues. In any case, the document should
include a comprehensive list of issues, which the workgroup should amend as necessary throughout the
development process.
Operation: The lead office should submit the Development Plan for Steering Committee review within
60 days of SAR approval (unless the Steering Committee agrees to another date). The lead office
submits the Plan to its Steering Committee Representative, who reviews the document before sending
25 copies to the Steering Committee Chair for distribution. The Steering Committee review period is
two weeks To get a Plan on an agenda, the Steering Committee member must submit it to the Office of
Regulatory Management and Evaluation, Regulation Development Branch by COB (4:00 p.m.) Tuesday,
15 days before the biweekly Wednesday meeting.
Steering Committee members review the package to ensure that it is complete and identify questions or
issues. The lead program office then briefs the Steering Committee on the plan at the biweekly
meeting Members will raise any questions or issues at that meeting. After discussion, and resolution
of questions and issues, the Steering Committee approves the Plan, perhaps contingent upon certain
revisions or clarifications. The Committee agrees upon an appropriate schedule for workgroup reports
and other review steps. A closure memo documents the Steering Committee meeting, including issues
raised, decisions made, schedule for workgroup reports, and next steps The Steering Committee
tracks progress on the rule through workgroup reports.
See Also: Guidelines and prototype Development Plans are available from Steering Committee
Representatives or the Regulation Development Branch (382-5475).
Fact Sheet 4 (Rev. 5/90)
Regulation Management Series
-------
WORKGROUP REPORTS
Purpose: Workgroup Reports keep the Steering Committee informed about workgroup progress on a
regulatory action. They describe: (a) issues and alternatives being addressed and resolved, (b) any
issues that need to be elevated for resolution, and (c) the status of ongoing work and any anticipated
delays The Steenng Committee's discussion of the Workgroup Report focuses on cross-media or other
issues or alternatives not being considered by the workgroup. Steering Committee concurrence with
the Report is designed to ensure that issues resolved by the workgroup are not raised again at a later
date, and that unresolved issues are dealt with in a timely way.
Preparing the Document: The workgroup chair prepares the Report in consultation with workgroup
members The document should summarize the status of issues but need not be exhaustive. It should be
sufficiently detailed to allow workgroup members to determine that all issues are included and that
their status is presented accurately. Steenng Committee Representatives are expected to confer with
their workgroup member(s). A cumulative or master list of issues (both resolved and unresolved)
should accompany the Report as an attachment. This list should reflect the issues outlined in the
Development Plan, and might not change throughout the workgroup effort unless issues change or new
ones anse. If no Development Plan is prepared, the first Workgroup Report should contain the initial
list of issues to be addressed. Any additional issues arising during the rule's development should be
added to the master list.
Operation: The lead office submits the Report to its Steering Committee Representative, who
reviews the Report before sending it to the Steering Committee Chair for distribution. (Workgroup
members should already have received a copy.) The Steering Committee review period is two weeks
To get a report on the agenda the Steering Committee Representative must submit 25 copies to the
Office of Regulatory Management and Evaluation, Regulation Development Branch by COB (4:00 p.m)
Tuesday, 15 days before the biweekly Wednesday meeting. At the meeting, the program office briefs
the Steering Committee on the Report. Typically the workgroup chair attends the Steering Committee
meeting to participate in the discussion. After discussion, the Steering Committee approves the Report
or requests revisions and makes recommendations. If issues must be elevated, Steering Committee
Representatives determine what these issues are and in what forum to raise them. The Steering
Committee Chair issues a closure memo that documents issues raised and decisions made at the
Steering Committee meeting.
See Also: Fact Sheet #3, "The Workgroup", available from the Regulation Development Branch (382-
5475) A Workgroup Report Format and copies of prototype Workgroup Reports are available from
Steering Committee Representatives.
Fact Sheet 5 (Rev. 5/90)
Regulation Management Series
-------
INFORMATION COLLECTION REQUESTS (ICRs)
Purpose: Under the Paperwork Reduction Act (PRA), Agency offices must prepare an ICR to obtain
OMB clearance for any activity that will involve collecting substantially the same information from ten
or more non-Federal respondents. ICRs are submitted for review initially to the Information Policy
Branch (IPB), in OPPE, and then to OMB. -Offices or workgroups may need to prepare ICRs for:
o information requirements to be included in a rule -- e.g., reporting, monitoring, or
record-keeping requirements, and/or
o other information collection activities -- e.g , conducting studies or surveys, sending
out application forms, doing audits, etc.
Information requirements in final rules may not be valid and enforceable until OMB clears the
corresponding ICR. In the absence of clearance, enforcement actions taken on the basis of information
so collected may be subject to challenge on grounds of non-compliance with the PRA.
Preparing the Document: An ICR consists of an SF 83 form plus an attached justification
statement. In this justification, the following points serve as the focus for both the IPB/OPPE and OMB
reviews:
o the statement of need for - and use of - the information to be collected,
o the plans for managing the information and assuring data quality;
o the calculations of cost to the government and burden on respondents, especially to
make sure that they are consistent with calculations of economic impact in the
rulemaking package; and
o a detailed explanation of any statistical components in surveys, including the sampling
and analysis plans
Operation: To address information requirements in rules, the first step should be to use the Start
Action Request to indicate that there may be reporting or record-keeping requirements. These
information requirements may involve rulemaking issues of interest to other offices. Such issues
should be discussed in the workgroup, and if unresolved should be included in workgroup reports to the
Steering Committee. Once the ICR is ready, the originating office's Information Management
Coordinator submits it to IPB This should be no later than when the rulemaking package first reaches
formal Agency-wide review (workgroup closure or Red Border review). IPB then reviews the ICR for
information policy issues and responds with any problems within two or three weeks. Any such
problems must be resolved at the latest in conjunction with Red Border review, since IPB must submit
the ICR to OMB on the date that the proposed rule is published. OMB review normally take 60-90 days.
In the case of information requirements in proposed rules, 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, a revised ICR must be submitted.
For other information activities, the ICR should be ready to submit four months before the infomation
collection is scheduled to begin - earlier if there may be survey design issues The program office
should discuss concepts at the workgroup level, and Development Plans should include enough lead time
to allow for preparation, review and clearance of the ICR. Bear in mind that for surveys a pilot or
pretest may be necessary and that - in some cases - the pilot or pretest may need its own ICR.
See Also: "Instructions for Preparation of Information Collection Requests*, available from IPB (382-
7206) or the Information Management Coordinator in your Assistant Administrator's office. For
further discussion of the PRA see 5 CFR Part 1320
Fact Sheet 6 (Rev. 5/90)
Regulation Management Series
-------
WORKGROUP CLOSURE MEETINGS
Purpose: The workgroup closure meeting is an alternative to Steering Committee review of the
decision package prior to Red Border (Assistant Administrators') review. This closure meeting
provides a forum for confirming that (a) .the workgroup has successfully completed its job, resolving
as many issues as possible and clearly defining others, (b) the rulemaking package is ready for AA, RA,
and DA-level review, and (c) Agency and external requirements have been met.
Participants. The Director of the Regulation Management Division (from Office of Regulatory
Management and Evaluation [ORME]), or a representative, chairs the closure meeting. The role of the
ORME chair is to facilitate closure, not to decide substantive issues Members of the workgroup
participate in the meeting as representatives of their Assistant or Regional Administrators
Participation in the closure meeting normally is a precondition for an office's participation in the Red
Border Review
Operation:
1. The Steering Committee Representative from the lead office requests a closure meeting
through the appropriate Desk Officer in the Regulation Development Branch of ORME
The lead office must provide a complete draft rulemaking package to workgroup
members at least ten calendar days before the closure meeting. This draft package
includes materials that normally are expected to be part of the Steering Committee
review--the rule, action memo, preamble, supporting analysis, information clearance
request (ICR), and other relevant materials. A copy of the memo announcing the
closure meeting must be sent simultaneously to all members of the Steering Committee
2. The typical format for the meeting is: with the ORME chair presiding, the workgroup
chair gives a brief summary of issues resolved and those still outstanding, and
describes any changes since the lead office distributed the draft package to the
workgroup Other workgroup members offer their respective Assistant or Regional
Administrators' positions (e.g., concurrence, concurrence with comment, concurrence
with conditions, or nonconcurrence). If there is more than one workgroup member
from an office, then they should be sure to coordinate their positions before the closure
meeting. The ORME chair encourages closure by clearly establishing:
a) matters that should be addressed before Red Border,
b) issues (if any) to be presented in Red Border,
c) participation in, and date for beginning, Red Border review.
3. Following the closure meeting, ORME will issue a brief summary that certifies a
package for Red Border review or documents other conclusions. This closure memo
defines the conditions, timing, and other aspects of Red Border review. The lead office
and affected parties resolve any problems, either before or during Red Border review,
using the Steering Committee as a forum if appropriate.
See Also: Fact Sheet #3, "The Workgroup", available from the Regulation Development Branch (382-
5475)
Fact Sheet 7 (Rev. 5/90)
Regulation Management Series
-------
RED BORDER REVIEW
Purpose: Red Border is the formal .review mechanism by which senior management (usually
Assistant and Regional Administrators and the General Counsel) reviews and approves regulatory
packages before they are presented to the Administrator or other approving official. 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 anse dunng Red Border review.
Participants: The Assistant Administrator for the lead office approves the package for Red Border
review by signing the transmittal memo. The review may include only the Assistant Administrator for
OPPE and the General Counsel. However, other Assistant Administrators or Regional Administrators
may participate if their offices were represented on the workgroup (or by approval from the lead
office Steering Committee Representative if they were not). The Steering Committee decides who will
participate when they review the action prior to Red Border.
Preparing the Document: The Red border package should include:
o Action Memorandum
o Preamble and Regulatory Text
o Communications Strategy
o Federalism Review Form (EPA Form 3720-11)
The lead office submits enough copies of the regulatory package
plus two, to the Regulation Development Branch (RDB). If the
Border and OMB review it should also include OMB form SF83 and
and rule.
Operation: The review period is generally three weeks. The lead Assistant Administrator may
request a shorter Agency review if the rulemaking is under a tight schedule; i.e., court or statutory
deadlines Any such request must be in wnting, and include the reason for expedited review. During
the Red Border review the appropriote RDB desk officer receives written comments from the
reviewing offices and transmits them to the lead office. After Red Border is complete and the lead
office has considered and responded to all comments, it prepares the package for OMB review
See Also: Fact Sheet #9, 'OMB Review Under E.O. 12291* and Fact Sheet #7 "Information Collection
Requests", available from the Regulation Development Branch (382-5475).
for all reviewing offices and regions,
rule is approved for concurrent Red
four additional copies of the preamble
Fact Sheet 8 (Rev. 5/90)
Regulation Management Series
-------
OMB REVIEW UNDER E.O. 12291
Purpose: Under Executive Order (E.O.) 12291, each proposed and final rule (including some policy
documents and guidelines) which the agency issues must be sent to OMB for review before the
Administrator signs it. The Order defines' two categones of rules: major and non-major. Major rules
are those having a very large impact on society, either in terms of costs (over $100m annually), or in
terms of effects on an industrial sector, employment, or international trade. The purpose of OMB
review is to assure that, within the constraints of their statules, agencies choose among the various
alternatives by considering the costs and benefits associated with each. OMB has exempted certain
high-volume classes of rules with limited impacts (e.g , pesticide tolerances) from E.O. 12291 review
Participants: The lead office responds to OMB issues or questions on its rule. The Steering
Committee Representative for that office takes the lead in arranging all OMB meetings and in
coordinating the office's response to OMB. The lead program office should include OPPE and OGC in any
meetings with OMB, and confer with other affected offices on the appropriate response before making
substantive changes. OPPE tracks and reports on the status and current issues of rules under OMB
review for senior management.
Operation: Except for the exempted rules -- and those in certain special categones (e.g. TSCA 8(a)
Rules) -- all rules are senl to OMB's Office of Information and Regulatory Affairs (OIRA) before they
are signed by the Administrator or a designated official. OMB review normally follows Red Border
review. If this sequence of review would cause EPA to miss a statutory or court-order deadline, the
Steering Committee may authonze concurrent OMB and Red Border review
To initiate the E.O 12291 review, the lead office must submit five copies of the preamble and rule along
with a single copy of a SF-83 form signed by their Steenng Committee Representative to the Regulation
Development Branch OPPE clears and signs the SF-83 for submittal to OMB. For intenm 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.
The penod for OMB review cited in Ihe Order varies according to the type of action: major rules have
a 60-day review at proposal and 30 days at final; non-major proposed and final rules have a 10-day
review If OMB does not complete its review within the specified review penod the OIRA desk officer
calls the ROB desk officer to extend the review. In virtually all cases, rules do not go forward for final
signature in EPA until the program office addresses OMB concerns and resolves outstanding issues
Court-ordered deadlines and stnngent statutory deadlines may occasionally require that EPA publish a
rule before OMB has finished its analysis and comment. After OMB review is completed the lead office
prepares the package for AX (Administrator's Correspondence Control) and the Administrator's
signature. The package includes two copies of the preamble and rule, the signed action memo,
communications strategy, Federal Register typesetting request (EPA Form 2340-15), and request for
reprints, if desired (EPA Form 2340-1). The lead office should deliver the package to RDB for
transmission to AX. Obtaining the Administrator's signature usually takes a week to ten days.
See Also: Fact Sheet #8, "Red Border Review", available from the Regulation Development Branch
(382-5479). Steenng Committee Representatives can advise on exemptions from E.O 12291 review
Fact Sheet 9 (Rev 5/90)
Regulation Management Series
-------
FEDERAL REGISTER PUBLICATION
Purpose: The Federal Register publication system was established by Congress as a means of
informing the public of regulations that affect them Publication in the Federal Register has certain
legal effects, including: providing official nolice of a document's existence and content; creating a
rebuttable presumption that the text is a true copy of the original document; establishing that the
document was duly issued, prescribed, or promulgated; and providing evidence that is recognized by a
court of law.
Preparing the Document: When preparing a document for Federal Register publication, the lead
office should follow the formal requirements of the Office of the Federal Register (OFR), found in the
Federal Register Document Drafting Handbook. The Federal Register package should include:
o the signed original of the preamble and regulation plus three copies
o the Federal Register Checklist, signed by the Steering Committee Representative or
other approving official,
o typesetting request (EPA form 2340-15); and
^o EPA form 2340-1 if reprints are being ordered
OFR follows stnct publication requirements, so even minor problems can delay publication. The most
common problems causing delay are: errors in codification; unclear graphs, charts, and tables; too
few copies; unclear signatures, omitting a typesetting request or Federal Register Checklist.
Operation: If the package requires the Administrator's signature the lead office must submit the
Federal Register materials with the package for transmission to AX (See Fact Sheet 9). In any case,
direct all Federal Register packages to EPA's Federal Register Officer, Regulation Development Branch
(RDB), Room 409WT, 382-7204. RDB reviews documents for consistency with OFR requirements and
transmits them to OFR for publication. Documents usually appear in the Federal Register within four
days after RDB approves them. However, if a document is particularly long (250 pages or more), and
contains many tables, graphs, and figures, publication will take at lease one week RDB provides a
listing on E-Mail that describes all documents sent to the Federal Register or
published within the past five days. To access this system simply: 1) sign onto E-Mail, 2)
type PRPOST, when the prompt appears, 3) type FED REG when "category" appears, and 4) read
or scan the listing.
See Also: Federal Register Document Drafting Handbook, available from the Agency's supply store.
Federal Register Checklist, available from Steering Committee Representatives or the Regulation
Development Branch (382-5475).
Fact Sheet 10 (Rev. 5/90)
Regulation Management Series
-------
THE REGULATORY FLEXIBILITY ACT
Purpose- The purpose of the Regulatory Flexibility Act of 1980 is to reduce the burden of Federal
regulations on small entities -- that is, small businesses, government jurisdictions, and private
organizations. The Act applies to all rules subject to the notice and comment procedures of the
Administrative Procedures Act (except grant regulations). It requires agencies to consider adverse
economic effects their regulations will have on small entities. For regulations that will have a
"significant impact on a substantial number" of small entities, agencies must consider alternative
measures by preparing a Regulatory Flexibility "Analysis (RFA). Agencies are encouraged to consider
establishing exemptions or tiering their regulations, when consistent with their statutory and program
objectives
Participants: The lead office is responsible for prepanng the RFA or certifying that there are no
significant impacts on small entities. The Regulation Development Branch (RDB) in the Office of
Regulatory Management and Evaluation (ORME) oversees EPA's compliance with the Act. EPA's Small
Business Ombudsman (in the Office of Small and Disadvantaged Business Utilization) can advise on small
business issues and the Small Communities Coordinator (Office of Regional Operations, State and Local
Relations) is the Agency lead on issues affecting small communities. The Small Business Administration
(SBA) has overall responsibility for the Act. It reviews the Agency's analyses and certifications SBA
also reports to Congress on Agency compliance with the Act.
Preparing the Document: In defining "small" entity the Agency may use SBA's definition or, in
consultation with SBA, it may establish its own definition and propose it for public comment If the
Agency decides that a rule will not have a significant impact on a substantial number of small entities,
it must certify and justify this finding in the rule's preamble at both proposal and promulgation The
Agency must send a copy of any certification to SBA at proposal or promulgation. If the Agency
determines that a rule will have a significant economic impact on a substantial number of small entities,
it must prepare an RFA The RFA should identify all alternatives to the chosen option and describe:
1 ) objectives/legal basis of the rule;
2) benefits derived from the proposed changes;
3) characteristics of the affected industry and analysis of demographics, cost,
competitive effects, and exemptions or allowances;
4) recordkeeping, reporting, or other compliance requirements; and
5) other regulations which may duplicate, overlap, or conflict with the proposed rule.
The Agency must transmit a copy of the RFA to the SBA at proposal. The RFA may be part of the
economic impact analysis. The final rule should include: a summary of public comments on the RFA, a
summary of the Agency's assessment of those comments, and any changes made in response to the
comments, a summary of each regulatory alternative; and a justification of the chosen alternative
Operation: The lead office must submit two copies of the RFA to RDB RDB will forward one of these
to SBA The act also requires the agency to improve its outreach to small businesses, government
jurisdictions and private organizations through such means as articles in trade publications, direct
mailings, and public hearings All items in the semi-annual Regulatory Agenda must include a finding on
small entity impacts ("yes" or "no"). The Small Business Ombudsman can participate actively in only a
small number of rules. For rules that will significantly affect small entities, the lead program office
should contact the Ombudsman as early as possible in the rule's development to assure that the office
has time to participate.
See also: "Guidelines for Implementing the Regulatory Flexibility Act", copies are available from the
Regulation Development Branch (382-5479).
Fact Sheet 11 (Rev. 5/90)
Regulation Management Series
-------
REGULATORY NEGOTIATION & CONSULTATION
Description: Negotiation and consultation with outside parties are an important part of the
rulemaking process at EPA. Such consultation during the Agency's development of regulations and
policy actions offers several benefits: it brings outside information and perspectives to the Agency's
decisions; it allows representatives of different interests to engage in policy deliberations with each
other and with the Agency,*- it builds support for 'the Agency's-decisions and increases the overall
efficiency of EPA's decision making process. Agency staff can rely on a variety of approaches that
EPA and other agencies have found effective, ranging from highly structured regulatory negotiations to
more informal processes such as policy dialogues, facilitated public meetings, and facilitated
workshops. With all of these approaches, the Agency uses an experienced, neutral facilitator to help
the parties prepare an agenda, define issues, share information, clarify interests, and otherwise
establish a process for achieving their goals.
Operation: Program offices are invited to call on the Regulatory Negotiation Project Staff in the
Regulation Management Division to help decide when to use a consensus-building approach and which one
to use The Project Staff can recommend an approach or a combination of approaches suited to an
office's needs. They can also provide criteria for selecting items as candidates for regulatory
negotiation
The Regulatory Negotiation Staff is trained in facilitating meetings and in training others in the use of
consensus-building approaches. When these activities require contract support, the Staff can direct the
program office to appropriate experts. The Project has a contract mechanism which program offices
can use to engage this outside support.
In the regulation development process, the Start Action Request (Fact Sheet #2) is the appropriate
point at which an office should consider what kinds of consultative approaches to incorporate into the
rulemaking. The workgroup should also consider these approaches in prepanng the Development Plan
(Fact Sheet #4). At both stages the Steering Committee reviews the documents and may inquire about
or recommend strategies for consulting with outside groups.
Agency Participation: The Steering Committee participates in the initial consideration of
consensus-building approaches in its review of SARs and Development Plans. When a lead office
participates in a regulatory negotiation, it represents the Agency as a whole in making decisions, in
this capacity, it must keep the workgroup and Agency managers informed of the status of negotiations,
assure that they express ideas and reservations in a timely manner and obtain agreement before
committing the Agency. In addition, formal negotiations will entail briefing senior managers, OMB, and
possibly the Administrator. When a lead office participates in less formal consensus-building
activities, it should keep workgroups informed and raise issues internally If it will be taking any
position that will commit the Agency.
See Also: "Regulatory Negotiation Selection Criteria", a project description, and a "Regulatory
Negotiation Overview", are available from the Regulatory Negotiation Project Staff (382-7565).
Fact Sheet 12 (Rev. 5/90)
Regulation Management Senes
-------
EPA'S RULEEMAKING
-------
November 2, 1988
EPA's RULEMAKING RESPONSIBILITIES
Neil Kerwin
A. EPA must administer a number of highly complex, comprehensive, costly and
controversial laws.
1. Complex - frequently dealing with issues at the cutting edge of regulatory
science and applied technology
2. Comprehensive - taken as a group, the statutes EPA administers require the
Agency to deal with virtually all types and sources of pollutants
3. Costly - the costs of enforcing and complying with environmental laws
varies by statute and program; some estimates exceed $70 Billion dollars
annually
4. Controversial - highly emotional issues; activism by all kinds of groups; high
litigation rates
B. EPA was delegated these wide*ranging responsibilities over a comparatively short
period of time.
C. EPA^was created in late 1970 by President Nixon's Executive Order that
consolidated IS programs in 5 departments under one roof. (Reorganization Plan
No. 3 of 1970 (3 CFR 1072), 1970). EPA inherited responsibility for air, water,
solid waste, pesticides and radiation programs in this manner.
D. Immediately, Congress set about to supplement EPA's authority with new laws.
New delegations of authority and amendments to existing authorities have
continued since the early 1970's. It is likely that there are more to come.
E. Congress delegates authority this way for a variety of reasons:
1. separation of powers
2. EPA's scientific, technical and management expertise
3. political demands from constituents
4. political controversies over what to do about environmental problems
F. Statutes enacted by Congress can be quite specific. Some establish clear goals,
criteria for determining what and how to regulate and timetables for doing so.
But all require clarification or refinement before a regulatory program can be put
in operation. EPA must frequently define key statutory terms and specify
numerous details regarding how regulated parties will comply with the law. EPA
is responsible for providing clarification and refinement
through its regulations.
G. A regulation issued by EPA has the full force of law. They are, in effect,
"administrative statutes". Because they impose obligations and affect the rights of
the public, EPA must follow certain policies and procedures when it develops
rules. These policies and procedures are found in general statutes (e.g. The
Administrative Procedures Act, Paperwork Reduction Act, Regulatory Flexibility
Act, etc.), specific statutes (EPA's authorizing legislation), Executive Orders (i.e.,
E.O. 12044; E.O. 12291), judicial decisions, and the Agency's own internal
regulation management system.
H. Because of the nature of its statutes, the development of regulations can be seen
as one of the primary functions of EPA. The Agency's success in developing
-------
2
regulations will, along with its enforcement efforts, determine how well it meets
its statutory obligations.
I. Regulation development in EPA combines law, science/technology, politics and
management.
-------
J EPA'S STATUTES AND OFFICES RESPONSIBLE FOR
THEM
The regulatory responsibilities of EPA are established in a number of statutes and
divided between a number of offices. The following is a list of these statutes and the
offices with primary responsibility for their implementation:
STATUTES
OFFICE WITH PRIMARY
RESPONSIBILITY
CLEAN AIR ACT
(CAA)
CLEAN WATER ACT
(CWA)
SAFE DRINKING WATER ACT
(SDWA)
MARINE PROTECTION, RESEARCH
& SANCTUARIES ACT (MPRSA)
TOXIC SUBSTANCES CONTROL ACT
(TSCA)
FEDERAL INSECTICIDE,
FUNGICIDE & RODENTICIDE ACT
(FIFRA)
Office of Air & Radiation
(Office of Air Quality
Planning & Standards,
Office of Mobile Sources)
Office of Water
(Office of Water
Regulations & Standards,
Office of Municipal
Pollution Control, Office
of Water Enforcement &
Permits, Office of Wetlands
Protection)
Office of Water
(Office of Drinking Water,
Office of Ground-Water
Protection)
Office of Water
(Office of Marine &
Estuarine Protection)
Office of Pesticides &
Toxic Substances
(Office of Toxic
Substances)
Office of Pesticides &
Toxic Substances
(Office of Pesticide
Programs)
-------
4
RESOURCE CONSERVATION &
RECOVERY ACT (RCRA)
EMERGENCY PLANNING &
COMMUNITY RIGHT-TO-KNOW ACT
OF 1986, TITLE III OF
SUPERFUND AMENDMENTS &
REAUTHORIZATION ACT (SARA)
Office of Solid Waste &
Emergency Response
(Office of Solid Waste,
Office of Waste Programs
Enforcement, Office of
Underground Storage Tanks)
Office of Solid Waste &
Emergency Response (Office
of Emergency & Remedial
Response); Office of
Pesticides & Toxic (Office
of Toxic Substances)
COMPREHENSIVE ENVIRONMENTAL
RESPONSE, COMPENSATION, &
LIABILITY ACT (CERCLA)
("Superfund")
Office of Solid Waste &
Emergency Response
(Office of Emergency &
Remedial Response, Office
of Underground Storage
Tanks)
ENVIRONMENTAL RESEARCH,
DEVELOPMENT, AND
DEMONSTRATION ACT
Office of Research &
Development
URANIUM MILL TAILINGS
RADIATION CONTROL ACT
Office of Air & Radiation
(Office of Radiation
Programs)
ASBESTOS HAZARDOUS EMERGENCY
RESPONSE ACT OF 1986
(AHERA)
NATIONAL ENVIRONMENTAL
POLICY ACT (NEPA)
FEDERAL FOOD, DRUG, AND
COSMETIC ACT (FFDCA)
Office of Pesticides &
Toxic Substances
(Asbestos Action Program)
Office of External Affairs
(Office of Federal
Activities)
Office of Pesticides and
Toxics (Office of Pesticide
Programs)
-------
5
k. Important EPA Statutes
1. CLEAN AIR ACT
a. passed in 1970 (amended in 1977)
b. Preceded by a number of air quality statutes; important subsequent
amendments
c. "most comprehensive environmental law in U.S. history"
d. the goal is to protect and enhance air quality in order to promote
public health and welfare
e. types of regulations:
National Ambient Air Quality Standards (NAAQS)
New Source Performance Standards (NSPS)
National Emission Standards Hazardous Air Pollutants
(NESHAP)
Mobile Source program
Prevention of Significant Deterioration (PSB)
f. recent/current regulation development efforts
NAAQS for lead, ozone, sulfur oxides
(revisions)
NESHAPS for asbestos (revision), chromium, perchlorethylene
dry cleaning
NSPS for perchlorethylene dry cleaning, solvent degreasing
2. CLEAN WATER ACT
a. passed in 1972 (major amendments in 1977, 1987)
b. also preceded by a number of water quality statutes
c. goal to achieve water quality suitable for protection and
propagation of aquatic life and provide for aquatic recreation
d. establish NPDES and major grant program for sewage treatment
plant construction
e. types of regulations
technology-based effluent guidelines for industrial and
municipal sources
NPDES & pretreatmentregulations
f. recent/current regulation development efforts
water quality standards revisions (toxic
pollutants)
effluent guidelines (offshore oil and gas, pesticides chemicals)
NPDES regulations (stormwater applications)
Sewage sludge (use and disposal regulations, state program
regulations)
3. SAFE DRINKING WATER ACT
a. passed in 1974 (amended in 1986)
b. Congress attempted to reverse the trend of increasing volumes of
pollutants entering surface and groundwaters. Incidence of water
borne disease continues at a disturbing rate. Between 1971-1984,
108,000 people were adversely affected.
c. goals is to ensure that public water supplies achieve minimum health
standards
d. Types of regulations
primary and secondary regulations specifying contaminant
levels
-------
6
control of underground injection
use of lead in plumbing and public water systems
e. Recent/current regulation effects
numerous primary regulations (disinfectants, filtration,
synthetic organic chemicals, inorganic chemicals)
ban on lead in plumbing and public water system regulations
underground injection technical requirements and enforce-
— -ment regulations
4. TOXIC SUBSTANCES CONTROL ACT (TSCAl
a. passed in 1976
b. part of a Congressional effect to create a comprehensive regulatory
program - "cradle to grave" control - for chemicals that may be
dangerous to man or the ecosystem; the other elements of the overall
strategy are found in the Resource Conservation and Recovery Act
(RCRA) and the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA, or Superfund), the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and
statutes dealing with asbestos
c. TSCA's goal is to regulate the creation, production and movement in
commerce of hazardous chemical substances before they escape and
do damage
d. Types of regulations:
premarket notification and testing of new chemicals
testing of existing chemicals
controls or prohibition on manufacture, use or disposal of
chemicals that pose an unreasonable risk
e. recent/current regulation development efforts
PCB-related rules
test rules
asbestos-in-schools inspection and abatement rule
follow-up on existing chemicals
5. RESOURCE CONSERVATION AND RECOVERY ACT
a. passed in 1976 (amended in 1984)
b. goal is to control solid waste management through rules for safe
disposal sites, regulation of dangerous wastes and promotion of
conservation and "recycling"
c. types of regulations
rules governing generation, collection, separation, recovery
and transport (i.e., "cradle to grave") of hazardous waste
d. recent/current regulation efforts
disposal facility criteria
groundwater monitoring
mining waste management
underground storage tank regulations
6. COMPREHENSIVE EMERGENCY RESPONSE.
COMPENSATION. AND LIABILITY ACT
a. passed in 1980 in response to a number of highly publicized
incidents involving toxic and hazardous waste dump sites (amended
in 1986)
-------
7
b. provided a $1.6 billion fund for clean-up, a "right-to-know" for local
governments and citizens and authority to respond to emergencies
involving leaking underground storage tanks
c. types of regulations
elements of National Hazardous Response Plan
rules governing reporting requirements
d. recent/current regulation effects
hazard-ranking systems
reportable quantities for releases (potential carcinogens),
chronic toxicants and radionuclides,
updates of National Priorities List
7. FEDERAL INSECTICIDE. FUNGICIDE AND
RODENTICIDE ACT
a. passed in 1947 (major amendment in 1972)
b. Congress sought to regulate the production, distribution and use of
pesticides and herbicides
c. types of rules
regulations and classification standards for pesticides based
on "general" or "restricted" use
d. prohibitions on use of unregistered pesticides
e. recent/current regulation effects
registration data requirements
restricted use classification for groundwater contaminating
pesticides
farmworker protection standards
8. THE PROBLEM OF CROSS-MEDIA POLLUTION
a. EPA's regulation development procedures were designed in part to
deal with pollutants that migrate from one medium to another, and
sources of pollution that many affect more than one medium. Cross-
media problems also involve two or more statutory authorities
administered by EPA
b. Some recent examples of substances or sources that have required a
cross-media approach:
chlorinated solvents, used for degreasing and in aerosol pro-
ducts, present risks in the workplace, in the home and may
pollute the air and drinking water. A variety of statutory
authorities, including TSCA, CAA, SDWA, CWA and RCRA
must be considered.
sewage sludge, a by-product of CWA regulations, may be
disposed of through incineration, in landfills, by ocean
dumping or used as fertilizers. Each presents a potential
threat to health or the environment. Dealing with these
problems can involve the RCRA, CAA, SDWA, and CWA.
c. These are two of a number of examples in which a cross-media
approach is crucial. EPA attempts to institutionalize the cross-media
perspective by using workgroups that draw on the expertise of
offices across the Agency to develop regulation.
-------
November 2, 1988
WHAT IS A RULE?
Rules are indispensable parts of our public policy system. Often, when Congress
enacts statutes, it delegates substantial responsibilities to agencies like EPA. Agencies
must implement and administer programs that meet the goals Congress has established.
Rarely are Congressional statutes specific enough for an agency to implement and
administer them without further refinement and clarification. For any regulatory
program, an agency must define the rights and obligations of those whom it will affect,
and must explain the procedures it will use when administering the program. These
essential details are provided through rules (or regulations, as are they are sometimes
called) developed by the responsible agency.
The Administrative Procedure Act, which establishes the basic legal requirements
for many of the functions performed by agencies, defines a rule in the following way:
" ... a statement of general or specific applicability and future effect
designed to implement; interpret, or prescribe law or policy or
describing the organization, procedure, or practice requirements
of an agency..."
Rulemaking (or regulation development, as it is called in EPA) is defined as:
"... the agency process for formulating, amending, or repealing a rule."
Rules can be distinguished from other things that agencies do when implementing
legislation. The major purpose of a rule is to encourage, guide or prohibit future
conduct. Rules establish the particular policies and procedures the agency will employ in
carrying out the statutory goals established by Congress. Implementing and enforcing
rules or resolving disputes are also important parts of EPA's responsibilities.
-------
November 2, 1988
TYPES OF RULES
The Administrative Procedure Act distinguishes several different types of
rules. This classification is important because some types of rules are exempt from some
of the APA's requirements.
For example, rules relating to "agency management or personnel or public
property, loans, grants, benefits, or contracts" are exempt from all of the APA's
procedural requirements outlined above, but they must meet publication and public
petition provisions. Interpretive rules and general statements of policy are also exempt
from notice and comment requirements, but they too must meet the Act's publication and
public petition provisions. The final category of rules, called "substantive" or
"legislative" rules, is subject to all the requirements listed above.
The distinction between substantive or legislative rules and interpretive rules and
general statements of policy is not always clear. Each type can be used to directly
implement or administer a statute. The Attorney General's Manual on the
Administrative Procedure Act distinguishes them in the following way:
Substantive (legislative) Rules:
issued by an agency pursuant to statutory authority and which implement the
statute..Jtave the force and effect of law
Interpretive Rules:
rules or statements issued by an agency to advise the public or the agency's
construction of the statutes and rules which it administers
General Statements of Policy:
statements issued by an agency to advise the public prospectively of the manner
in which the agency proposes to exercise discretionary power.
The distinction between legislative and interpretive rules is frequently unclear
since each can have a substantial effect on the public. Because of this the Administra-
tive Conference of the United States has recommended that regardless of the exemption
contained in the APA, when an agency is preparing an interpretive rule or a policy
statement that will substantially affect the public, it should follow notice and comment
process.
There is another important way to classify regulations that has important
implications for the way they are developed. In 1981, President Regan issued Executive
Order 12291 which mandated new procedures for "major" regulations. A "major"
regulation is one which is likely to result in:
1. An annual effect on the economy of $100 million or more;
2. A major increase in costs or price for consumers, individual industries. Federal,
States or local government agencies or geographic regions: or
-------
2
3. significant adverse effects on competition, employment, investment, productivity,
innovation, or on the ability of the United States-based enterprises to compete
with foreign-based enterprises in domestic or export markets.
The Executive Order requires that agencies prepare regulatory impact analyses for
major rules, and that plans to develop them be published semi-annually in a document
called the Regulatory Aeenda. EPA has extended this classification system by adding the
categories of "significant"-.and-."minor". A "significant" rule is one that does not meet the
Executive Orders criteria for "major" but may:
1. have significant adverse impact on the public, or
2. raise important health or intermedia issues, or
3. have important effects on the operations of Regional or other program
offices, or
4. have broad geographic effects
Minor rules are ones that meet neither the criteria for "major" nor "significant".
These designations are important within EPA because they determine whether certain
procedures and documents will be required as part of the regulation development process.
The relationship between these categories or rules, regulation development procedures,
and internal decision documents is explained more fully under the topic page, What is a
Ri!l£-
-------
November 2, 1988
BASIC ELEMENTS OF REGULATION DEVELOPMENT
Regulation development is an important form of lawmaking. The Constitution
grants the legislative power exclusively to Congress, whose members are expected to
exercise it on behalf of the people they represent. Consequently, when Congress
delegates part of this power it does so subject to a number of vary important conditions.
The minimum standards governing the exercise of rulemaking authority are found in the
Administrative Procedure Act.
THE ADMINISTRATIVE PROCEDURE ACT
When writing rules the Environmental Protection Agency must comply with the
provisions of the Administrative Procedure Act (APA). This law was enacted by
Congress in 1946 to bring a degree of regularity to certain functions performed by
agencies of the federal government. One of those functions is rulemaking (or regulation
development), and to satisfy the Act's requirements the Agency must:
1. Place a notice in the Federal Register announcing the Agency's proposed
rule. The notice must identify the law that requires or allows EPA to
write the rule. It also contains the actual contents of the proposed rule or
a description of the subjects and issues it addresses.
2. Provide an opportunity for anyone interested in the rule to comment, in
writing, on its proposed content.
3. Include in the final rule a statement of basis and purpose, which explains
to the public why the rule was written and the supDort for the Aeency's
decision.
The APA contains the minimum standards that the Agency must employ when writing
rules. Frequently, these are augmented by additional procedures required by Congress,
the courts or the Agency itself.
-------
REGULATORY POLICY GUIDELINES
1. Regulations should be issued only on evidence that their
potential benefits exceed their potential costs.
Regulatory objectives, and the methods for achieving
those objectives, should be chosen to maximize the net
benefits to society.
2. Regulation of prices and production In competitive
markets should be avoided. Entry into private markets
should be regulated only where necessary to protect
health or safety or to manage public resources
efficiently.
3. Federal regulations should not prescribe uniform quality
standards for private goods or services, except where
these products are needlessly unsafe or product
variations are wasteful, and voluntary private standards
have failed to correct the problem.
4. Regulations that seek to reduce health or safety risks
should be based upon scientific risk-assessment
procedures, and should address risks that are real and
significant rather than hypothetical or remote.
5. Health, safety, and environmental regulations should
address ends rather than means.
6. Licensing and permitting decisions ar.d reviews of new
products should be made swiftly and snould be based on
standards that are clearly defined in advance.
7. Qualifications for receiving government licenses should
be the minimum nec^sirary. where there are more
qualified applicants' than available licenses, the
licenses should be allocated by auction or random
lottery rather than by administrative procedures.
8. Where regulations create private rights or obligations,
unrestricted exchange of these rights or obligations
should be encouraged.
9. Pederal regulations should not preempt State laws or
regulations, except to guarantee rights of national
citizenship or to avoid significant burdens on
interstate commerce.
10. Regulations establishing terms or conditions of Federal
grants, contracts, or financial assistance should be
limited to the minimum necessary to achieving the
purposes for which the funds were authorized and
appropr iated.
Final Report (August, 1983) of the
Presidential Task Force on Regulatory Relief
-------
EPA MUST COMPLY WITH THE FOLLOWING
NON-EPA STATUTES
Statute/Executive Order
"National Environmental Policy Act
'Endangered Species Act, Section 7
Implementing Regulations
40 CFR Parts 1500-1508
(EPA) 40 CFR Part 6
50 CFR Part 402
"National Historic Preservation Act, Section 106 36 CFR Part 800
(EPA) 40 CFR 6.300
"Wild and Scenic Rivers Act, Section 7
"Fish and Wildlife Coordination Act,
Section 662
"Coastal Zone Management Act, Section 307 (c)(1)
"Coastal Barrier Resources Act, Section 5
"Executive Order 11988—F1 oodplaln Management
36 CFR Part 297
(EPA) 40 CFR 6.300
(EPA) 40 CFR 6.300
15 CFR 930
(EPA) 6.300
US Water Resources
Guidelines, 40 FR 6030
(EPA) 40 CFR 6.300, &
Appendlx A
"Executive Order 1I990--Protect1on of Wetlands
"Farmland Protection Policy Act
(EPA) 40 CFR 6.300, &
Appfendlx A
7 CFR Part 658
(EPA) 40CFR 6.300
-------
SOURCES OF
RULEMAKING
-------
LEGAL REQUIREMENTS FOR RULEMAKING
AND WHY EPA DOES RULES
I. Introduction
A. Congress enacts statutes, and the Executive Branch
carries them out. Congress often delegates part of
its power to Executive Branch agencies in general
regulatory statutes that give the agencies power to
fill in the gaps and impose specific requirements,
through form of rules or orders. Congress prescribes
the procedures for promulgating them.
B. Congress may order agencies to do rules, leave rules
to agencies' discretion, or set up procedures for
citizens to force agencies to do rules.
II. Rulemaking Procedures
A. The Administrative Procedure Act (APA), enacted in
1946, has remained substantially unchanged. It sets
out the basic minimum requirements for rulemaking.
1. The APA defines a rule (5 U.S.C. 551(A)) as:
...the whole or a part of an agency statement
of general or particular applicability and
future effect designed to implement, interpret,
or prescribe law or policy or describing the
the organization, procedure, or practice
requirements of an agency ....
Thus a rule can be the complex set of requirements
appliable to many people published in the Federal
Register and maintained in the Code of Federal
Regulations (CFR) or a specific order applicable
to a single person which is never published.
2. The APA sets out basic requirements for making a
rule (5 U.S.C. 553) which apply to all rules.
These requirements contemplate publication in
the Federal Register. However, rules do not
have to be published in the Federal Register if
the agency gives those persons subject to them
actual notice of the rule. Generally rules
apply to many people and are published in the
Federal Register.
2. Basic requirements:
a. Place a notice in the Federal Register to
announce the proposed rule which identifies
-------
-2-
the time, place, and nature of the rulemaking
proceedings, the statutory authority, and
either the terms or substance of the proposed
rule or a description of the subjects and
issues involved.
b. Provide an opportunity for anyone interested
in the rule to comment on it in writing.
c. Publish the final rule in the Federal Register,
including a statement of the basis and purpose
of the rule to explain why it was written
and to support the agency's decision, at
least 30 days before before its effective date.
3. Exceptions.
a. The requirements to publish a proposed rule
and receive comment on it are not applicable
to interpretative rules, general statements
of policy, or rules of agency organization,
procedure, or practice.
b. An agency can waive the requirements to
publish a proposed rule and receive comment
on it when the agency "for good cause" finds
that publication of a proposed rule and
providing for comment on it are "impracticable,
unnecessary, or contrary to the public
interest." In this case the agency may publish
a final rule directly but must include the
good cause finding and the reasons for it.
c. The requirement to publish a rule 30 days
before its effective date does not apply:
i. To a substantive rule that grants or
recognizes an exemption or relieves a
restrict ion.
ii. To interpretative rules and statements
of policy.
iii. If the agency finds that there is good
cause to make it effective sooner and
publishes the finding with the rule.
4. Actual EPA Practice
a. Advance Notice of Proposed Ruleinaking--used
to get general comment on issues before
specific rule language is proposed.
-------
-3-
b. Proposed Rules
1. EPA proposed rules always contain actual
rule language.
2. EPA often provides for public hearings as
an additional way to obtain public comment.
3. Often EPA provides 60 days or more for
public comment.
c. Final Rules
1. Some final rules are made effective more
than 30 days after publication.
d. Interim Final Rules
1 . Sometimes EPA makes a proposed rule
"interim final" but asks for comment.
This is in effect promulgating a final
rule without an opportunity for public
comment and is subject to the APA limits.
B. Specific EPA statutes often contain additional
requirements for conducting rulemaking, including
requirements for public hearings, opportunities for
cross-examination, or different time deadlines than
those in the APA. In some cases, specific statutes
give EPA authority to make proposed rules effective
immediately while comment is being obtained.
C. Other requirements for rulemaking procedures flow
from other general statutes such as the Paperwork
Reduction Act, the Federal Advisory Committee Act,
and the Regulatory Flexibility Act.
D. Within the Executive Branch other requirements can
also be imposed such as the current Executive Order
12291 which requires 0MB review of proposed and
final rules before issuance in most circumstances.
E. Courts can impose additional requirements for
rulemaking in individual situations as well.
III. What Forces EPA to do Rules?
A. The impetus to do rules comes from a variety of
sources, but it all comes back to statutory
requirements one way or another. Directly or
indirectly, statutes require agencies to do rules.
-------
-4-
B. Statutory Requirements
1. Many different kinds.
a. The Administrator shall issue a regulation...
b. If the Administrator finds...the Adminis-
trator shall issue a rule...
c. The Administrator may by rule...
d. If the Administrator determines...the Admin-
istrator may promulgate a regulation...
2. Some requirements are explicit, others implicit.
a. The Administrator shall prescribe...
b. The Administrator may require...
3. In most cases, statutory authority which requires
or allows the Administrator to take regulatory
action of some type requires the Administrator to
use rulemaking whether stated or not.
B. Statutes may prescribe what to do or when or both.
They can require rules directly, or only after
certain outside events occur. Requirements may apply
to proposed or fi.;al rules or both.
C. Court-ordered rules flow from citizens petitions
provisions in EPA statues or general petitions under
the APA. They can also flow from citizen suits to
enforce statutory requirements.
D. Some rules are truly EPA initiated. A statute may
give EPA authority to issue specific rules using
"may" language. A statute may contain general rule-
making authority to do necessary rules. The APA
allows EPA to do interpretative, policy, and
procedural rules without specific statutory authority.
-------
ADDITIONAL PROCEDURAL REQUIREMENTS
ESTABLISHED BY CONGRESS FOR EPA RULEMAKING
Frequently Congress has added procedural requirements over and above those
found in the Administrative Procedure Act
when delegating authority to EPA. In an effort to ensure all affected interests are heard
and all significant issues are fully explored, Congress requires the Agency to do more
than provide an opportunity to comment and explain the basis and purpose of a new
rule. The following statutes that EPA administers contain additional procedural require-
ments.
Safe Drinking Water Act (1974)
For most rules:
opportunity for a public hearing
Agency consultation with an advisory committee and the Science Advisory
Board when developing regulations
Toxic Substances Control Act (1976)
For certain rules:
explanation of reasons for a proposed rule
oral hearings required
cross examination and opportunity for parties to rebut on disputed issues
of mutual fact
review by courts based on a more rigorous standard than most (substantial
evidence)
Clean Air Act Amendments of (1981)
For certain rules:
establish a more elaborate rulemaking docket
more staggered notice requirements than most other rules
opportunity for oral hearing
opportunity for rebuttal comments
judicial review based solely on information in the rulemaking docket
Clean Water Act Amendment (1981)
For certain rules:
60 day comment period for proposed rule
public hearing if requested within 30 days of publication, as appropriate
review in courts based on a more rigorous standard than most rules (substa-
ntial evidence)
deadlines for effective date of standard
From several perspectives, the process used to develop rules is as important as
the substance of the requirements it establishes. EPA has established a system for
regulation development that attempts to minimize the possibility of procedural error,
ensure ample opportunity for public participation, and guarantee that all substantive
issues are raised and considered carefully.
-------
EXAMPLES OF STATUTORY PROVISIONS
REQUIRING OR ALLOWING RULES
1. SARA Section 322(c) on trade secrets:
"As soon as practicable after the date of enactment
of this title, the Administrator shall prescribe
regulations to implement this section."
Section 326 limits EPA by allowing citizens to sue
"[t]he Administrator for failure to ... promulgate
trade secret regulstions under section 322(c)."
2. TSCA section 6(e):
"Within six months after January 1, 1977, the
Administrator shall promulgate rules to...."
TSCA section 20 authorizes citizen suits "against
the Administrator to compel the Administrator to
perform any act or duty under [TSCA] which is not
discretionary."
3. FIFRA section 8(a):
"The Administrator may prescribe regulations
requiring producers to maintain such records with
respect to their operations and the pesticides and
devices produced as he determines are necessary for
effective enforcement of this subchapter."
4. CAA section 112:
"Within 180 days after the inclusion of any air
pollutant on [the list of hazardous air pollutants],
the Administrator shall publish proposed regulations
establishing emission standards for such pollutant...."
5. TSCA section 4(e):
Establishes an Interagency Testing Committee (ITC)
to designate chemicals for priority testing and
provides that "[w]ithin the 12-month period beginning
on the date of [the ITC designation] the Administrator
shall with respect to [such chemical] either intiate
a rulemaking proceeding... or... publish in the
Federal Register the Administrator's reason for not
intiating such a proceeding."
-------
-2-
6. F.VPCA section 306:
Provides than the Administrator list categories of
sources. Within one year of such a listing "the
Administrator shall propose and publish regulations
establishing Federal standards of performance for
new sources within such category." After comment
"he shall promulgate within 120 days after
publication [of the proposed rules]."
7. RCRA section 7004:
"Any person may petition the Administrator for the
promulgation, amendment, or repeal of any regulation
[under RCRA]."
8. TSCA section 6(a):
"If the Administrator finds that there is a
reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use, or
disposal of a [chemical], or that any combination of
such activities, presents or will present an
unreasonable risk of injury to health or the
environment, the Administrator shall by rule apply
o.ie or more of the following requirements ...."
9. SARA section 313:
Allows any person to "petition the Administrator to
add or delete a chemical from [the list of toxic
chemicals].... Within 180 days after receipt of a
petition, the Administrator shall...:
(A) Initiate a rulemaking to add or delete
the chemical to the list...
(B) Publish an explanation of why the
petition is denied."
-------
55:r. Crr.e-ress COJTOIITTEE PRIXT
* 51 .5 0 5-5 4^ H
THE SAFE DRIXKIXG TTATER ACT
A- AMENDED THROUGH NOVEMBER 1'
NOVEMBER 19:
SERIAL NO. 9S-10
Primed for tbe use of the Senate Committee on Ennr'.Qiriea* md
Public Works
U S GOVERNMENT PRINTING OFFICE
—|>M WASHINGTON 1977
-------
3
(3) which floes not sell water to any person; and
C4) which is not a carrier which conveys passengers in interstate
commerce.
NATIONAL DRINKING WATER REGULATIONS
Sec. 1412. fa)fl) The Administrator -hall publish proposed na-
tional interim primary drinking water rpgulations within 90 days after
thp date of enactment of this title. Within ISO day-; alter h (Jate of
enactment, he -hall promulgate such regulations with such modifica-
tions as he deems appropriate. Regulations under this paragraph may
be amended from time to time.
(2) National interim primary drinking water regulation- promul-
gated under paragraph (1) -hall protect health to the extent feasible,
using technology, treatment technique*;, and other means, which the
Administrator determines are generally available (taking costs into
con-ideration) on the date of enactment of this title.
(¦>) The interim primary regulation- firct promulgated under para-
graph (1) shall take effect eighteen months after the date of their
promulgation.
(b)(1)(A) Within 10 days of the date of the report on the study
conducted pursuant to sub-ection (e) is. submitted to Congress, the
Administrator -hall publish in the Federal Register, and provide op-
portunity for comment on, the—
fi) proposals in the report for recommended maximum con-
taminant levels for national primary drinking water regulations,
and
(ii) list in the report of contaminants the levels of which in
drinking water cannot be determined but which may have an
adverse effect on the health of persons.
(B) Within 90 day- after the date the Administrator makes the
publication required by subparagraph (A), he -hall by mle establish
recommended maximum contaminant levels for each contaminant
which, in his judgment ba-ed on the report on the -tudy conducted
pursuant to sub-ection fe), may have any adverse effect on the health
of persons. Each such recommended maximum contaminant level shall
be set at a level at which, in the Administrator'- judgment based on
such report, no known or anticipated adverse effects on the health
of persons occur and which allows an adequate margin of safety. In
addition, he shall, on the ba-is of the report on the study conducted
pursuant to subsection (e), list in the rules under this subparagraph
any contaminant the level of which cannot be accurately enough
measured in drinking water to establish a recommended maximum con-
taminant level and which may have any adverse effect on the health of
persons. Based on information available to him, the Administrator
may by rule change recommended levels established under this sub-
paragraph or change such list.
(2) On the date the Administrator establishes pursuant to para-
graph (1)(B) recommended maximum contaminant levels he shall
publish in the Federal Register proposed revised national primary
drinking water regulations (meeting the requirements of paragraph
(.°>)). Within 180 days after the date of such proposed regulations, ne
shall promulgate such revised drinking water regulations with such
modifications as he deems appropriate.
-------
(Actual "Deadline" language
from a Judicial Decision)
UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
ENVIRONMENTAL DEFENSE FUND, et al.,
"Plaintiffs
V
Civil Action No
85-1747
FILED
LEE M. THOMAS, Administrator, U.S.
Environmental Protection Agency, et al.#
Defendants.
JAN 2 8 1236
ORDER AND DECLARATION
U C. DiciT'iCT CO'Jn'
D.STRICT ^OLU'rtaiA
This matter comes before the court on the parties'
cross-motions for summary judgment. After consideration of the
motions, the oppositions thereto, the amici curiae brief, and the
January, 1986,
ORDERED that defendants' motion for leave to file a
response to plaintiffs' December 23, 1985 submission is granted;
and it is further
ORDERED that plaintiffs' motion for summary judgment is
granted in part and denied in part, and defendants' motion for
summary judgment (as supplemented) is granted in part and denied
in part; and it is further
DETERMINED AND DECLARED that defendant Environmental
Protection Agency has failed to perform its mandatory duty under
Section 3004(w) of the Resource Conservation and Recovery Act
("RCRA"), 42 U.S.C. 6924(w); and it is further
ORDERED that no later than June 30, 1986, defendant
entire record herein, it is, by the court, this >^"3 day of
1
-------
Environmental Protection Agency shall promulgate final permitting
standards for underground tanks pursuant to Section 3004(w) of
RCRA; and it is further
DETERMINED AND DECLARED that defendant Office of
Management and Budget has no authority to delay the promulgation
of final permitting standards for underground tanks pursuant to
Section 3004(w) of RCRA by withholding approval of the standards
past June 30, 1986; and it is further
DETERMINED AND DECLARED that defendant Office of Management
and Budget has no authority to delay the promulgation of EPA
regulations arising from the Hazardous and Solid Waste Amendments
of 1984 of the RCRA, Pub. L. 98-616 (Nov. 8, 1984), by
withholding approval past statutory or judicial deadlines.
UNITED STATfci* OISTKiLT JUDtj£
2
-------
Thursday
March 4, 1982
(An example of an ANPRM)
Part IV
Environmental
Protection Agency
National Revised Primary Drinking Water
Regulations, Volatile Synthetic Organic
Chemicals in Drinking Water; Advanced
Notice of Proposed Rulemaking
-------
9350
Federal Register / Vol. 47. No. 43 / Thursday. March 4. 1982 / Proposed Rules
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 141
IWH-fRL-201ft-7I
National Revised Primary Drinking
Water Regulations, Volatile Synthetic
Organic Chemicals tn Drinking Water
agency: Environmental Protection
Agency (EPA).
action: Advance notice of proposed
rulemaking.
summary: EPA is considering proposal
of regulations as well as non-federal
regulatory approaches to limit human
exposure to high levels of certain
volatile synthetic organic chemicals
(VOCs) that have been detected in
drinking water. EPA is issuing this
Advsnce Notice of Proposed
Rulemaking (ANPRM) as an invitation
to the public to comment on the
following broad issues:
• What is the significance of
contamination of dnnking water by VOCrf
• Should national standards be Mt fdr
VOCsT
• If standards are appropriate, bow should
levels be established?
EPA requests public analyses,
comments and information on all
aspects of this most important issue
involving the appropriate balance of
public health protection against
practical implementation of the drinking
water program under the requirements
of the Safe Drinking Water Act (SDWA).
dates: Please submit written public
comments to the address listed below
'on or before lune 2.1982.
A public meeting will be held on April
28.1882. beginning at 9 a.m. Persons
planning to make statements at this
meeting are encouraged to submit a
written copy of their remarks at the time
of the meeting.
addresses: Send written comments to
Comment Clerk, Criteria and Standards
Division. Office of Drinking Water
(WH-550), Environmental Protection
Agency. 401 M Street SW.. Washington.
D.C 20480. A copy of all comments will
be available for review during normal
business hours at the EPA. Cntena and
Standards Division. Room 1109 ET, 401
M Street. SW., Washington. D.C 2046a
A public meeting will be held at EPA.
Room 3906. 401 M Street SW„
Washington. D.C. It is requested that
anyone planning to attend (especially
those who plan to make statements]
register in advance by calling or writing
Ms. Arnetta Davis at 202/472-5030, EPA,
WH-550, 401 M SU SW.. Washington.
D.C 20480.
Technical workshops will be held at
several locations for a full discussion of
issues and a complete exchange of
tnchniral information and data. Dates,
locations and other information on the
technical workshops can be obtained
from the American Water Works
Association Research Foundation. 6866
Quincy Avenue. Denver. Colorado
80235. which is the grantee conducting
the workshops for EPA.
pom further information contact:
Joseph A. Cotruvo. Ph. D, Director.
Criteria and Standards Division. Office
of Drinking Water fWH-550),
Environmental Protection Agency, 401 M
Street SW, Washington. D.C 20460,
Telephone 202/472-5018.
SUPPLEMENTARY INFORMATION:
L Regulatory Framework
~. Background an VOCa in Drinking Water
~L Alternatives under Consideration
rV. References
V. Request for Comments
L Regulatory Framework
Today's ANPRM initiates a dialogue
with interested parties on how best to
deal with the contamination of dnnking
water by VOCs under the provisions of
the SDWA. EPA is considering a wide
variety of alternatives, ranging from
nan-federal regulatory approaches, such
as the provisions of Information and
guidance to the establishment of formal,
enforceable standards. The Agency's
actions must be based on its statutory
duties and authorities, and described
below Is the legal framework within
which the alternatives will be
considered.
Section 1412 of the SDWA provides
for two sets of primary regulations^
interim and revised. EPA promulgated
interim regulations setting maximum
contaminant levels (MCLs) for
microbiological contaminants, turbidity,
tnhalomethanes. radionuclides and
selected organic and inorganic
chemicals (see 40 CFR Part 141, Subpart
B). The Interim regulations also Include
requirements for periodic monitoring,
analytical methods, reporting, public
notification and recordkeeping, (see 40
CFR Part 141. Subparts C and D).
EPA promulgated the interim
regulations as the Erst phase of a three-
phase statutory process for identifying
and regulating harmful contaminants in
the nation's dnnking water. Section
1412(a)(1) required EPA to promulgate
interim regulations that "shall protect
health to the extent feasible." using
generally available technology and
taking cost and other factors into
consideration. Phase two provides that
EPA shall enter into a contract with the
National Academy of Scienciea (NAS) to
conduct a study to assess the potential
health effects of contaminants in
drinking water which might be harmful
to health and to provide EPA with
proposed Recommended MCLs (RMCLs)
(see section 1412(e)(1)). Completion of
the NAS report was to trigger Phase
three. EPA's statutory obligation to issue
recommended MCLs and revised
primary regulations.
Section 1412(b)(1)(B) requires EPA to
establish recommended MCLs at a level
where "no known or anticipated
adverse effects on the health of persons
occur and which allows an adequate
margin of safey". Recommended MCLs
are health goals, not enforceable
standards. On the date EPA establishes
RMCLs. section 1412(b)(2) requires EPA
to propose a revised primary dnnking
water regulation for each contaminant
for which there is a RMCL (section
1412(b) (2) and (3)). The revised MCL
should be "as close to" the
recommended MCL "as is feasible"
(section 1412(b)(3)), and this would
reflect allowances for the cost and
feasibility of treatment
While the NAS issued its report
"Drinking Water and Health." in June
1977. 42 FR 35768 (July 11.1977). the
report contained no specific
recommended MCLs. In the absence of
specific NAS proposals. EPA delayed
promulgation of any recommended
MCLs at that time. This ANPRM is
intended to initiate discussions that will
enable the Agency to determine whether
RMCLs and revised regulations should
be established for VOCs and if so at
what levels.
In addition, to the regulatory
requirements of section 1412 of the
SDWA, the Act also provides EPA with
additional authorities for ensuring the
safety of the nation's drinking water.
Section 1442(a)(2)(B) authorizes EPA to
provide technical assistance to States
and publicly owned water systems to '
assist in responding to and alleviating
any emergency situation which the
Administrator determines presents a
substantial danger to the public health.
Section 1445(a) authorizes EPA to
require by regulation any public water
supplier to keep records, make reports,
conduct monitoring and provide such
other information to assist EPA in
establishing regulations, determining
compliance with SDWA. evaluating
health risks of unregulated
contaminants, or advising the public of
such nsks. Finally, section 1431
authorizes EPA to take such actionu as
the Administrator deems necessary to
protect the public health from a
contaminant that may present an
imminent and substantial
endangerment
-------
27228
Faderal Register / Vol. 52. No. 138 / Monday, fuly 20. 1987 / Proposed Rules
(Example of a Public
Petition for rulemaking)
ENVIRONMENTAL PROTECTION
AGENCY
b40 CFR Part 372
torrs ioooo*. pm.-32is-7i
toxic wnsmm nfmw nvpoRviy!
CoiwwunltY Righi-To-Know
AOSMCr Environmental Protection
Agency (EPA).
AC rKM: Proposed rule.
: EPA is granting ¦ petition by
proposing to delete the substance butyl
benzyl phthalate from the list of toxic
chemicals under section 313 of Title III
of the Superfund Amendments and
Reauthorization Act of I960. EPA
proposes to amend the proposed rule
codifying the list of chemicals published
on June 4.1987 (33 FR 21132). Section
313(e) allows any person to petition the
Agency to modify the list of toxic
chemicals for which toxic chemical
release reporting is requited.
Co us tents: Written comments should
be submitted on or before October 19.
1987.
iptwiini. Written comments should
be submitted in triplicate to: Section 313
Petition Coordinator. OTS Docket Clerk.
OTS Resding Room NE-GOM.
Environmental Protection Agency. Mail
Stop TS-7B3. W1MSL SW,
Washington. DC 20440. Attention:
Docket Control Number OPTS-G08007.
Edward A. Klein. Director. TSCA
Assistance Office (TS-799). Office of
Toxic Substances. Environmental
Protection Agency. Rra. E-542.401M Su
SW„ Washington. DC 20480. (202) 554-
1411.
A. Statutory Authority
The response to the petition and
proposed deletion are Issued under
section 313(e)(1) of Title 111 of the
Superfund Amendments and
Reauthorization Act of 1988 (Pub. L 90-
498. -SARA" or "the Act"). Title m of
SARA is also referred to aa the
Emergency Planning and Community
Right'to-Know Act of 1986.
B. Background
Title m of SARA is Intended to
encourage and support emergency
pluming efforts at the State aod local
level and to provide the public and local
governments with information
concerning potential chemical hazards
present in their communities.
Section 313 of Title 10 requites owners
and operators of certain facilities that
manufacture, process, or otherwise use a
listed loxic chemical to report annually
their releases of such chemicals to the
environment. Only facilities that have
manufacturing operations (in Standard
Industrial Classification Codes 20
through 39) and have 10 or more
employees must report. Such reports are
to be sent to both EPA and the State in
which the facility is located. The basic
purpose of this provision is to make
available to the public information
about total annual releases of toxic
chemicals from industrial facilities in
(heir community. In particular. EPA is
required to develop a computer data
base containing this toxic chemical
release informstion and to make it
accessible by telecommunications on a
cost reimbursibie basis.
For reporting purposes, section 313
establiahes an initial list of "toxic
chemicals" that is composed of 329
entries. 20 of which are categories of
chemcals. This list is a combination of
lists of chemicals used by the States of
Maryland and New Jersey for emissions
reporting under their individual nght-to-
know laws. Section 313(d) authorizes
EPA to modify by rulemaking the list of
chemicals covered either as s result of
EPA's self-initiated review or in
response to petitions under section
313(e).
Section 313(e)(1) provides that any
person may petition the Agency to add
chemicals to or delete chemicals from
the list of "toxic chemicals." EPA issued
a statement of policy and guidance in
the Federal Register of February 4.1987
(52 FR 3479|. This statement provided
guidance to potential petitioners
regarding the recommended contents
and format for submitting petitions. The
Agency must respond to petitions within
180 daya either by initiating a
rulemaking or by publishing sn
explanation of why the peution is
denied. If EPA fails to respond within
180 dsys. it is subject to citizen suits. In
the event of a petition from a State
governor to add a chemical under
section 313(e)(2). if EPA faus to act
within 180 days. EPA must issue a final
rule adding the chemical to the list
Therefore. EPA is under specific
constraints to evaluate petitions and to
issue a timely response.
Slat* governors may petition the
Agency to add chemicals on the basis of
any one of the three toxicity criteris
listed in section 313(d) (ecute human
health effecta. chrome human health
effects, or environmental toxicity). Other
persona may petition to add chemicals
only on the basis of acute or chronic
human health effects. EPA msy delete
substances only if they fail to meet any
-------
FederalRsgialer / Vol. 5Z. No. 133 / Monday, [uly 20. 1967 / Proposed Ruies
17227
of the criteria contained in section
313(d).
Chemicals are evaluated for inclusion
on the list based on the criteria in
section 313(d) and using generally
accepted scientific principles or the
results of properly conducted laboratory
tests, or appropriately designed and
conducted epidemiological or other
population studies, that arc available to
EPA.
II. Description of Petition
The Monsanto Company has
petitioned the Agency to delete butyl
benzyl phthalate (BBP). CAS No. 85-6fr-
7. from the list of toxic chemicals. The
Agency received the petition on January
12.1967. and under the statutory
deadline must respond by {uly 10.1987.
Monsanto submitted extensive
documentation to support its claim that
BBP fails to meet any of the statutory
criteria in section 313(d).
III. EPA's Review of Butyl Baoxyf
Phthalate
A. Chew/sUy Profile
Monsanto submitted documentation
of the physical/chemical properties of
BBP. The Agency was able to verify
certain of these properties, including
vapor pressure and solubility (Ref. 3).
B. Toxicity Evaluation
Then is a considerable amount of
data available concerning the health
and environmental effects of butyl
benzyl phthalate. EPA reviewed data on
the following effects that may be
associated with this chemical: Acute
toxicity, carcinogenicity, mutagenicity
[i.e.. heritable gene and chromosome
mutations), developmental toxicity,
reproductive toxicity, neurotoxicity,
other chronic health effects (including
hepatotoxiaty). and acute and chronic
ecotoxicity. These data consist of
documents provided by Monsanto,
documents obtained from the National
Toxicology Program (NTP) of tha
National Institutes of Health and other
Government agencies, and articles
retrieved from a search of recent
available literature (over the last 10
years). A more comprehensive
discussion of the various toxicities iad
supporting documentation can be food
in the document titled "Hoard
Assessment of n-Butyl Benzyl
Phthalate" in the public docket (Ret 7%
1. Acute toxicity (human health). BBP
has very low acute toxicity, as shown by
rat oral and rabbit dea&al acuta toxicity
values, and is practically aammlaite^ to
rabbit eyeaaod aki&.
2. Carcutapmticity. An IfTP bioasaay
was conducted in female rata and in
mtce of both sexes. Female rats had
increased incidences of leukemia at the
high dose only llow-dose females and
untreated controls had the same
incidence of leukemia), and male and
female mice showed no carcinogenic
response. The Agency agrees with the
conclusion reached by the International
Agency for Research on Cancer that
these results, taken together, are
equivocal evidence of carcinogenicity.
The Carcinogen Assessment Croup has
preliminarily placed BBP in EPA's
weight-of-evidence category 0 (i.e»
available evidence inadequate to
determine human carcinogenic
potential). EPA further concludes that,
for purposes of section 313. the available
evidence does not indicate that BBP
causes or can reasonably be anticipated
to cause cancer in humans.
3. Mutagenicity. BBP was negative in
s variety of genotoxidty lasts available
for review. The available evidence is
insufficient to establish that BBP causes
or can reasonably be anticipated to
cause heritable genetic mutations in
humans.
4. Developmental/reproductive
toxicity. The only data on
developmental toxicity available to EPA
is a Monsanto-sponsored teratology
study of BBP by Industrial Bio-Test
Laboratories. Inc. (Ref. 7). At the dose
levels used (0. 3. and 10 tng/kg/day), no
signs of maternal or developmental
toxicity were seen, which Indicates that
the dose levels used wet* too low.
However, given the reputation of
Industrial Bio-Test Laboratories and the
suspicion with which their data are
regarded, it can be concluded that
essentially there an no data to assess or
predict the potential developmental
toxicity of BBPat this time.
Although BBP has been shown to
cause advene effects 00 testicular
tissus as well ss other organs of ths
male reproductive system, these effects
are only seen at very high doeaa (> 1 g/
kg/day) and are not seen at lowet
levels.
5. Neurotoxicity. Available data
Indicate that BBP Is not significantly
neurotoxic in in that the effects
seen were not seiars or umsuiihla
a. Otter chronic beoltb tfftct*. ESacU
on the liver and other organs. If shotted
at all. seem to occur only et very high
doses (> 1 f/kg/day). Bianrirreiatad
effects noted m two studies am viewed
as btologssaiiy iimpniflraaL
7. Eco toxicity. Based as the-
information discussed below. EPA has
concluded that BBP is mdantsijr but
not highly eeotoxic.
All aquatic acute basicity esless wen
>109 ppb (in fact 4 out of 6 fish «f>ties
were >1 ppn}; all mammalian acuta
LDwS were >5 tng/kg: all aquatic
chronic toxicity Maximum Acceptable
Toxicant Concentrations (MATCs) were
> 10 ppb 1 in fact. 3 out of 3 algaaaoecies
were > 100 ppb); and ail mami
chronic MATCs were >2 mg/k^ood.
The toxicity of BBP is expected to be
lower for fish ingesting sediments
containing BBP than for organisms
exposed to BBP in the water column,
because the fish will metabolize BBP by
hydrolyzing it to a less toxic form.
There is low concern for potential
bioconcentration because
bioconcentration factors for aquatic
organisms are all below 1.00Q. This
value is an approximate demarcation
between s low concern level and the
beginning of s range of values of
moderate concern for bioconcentration.
The halMife for primary
biodegradation (deestenfication) of BBP
(a dlesterl Is approximately 2 days,
which indicates that the substance
should have low persistence in the
environment
G Use. Release. and Exposure Analysis
Because the Act provides EPA with
broad discretion to deny section 313—.
petitions, the Agency has undertaken to
confirm Monsanto's documentation of
the production, use. release, and
environmental exposure scenario* for
BBP (Refs. 1.4. and 5).
1. Production. The Agency h,
confirmed that Monsanto is the . . J.S.
manufacturer of BBP. The chemical is
produced exclusively at a plant in
Bridgeport NJ. EPA's estimate of the
1968 U.S. production volume for BBP is
64 to 65 million pounds, which
represents so sveraga growth per year
of l.S percent from 1984. Annual imports
of BBP. primarily from Western Europe,
are believed to be approximately 1
million pounds.
EPA's market analysis indicates that
more than half of all BBP (perhaps as
much as 90 percent according to
Monsanto) is used as a plastiozsr in
resilient vinyl flooring. Other maior
applications for BBP an as a piastiazer
in polyvinyl acetate foams and adhesive
emulsions, as an mart pes acids
ingredient and in s variety of coatings.
2. Releaee. The releases of BBP to au
and land from ths manufacturing facility
are quite lose based ea data supplied by
Monsanto. The aqueous effluent levels
from the plsnt have also been found to
be low. with values of
-------
REGULATION DEVELOPMENT
OVERVIEW
-------
Purposes of Regulation
Development Process
1. Priorities
2. Issues
3. Experts
4. Direction
5. Quality
6. Ripeness
m
'wmmmMmMmmk
-------
STEERING COMMITTED
OPPE
CHAIR (OSR)
OECM
ORD
OPTS
OSWER
OGC
OAR
ON
OARM
OEA
Regions
Program & Workgroup Reps
-------
STEERING COMMITTEE THEMES
s/
Accountability ^ ~Across
» Down
v Collective Responsibility
"Agency as well as office"
\/ Cross-media issues
"Lateral problem-solving"
-------
Start-Up and Planning
SAR
Workgroup
Develop
Plan __
s/ Initiate work
yj Get commitments
yj Lay out tasks
Issues/alternatives
Expectations
-------
Decision, Drafting, Closure
Regulatory
Workgroup
Workgroup
Scoping
Reports
Closure
• Assess option
• Work through issues
• Conduct analysis
• Prepare documents
• Reach closure
-------
Concurrence and Issuance
Red
Border.
. A
OMB
Administrator
>/
v/
v/
v/
Elevate/resolve/decide final
issues
Obtain concurrence & comment
of record
Complete OMB review
Approval & signature
Public notice
Federal
Register
-------
EPA's Regulatory Development Process
Program Office
Tsar
SchedLte
CJassifcafion
baas
WortynapMerrtH^p
ConvnttM
mw
WorkGroup
Analysis-Dadcpmertof Options
DgvebpmaiPbn
NjH WWyctpRapals
4
9
Options Selection
*
mm
hogs
WoifcGtoup
Analysis
RefinemertdQpians
6
mm®
W0fkO0(4>
Closure Meeting
8
ffc ¦ Ming
neaBorav
9
mmmmsmm
•* William K. Reilly ¦>
W
\L
10
irrj
11 12 13 14 15
HBH -> Rep"' ®'ei" +
BOH 4"10
WorkGroup
Analyze Comments
40CFR
-------
THE STEERING COMMITTEE
Purpose: The Steering Committee is a standing group with representation from each Assistant
Administrator and the General Counsel. II is the primary mechanism for coordinating and integrating
the Agency's regulatory development activities. Its key functions are to approve Start Action
Requests (SARs); charier and monitor the progress of staff-level workgroups, especially regarding
cross-media or inter-office problem-solving; and ensure, when appropnate, that significant issues are
resolved or elevated to top management. Regions participate in Steenng Committee activities through
Regional Regulatory Contacts. These Contacts coordinate reviews in the Regions and facilitate rule-
related activities for the Regional Administrators (RAs).
Participants:
CHAIR: Thomas Kelly
382-4001
OW' James Home
382-7818
OE: Winston Haythe
475-8783
OAR: Robert Brenner
475-7717
ORD: Jay Benforado
382-7669
OARM: Robert English
382-5000
OPPE: Dan Fionno
382-4012
OPTS: Judy Nelson
382-2890
OSWER: Elizabeth LaPointe
382-4617
OGC: Gerald Yamada
475-8064
Operation: The Steering Committee meets biweekly (every other Wednesday), with additional
meetings scheduled as necessary. Its regular format is (a) review of Development Plans (b)
consideration of pending Workgroup Reports (c) discussion and disposition of SARs. and (d) other
issues. Upon request, the Chair will schedule a separate meeting to consider a proposed or final
rulemaking package, or arrange for some other form of Steenng Committee review. Any office may
submit documents or issues (or the agenda through its Steering Committee Representative. Regional
Contacts receive all Steering Committee documents. Typically they are not able to attend meetings,
but Regions can send written comments. Due to time limitations, they may call the Regulation
Development Branch (RDB) in the Office of Regulatory Management and Evaluation with issues, so that
RDB can present these views at a meeting. After each meeting, the Committee Chair issues a closure
memo thai documents outstanding issues, agreements, and actjon to be taken. RDB provides staff
support for the Committee.
In addition to their role as members of the Steering Committee, these 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, and Federal Register
activities); serve as their Assistant Administrator's liaison with OMB under Executive Orders 12291
and 12498; and direct their programs' review of other offices' regulatory development activities.
See Also: Administrator's Memorandum, The Regulatory Development Process: Change in Steering
Committee Emphasis" (October 16, 1986); and "Information Sheet to Guide New Steering Committee
Process" (November 19. I986). Available from the Regulation Development Branch (382-5475).
fact Sheet 1 (Rev. 5/90)
Regulation Management Series
-------
OVERVIEW OF THE REGULATiC JEVELOPMENT PROCESS
FOR MAJOR RULES
«A
REGULATORY
SCOPING
MEETING
CONVENE
WORKGROUP
SUBMIT
DEVELOPMENT
PLAN TO
STEERING
COMMITTEE
SUBMIT
START ACTION
REQUEST (SAR)
STEERING
COMMITTEE
APPROVES
DEVELOPMENT
PLAN
WORKGROUP
REPORTS
TO STEERING
COMMITTEE
WORKGROUP
PREPARES
DECISION
PACKAGE
I 1
WORKGROUP
CLOSURE MEETING
UPON AGREEMENT
OF STEERING
COMMITTEE
0
I 0
DECISION
PACKAOE TO
RED BORDER
REVIEW
DECISION PACKAGE
TO OMB
;>
ADMINISTRATOR'S
SIGNATURE
¦N
V
PR0P08ED
RULE
PUBLI8HE0
IN FEDERAL
REGISTER
t 2
'
PUBLIC
COMMENT/
PUBLIC
MEETING
o
o
1 3
I 4
I S
1 •
I 1
1 •
1 9
WORKGROUP
REVIEWS
PUBLIC COMMENT
WORKGROUP OR
STEERING
COMMITTEE
CLOSURE
WORKGROUP
REPORTS TO
STEERING
COMMITTEE
DECISION
PACKAGE TO
RED BORDER
REVIEW
WORKGROUP
PREPARES
DECISION
PACKAGE
ADMINISTRATOR'S
SIGNATURE
DECISION PACKAGE
TO OMB
20
FINAL
RULE
PUBLISHED
IN FEDERAL
REGISTER
-------
OVERVIEW OF THE REGULATION DEVELOPMENT PROCESS
FOR SIGNIFICANT RULES
SUBMIT
START ACTION
REQUEST (SAR)
CONVENE
WORKGROUP
SUBMIT
DEVELOPMENT
PLAN TO
STEERING
COMMITTEE
STEERING
COMMITTEE
APPROVES
DEVELOPMENT
PLAN
WORKGROUP
REPORTS
TO STEERING
COMMITTEE
<1
o
o
o
11
PROPOSED
RULE
PUBLISHED
IN FEDERAL
REGISTER
'UBLIC COMMENT/
PUBLIC MEETING
WORKGROUP
CLOSURE MEETING
UPON AGREEMENT
OF STEERING
COMMITTEE
WORKGROUP
PREPARES
DECISION
PACKAGE
DECISION
PACKAQE TO
RED BORDER
REVIEW
ADMINISTRATOR'S
SIGNATURE
DECISION PACKAOE
TO OMB
SEOUSNTIAl
UNLESS SPECIAL
CURCUMSTANCES
<0
o
o
1 s
1 4
1 S
1 s
I T
IS
1 •
FINAL
RULE
PUBLISHED
IN FEOERAL
REGISTER
DECISION
PACKAGE TO
RED BORDER
REVIEW
WORKGROUP
REVIEWS
PUBLIC COMMENT
WORKGROUP
REPORTS TO
STEERING
COMMITTEE
WORKGROUP OR
STEERING
COMMITTEE
CLOSURE
WORKGROUP
PREPARES
DECISION
PACKAGE
ADMINISTRATOR'S
SIGNATURE
DECISION PACKAGE
TO OMB
-------
OVERVIEW OF THE REGULATION DE"'~'.OPMENT PROCESS
FOR MINOR k iS
CONVENE
WORKGROUP
SUBMIT
START ACTION
.REQUEST (SAR)
WORKGROUP
PREPARES
DECISION
PACKAGE
WORKGROUP
REPORTS
TO STEERING
COMMITTEE
(OPTIONAL)
WORKGROUP
:losure meeting
(OPTIONAL)
O
O
DECISION
PACKAGE TO
RED BORDER
REVIEW
WORKGROUP
REVIEWS
PUBLIC COMMENT
PUBLIC COMMENT/
PUBLIC MEETING
ADMINISTRATOR'S
SIGNATURE
DECISION PACKAOE
TO OMB
SCOUSNTIftl
UNLESS SPECIAL
CIRCUMSTANCES
<1
1
WORKGROUP
REPORTS TO
STEERING
COMMITTEE
(OPTIONAL)
WORKGROUP
PREPARES
DECISION
PACKAOE
WORKGROUP OR
STEERING
COMMITTEE
CLOSURE
(OPTIONAL)
OECI8IOM
PACKAOE TO
RED BORDER
REVIEW
DECISION PACKAOE
TO OMB
ADMINISTRATOR'S
SIGNATURE
-------
RED BORDER REVIEW
Purpose: Red Border is the formal review mechanism by which senior management (usually
Assistant and Regional Administrators and the General Counsel) reviews and approves regulatory
packages before they are presented to the Administrator or other approving official. 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.
Participants: The Assistant Administrator for the lead office approves the package for Red Border
review by signing the transmittal memo. The review may include only the Assistant Administrator for
OPPE and the General Counsel. However, other Assistant Administrators or Regional Administrators
may participate if their offices were represented on the workgroup (or by approval from the lead
office Steering Committee Representative if they were not). The Steering Committee decides who will
participate when they review the action pnor to Red Border.
Preparing the Document: The Red border package should include:
o Action Memorandum
o Preamble and Regulatory Text
o Communications Strategy
o Federalism Review Form (EPA Form 3720-11)
The lead office submits enough copies of the regulatory package
plus two, to the Regulation Development Branch (RDB). If the
Border and OMB review it should also include OMB form SF83 and
and rule.
Operation: The review period is generally three weeks. The lead Assistant Administrator may
request a shorter Agency review if the rulemaking is under a tight schedule; i.e., court or statutory
deadlines. Any such request must be in wnting, and include the reason for expedited review. During
the Red Border review the appropriote RDB desk officer receives written comments from the
reviewing offices and transmits them to the lead office. After Red Border is complete and the lead
office has considered and responded to all comments, it prepares the package for OMB review.
See Also: Fact Sheet #9, "OMB Review Under E.O. 12291" and Fact Sheet #7 "Information Collection
Requests', available from the Regulation Development Branch (382-5475).
for all reviewing offices and regions,
rule is approved for concurrent Red
four additional copies of the preamble
Fact Sheet 8 (Rev. 5/90)
Regulation Management Series
-------
WORKGROUP
OPERATIONS
-------
THE WORKGROUP
Purpose: Workgroups are EPA-wide, staff-level groups formed to develop regulatory actions and
supporting materials. The workgroup's primary responsibilities are to: 1) support the lead office in
its design, technical and analytical work; 2) identify and assess principal policy issues and options,
especially those that are cross-media; 3) resolve issues or elevate them for upper management's
resolution; 4) ensure the quality and completeness of regulatory packages. Workgroup members are
expected to represent the policy positions and perspectives of their management as well as to
contribute their technical and analytic expertise.
Participants: Typically the lead office will place several people on the workgroup to support the
chair and conduct the bulk of the technical, analytical, and drafting work. OGC, OPPE, and often ORD
and OE participate; other program offices-OAR, OPTS, OSWER, and OW-often participate actively
especially when there are significant inter-media issues. OARM and Regional Offices participate less
frequently. If a Steering Committee Repreentative assigns more than one workgroup member, they
usually designate one person as lead to represent their Assistant Administrator's position and
coordinate the efforts of the other members (If workgroup progress requires that there be a single
lead from other offices, the lead program Steering Committee Representative can ask each office to
designate a lead workgroup member) Except in special cases, it is difficult for Regions to participate
actively on workgroups. Therefore, the lead office should initiate efforts to solicit Regional office
perspectives, especially those that pertain to implementation issues.
Operation: The workgroup's formal operation begins with the approval of the Start Action Request
(SAR) and the chartering of the workgroup by the Steering Committee. The lead office chairs and
convenes workgroup meetings. Other members of the workgroup are assigned by their offices'
Steering Committee Representatives. How the workgroup should operate will vary, depending on the
rulemaking The workgroup chair should discuss and clarify members' roles and expectations early in
the process to avoid misunderstandings. The workgroup's first responsibility, for major and
significant rules, is to prepare a Development Plan, which the Steering Committee reviews. For most
rules, the Steering Committee will ask the workgroup to report on its progress through periodic
Workgroup Reports, which the workgroup chair must prepare. To ensure workgroup and Steering
Committee consensus on the agenda of issues for discussion, the workgroup chair should prepare a
comprehensive list of issues (originally part of the Development Plan for major or significant rules)
and revise it as appropriate throughout the rulemaking.
See Also: Fact Sheet #5, "Workgroup Reports", available from the Regulation Development Branch
(382-5475)
Fact Sheet 3 (Rev. 5/90)
Regulation Management Series
-------
REGULATION DEVELOPMENT BRANCH
RDB Desk Officers oversee the regulation development process and ensure that each
regulation is complete and issues sufficiently identified and resolved to proceed to the next
review phase. They review SAR's, Development Plans, Workgroup Reports and Red Border
packages and prepare follow-up memos for Steering Committee, Workgroup Closure, and
Regulatory Scoping meetings. Desk Officers also track rules sent to OMB for review. Each
officer has a specific area of responsibility, and provides procedural assistance to workgroup
members and program offices on rules as they develop.
RDB Desk Officers and areas of responsibility are:
1. Scott Furlong - Air Stationary Source
Programs, CAA and AEA 382-7202
2. Nancy Helm - Superfund, CERCLA and SARA 382-7206
Darryl Adams - Solid Waste Programs, RCRA 382-7560
3. Angela Suber - Water Programs, CWA, SDWA 382-7205
4. Mary Miller - Air Mobile Source Programs
and Other Authorities 382-5251
5. Phil Schwartz - Pesticides and Toxics Programs
FIFRA and TSCA 382-5493
RDB staff also provide assistance with Federal Register Publication
Vickie Reed - Federal Register Officer
382-7204
-------
CONDUCT GUIDELINES FOR WORK GROUP MEMBERS
The primary purpose of the work group is to identify and
resolve key issues early in the development of regulations and/or
policy statements which are produced by the component offices
within EPA. As a work group member', you are responsible for
accurately and effectively representing your program office's
needs and interests. In addition, you have an obligation to
ensure that the regulation development process is completed as
expeditiously as possible. To fulfill this responsibility, you
must:
1. Represent your program. Be well-informed on your office's
perspective on a particular issue and clearly present this
to the other work group members. Work group members are
responsible for giving written or oral presentations to
their management as necessary in order to ensure they have
the ability to represent their respective office's
interests adequately.
To the extent possible, attend all meetings of the work
group in person rather than by proxy.
2. Keep your management informed. It is your duty to keep
management informed of the progress of the work group.
Take and keep clear and concise notes of work group
meetings. This will enhance your ability to explain key
issues, and document past decisions that were made by the
group.
Brief your immediate supervisor periodically on the outcome
of the work group meetings. Focus on what is of importance
to your program office and clearly present any unresolved
issues you feel merit the attention of the Office Director.
3. Know your facte. Be sure of your facts and be prepared to
document them. Be clear about concerns for which adequate
information is not available to fully support a position.
Challenge other work group members when they make
unsubstantiated statements. Encourage others to follow
your example of scrupulous adherence to the facts.
4. Listen closely. Try to comprehend what motivates other
work group members to raise particular issues. If you do
not understand what was said, and further group discussion
on that issue would detract from the effectiveness of the
work group meeting, arrange a follow-up meeting with the
work group member(s) to clarify facts or issues.
5. Get help when you need it. If you do not have adequate
expertise on an issue, then work to develop the expertise
before taking a position. As an alternative have another
staff member from your office, who does have the expertise,
assist you or take your place in that meeting of the work
group.
-------
6. Be prepared to negotiate. Although your goal is to assure
that the final product reflects or is consistent with your
program's goals and strategies, realize that concessions
are often necessary in the course of a "deliberative"
process. Be prepared to distinguish between "essential"
and "desirable" positions you advocate and be ready to
concede positions that are not essential to your office.
When you have a concern, suggest solutions and present
several options for the work group's consideration.
Recognize personal biases that may impede the work group's
progress. Distinguish between issues that are relevant to
your office's position and those that reflect your personal
views.
7. Elevate issues quickly. After negotiations, and if the
work group does not support your stance on an issue you
deem to be essential to your office, raise the issue to the
Office Director level before the work group reaches
closure. Be aware that this will almost certainly slow
down the process and that it should be done only as a last
resort. Make sure your management supports the position
you are taking.
8. Do your share of the work. Ultimately, it is the work
group's responsibility to draft the regulation or policy
statement. Although the lead office usually writes the
draft, remember that you are the one who can best
articulate your office's concerns. Be prepared to write
portions of the final document. Volunteer to write those
sections where you are best qualified to define an issue
and recount the work group's resolution.
Incorporate all provisions on which the work group achieved
consensus. Refrain from including personal biases in the
final product.
9. Be an expediter. Remember that time is critical and that
you should complete your sections of the final product as
soon as possible to allow for review. Circulate your
working draft to the other work group members as soon as it
is completed.
Review draft documents within the time provided by the lead
office (usually within two weeks of receiving the current
draft). If your comments are not received within this time
and you have made no alternative arrangements with the lead
office, then your concurrence may reasonably be assumed by
the work group.
10. Remain professional and courteous at all times. You will
earn the respect of fellow work group members, and
ultimately enhance the work group's overall effectiveness.
-------
START ACTION REQUESTS
Purpose: A Start Action Request (SAR) initiates work on a rule or related action and establishes the
Agency workgroup. It provides brief, descriptive information and should be prepared at the very
outset of an office's effort. Its principal purposes are to alert other Agency offices to the lead office's
intention to develop a rule, and provide the Steenng Committee with the opportunity to discuss and plan
for the inter-office or inter-media aspects of the action. In addition, submitting the SAR to the
Steering Committee is the mechanism for. (a) reaching agreement on the necessary review steps (e.g.,
a Development Plan, Workgroup Reports, and an Information Collection Request), and (b) helping all
Agency programs decide at the start of the process whether to designate members to participate on the
workgroup and what skills would best contribute to the rulemaking.
Preparing the Document: The SAR is a one-page form with instructions on the reverse side. It
asks primarily for descriptive information, which should be available to the lead office when it starts
work on the regulation. The most important category of information on the form is Item 4, called
"Description of Action " The Steering Committee uses this information to determine the significance of
the action for the Agency and for individual offices, the need for a Development Plan or other planning
documents, the composition of the workgroup, and the type of management review that is appropriate.
For these reasons, the description should give information on any likely cross-program effects, issues
or problems. The description should'
o clearly define the problem, including its health and environmental significance;
o indicate the effect of the problem and the intended regulatory action on other
environmental media or programs;
o identify the tPA Regions and other groups that should be involved;
o specify the kind of expertise and level of participation expected from workgroup
members.
Operation: The lead office Steering Commitee Representative approves the SAR, catagorizes it as
either 'discussion" or "nondiscussion", and submits 25 copies to the Regulation Development Branch
(RDB) for distribution. "Discussion" SARs warrant a briefing from the lead office to facilitate approval
and workgroup nominations. "Nondiscussion" SAR's are considered automatically approved and only
require nomination of workgroup representatives at the meeting. The lead office should submit
"nondiscussion" SARs 15 days prior to the biweekly Steering Committee meeting. Steering Committee
Representatives can decide before the final agenda is set (one week before the meeting} if the SAR
needs a briefing and RDB can reschedule it as a "discussion" item. * Discussion" SARs need only be
submitted 8 days before the Steering Committee meeting for inclusion in the final agenda. The
Committee approves the SAR, charters a workgroup, designates workgroup members, and determines
what further reviews are appropriate. If the SAR does not provide sufficient information for Steenng
Committee Representatives to select their workgroup members, they can give RDB the name or names
after the meeting. RDB will include these names in the closure memo for the meeting. The lead office
then convenes the workgroup.
See Also: SAR forms, guidelines, and prototypes are available from Steering Committee
Representatives or from the Regulation Development Branch (382-5475).
Fact Sheet 2 (Rev. 5/90)
Regulation Management Series
-------
°*!eas~ aad instructions on back o~o completing this (o^
j>EPA Start Action Request
From (lead office) Signature (Steenng Committee Representative) Date
i ., , \ y ,/ J . /
Office of Emergency and Remedial Ret
IdenW,ration Vun.ner
y'U'odaA'ci.a. y/zif&r-
1 Title of Action •J 2a Classification
Update of Oil Pollution Prevention Regulation | X j Major j | Significant j [ Minor
2b Explanation of Classification
Because of the size of the regulated community (an estimated 650,000 facilities), any
significant requirement will result in compliance costs exceeding §100 million.
3a Statutory Authority 3b. CFR part number
Section 311 (3)(1)(c) of the Clean Water 40 CFR Part 112
Act, as amended 33 U.S.C. 1251 et seq.
4 a Descnption of Action
Following a ma^or oil spill with substantial environmental impacts, an interagency
task force reviewed the adequacy of regulations concerning the prevention and control
of oil spills. The task force recommended a significant upgrade to the Oil Pollution
Prevention Regulation and an inventory of the regulated community. Because of the
need for rapid upgrade of the regulation and the time required to inventory the reg-
ulated industry, a two phased regulatory approach is being pursued. In Phase I, widely
accepted industry practices that are currently recommended practices m the regulation
will be changed to required practices. Also, to facilitate an inventory of facilities
subject to the regulation, a provision will be added requiring facilities to notify
EPA of their existence. The Phase II regulatory effort will address other recommended
modifications. The major issues for workgroup resolution are the scope of the
regulatory changes appropriate for the Phase I regulation.
4b Other regulatoiy programs that this action may conflict with, duplicate, or otherwise affect
Proposed regulations under Subtitle I of the Solid Waste Disposal Act, as amended,
regulating underground storage tanks containing oil. The Oil Pollution Prevention
Regulation applies to all nontransportation related facilities, including underground
storage layqey than 42.OOP gallons.
4c Court-ordered or statutory deadlines for this action
N/A
4d Consequences of not taking this action
Increased probability of legislation imposing a regulatory program for above-ground
storage tanks, possibility of additional major spills by facilities not contplyinc[ with
5 Project Manager
John E. Riley
Telephone
382-2190
Mad code industry standari
OS-210
6 Timetable (check one of the boxes below)
| y | (for Major and Significant actions) Development Plan will be submitted to the Steenng Committee by - Date
I (for Minor actions) Draft regulations will be - -.bmiited for closure or Red Border by - Date
10/21/88
Miscellaneous Review and Procedural Requirerru
a Might this action have a significant impact cn - t't 'j-:inesses. small governments, or small organizations?
b Will this action impose reporting or recorcikef- -1 ••^1'onvnts that will require 0MB approval7
X
X
EPA Form 3720-10 (Rev. 7-87) Previous editions
-------
Start Action Request
Instructions
Please read these instructions before completing this
Exemptions: The following categories of action do not
require this form
a. Approval or disapproval revisions to State Imple-
mentation Plans and redesignation under the Clean
Air Act,
b. Pesticide tolerances, experimental use permits,
emergency exemptions and regulations to exempt
pesticides from FIFRA under Section 25(b) because
it has been determined that the pesticide (1) is
adequately regulated by another agency, or (2) is
the type of pesticide that does not need to be sub-
ject to FIFRA in order to carry out the purposes
of FIFRA.
c. Approval of Solid Waste Management Plans and
State Authorizations under RCRA. and
d. Regulations for which the Administrator has dele-
gated approval authority
General Instructions: The Regulation Management
Staff m the Office of Standards and Regulations will
insert the identification number and will distribute the
form The form should be completed by the initiating
Assistant Administrator Items without specific instruc-
tions are considered to be self-explanatory
Item 1 * The title of this action should be descriptive and
distinguish it from other regulations The title should be
brief
Items 2 and 3: Classify all actions as "Major", "Signifi-
cant. or Minor " The criteria for "Major" are
a. An ann ual effect on the economy of $ 100 million or
more, or
b. A major increase in costs or prices for consumers,
individual industries. Federal. State, or local govern-
ment agencies, or geographic regions, or
c. Significant adverse effects on competition, employ-
ment, investment, productivity, innovation, or on
the ability of U S.-based enterprises to compete
with foreign-based enterprises in domestic or
export markets. "Significant" regulations are those
that do not meet the criteria for "Major" but that
may
° have significant adverse consequences for
the public, or
° raise important public health or intermedia
issues, or
0 have important effects on the operations of
Regional or other program offices, or
0 have broad geographic effects
Regulations are "Minor" if they meet none of the criteria
for "Major" or "Significant "
Item 4: Include such useful material as.
a. the expected environmental benefits, pollutants
controlled, and the sources covered, and
b. explanation of how the regulation fits into EPA's
programs, and how it relates to other regulations
c. Identify the reason for any mandatory deadlines
and give the actual deadlines
d. Discuss the consequences of not taking regulatory
action and why it is necessary to take the regula-
tory action [In reviewing this request. OPPE may
ask you to explain why this is the appropriate time
to develop the action, and why the effort will make
the best use of our resources in view of competing
prioritiesj
Item 5. Cite the primary statutory authority
Item 6: Cite the most probable CFR part number Cv -
suit the Office of the Federal Register if a new part is
needed Include subpart or subsection, if known
Item 7- Include name, phone number, and mail code
Item 8: All "Major" and "Significant" regulations musi
have a Development Plan The Assistant Administrator
for Policy, Planning and Evaluation may waive the
Development Plan requirement for specific "Sigmfi
cant" regulations All "Major" and "Significant" regula
tions must have a Steering Committee or Consen
Calendar review before entering Red Border review Al
regulations must have a Red Border review
Item 9.
a. If yes. the lead office should consider preparing ,
Regulatory Flexibility Analysis Any analysis that i
done should identify effects on small businesses
governments, or organizations
b. If yes. the lead office must work with the Office c
Standards and Regulations to obtain OMB approv
al under the Paperwork Reduction Act of 1980
EPA Form 3720-10 (10-84) flevarM
-------
WORK GROUP MEMBERSHIP INVITATION
T>~ OF ACTIOH/lOCMTIFICATftOM NUMBER
late of Oil Pollution Prevention Regulation
FROM ola Ike week
1 *»k trim, pcicoi jom n*k to Mad to k*
~ f mU like to k*Tt Ik* ptntM Us tod below to «fce
¦«k iiuuv. If IWw at* ma afiMak from year office lk»l*d
Mm, t»aciU |ow t net a«n ai ¦ far lad) oQ aa Uke atmia.
tke MkVoaiUPkMi Mmfldi fan to mm? ™' 10
WORK CROUP MEMBERS
OFFICE
NAME
¦MAIL. COPE
PMOME
OGC
/c'f
""lao Tynm
LE-132S
382-7703
OPPE
Jt ~fa feoff
Sluwun Niu.»ias
PM-22 0
382
OW
Gary Polvi
EN- 338
475-8316
OUST
Rich Braddock
OS-400
382-3257
OSW
Robert April
OS-322
382-7937
OWPE
Lloyd Guerci
OS-510
382-4812
OERR
John Rilev
OS-210
3R?-?l<»rr
OERR
John Cunninqham
OS-210
382-4130
R
David Lopez
OS-210
382-7731
OERR
Betti Van Epps
OS-240
475-8864
OERR
Tom Kady
OS-210
321-6240
Region I
David Tordoff
860-4362
Region III
Tom Massey
397-8132
Region IV
Warren Dixon
347-3931
Region V
Robert Bowden
886-6236
Region VI
Don Smith
255-2270
Region VII
William Keffer
757-3888
U.S. Coast Guard
Fred Presley
267-0435
National Bureau of Standards
John Smith
OS HA
Richard Brogan
523-7216
CPA Fw 3730-10* ()-7V)
-------
COMMON PROBLEMS IN COMPLETING THE
START ACTION REQUEST (SAR)
1. TITLE:
Insufficient attention paid to giving a rule a
"final" title that clearly and concisely
articulates the rule's content. The title thus
requires revisions.
2. DESCRIPTION OF ACTION:
Often does not give sufficient information to
clearly describe what the rule is intended to ac-
complish, that is i.e., what is to be regulated,
the regulated entities, the nature of the environ-
mental problem to be addressed, etc. You need
information to effectively appoint workgroup
members.
3. OTHER REGULATORY PROGRAMS AFFECTED:
This item is used to request information on
programs duplicated or in conflict, now, it asks
to indicate explicitly what other agency rules
will be "affected" by the proposed rule. This
allows Steering Committee members to know how they
are involved so they can properly assign workgroup
members.
4. CONSEQUENCES OF NOT TAKING THIS ACTION:
This is rarely treated seriously by programs. It
should articulate the implications for the AGency
(e.g. violation of deadlines) and for the
environmental/problem, of deferring action or of
taking no action.
5. STATUTORY AUTHORITY:
It should indicate both the name of the statute
and the section number(s) (e.g., RCRA section 321)
and the U.S. code cite(s). Primary one should be
indicated first if there are more than one.
-------
DEVELOPMENT PLANS
Purpose: The Development Plan sets forth the framework for developing proposed major or
significant Agency rules. Its purpose is to explain the need for the action; identify regulatory goals and
objectives, present the major regulatory issues and alternatives; identify any policies, decision
criteria or other factors that will influence regulatory choices; and present the work plan and resource
requirements for developing the regulation.
The Development Plan is prepared for Steering Committee review. This review is meant to identify the
full range of issues early in the process. The Steering Committee will: (a) raise cross-media or other
issues or alternatives not identified in the Plan; (b) inform the lead office of related activities
underway in the Agency, (c) encourage coordination of Agency resources, experience and policies; and
(d) review the work plan and schedule to decide how the various offices will participate and whether
they can meet the time and resource needs of the lead office.
Preparing the Document: The lead office prepares the document with participation from the
workgroup The document should include detail commensurate with the complexity and importance of
the rule. To the extent possible -- based on previous expenence and available data -- the plan should
describe the environmental problem and issues, and the alternatives to be considered in addressing
them It should also address enforcement and implementation issues. In any case, the document should
include a comprehensive list of issues, which the workgroup should amend as necessary throughout the
development process
Operation: The lead office should submit the Development Plan for Steering Committee review within
60 days of SAR approval (unless the Steering Committee agrees to another date) The lead office
submits the Plan to its Steering Committee Representative, who reviews the document before sending
25 copies to the Steering Committee Chair for distribution. The Steering Committee review period is
two weeks To get a Plan on an agenda, the Steering Committee member must submit it to the Office of
Regulatory Management and Evaluation, Regulation Development Branch by COB (4:00 p.m.) Tuesday,
15 days before the biweekly Wednesday meeting.
Steering Committee members review the package to ensure that it is complete and identify questions or
issues The lead program office then briefs the Steering Committee on the plan at the biweekly
meeting. Members will raise any questions or issues at that meeting. After discussion, and resolution
of questions and issues, the Steering Committee approves the Plan, perhaps contingent upon certain
revisions or clarifications. The Committee agrees upon an appropriate schedule for workgroup reports
and other review steps A closure memo documents the Steering Committee meeting, including issues
raised, decisions made, schedule for workgroup reports, and next steps. The Steering Committee
tracks progress on the rule through workgroup reports.
See Also: Guidelines and prototype Development Plans are available from Steering Committee
Representatives or the Regulation Development Branch (382-5475).
Fact Sheet 4 (Rev. 5/90)
Regulation Management Series
-------
MAR - 4 B8b
DEVELOPMENT PLAN GUIDANCE
Development plans should follow the format below, and address the questions listed.
Provide information to the extent available. You can obtain sample development plans
and assistance from your Regulation Management Branch Desk Officer (3B2-5475).
I. INTRODUCTION
II. GOALS OF PROPOSED REGULATORY ACTION
- In summary, what are the specific goals of this rulemaking (including both
statutory and Agency priorities)?
III. BACKGROUND AND NEED FOR THE REGULATION OR REVISIONS
1 . Historical Statutorv/Reoulatorv Background
- What is the historical context for the current activity? What laws and
regulations already exist within EPA?
2. Need for Regulation
- What is the statutory or legal mandate justifying the proposed
regulation (or revisions) and its priority level?
- What are the key statutory or legal requirements EPA will address in
the proposed regulation?
- What, if any, deadlines must EPA meet (legal or internal Agency)?
- What experience in the program area indicates a need for the
regulation or revisions? (i.e., based on experience to date, what are
strengths and weaknesses of existing federal and state efforts?)
4. Cross-Media and Cross-Aoencv Experience
- What other programs or agencies (including state programs) are
currently regulating in this area, with which coordination may be
required, and what is their interest or statutory mandate?
IV. ENVIRONMENTAL/HEALTH PROBLEM
1. Problem Definition
- What specific activities (e.g. by industry, the public) are damaging
health or the environment, and what is the link between those
activities and the negative results? (A Chart or Model of the Risk
Management Problem is helpful.) If the "problem" addressed is
not an environmental/health one, indicate what it is.
-------
• What is the extent of the problem (i.e., number of pofluters, amount of
pollutant discharged, extent of media contamination and exposure,
etc.)? Do we have adequate risk assessment data to describe/quantify
the problem (both activities and impacts), and if not, what additional
data are needed, and can we obtain them in a timely fashion?
- What simplifying assumptions is the lead program/workgroup making
in characterizing the problem in order to make the problem
manageable (e.g., exposure remains constant over a lifetime)?
2. Problem Significance
- How significant is the health and environmental risk, in terms of scope
of activity, extent of exposure, scope and irreversibility of damage, and
urgency of action needed?
- What priority does it have in risk management terms, both from a
cross-media standpoint and within the particular medium?
V. ISSUES AND ALTERNATIVES CONSIDERED
1. Kev Issues and Alternatives
- What are the key issues this rule will address, including cross-media
issues? Issues may relate to the universe of pollutants to be regulated,
who implements the regulation, the regulatory strategy, the regulated
entity , etc. See "Identifying Regulatory Issues" for a listing of types
of issues and alternatives to be considered.
For each issue being considered:
- What reasonable, legal and technically feasible alternatives has the
workgroup identified? Has it considered risk communication
alternatives?
- What is the assumed link between implementation of the regulatory
alternatives and problem mitigation?
- What major uncertainties, if any, must it address with respect to
the available alternatives?
2. Factors Influencing Selection of Alternatives
- Are there any generic decision rules drawn from Agency policy that
will influence the selection of alternatives?
- Are there other factors that may heavily influence the selection
process?
- Are there alternatives precluded under existing law that might be
environmentally or administratively preferable or more cost-
effective?
Should this regulation be subject to the DA's options selection process?
-------
WORK PLAN
1. Data Sources and Projected Analyses
- Given the major areas of uncertainty, how do we plan to resolve them?
- What data sources are there on the problem and regulatory options?
Is the quality of the available data (if known) sufficient to address
projected regulatory decisions?
- What studies or analyses is the lead program planning? In what
areas? From what sources? To address what issues and decisions?
With EPA or contract personnel?
2. Workgroup Membership
- Who are the workgroup members, and what offices do they represent?
Are there groups not represented that should be?
3. External Involvement and Communication
- Which federal or state agencies and other organizations will the lead
program involve in the rulemaking, and in what capacity?
- What mechanisms will the lead office use for communicating with such
outside participants and the general public during regulation
development and implementation?
- How will the workgroup integrate external comments into the
development process?
- Would some form of negotiated rulemaking or other consensus-based
process be useful in developing this rule?
4. Schedule
- What is the proposed schedule for developing the regulation, including
milestones and outputs, contract deliverables, RIA, ICR (if required)
etc.? (This should cover the rulemaking through promulgation.)
- What is the projected schedule of workgroup meetings and reports to
Steering Committee (give projected month and year)?
5. Resource Requirements
- Estimate Agency personnel resources required to develop the
regulation through promulgation, and indicate the sources,
(e.g., 5 FTE's from OPTS, 2 from ORD, etc.)
- Estimate contract resources needed through promulgation, and
which offices will be sponsoring the work.
-------
MAR - 4 |988
Identifying Regulatory Issues
Developing a regulation requires making decisions on a whole range of regulation design
issues. These issues relate to a variety of regulatory program characteristics. The list
below is intended to help the workgroup think through its task and lay out the issues and
alternatives to be included in the Development Plan. The characteristics listed are not
necessarily all-inclusive.
Design Issues
1. What to regulate: Universe of pollutants
- Waste streams vs. toxic ingredient only
- End product only vs. intermediates
- All members of pollutant class or just certain groups/classes (based on
amount produced/released, toxicity, availability of detection method or
remedy, etc.)
- Point vs. nonpoint sources
2. Whom to regulate: Universe of polluters
- Producers, formulators/packagers, transporters, users, disposers
- Exclusions, waivers, grandfathering
- Small business or producer exclusion (based on business size, amount
of revenue or production, or # employees)
- Time exclusions (based on date initiated business/production)
3. How to categorize regulated entity or pollutant
- By site (using screening criteria or model, etc.)
- By waste stream (or waste by-products) produced
- By type of product produced (e.g., industry sector)
4. When to regulate: Point in process or pollutant path
- Manufacture
- Transport
- Storage
- Use
- Disposal
5. What existing control systems to be evaluated as models
- Industry programs
- State and local programs
- Federal programs
6. Extent of coordination with other EPA offices, federal agencies, state and
local governments
- Deferral to more stringent state/local standards
- Incorporation of standards from other EPA/agency programs
- No coordination required
-------
7. How to reguJate
- Performance standards
- Design standards
- Technology-based standards (BAT, BEJ, BCT)
- Educational programs/grants (e.g., risk communication programs)
(7a) Criteria for determining standard level (i.e., how clean is clean)
- Return to natural background level
- 100% cleanup (no discharge)
- No exposure
- Ban production
- Discharge at "safe" levels (human exposure vs. flora/fauna exposure)
- certain rates or concentration levels
- specified amounts (based on time or % of production)
- Standard related to available control technology (e.g. BAT, BCT, BEJ)
(7b) Mechanism for setting standards or selecting remedies
- Permits
- Uniform national standards
- Standards matched to specific category of pollutant, amount, etc.
Implementation Issues
8. Who implements
- Federal only
- State delegation with federal oversight
- State only, no Federal oversight
9. How regulation takes effect
- All entities or wastes regulated as of specified date
- Phased-in regulation (e.g., by classes of entities or pollutants, or based
on size, amount produced, availability of technology)
10. Who oversees, reports, enforces
- Federal, state or local government; public; industry
11. Responsibility for remedy selection
- Government, permit writer or regulated entity
12. Types of remedies
- Civil fines/compensation (per incident, per day or per exposure, actual
monetary or punitive damages)
Civil (injunctions, closure)
- Criminal (misdomeaner, felony)
- Self-correction (industry does treatment/cleanup)
13. Incentives/disincentives provided
- Grants (monetary incentives) vs. fines (disincentives)
- Protection from or imposition of liability
- Exclusion from regulation if certain requirements met: e.g., if use new
technology, if cease operation by certain date, if recycle, etc.
- Involvement in remedy selection or other aspect of decisionmaking
- Preferences specified (for use of specific remedies, technology, etc.)
-------
DO NOT CITE
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
REGULATORY DEVELOPMENT PLAN
PESTICIDE REGISTRATION STORAGE
AND DISPOSAL DATA REQUIREMENTS
40 CFR 158
(SAR #2724)
3 August 1989
DO NOT CITE OR DISTRIBUTE OUTSIDE OF THE AGENCY
-------
REGULATORY DEVELOPMENT PLAN
PESTICIDE REGISTRATION STORAGE AND DISPOSAL DATA REQUIREMENTS
40 CFR 158
CONTENTS
I. Introduction 1
II. Goal of Proposed Regulation 1
III. Background and Need for Regulatory Action 2
Statutory and Historical Background 2
Need for Regulation 2
Program Experience 3
IV. Environmental/Health Problem 3
V. Issues and Alternatives 4
VI. Work Plan 4
Data Sources 4
Regulatory Impact Analysis 4
Workgroup Members 5
External Involvement and Communication 6
Schedule 6
Resource Requirements 8
-------
I. introduction
This regulatory development plan will provide direction to the
intended development of regulatory data requirements for pesticide
storage and disposal as defined under Section 19(a)(1)(A) of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as
amended. The new FIFRA amendments of 1988 (FIFRA '88) became
effective December 24, 1988 and significantly expanded the Agency's
authority to gather information on pesticide storage and disposal
during the pesticide registration process.
Under FIFRA '88, the Agency may require the submission of
technical data during the registration (Section 3) and the
reregistraton or renewal (Section 6) processes. The purpose of
requiring these data and related information is (1) to provide the
Agency with means to inform users, emergency personnel, and the
general public on the safe, effective, economically feasible and
user applicable processes to store and dispose of pesticides,
nnsates and containers after normal use and (2) to provide
information to help EPA determine whether a pesticide should be
registered or reregistered.
The development of this regulatory amendment to 40 CFR Part 158
is an integral part of the regulations for the safe storage,
disposal, transportation and recall of pesticides (40 CFR 165) whose
development is presently m progress. The development of these two
regulatory packages will proceed on approximately the same
regulatory schedule.
II. Goal of Proposed Regulatory Action
Develop Regulatory Data Requirements and Introductory
Information for Inclusion in 40 CFR Part 158
The authority to require data and associated information on the
storage and disposal/detoxification of pesticides during
registration or reregistration (or renewal) procedures was made
explicit by the amended of FIFRA '88. The requirement to submit
information on the storage stability of pesticides is already a part
of 4ij CFR 158. 190, with reference to the study procedures and data
to be submitted in Pesticide Assessment Guideline, Subdivision D,
Section 63-17. Current data requirements also include information
on the environmental fate of pesticides as applied (40 CFR Part
158.290). There are no requirements in the existing regulations (40
CFR Part 158) for the submission of data on (1) the degree of
effectiveness of liquid container rinsing or dust and granular bag
shaking before disposal of these containers, (2) the disposal or
recyclability of the empty containers, (3) the storage integrity of
the pesticide containers, or (4) the degradation of the concentrated
end-use product or dilute nnsates in the environment.
The Office of Pesticide Programs, Office of Research and
-------
Development, and the Office of Solid Waste will collaborate on the
type of data that will be required in order to address the concerns
about disposal of registered pesticides and their containers. EPA
will also collaborate with the U.S. Department of Agriculture and
respective State Departments of Agriculture in the development of
these registration data requirements. t*his collaboration will
extend to all of the below listed goals as they are all integral
parts of the overall project.
Final Regulatory Completion Date: December 1991
III. BACKGROUND AND NEED FOR THE REGULATIONS
1. Statutory and Historical Background
The 1972 Federal Environmental Pesticide Control Act (FEPCA)
amendments to the FIFRA established for the first time provisions
for Federal control over the transportation, storage, arid disposal
of pesticides and containers. Section 19 of FIFRA '72 also required
the development of regulations and procedures for the acceptance and
safe disposal of certain cancelled pesticides. In light of
uncertainties regarding EPA's ability to enforce the regulations,
the Agency issued Recommended Procedures for the Disposal of
Pesticides and Pesticides Containers, together with Regulations for
Acceptance of Certain Pesticides, on May 1, 1974 (40 CFR Part 165).
While the disposal and storage procedures were binding on Federal
agencies, the larger issues of controlling storage and disposal of
unused pesticides by registrants and the user community were left
unaddressed.
The Agency attempted to increase its control over unused
pesticides on October 15, 1974, with the issuance of Proposed
Regulations for Prohibition of Certain Acts Regarding Disposal and
Storage of Pesticides and Containers. Under this proposal,
specified methods of disposal (open dumping, water dumping) would
have been prohibited. However, since improper disposal was not
listed among the prohibited acts in FIFRA Section 12, it was judged
that the proposed rules would not be enforceable.
Instead, the Agency opted to control the management of unused
pesticides with a combination of label directions for disposal
(which are enforceable against handlers and users) and an
information program to encourage the adoption of rules by States.
State and local rules that have emerged in response to local demands
vary widely according to different agendas and priorities, causing
confusion in the regulated community.
2. Need for Regulation
The purpose of these data requirements is to provide the Agency
with information on (1) the stability of the pesticide products and
their containers in order that they may be safely stored for long
periods of time (five years or more) without posing undue risk to
-------
personnel who work in pesticide storage facilities and (2) tne
routes of possible degradation or detoxification of the pesticide
end-use product and equipment rinsates in order that they may be"
disposed of safely and properly without insult to the environment or
harm to humans and wildlife.
3. Program Experience
Groups with an interest in FIFRA issues, such as the American
Association of Pesticide Control Officials (AAPCO) and the State
FIFRA Issues and Research Evaluation Group (SFIREG), have indicated
their support for consistent regulatory coverage of pesticide
disposal that is coordinated between OPP and OSW. Also, industry
trade associations have offered to lend their collective practical
experiences to help in the development of practical regulations.
The pesticide user community, which currently is heavily regulated
by FIFRA, ordinarily looks to the FIFRA program for guidance, and
believes pesticide storage and disposal regulations should be
promulgated under FIFRA. It should be noted that pesticide wastes
and empty containers also fall under the regulatory control of RCRA.
This double regulatory process can lead to confusion at the State
and local levels of government and in the disposal of these items.
IV. ENVIRONMENTAL/HEALTH PROBLEM
Threat to human health and the environment posed by mis-
management of unused pesticides and pesticide equipment rinsates is
largely unmeasured. However, there are documented cases of injury
to humans and animals in addition to ground and surface water
contamination. The latter menace appears to be significant.
Continuous rinsing and washing at the same location creates a point
source which can result in residue buildup that could leach into
surface or groundwater. The sheer volume of material for disposal
dictates the need for more regulatory control.
Pesticide wastes result from the use of pesticides in
agriculture, structural pest control operations, household uses,
vector control programs, and in general, the utilization of
chemicals to control pests. Wastes appear in a variety of forms:
excess dilute pesticide solutions resulting from left-over
tank mixes, spray equipment rinsate, and rinsing of empty
containers;
excess concentrates or unused formulated products.
Large numbers of empty containers are the most visible disposal
issue. Containers that are emptied in accordance with hazardous
waste laws, while not defined as hazardous wastes, are often refused
by disposal facility operators because of the potential
contamination problems that may result. This often leaves pesticide
users with a problem of empty container disposal.
-------
Mixing/loading, equipment cleaning, and container rinsing
operations, at fixed locations over a period of years can result,in
residue build up and may become a threat to the environment. Dilute
pesticide solutions, e.g., leftover tank contents and equipment
nnsates, represent the largest part of the agricultural pesticide
disposal problem. Good management practices (waste minimization)
can play a major role in preventing the creation of toxic waste
sites and the potential threat to ground and surface waters. Also,
household pesticide wastes-have become a point of increasing concern
to land disposal facility operators.
V. ISSUES AND ALTERNATIVES CONSIDERED
The Workgroup has identified the following key issues that will
require resolution in the regulation development process:
Federal/State/Local Interface Issues: A number of states allow
the disposition of pesticide rinsates in "detoxification systems."
The practice of using these systems as means for detoxification of
these rinsates in batch systems, such as controlled evaporation
systems, for various pesticide products and mixtures will be
addressed as a data requirement.
Disposal Technology: There is probably no one disposal
technology that is best for all pesticide wastes. There is a need
to identify the best available technology which could include
treatment, destruction and/or detoxification, for each pesticide
product or, more likely, groups of products of similar active
ingredients. Technologies need to be product or group specific, as
there are a wide variety of formulations such as liquids, powders
and granulars for practically every active ingredient. The
pesticide registrants will be asked to provide data on the best
available disposal methods technology for each pesticide product or
groups of similar products within active ingredient classes. This
need for disposal methodologies will also extend to the rinsing of
containers and shaking of bags to determine their cleanliness and to
the disposal/destruction of pesticide containers.
The development of these disposal technologies will be
undertaken in concert with OSW as they deal with pesticide issues
and RCRA.
Pesticide Storage: The authorization to acquire data m order
to determine the safe storage of pesticide is also addressed in
FIFRA Section 19(a)(1)(A). Data will be required in order to assess
the longterm (greater than five years) integrity of the storage
containers.
Section 6 Data Requirements: FIFRA '88 Section 19(a)(1)(A)
authorized EPA to require safe storage and disposal data under
Section 6 of FIFRA. It has been decided that the data requirements
of 40 CFR Part 158 will address these particular data requirements
under the normal registration data requirements. The "when
required" paragraph of the appropriate Pesticide Assessment
-------
Guideline Subdivisions will address the types and timing for these
particular studies.
VI. WORK PLAN
1. Data Sources and Proiected Analyses
There is uncertainty about the levels of pesticides in liquids,
usually water, used to wash equipment or rinse containers. The EPA
container design study, which is presently underway, will research
the best methods for removal of pesticides from containers and
disposal/reuse of the rinse water. This study will be used to
develop procedures for the removal of pesticides from containers.
These procedures will be the basis for similar studies that will be
required of the registrants to determine container cleanliness.
Information on the best methods to detoxify small and large
quantities of pesticide, both dilute and concentrate, by methods
that may be available to homeowners, farmers, professional
applicators, and others may be required of the pesticide
registrants. At present EPA's ORD and OSW are working on various
technologies in order to help provide both OSW and OPP with
information on the safe storage and disposal of pesticides
especially of home use products and of large quantities. These
technologies will also be used to provide procedures to be used in
the development of additional technology by the pesticide
registrants for their specific products or product groups. The
Agricultural Research Institute has also been asked to assist the
Agency in the development of these technologies.
Information from public comments will also be considered by the
Workgroup. The public comment period is projected to be from
October 1, 1990 - January 1, 1991.
2. Regulatory Impact Analysis
A Regulatory Impact Analysis (RIA) will be undertaken by the
Economic Analysis Branch, Office of Pesticide Programs as a part of
the development this regulation.
3. Workgroup Membership
Name
Office
Mail Code FTS
Alex Tarsey
Jean Frane
John Street
Richard Dumas
Ray Krueger
Rob Denny
Robert Hoist
Janice Jensen
EFED,OPP
EFED,OPP
EFED,OPP
EFED,OPP
BEAD,OPP
SRRD,OPP
SRRD,OPP
PMSD,0PP
(H7507C) 557-5734
(H7507C) 557-7706
(H7507C) 557-8245
(H7507C) 557-0481
(H7503C) 557-1741
(H7508C) 557-2783
(H7508C) 557-0944
(H7502C) 557-7711
-------
Don Eckerman
Janet Auerbach
Barbara Pace
Marged Harris
Reva Rubenstein
Noelle Lambert
David Stangel
Paul Des Rosiers
Gary Deutsch
Karen Angulo
Mark Muldoon
Cathleen Somich
Steven Dwinell
David Scott
FOD,OPP
RD, OPP
OGC
OGC
OSW
OSW
OCM
ORD,OEETD
OSR, OPPE
Reg III
USDA, ARS
USDA, ARS
FL Dept Env. Reg.
IN State Chemist Office
(H7506C) 557-7891
(H7505C) 557-7400
(LE-132P) 3 82-7505
(LE-132S) 475-8690
(OS-3 3 2) 382-4798
(OS-3 3 2) 382-4779
{EN-342) 382-7825
(RD-681) 382-2722
(PM-223) 382-7568
3HW42 8-597-8067
ice 317-494-1587
301-344-3233
301-344-3233
904-488-3601
4. External Involvement and Communication
US Department of Agriculture, the Department of Defense and
representatives from State lead agencies, who are also members of
the State FIFRA Issues and Research Evaluation Group (SFIREG), will-
be involved at the workgroup level in the development of these
regulations through input to the 40 CFR Part 165 regulatory
workgroup.
The Field Operations Division, Office of Pesticide Programs,
will develop a communications strategy before the NPRM goes in the
Federal Register.
External comments received during the public comment period
will be analyzed by the workgroup and the appropriate information
will be incorporated into the regulations.
5. Schedule
OPP explored the possibility of maintaining the regulatory
activities described in Section 19(a) of FIFRA all under one start
action request and development plan. The was rejected due to the
nature of the regulatory actions required under each CFR part.
After careful consideration, OPP decided that the regulatory
processes will be more manageable with two regulatory packages but
with one schedule. The schedule presented below is the same as that
for 40 CFR Part 165 (with the exception of the delayed startup
period for Part 158). This is due to the strong belief that these
two regulations are intertwined and the presentation of one without
the other will create difficulties in understanding the Agency's
overall regulatory concept with respect to pesticide use and
deposition.
The projected schedule for major milestones, particularly for
-------
those furtner in the future, is somewhat speculative and is not-yet
complete. To the extent that milestones and outputs may be
predicted, they are listed below.
Date Item
May 22, 1989
May 22, 1989
June 15, 1989
July 26, 1989
August 4, 1989
August 9, 1989
August 23, 1989
August 23, 1989
November 1, 1989
December 1, 1989
January 2, 1990
January 30, 1990
February 1, 1990
April 15, 1990
June 1, 1990
August 1, 1990
September 1, 1990
October l, 1990
January 1, 1991
March 1, 1991
Start Action Request prepared
Workgroup formed
Draft Development Plan to Workgroup
Start Action Request presented to
Steering Committee
Draft Development Plan to OPP Office
Director
Development Plan to Assistant
Administrator
Development Plan to Steering Committee
First Workgroup Report to Steering
Committee (with 40 CFR Part 165
Report)
Draft NPRM with Subdivision P to
Workgroup
Draft NPRM to Office Director
Draft NPRM to Assistant Administrator
Second Workgroup Report (recommend
workgroup closure)
Draft NPRM to Steering Committee
Draft NPRM to Red Border
Draft NPRM to 0MB, USDA, SAP, Congress
Projected OMB release
NPRM to AX
Publish NPRM in Federal Register
Close of public comment period
Third Workgroup Report
-------
April 1. 1991
May 15, 1991
June 1, 1991
July l, 1991
July 1, 1991
July 15, 1991
July 15, 1991
August 1, 1991
September l, 1991
October 1, 1991
November l, 1991
Workgroup response to comments
(several meetings may be needed)
Fourth Workgroup Report
FR Final ^le for comment and
workgroup concurrence to OGC, OPPE,
01A, ODW, ORD, FDA, USDA, etc.
FR Final Rule to OD, OPP
Fifth Workgroup Report, recommending
workgroup closure
FR Final Rule to AA, OPTS
Workgroup Closure
FR Final Rule to Red Border
FR Final Rule to OMB, USDA, SAP,
Congress
Projected release from OMB
Forward to AX for Administrator's
Signature
December 1, 1991
Publish Final Rule in Federal Register
> The draft and final Regulatory Impact Analysis will be
completed at the times the regulations are proposed and
made final, respectively.
> Information Collection Requests: One ICR may be needed in
order to cover the general collection of storage and
disposal data for pesticide registration.
6. Resource Requirements
EPA personnel resources:
> Headquarters: 2 FTEs from OPP/EFED working full time
on 40 CFR 158. Workgroup members should expect to
spend up to 2 days per month on Part 158 activities
for the next 18 months.
> Regions: 0.5 FTE
Contract resources:
> Contract resources will be used as available under
-------
the 40 CFR Part 165 rulemaking.
> RIA support through BEAD,OPP contract (160-240
hours).
-------
WORKGROUP REPORTS
Purpose: Workgroup Reports keep the Steering Committee informed about workgroup progress on a
regulatory action. They descnbe' (a) issues and alternatives being addressed and resolved, (b) any
issues that need to be elevated for resolution; and (c) the status of ongoing work and any anticipated
delays. The Steering Committee's discussion of the Workgroup Report focuses on cross-media or other
issues or alternatives not being considered by the workgroup. Steering Committee concurrence with
the Report is designed to ensure that issues resolved by the workgroup are not raised again at a later
date, and that unresolved issues are dealt with in a timely way.
Preparing the Document: The workgroup chair prepares the Report in consultation with workgroup
members The document should summanze the status of issues but need not be exhaustive It should be
sufficiently detailed to allow workgroup members to determine that all issues are included and that
their status is presented accurately. Steering Committee Representatives are expected to confer with
their workgroup member(s). A cumulative or master list of issues (both resolved and unresolved)
should accompany the Report as an attachment. This list should reflect the issues outlined in the
Development Plan, and might not change throughout the workgroup effort unless issues change or new
ones arise If no Development Plan is prepared, the first Workgroup Report should contain the initial
list of issues to be addressed. Any additional issues arising during the rule's development should be
added to the master list.
Operation: The lead office submits the Report to its Steering Committee Representative, who
reviews the Report before sending it to the Steering Committee Chair for distribution. (Workgroup
members should already have received a copy.) The Steenng Committee review period is two weeks.
To get a report on the agenda the Steering Committee Representative must submit 25 copies to the
Office of Regulatory Management and Evaluation, Regulation Development Branch by COB (4:00 p.m)
Tuesday, 15 days before the biweekly Wednesday meeting. At the meeting, the program office briefs
the Steering Committee on the Report. Typically the workgroup chair attends the Steering Committee
meeting to participate in the discussion. After discussion, the Steering Committee approves the Report
or requests revisions and makes recommendations. If issues must be elevated, Steering Committee
Representatives determine what these issues are and in what forum to raise them. The Steering
Committee Chair issues a closure memo that documents issues raised and decisions made at the
Steering Committee meeting.
See Also: Fact Sheet #3, "The Workgroup", available from the Regulation Development Branch (382-
5475). A Workgroup Report Format and copies of prototype Workgroup Reports are available from
Steering Committee Representatives.
Fact Sheet 5 (Rev 5/90)
Regulation Management Series
-------
^¦R - 4 1988
WORKGROUP REPORT GUIDANCE
Workgroup reports should follow the format below, and address the questions under each
heading. You can obtain sample workgroup reports and assistance from your Regulation
Management Branch Desk Officer, at 382-5475.
WORKGROUP REPORT # : RULE TITLE [SAR #]
Covering Period from Date To Date
Office and Report Date
1. Introduction
a. Indicate the workgroup meetings covered by this report, and any other
pertinent introductory information.
b. Key Issues: Attach the complete list of issues the workgroup is addressing
as Attachment A to every workgroup report. Group related issues if they fall
into categories, and number issues. A question format for stating issues is
preferred. If new issues have emerged since a previous report, add to issues
list under appropriate category, and mark with asterisk. Issues should
parallel those listed in the development plan.
2. Issues Resolved
For each issue resolved since the SAR or last workgroup report, indicate:
- Statement of Issue: What the issue is, preferably in the form of a
question. (Place an asterisk in front of new issues.)
- Alternatives Considered: The alternatives considered, who eliminated
any of them, and why
- Approach Selected: How the issue was resolved, including (1) the
decision made, and (2) the decision-making process used
3. Unresolved Issues Under Discussion
For each issue under discussion (excluding those not yet addressed), indicate:
- Statement of Issue: What the issue is, preferably in the form of a question
- Status: Indicate the different offices' positions toward the issue, and
why it remains unresolved. Indicate if the lead program has established
a process for resolving the issue within the workgroup, or whether
to elevate the issue for resolution. If the lack of resolution relates
to the inadequacy of available data, indicate what data are needed, and the
time and resources required to obtain them.
-------
4. Status of Technical and Analytic Support Work
a. Status of Studies/Analyses. Indicate the status of principal studies and
analyses supporting the rulemaking.
b. Sufficiency of Studies: Are the current studies sufficient in terms of quality
and scope to meet project needs? If not, indicate what further studies are
needed to support the project.
c. Timeliness of Studies: Are the studies on schedule, and if not, what are
the implications?
5. Operation of the Workgroup
a. Participation: Is participation in the workgroup sufficient to address
important issues and other aspects of the rulemaking? (Attach list showing
office representation by meeting date, if pertinent.) Does the workgroup
need additional participation from any party, whether a current member or
not?
b. Anticipated Delays: Do you anticipate any delays from the originally
proposed schedule, and if so, for what reason? Will anticipated delays cause
the Agency problems with any deadlines, and if so, can delay be avoided?
c. Significant Changes: Are there any other significant changes since the
original SAR and/or development plan that will affect workgroup operation?
-------
^tosr%
$ £S *
IJffly
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
AUG I 4 I98T
OFFICE OF
WATER
MEMORANDUM
SUBJECT:
FROM:
Interim Work Group Report on the Draft Proposed
Amendments to the General Pretreatment Regulation
(40 CFR Parts 122 and 403) to Implement the
Recommendations of the Domestic Sewage Study
(SAR No. 2342)
George F. Ames
Director Water Policy Office
TO:
Thomas Kelly
Chairman Steering Committee
Attached for presentation to Steering Committee by Frank
Hall on September 2, is an interim work group report on the
draft proposed amendments to the General Pretreatment
Regulation (40 CFR parts 122 and 403) to implement the
recommendations of the Domestic Sewage Study.
The Domestic Sewage Study was submitted to Congress on
February 7, 1986. As a follow-up to the study, Section 3018(b)
of the Resource Conservation and Recovery Act (RCRA) directs
the Administrator to revise existing regulations and to
promulgate such additional regulations as are necessary to
ensure that hazardous wastes discharged to POTWs are adequately
controlled to protect human health and the environment. This
is an interim work group report to the Steering Committee on
the development of the proposed amendments to the General
Pretreatment Regulation to carry out the recommendations of
the Domestic Sewage Study.
cc: Rebecca Hanmer
Frank Hall
-------
£ ™ \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
ussy WASHINGTON. D.C. 20460
-w ,<^
*1 PR Cft
AUG I 2 1987
MEMORANDUM
OFFICE OF
WATER
SUBJECTi
FROM!
Interim Work Group Report on the Draft Proposed
Amendments to 40 CFR Parts 122 and 403 to Implement
the Recommendations of the Domestic/Sewage Study
(SAR No. 2342)
Frank Hall, Deputy Directo
Permits Division (EN-336)
TO:
George Ames, Director
Water Policy Office (WH-556)
This is
Committee on
40 CFR Parts
the Domestic
the Steering
and to start
regulations
an interim work group report to the Steering
the development of the proposed amendments to
122 and 403 to carry out the recommendations of
Sewage Study. The report is intended to inform
Committee about issues involved in the regulation
people thinking about the subject before the
themselves circulate to the Steering Committee.
The Domestic Sewage Study was submitted to Congress on
February 7, 1986. As a follow-up to the Domestic Sewage
Study, Section 3018(b) of the Resource Conservation and
Recovery Act (RCRA) directs the Administrator to revise
existing regulations and to promulgate such additional
regulations as are necessary to ensure that hazardous wastes
discharged to POTWs are adequately controlled to protect
human health and the environment.
The Agency's first step towards promulgating these
regulations was an Advance Notice of Proposed Rulemaking
(ANPR) published in the Federal Register on August 22, 1986
(51 FR 30166). The next step was another Federal Register
notice published on June 22, 1987 (52 FR 23477) which responded
to public comments on the ANPR and discussed all the activities
that EPA has under way to carry out the recommendations of
the Study. The third step is the proposed amendments to 40
CFR Parts 122 and 403 (a list of these proposed amendments
is attached).
-------
-2-
Thc work group on the DSS follow-up (a list of which is
also attached) was actively involved in preparing the two
earlier Federal Register notices. The work group was expanded
before the preparation of these draft proposed amendments to
include more members familiar with the national pretreatment
program and more Regional members. The work group met on May 5,
May 8, and July 30 to discuss various issues and to submit
comments on the draft proposals. Following is a brief discussion
of the principal issues raised at the meeting and in written
comments submitted by work group members.
ISSUES?
Specific Discharge Prohibitions
o Ignitability: Proposal would forbid discharges to sewers
of pollutants with a closed cup flashpoint of less than
140" F (the RCRA flashpoint for liquid hazardous wastes).
The work group recommended, and we agreed, to reference
the RCRA closed cup test methods in the next draft.
o Reactivity: Proposal would forbid discharges that result
in toxic gas'es, fumes, or vapors in a quantity capable of
causing worker health or safety problems. A work group member
suggested checking Occupational Safety and Health
Administration (OSHA) regs for possible overlap and
inconsistency. We agreed.
Spills and Batch Discharges
o Proposal would provide that POTWs with approved programs
must require their industrial users to develop and implement
plans to control and prevent spills and batch discharges.
The work group discussed the feasibility of EPA imposing the
requirements directly on industrial users instead of having
POTWs develop the plans, but it was decided that this
would be impractical due to the loss of flexibility by POTWs
and the difficulty of deciding which industrial users should
have such plans. However, we will be soliciting comment on
this option in the proposal, as well as on the possibility
of requiring POTWs to develop such plans for significant
industrial users only.
Some work group members expressed concern that the proposed
regulatory language would require notification of innocuous
spills and routine batch discharges. We agreed to
investigate clarifying the requirements to eliminate
this concern. We also agreed to add preamble language to
the next draft explaining more about the general purpose
of spill plans and discussing forthcoming Agency guidance
on this subject.
-------
-3-
Notification Requirements
o Proposal would require industrial users to notify EPA,
States, and POTWs of discharges to sewers of listed or
characteristic hazardous wastes, and submit a waste
minimization certification. We agreed to clarify in the
next draft that this is a one-time notification requirement,
which should be followed up by other existing or proposed
reporting requirements. Some work group members suggested
that we consider requiring the use of certain existing
RCRA forms to submit the notification, and we agreed.
We also agreed to consider expanding the certification
requirement to include more specific follow-up measures.
Mandatory Permits or Individual Control Mechanisms for
Industrial Users
o Proposal would require that POTWs with approved programs
must have the legal authority to issue individual discharge
permits to each significant industrial user. We agreed with
the work group to amend the regulatory language in the next
draft to clarify that individual agreements between
POTWs and industrial users with certain minimal elements
were acceptable (not necessarily an NPDES-type permit).
The purpose of this change is to avoid confusion about
what constitutes an acceptable control mechanism for
industrial users.
Toxicity Screens by POTWs
o Proposal would require all existing POTWs to conduct whole
effluent biological toxicity screening as part of their
NPDES permit application requirements. Proposal would
also require POTWs with approved programs to conduct
such screening once a year as part of their permit
monitoring requirements. Regional members of the work
group expressed concern about how the proposal would
affect different toxicity screening procedures already
required by EPA Regions and States. We agreed with the
work group to add regulatory language to the next draft
stating that other screening procedures determined by the
Director to be equivalent are acceptable.
One Region believed that this language would not be
sufficient to allow Regions and States flexibility to
follow their own procedures, since pressures would inevitably
arise to adopt the procedures specified in the regulation.
This Region recommended requiring toxicity screening as
specified by the Director, without spelling out procedures.
We agreed to consider this suggestion further with the
work group. We also agreed to expand the preamble language
to discuss toxicity-based permit limits and toxicity
reduction evaluations more fully and to discuss in the next
draft the Agency's plans for proposing new application
requirements for POTWs.
-------
-4-
Technology-Based Local Limits
o Proposal would require POTWs with approved programs to
obtain legal authority to develop local limits based on
a best professional judgment determination of BAT. The
work group recommended that we just solicit comments
on this as an option rather than formally propose new
requirements at this time. The reason is that we do not
yet have sufficient data to know which kinds of dischargers
and/or situations warrant the use of technology-based
local limits. We agreed to delete the proposed regulatory
language from the next draft.
The proposal already solicits comment on which industrial
categories might be appropriate for requiring technology-
based local limits (i.e., pharmaceuticals, pesticides,
hazardous waste treaters) or whether such limits should
be required on a case-by-case basis where other control
mechanisms have proved inadequate to protect human health
and the environment.
Enforcement of Categorical Standards and Program Implementation
o Proposal would add a new definition of "significant industrial
user" to the regulations. The work group recommended that
the definition be changed to conform more closely to the
definition employed in EPA's 1986 pretreatment enforcement
guidance. We agreed to include this change in the next
draft.
o Proposal would require POTWs with approved programs to
update their industrial user inventories and lists of
significant industrial users every 30 months. The work
group recommended that this updating be required once a
year so that it could be included in the annual reports
that POTWs submit to Approval Authorities. We agreed to
incorporate this change in the next draft.
o Proposal would require POTWs with approved programs to
evaluate in writing every 30 months the need to revise
local limits and then revise them if necessary. The work
group recommended that this evalutiort be required once a
year together with annual updating of industrial user
inventories and the annual reports already submitted
to Approval Authorities. We agreed to include this change
in the next draft, and to discuss in the preamble the
circumstances under which local limits should be revised.
-------
-5-
o Proposal would require POTWs with approved programs to
inspect and sample at least 50% of significant industrial
users each year and inspect and sample all significant
industrial users every 30 months. The work group
recommended that POTWs be required to inspect and sample
all significant industrial users every two years, and
that the proposal solicit comment on how many (50%, 25%,
etc.) should be done in one year. We agreed to include
this change in the next draft.
o Proposal would require POTWs with approved programs to
develop and implement an enforcement response plan describing
how the POTW will investigate and respond to industrial
user violations. We agreed with the work group to refer
in the preamble to the Agency's 1986 pretreatment enforcement
guidance on such plans to give a clearer picture of the
appropriate contents of such plans, including a timely
response schedule.
o Proposal would require categorical significant industrial
users to sample their effluent every sixty days and
report results in the twice yearly compliance reports that
categoricals already submit to POTWs. Proposal would also
require noncategorical significant industrial users to
sample every eight months and report results to the POTW
every 24 months. The work group believed that little
justification exists for treating categoricals and
noncategoricals differently, and recommended that all
significant industrial users be required to sample quarterly
for regulated pollutants (or other pollutants as required
by the POTW) and include the results in the twice yearly
compliance reports (the work group recommended extending
this compliance report requirement to significant
noncategorical industrial users). We agreed to include
these changes in the next draft.
Miscellaneous
o We are also planning to add to the next draft a brief
preamble discussion of POTW air emissions and the possibility
of future regulation under RCRA and/or the Clean Air Act.
We are continuing to discuss with OPPE the resource
burdens associated with the proposal, and we are discussing
with OECM whether we should require POTWs to incorporate
program changes before the renewal of their NPDES permits.
-------
-6-
I am very pleased with the progress of the work group so
far and I anticipate that the next report will be the work
group closure memo. We plan to submit the proposal to Red
Border by October 30. If you have questions about any of the
issues, please call me a't 474-9545 or have your staff call
Marilyn Goode at 475-9534.
Attachments
cc: Domestic Sewage Study Follow-Up
Work Group members
-------
Appendix A
PROPOSED REGULATORY CHANGES TO
IMPLEMENT DSS RECOMMENDATIONS
Specific Discharge Prohibitions
o Ignitability/Explosivity: Propose to amend §403.5{b)
to forbid discharges with a closed cup flashpoint
of less than 140° F, or that result in an exceedance
of 20% of the lower explosive limit (LEL) at any
point within the POTW (pp. 9-16 of the preamble).
o Reactivity: Propose to amend §403.5(b) to forbid
discharges that result in toxic gases, fumes, or
vapors in a quantity capable of causing worker health
or safety problems. Propose to amend §403.5(c) to
require POTWs to implement this prohibition by
establishing numerical discharge limits or other
controls where necessary based on human toxicity
criteria or information (pp. 16-20 of the preamble).
Spills and Batch Discharges
o Propose to amend §403.8 to provide that POTWs with approved
programs must require their IUs to develop and implement
procedures to prevent and control spills and batch discharges
(pp. 25-31 of the preamble).
Trucked or hauled wastes;
o Propose to amend §403.5(b) to forbid the introduction of
trucked or hauled pollutants except at discharge points
designated by the POTW (pp. 31-33 of the preamble).
Notification Requirements
o Propose to amend §403.12 to require all IUs to notify
EPA, States, and POTWs of discharges of listed or
characteristic hazardous wastes. Notification should
take place within 6 months of effective date of regs,
or within three months of regs identifying new
hazardous wastes. Wouldn't apply to pollutants reported
under other reporting requirements. Waste minimization
certification would also be required (pp. 34-37 of the
preamble).
Mandatory permits (or individual control mechanisms) for IUs
o Propose to amend §403.8 to require that POTWs with approved
programs must have the legal authority to issue individual
discharge permits to each IU defined as significant under
our new definition of significant IU (pp. 37-39 of the
preamble).
-------
Appendix A
-2-
Toxicity Screens by "POTWs
o Propose to amend §122.21 to require all existing POTWs to
conduct whole effluent biological toxicity screening and
report results in their NPDES permit applications (pp.
45-51 of the preamble).
o Propose to amend §122.44 to require equire POTWs with
approved pretreatment programs to conduct such screening
once a year as part of the monitoring requirements of their
NPDES permits (p. 47 of preamble).
Technology-Based Local Limits
o Propose to amend §403.8 to require POTWs to obtain legal
authority to develop local limits based on a BPJ
determination of BAT.
Enforcement of Categorical Standards and Program Implementation
o Propose to amend §403.8 to require POTWs with approved
programs to update their IU inventory every 30 months
(pp. 71-73 of the preamble) and update their list of
significant IUs at the same time. Propose to amend
§403.12 to require POTWs to notify significant IUs of
their status as such and the consequences (p. 76 of the
preamble).
o Propose to amend §403.8 to require POTWs with approved
programs to evaluate in writing every 30 months the
need to revise local limits and then revise them if
necessary (pp. 73-74).
o Propose to amend §403.3 to add a new definition of
significant industrial user (pp. 74-76 of the preamble)
o Propose to amend §403.8 to require POTWs with approved
programs to inspect and sample the effluent from at least
50% of significant IUs each year and inspect and sample
each significant IU at least once every 30 months (pp.
74-76 of the preamble).
o Propose to amend §403.8 to require POTWs with approved
programs to develop and implement an enforcement response
plan describing how the POTW will investigate and respond
to IU violations (pp. 77-78 of the preamble).
o Propose to amend §403.8 to establish criteria for
"significant noncompliance" which POTWs with approved
programs must publish in the newspaper (pp. 79-83 of the
preamble).
-------
Appendix A
-3-
o Propose to amend §403.12 to require noncategorical
significant IUs to report to their POTWs at least once
every 24 months information on the concentration and
flow of pollutants being discharged to the POTW. These
reports must be based on monitoring performed at least
every 8 months (pp. 83-85 of the preamble).
o Propose to amend §403.12 to require categorical IUs
to sample their effluent at least once every 60
days and include the results of such sampling in their
twice-yearly compliance reports (pp. 85-86 of the
preamble).
-------
WORKGROUP CLOSURE MEETINGS
Purpose: The workgroup closure meeting is an alternative to Steering Committee review of the
decision package prior to Red Border (Assistant Administrators') review. This closure meeting
provides a forum for confirming that (a) Jhe workgroup has successfully completed its job. resolving
as many issues as possible and clearly defining others, (b) the rulemaking package is ready for AA, RA,
and DA-level review, and (c) Agency and external requirements have been met.
Participants. The Director of the Regulation Management Division (from Office of Regulatory
Management and Evaluation [ORME]), or a representative, chairs the closure meeting. The role of the
ORME chair is to facilitate closure, not to decide substantive issues. Members of the workgroup
participate in the meeting as representatives of their Assistant or Regional Administrators
Participation in the closure meeting normally is a precondition for an office's participation in the Red
Border Review
Operation:
1. The Steering Committee Representative from the lead office requests a closure meeting
through the appropriate Desk Officer in the Regulation Development Branch of ORME.
The lead office must provide a complete draft rulemaking package to workgroup
members at least ten calendar days before the closure meeting This draft package
includes materials that normally are expected to be part of the Steering Committee
review-the rule, action memo, preamble, supporting analysis, information clearance
request (ICR), and other relevant materials. A copy of the memo announcing the
closure meeting must be sent simultaneously to all members of the Steering Committee
2. The typical format for the meeting is: with the ORME chair presiding, the workgroup
chair gives a brief summary of issues resolved and those still outstanding, and
describes any changes since the lead office distributed the draft package to the
workgroup. Other workgroup members offer their respective Assistant or Regional
Administrators' positions (e.g , concurrence, concurrence with comment, concurrence
with conditions, or nonconcurrence). If there is more than one workgroup member
from an office, then they should be sure to coordinate their positions before the closure
meeting. The ORME chair encourages closure by clearly establishing:
a) matters that should be addressed before Red Border,
b) issues (if any) to be presented in Red Border,
c) participation in, and date for beginning, Red Border review
3 Following the closure meeting, ORME will issue a brief summary that certifies a
package for Red Border review or documents other conclusions This closure memo
defines the conditions, timing, and other aspects of Red Border review. The lead office
and affected parties resolve any problems, either before or during Red Border review,
using the Steering Committee as a forum if appropriate
See Also Fact Sheet #3, "The Workgroup*, available from the Regulation Development Branch (382-
5475)
Fact Sheet 7 (Rev. 5/90)
Regulation Management Series
-------
f 4% \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
15SS, ? WASHINGTON, O.C. 20460
%
APR | | 1988 OFFICE OF
POLICY, PLANNING AND EVALUATION
MSPPRAypVH
SUBJECT: Workgroup Closure for the National Primary Drinking
Water Regulation for Arsenic
FROM! Odelia Funke, Acting Director
Information and Regulatory Systems Division
TO: George Ames, Steering Committee Representative
Office of Water
Craig Vogt, Chair
Primary Drinking Water Regulations Workgroup
This memorandum documents the March 31, 1988 workgroup
closure on the proposal for setting an MCLG/MCL for arsenic. OAR
and ORD nonconcurred and OGC concurred, but expressed
reservations about the package as it now exists. OW will work
with these offices to address their concerns before the package
begins Red Border.
Position of Each Office
A. OSWER - Concurred with No Comment.
- OSWER agrees with OW's recommended proposal. They had
not reviewed the package in enough detail to offer editorial
suggestions.
B. OGC - Concurred with Comment.
OGC had two comments regarding the proposed MCLG.
First, based on OW's preamble discussion, OW needs
more data to sufficiently demonstrate that arsenic is
essential to human health before they can promulgate
the MCLG essentiality option. Editorial changes will
not fix this; there is a more fundamental issue here,
one requiring weight-of-evidence.
- Second, there is significant legal vulnerability
associated with promulgating the essentiality option for
setting the MCLG. OW needs a stronger record and rationale
to establish: that arsenic is essential in humans, the
-------
2
essential level (if one exists), the amount of inorganic
arsenic in the diet, and the justification for other
assumptions presented in the rationale.
- OGC further commented on the MCL. Relying solely on
national costs to establish the MCL makes EPA legally
vulnerable, especially regarding the disparity between the
achievable level and the MCL. (This vulnerability is
greater than EPA experienced with the VOC rule).
Furthermore, OW should clearly explain the criteria they
used to determine acceptable costs.
- OGC agreed to supply written and editorial comments in a
few days.
B. ORD - Nonconcurred. ORD has agreement on this position
through to the Office Director level. They promised to
brief the AA and get his position by the middle of the next
week. They will also provide written comments then.
- ORD nonconcurred because option two, the essentiality
option, establishes a daily human nutritional requirement.
This conflicts with the Risk Assessment Forum (RAF) Report,
which states that such a level should not be set until
essentiality is established.
- The data presented for setting the NOAEL is
contradictory. (The Taiwanese study did show effects at the
level OW is proposing as a NOAEL).
- OW should address the risk of internal cancer due to
arsenic intake in this proposal. ORD expects to have data
to support this in about three weeks.
C. OAS = Nonconcurred.
- Presenting an option based on essentiality for arsenic is
inconsistent with the RAF report and has implications for
OAR's arsenic standard. OAR's standard, which is now being
challenged in court, is supported by the RAF Report. OW's
action might shift the burden of proof for OAR (they might
have to prove to the court that the RAF report is right and
that the OW proposal is wrong). OAR believes it is
appropriate for OW to discuss essentiality and ask for
public comments, but it does not merit being put forward as
an option. OAR has suggested language changes.
- OW is inconsistent in the discussion of the
carcinogenicity of arsenic. In one discussion OW asserts
that arsenic is a carcinogen (which is consistent with RAF's
-------
3
classification of arsenic as a class A carcinogen).
However, in another discussion OW questions whether the
Agency's conclusion is valid and requests public comment.
- OAR suggests that OW address and dismiss the commenter's
statement, that residents of Nevada and California knowingly
consume elevated levels of arsenic in their drinking water
(page 59c). This statement is unqualified. Do all
residents know the levels and the implications of drinking
such levels? How are they notified of this? What is the
source of the commenters information? OAR said this is a
minor comment.
- OW should not assert that there is very low risk
associated with low doses of arsenic. This language
(appearing on pages 51b and 59c) implies the existence of a
threshold for cancer effects. This contradicts the RAF
report. The Agency has not agreed that a threshold exists
for arsenic. This language would have ramifications for
OAR's arsenic standard. OAR has suggested revisions.
- The Relative Source Contribution (RSC) section does not
discuss the RSC due to air or food. OAR has suggested
language changes. OW explained that they base the DWELL
100% on drinking water, and do not factor in other types of
exposure.
- OW does not sufficiently explain why they selected the
MCL they selected. The proposed MCL may not be protective
against noncancer health effects, black foots disease, for
example. It is not clear if the proposed MCL protects
sufficiently against cancer effects, since the cancer risk
level is 10~3. It appears that the only rationale for
selecting the proposed MCL is due to costs. The costs do
not consider internal cancers or noncancer health effects.
OAR believes if OW included these things, a different MCL
might be appropriate. OW noted that the draft had an error,
and the risk level should be 10~4, not 10~3.
D. OPPE - Concurred with Comment.
- OPPE is concerned about how essentiality is
characterized. They promised written comments on the new
text by the next Thursday or Friday.
- OPPE wants to work through the essentiality, NOAEL and
residual risk issues with OW before this rule goes final.
OPPE supports proposing the essentiality option.
However, OW should be careful how they characterize it, to
take into account the RAF position and address ORD and OAR
concerns.
-------
4
- The findings of the RfD workgroup are important to
establish the MCL. There should be agreement on how to
characterize residual risk. OPPE supports doing additional
analysis; they commented that it might be appropriate to
develop an alternative MCL option even before proposal.
- OW should make sure that the MCL is protective enough.
The non-fatal cancers and break-even analysis considering
noncancer effects could force the MCL lower.
- OPPE questioned whether OW can propose a regulation that
incorporates a modifying factor that the Agency has not
approved. OW intends to change this factor if the Agency
decides it should do so.
- OPPE noted that the DWELL is relatively new, and that
this proposal has a wider deviation between the MCLG and the
MCL than usual.
E. Risk Assessment Forum.
It is possible that arsenic is essential to human health,
and OW should acknowledge it. However, the weight of
evidence does not support establishing a level: the RAF has
found it is not "proven", but "plausible". The first level
of evidence is not anywhere close to being established.
Therefore, the RAF believes that OW should not set an
essentiality level.
General Requirement?
OW addresses E.O. 12291, Paperwork Reduction Act, and the
Regulatory Flexibility Act in the Phase II package. Arsenic is
part of that package. If the Agency does not resolve the arsenic
issues rapidly enough to "catch up" with Phase II, OW will add
these sections and propose arsenic separately. If this happens,
OW will also consult with OSR to ensure that the new package
complies with Federal Register requirements.
Red Border Review - OW expects to start Red Border by April 22,
1988, with OGC, ORD, OAR, OPPE and Region I participating.
OMB Review - In keeping with current Agency policy, this
package will go to OMB after Red Border is complete.
cc: Closure Meeting Attendees
Steering Committee Representatives
Regional Regulatory Contacts
-------
INFORMATION
COLLECTION
-------
INFORMATION COLLECTION REQUESTS (ICRs)
Purpose: Under the Paperwork Reduction Act (PRA), Agency offices must prepare an ICR to obtain
OMB clearance for any activity that will involve collecting substantially the same information from ten
or more non-Federal respondents. ICRs are submitted for review initially to the Information Policy
Branch (IPB), in OPPE, and then to OMB. - Offices or workgroups may need to prepare ICRs for:
o information requirements to be included in a rule — e.g., reporting, monitoring, or
record-keeping requirements, and/or
o other information collection activities ~ e.g., conducting studies or surveys, sending
out application forms, doing audits, etc
Information requirements in final rules may not be valid and enforceable until OMB clears the
corresponding ICR. In the absence of clearance, enforcement actions taken on the basis of information
so collected may be subject to challenge on grounds of non-compliance with the PRA.
Preparing the Document: An ICR consists of an SF 83 form plus an attached justification
statement. In this justification, the following points serve as the focus for both the IPB/OPPE and OMB
reviews:
o the statement of need for ~ and use of - the information to be collected;
o the plans for managing the information and assunng data quality;
o the calculations of cost to the government and burden on respondents, especially to
make sure that they are consistent with calculations of economic impact in the
rulemaking package; and
o a detailed explanation of any statistical components in surveys, including the sampling
and analysis plans.
Operation: To address information requirements in rules, the first step should be to use the Start
Action Request to indicate that there may be reporting or record-keeping requirements. These
information requirements may involve rulemaking issues of interest to other offices. Such issues
should be discussed in the workgroup, and if unresolved should be included in workgroup reports to the
Steering Committee Once the ICR is ready, the originating office's Information Management
Coordinator submits it to IPB. This should be no later than when the rulemaking package first reaches
formal Agency-wide review (workgroup closure or Red Border review). IPB then reviews the ICR for
information policy issues and responds with any problems within two or three weeks. Any such
problems must be resolved at the latest in conjunction with Red Border review, since IPB must submit
the ICR to OMB on the date that the proposed rule is published. OMB review normally take 60-90 days.
In the case of information requirements in proposed rules, 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, a revised ICR must be submitted.
For other information activities, the ICR should be ready to submit four months before the infomation
collection is scheduled to begin ~ earlier if there may be survey design issues. The program office
should discuss concepts at the workgroup level, and Development Plans should include enough lead time
to allow for preparation, review and clearance of the ICR. Bear in mind that for surveys a pilot or
pretest may be necessary and that - in some cases -- the pilot or pretest may need its own ICR.
See Also: "Instructions for Preparation of Information Collection Requests", available from IPB (382-
7206) or the Information Management Coordinator in your Assistant Administrator's office. For
further discussion of the PRA see 5 CFR Part 1320.
Fact Sheet 6 (Rev. 5/90)
Regulation Management Series
-------
Information Collection Request
Handbook
Information Policy Branch
Office of Policy, Planning & Evaluation
-------
ABOUT THIS HANDBOOK
The Information Policy Branch (IPB) has developed this
handbook to assist the EPA employee who must write an Information
Collection Request (ICR). - The Paperwork Reduction Act (PRA)
requires that EPA prepare ICRs to explain and justify any
activity that involves collecting information from ten or more
non-federal respondents. The PRA also requires that we submit
our ICRs to OMB for approval and that we make them available to
the public for comment.
Under Agency procedures, IPB must evaluate an ICR for
compliance with the PRA before we send it to OMB. Often, IPB
first learns of a proposed collection activity when we receive an
ICR for clearance. Making changes to the information collection
at this stage, after the basic design is in place, is likely to
be difficult and disruptive. To avoid complications and delays,
look to IPB for guidance throughout the ICR development and
approval process—from deciding whether you need to do an ICR to
negotiating the terms of clearance with OMB.
To help you decide if your proposed collection falls under
the PRA, the IPB has written a fact sheet entitled "Information
Collection Requests—Do You Need OMB Clearance?" (see Appendix
A). If you or your supervisor have not read this fact sheet and
discussed your program's collection activities with your IPB Desk
Officer (see Appendix B), stop here and give him or her a call.
You may not need this handbook—at least, not right now.
When you are certain that your collection requires OMB
clearance, use this handbook to guide you, item-by-item, in
preparing the ICR supporting statement. All ICRs must address
each topic in "Part A of the Supporting Statement" (see our
introductory comments on format, p.7). If your collection
involves statistical methodology, typically the case with
surveys, you will also need to use a separate part of the
handbook, entitled "Part B of the Supporting Statement," to help
you put together the documentation that OMB requires for your
survey design. In any event, to complete your ICR submission you
must fill out a "Request for OMB Review" form—the SF-83; we
encourage you to use the electronic "smart" version of this form
that IPB has available to guide you through this part of the ICR.
(Contact your IPB desk officer for more details.)
This handbook will encourage you to think about the
•information policy and management issues raised by your program's
information collection. For example, it will ask you to:
*¦ Develop a plain-English summary of -your ICR and
describe the program context in which it will operate;
-------
2
Focus precisely on how you will use the collected
information—including the decisions it will support;
* Review your information management procedures and
consider the improvements technology may offer; and
> Calculate the burden hours and dollar costs for your
collection.
Doing these things will make it easier for you and others to
evaluate the proposed ICR in the context of your program's other
information collection activities.
IPB designed this handbook to serve as a comprehensive
document, offering guidance on completing ICRs for the entire
spectrum of Agency collection activities. Therefore, as you use
it, bear in mind that it may go into more detail in certain areas
than you need or find helpful. Never let the handbook become an
obstacle to preparing your ICR. If the guidance seems unclear or
inappropriate, give your IPB desk officer a call. Together,
you'll be able to decide on the best way to complete the ICR in
the case at hand.
-------
TABLE OF CONTENTS
This edition of our guidance replaces all earlier versions.
As you scan the table of contents, you may notice that we've
reorganized the subject areas by grouping conceptually related
items. We've also expanded the contents somewhat—in both Parts
A and B—to clarify certain items, elaborate on others, and
inform you of new OMB requirements. Although these changes may
require some reorientation for the veteran ICR writer, we believe
that they will make the ICR more logical, and therefore simpler,
for writer and reviewer alike.
I THINKING ABOUT THE SUPPORTING STATEMENT
INTRODUCTORY MATTERS
> Objectives 5
> Initial vs. Renewal ICRs 5
> Consolidated ICRs 6
> When to Complete Part B 7
> Information-Intensive Rules 7
> Format, Content, and Style 7
> What Happens to Your ICR 8
II PART A OF THE SUPPORTING STATEMENT
1. IDENTIFICATION OF THE INFORMATION COLLECTION
(a) Title and Number of the Information Collection . 9
(b) Short Characterization 9
2. NEED FOR AND USE OF THE COLLECTION
(a) Need/Authority for the Collection 10
(b) Use/Users of the Data 11
3. THE RESPONDENTS AND THE INFORMATION REQUESTED
(a) Respondents/SIC Codes 12
(b) Information Requested
(i) Data items 13
(ii) Respondent activities 13
4. THE INFORMATION COLLECTED—AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT
(a) Agency Activities 14
(b) Collection Methodology and Management 15
(c) Small Entity Flexibility 16
(d) Collection Schedule 17
5. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION
CRITERIA
(a) Nonduplication 17
-------
(b) Consultations 18
(c) Effects of Less Frequent Collection 19
(d) General Guidelines 19
(e) Confidentiality and Sensitive Questions
(i) Confidentiality 20
(ii) Sensitive questions 21
6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION
(a) Estimating Respondent Burden 22
(b) Estimating Respondent Cost 2 6
(c) Estimating Agency Burden and Cost 28
(d) Bottom Line Burden Hours and Costs/Master Tables 29
(i) The simple collection 30
(ii) The Agency tally 31
(iii) The complex collection 32
(iv) Variations in the annual bottom line .... 33
(d) Reasons for Change in Burden 3 3
(e) Burden Statement 34
III PART B OF THE SUPPORTING STATEMENT
1. SURVEY OBJECTIVES, KEY VARIABLES AND OTHER PRELIMINARIES
(a) Survey Objectives 35
(b) Key Variables 36
(c) Statistical Approach 36
(d) Feasibility 37
2. SURVEY DESIGN
(a) Target Population and Coverage 37
(b) Sample Design 38
(i) Sampling frame 3 8
(ii) Sample size 39
(iii) Stratification variables 39
(iv) Sampling method 4 0
(v) Multi-stage sampling 4 0
(c) Precision Requirements
(i) Precision targets 40
(ii) Nonsampling error 41
(d) Questionnaire Design 41
3. PRETESTS AND PILOT TESTS 41
4. COLLECTION METHODS AND FOLLOW-UP 4 2
(a) Collection Methods 42
(b) Survey Response and Follow-up 43
5. Analyzing and Reporting Survey Results
(a) Data Preparation 4 3
(b) Analysis 44
(c) Reporting Results 44
IV APPENDICES
-------
THINKING ABOUT THE SUPPORTING STATEMENT
INTRODUCTORY MATTERS
> OBJECTIVES
Once issued by the Agency, the ICR supporting <+ '
statement is an official document that demonstrates that a
proposed or ongoing information collection activity complies with
the Paperwork Reduction Act (PRA) and with OMB's implementing
regulations.
Satisfying the requirements in both the PRA and OMB's
regulations is a key objective of your ICR. To do so, the
supporting statement must clearly establish each of the following
items: the legal authority for the collection; the need for the
information and the use to which you will put it; the advantages
of the collection method you've selected over alternative
approaches; and the estimated hour burdens and dollar costs of
the collection.
As you prepare your ICR supporting statement, keep in mind
that under the PRA a federal agency should:
¦ request only the information which it needs to
fulfill its program objectives;
¦ impose the minimum burden on respondents;
¦ avoid duplicating data already in the government's
possession; and
¦ demonstrate "practical utility"; that is, explain how
the data—as collected, tabulated, and stored—will
help the Agency meet its objectives in a timely manner.
These standards figure prominently in OMB's review process;
they also promote sound and efficient information management.
> INITIAL VS. RENEWAL ICRs
The supporting statement will be a qualitatively different
document depending on whether you are requesting original
ICR Handbook 2/90
-------
6
clearance or renewing a prior or ongoing collection.1 An initial
ICR tends to be speculative: since the regulated community has
not yet responded to the collection request, the justifications
in an initial ICR are usually based on estimated benefits and
costs, and analogies to similar collections~ In contrast, a
renewal ICR must discuss the differences between original
expectations, as embodied in the initial ICR, and actual
collection experiences and results.
> CONSOLIDATED ICRs
If several collections contribute to the same decision or
program activity, you might find it desirabLe to consolidate them
in one ICR. For example, you might have a program that involves
an application form, a reporting form, and a recordkeeping
requirement; to combine these three activities in one ICR, you
would request joint clearance and address each activity
separately in the supporting statement. Although the SF-83 would
show the combined hours, the supporting statement would have to
provide burden hour and cost estimates for each activity.
When you consider consolidating multiple collections, look
for ones that are logically related. Good candidates might
include groups of collections that: support the same program
office decisions; follow sequentially—e.g., application form and
recurring report or recordkeeping; or affect the same set of
respondents in similar ways, where they are appropriate,
consolidations offer a substantial savings in paperwork and in
administrative chores connected with the ICR clearance process.
They may also provide a more coherent picture of the information
components of an Agency program.
Always consult your IPB desk officer when you're thinking
about consolidating ICRs. He or she can help you assess whether
a consolidated ICR would effectively and accurately reflect the
roles of the collections in achieving an EPA program mission, and
what impact consolidation might have on the clearance process.
1 To avoid a lapse in clearance, you must renew your ICR
prior to its expiration date. IPB circulates a "tickler" memo
that will alert you at least six months in advance of your ICR's
expiration date. As you plan for renewal or any clearance
request, allocate up to four months in your schedule for internal
Agency and OMB reviews. 0MB clears an ICR for a maximum of three
•years at a time.
ICR Handbook 2/90
-------
7
> WHEN TO COMPLETE PART B
While all ICRs must include a Part A, Part B is only
necessary if the collection involves statistical methodology.
Statistical ICRs—usually surveys—gather information from a
"sample" of people, businesses, or institutions in an attempt to
learn something about the entire group, or "population," from
which the sample is drawn.
Many collections do not need to be statistical to meet
program needs. A study that collects data from the entire
population of interest (a census), a case study, or an anecdotal
study focusing on selected members of a population are not
statistical, and therefore would not require a Part B. However,
when you opt for a nonstatistical collection, Part A of the
supporting statement must convince the reviewer that the
nonstatistical approach is appropriate for your decisionmaking
needs.
> INFORMATION-INTENSIVE RULES
For rule-related collections with significant dollar costs,
the supporting statement should be consistent with and, to the
extent possible, cross-reference the descriptions and cost
accounting contained in the Regulatory Impact Analysis (RIA).
This is particularly important where information costs are a
significant fraction of total regulatory or compliance costs.
The analyst preparing the ICR and his counterpart working on the
RIA should have in mind the same program model and cost elements.
> FORMAT, CONTENT, AND STYLE
The sections of this handbook that follow describe each of
the topics that you must address in your ICR supporting
statement, in the order that you must address them. Use these
same topic headings in vour supporting statement. If, after
careful consideration, you see no relationship between a handbook
topic and your collection, then include the topic heading, state
"This section is not applicable," and briefly explain why.
When deciding what amount of detail is appropriate for your
ICR, maintain an approximate correlation between the burdens
you've imposed on the public and your level of justification.
Typically, the reviewer scrutinizes burdensome collections more
closely, and therefore you'll want to bolster your supporting
statement accordingly.
Before you begin to prepare your ICR, read the entire
ICR Handbook 2/90
-------
8
handbook to acquaint yourself with its scope and logical flow. _
If you believe that the handbook is asking you for the same
information in more than one section, include a summary
description first and your detailed analysis in the later
section. As you write, remember to use nontechnical vocabulary
and the active voice.
> WHAT HAPPENS TO YOUR ICR
After you deliver your ICR to IPB, our control officer will
assign it a control number (if it's a new ICR) and log the
package into our computerized tracking system; this event starts
our thirty-day review period. During this time, your IPB desk
officer will analyze the ICR justification statement and any
supporting documentation included with it, raise/resolve issues,
and prepare a comment or clearance memorandum for review by the
IPB branch chief and the Regulatory Management Division (RMD)
director.2
Once the ICR successfully completes IPB/RMD review, our
control officer sends it to OMB. At about the same time, IPB
publishes a notice in the Federal Register (for nonrule-related
packages) that announces both the submission of the ICR to OMB
and the opening of the comment period; a similar notice appears
in the preamble of rules with information collection components.
OMB has sixty-days from the day of receipt to review rule-
related ICRs, and the option to extend its review for an
additional thirty days for nonrule ICRs. Typically, OMB allows
thirty to forty-five days for public comment before reviewing the
ICR. OMB announces its disposition of the ICR in an "action
notice," which is sent to IPB, and that we, in turn, forward to
your Information Management Coordinator (IMC).
To keep you apprised of your ICR's status throughout the
review process, IPB prepares a monthly report on ICRs currently
under review—either at IPB or OMB—that we send to each IMC.
2 The RMD (formerly the Information and Regulatory Systems
Division) director carries out day-to-day PRA responsibilities on
behalf of the Assistant Administrator for OPPE, the Agency's
senior PRA official.
ICR Handbook 2/90
-------
PART A OF THE SUPPORTING STATEMENT
1. IDENTIFICATION OF THE INFORMATION COLLECTION
1(a) TITLE AND NUMBER OF THE INFORMATION COLLECTION
Give the title of the ICR and its four-digit EPA
tracking number. For' new ICRs, your IPB desk officer will assign
this number. If you are renewing an existing ICR, use the
current number.
The ICR's title should clearly identify the collection to an
informed non-expert. If the ICR involves an application, a
report, recordkeeping, monitoring, testing, a survey, or
combination of these, say so in the title. Keep the title brief
(not more than 95 characters), but be as descriptive as possible
and do not simply cite statutes, regulations, or form numbers.
Example: "Toxic Release Inventory Report (SARA Sec.
313(g))" rather than "SARA Sec. 313 Periodic Reporting
Form R"
Example: "National Survey of Pesticides in Drinking
Water Wells" rather than "National Pesticide Survey"
1(b) SHORT CHARACTERIZATION
Provide a short summary of your information collection. This
statement should be no more than one page long, unless the ICR is
especially complex or a consolidation. In it, highlight the major
components of the collection in a way that would be meaningful to
an informed nonexpert. Be sure to address the following:
¦ Type of collection (e.g., permit application, periodic
report, test data, recordkeeping, survey, etc.);
¦ Who's collecting (give the organizational context;
e.g. , the Program Implementation Branch, Permits
Division, Office of Water Enforcement and Permits (OWEP),
Office of Water);
¦ What's being collected (briefly describe the content
of the collection, e.g., data on levels of dioxin in fish
ICR Handbook 2/9 0
-------
10
tissue and bottom sediment from waters receiving pulp and
paper mill effluent);
¦ Why (explain the purpose or regulatory role for the
collection; e.g., the Program Implementation Branch will
use the data in setting permissible dioxin discharge
levels for pulp and paper mills' NPDES permits);
M Who'll use the information (e.g., OWEP, other program
offices, trade associations, environmental groups etc.);
and
¦ How it will be collected/stored (e.g., mills may submit
copies of the specified laboratory analyses, which will
be stored on the NPDES computer database).
Beyond serving as a snapshot of the collection, the short
characterization offers a frame of reference for the detailed
descriptions in later sections of the supporting statement.
2. NEED FOR AND USE OF THE COLLECTION
2(a) NEED/AUTHORITY FOR THE COLLECTION
In this section, fully describe why you need the information
and under what legal authority you will collect it.
While all EPA enabling statutes provide general authority to
collect information (e.g., TSCA §8, CAA §114, CWA §308), some
collections are specifically required bv statute or court order.
For these collections, simply provide the citation and pertinent
text; in so doing, you will demonstrate both need and authority.3
For all other collections, you will have to establish need by
responding to the following two questions:
¦ What Agency decision requires this information?, and
3 On occasion, statutes or court orders will spell out in
detail the collection requirements (see, for example, the
Asbestos Information Act, section 2). If you confine your
collection to the specific requirements of the statute—verbatim
-and exercise no discretion whatsoever in implementing the
collection, you may not have to do an ICR. Contact your desk
officer if you think this exception applies to your proposed
activity.
ICR Handbook 2/90
-------
11
¦ What Agency goal will be aided by the collection?
Then, to establish legal authority, cite the principal
authorities and explain how they relate to your collection.
Below, we've listed the most commonly referenced authorities
and how to cite them.
*¦ The United States Code: USC number. (Use the Public
Law number only if the law is not yet codified.)
*¦ An Executive Order: E.O. number.
~ A codified regulation: principal section of the Code
of Federal Regulations (CFR).
~ A promulgated but not yet codified regulation: title
and date/page it appeared in the Federal Register.
In an appendix to your supporting statement, attach copies of
the relevant sections of statutes, regulations, or judicial/
administrative decrees.
2(b) USE/USERS OF THE DATA
In addition to showing need, the PRA requires you to state
specifically how you will use the information you propose to
collect to meet your program objectives. Although closely linked
conceptually, the PRA treats need and use (or "practical utility")
as distinct elements, and therefore we ask you to address them in
separate sections of your supporting statement.
In this section, continue the narrative you began in 2(a) by
describing how the information you collect will fulfill the needs
of your program office.
¦ First and foremost, discuss the specific role(s) the
information will play in your program's regulatory
decisions. For example, a summary of your discussion
might read: the Office of Toxic Substances uses
production and exposure data on chemical Q in assessing
human health risks and ultimately in deciding whether to
regulate its production.
¦ Then, describe who will use the information (include
those who receive and redistribute it) . For example,
again in summary form: the Chemical Screening Branch
collects production and exposure data on chemical Q for
use by the Exposure Evaluation Division in assessing
health risks.
ICR Handbook 2/90
-------
12
In addition to intra-Agency users, identify anticipated inter-
agency and private-sector users, and explain how they might use
the data.
For a complex report, questionnaire, or other collection
instrument, address the issue of use/users section-by-section.
Do not, however, include an extensive description of the collection
activity; you'll provide that information in section 3.
3. THE RESPONDENTS AND THE INFORMATION REQUESTED
Now that you've described the "why" of your collection—why
the information is important to the Agency—examine the "who"—who
your respondents are—and the "what"—what they must do to supply
the information you request.
3(a) RESPONDENTS/SIC CODES
List the major categories of respondents to your collection,
i.e.: businesses, by industry; governments, by state or locality;
non-profit organizations; and individuals.
Then, for each category provide the appropriate three or
four-digit SIC code (include no more than five).4 In addition,
explain why you have chosen these particular categories of
respondent to be the source of your information—at least where the
reason is not obvious from earlier descriptions of the collection.
Example: The Office of Pesticide Programs will survey
processors of raw agricultural commodities (RACs) in the
following industries—Canned, frozen, and preserved
fruits, vegetables, and food specialties (SIC #203) ;
Grain mill products (#204); Sugar and confectionery
products (#206); Fats and oils (#207) ; and Beverages
(#208)—because the Agency lacks data on RAC waste by-
products from these industries.
You'll find all SIC codes in the Standard Industrial
Classification Manual: 1987, National Technical Information
Service. Order # PB 87-100012. IPB has a copy.
ICR Handbook 2/90
-------
13
3(b) INFORMATION REQUESTED
(i) Data items
List each data item or group of related data items that you
have requested from the public. Divide these into reporting items
and recordkeeping items.
Example: Report on: (1) chemical identifiers, (2)
facility/corporate identifiers, (3) facility activities,
i.e., production volumes, process by-products, on-site
uses, and (4) customers' uses; and maintain records on:
(1) production volumes, (2) process by-products, and (3)
on-site uses.
For lengthy form-related collections (more than three pages),
simply attach a copy of the instrument to the supporting statement.
For rule-related collections, cross-reference the data items
with the specific rule provisions that require them. For renewals,
also indicate any additions, deletions, or changes to the data
items since the last clearance (this accounting will help you to
explain the changes in respondent burden in section 6(e)).
(ii) Respondent Activities
Next, define all of the activities a respondent must engage
in to assemble, "submit," or store the data items you just listed
in the previous section. Select or develop a "representative"
respondent who typifies the group and adequately portrays the
breadth of activities related to the collection. (If the
collection involves diverse entities, you may need to use more than
one model.)
Use the following checklist to develop your list of respondent
activities. Try to categorize all activities under these headings,
but don't hesitate to add subheadings, as appropriate. (You will
use this list to form one axis of your respondent burden/cost
matrix in section 6.)
To complete the collection, consider whether the respondent
would:
~ read a regulatory provision, or read or listen to form
instructions;
*¦ plan activities;
receive training;
ICR Handbook 2/90
-------
14
~ create information, that is: research, analyze or
write documents; run tests; or develop, construct or
modify equipment;
~ gather information, that is: observe, search or inspect
samples or sites (existing data); or question or poll
individuals;
* process, compile, and review information for accuracy
and appropriateness;
~ complete written forms or other paperwork;
*¦ substantiate a claim of confidential business
information;
~ record, disclose, or display the information; or
+ store, file, and maintain the information.
If a particular data item is especially resource-intensive,
you may wish to analyze it separately. If your collection will
last more than a year, consider each task on an annual basis.
Finally, go through your list and mark those activities that
qualify as "customary and usual business practice" with the letters
"CBP"; they are exempt from further burden and cost analysis.5
Following your list, briefly justify each CBP designation.
4. THE INFORMATION COLLECTED—AGENCY ACTIVITIES. COLLECTION
METHODOLOGY. AND INFORMATION MANAGEMENT
4(a) Agency Activities
In accounting for burden and cost, respondent activities only
5 To qualify as "customary and usual business practice,"
(CBP), the paperwork requirement must duplicate an activity
currently carried out by the respondent in the normal course of
doing business—either as a standard operating procedure or to
comply with some legal requirement. For example, requiring
chemical manufacturers to keep production volume records would be
considered CBP, provided that they maintain these records as part
of their normal business activities and would not have to alter
the records or their recordkeeping practices to satisfy the
requirement. (See 5 CFR 1320.7(b)(1))
ICR Handbook 2/90
-------
15
tell half the story, the Agency activities related to the
acquisition, analysis, storage, and distribution of the information
tell the rest.
Use the following list to guide you in assembling your
inventory of Agency activities. (You will use this list to form
one axis of your Agency bilrden/cost matrix in section 6.)
Consider whether the Agency will:
~ develop a rule, report form, questionnaire or other
collection instrument;
~ set up a master database;
~ answer respondent questions;
~ audit or review data submissions;
~ record or enter the submissions;
~ analyze requests for confidentiality and provide
appropriate protection;
~ reformat and distribute the data;
*¦ store the data.
4(b) COLLECTION METHODOLOGY AND MANAGEMENT
To demonstrate that the information you collect will be
useful—accurate, reliable, and retrievable—once collected,
briefly describe each information management technique or
technology—from data quality objectives to electronic report-
ing—that you have selected for the collection. We are
particularly interested in instances where you use technology
to decrease reporting burden or increase collection efficiency.
To begin, if your collection is a survey or is form-related,
state whether you have pretested the collection instrument.6 Then,
6 Pretests often provide valuable feedback on the
effectiveness of your collection instrument, highlighting
imprecise, ambiguous or redundant questions, and indicating where
further inquiry is needed. The pretest may also furnish a
reliable estimate of the time and effort required to complete the
form or questionnaire; this estimate is your best source for
calculating the burden and cost of the collection. Remember: if
conducted with fewer than ten individuals or with your
ICR Handbook 2/90
-------
16
for all collections, answer the following questions, as
appropriate:
¦ How will you check data quality?
¦ What machines and processing technology will you employ?
¦ How will you enter and store the data?
¦ How may the public-access the data?
If, -for example, you considered using a telephone survey
instead of a written questionnaire, or allowing respondents to
report electronically, but chose not to, explain why. Mention any
technical or legal obstacles that you encountered.
Example: We are giving respondents the option of
reporting electronically, using an ANSI X12-compatible
format that we define in guidance materials. We have
acquired software that will perform edit-checks on the
electronic submissions and will automatically upload the
error-free submissions to our database, which resides on
an AT-class PC. We will provide the public with access
to the non-confidential data that is submitted by
creating an electronic report and posting it on public-
access electronic bulletin boards.
To help you explore the technologies available for data
management, we recommend that you contact EPA's Office of Resources
Management (OIRM). OIRM staff keep abreast of the information
technologies employed in and around the Agency, and can help you
meet your data management needs in the most efficient and cost-
effective way. They are also aware of opportunities for (and
barriers to) data sharing across programs.
4(C) SMALL ENTITY FLEXIBILITY
Absent a statutory requirement or other substantial need, OMB
will not approve an ICR unless it demonstrates that the Agency "has
taken all practicable steps to develop separate and simplified
requirements for small businesses and other small entities" (5 CFR
1320.6(h)).
Identify in this section the alternative collection procedures
or other actions (e.g., a reporting exemption) that you will
institute to minimize the burden for small entities. In your
description, define what you mean by "small." If your office has
prepared an RIA or similar economic analysis, provide excerpts from
officemates, the pretest will not require a separate OMB
clearance.
ICR Handbook 2/90
-------
17
it on the information costs for small entities.
Remember, you must consider the option of less burdensome
collection mechanisms even if only a few of your respondents are
small entities.
4(d) COLLECTION SCHEDULE
In this section, provide a schedule for the information
collection. A schedule is especially useful when you propose a
survey, but is helpful for other collections as well. As part of
the schedule, indicate the important collection milestones. List
these events in sequence, beginning with the collection start date,
and, where appropriate, note the estimated due dates.
Give the schedule a program/regulatory context by including
related non-collection milestones (e.g.,the projected rulemaking
date). Remember to note recurring activities (e.g., quarterly
monitoring). If you intend to make the information available to the
public, state when.
In complex multi-step collections, where timing is an
important factor, illuminate the schedule with a timeline or Gant
chart. For simple routine collections, a brief description, like
the one below, should suffice.
Example: This pretest is a one-time collection of
information conducted for the purpose of identifying
problem areas on the Tier I and II forms. We will
distribute pretest materials between May 1 and 15, 1989,
and expect to receive completed forms early in June.
5. NONDUPLICATION. CONSULTATIONS. AND OTHER COLLECTION CRITERIA
The subjects in this part of the guidance ask you to verify
and affirm that your collection satisfies OMB*s collection
guidelines, has public support, and does not duplicate another
collection.
5(a) NONDUPLICATION
OMB will not approve an information collection, unless the
Agency demonstrates that it has taken every reasonable step to
avoid duplication (5 CFR 1320.4).
In this section, document your efforts to learn whether the
ICR Handbook 2/90
-------
18
information that you request is available from other sources.
Include the names of the databases, directories, and other sources
you consulted- When there is the appearance of possible
duplication, explain, in summary, why the collections are
nonduplicative.
Example: We learned from members of the work group that
the Securities and Exchange Commission (SEC) collects
data similar to that requested in jthis ICR. In talking
with SEC staff, we discovered, however, that although the
financial data are the same, the respondents are not.
The SEC only collects data from publicly held
corporations, whereas our respondents will be private
companies.
You might begin your search for data duplication by talking
to your IPB desk officer. The desk officer is familiar with the
ICRs in your program area, and can help you search the following
databases for similar federal collections.
*¦ EPA Information Systems Inventory (available at the
Headquarters Library)
*¦ Paperwork Reduction Act Management System Inventory of
ICRs (available at IPB)
+ EPA Surveys file (IPB)
*¦ EPA Library's on-line services
If you plan to collect chemical-specific information, consider
OPTS's Comprehensive Assessment and Information Rule (CAIR). The
CAIR offers federal data collectors a comprehensive list of
questions that are cleared by OMB (on topics from chemical
properties and production processes to worker exposure), savings
on collection costs, and access to an expanding database. (Contact
IPB's OPTS desk officer for more details.)
5(b) CONSULTATIONS
As a means of planning your collection, monitoring its
usefulness, and learning of ways to minimize burdens, OMB
regulations require periodic consultation with respondents and data
users. You must consult with actual or potential respondents prior
to the initial collection, and, thereafter, in conjunction with the
ICR renewal—even if the collection has not changed.
Give the name, phone number, and affiliation of all non-EPA
persons who you consulted on any aspect of the collection. Also,
describe other public contacts or opportunities provided for public
comment (e.g., public meetings and workshops). Briefly summarize
the reactions of interested parties.
ICR Handbook 2/90
-------
19
When the collection touches on subjects that might interest
other agencies, be sure to solicit their opinions and advice. When
the project involves state or local governments, it is good
practice to consult with the organizations that represent them
(e.g., STAPPA, ASTWMO, and the Council of State Governments).
5(c) EFFECTS OF LESS FREQUENT COLLECTION
For collections with periodic reporting or recordkeeping,
illustrate the effects that collecting the information less
frequently would have on Agency decisions. It is particularly
important to discuss these effects whenever the yearly burden hour
total is significant and whenever vou require quarterly reporting
or recordkeeping (requests for reports more often than quarterly
must be justified in section 5(d)).
For example, if you require quarterly compliance reports,
explain why quarterly reporting is essential for enforcement or
other program decisions; why wouldn't less frequent reporting
suffice?
Example; For self-insurance to be an effective safeguard
against liability from ocean incineration operations, a
firm's assets must remain above a minimum level at all
times. Coast Guard staff administering a self-insurance
program similar to that proposed in this ICR have
cautioned that several regulated firms have experienced
sharp decreases in net assets in periods shorter than
six months. Therefore, reporting less than quarterly
might undermine the efficacy of a self-insurance program.
5(d) GENERAL GUIDELINES
OMB's regulations specify general guidelines to which all
federal data requestors must adhere. If your collection violates
these guidelines, OMB will not approve it, unless you can
demonstrate that the collection activity satisfies either a
statutory requirement or some other substantial need. (See 5 CFR
1320.6)
Thoroughly justify any provision in your ICR under which
respondents would:
¦ Report information to the Agency more often than
quarterly;
¦ Retain records, other than health, medical, or tax
ICR Handbook 2/90
-------
20
records, for more than three years;
¦ Participate in a statistical survey that is not
designed to produce data that can be generalized to the
universe of study;
¦ Prepare a written response to an information collection
in less than 30 days after receipt;
¦ Maintain or provide information in a format other than
that in which it is customarily maintained;
¦ Submit proprietary, trade secret or other confidential
information unless the Agency can demonstrate that it has
instituted procedures to protect confidentiality to the
extent permitted by law (see section 5(e));
¦ Submit more than an original and two copies of any
document;
¦ Receive remuneration (unless they are Agency
contractors or grantees);
¦ Have to submit information in a non-automated format
when automated techniques or other forms of information
technology are available (see section 4(b));
¦ If small entities, have to follow the same collection
procedures as the other respondents (see section 4(c));
¦ If grantees, have to submit or maintain information
beyond that which is required under 0MB Circulars A-102
and A-110.7
5(e) CONFIDENTIALITY AND SENSITIVE QUESTIONS
(i) Confidentiality
Describe the measures you plan to take to assure the
confidentiality of collected information. If you base these
Circular A-102 sets out the policies that the federal
government must follow in managing grants and cooperative
agreements with state, local, and federally recognized Indian
tribal governments. Circular A-110 establishes the policies that
federal agencies must follow in the administration of grants to
institutions of higher education, hospitals, and other nonprofit
organizations. Copies of the circulars are available from IPB.
ICR Handbook 2/90
-------
21
measures on an environmental statute, like the Federal Insecticide,
Fungicide and Rodenticide Act, or on the Agency's confidentiality
regulation (40 CFR 2.201 et seq.), simply cite the relevant
provisions.
If the measures are not based on a standard authority or do
not cover all aspects of the collection, discuss how you'll handle,
store, and dispose of confidential information. Describe, as
appropriate, your measures for:
> assuring computer data security;
preventing disclosure of information containing
personal or organizational identifiers;
»• disposing of completed forms that are outdated;
*¦ storing hardcopy files;
~ monitoring contractor involvement in your collection,
(ii) Sensitive Questions
If you ask any questions concerning sexual behavior or
attitudes, religious beliefs, or other matters usually considered
private, state how you will use the information and what decisions
it will support. Also, explain how you will justify the questions
to the respondents and obtain their consent.
Remember to verify that your collection complies with the
Privacy Act of 1974 and 0MB Circular A-108.8
In December, 1985, 0MB revised Circular A-108,
"Responsibilities for the Maintenance of Records about
Individuals by Federal Agencies," and incorporated it into a new
Circular, A-130, "Management of Federal Information Resources."
ICR Handbook 2/90
-------
22
6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION
In part 6, you must tackle the important, if sometimes
challenging, task of estimating the burden and cost of your
collection. In general, the collection activities you
defined in sections 3 and 4 -should help you develop your
estimates; however, you must ensure that all estimates are
consistent with the Regulatory Impact Analysis (RIA) or other
economic analysis, as applicable.
Your primary objective in part 6 is to produce a set of master
tables or spreadsheets—illustrated by the prototype on the next
page—that offers the reviewer a detailed snapshot of the annual
burden and cost of your collection—both for the respondents and
EPA. For respondent burden/cost, you will need to develop a
separate master table for each respondent type and for each form
in a multi-form ICR, and then aggregate these tables to present the
bottom line burden and cost totals for your collection. For EPA
burdens/costs, however, you will be able to display annual EPA
burden and cost figures in a single master table.
In the material that follows we indicate what you must discuss
in the write-ups for each section of part 6 to explain how you
arrived at the particular estimates for your tables. At the same
time, we guide you—with worksheets and examples—through a
straightforward, multistep process for assembling each master
table, and figuring the bottom line annual burdens and costs of the
collection.
6(a) ESTIMATING RESPONDENT BURDEN
Return to the respondent activities that you listed in section
3, and review your list(s) to verify that you have covered the
entire spectrum of collection-related activities. If you have
developed more than one "representative" respondent type, remember
to review the collection activities for each, keep separate
burden/cost estimates (you'll aggregate them in section 6(d)), and
prepare individual master tables.
ICR Handbook 2/9Q
-------
MASTER TABLE PROTOTYPE
Annual Respondent Burden/Cost Estimates
Collection Activities
Burden
Hours
fDer vear)
Hrs
Cost
1. Read/hear rule or any
collection instrument
(inclu. compliance
determination)
Mgmt.
§ $49
15
Tech.
§ $33
15
Cler.
0 $15
5
35
$ 885
2. Receive training
0
20
10
30
520
3. Plan activities
20
10
5
35
960
4. Create information
5
20
5
30
635
5. Gather information
0
50
10
60
1120
6. Process, compile, and
review information for
accuracy and appropri-
ateness
0
30
20
50
840
7. Complete written forms
or other instruments
0
10
20
30
4,40
8. Record, disclose,
display, or report the
information
0
15
20
35
540
9. Store, file or main-
tain the information
0
5
50
55
700
10. (a) Buy toxic sampler
(b) Equipment cost
(1 year only)
4
40
10
54
1060
15000
11. (a) Maintain sampler
(b) Annual supplies
12. Sample daily (1 yr.)
0
100
10
110
2120
4000
0
200
40
TOTAL:
240
764
4480
$ 33300
ANNUAL BURDEN: Hr. total (764)
X NO.
of Respond.s(25)
= 19,
100 hrs.
ANNUAL COST: Cost total ($33300) x No. of Respond.s(25) = $ 832.500
ICR Handbook 2/90
-------
24
Then, using Worksheet 1 (below) as a guide, reproduce vour
list of collection activities in the left-hand column. Exclude
from your list activities designated "customary and usual business
practice" (see section 3(b)(ii)).
Worksheet 1; Annual•Respondent Burden/Cost Estimates
Collection Activities Burden Hours (per year) Costs
Mgmt. Tech. Cler.
1. Read/hear rule or
any coll. instrument
instructions (inclu.
compliance determina-
tion)9
2. Receive training
3. Plan activities
4. Create information
5. Gather information
6. Process, compile, and
review information
for accuracy and
appropriateness
7. Complete written forms
or other instruments
8. Record, disclose,
display or report the
information
9. Store, file or main-
tain the information
9 To determine whether an information collection applies to
them, many individuals will read a rule or instrument
instructions but will not actually respond to the collection.
Since the burden associated with this activity—known as
"compliance determination"—can be substantial, you must include
it as a subcategory in your estimate for item one.
ICR Handbook 2/90
-------
25
Now, start with item one and estimate the time (burden hours)
that an individual respondent of this type will require for each
activity, and apportion this estimate by labor category.1 For
collections that occur more than once a year, be sure to multiply
your estimates by the appropriate multiplication factor (e.g.,
hours for activities related to filing quarterly reports should be
multiplied times four); this accounting will ensure that your
burden estimates reflect annual totals.
Do not conduct special surveys to estimate burden. If you
plan to pretest a questionnaire or other reporting form, ask
respondents at the time of the pretest for burden information.
Otherwise, base your estimates on informal consultations with nine
or fewer respondents or on your experience with similar
collections. Remember to list all consultations in Section 5(b).
In your write-up for this section, explain how vou derived the
burden estimates. While this description may be brief, it must
include at least the source(s) for your estimates of burden hours
and of reports submitted, and your assumptions.
Example: We based our burden hour estimates on the
results of a pretest of the new chemical inventory
reporting form. We asked nine chemical manufacturers and
processors—ones representative of the respondent
universe—to complete the form, and indicate the job
title of the individual who answered each section, the
time required to do so, and whether the requested
information was readily available. We also asked the
pretest participants to estimate how many times per year
they would add chemicals to the inventory or amend
current listings.
From the pretest, we learned that several questions
that we had assumed would require some testing—and
consequently fall under data creation on our activities
list—were in fact answerable from current records, and
therefore would demand only a clerk's time and not a
technician's. We also discovered, however, that most
companies rely on an attorney to review the form before
signing the certification statement, and so have added
a "legal" labor category.
10 You may add other labor categories (e.g., legal), as
appropriate.
ICR Handbook 2/90
-------
26
6(b) ESTIMATING RESPONDENT COSTS
With burden hour estimates in place, calculating the
collection costs is simple. Return to Worksheet 1. For the first
activity, multiply the hours in each labor category by the
appropriate dollar per hour amount. Then, sum the dollar amounts
for the three labor categories, and record the total in the cost
column on the right. Repeat this procedure for each activity in
Worksheet 1.
Example:
Collection Activities Burden Hours (per year) Costs
Mgmt. Tech. Cler.
e S49 e $33 e sis
1. Read/hear rule or
any collection
instructions 4 4 1
($196) + ($132) + ($15) = $343
Next, add to the dollar totals for burden the other costs
associated with the collection. These costs should appear on your
worksheets (and ultimately on your master tables) both as line-item
subcategories in your list of collection activities and as dollar
amounts in the cost column.
Total costs should include:
~ Labor (for clerical, technical, managerial, and other
employees—as you've calculated on Worksheet 1);
~ Capital (for equipment, machinery, and construction);
and
~ Operating and Maintenance (O&M) (for labor and
equipment needed over time).
Example:
Collection Activities
1. Read/hear rule or
any collection
instructions
Burden Hours (per year)
Mgmt Tech Cler
0 $49 3 $33 P $15
Costs
1 $ 343
ICR Handbook 2/90
-------
27
9.(a) Buy toxic sampler
(b) Equipment cost
(year 1 only)
4
40
10
15,000
1, 666
10.(a) Maintain sampler
(b) Annual supplies
100
10
3,450
4,000
11. Sample daily (1 yr)
200
40
7, 200
If the activity is new or a modification of an existing
collection, include the start-up or developmental costs. You may
choose to average these costs over the anticipated life of the
collection. For ongoing activities, omit capital costs previously
incurred. When calculating costs generally, consider inflation and
depreciation rates; for equipment costs, indicate whether the costs
are net or include depreciation. Again, maintain consistency with
the RIA or other collection-related economic analysis.
In your write-up for this section, briefly explain how vou
derived your cost estimates; specify the source for your labor
rates and all accounting assumptions.11
Example: Since our regulation and associated collection
will have a minor economic impact on respondents, it was
not the subject of a regulatory impact analysis. For
labor rates and associated costs, we relied on the
Comprehensive Assessment and Information Rule (CAIR)
economic analysis, which measured costs to the same
industry affected by our collection, and estimated hourly
labor rates as follows: management @ $49; technical §
$33; clerical @ $15. To the CAIR economic data, we added
an inflation factor (3% per year), so that our estimates
would reflect current costs.
11 Labor rates should be consistent with the RIA or some
other economic reference; if none is available, contact your IPB
desk officer. Rates should generally reflect a graded scale in
which an hour of management time is more costly than an hour of
technical time, and an hour of technical time is, in turn, more
costly than an hour of clerical time. Rates should also include
the cost of overhead and benefits, as appropriate.
ICR Handbook 2/90
-------
28
6(C) ESTIMATING AGENCY BURDEN AND COST
Return to the agency activities that you listed in section 4,
and review your list to confirm that you have captured all
collection-related activities. (Note: you will only need to
prepare one master table for the agency, regardless of the number
of respondent types or forms associated with the collection.)
Then, using Worksheet 2-(below) asa guide, indicate the hours
of agency work needed for each activity, and apportion this
estimate by labor category, if you can, or simply provide the
composite hours. Be sure to multiply your estimates by an
appropriate multiplication factor for each activity that happens
more than once a year.
Worksheet 2: Annual Agency Burden/Cost Estimates
Collection Activities Burden Hours (per vearl Costs
Mgmt. Tech. Cler.
1. Develop rule,
questionnaire, or
other collection
instrument
2. Develop a master
database
3. Answer respondent
questions
4. Audit/review data
submissions
5. Record/enter the
submissions
6. Analyze requests for
confidentiality and
provide appropriate
protection
7. Reformat and
distribute the data
8. Store the data
ICR Handbook 2/90
-------
29
To estimate agency costs, repeat the procedure presented ih
section 6(b) for estimating respondent costs: burden hours per
activity x labor rate(s), figuring in capital and operating
costs, as appropriate. When compiling agency costs, remember to
include contractor hours.
In your write-up for this section, briefly explain how vou
derived vour burden and cost estimates.
Example: We based our burden estimates on our prior
experience in developing, gathering information for, and
setting up a chemical inventory data base. Because the
current project/collection represents a more comprehen-
sive effort than our last and because costs have risen
over time, we have revised our estimates accordingly.
Since the activities for the collection usually involved
teamwork, with a mix of workers at various GS levels, we
used composite burden hours and calculated hourly costs
at the GS-12 level ($27.60). However, we did hire a
contractor to modify our computer system and to input the
new data, which accounts for the labor category breakdown
and relatively higher costs for line items 2 and 5 on our
activities list.
6(d) BOTTOM LINE BURDEN HOURS AND COSTS / MASTER TABLES
If you have carefully followed the instructions and completed
the worksheets leading up to this section, calculating the bottom
line burden hours and costs for your collection becomes a simple
math exercise—and displaying the master tables just a matter of
transposing numbers.
For clarity, we have distinguished the simple collection—
with just one respondent type or reporting form—from the more
complex—with multiple respondent types or forms. Deriving the
bottom line for the complex collection will require that you apply
the procedures described for the simple collection to each form or
respondent type plus one extra step: aggregating the burden hour
and cost totals from all master tables; for this purpose, we
provide a prototype aggregation table.
12 The current hourly rate for a GS-12—the median grade for
both an environmental protection specialist and program analyst—
is $27.60 (including benefits). To calculate the hourly rate for
any GS level, multiply the annual pay rate for a particular GS
level (step 1) times 1.16 (the benefits multiplication factor),
and divide by 2080 (the number of work hours per year).
ICR Handbook 2/90
-------
30
(i) The simple collection
For the simple collection, you will need just two master
tables—one for the respondents and one for EPA.
To calculate the bottom line respondent burden hours and
costs, return to Worksheet 1, and derive the burden hour total for
an individual respondent by adding down the column in each labor
category and then adding across.
Example:
Collection Activities Burden Hours (per vearl Total
Mgmt. Tech. Cler.
1. Read/hear rule or
any collection
instructions 4 4 1
9. Buy Toxic Sampler
Equipment Cost
(Year 1 Only)
10. Maintain Sampler
Annual Supplies
11. Sample daily (1 yr)
8 + 344 + 61 413 hrs.
Then, multiply the individual burden hour total times the
estimated number of respondents per year to obtain the total annual
burden for all respondents.
Example:
ANNUAL BURDEN: Hr. total (413) x No. of Respond.s (25) = 10.3 2 5hrs.
To derive the total collection costs for an individual
respondent. simply add down the cost column on Worksheet 1.
4 40 10
100 10
200 40
ICR Handbook 2/90
-------
31
Example:
Collection Activities Burden Hours Costs
Mgmt. Tech. Cler.
e $49 e $33 e S15
I. Read/hear rule or
any collection
instructions $ 343
• • «
9. Buy Toxic Sampler 1,666
Equipment Cost
(Year 1 Only) 15,000
10. Maintain Sampler 3,450
Annual Supplies 4,000
II. Sample daily (1 yr) 7,200
$31, 659
Then, multiply the individual total cost by the number of
respondents per year to obtain the total annual costs for all
respondents.
Example:
ANNUAL COST: Cost total ($31659) x No. of Respond, s (25) = S791,475
Now you have the bottom line burden and cost estimates for
respondents and all the information you need for your master table.
Display vour respondent master table here.
(ii) The Agency tally
To derive the annual burden for Agency activities. go to
Worksheet 2 and repeat the steps you used to tally the burden hours
for an individual respondent. If you used composite hours, just-
tally the one burden hour column. To derive annual Agency costs,
simply sum the cost column on Worksheet 2.
Now you have the bottom line burden and cost estimates for
ICR Handbook 2/90
-------
32
EPA, and all the information you need for your master table.
Display vour Aaencv master table here.
(iii) The complex collection
For the complex collection, you will need multiple master
tables—one for each respondent type or reporting form, and one for
EPA (see subsec.(d)(ii)). To derive the bottom line annual burden
hours and costs, you must aggregate the totals from each master
table.
Using the procedures and examples for the simple collection
(subsec.(d)(i)), calculate the annual burden for an individual
respondent/form of each type, and then multiply the individual
burden hours times the estimated number of respondents (of this
type or for this form) per year to obtain the annual burden total
for each respondent type/form. Use a similar procedure—also set
out in subsec.(d)(i)—to calculate annual respondent costs for each
respondent type/form.
Now you have the annual burden and cost totals for all
respondent types and reporting forms, and all the information you
need for your master tables. Display all master tables here.
With completed master tables in hand, simply fill in the
aggregation table (prototype below) to derive the bottom line
annual respondent burdens and costs for the entire collection.
AGGREGATION TABLE PROTOTYPE
Total
Burden Hours
Total
Costs
Respondent Master Table # 1
19,100
$832,500
Respondent Master Table # 2
7,325
245,790
Respondent Master Table # 3
3,260
128,440
Bottom line
29,685 hrs. $1,206,730
ICR Handbook 2/90
-------
33
(iv) Variations in the annual bottom line
If you can anticipate significant variation (>25%) in the
annual respondent reporting/recordkeeping burden or cost over the
course of the clearance period you have requested, include a
separate master table for each variant year that illustrates the
changes in collection activities. (Be sure to label the table with
the appropriate year.) If the collection is complex, provide a
supplemental aggregation table that shows the bottom line burden
hours and costs for that year. If government burdens and costs
also vary significantly, display a separate master table that
reflects the changes.
During the term of approval, EPA will use the information from
these supplemental tables to inform OMB of the changes in your
collection and to maintain accurate records of your collection
activities.
6(d) REASONS FOR CHANGE IN BURDEN
If you are renewing or modifying an existing ICR, you must
indicate and explain any change in the respondent burden since the
last clearance.
Review your list of data items in section 3(b) and note, in
this section, the changes that you indicated to have taken place
since the last clearance. Using your activities lists and burden
tables from this and the previous ICR, calculate the burden hour
increase or decrease attributable to these changes. Remember to
review the burden tables to identify changes in the number of
respondents or in the frequency of response.
Label each change either "program change" or "adjustment"; a
program change results from deliberate agency action and an
adjustment. conversely, stems from actions outside the agency's
control.13
Use this section to highlight changes in the collection—
touting program changes that lead to burden decreases and carefully
explaining any program change increases.
13 Examples of a "program change": adding, dropping, or
changing questions; expanding the use of a form to include more
respondents; changing the frequency of collection; or, changing
the eligibility requirements in a way that affects the number of
applicants. Examples of an "adjustment": changes in the number
of firms in an affected industry or in the size of the respondent
population; or, corrections of clerical or computational errors.
ICR Handbook 2/90
-------
34
Example: Since our last clearance, we decided to revise
and update the chemical inventory data base. In
preparation, we reviewed our chemical inventory reporting
form and discovered that several of the data fields were
no longer useful; we have deleted them from the new form,
for a burden savings of X hours (program change). We
have also added a "de minimis" reporting exemption, which
means that .approximately 10% of -chemical manufacturers
and processors will no longer have to report, for an
additional burden savings of Y hours (program change).
Nevertheless, because the industry has grown, we expect
the total number of respondents to go up, and the burden
for the collection to increase on this account by Z hours
(adjustment).
6(e) BURDEN STATEMENT
In an attempt to increase public participation in the
paperwork clearance process—as mandated by the 1986 amendments to
the PRA, 0MB's regulations now require that all forms and
information collection-related Federal Register notices include a
burden statement (commonly known as the "burden box"). This
statement must provide an estimate of the average burden per
response and request comment on that estimate; a boilerplate
version follows.
Example: Public reporting burden for this collection of
information is estimated to average hours (or
minutes) per response, including the time for reviewing
instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and
reviewing the collection of information. Send comments
regarding this burden estimate or any other aspect of
this collection of information, including suggestions for
reducing the burden, to Chief, Information Policy Branch,
PM-223, U.S. Environmental Protection Agency, 401 M St.,
S.W., Washington, D.C. 20460; and to Paperwork Reduction
Project (OMB # 20xx-xxxx), Office of Information and
Regulatory Affairs, Office of Management and Budget,
Washington, D.C. 20503.
In this section, include a burden statement tailored to vour
collection, with an hour estimate expressed as a straight average,
as in the example, or as a range. Provide individual estimates for
each respondent type or collection requirement (e.g. , for each form
in a multi-form collection), and include in the burden description
only those activities that accurately reflect your collection.
ICR Handbook 2/9 0
-------
PART B OF THE SUPPORTING STATEMENT
Complete Part B only after you have decided that a
statistical survey is the best approach for satisfying your >*
program's information needs. If you have not considered the [\>1
various collection alternatives, contact your IPB desk LjU
officer, he or she, together with an OPPE statistician, can
help you to explore the full range of collection devices,
weigh their relative merits, and choose an approach that is most
likely to meet your collection objectives.
For additional advice on matching information needs with
collection methods, we recommend that you consult EPA's two-volume
Survey Management Handbook (hereinafter, Survey Handbook) (EPA-
230/12-84-002, Nov. 1983). These volumes, written for the
nonstatistician, discuss in detail survey design and management,
and can help you both to prepare the ICR and to plan and implement
the survey itself. The Survey Handbook is, however, only a
supplemental aid: do not attempt to design a statistical survey on
your own; instead, consult a statistician whose expertise is survey
design. If you have trouble locating or selecting a survey
specialist, IPB can help.
In Part A, you explained—from an information management
perspective—what Agency need your request would fill, what
specific information you would collect, how you would collect,
store, and disseminate it, and the burdens and costs associated
with these activities. In Part B, you must explain—from a
statistical viewpoint—your survey objectives, design, and
methodology, in a way that convinces the reviewer: first, that the
proposed collection is the most efficient and practical way to
achieve your survey objectives; and second, that the survey results
will be complete, reliable, and applicable to the universe of
study.
1. Survey Objectives. Key Variables and Other Preliminaries
1(a) Survey Objectives
Thoughtfully crafted survey objectives serve a dual function:
they acts as guideposts as you explain the survey design and
methodology in the rest of Part B, and they help make the case to
the reviewer that the survey is justified.
ICR Handbook 2/90
-------
36
State the survey objectives in the form of issues or questions
for resolution.
Example:
Issue #1. Whether -new oil refineries equipped with
advanced pollution control devices can meet EPA standards
for S02 and particulate -emissions.
Issue #2. Whether existing refineries that are
retrofitted with advanced pollution control equipment
can meet EPA's S02 and particulate standards.
If you prefer, you may phrase the issues as goals, e.g., "To
investigate which pollution control devices meet . . . ." Make
the statements as descriptive as possible. For the sample issues
above, you might specify the process points at which emissions
occur and the control devices used to limit them. In addition,
keep your issues narrowly focused. It is much better, and clearer,
to list out issues individually than to lump them together in one
statement.
1(b) Key Variables
Identify and describe the key variables on which the survey
results will turn. A key variable is a characteristic of the
entities you are investigating, e.g., a facility or a process, that
may vary from one individual to another.
Example; Working from the sample issues above, possible
variables include: type of oil refining process;
production volumes; type of pollution control device;
amount of unused capacity in existing control devices;
sources of emissions; mix of toxic and conventional
pollutants; and plant age.
Then, give the reviewer a sense for how the variables might
influence the survey results. For instance, you might discuss what
performance level is generally considered peak efficiency for
different types of control equipment.
1(c) Statistical Approach
Briefly explain why you selected a statistical—rather than,
for example, an anecdotal or census—approach for the collection.
In your discussion, confirm that the anticipated survey results
will satisfy the survey objectives and your program's information
needs.
ICR Handbook 2/9 0
-------
37
Also, if you plan to use a contractor for any aspect of the
survey, state the name and address of the firm, and indicate on
which component(s) (i.e., design, tabulation, etc.) the contractor
will provide support.
1(d) Feasibility
The best laid objectives cannot ensure the success of your
survey if you have failed to plan the administrative components
with equal care. As a check on your administrative planning and
to demonstrate the thoroughness of your survey preparations, answer
the following questions:
¦ What obstacles might the respondent face in completing
the survey? For example, might the respondent have
trouble accessing data? Is the data in the form you have
requested? What steps have you taken to facilitate
response?
¦ Are sufficient funds available to complete the survey
as designed? If not, how will you secure additional
funding? What survey design changes might you need to
make in the absence of funds? How might these changes
affect the survey results?
¦ Will the survey results be ready in time to serve your
program's decision-making needs? Without reproducing the
schedule you furnished in Part A, confirm that the survey
results will be available for timely use in program
office decisions.
2. Survey Design
In this section, you must describe in detail the mechanics of
your survey design—from how you have selected the respondent pool
to what type of questions you will ask in the survey instrument.
2(a) Target Population and Coverage
The "target population" is comprised of all the individuals,
businesses, facilities, manufacturing processes, or other "units"
that you wish to study. "Coverage" refers to the subset of the
target population on which the survey will focus.
Describe your target population and coverage group, and how
ICR Handbook 2/90
-------
38
they relate to your information needs—if this relationship is not
obvious from your discussion of need in Part A.
Example: To respond to a Congressional inquiry on the
health threat posed to elderly citizens living in cities
with high benzene concentrations, we have targeted
individuals 65 and over as the population of interest and
will focus our survey coverage on members of this group
that live in cities whose benzene concentrations exceed
EPA standards.
Example: To assess the feasibility of instituting large-
scale recycling as a regulatory alternative to land
disposal, we have selected municipalities with active
recycling plants and programs as our target population,
from which our survey will cover only those
municipalities with 100,000 or more inhabitants.
If you omitted from your coverage a subset of the target
population that would seem logically to belong, explain why you
excluded that group.
2(b) Sample Design
Sample design is the multi-step process used to select the
individual "units," or respondents, for a survey from among the
covered population. Designing the sample typically involves
selection of the following: a sampling frame, an appropriate
sample size, stratification variables, and the procedure for
selecting the sample from the frame. (A sampling expert should
assist the survey specialist in designing the sample.)
(i) Sampling frame
The sampling frame is the set of potential respondents from
which the sample will be drawn. It is often simply a composite of
lists—from trade associations, commercial listing services, and
in-house databases—that should include all units, without
duplication, from the population of interest.
Attach a description of the sampling frame as an appendix to
Part B, and in this section discuss: how you assembled the
sampling frame; the potential legal or regulatory obstacles (e.g.,
confidentiality) to using the frame; and whether the frame is
current, complete, and nonduplicative.
Example: We obtained the sampling frame for our asbestos
removal survey from New Jersey's database of "Demolition/
renovation contractors certified to remove asbestos."
ICR Handbook 2/90
-------
39
The database, maintained by the state's Department of
Natural Resources, is in the public domain and updated
annually.
(ii) Sample size
The sample size is the actual number of units to be included
in the survey. Sample size directly affects the level of survey
precision. (For a complete discussion on the relationship between
sample size and precision, consult the Survey Handbook, Vol. II).
In this section, state the proposed sample size and then
briefly discuss how it was selected. Provide a sense of the
tradeoffs made between precision and other concerns, like cost.
(iii) Stratification variables
Stratification is the method used to segment a population
into homogeneous groups. The ultimate goal of stratification is
to reduce the sampling error or, looked at another way, to increase
the precision of estimates derived from sample data.1
If applicable, describe the stratification variables: how
they were selected, and how they will improve the survey estimates.
Example: One hundred and fifty chemical companies
produce chemical Q. Of these, the ten largest produce
75% of the national output (in both weight and sales).
Therefore, we will create at least two strata—the ten
largest producers in one and all other firms in one or
two other strata—and select separate samples from each.
We will survey each of the ten largest companies. As a
result of stratification, our estimates of the
characteristics of interest for chemical Q will have
greater precision.
Stratification creates, in effect, a separate sample from
each stratum of the covered population. Statisticians use each
sample to estimate the population characteristic for the stratum,
and then combine all the estimates to obtain the overall
population characteristic. Use of a stratified sample permits
the survey designer to include the larger units in proportion to
their contribution to, say, the total emissions for an industry,
and hence to increase the precision of the population estimates.
Stratification is frequently based on either size or output.
ICR Handbook 2/90
-------
40
(iv) Sampling method
The sampling method is the set of rules or procedures for
selecting the individuals, or "sample," for the survey from the
population of interest, or "sampling frame." In this section,
state the sampling method chosen for the survey and then discuss
how you will use it to select your sample.
Since the goal of most survey designers is to generalize the
sample findings to the population of interest, they recommend
random, or probability, sampling. If you've selected a nonrandom
method, you must convince the reviewer that it will yield results
that are representative of the population sampled and will meet
the objectives of your survey.
(v) Multi-stage sampling
Multi-stage sampling is a method for selecting the sample of
respondents that employs more than one sample frame and sampling
procedure. For instance, if the survey objective is to assess
emissions from an industrial process, several stages of sample
selection might be involved—e.g., stage one sampling frame: a
listing of all facilities with the process of interest; stage two:
a listing of all individual processes within a sampled facility;
etc.
If your survey involves multi-stage sampling, describe the
sample design at each sampling stage; include sample size,
stratification variables, and sampling method.
2(c) Precision Requirements
(i) Precision targets
By precision, we mean the measure of how closely estimates
made from the sample data approximate the characteristics of the
population of interest.15 In this subsection, indicate the target
level of precision for at least one of the principal key variables,
and confirm that this degree of precision will satisfy your
decision-making needs. (For a discussion of precision, see the
Survey Handbook, Vol.1, chap.3.)
Statisticians often express the target "level of
precision" as a confidence interval estimate of one of the key
variables. Your survey could be designed so that you would be 90
percent confident that your estimate—of say, the proportion of
sites contaminated with PCBs—is within five percentage points of
the "true" value of this unknown characteristic.
ICR Handbook 2/90
-------
41
(ii) Nonsampling error16
Certain nonsampling errors—those that are not random—lower
the accuracy of sample estimates and directly affect survey
precision. Of particular concern are biases, i.e., nonsampling
errors that affect the entire sample. An example of bias would be
a faulty measurement procedure that consistently underestimates
the level of a pollutant. A particularly serious form of bias
results from nonresponse. because the potential exists that those
who do not respond are different—in the worst case, all similarly
different—from those who do.
In this section, discuss the potential sources of nonsampling
error, the steps you will take to minimize its impact on sample
estimates, and what affect you think it may have on the value of
the survey as a decision-making tool.
2(d) Questionnaire Design
Now that you have described how you will select a sample and
what level of precision you anticipate, only one design component
of your survey remains: the instrument itself. Straightforward,
unambiguous questions—logically arranged—avoid biases and are
the hallmarks of a well-designed questionnaire.
In this section, justify each question or group of related
questions by linking it to a specific survey objective. The
supporting statement is not complete without this analysis; if
you have already done it in Part A, simply note here in which
section.
Then, explain why you selected a particular style of question,
e.g., multiple choice versus fill-in-the-blanks, or open-ended
versus pre-coded responses. Also, describe the steps you have
taken to ensure the reliability and usefulness of the design.
Be sure to append a copy of the questionnaire to Part B.
3. Pretests and Pilot Tests
We recommend that you always pretest the survey instrument.
Nonsampling error is a general term used to refer to all
survey errors other than those derived from using a sample to
estimate population characteristics.
ICR Handbook 2/90
-------
42
A pretest often reveals problems in the questionnaire design, e.g.,
poorly phrased, misleading or missing questions. If defects of
this type are not detected and corrected, they might lead to
serious bias in the survey results.
While a questionnaire pretest is always advisable, you need
only pilot test major surveys. The pilot test replicates the
entire survey—on a smaller scale—and consequently enables you to
test all phases of the survey, from sampling to data tabulation.
In this section, indicate when you pre- or pilot tested the
survey, or when you plan to do so. If you've completed the pretest
or pilot test, outline the significant findings and the changes you
have made to the survey questionnaire/methodology based on those
findings.
If you are planning a test, briefly describe the sample
selection procedures and size, and the timing for the collection.
Example: To pilot test the chemical reformulator survey,
we selected nine companies based on the following
criteria: number of chemicals on-site; number of
employees; TSCA compliance history; and geographic
location. These characteristics correspond to the
anticipated variation among survey respondents. If the
pilot takes place as scheduled, we will have time to
incorporate test results into the design before the
survey start date.
Note: Pretests or pilot tests involving more than nine
respondents require separate 0M5 clearance.
4. Collection Methods and Follow-Up
The collection method you select—in combination with your
nonresponse follow-up—directly influences the survey response
rate. Survey response, in turn, affects the precision of sample
estimates and ultimately the quality of survey results.
4(a) Collection Methods
Many factors typically play in the selection of a collection
method, among them: the characteristics of the survey sample; the
target response rate; the respondent's obligation to reply; the
program's data requirements; and the availability of funding. In
addition, major surveys may require a combination of collection
methods, e.g., a mail survey as the primary device and follow-up
ICR Handbook 2/90
-------
43
telephone calls to obtain additional data on selected variables..
In this section, state which collection method(s) you have
selected and why. If you have chosen an interview method, briefly
describe the interviewer training program afid any special
qualifications the interviewers must have.
Example; To accurately detect inconsistencies in survey
responses, interviewers must have a working knowledge of
both general chemistry and the Toxic Release Inventory
(TRI) form. A bachelor's degree in chemical engineering
is a prerequisite for selection. Interviewers will
receive intensive training on the TRI forms and related
reporting requirements.
4(b) Survey Response and Follow-up
State the target response rate and describe how you will
measure and evaluate the actual response rate. If you plan an
interview survey, briefly discuss the methods you will use to
record survey data.
Then, describe your follow-up plan for gathering missing
survey data, or simply include the follow-up schedule.
Note: To increase the response rate, we recommend that you offer
potential respondents a summary of the survey results.
5. Analyzing and Reporting Survey Results
5(a) Data Preparation
Before any analysis can begin, the data must be transferred
from the questionnaire to a machine readable format and edited.
Briefly describe your proposed data entry procedures and quality
control measures. State whether you will use in-house or
contractor resources to process the data.
Example; An in-house computer edit program will verify
that data submitted on fugitive emissions is internally
consistent, as keyed. The program will also flag missing
data items and other inconsistencies, as well as items
with potential keystroke errors.
Also, describe the procedures you will use for estimating
missing data items.
ICR Handbook 2/90
-------
44
5(b) Analysis
For survey purposes, "analysis" means categorizing, ordering,
manipulating, and summarizing raw data, with the goal of answering
research questions and satisfying survey objectives.
In this section, describe the statistical procedures that you
will use to analyze the data, and how you will display the survey
results.
¦ If you plan to use table shells, provide samples here.
(See the Survey Handbook, Vol.1, chap.5.)
¦ If you are going to perform regression analyses, state
what the dependent and independent variables will be, and
the form of the regression equation. (Consult your
statistician.)
5(c) Reporting Results
Outline your plans for making the survey results and summary
reports available to government personnel and the public.
Example; Agency personnel will not have direct access
to the CAIR database. Instead, with confidential
business information clearance, an individual will be
able to request information from the OTS staff member
designated as database manager. The database manager
will produce a tailored numerical report in response to
the inquiry.
Finally, indicate what documentation you will make available
to explain the workings of the database.
ICR Handbook 2/90
-------
Appendix A
INFORMATION COLLECTION REQUESTS; DO YOU NEED OMB CLEARANCE?
Under the Paperwork Reduction Act (PRA), you must prepare an
Information Collection Request (ICR) package to obtain OMB
clearance for any activity' that will involve collecting
substantially the same information items from ten or more non-
Federal respondents in a given year. (However, see the
discussion of exemptions at the bottom of this page.)
So, you might need to prepare ICRs for:
information requirements in a proposed rule, e.g. ,
reporting, monitoring, recordkeeping;
~ other information collection activities, e.g.,
studies or surveys, application forms, audits, and
similar standardized data collection activities.
OMB's regulations apply to anv "collection of information"
as broadly defined in 5 CFR 1320.7. The definition includes:
~ written report forms, application forms, schedules,
questionnaires, or reporting or recordkeeping
requirements;
~ other vehicles for collecting information, such as
rules or regulations, policy statements, information
requests, bulletins, instructions, contracts, planning
requirements, circulars, requests for proposal or other
procurements, oral communications, labeling require-
ments, and telecommunication requests;
~ questions posed to agencies, instrumentalities, or
employees of the United States, if the results are to
be used for general statistical purposes.
Your collection is exempt from OMB review under the
following circumstances:
¦ When you request information from fewer than ten persons
in a given year, except that:
(a) a collection requirement contained in a rule of
"general applicability" is presumed to involve ten or
more persons. OMB defines general applicability as the
potential to affect ten or more persons; consequently,
collection components in very few rules will fall under
-------
2
the less than ten exemption.
(b) a collection addressed to "all or a substantial
majority" of an industry is not exempt.
¦ When undertaken as part of: a criminal investigation/
prosecution; a civil action to which the government is a party;
or an administrative action/investigation of specific persons or
entities, but only after a "case file," or its equivalent, is
opened. (See §1320.3(c).)
¦ When it falls under one of the exceptions to the
definition of "information" contained in §1320.7(j), for example:
~ facts or opinions submitted in response to general
solicitations of comments from the public, published in
the Federal Register or other publications;
+ examinations designed to test the aptitude,
abilities, or knowledge of the persons tested and the
collection of information for identification or
classification in connection with such examinations; or
* facts or opinions obtained through nonstandardized
follow-up questions designed to clarify responses to
approved collections of information.
If vou are still not sure whether vou need OMB clearance,
contact your desk officer in the Information Policy Branch.
Appendix B to this Handbook contains a complete list of desk
officers and their areas of responsibility.
-------
Appendix B
INFORMATION POLICY BRANCH DESK OFFICERS
The desk officers in the Information Policy .Branch (IPB) are
responsible for day-to-day implementation of the Paperwork
Reduction Act (PRA) at EPA. As their primary duty, the desk
officers review all Information Collection Requests (ICRs) to
ensure that they comport with the requirements of the PRA and
OMB's implementing regulations, and with good information
resources practices in general. In addition, the desk officers
compile the annual Information Collection Budget and perform
special reviews of Agency information collection activities.
The desk officers—generally assigned to specific media
areas—and the rest of the IPB team will be happy to answer any
questions you may have about preparing your ICR or about the ICR
clearance process.
Branch Chief
David Schwarz (382-2706)
Desk Officers
Rick Westlund (382-2745)
Solid Waste; Waste Enforcement; Underground Storage Tanks
Carl Koch (382-2739)
Superfund; Community Right to Know; Chemical Emergency
Preparedness; Pollution Prevention
David Di Fiore (382-2744)
Pesticides & Toxics; Legal Issues
Harold Hodges (382-2468)
Pesticides & Toxics
Carla Levesque (475-9498)
Air & Radiation
Harold Woodley (382-2738)
Water; Drinking Water
Wanda Haxton (382-2709)
Administration; Research & Development; Regions
* * *
Jim Daley (382-2743)
Statistician
Sandy Farmer (382-2740)
ICR Control Officer
-------
REGULATORY
FLEXIBILITY
-------
THE REGULATORY FLEXIBILITY ACT
Purpose: The purpose of the Regulatory Flexibility Act of 1980 is to reduce the burden of Federal
regulations on small entities -- that is, small businesses, government jurisdictions, and private
organizations. The Act applies to all rules subject to the notice and comment procedures of the
Administrative Procedures Act (except grant regulations). It requires agencies to consider adverse
economic effects their regulations will have on small entities. For regulations that will have a
"significant impact on a substantial number' of small entities, agencies must consider alternative
measures by preparing a Regulatory Flexibility Analysis (RFA). Agencies are encouraged to consider
establishing exemptions or tiering their regulations, when consistent with their statutory and program
objectives.
Participants: The lead office is responsible for preparing the RFA or certifying that there are no
significant impacts on small entities. The Regulation Development Branch (RDB) in the Office of
Regulatory Management and Evaluation (ORME) oversees EPA's compliance with the Act. EPA's Small
Business Ombudsman (in the Office of Small and Disadvantaged Business Utilization) can advise on small
business issues and the Small Communities Coordinator (Office of Regional Operations, State and Local
Relations) is the Agency lead on issues affecting small communities. The Small Business Administration
(SBA) has overall responsibility for the Act. It reviews the Agency's analyses and certifications. SBA
also reports to Congress on Agency compliance with the Act.
Preparing the Document: In defining "small" entity the Agency may use SBA's definition or, in
consultation with SBA, it may establish its own definition and propose it for public comment. If the
Agency decides that a rule will not have a significant impact on a substantial number of small entities,
it must certify and justify this finding in the rule's preamble at both proposal and promulgation. The
Agency must send a copy of any certification to SBA at proposal or promulgation. If the Agency
determines that a rule will have a significant economic impact on a substantial number of small entities,
it must prepare an RFA. The RFA should identify all alternatives to the chosen option and describe:
1) objectives/iegal basis of the rule;
2) benefits derived from the proposed changes;
3) characteristics of the affected industry and analysis of demographics, cost,
competitive effects, and exemptions or allowances;
4) recordkeeping, reporting, or other compliance requirements; and
5) other regulations which may duplicate, overlap, or conflict with the proposed rule.
The Agency must transmit a copy of the RFA to the SBA at proposal. The RFA may be part of the
economic impact analysis. The final rule should include: a summary of public comments on the RFA; a
summary of the Agency's assessment of those comments, and any changes made in response to the
comments; a summary of each regulatory alternative; and a justification of the chosen alternative.
Operation: The lead office must submit two copies of the RFA to RDB. RDB will forward one of these
to SBA The act also requires the agency to improve its outreach to small businesses, government
jurisdictions and private organizations through such means as articles in trade publications, direct
mailings, and public hearings. All items in the semi-annual Regulatory Agenda must include a finding on
small entity impacts ("yes" or "no"). The Small Business Ombudsman can participate actively in only a
small number of rules. For rules that will significantly affect small entities, the lead program office
should contact the Ombudsman as early as possible in the rule's development to assure that the office
has time to participate.
See also: "Guidelines for Implementing the Regulatory Flexibility Act", copies are available from the
Regulation Development Branch (382-5479).
Fact Sheet 11 (Rev. 5/90)
Regulation Management Series
-------
^Ito sr4
S 'i
.S3ZJ
-v
4(
UNITED STATES ENVIRONMENTAL PROTECTION AGcNC
WASHINGTON. D C. Z0460
MAY 2 4-^8*
OFFICE OF
POLICY PLANNING AND EVALUATION
MEMORANDUM
SUBJECT: Compliance with the Regulatory
Additional Guidance
FROM
Milton Russell, Assistant Administrator
for Policy, Planning, and Evaluation
TO
Assistant Administrators
General Counsel
As part of the Agency's ongoing efforts to improve com-
pliance with the Regulatory Flexibility Act (RFA), the Office
of Standards and Regulations (OSR) of OPPE has reviewed
Agency guidance and procedures concerning the Act. To fulfill
our obligations under the RFA, the Agency must improve its
efforts in several areas, including the quality'of regula-
tory flexibility certifications, how we handle regulations
under review, and listings in the Regulatory Agenda. This
memorandum restates the Agency's obligations in each area as
a guide for your offices to improve EPA's compliance.
The RFA requires federal agencies to consider the
impacts of their regulatory actions on small entities (small
businesses, small governmental jurisdictions, and non-profit
organizations). Agencies must either perform a Regulatory
Flexibility Analysis of the economic impacts of a rule on
small entities, or certify that the rble will not have a
significant impact on a substantial number of small entities.
The Administrator's February, 1982, "Guidelines for
Implementing the Regulatory Flexibility Act" outlines what
should be included in the analyses and certifications. I am
enclosing a copy of these Guidelines. Please make sure your
staff has copies and is familiar with the requirements.
Certifications
For most rules, the Agency certifies "no significant
impact." However, these certifications do not always provide
a complete rationale for the finding as required by the Act.
The preamble for both the proposed and final rules should
Certifications and Analyses
-------
-2-
explain the Agency's rationale for the finding of no significant
impact. If there is no change in the finding or rationale after
proposal, the explanation in the final rule may be a brief
summary. In addition, the final rule's preamble should
respond to all significant public comments concerning the
certification.
The Agency must define "small" for each rule, unless it
is clear that the regulation will have insignificant impacts
on any affected entities. We may use Small Business Adminis-
tration (SBA) definitions which are based on number of employees
and/or annual receipts. Alternately, we may define "small"
for a rule; in this case, the proposal should explain the
Agency's definition and ask for public comment on it. Because
SBA has oversight authority for the Act, EPA should send a
copy of the proposed definition to the EPA contact at SBA
before the proposal is published. Copies of any correspondence
with SBA should be sent to Jacqueline Patterson in the Regulation
Management Staff (RMS), Office of Standards and Regulations,
PM-223.
Analyses
If your rule will have a significant impact on a sub-
stantial number of small entities, a Regulatory Flexibility
Analysis is required. An initial analysis must be included
or summarized in the proposal. The final analysis (or a
summary of it) and responses to public comments must be
included in the final rule. If the Agency's position has
changed since proposal, the revised rationale must appear in
the final rule. The RFA requires that EPA forward copies of
all such analyses to the Office of Advocacy at SBA. Therefore,
two copies of the analysis, or any background document which
is the basis for an initial or final Regulatory Flexibility
Analysis, should be sent to the Regulation Management Staff.
RMS will send a copy to SBA.
Regulations Under Review
The Act calls for EPA to review each regulation that
has a significant impact on a substantial number of small
entities. These regulations must be reviewed by 1991, or
within ten years of the publication date of the final rule.
To determine whether or not an existing regulation adversely
affects small entities, each review should analyze the actual
impacts of the current requirements on small entities. For
those that have a significant impact, a full Regulatory
Flexibility Analysis should be conducted.
-------
-3-
The findings of these analyses should be summarized in
the preamble of the notice announcing the completion of the
review. In the case of those reviews that included a full
Regulatory Flexibility Analysis, the preamble should also
state when the Agency will review the regulation again.
Some program offices do not issue a public notice at
the end of the initial review stage if the review leads to
a rulemaking to revise the existing standard. In these
cases, a summary of the impacts on small entities of both
the existing rule and the proposed revisions should appear
in the preamble of the newly proposed action.
The Regulatory Agenda
Requirements for the Regulatory Agenda parallel some of
the previous guidance for regulations under review. The
Regulatory Agenda is published in the Federal Register during
April and October of each year to inform interested parties
of EPA's regulatory actions and their progress. The Agenda
summarizes the status of regulations under development,
revision, and review, and contains specific information on
each.
Each regulation listing, whether for a proposed rule or
a review, must note the Agency's determination of whether
the regulation will have a significant impact on a substantial
number of small entities. A separate "Small Entity" line is
used for this purpose. If the program office designates
"Yes," it expects that the rule will have a significant
impact on a substantial number of small entities, and therefore
that EPA will perform a Regulatory Flexibility Analysis for
that rule. In the abstracts for these rules, beginning with
the next Agenda, the program offices should briefly characterize
the small entities that the Agency expects will be affected.
These abstracts should also include information on any exemptions
or alternatives for small entities that the Agency is considering.
In the Agenda abstract of each regulation being reviewed
under the RFA, the program office should briefly address the
current rule's impacts on small entities and any revisions
under consideration that may alleviate these impacts. Upon
completion of the review, the results should be summarized
in the completed review section of the Agenda. Currently,
Agenda abstracts for completed reviews only announce the
Agency's decision of whether to revise, rescind, or leave a
rule unchanged. Starting with the next Agenda an explanation
for this determination should also be included. OPPE will
-------
-4-
incorporate this addition in our guidance for preparing the
October, 1984 Agenda.
*****
If your staff needs assistance in complying with the
Regulatory Flexibility Act, or more copies of the Adminis-
trator's "Guidelines," please have them contact the Regulation
Management Staff in the Office of Standards and Regulations
at 382-5475.
Attachment
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
FEB 9 1182
TMC ADMINISTRATOR
MEMORANDUM
SUBJECT EPA Implementation of the Regulatory Flexibility Act
The Regulatory Flexibility Act is a regulatory reform
initiative that affects the way EPA develops and analyzes
regulations that have significant Impacts on "small entities,"
a term which includes small businesses, small organizations,
and small governmental organizations. The purpose of the Act
is to ensure that while achieving the Agency's statutory goals,
our regulations do not impose unnecessary costs on small entities.
I have approved the attached document, which will serve as
internal EPA guidelines for implementing the Act. EPA already
has the best record of any agency in the government for analyzing
the impacts of its regulations on small entities and for setting
exemptions to reduce unnecessary burdens. These guidelines give
guidance for improving that record as well as meeting the require-
ments of the Act. They will also ensure that our preambles to
proposed and final rules do a better job of explaining impacts
on small entities as well as the measures we have taken to
minimize them.
These guidelines explain how to implement the Regulatory
Flexibility Act's general provisions for analyzing, reviewing,
and giving public notice of EPA's regulations. Some of the more
important points are summarized here.
Defining Small Entity. The Act requires us to define "small
entity" for regulatory actions, using either the definition
prescribed in the Act or a more appropriate definition if neces-
sary. In many cases, we will want to use a different definition
of small entity from that used in the Act. The public and the
TO:
Associate Administrators
Assistant Administrators
Regional Administrators
Office Directors
Contents of the Guidelines
-------
2
Small Business Administration must have an opportunity to comment
on any definitions we develop. The guidelines explain how to go
about developing a definition at the time that a regulation is
proposed.
Significant Impact on a Substantial Number, of Small" Entit-lesv
The key in determining how the Act applies to a specific regulation
is deciding whether there is a significant economic impact on a.
substantial number of small entities. If there is such an impact,
EPA must: (1) prepare a Regulatory Flexibility Analysis.for the
regulation, (2) identify it in the Regulatory Agenda, (3) review
it periodically, and (4) make special efforts to involve small
entities in the regulatory development process. A proposed.regulation
which will not have such impact must include a certification that
the special analysis is unnecessary.
The guidelines that accompany this statement give criteria
for EPA'8 offices to use in determining whether there is a
significant economic impact on a substantial number of small
entities. These criteria are not absolute numbers to be applied
inflexibly to all cases. They are meant for guidance purposes.
In practice, deciding the nature of the impact will have to be
done on a case-by-case basis. Especially in cases involving
reporting and recordkeeping requirements, program offices should
err on the side of applying the Act.
Contents of the Regulatory Flexibility Analysis. The
Regulatory Flexibility Analysis is similar to the traditional
economic analyses EPA has long prepared. The chief emphases
are that in doing this analysis the Agency must estimate impacts
on small entities as a group distinct from other entities and
must consider alternatives that may minimize the impacts while
still achieving the statutory objectives. In most cases, I expect
that there will be cost-effective alternatives that will allow
flexibility for small entities, while still achieving our goals.
In cases where the Agency does set special exemptions for small
entities, -the responsible program will justify any Inconsistencies
with other exemptions for the same group ;f--entities set by other
EPA programs.
The Regulatory Flexibility Analysis may be combined with any
other required analyses, but a separate summary of it should
appear in the preamble to proposed and final- regulations. This
should describe clearly and succinctly to the public the steps we
have taken to assess the effects of our rules on small entities
and to justify any expected adverse effects that are necessary
for achieving our environmental goals.
-------
Periodic Review eg Existing Regulations. All EPA regulations
that have a significant impact on a substantial number of small
entities will be reviewed at least once every ten years. EPA's
offices will consolidate these reviews with those already initiated
under Executive Order 12291* the Task Force on Regulatory Relief,
the Paperwork Reduction Act# and other authorities. The Associate
Administrator for Policy and Resource Management will coordinate
the Agency'8 review efforts. These reviews will occur once every
five years to be consistent with EPA's policy to review all regu-
lations once every five years.
Conclusion
The goals of the Regulatory Flexibility Act are the same as
the goals of this Administration. It requires us to find more
flexible* Innovative* and inexpensive ways to meet the Agency's
responsibilities for protecting environmental quality.
Jape Be Sorsueh
Anne M. Gorsuch
Attachment
-------
GUIDELINES FOR IMPLEMENTING THE REGULATORY FLEXIBILITY ACT
The Regulatory Flexibility Act (the Act) requires all
Federal agencies to fully analyze the effects of their regula-
tions on small entities and to involve these'entities more
actively in developing and reviewing regulations. ("Small
entities" here includes small businesses, small' governmental
jurisdictions, and small organizations). The Act's purpose
is to encourage agencies to minimize the effects of their
regulations on small entities.
The Act does not amend or repeal any other statutory
mandates. Therefore compliance with the Act must not compro-
mise adherence to the requirements of other statutes.
HOW TO COMPLY WITH THE ACT: AN OVERVIEW
When the Act applies to a regulation under development,
EPA (usually the lead program office) must assess the likely
effects of the regulation to determine whether it will "have
a significant economic impact on a substantial number of
small entities." This means that the Agency must establish
a definition of "small entities", and then apply the criteria
for "significant economic impact" and "substantial number".
To document its conclusions, the Agency must report its
decision in the Regulatory Agenda.
Based on this initial decision on the likely effects of
the regulation on small entities, the lead office must, in
the proposed regulation, either:
a) certify that there is not a significant
impact on a substantial number of small
entities
— or —
b) prepare a Regulatory Flexibility Analysis (RFA)
and make a special effort to involve small entities
in developing the regulation.
Existing regulations that satisfy the criteria for
"significant economic impact" and "substantial number" are
subject to a periodic review requirement.
-------
-2-
The structure of these guidelines reflects these steps.
The outline is:
I. When the Act Applies to EPA Regulations
II. Defining "Small Entity"
III. The Criteria for "Significant Economic Impact"
and "Substantial Number"
IV. Reporting Information on Small Entities in
the Regulatory Agenda
V. Certifying That There is Not a Significant Impact
on a Substantial Number of Small Entities
VI. The Regulatory Flexibility Analysis (RFA)
VII. Involving Small Entities in Regulation Development
and Review
VIII. Periodic Review of Existing Regulations
I. WHZN* THE ACT APPLIES TO EPA REGULATIONS
The Regulatory Flexibility Act applies to any rule or regula-
tion that must undergo "notice and comment" under section 553(b)
of the Administrative Procedure Actr or any other law.
Some regulations are subject to some but not all requirements
of the Act. For example, grant regulations are specifically
included in the general definition of "rule" in section 601.
However, they are not subject to the analytical requirements
of sections 603 and 604 since the Administrative Procedure Act
explicitly exempts them from notice and comment requirements.
Accordingly, OGC has determined that grant regulations do not
require an RFA. However, grant regulations are still subject
to the other requirements of the Act, e.g., section 602 on the
Regulatory Agenda and section 610 on the periodic review of
regulations.
If a program office is uncertain whether the Act applies
to an action it is preparing to propose in the Federal Register,
it should contact the Office of General Counsel and the Office of
Standards and Regulations for advice.
-------
-3-
II. DEFINING "SMALL ENTITY"
The Act requires an RFA for regulations that have a signifi-
cant economic impact on a substantial number of small entities.
To determine whether a regulation meets this test, EPA programs
will often need to start out with a clear definition of "small
entity" (unless it is clear that the regulation will have
insignificant impacts on any affected entities, whether large
or small). For this purpose, the lead office may either: 1) use
the definitions of "small entity" in the Act, or 2) develop its
own definitions.
Lead offices should always seriously consider using the
definitions in the Act before deciding to develop an alternative.
To establish its own definition, the lead office must consult
with the Office of Advocacy of the Small Business Administration
(SBA) and provide the public an opportunity for comment.
A. The Act's Definitions and How To Use Them
The Act recognizes three kinds of small entities and defines
them as follows:
o Small business — any business which is independently
owned and operated and not dominant in its field as
defined by Small Business Administration regulations
under section 3 of the Small Business Act.
o Small organization — any not-for-profit enterprise
that is independently owned and operated and not dominant
in its field (e.g. private hospitals and educational
institutions).
o Small governmental jurisdiction — any government of
a district with a population of less than 50,000.
The Act's definition of "small business" is based on SBA's
definitions. These are listed in 13 CFR Part 121 by Standard
Industrial Code (SIC) categories. If lead office staff need
further assistance to identify size cutoffs SBA uses to define
small business, they should consult with the Industrial Analysis
Staff in the Office of Policy Analysis.
If a regulation covers several SIC categories, the lead office
may be faced with different SBA definitions for the different SIC
categories. In that case, SBA suggests picking any one of the
definitions and using it to analyze the regulation's effect on all
of the regulated categories. In other cases, a particular SIC
category may list different SBA definitions for different purposes,
-------
-4-
e.g. , one definition for procurements and another for grants.
Again, SBA suggests selecting one definition to use in the
analysis. For SIC codes that have no SBA definition, the lead
office may use SBA's generic cutoff of 500 employees.
B. Guidelines for Developing New Definitions
There will be many cases where the Act's definitions are
not appropriate for EPA's analytic purposes. SBA's definitions
for small business are generally based on the total number of
employees in the enterprise# while many of EPA's regulations and
analyses deal specifically with polluting plants or production
processes (e.g.* as reflected in different kinds of waste streams).
Again, the 50/000 population cutoff for small governmental juris-
dictions may not be appropriate for EPA programs dealing with
municipalities and other small governments. Of course, in the
case of a regulation that affects small organizations, the lead
office will always need to define these entities, since the Act
gives no specific guidance (beyond saying that they are not-for-
profit, independently owned and operated, and not dominant in
their field).
Note: Before developing an alternative definition, consider
whether the regulation will in fact have a significant economic
impact on a substantial number of small entities under the defini-
tions of "small entity" in the Act. Where this is the case, you
may simply certify in the preamble that the RFA is not necessary —
there is no need to consider developing an alternative definition.
For example, you may take this shortcut if the regulation will
have no economic impact no matter what definition the Agency uses.
To develop its own definition(s) for "small entities" the
lead office should follow these four analytic steps:
1. Identifying the regulated population. This involves
identifying the industrial processes and/or products
that need regulation. This step is of course basic to
developing the regulation itself.
2. Identifying size segments. Once Staff have identified
the processes or products to be regulated, they will
have to map out the range of size segments of the
entities that use these processes or make the products.
These size segments can be based on any one, or combi-
nation, of a variety of factors — e.g. number of
employees, volume of waste discharge, or volume of
production. The resulting range should account for
all entities affected by the regulation. For example,
a range of size segments based on employment might
be: 1-15 employees, 16-40 employees, 41-100 employees
and 100+ employees. A range based on air pollutant
emissions might be: 1-6 lbs/hr, 6-23 lbs/hr,
23-57 lbs/hr, etc. An example of volume of production
would be a definition of "small refiner" based on daily
production capacity.
-------
-5-
3. Selecting a quantitative cutoff point for small
entities. The program office must decide where in
the range of size segments it should make the cutoff
for "small entity." This cutoff should be expressed
in quantitative terms (e.g., number of employees,
volume of waste discharge). Using the first example
in item 2 above, a program may decide that the cutoff
point would be 41. All firms with less than 41
employees would be "small;" all firms with 41 or
more employees would be "large."
The lead office may use the following kinds of criteria
to select the cutoff point:
o The point at which the adverse economic impacts
appear to rise or fall substantially, for example
in the form of higher costs or closures;
o The point in the range of size segments that most
approximates SBA's definitions (this would require
correlating EPA's definitional unit to SBA's
entity-based approach); or
o The point at which the regulation effectively
includes a large number of regulated entities
without covering a large portion of the pollution
problem (e.g. 50% of regulated entities but only
10% of total discharge of the pollutant).
4. Justifying the cutoff point vis-a-vis the definition
in the Act. The program must explain why it made the
cutoff where it did and why this cutoff is preferable
to the definition in the Act. It should also identify
any public sources of information used to develop this
definition, to help the public and SBA when they comment.
In following these four steps, lead offices should try to
develop a definition that they can use again for later rulemaking -
to avoid having to develop an alternative definition every time
they propose a new regulation. However, different programs may
use different definitions for analyzing the same industry. (Of
course exemptions granted to small entities should be consistent
from program to program, but this is a different matter — see
section VI below.)
C. Procedural Requirements for Developing New Definitions
If the lead office decides to propose an alternative definition,
it must consult with SBA before CPA proposes the regulation in
the Federal Register. This should be done when the package is
-------
-6-
prepared for Steering Committee review, or earlier. A telephone
call to Kevin Bromberg at SBA (202/634-6115) will usually be
sufficient. If the lead office prefers official correspondence,
it can write directly to:
Frank Swain
Chief Counsel
Office of Advocacy
Small Business Administration
1441 L Street, NW
Washington, D.C. 20435
A copy of any correspondence with SBA should be sent to Daniel
Fiorino, EPA's Regulatory Flexibility Officer and official
liaison with SBA, at PM-223, 419B West Tower (202/382-5480).
The program office must also offer its proposed alternative
definition(s) for public comment. This definition may appear in
the Advance Notice of Proposed Rulemaking (ANPRM). If there is
no ANPRM, it must appear in the preamble to the proposed regula-
tion, either as part of the summary of the Regulatory Flexibility
Analysis or as part of the certification that the analysis is
unnecessary. The description of the alternative definition in
the preamble must describe the four analytic steps outlined on
pp. 5 and 6 above (identifying the regulated population, ident-
ifying size segments, etc.).
III. THE CRITERIA FOR "SIGNIFICANT ECONOMIC IMPACT" AND
"SUBSTANTIAL NUMBER"
Given a definition for "small entity", the lead office will
then have to consider whether the regulation will have a "signifi-
cant economic impact" on a "substantial number" of small entities.
Following are criteria for determining (1) what is a
substantial number and (2) what is a significant economic impact.
However, the legislative history of the Act indicates
that agencies should not limit themselves to strict decision
criteria, but rather should seek to determine on a case-by-case
basis whether a "significant economic impact on a substantial
number of small entities" will occur. Thus, although these
criteria may serve as guidance for determining the need to do an
RFA, the lead office should use its best judgment on a case-by-case
basis in deciding when an RFA might be appropriate for regulations
that do not strictly meet the criteria.
A. What Is a Substantial Number of Small Entities?
In general, a "substantial number" of small entities is
more than 20 percent of these entities (as defined). The lead
office should consider the percentage of small entities affected
for each industry the proposed rule would cover.
-------
-7-
Lead offices should not regard the 20% rule as fixed.
There may be eases where the intent of the Act would imply the
need to do an RFA even though less than 20% of small entities are
affected. For example, a regulation affecting hundreds of small
entities, regardless of whether that number represents 20%, should
undergo the further screening below. In addition, there may be
some regulations which would impose such severe economic hardship
on a few small entities that an RFA would be necessary, even
though the total number of entities affected is not substantial.
Note; By exempting many if not all of the class of small entities
from the requirements of its regulation, a lead office will be
able to reduce the "number" of entities affected and perhaps
eliminate the need to do the RFA.
B. What is a Significant Economic Impact on Small Entities?
There is a significant impact on small entities whenever
any of the following criteria are satisfied:
o annual compliance costs (annualized capital, operating,
reporting, etc.) increase total costs of production for
small entities for the relevant process or product by
mare than 5%;
o compliance costs as a percent of sales for small entities
are at least 10% higher than compliance costs as a percent
of sales for large entities.
o capital costs of compliance represent a significant
portion of capital available to small entities, considering
internal cash flow plus external financing capabilities;
o the requirements of the regulation are likely to result
in closures of small entities.
The lead office may consider other, similar criteria for
significance if these criteria are not appropriate. In esti-
mating costs, the lead office should pay close attention to
financing, reporting, testing, recordkeeping, legal and
consulting costs.
C. Regulations That "Benefit" Small Entities
Lead offices do not have to prepare an RFA for regulations
that significantly "benefit" small entities. Taking the time to
prepare an RFA on such actions would be directly contrary to the
major purpose of the Act. It would slow down and discourage,
not speed up and promote, actions to reduce the regulatory burden
on small entities.
-------
-8-
Naturally, some regulations that appear to "benefit" some
entities may harm others. For example, exemptions or other forms
of special treatment for some small entities may be to the potential
disadvantage of others. In these cases the lead office will still
have to seriously consider providing an RFA, to demonstrate that
this treatment minimizes harm to other small entities to the extent
consistent with the program's goals.
Even though the lead office may not always need to perform
an RFA, it should set out a separate section of the preamble
explaining how its regulatory decision contributes to the goals
of the Act. This section should discuss how the special treatment
or exemption was decided upon and what alternatives were considered.
IV. REPORTING INFORMATION ON SMALL ENTITIES IN THE
REGULATORY AGENDA
Section 602 of the Act requires that EPA identify in its
Regulatory Agenda any regulations that are likely to have
a significant economic impact on a substantial number of small
entities. The purpose o£ this requirement is to help small
entities identify upcoming proposals or final rules of particular
importance to them.
Contents of the Regulatory Agenda
The Agenda will deal with this requirement of the Act in the
following three ways:
1. To give small entities general notice of regulations
that may affect them, EPA will add one of the following
three determinations to the category Small Entity:
o Likely — (to have a significant impact, etc.)
o Unlikely — (to have a significant impact, etc.)
o Not yet determined
2. If EPA is certain that an RFA will be prepared it will
indicate this by adding "RFA" to the Analysis category.
All regulations proposed before January 1, 1981, are
exempt from the RFA requirement.
3. Finally, if EPA is considering or has proposed an exemp-
tion for a certain class of small entities, it will add
a sentence to the "Description" explaining the exemption
and identifying the small entities by SIC code or other
means.
-------
-9-
V. CERTIFYING THAT THERE IS NOT A SIGNIFICANT IMPACT
ON A SUBSTANTIAL NUMBER OF SMALL ENTITIES
After reviewing the criteria for significant economic impact
on a substantial number of small entities as defined, the lead
office may conclude that a Regulatory Flexibility Analysis is
unnecessary. Section 605(b) of the Act allows the Administrator
to certify at the time of publication of the proposed or final
rule that it, will not, if promulgated, have a significant economic
impact on a substantial number of small entities. (The Agency
must transmit this certification to SBA — see section VI G
below). Proposed rules must be certified so that the public has
an opportunity to comment on EPA's decision not to do an RFA.
The certification is a legally conclusive determination that
the RFA is unnecessary. The Administrator may delegate the
authority to certify to other Agency officials who already have
delegated authority to sign regulations.
Note: If the Regulatory Flexibility Act does not apply to an
action because it is not a rulemaking that must undergo notice
and comment procedures (see section I above), the lead office
should not certify at all.
A certification should contain the following elements as
appropriate:
1) A statement that the regulation, if promulgated,
will not have a significant impact on a substantial
number of small entities.
2) A "succinct statement" explaining how EPA reached
the conclusion in 1 above. This statement should
include the following elements.
o It should make clear the lead office's reasoning,
especially for important regulations.
o It should include the criteria osed to determine
that the rule will not have a "significant
impact" on small entities.
o If the regulation benefits small entities, the
lead office must identify the nature of the
benefit and what entities will receive it. It
must also state that benefits for some small
entities do not impose disadvantages or burdens
on other small entities covered by the same
regulation.
3) An identification of the definition of "small entity"
that was used (if EPA decided not to use a definition
from the Act).
-------
10-
I£ an alternative definition was used, a summary of
the steps EPA went through to develop that definition
as set out in section IIB, above. This is necessary
so that the public and SBA can meaningfully comment
on the definition.
4) An identification of the affected industries by SIC
codes if possible.
Certification Baaed on Exemption for Small Entitles
In some cases, a program office may decide to certify that
the RFA is unnecessary because it has already decided to exempt
some or all of the small entities. To justify the exemption
selected, the certification should cover the following points:
o Why the lead office selected the exemption where it did.
o The identity by SIC code (if available) of the industries
subject to the exemption.
o If the exemption is only for a subclass within the defined
universe of small entities, why the remaining impacts on
the nonexempt small entities do not meet the criteria
for significant impact and substantial number.
VI. THE REGULATORY FLEXIBILITY ANALYSIS (RFA)
If a lead office concludes that its regulatipn will have
a significant economic impact on a substantial number of small
entities, it must prepare a Regulatory Flexibility Analysis
(RFA). Section 603 of the Act requires that the initial
analysis be made available for public comment at the time of
proposal. Section 604 requires that the final analysis and
response to comments be part of the final rulemaking package.
A. How the RFA Relates to Other Analyses
The Act and Executive Order 12291 authorize agencies to
combine the RFA and the Regulatory Impact Analysis (RIA). However,
there may be some confusion over how to do this, because of the
differences between the requirements of the Act and the Order.
The Act requires that EPA identify and consider alternatives
that minimize the impacts of a regulation on small entities, but
it does not require that the Agency select the alternative with
-------
li-
the least net cost. Section 606 of the Act clearly states that
the requirements of the RFA do not alter standards otherwise
applicable by law. On the other hand, section 2 (d) of the
Order does require that agencies select the alternative involving
the least net cost to society, based on a cost-effectiveness
analysisr whenever that is legally acceptable. In short, when
either the RFA or the RIA conflict with a statutory mandate,
the resulting decision must conform to the statute rather than
vice versa.
In practice, the alternative that both achieves statutory
objectives and minimizes Impacts under the Act will probably be
identical to the alternative favored for cost-effectiveness reasons.
In a few cases# however, the lead office may find that the RIA
and the RFA point to different options. The Agency would have
to resolve such issues on a case-by-case basis.
B. What the Act Requires in an RFA
The central focus of the RFA should be on the economic impact
of a regulation on small entities (e.g., by identifying the costs
of compliance) and on the alternatives that might minimize the
impact and still accomplish the statutory objectives. The level
of detail and sophistication of the analysis should reflect the
significance of the impact on the small entities. A complete RFA
should contain the following elements as appropriate:
1. Explanation of Why EPA is Considering Action.
2. Objectives and Legal Basis of the Rule.
3. Identification of Alternatives. At the time of proposal,
the lead office must identifyalternatives that would
minimize the impact of the regulation on small entities.
It should not propose a regulation with a statement
that it will, perhaps as a result of public comment,
develop alternatives later. The Act requires that the
alternatives be part of the proposed RFA to ensure
that the public will have adequate opportunity to comment.
4. Demographic Analysis. This should:
o identify the small entities to which the rule applies:
o estimate the number of entities affected (if possible);
o provide a profile of the industry divided into size
segments;
-------
12-
o include the steps used to develop a definition of
small entity;
o identify the four digit Standard Industrial Codes
(SIC) for the affected small entities.
If the lead office has segmented the industry on a
non-firm basis (e.g.* amount of discharge), it should
also identify the characteristics of the real firms
that will have to shoulder the burdens of the regulation.
5. Cost Analysis. This analysis should identify all
costs for small entities associated with each of the
alternatives and estimate the classes of small entities
that will be subject to the costs. The relevant costs
here include both direct compliance costs and reporting,
recordkeeping and other administrative costs. The
analysis should also identify the professional skills
needed to prepare required reports or records.
6. Competitive Effects Analysis. The UFA should compare
costs of compliance for small and large entities to
determine if the small entities are affected dispropor-
tionately. It should analyze the ability of small
entities to pass on these costs in the form of price
rises and the effects on profitability It should also
predict the resulting effects (if any) on closures,
production, and employment in each segment. This
should be done for each significant alternative to the
extent possible.
7. Exemptions or Allowances. If EPA decides to reduce
the burdens of the regulation on small entities
through exemption or allowance, it should identify
any other EPA regulations that granted a different
exemption or allowance to the same industry. If
inconsistency is necessary, EPA should explain its
rationale for the exemption it is using. If no
exemptions or allowances are granted, the lead
office must explain why EPA's statutory goals
prevented flexibility.
8. Identification of Overlapping Regulations. The RFA
must identify any overlapping EPA regulations and/
to the extent possible, overlapping regulations
of other Federal agencies.
9. summary of Public Comments. Section 604(a) requires
that in the final rulemaking EPA summarize issues
raised by public comments, EPA's assessment of
those issues, and any changes made in the regulation
in response to the comments. The final analysis
-------
-13-
must also explain why EPA rejected any alternatives
that would have reduced the impact on small entities
while still achieving statutory objectives.
10. Periodic Review. EPA reviews all its regulations
once every five years. The RFA should state when
EPA will review the regulation.
C. Summary of the RFA in Preamble to Proposed and Final Rules
To facilitate review of the results of an RFA, the program
should always summarize the analysis in a separate section of the
preambles to proposed and final rules. At the minimum this summary
should identify the small entities affected, the alternatives under
consideration, and the impacts of each alternative. We should also
include a summary of how the program developed any alternative
definition.
When possible, the analysis should be done as part of the
standard economic or regulatory impact analysis. The RFA may not
have to be a background document if the summary in the preamble is
adequate.
D. Consistency in Exempting Small Entities
One of the major goals of the Act is to encourage agencies
to "tier" their regulations, that is, to exempt small entities
or to set less stringent requirements for them. EPA already
follows this practice in many of its regulations. Often, however,
entities find they are defined as "small" for some regulations
but not for others.
Although some inconsistencies may be justified, EPA should be
aware of them when it develops a new regulation. When preparing
an RFA, the lead office should investigate the exemptions granted
to small entities by other EPA regulations, and should try to
exempt consistently with other EPA regulations affecting the same
industry. If the lead office must exempt differently, it should
be careful to justify its decision so that EPA will not appear to
be ignoring the need for consistency.
The Industrial Assistance Staff in the Office of Policy Analysis
will help lead offices identify inconsistent existing exemptions.
As a further aid, the Regulation Management Staff in the Office of
Standards and Regulations will maintain a catalogue of exemptions
based on certifications and RFAs prepared by lead offices, and on
exemption information included in the Agenda.
In many cases, it may not be immediately apparent whether
exemptions are consistent. For example, one exemption may be
based on wastewater flow, and another may be based on pounds of
sulfur dioxide emitted per hour. In these cases, the lead office
-------
-14-
should investigate relevant background documents and make a
reasonable attempt to relate exemptions, for example, in terms
of a common size indicator such as plant employment.
E. SBA Review of RFA's
-------
-15-
o Arrange for open conferences with affected groups, both
before the NPRM and during the comment period.
o Directly notify interested small entities, trade associa-
tions , etc. of the publication of NPRM.
VIII. PLAN FOR PERIODIC REVIEW OF REGULATIONS
Section 610 of the Regulatory Flexibility Act requires
agencies to review existing regulations that have a significant
economic impact on a substantial number of small entities.
Agencies must review existing regulations within ten years of
the effective date of the Act (or by January 1, 1991) . Regula-
tions adopted after the Act takes effect must receive a review
within ten years after their promulgation.
The Agency must publish annually a list of regulations
covered by the Act that it will review during the coming year.
At a minimum, the list must describe the rule, explain its neces-
sity and legal basis, and invite public comment on the rule.
How EPA Should Review Existing Regulations
EPA policy is to review all existing regulations once every
five years. Review of regulations that have significant impacts
on small entities will therefore occur on a five-year rather
than on a ten-year basis.
EPA will have its reviews under the Act coincide with other
reviews of existing rules required of the Agency (by statute, by
Executive Order 12291, and by the Paperwork Reduction Act (PRA)).
The reviews under the Act will fit in with the procedures EPA
uses for reviewing regulations under 12291. The reviews should
proceed as follows:
1. When reviewing regulations under 12291, the PRA, and
other statutes (or in response to the Task Force on
Regulatory Relief), lead offices will also decide if
the regulation has a significant economic impact on a
substantial number of small entities, using the criteria
in section III. Lead offices will also screen regulations
identified in small business complaints or in the response
to EPA's Federal Register notice on reviewing regulations
under the Regulatory Flexibility Act.
2. Assistant Administrators will decide which of their
regulations will be reviewed for regulatory flexibility
in any year. They will submit an annual list of these
to the Associate Administrator for Policy and Resource
Management.
-------
-16-
3. Beginning in 1981, CPA will annually identify regulations
to be reviewed (under the Act or 12291) in the October
Regulatory Agenda.
Identification in the Agenda will include the
following elements:
o description of the regulation,
o the need for and legal basis of the rule,
o description of the kinds of small entities
affected by the rule,
o contact person for the rule.
4. EPA will ask for public comment on how, if at all,
these regulations should be revised.
5. For those regulations that lead offices decide to
review for regulatory flexibility, they will consider
impacts on small entities together with the following
factors outlined in the Act:
o continued need for the regulation;
o complaints or comments received concerning the
regulation;
o complexity of the regulation;
o extent to which the regulation overlaps, duplicates
or conflicts with other Pederal regulations and
with State and local government regulations; and
o length of time since the regulation has been evaluated
or the degree to which technology economic conditions,
or other factors have changed in the area affected
by the regulation.
6. EPA will announce the result of the reviews (i.e.,
revision necessary or not) in the Federal Register.
EPA will summarize and respond to public comments
received.
7. Revisions to regulations will follow normal Agency
procedures for regulation development, including oppor-
tunities for public participation.
A "review" will consist of an evaluation of both available
information sources and any public comments. Normally work
groups headed by the lead office will conduct the reyievs.
-------
17
The review should not require additional collection of data.
However, there may be cases where there is not enough data
to review the regulation, although comments from the public do
suggest a need for revision. The Agency should then either
obtain additional data for a review or else revise the regulation.
If EPA decides to revise the regulation, an RFA, if appropriate,
can then be prepared during the normal regulation development
procedure.
The Agency will decide to revise a regulation if it deter-
mines (1) that the existing burdens on snail entities are
unreasonable or (2) that there are alternatives that should be
considered because they may minimize impacts on small entities.
-------
PUBLIC
PARTICIPATION
-------
PUBLIC PARTICIPATION
AND
COMMUNICATIONS
STRATEGIES
-------
GOALS AND STRATEGIES FOR PUBLIC PARTICIPATION
GOALS:
Development of better regulations
Educating public about relevant issues and the benefits to be gained
Laying foundation for more compliance and less litigation
Achieving public acceptance of final product
STRATEGIES:
Take the initiative
Target specific groups: opponents and proponents
Listen AND react: importance of two-way communication
Differentiate between rhetoric and bottom-line concerns
Consider array of citizen participation tools: informal meetings, booklets,
special mailings, development of materials that simplify issues, hearings
Develop a plan with objectives, timetables, and specific actions
SPECIAL CONSIDERATIONS:
Stay in touch with Agency commitment to public participation
Devote sufficient staff, time, and resources
Avoid bureaucratic inertia; take risks
Consider drawbacks of public hearings
Keep objective of fair and sensible regulation in mind
If surveys are used, differentiate between elected officials and opinion
leaders
Develop well-written materials appropriate to different forms of
participation
-------
WHY PUBLIC PARTICIPATION?
Is it Required by law?
The Administrative Procedure Act and a number of environmental statutes require
EPA to provide the public an opportunity to participate in the development of
regulations. These requirements reflect fundamental Constitutional principles. People
have the right to express their preferences with regard to laws that affect their lives.
Those who make the law must be responsive to popular preferences.
Participation Allows the Agency to Educate Itself
Interested organizations and individuals can provide valuable information to the
Agency during the regulation development process. They possess scientific, technical
and economic information. From them, the Agency can learn how the regulated
community is likely to respond to a particular rule, and the potential obstacles to
implementation, compliance and enforcement. These kinds of data and observations
can greatly assist the Agency in determining whether a regulation under development
is an effective and efficient way to solve a given environmental problem.
Participation Educates the Public
By taking advantage of opportunities to participate in the development of regulations
the public can learn more about the substance and process of EPA's work. This
promotes a better understanding of the difficulty and complexity of EPA's regulatory
tasks and allows the public to contribute more effectively to the regulation
development process. Participation also leads to a more informed regulated
community which can, in turn, facilitate the process of implementation and
compliance. a sUfil M
Participation Is Important to Judicial Review
Many of the regulations EPA develops are challenged in court. Participation may
reduce the likelihood of such litigation. When lawsuits do occur, the courts
frequently look to the records of public participation to determine if the Agency
acted in a legal and responsible manner. The record of public participation can
provide important support for the substance of a regulation. It can also confirm
that EPA extended the opportunities to participate, that responded to the comments
of the interested public.
-------
FORMS OF PUBLIC PARTICIPATION
PUBLIC PARTICIPATION CAN TAKE MANY DIFFERENT FORMS, INCLUDING:
o Written comments submitted in response to a notice of proposed rulemaking
or an advance notice of proposed rulemaking
o Membership in a group that advises the Agency on policy issues
o Attendance at meetings with Agency personnel on particular matters relevant
to a specific regulation
o Attendance at public briefings sessions or public meetings held to elicit views
on specific rules
o Petitioning the Agency to undertake rulemaking in a particular area
o Membership in a regulatory negotiation group
Those involved in regulation development must select the form(s) of participation
best suited to the issues and audiences of a particular regulation.
-------
11° 3'4ps taken by the Agency
to improve our communications. The Office of External Affairs
has developed a flexible approach to communicating with the
general public and specific af fected/i nte rested constituencies --
the communications strategy process. The attached EPA Order
establishes for the first time the commu ni cat i o ns strategy process
as a recognizable method for involving the public in our decision-
making, and then announcing major Agency actions to the public.
The notification planning process, in which many of you a r-e
al ready participating, is only one phase in a strategic communica-
tions continuum. We will now begin to implement the three-part
communications strategy which incorporates the Management Theme
of Negotiation and Consultation and therefore includes: (1)
consultation planning be f o re a significant Agency decision is
made or action is taken"; ( 2) notification planning for a nnou nc i ng
major Agency decisions, actions or nolicies, and (3) fo11ow-up
planning, to insure we co nt i nue to listen to the public we serve.
In order to assist the Agency in our implementation of con-
sultation planning (phase one of a communications strategy),
and thus implementing our nanagement theme of Negotiation and
Consultation, OEA yd 11 utilize the Consu 1 tation-Negotiatlon-
Consensus building (CNC) protocol. The CNC protocol was developed
by the Baltimore Forum's "Negotiation and Consultation" the-ne
workgroups, to assist AAs, SAs and Senior managers to fully incor-
porate public involvement in decision-making as an integral part
of communications planning.
In addition, the order requires an annual communications plan
from each AA and RA. The annual communications plan outlines each
organization's communications needs in relation to its program
priorities. This is where annual communications planning
coincides with annual operating guidance, annual workload modelling,
annual SPMS measures, annual pe rf o rma nee-st a nda rd s setting, annual
travel budgeting. These activities must be joined so that programs
can effectively incorporate consultation and negotiation into daily
management responsibilities.
-------
)ur "fish bowl" policy is indeed lesigned to insure that EPA
.nanagers and staff remain open and accessible to mpnbers of the
public representing differing points of view, and to involve as
well as 1 nf on the Tjblic in our decisions. While you may find
some additional travel or time resources are needed to begin
communicating "at the front end" of a decision, you will also
find that consistent and planned communications can prevent
protracted debate, misunderstanding and litigation by our
¦iffected constituencies.
I encourage every EPA manager to carefully review the Order
and to incorporate our management theme, to utilize communications
strategies and, in particular, to emphasize consultation with
and involvement of the public in our decision-making.
Lee M. Thomas
Attachme nt
-------
"S-EPA
Classification No 1510.1
Approval Oate-
COMMUNICATION STRATEGY DOCUMENT DEVELOPMENT
1. PURPOSE. This Order establishes Che Agency's policy, guidelines, and
procedures for developing Communication Strategy Documents during the
formulation of a decision and before the announcement of Agency actions
and initiatives. Actions include, but are not limited to, regulatory
announcements, releases of significant findings or results, policy changes
and program actions 07 decisions which nay have national, state or local
impact.
2. BACKGROUND.
a. One of the most significant responsibilities of the EPA as a
regulatory agency is to Inform thd public, the Congress and the regulated
community of Agency activities. The trust and integrity of the EPA Is
maintained in the minds of the public only by conducting business openly
and fairly.
b. The central theme of External Affairs is to ensure that the EPA
communicates with affected constituencies In one credible voice, through
a coordinated and comprehensive process. This process Is a continuum,
beginning with development of a consultation/negotiation plan at the start
of the decision making process, moves into development of a notification
plan after the EPA decision is made, and evolves into a follow-up and
feedback process. The planning tool for this consultation/notification/
follow-up continuum, is the development of a document outlining an
internal and exterpal communication strategy.
c. The development of Communication Strategy Documents directly
involves senior EPA management and program officials. This ensures both
early identification of issues prior to the announcement of Agency
actions and consistent, broad input in formulating Agency communications.
3. POLICY. Communication Strategy Documents will be developed for all
major actions by the appropriate Assistant and Associate Administrator,
General Counsel, or Regional Administrator. Regional Documents are
required only in cases with multiregional or national implications, and
EPA Form 1315 I 2A (5 86)
-------
EPA Order
1510.1
those that Involve significant headquarters activity. The management of
EPA's national external communications activities Is the responsibility
of the Assistant Administrator for External Affairs. In addition to
developing Communication Strategy Document*?, each Assistant and Associate
Administrator, General Counsel," and Regional Administrator will develop
an annual communication plan.
4. RESPONSIBILITIES AND PROCEDURES.
a. General. The Assistant Administrator for External Affairs oversees
and assists program offices-and Regions In the development of required
Communication Strategy Documents. Documents provide^the necessary framework
for the announcement of a given agency action. The document contains a
statement of the issue, the audience, the message being sent, specific
targeted communication vehicles, an assessment of the need for community
involvement, and the plan for structured execution and follow-up. The
Assistant Administrator for External Affairs approves the final draft of
each Communication Strategy Document being submitted to the Administrator.
b. Communication Strategy Document.
(1) The Communication Strategy Document is prepared in a recommended
format (attachment A). This format has Jjeen developed by program and OEA
communication strategists.' It meets common needs and ensures that communi-
cation Information is provided to the OEA, the Administrator, the
communication strategists, and working groups.
(2) Communication Strategy development is a regularly occurring
process through which activities of the agency are internally discussed,
affected and/or Interested parties are consulted with, and Issues resolved
in advance of an announcement or action. The production, review, and
modification of Communication Strategy Documents ensures a thorough and
planned course of action.
(3) There Is no preestablised point in time when a strategy must
be initiated by a program office. However, it Is the policy of the Agency
that all actions which require the approval of the Administrator have a
Communication $fcrategy Document prior to being forwarded for approval to
the Office of the Administrator.
c. External Affairs Communication Strategist. Each office within
the Office of External Affairs has one Communication Strategist. These
employees serve four distinct purposes: (1) to maintain an awareness of
program Issues and priorities and serve as a conduit for information
exchange between program officials, program liaisons, and the Communication
Strategy workgroups; (2) to represent assigned program views and positions
throughout the development of a communication strategy; (3) to represent the
interests of their OEA offices In the formulation of each plan, and provide
advice and recommendations on specific news media, congressional,
constituency, Intergovernmental or federal agency issues; and (4) to ensure
-2-
-------
r.PA Order
1510.1
chat communication strategies are properly executed by providing 1. • riMtion
about specific strategies and issues to other G£A and EPA offices.
d. Program Office Liaison
(1) Each Assistant, Associate, and Regional Administrator and the
General Counsel must have someone serve as a program liaison to carry out
the following duties: (1) identify Issues requiring communication strategies;
(2) serve as a central program repository for background information on
the action to be communicated; and (3) when required, work with an OEA
task group for plan development. The program liaison must be authorized
to speak and act for his or her office/region. Developing Communication
Strategy Documents and community involvement plans remains the responsibility
of program and regional offices.
(2) The program liaison notifies his or her OEA Communication
Strategist about headquarters or regional program intentions on any
action which may require an Agency announcement. The OEA Communication
Strategist then reviews the background information and discusses possible
communications actions with the program liaison. These actions range
from routine (no announcement necessary) to complex (Communication
Strategy Document required). The program liaison helps to ensure broad
input from headquarters or regional program offices. The program liaison
serves as the principal representative of the program for issues
identified in regularly scheduled/media task group meetings.
e. Communication Strategy Working Groups. Every week the OEA
Communication Strategist, the program liaison, selected program repre-
sentatives, and a representative of the Assistant Administrator for
External Affairs meet to discuss future and pending communication
plans, resolve issues, and outline communication options. These working
groups help ensure that agency announcements and activities for
constituency participation are credible and well coordinated across all
Agency programs.
f. Regional Contact. A critical responsibility of each Communication
Strategist is assisting with regional coordination. Each program liaison,
strategist, and working group representative must ensure regional
coordination when developing and executing a communication strategy
associated with issues that Impact multiple regions and/or headquarters.
Without duplicating existing regional coordination activities, the
Office of Regional Operations, the Office of Public Affairs' regional
coordinator, and the regional program liaisons must share information
if the Communication Strategy process is to be successful.
g. Regional Strategy Implementation. Each Region Is responsible for
effectively communicating the activities of its programs. Written
communication strategy documents are necessary in cases with major
multlregional or national implications, or in cases that involve signi-
ficant headquarters activity. Consultation with headquarters OEA is
expected for these strategies.
-3-
-------
I?A OrMer
15 10.1
5. DE-INITIONS.
(a) Actlnn - A sign! fleant Agency action or proposed action which triggers
the
-------
EPA Order
ATTACHMENT A
1510-1
COMMUNICATION STRATEGY DOCUMENT
Nature of Action:
(Brief description of the decision,
Initiative, finding, report or, other
action triggering strategy development)
Background:
(Description of the nature of the action,
purpose and expected result)
Timing:
(Key decision announcement, release or
notification dates)
Congressional
Involvement and
Notif ication:
(House and Sehate members and/or committees
who have beerr consulted with and are to be
notified)
Constituency
Groups Involvement
and Notification:
(Affected constituency groups which have been
consulted with and are to be notified)
Federal/State
Involvement and
Notification:
(Federal, State or local government entitles
which have been consulted with and are to be
notified)
Special
Notification:
{Special mailings or notices to other affected
groups: trade press, public interest organi-
zations or local community groups)
Materials Needed:
(Fact sheets, press releases, Q's and A's or
Agency Contacts:
(Key Headquarters and Regional contacts and
telephone numbers)
-------
-------
REGULATORY
NEGOTIATION
&
CONSENSUS BUILDING
-------
REGULATORY NEGOTIATION & CONSULTATION
Description: Negotiation and consultation with outside parties are an important part of the
rulemaking process at EPA. Such consultation during the Agency's development of regulations and
policy actions offers several benefits: it brings outside information and perspectives to the Agency's
decisions; it allows representatives of different interests to engage in policy deliberations with each
other and with the Agency; It builds support for the Agency's decisions and increases the overall
efficiency of EPA's decision making process. Agency staff can rely on a variety of approaches that
EPA and other agencies have found effective, ranging from highly structured regulatory negotiations to
more informal processes such as policy dialogues, facilitated public meetings, and facilitated
workshops. With all of these approaches, the Agency uses an experienced, neutral facilitator to help
the parties prepare an agenda, define issues, share information, clarify interests, and otherwise
establish a process for achieving their goals.
Operation: Program offices are invited to call on the Regulatory Negotiation Project Staff in the
Regulation Management Division to help decide when to use a consensus-building approach and which one
to use. The Project Staff can recommend an approach or a combination of approaches suited to an
office's needs. They can also provide criteria for selecting items as candidates for regulatory
negotiation
The Regulatory Negotiation Staff is trained in facilitating meetings and in training others in the use of
consensus-building approaches When these activities require contract support, the Staff can direct the
program office to appropriate experts. The Project has a contract mechanism which program offices
can use to engage this outside support.
In the regulation development process, the Start Action Request (Fact Sheet #2) is the appropriate
point at which an office should consider what kinds of consultative approaches to incorporate into the
rulemaking The workgroup should also consider these approaches in prepanng the Development Plan
(Fact Sheet #4). At both stages the Steering Committee reviews the documents and may inquire about
or recommend strategies for consulting with outside groups.
Agency Participation: The Steering Committee participates in the initial consideration of
consensus-building approaches in its review of SARs and Development Plans. When a lead office
participates in a regulatory negotiation, it represents the Agency as a whole in making decisions. In
this capacity, it must keep the workgroup and Agency managers informed of the status of negotiations,
assure that they express ideas and reservations in a timely manner and obtain agreement before
committing the Agency In addition, formal negotiations will entail briefing senior managers, OMB, and
possibly the Administrator. When a lead office participates in less formal consensus-building
activities, it should keep workgroups informed and raise issues internally if it will be taking any
position that will commit the Agency.
See Also: "Regulatory Negotiation Selection Criteria'1, a project description, and a "Regulatory
Negotiation Overview", are available from the Regulatory Negotiation Project Staff (382-7565)
Fact Sheet 12 (Rev. 5/90)
Regulation Management Senes
-------
REGULATORY NEGOTIATION
I. Background
A. EPA's Traditional Approach to Regulatory Development
1. EPA usually develops its rules using the informal
notice-and-comment procedure of the Administrative
Procedures Act (APA).
2. EPA must defend about 80% of its final rules in court.
B. The Beginning of the Regulatory Negotiation Project
1. Rationale - In late 1982, EPA began the project with the belief that
there must be a way to develop some of its rules that would reduce
the high litigation rate and related costs and delays.
2. Purpose - To investigate (1) the value of developing rules
by negotiation, (2) the types of rules which are best suited for this
process, and (3) the procedures and circumstances which best foster
successful negotiations.
3. Form - A demonstration effort to develop two proposed rules by
consensus through face-to-face negotiations among affected parties.
C. The Continuing Value of the Project
1. Success of the first two demonstration negotiations has lead to a
total of seven regulatory negotiations completed to date.
(1) Nonconformance Penalties for Heavy-Duty Engine
Mannufacturers
(2) Emergency Pesticide Exemptions Under } 18 of FIFRA
(3) Standards for Farmworker Protection From Agricultural
Pesticides
(4) New Source Performance Standards for Woodburning Stoves
(5) Major and Minor Modifications to RCRA Permits
(6) Underground Injection of Hazardous Wastes
(7) Asbestos in Schools (Asbestos Hazardous Emergency Response
Act)
Five resulted in a consensual agreement being used as the basis for
a published Notice of Proposed Rule-making (NPRM), and three of these
have been published as final rules. A sixth resulted in areas of agreement
being used as a partial basis for a published NPRM. A seventh was useful
for people in their exchange of information, but areas of agreement were
insufficient as a basis for an NPRM; this NPRM is still unpublished.
-------
2
2. Experience confirms that regulatory negotiation offers an innovative
opportunity to use the time and resources of the Agency and its
constituencies more effectively, involve the public more fully and
openly, produce better regulations, and reduce lawsuits and delay.
D. Expansion of the Project
1. The principles of negotiation and collaboration apply not only to
rulemaking but to all Agency activities, as conveyed in the
Administrator's negotiation and consultation theme.
2. The RNP staff provides support in structuring and managing other
consensus-building processes which are less formal than regulatory
negotiation for various Agency activities. A menu of consensual
approaches is available from the RNP staff.
II. What Regulatory Negotiation Can Do For You
A. Your Potential Benefits When Regulatory Negotiation. Results in a
Consensual Agreement
1. A better proposal
2. A sounder factual base
3. Fewer, milder public comments
4. Quicker promulgation
5. Eased implementation
6. Better communication among EPA, the other participants, and their
organizations
7. Accelerated OMB and internal reviews
B. Your Potential Benefits Even If Regulatory Negotiation Results In No
Consensual Agreement
1. Productive exchange of technical information
2. Valuable insights about "real world" practices and conditions
3. Identification of previously unidentified experts
4. Better mutual understanding of the issues
5. Better communications among EPA, the other participants, and their
organizations
III. How Regulatory Negotiation Works
A. Overview
1. Brings together a balanced representation of affected parties and
EPA at the pre-proposal stage.
2. Negotiations, conducted as federally chartered advisory committees,
aim at reaching a consensus on which to base a Notice of Proposed
Rulemaking (NPRM).
3. EPA commits to using any consensus within its statutory authority
as the basis for the NPRNt
-------
3
4. Once EPA publishes the NPRM, procedural requirements of the APA
and other relevant statues apply.
B. Participation
1. The office responsible for developing a rule chooses a senior EPA
official to act as the Agency's chief negotiator.
2. Individuals representing the regulated community, environmental
groups, state and local government, and other affected stakeholder
negotiate on behalf of their constituencies.
3. The RNP staff provides design, administrative, and logistical
support.
C. Timing
As soon as the office responsible for developing a rule can determine that
it might benefit from regulatory negotiation or another collaborative
approach, it should raise the issue at Steering Committee. If the office is
ready to make this determination at the Start Action Request stage, this is
a good time to raise the issue.
D. Convening Phase
1. Convening is the important stage of determining whether an item is
ripe for negotiation.
2. Step One - The lead office and the RNP staff work jointly to
ensure the item meets EPA's threshold criteria (see attachment). The
RNP staff helps select a convenor to identify and initiate contact
with potential participants. To go to step two, the convenor must
recommend the item as a likely candidate.
3. Step Two - Individuals give the convenor their firm commitments to
proceed and their assurance they can represent their constituencies.
EPA publishes a Federal Register notice announcing
(1) its intent to negotiate, (2) an organizational
meeting for potential participants to review the scope,
timing, and procedures of negotiations and to make a
joint commitment to go forward, and (3) an invitation
for comments on the negotiation plan. With
commitments in place and no adverse comments, EPA
then charters a federal advisory committee and begins
negotiations.
E. Pre-Negotiation Training
EPA holds a day of negotiation training before negotiations begin to give
parties a common skill base.
F. Protocols of Operation
EPA submits draft protocols of operation (groundrules) to the negotiation
-------
4
committee for consideration, reform regulation, and approval. Protocols
address such procedural agreements as operating by consensus, a party's
(including EPA's) right to leave the table at any time, and use of the joint
resource dollars pool.
G. Negotiations
1. Negotiations sessions have generally been held on a monthly
schedule for 1-2 days, with a day for a general session and a day
for workgroup meetings. Meetings may be held in Washington or at
other locations convenient to the participants.
2. Documents may be exchanged and conference calls held in the time
between meetings. Negotiations have taken from 3-8 months
depending on deadlines set by the program office.
3. The negotiation is chaired by a neutral facilitator whose task is to
keep the negotiations moving toward consensus. The RNP staff
helps locate and retain the services of the facilitator. The
facilitator may also record and distribute meeting summaries.
4. A resource pool is generally available to fund joint short-term
research needs and costs of some parties participation.
5. The program office works to keep the EPA workgroup, steering
committee and OMB regularly informed of the progress of the
negotiations and to get their input on issues as they arise, so that
workgroup and OMB input to the negotiations is timely.
H. Closure of Negotiations
1. At the end of the negotiation period the committee either reaches
consensus on actual language of an NPRM or set of
recommendations or advises that consensus cannot be reached.
2. Negotiation committees do not generally take an active part in
review and response to public comment after publication of the
NPRM, although the members are kept informed of the progress of
the rule.
-------
EPA REGULATORY NEGOTIATION CANDIDATE
SELECTION CRITERIA
It is important to screen potential rulemakings to identify instances where
negotiation of the rule has a high probability of successful use. The Regulatory
Negotiations Project uses the following criteria to scfeen and select appropriate items.
We developed them based both on a thorough review of the considerable literature on the
use of negotiations to resolve a wide range of environmental disputes and on a careful
analysis of instances in which regulatory negotiations have been used. An item need not
meet all of these criteria to be qualified as a candidate.
Criteria for the Item
o The proposal should require the resolution of a limited number of
interdependent or related issues, none of which involve fundamental
questions of value, or extremely controversial national policy. Rulemaking
that involves 2nd tier, "how-to" implementing rules may be more likely to
be successful.
o The policy implications of the issues to be resolved are more-or-Iess limited
programmatically, i.e., the rulemaking will not establish binding precedents
in program areas not encompassed by the negotiations. Complex multi-
media issues may be difficult to resolve.
o There must be a sufficiently well-developed factual base to permit
meaningful discussion and resolution of the issues.
o There should be several ways in which the issues can be resolved.
o There should be a firm deadline imposed upon the negotiations by EPA
due to some statutory, judicial or programmatic mechanism. The deadline
should provide adequate time for negotiation of the issues.
Criteria for the Participants
o Those participants interested in or affected by the outcome of the
development process should be readily identifiable and relatively few in
number. Participants should be able to represent and reflect the interests
of their constituencies.
o The parties should have some common goals. They should be in good faith
about wanting to participate in negotiations. They should feel themselves
as likely, if not more likely, to achieve their overall goals using
negotiations as they would through traditional rulemaking.
o Some of the parties should have common positions on one or more of the
issues to be resolved which might serve as a basis for agreement during the
course of negotiations.
o The parties should view themselves as having an ongoing relationship with
the Agency beyond the item under consideration.
o Any ongoing litigation does not inhibit the parties' willingness or ability to
engage in genuine give-and-take.
-------
Environmental Hazards
The Superfund, RCRA and Toxic Tort Law Advisor
Copynght © 1990 Prentice Hall Law & Business, Inc
February 1990 Volume 2 Number 2
EPA's Regulatory Negotiation
And Other Consensual
Activities
With so many constitvents vying for their
interests m EPA actions, the agency is
increasingly using consultative ap-
proaches in its activities This article
outlines the development of these ap-
proaches, and discusses some particular
successes
By Chris Kirtz
At any given time, EPA has approximately 200 to 250
regulations under development Over 95 percent of these
are statutorily required TTiese are usually developed using
the informal notice-and-comment requirements of the
Administrative Procedures Act Using this approach, EPA
gathers facts, requests information, fashions a regulatory
strategy, and proposes a rule The Agency then solicits
public comment and often conducts public hearings Most
of EPA's proposed rules engender large numbers of m-
depth comments After reviewing the comments received,
the Agency promulgates a final rule Approximately 80
percent of these "major" final rules are challenged in
court
In late 1982, EPA felt there must be a better way to
proceed for at least some of the large number of regula-
tions we have under development With that in view, in
early 1983, we began a demonstration project to attempt
to develop two proposed rules by face-to-face negotiations
among affected parties The project's purpose was to
investigate the value of developing regulations by negotia-
tion, the types of regulations which were most appropriate
for this process, and the procedures and circumstances
which best fostered successful negotiations
Chns Kirtz is the Director of EPA's Regulatory Negotiation Project
The project operates under the auspices of EPA's Regulatory
Management Division
Contents
Articles
1
EPA's Regulatory Negotiation
Project
by Chns Kirtz
8
Getting to Coverage with Your
Insurer
by Ellis R Mirsky
13
The Battle Between industry and
CGL Carriers
by Richard Pettigrew and Dorothy
Korszen
Departments
19
Settlement News
U S v General Refuse Service,
Inc, et al (Miami County
Incinerator, Miami, Ohio)
U.S v Avondale Industries, Inc
(Dutchtown Oil Facility,
Ascension, La )
US v EI du Pont and Todtz
(Todtz Farm Site, Camanche,
Iowa)
25
Cleanup Decisions
Teledyne Wah Chang Site (Albany,
Ore )
Punty Oil Sales (Malaga, Calif)
Shendan Disposal Services Site
(Waller County, Tex )
27
Resource File
Regional ARAR and LDR Contacts
-------
Based on the success of the first two negotia-
tions, described in more detail below, we continued
with additional negotiations We believed at the
outset, and believe even more strongly now, that
Regulatory Negotiation offers an innovative oppor-
tunity to use EPA's time and resources, and those of
interested parties more effectively; mvolve the
public more fully and openly, produce better regu-
lations, and reduce litigation, uncertainty, and delay
in rulemakings
To date, we have conducted seven negotiations
and an eighth is underway. At any given time, we
are either in the process of conducting negotiations,
evaluating additional candidates, or both.
How Regulatory Negotiation Works
Regulatory Negotiation brings together a bal-
anced mix of parties and interests, including EPA, at
the pre-proposal stage. Negotiations are conducted
by federally-chartered advisory committees, with
the goal of reaching a consensus on which to base a
Notice of Proposed Rulemaking. EPA's promise is
to use any consensus reached—within its statutory
authority—as the basis of the proposal Once a
regulation is proposed by EPA, all procedural
requirements and safeguards of the Administrative
Procedures Act and other relevant statutes apply
A senior EPA official selected by the office
responsible for developing the rule acts as EPA's
chief negotiator He or she is empowered to commit
for the agency Individuals representing definable
interests among the regulated community—envi-
ronmental groups, enforcement officials, states, and
other affected stakeholders—negotiate on behalf of
their constituencies The Regulatory Negotiation
project staff, part of the EPA office which manages
the regulatory development process and which is
organizationally independent of the program office,
provides the necessary administrative, logistic and
other support
Convening Phase
The convening phase covers the important work
of determining whether an item is appropriate for
negotiation It has two steps In step one, we ensure
that the item meets EPA's threshold evaluation
criteria These selection criteria (see box on page 4)
were developed after a review of the literature on
negotiating environmental disputes. We also select a
convenor to identify and make initial contact with
potential participants and, after making these con-
tacts, to recommend whether or not the item
appears to be a likely candidate. If the convenor and
the Regulatory Negotiation staff believe a sufficient
balance and mix of parties and interests will
negotiate in good faith, on an identified set of
issues, within a designated time penod, and under a
generally understood set of ground rules, we pro-
ceed to step two
In step two, the convenor requests firm commit-
ments from individual parties to proceed, and their
assurance that they are able to speak for their
organization/constituency. If these commitments
are received, EPA publishes a Federal Register
By approving the
protocols, the parties
make the negotiation their
own from the outset, and
start with a positive
experience of achieving
consensus.
notice announcing its intent to negotiate the item.
This notice announces an open organizational meet-
ing with potential participants to review the scope,
timing and procedural aspects of the negotiation,
and to confirm the group's commitment to proceed
The notice also invites public comment on any
aspect of the negotiation plan If the parties at the
organizational meeting want to proceed and no
adverse public comments are received which cause
EPA to reconsider, we charter a committee under
the Federal Advisory Committee Act (FACA) and
commence negotiations
Pre-negotiation Orientation/Training
On the day before the first formal negotiation
session, we provide a full day of orientation and
training in negotiation The day gives the partici-
pants a common skill base, language, and set of
assumptions, to apply to the negotiation they are
about to begin Participants and facilitators alike
have reported this is extremely valuable in helping
the committee achieve consensus
Groundrules or Protocols of Operation
The facilitator prepares draft ground rules or
protocols for each negotiation committee's consider-
ation, reformulation, and approval at the first
meeting. These drafts reflect the features v/hich
earlier groups have found useful By approving the
protocols, the parties make the negotiation their
own from the outset, and start with a positive
experience of achieving consensus
2
ENVIRONMENTAL HAZARDS, February 1990, Volume 2, Number 2
-------
Facilitation
A neutral facilitator chairs the negotiations and
keeps the process moving smoothly "Hie facilitator's
job is to keep the parties talking, listening and
moving toward consensus. For the first negotiation,
we engaged a contractor to act as facilitator For the
second, we used an EPA official who was organiza-
tionally independent from the program office ac-
countable for the rule under negotiation Our third
and fourth were co-facilitated by a contractor and
an Agency official independent of the program
office Contractors facilitated the fifth, sixth, and
seventh negotiations, and are facilitating our eighth
Negotiated Rulemaking to Date
Nonconformance Penalties
After extensive analysis, we selected Noncon-
formance Penalties as our first negotiation item
These penalties are designed to provide temporary
relief for manufacturers Oi" heavy-duty trucks or
vehicles who initially cannot meet EPA emissions
standards, which are based on the most advanced
technology Manufacturers are allowed to sell non-
conforming engines, provided they pay a penalty
The penalty is intended to cost nonconforming
manufacturers as much as compliance would have
cost the first year, and to create an incentive for
future compliance by increasing the penalty in
subsequent years.
In Apnl 1984, EPA held an informal organiza-
tional meeting which nearly every potential party
attended In accordance with the process above,
EPA then formally announced the establishment of
the Committee Members included foreign and
domestic heavy-duty truck and engine manufactur-
ers, environmental organizations, state pollution
control officials, trade associations, and EPA
The Committee held its first meeting on June
14, 1984, and allotted four months to complete the
negotiations The group reached consensus on the
core issues within that time, and EPA published a
proposal in the March 6, 1985 Federal Register
Only thirteen comments were received, all from
participants, all supporting the consensus EPA
promulgated final regulations on August 30, 1985
No litigation has ensued
Emergency Pesticide Exemptions
Section 18 of FIFRA allows the Administrator to
exempt federal or state agencies from its provisions
if he or she determines that emergency conditions
requiring such action exist EPA issued implement-
ing regulations in 1973 Internal and external
analysis indicated they were ripe for improvement.
In August 1984, EPA formed an Advisory
Committee to negotiate new Emergency Pesticide
Exemption requirements Membership included
representatives of environmental organizations,
users, state agricultural and health departments,
trade associations, the U S Department of Agricul-
ture, and EPA. The Committee first met at the end
of September and designated four months for its
negotiations
Within the time allotted, the Committee reached
full consensus on the exact wording of text and
preamble of the Notice of Proposed Rulemaking
The proposal appeared in the April 8, 1985 Federal
Register EPA received nineteen comments Three
from participants supported the proposal The oth-
ers raised relatively minor points of interpretation or
concern EPA promulgated final regulations on
January 15, 1986 No litigation has ensued
Farmworker Protection Standards
EPA decided to revise its 1974 standards to
reflect the latest data on worker hazards, innova-
tions in available protective clothing, and to im-
prove overall compliance
After extensive discussions with potential par-
ties, EPA chartered a Negotiating Committee, which
first met in November 1985 Membership included
a mix of grower, farmworker, state, and enforce-
ment interests
These negotiations took a different path than
the first two After four months of work, members
representing a major interest group announced they
would not return to the negotiations Under the
Committee's ground rules, any party could leave at
any time without prejudice Consistent with these
rules, EPA acted to balance the rights of those who
chose to leave with those wanting to continue
EPA investigated all options to bring back to the
negotiation those who had left, and continued to
treat them as full participants, always entitled to
return The remaining parties agreed that, if the
Environmental Hazards
Tfc* tCM odTkK Tbn L— AOrwut
Copynghl C 1990 Prentice Hall Law & Business, Inc
All nghts reserved No pari of this publication mat be reproduced
or transmitted in an\ form or b> anv means, electronic or mechanical
including photocopy, recording, or any information storage and
retrieval system without permission in writing from the publisher
En\ironmental Hazards (ISSN 1043-5700) is published rnonthK b\
Prentice Hall Lau & Business. 910 Sylvan Avenue, Englewood Cliffs
New Jersev 07632 (201) B94-853B One year subscription (12 issues)
costs $245 (First Class postage paid at Baltimore, Maryland and at
additional mailing offices) Postmaster Send address changes to
Environmental Hazards Prentice Hall Lavs & Business 910 SvUan
Avenue, Englewood Cliffs, New Jerse\ 07632
3
ENVIRONMENTAL HAZARDS, February 1990. Volume 2, Number 2
-------
EPA Regulatory Negotiation Candidate Selection Criteria
It is important to screen potential rulemak-
ings to identify instances where negotiation of
the rule has a high probability of successful use.
The Regulatory Negotiation Project uses the
following criteria to screen and select appropnate
items We developed them based both on a
thorough review of the considerable literature bn
the use of negotiations to resolve a wide range of
environmental disputes and on a careful analysis
of instances in which regulatory negotiations
have been used An item need not meet all of
these criteria to be qualified as a candidate.
Criteria for the Item
• The proposal should require the resolution
of a limited number of interdependent or
related issues, none of which involve
fundamental questions of value, or ex-
tremely controversial national policy
Rulemaking that involves second tier,
"how-to" implementing rules may be
more likely to be successful
• The policy implications of the issues to be
resolved are more or less limited program-
matltally, i e, the rulemaking will not
establish binding precedents in program
areas not encompassed by the negotia-
tions. Complex multi-media issues may be
difficult to resolve
• There must be a sufficiently well-devel-
oped factual base to permit meaningful
discussion and resolution of the issues
• There should be several ways in which the
issues can be resolved
• There should be a firm deadline imposed
upon the negotiations by EPA due to
some statutory, judicial or programmatic
mechanism TTie deadline should provide
adequate time for negotiation of the is-
sues.
Criteria for the Participants
• Those participants interested in or affect-
ed by the outcome of the development
process should be readily identifiable and
relatively few in number Participants
should be able to represent and reflect the
mterests of their constituencies
• The parties should have some common
goals They should be in good faith about
wanting to participate in negotiations
They should view themselves as likely, if
not more likely, to achieve their overall
goals using negotiation as they would
through traditional rulemaking
• Some of the parties should have common
positions on one or more of the issues to
be resolved which might serve as a basis
for agreement during the course of negoti-
ations
• The parties should view themselves as
having an ongoing relationship with the
Agency beyond the item under consider-
ation.
• Any ongoing litigation does not inhibit the
parties' willingness or ability to engage in
genuine give-and-take
absent group did not return, they would continue to
share information among themselves and develop a
draft rule striving to balance all interests, without
purporting to represent a "consensus" of all original
members, and without EPA being bound by the
negotiated draft EPA published a Notice of Pro-
posed Rulemaking in the Federal Register on July 8,
1988 Hundreds of comments were received EPA is
currently preparing final regulations
Woodburning Stoves
Air emissions from woodstoves pose a signifi-
cant and growing problem. New control technolo-
gies can greatly reduce emissions and are now
commercially available. On August 2, 1985, EPA
announced plans to develop New Source Perfor-
mance Standards for Residential Wood Combustion
Units
In February 1986, EPA chartered an Advisory
Committee to negotiate these standards Member-
ship included a balanced mix of woodstove and
catalyst manufacturers, public interest groups, and
state officials
The first full Committee meeting was held in
March 1986, and the Committee completed negotia-
tions as scheduled on August 21, 1986, with
agreement on the core issues It appointed a draft-
ing work group to fashion preamble and regulatory
language The Committee as a whole ratified the
work group's proposed regulatory language, and
4
ENVIRONMENTAL HAZARDS, February 1990, Volume 2, Number 2
-------
EPA published the proposed rule on February 18,
1987. The public comment penod closed on April
20, 1987. EPA received over fifty comments and
published the final rule on Apnl 26, 1988 No
litigation has ensued
RCRA Minor Permit Modifications
Current EPA regulations govern when and how
hazardous waste management facilities may modify
Resource Conservation and Recovery Act (RCRA)
permits The regulations establish two modification
categories—major and minor. In recent years, EPA
permittees and members of the public have recog-
nized the need to revise these procedures to develop
a more flexible and workable permit modification
system
In August 1986, EPA chartered an Advisory
Committee to negotiate on proposed changes to the
permitting procedures for minor modifications
Memberships included representatives of public
interest groups, trade associations, industry, States,
and EPA The Committee held its first meeting on
September 10, 1986, and completed its work on
February 23, 1987 Twenty of the twenty-one
members ratified the document the group fash-
ioned The Notice of Proposed Rulemaking was
published in the Federal Register on September 22,
1987 EPA received 55 public comments The final
rule was published in September 1988 There has
been no litigation on this rulemaking
Underground Injection
The Hazardous and Solid Waste Amendments
of 1984 (HSWA) contain provisions curtailing near-
ly all aspects of hazardous waste injection beyond
specified dates, unless EPA finds such disposal
protects human health and the environment. EPA
estimates that 60 percent of the hazardous wastes
disposed on land are injected
In September 1986, EPA chartered an Advisory
Committee to negotiate these standards Member-
ship included representatives of public interest
groups, trade associations, industry, States, and
EPA On March 31, 1987, after seven months of
meeting, the negotiation ended Though the group
reached substantial agreement on many points, no
across-the-board consensus was achieved EPA
published the proposed rule in the Federal Register
on August 27, 1987 The public comment penod
closed on October 27, 1987 EPA received approxi-
mately 30 comments and published the final rule in
July 1988 Environmental and industry groups have
challenged the rule on unresolved issues Oral
argument is scheduled for February 1990
Asbestos in Schools
On October 22, 1986, Congress enacted the
Asbestos Hazard Emergency Response Act (AH-
ERA), directing EPA to regulate asbestos problems
in public and pnvate schools, and establishing a
deadline of April 20, 1987, for proposing regula-
tions These regulations had to address inspections
for asbestos-containing materials (ACM), response
actions, periodic surveillance programs, operations
and maintenance programs, asbestos management
plans, and transportation and disposal of waste
ACM
In February 1987, EPA chartered an Advisor)'
Committee Membership included representatives
of education groups, school service employees,
asbestos product manufacturers, asbestos abate-
ment workers, contractors, designers, industrial
hygienists, school distncts, public interest groups,
States, and EPA
The Committee held its first meeting on Febru-
ary 5, 1987 By Apnl 3, 1987, under a very short
deadline, members representing 20 of the 24 inter-
ests on the Committee agreed to use regulatory
language covenng most issues as a basis for the
proposed rulemaking The proposed regulation was
signed on schedule, and appeared in the Federal
Register on Apnl 30, 1987 EPA received over 130
comments EPA published the final rule in the
Federal Register on October 30, 1987 Litigation
ensued and—with several negotiators intervening
on EPA's behalf—was resolved in EPA's favor in
May 1988 EPA feels the scope of the litigation was
greatly curtailed as a result of the negotiation
process
Fugitive Emissions
EPA recently convened a regulatory negotiation
to address fugitive emissions of toxic chemicals and
volatile organic compounds (VOCs) from equip-
ment leaks—such as valves, pumps, and flanges
These are a significant source of air pollution
Indeed, by some estimates, leaks constitute between
one- and two-thirds of all routine, non-accidental
emissions from chemical plants
Current fugitive emission regulations basically
require that equipment be inspected quarterly for
leaks with a portable hydrocarbon detector They do
not provide the means for calculating the level of
emissions Nor does the approach ensure emission
rates that are readily achievable However, accurate
emission levels are necessary for baseline and
residual risk assessments for new regulations, issu-
ing permits for new facilities, establishing appropri-
ate emission fees, and so companies can properly
report emissions
5
ENVIRONMENTAL HAZARDS, February 1990, Volume 2, Number 2
-------
In this regulatory negotiation, EPA, the petro-
chemical, rubber, and pharmaceutical industries,
environmental organizations, and state and local
governments are working together to develop a
consensus on
• a new standard based upon the maximum
available control technology for control of
fugitive emissions from equipment leaks,
• emission factors for fugitive emissions of
VOCs from equipment leaks to better quanti-
fy the magnitude of the leaks; and
• a format that could be used to implement a
risk based standard for toxic organic emis-
sions of hazardous air pollutants from equip-
ment leaks. Specific risk limits or goals will
not be a subject of the negotiations.
EPA intends to develop generic standards that
would be applicable to all chemical manufacturing
facilities that use as raw materials or produce as
intermediates, co-products, or final products any of
the 191 chemicals in the proposed Clean Air Act
amendments The precise sources need to be further
defined
The negotiating committee meets approximately
once a month, alternating between Washington and
Durham, N C Members of the public are welcome
to attend, and should call Debbie Dalton, the
Deputy Project Director at 202-382-5495
Other Consensus Activities
After the first several negotiations, top EPA
management realized that the principles of consul-
tation, collaboration, negotiation, and consensus
were workable ones which were not limited exclu-
sively to the rulemaking arena Now, in all Agency
activities, EPA has expanded the use of consensual
The principles of
consultation, collaboration,
negotiation, and
consensus are not limited
exclusively to the
rulemaking arena.
principles to better include in Agency decision-
making the viewpoints of representatives from
industry, environmental organizations, states, local
governments, and other affected interests Thus far
EPA has engaged in policy dialogues; conducted
facilitated public meetings, sponsored studies,
workshops, and strategic planning sessions; and
hosted trainings in consensual decisionmaking for
personnel across the Agency
The Regulatory Negotiation Project staff helps
coordinate these consensual activities by providing
the needed support directly, drawing on available
in-house expertise, or locating and helping to-
manage appropriate outside experts
What We Have Learned
From our experience with regulatory negotia-
tions and consensual activities, we have learned
several things".
• Selecting an appropriate item is our most
critical step, and success is most likely when
the item is "npe," the parties and issues
identifiable, and the parties willing to negoti-
ate in good faith.
• The process can be beneficial to EPA and the
parties even when the committee does not
reach full consensus
• The process can balance the needs of parties
who feel they must leave with those parties
who remain and wish to continue
• Regulatory negotiations can succeed with an
inside or an outside facilitator and/or conve-
nor The nature of the rule and the needs of
the group should dictate which combination
of inside, outside, or co-facilita-
tors/convenors would be most effective
• Although negotiations have been somewhat
more demanding of staff time than first
anticipated, participants (including EPA)
have reported they feel the time and energy
invested were worthwhile They have point-
ed to the quality and comprehensiveness of
the proposals, and to the enhanced commu-
nication among participants which they said
would produce positive benefits in future
interactions
• While regulatory negotiation is not a pana-
cea, it appears to hold considerable promise
as an efficient and effective way to develop
select EPA regulations
• Rules developed by negotiation are often
more innovative and pragmatic
• Consensus, collaboration, and negotiation
have considerable utility as management
tools in the nonregulatory as well as the
regulatory context
Whafs Next
In his January 31st, 1989 statement to the
Senate Confirmation Committee on Environment
and Public Works, Mr Reilly pledged " wide
consultation and cooperation with Congress, the
states and localities, with business, professional and
6
ENVIRONMENTAL HAZARDS, February 1990, Volume 2, Number 2
-------
environmental groups in the search for the best
ideas for more effective policies and programs" as
one of his five principal priorities
Continuing to use negotiation, consultation and
consensual approaches to develop regulatory and
other items as a major Agency management theme,
EPA will screen future regulatory and other activi-
ties to ensure that we capitalize on any opportuni-
ties to improve communication with those affected
by our actions, and to do a more effective job of
fashioning better regulations and policies
How You Can Participate
The EPA is always seeking additional regula-
tory negotiation candidates
Readers are invited to suggest candidates for
regulatory negotiation EPA is open to nomina-
tion of rules at the pre-proposal stage of rulemak-
ing involving any environmental statute adminis-
tered by the Agency In evaluating possible rules
to suggest to EPA, we recommend you ask the
following questions If you can answer yes, then
the rule may be appropriate for regulatory nego-
tiation
1 Does the rule set forth how to administer a
program or a standard rather than setting a
. numerical standard7
2 Are the parties and interest sectors affected
by the rule easily identifiable, reasonably limited
in number and potentially interested in good
faith negotiations to resolve differences7
3. Are the issues to be discussed reasonably
limited in number, and is the data base sufficient
to support informed discussion7
4. Can the parties resolve the issues without
compromising fundamental questions of value or
principle7
If you have items to propose for regulatory
negotiation, or some other consensus building
approach; or have further questions, contact
Chns Kirtz, Director
Regulatory Negotiation Project
USE.PA, 401 M Street, SW (S-305)
Washington, D C 20460
(202) 382-7565
7
ENVIRONMENTAL HAZARDS, February 1990, Volume 2, Number 2
-------
-------
PUBLIC COMMENTS
AND
THE DOCKE1
-------
March 1, 19*90
PUBLIC PARTICIPATION: RECORDING OUTSIDE COMMENTS
Gerald H. Yamada
Deputy General Counsel
Authority for informal, or "notice and comment" rulemaking is established in the
Administrative Procedure Act (5 U.S.C. Section 553). It requires the following:
o Publication of a proposed rule in the Federal Register:
o Offer the public an opportunity to submit written comments
on the proposal;
o Publication of the final rule, notifying the public that it
becomes effective no sooner than 30 days after its appearance
in the Federal Register.
In EPA, a number of questions commonly arise in the course of informal
rulemaking:
1. Are there any restrictions on initiating or responding to contacts with persons outside
the Agency during informal rulemaking?
Yes, there are several:
(a) FEDERAL ADVISORY COMMITTEE ACT (FACA). FACA establishes
certain procedures that must be followed when a Federal
official seeks advice from a group which has a representative
other than a Federal or State employee. The procedures
include obtaining a committee charter, notifying Congress,
having balanced membership, and holding open meetings
which are announced in advance in the Federal Register.
(b) REGULATORY WORKGROUP PARTICIPATION. With the exception of
representatives of other Federal agencies and State
government representatives, no one outside the Agency can
participate in the rulemaking workgroups.
This means that the regulated community and other interested groups
cannot be represented on workgroups other than negotiated rulemakings.
(c) FUNDING FOR PARTICIPANTS. The Agency cannot pay the
expenses or compensate a non-Federal party for intervening
in regulatory or adjudicatory proceedings. This includes a
prohibition on reimbursement for travel or lodging, or for
appearing as a witness in an EPA rulemaking hearing.
(d) EMPLOYEE CONFLICT OF INTEREST RESTRICTIONS. As a general rule,
-------
2
an Agency employee cannot participate in the development of
regulations in which the employee, spouse, minor childen, or
an organization in which the employee has an official
position has a financial interest. The most common example
is corporate stock ownership. In some instances, a waiver of
this general rule can be obtained from the Office of General
Counsel.
(e) EX PARTE COMMUNICATIONS. An ex parte communication is an
outside contact that occurs after the close of the public
comment period for a proposed rule but before promulgation
of the final rule. The fact that such a contact occurred or
any new information about the proposed rule that was
communicated during the contact must be recorded in writing
and placed in the public record.
2. Which outside contacts must be recorded for the public record?
ALL CONTACTS WITH:
(a) the regulated community, environmental groups, trade
associations, civic groups, etc.
(b) State and local government officials
(c) Congressional letters, meetings or hearings
(d) written communications from other Federal agencies
including OMB
3. Where are outside contacts recorded and retained?
Written statements describing the timing and substance of outside contacts are
placed in the public record. The public record is a compilation, generally indexed
chronologically, of all documents, communications and related materials
considered during the course of Agency rulemaking. The public record must be
available after a proposed rule is published for anyone who wishes to review it.
4. Does the timing of outside contacts during regulation development make any
difference?
(a) You need n£i record outside contacts that occur before the
notice of proposed rule-making.
(b) You must record outside contacts that occur during the
public comment period for a proposed rule.
(c) You must record outside contacts that occur after the close of
the public comment period, but before the final rule is
published.
5. What happens if OMB has outside contacts regarding a regulation under development
in EPA?
If OMB decides to meet with anyone interested in a regulation under
development in EPA, the Office of General Counsel is informed by OMB
in accordance with procedures established by the Office of Information
and Regulatory Affairs. Any written material submitted to OMB by
outside contacts are forwarded to OGC and we forward them to the
program office.
-------
3
6. What happens if I receive new and significant factual information or data after
proposal of the rule?
You have three options, and the one you choose depends on how the new
information or data has affected your thinking about your proposed rule.
(a) The information may suggest a change in the rule. If the
change is one that could have been reasonably anticipated in
light of your original proposal, you may be able to
promulgate the rule with the change. However, since this is
often a close question you may need to reopen the comment
period through a Notice of Availability of Information. This
alerts those interested in the rule to the existence of the
information,
allowing them to review it. You will, of course, describe the new
information or data and the reasons for the possible changes.
(b) The information or data might convince you to make changes
that represent a significant departure from the rule you
proposed, and could not be reasonably foreseen by your
original proposal. In these cases you should reopen the
comment period on this issue by either a Notice of
Availability of Information or a formal reproposal of the
rule, which includes reference to the new information or
data.
(c) In rare cases the information or data you receive is so
substantial and unanticipated that it requires you to rethink
in a fundamental way the approach you have taken in your
proposal. The best course of action is to withdraw the
proposal and start from scratch.
7. Are there materials relevant to a rulemaking that should not be put in the public
record?
YES, THERE ARE A COUPLE.
(a) Confidential business information or trade secret data should
never be put in the public record.
(b) Internal memoranda, discussion papers, or other materials
that would result in premature disclosure of the Agency's
thought processes prior to publishing the proposal rule should
not be put in the public record. These "deliberative
materials" are specifically exempted from disclosure under
the Freedom of Information Act.
You need not put summaries of oral communications in the public record
unless they qualify as ex parte contacts.
-------
4
8. What if outside parties contact me for information related to a rulemaking prior to
publication of the final rule?
Outside parties have access- to the public record and are free to use the
Freedom of Information Act to attempt to obtain whatever materials they
desire. The Freedom of Information Act exempts deliberative materials
from disclosure, so this type of information should be retained by the
Agency. There is, however, one exception. Chairpersons of Congressional
committees with jurisdiction in an area affected by an ongoing rulemaking
are not subject to any of the exemptions under FOIA. Inquiries from other
Members of Congress are treated in the same manner as inquiries from
outside parties.
9. Why does the Office of General Counsel place such importance on the preamble to the
final rule?
The preamble is the bridge between the proposed rule and the final rule.
It explains the legal authority of the rulemaking, the factual and/or policy
basis for the substance of the rule, the procedures used to develop it and
your response to comments on the proposal. It is also an important source
of information for courts who review the rule if it is challenged in a
lawsuit filed against the Agency. Therefore, the preamble should be
drafted with care.
-------
UNIFORM RULEMAKING
DOCKET GUIDANCE
OCTOBER 1989
INFORMATION MANAGEMENT & SERVICES DIVISION
OFFICE OF INFORMATION RESOURCES MANAGEMENT
U.S. ENVIRONMENTAL PROTECTION AGENCY
401 M STREET SW
WASHINGTON, DC 20460
-------
UNIFORM RULEMAKING DOCKET GUIDANCE
SEP ' 8 1.989
SEPTEMBER 1989
Information Services Branch
Information Management and Services Division
U.S. Environmental Protection Agency
401 M Street, S.W. PM-211D
(202) 475-8710
-------
UNIFORM RULEMAKING DOCKET GUIDANCE
CONTENTS
I. PURPOSE OF GUIDANCE
A. Purpose 1
B. Audience 1
C. Scope 2
D. Background 2
E. Office Roles 3
F. Continued Development and Coordination 3
G. Acknowledgements 4
II. DOCKET DEFINITIONS 5
A. Administrative Record 5
B. Rulemaking Docket 5
C. Public Comments 5
III. MATERIAL INCLUDED IN THE DOCKET 6
A. Overview 6
B. Types of Materials Included 6
C. Comments Received after a Comment Period 7
D. Comments Received after a Rule is Signed 8
-------
E. Information Received after a Rule is Signed 8
F. Criteria for Referencing Information 8
G. Program Procedures 9
IV. MATERIAL EXCLUDED FROM THE DOCKET 10
A. Deliberative Documents 10
B. Materials Available from Other Sources 10
V. ACCESS 11
A. Program Staff Role 11
B. Docket Staff Role 11
C. Duplication Fees 12
D. Outreach 12
VI. RECORDS MANAGEMENT 14
A. Active Records 14
B. Retention and Disposal of Inactive Records 15
C. Retirement and Retrieval of Inactive Records 16
D. Safeguarding of Records 16
E. Micrographic Management 16
F. Records Management Assistance 17
i i
-------
UNIFORM RULEMAKING DOCKET GUIDANCE
I. INTRODUCTION
A. Purpose
The purpose of the Uniform Rulemaking Docket Guidance is to provide
a working tool for improved coordination of EPA dockets that will
result in better information service. The Guidance will help EPA
meet the following goals for the dockets:
• Improve the integrity and consistency of dockets.
• Improve user access and understanding of docket
procedures.
« Document Agency-wide docket policy and procedure.
B. Audience
The Guidance is intended for two primary user groups: the public and
EPA staff.
EPA strives in all its activities to provide the public with
information to make informed decisions on environmental issues.
The dockets are a major EPA public access point, and are especially
important to those who are subject to and must comply with
environmental regulations. The Guidance is a step in assuring
comprehensive, convenient public access to regulatory information.
The other primary audience of the Guidance is the EPA staff,
including program managers and regulatory developers. For EPA
staff, the Guidance is a tool to assist in managing and developing
dockets. The Guidance provides a common language for EPA
programs to share information and identify program-specific needs.
This improved Agency communication will lead to more consistent
communication with the public.
1
-------
C. Scope
The Guidance addresses Agency-wide policy issues that pertain to
the above-stated purpose and goals. Most of the information defines
the general legal framework in which the dockets operate.
Procedures and requirements specific to a program or statute are
not addressed here. The final section summarizes Agency records
management practices that relate to material contained in the
public docket.
D. Background
There are eight major EPA dockets in Headquarters: the Public
Information Reference Unit (PIRU), the Clean Air Act (CAA) Docket,
the Resource Conservation and Recovery Act (RCRA) Docket, the Safe
Drinking Water Act Docket, the Underground Storage Tanks Docket,
the Toxic Substances Control Act (TSCA) Docket, the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA or Pesticide)
Docket, and the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA or Superfund) Docket.
EPA's Office of Information Resources Management (OIRM),
Information Management and Services Division (IMSD), Information
Services Branch (ISB), manages the Public Information Reference
Unit and also annually publishes "A Pathfinder to Major EPA Dockets"
to improve access to docket information and improve coordination
between program dockets. In March 1988, ISB initiated an informal
workgroup of staff from the major dockets to share information on
procedural issues.
In September 1988, the Regulatory Steering Committee received a
report from an impartial survey conducted by the Office of General
Counsel (OGC) to determine whether an Agency-wide consolidated
docket system should be established. One of the recommendations of
the report was to establish a formal Agency-wide workgroup to
develop general operating guidance for dockets. The Steering
Committee asked ISB to lead this workgroup to develop general
operating guidance for all dockets.
2
-------
E. Office Roles
Many EPA offices contribute to the development and operation of EPA
dockets. Each major EPA program maintains at least one docket, and
some programs have multiple dockets.
The Office of the General-Counsel (OGC) provides legal guidance to
the programs for all regulatory activities. OGC consults with the
programs to resolve legal questions and concerns about docket
issues.
The EPA Institute sponsors classes on regulatory development for
program staff and administrative support staff to improve EPA's
regulatory development capabilities.
The Office of Information Resources Management manages one
docket, and provides information services and products.
F. Continued Development and Coordination
During the development of the Uniform Rulemaking Docket Guidance,
several issues were identified for continued coordination. Example
topics for future coordination are: uniform procedures; standard
indexing terms; a permanent forum for networking, communication,
and outreach to users, and uniform tools for technical services, such
as collection maintenance and storage and retrieval techniques.
The next step in continued development and coordination of dockets
is for each program to document its docket policies and procedures
using the Guidance as a base. Each program should note in its
policies and procedures any program-specific exceptions to the
Guidance. Program policies and procedures should be updated
annually. Current policy and procedures information serves the
following purposes:
• Communication with docket users.
• Communication with program regulatory development and
management staff.
• Orientation of docket operational staff.
3
-------
G. Acknowledgements
The Office of General Counsel (OGC) determined the need for Uniform
Guidance, and worked with OIRM's Information Services Branch (ISB)
to develop the Guidance with input from EPA programs. ISB led a
Docket Workgroup with representatives from EPA programs and
Regional offices. Each Workgroup member actively represented its
program, and cooperated to develop Agency-wide Guidance. In areas
where the Workgroup was unsure or divided on how to proceed, OGC
developed Agency-wide Guidance.
Following are EPA staff who deserve commendation for developing
the "Uniform Rulemaking Docket Guidance: " Larry Achter, Mary
Adler, Suzanne Annand, Jacqueline Brown, Gloris Butler, Judy A.
Earle, Paul E. Frazier, Gwenn Gebhard, Jerri Green, Richard Hyde, Phil
Jalbert, Carla Levesque, Thea McManus, Patricia Minami, Therese
Murtagh, Libby Noronha, Harvey Nozick, Cynthia Puskar, Anne
Randolph, Brigid Rapp, John A. Richards, Barbara Roth, Bruce
Rothrock, Doug Sellers, David Schwarz, Bob Shimshock, Rebecca
Slack, Karen Tarnow, and Romona Trovato.
For further information on the Uniform Rulemaking Docket Guidance,
contact Brigid Rapp or Gloris Butler, Information Services Branch,
Office of Information Resources Management, 475-8710.
4
-------
II. DOCKET DEFINITIONS
A. Administrative Record
The "Administrative Record" is a set of documents that is the basis
for any federal agency administrative action, including, but not
limited to, rulemaking. Under the Administrative Procedure Act
(APA), any judicial review of a final agency action is based on the
administrative record. Administrative actions that are not rules
may include denials of citizens' petitions, individual permit
decisions, and exemption decisions. These actions are typically
based on an administrative record.
B. Rulemaking Docket
The "Rulemaking Docket" is a collection of documents that is the
basis for EPA rulemaking actions. Some statutes refer to a
"rulemaking record" or a "docket," and others refer to the "record."
Those same terms are often used to describe the collection of
documents available to the public which reflect the Agency's
consideration and promulgation of a rule, or "public docket." Since
an "administrative record" is not usually formally identified until a
challenge to an Agency rule, the "public docket" and the "record" will
not necessarily be the same.
C. Public Comments
"Public Comments" are all incoming information received by the
Agency that is clearly in response to Federal Register notices
published by the Agency.
5
-------
111. MATERIAL INCLUDED IN THE DOCKET
A. Overview
In general, the rulemaking docket contains the information relied
upon by the Agency, public comments, and other documents the
Agency considers relevant to its rulemaking decisions.
In addition, the Agency dockets contain administrative information
that affects public use of docket materials, including a
comprehensive index of all materials contained in the docket. This
information will also explain how, when and where docket materials
may be accessed.
B. Types of Materials Included
The rulemaking docket shall include, but is not limited to:
• A copy of each proposed rule, final rule or other rulemaking
notice (e.g., Advance Notice of Proposed Rulemaking) for a
regulatory action signed by the Administrator or {Assistant
Administrator in the case of a supplemental notice).
• All documents cited in the Federal Register notice.
• Information considered by the Agency in drafting the proposed
or final rule, which may include data, analyses, reports,
minutes, and transcripts, summaries and transcripts of
public meetings, telephone calls, and public statements made
by EPA employees in their official capacities.
• Public comments: Comments may include data, letters,
information and other materials addressed to the Agency by
any person during the comment period that are clearly in
response to Federal Reoister notices published by the Agency,
as well as summaries and transcripts of public meetings,
telephone calls and public statements made by EPA
employees in their official capacities.
• State comments.
6
-------
• OMB Comments: Written comments from the Office of
Management and Budget (OMB) should be included in the
rulemaking docket. Comments received by OMB from outside
parties on Agency rulemaking actions should also be included
in the rulemaking docket.
Procedures have been established with OMB to ensure that
such comments are provided to EPA through the Office of
General Counsel and forwarded to the program for inclusion
in the rulemaking dockets.
Additionally, oral communications with OMB regarding
significant new factual data or information affecting a
rulemaking (including a meeting with an interest group),
should be summarized in writing and placed in the rulemaking
docket.
C. Comments Received After a Comment Period
The Agency is not required to consider late comments. However, the
normal practice in most programs is to consider late comments
whenever possible. The Office of General Counsel generally
recommends to program contacts that they consider comments
submitted late where possible, since failure to do so could result in
unnecessary legal action by the commenters. Late comments may
also provide important supporting information for the rule.
If comments received after the close of a comment period contain
significant new factual data or information that might affect the
Agency's decision, the program office should, in consultation with
the Office of General Counsel, consider re-opening the comment
period.
Whether or not the program chooses to consider late comments, the
comments should be included in the rulemaking docket. Late
comments should be put in a separate part of the rulemaking docket
and labeled as late. A comment is considered late if the postmark is
dated the business day after the date given in the Federal Register
notice as the "comments should be received by" date.
7
-------
D. Comments Received After A Rule Is Signed
Comments received after the date of signature by the Administrator
of a final rule may be added to the rulemaking docket, but should be
put in a separate section and clearly designated as post-
promulgation documents.
Note: Although comments received after the Administrator
signs of a final rule may be part of the rulemaking docket, they
are not part of the administrative record.
E. Information Received After A Rule Is Signed
Generally, there is no official "closing" date for a rulemaking docket.
However, documents supporting a rulemaking must be completed on
the date that the rule is signed by the Administrator. (Completed
documents may still be proofed and typed after the rule is signed.)
Documents supporting a rule may be physically placed in the
rulemaking docket after the signature date. However, it is strongly
recommended that documents which support a rulemaking be
physically placed in the rulemaking docket by the signature date to
avoid disputes in challenges to the rule over when the documents
were completed.
F. Criteria for Referencing Information
When information is referenced, but not included in a rulemaking
docket, that information should be readily available to the public. If
the information is not readily available to the public from a source
outside the docket, a copy of the information should be placed in the
rulemaking docket. Generally, it will be easier for the Agency to
place information in the rulemaking docket than for the public to
trace it from a reference. Accordingly, information should be
included in the rulemaking docket whenever practical.
An important exception to this general rule pertains to Confidential
Business Information (CBI). CBI cannot be made available to the
public, but a statute may require that CBI be included in the
8
-------
rulemaking docket (e.g. the Clean Air Act). While the actual CBI
cannot be physically placed in the rulemaking docket, it can be
incorporated by reference. The actual CBI is maintained in a
confidential file. Reference to the CBI allows the information to be
included while not physically placing the CBI into the rulemaking
docket.
G. Program Procedures
Each program should develop written procedures to ensure that all
information supporting the final Agency rule is completed prior to
the signature date. Operational procedures could include one of the
following methods:
• Certification by the program office responsible for a
rulemaking action that the rulemaking docket is complete.
One operational method of securing certification is the use of
a form developed by the docket staff that is signed by both
the program office and the docket staff stating that the
rulemaking docket is complete.
• Review of the documentation by the Office of General Counsel
(OGC) through a written list of the documentation, such as
the docket index, developed by the docket staff for OGC
review and approval.
9
-------
IV. MATERIAL EXCLUDED FROM THE DOCKET
A. Deliberative Documents
The deliberative process privilege protects from public disclosure
certain intra- and inter-Agency documents that are part of a
decision-making process. .Such documents could include, but are not
limited to, the ACTION MEMO which transmits a regulatory package
to the Administrator for signature, briefing papers that discuss
various options for the Administrator's consideration, minutes or
notes on in-house meetings on regulatory options and drafts of the
proposed or final rule. As a general rule, such documents are not
included in the rulemaking docket. The determination as to whether
or not a particular pre-decisional, internal document should be
included in the docket can only be made on a case-by-case basis.
If the document is determined to be protected by the deliberative
process privilege, it may still be included in the rulemaking docket
if policy considerations so dictate. Accordingly, the Office of
General Counsel should be consulted when deciding whether these
documents are included in the rulemaking docket.
B. Materials Available from Other Sources
If materials maintained for public distribution by other sources
(e.g., other EPA offices that make information available to the
public, libraries, the Government Printing Office, and the U.S.
National Technical Information Service) are referenced, but not
included, in a docket, explicit instructions for accessing that
information must be contained in the reference to include, when
appropriate, the document title and document number and any other
pertinent information that will assist the public in accessing the
information.
10
-------
V. ACCESS
A. Program Staff Role
The program office is responsible for providing the rulemaking
docket with a complete, current record of ail rulemaking actions,
with background materials and public comment received, in order to
ensure the completeness and accuracy of the rulemaking docket.
Program staff responsibilities in the development of a rulemaking
docket also include the following:
• Inform the docket staff that a rulemaking will occur
requiring the development of a supportive docket.
• Produce and procure all program office, contractor and
Regional office materials relevant for docket development.
Review all materials for relevancy and confidentiality.
• Ensure that material is legible for duplicating (photocopy,
microfilming, etc.) and submit in an organized manner.
• Secure review of all rulemaking docket materials and indexes
by the Office of General Counsel and/or Office of Regional
Counsel prior to the Administrator's signature.
B. Docket Staff Role
The docket staff is responsible for processing docket materials in a
timely manner, and organizing it for secure storage, and convenient
retrieval.
Docket staff must also ensure the existence and availability of an
index. In the future, EPA may develop more coordination of docket
indexes so that access and retrieval methods will be standard
across dockets. Ideally, indexes will be automated, and will provide
many access points; such as title, subject, or date, for docket
information. Increased coordination in this area will not only
improve public access, but will also avoid the excess cost of
developing many different systems.
11
-------
C. Duplication Fees
In June 1988 a docket interim fee schedule draft policy was
approved by the Office of General Counsel and the Office of Financial
Management Division. Following are the fees set by the policy:
• If 266 pages or less are copied: No charge.
• If more than 266 pages are copied, an administrative fee
of $25.00 plus $.15 for each page starting with page 267.
The policy is based on the Agency's regulations implementing the
Freedom of Information Act fee schedule. If the Agency cannot
collect more in fees than it costs to process a fee, the fee will be
waived. The $25.00 amount reflects the cost to the Agency of
processing a fee.
D. Outreach
Each docket should provide users with information to help them
utilize docket materials. This information may be in the form of
policy and procedures manuals, brochures, indexes, or other
materials. Dissemination methods may be through on-site visits,
mailings, or other communication mechanisms focused on current
and potential docket users.
"A Pathfinder to Major EPA Dockets" is published annually by the
Information Services Branch, Office of Information Resources
Management, to improve access to docket information and improve
coordination between program dockets. The Pathfinder contains the
following information to guide users to docket information:
• Docket Name
• Description of scope and services
Ruling, Statute Authority Citations
• Content of Docket
• Location
12
-------
• Service Provided: Access services and hours open
• Contact: Name and Telephone
• Mailing Address
Staffing
• Security Clearance Requirements
• Automation (index)
• Records Retirement Schedules
• Freedom of Information Act Requests
13
-------
VI. RECORDS MANAGEMENT
The following section addresses Agency records management
procedures as well as good records management practices which
pertain to the Agency's active dockets.
A. Active Records
General elements of public docket filing practices must guarantee
the physical Integrity of the Agency's dockets at all times. It is
most important to have all docket material for each docket in one
location. The following techniques should be employed to help
assure complete documentation, and the continued integrity of that
documentation:
• EPA program staff should forward documents to the docket
staff for incorporation into the docket as soon as documents
are ready to be filed.
• New documents should be reviewed and classified on a daily
basis and placed in the proper files.
• Each dockets' file index must be maintained simultaneously
with docket updating to ensure the material is always
properly organized and accessible.
• No document should be removed from the public file during
the notice and comment process.
• When in use for reading or copying, documents in public files
should be controlled and charged out to the individual using
the documents. If there is no electronic system for charging
out documents then manual checkout procedures must be in
place. If a manual system is used, it is advisable to use a
Chargeout Record, Optional Form 23, which is filled out and
put in the files in the place of records being removed.
• Docket staff should immediately return information or
records to the files when it is no longer needed and activate
a periodic verification of charged records to ensure timely
return by program offices.
14
-------
• Either a pagination and binding system or a periodic program
staff verification process for every docket must be part of
routine operations to ensure continued integrity of the
docket.
• Routine maintenance such as: labeling replacement, repairing
of torn folders, etc., should be incorporated in the daily
procedures.
B. Retention and Disposal of Inactive Records
Inactive records should not be maintained in costly office space and
should be transferred to the Federal Records Center (FRC) in
accordance with the EPA Records Control Schedules. The Records
Control Schedules state the retention and disposition of the
Agency's records, which varies from docket to docket. The chart
below shows the particular Records Control Schedule that
corresponds to each docket and the item on the schedule where the
retention and disposition of the docket material can be found.
Copies of the schedules can be obtained from the Agency's Records
Management Office in the Office of Information Resources
Management. The Office is located in Room M2003.
Docket
Schedule
Schedule
Item Number
Central (Air) Docket Air Quality
Planning and
Standards
5
Drinking Water Docket Water Program
7
Pesticides Docket
Pesticide Program
46, 55
Public Information
Reference Unit Docket
Information and
Resources Management
24
Resource Conservation Solid Waste Program
and Recovery Act Docket
1 3
1 5
-------
Superfund Docket
Emergency and
Remedial Response
1 4
Toxic Substances
Docket
Toxic Substances
13
Underground Storage
Tank Docket
(Records for this program have
not been scheduled)
C. Retirement and Retrieval of Inactive Records
Once it has been determined through the use of the EPA Records
Control Schedules that docket materials have become inactive, they
can be retired to the FRC. Records that have been previously retired
to the FRC can be easily retrieved, usually in 24 hours. Both
retirement and retrieval of records must be done through the
Agency's Records Management Office. The Office provides
information on procedures for records retirement and retrieval on
request.
D. Safeguarding of Records
Due to the critical nature of the docket material, special care should
be taken to safeguard these records. The best possible way to
provide this protection without major impact on records storage
space is to number and bind all materials. Another approach is to
back up the record copy with another copy, either in hardcopy or
microform. This will safeguard against unforeseen destruction of
records material. Also, particular attention must be given to
records that contain sensitive information such as Privacy Act,
confidential business information, or enforcement sensitive
information..
E. Micrographic Management
Microform is an acceptable medium for storing docket material. Use
of any form of micrographics requires initial records arrangement
and quality review prior to filming, as well as film quality control
after filming to guarantee a quality product. Micrographics can
provide the solution to storage problems presented by paper copies,
and is an excellent method for backing up the record copy. Care must
16
-------
be taken in selecting a micrographics system, particularly for active
regulatory files, to ensure that the integrity of the record
sequencing and individual document identity are preserved both in
creation of the copy and during subsequent public access. If a
micrographic system is under consideration for a particular docket
operation, the approval of the Agency's Records Management Office
must be obtained. As outlined in the EPA Records Management
Manual, there are a number of requirements that must be met before
such a system can be developed. All mt'crographic systems must
conform with the requirements of 36 CFR Part 1230.
F. Records Management Assistance
Please contact the Agency's Records Management Office for further
information regarding any of the above sections. The records
management staff is always available to assist in any way it can
with records management concerns. The Office is located in M2003
in Waterside Mall and can be reached at 475-8675.
17
-------
DRAFT UNIFORM RULEMAKING DOCKET GUIDANCE
SUPPLEMENTARY REPORT
ON COMMENTS AND RESPONSES
Office: Office of Water ___
SEP '8/989
Representative: Cynthia Puskar
Docket: The Safe Drinking Water Act Docket
Comment: We question the response to our comment that in
Section III, B, "Types of Materials Included," the phrase
"The rulemaking docket may include, but is not limited to..."
should be changed to read "The rulemaking docket must or
should include but is not limited to..."
Response: The phrase has been changed to read: "The
rulemaking docket shall include, but is not limited to..."
Office: Office of General Counsel
Representatives: Paul Frazier, Mary Adler
Docket: The Clean Air Act (CAA) Docket
Comment: In Section III, B, "Types of Materials Included,"
the sentence "A copy of each proposed and/or final rule
signed by the Administrator" should be revised as follows:
"A copy of each proposed rule, final rule or other rulemaking
notice (e.g., Advanced Notice of Proposed Rulemaking) for a
regulatory action signed by the Administrator (or Assistant
Administrator in the case of a supplemental notice).
Response: This change was made.
Comment: In Section III, B, add comments from State
governments to the list of types of materials included.
Response: State comments were added.
Comment: In Section III, E, Information Received After A
Rule Is Signed, change "However, information supporting a
rulemaking..." to "However, documents supporting a
rulemaking..."
Response: This change was made.
-------
Comment: In Section III, E, Information Received After A
Rule is Signed, change the last sentence: "However, it is
strongly recommended that documents which support a
rulemaking be physically placed in the rulemaking docket by
the signature date to avoid disputes or challenges to the
rule." It should read:
"However, it is strongly recommended that documents which
support a rulemaking be physically placed in the rulemaking
docket by the signature date to avoid disputes in challenges
to the rule over when the documents were completed."
Response: This change was made.
Comment: In Section III, G, Program Procedures, it states
"Review of the documentation by the Office of General Counsel
(OGC) through a written list of the documentation developed
by the docket staff for OGC review and approval. Note that
the documentation may be a copy of the docket index.
Response: The statement was expanded to read: "Review of
the documentation by the Office of General Counsel (OGC)
through a written list of the documentation, such as the
docket index, developed by the docket staff for OGC review
and approval."
Comment: In Section VI, A, Active Records, there is an
apparent inconsistency. One statement is "No document should
be removed from the public file during the notice and comment
process." The next statement is "Documents being removed
from files should be controlled and charged out to the
individual removing the documents."
Response: The second statement was changed to read: "When
in use for reading or copying, documents in public files
should be controlled and charged out to the individual using
the documents."
-------
Docket Workgroup Meeting
September 19, 1989
Conference Center Room 8S
Agenda
RECAP PROGRESS
GOALS: Develop Workgroup
Develop general guidance to improve integrity and
consistency of Agency Dockets.
Study and plan for ongoing Docket coordination
objectives, including:
Forum for communication and networking.
Method of periodic review for continued
consistency.
Need for Agency-wide regulations on Docket
procedures.
Liasion with other Agency records management
initiatives.
PRIMARY PRODUCT: Guidance
Provides tool for ongoing coordination.
Developed in a legal framework that addresses statutory
differences.
States the need for documented standard operating
procedures for each docket.
-------
NEXT STEPS:
Report to Steering Committee
- Deliver Guidance.
- Note that it will be developed into policy for green
border review.
- State need for continued coordination.
- Note need for consolidate placement of dockets.
Develop Docket Policy.
- Request workgroup review.
- Initiate and monitor green border process.
ISB's role in coordination, FY 90:
- On request, consult with dockets on development of
procedures.
- On request, provide forum for communication on
docket-wide issues; e.g., fee collection procedures.
- Continue updating/production of docket pathfinder.
- Include dockets in any development of clearinghouse
issues.
- Provide assistance in automation of docket
information.
-------
PATHFINDER TO
MAJOR EPA DOCKETS UPDATE
DECEMBER 1987
(Revised)
PREPARED BY:
GLCRISJ BUTLER
INFORMATION SERVICES BRANCH
INFORMATION MANAGEMENT & SERVICES DIVISION
OFFICE OF INFORMATION RESOURCES MANAGEMENT
-------
CONTENTS
INTRODUCTION i
PUBLIC INFORMATION REFERENCE UNIT .... 1
CENTRAL DOCKET 2
RESOURCE CONSERVATION & RECOVERY ACT DOCKET 3
SUPERFUND DOCKET .... 4
Regional National Priority List Docket Contacts 5
DRINKING VWTER DOCKET 6
TOXIC SUBSTANCES DOCKET 7
PESTICIDES DOCKET 9
UNDERGROUND STORAGE TANK TICKET 10
-------
INTRODUCTION
Dockets are the official, legal files of rulemaking documents. They include: official statements of the Administrator's
position, represented by published rulemaking documents; information considered by the Agency during rulemaking,
transcripts of hearings; litigation records, and comments received from persons outside the Agency The Dockets are
open to the public in accordance with the requirements set forth in the Freedom of information Act (FOIA), 5 U S C. 552
The major dockets in EPA are (1) Public Information Reference Unit (Water, Air), (2) Central Docket (Air), (3) Resource
Conservation & Recovery Act (RCRA) Docket, (4) Superfund Docket, (5) Drinking Water Docket, (6) Toxic Substances
Docket, (7) Federal Insecticide, Fungictde & Rodenticide Act (Pesticides) Docket and (8) Underground Storage Tank
Docket. These Dockets and Freedom of Information Act (FOIA) materials are required to be maintained through provisions
of each of the regulatory statues they support. All supporting documentation must be indexed, filed and kept in a secure
location. They are retrieved when a visitor examines the index and requests a particular set of documents from the
Docket clerk -Most of the Dockets charge a reasonable copying fee for duplication (as specified upon FOIA requirements)
PURPOSE
This pathfinder is designed as a guide to the major EPA Dockets It should be of assistance to staff at EPA Headquarters,
Regional Libraries, other government agencies and the public who require information about EPA rulemakings
-------
PUBLIC INFORMATION REFERENCE UNIT (PIRU)
DESCRIPTION:
PIRU provides public access to regulatory information supporting the Agency's actions administered under (1) the Clean
Air Act (primarily, the State Implementation Plans), and (2) the Clean Water Act (pnmanly, the Effluent Limitation
Guidelines). Records are submitted to PIRU (indexed) by the programs within EPA or the Regions for public inspection
and photocopying. PIRU also has information supporting other ERA regulations issued under the following statutes:
Resource Conservation & Recovery Act (RCRA), Safe Dnnkmg Water Act, Noise Control Act and The Marine Protection,
Research and Sanctuaries Act
RULING, STATUTE AUTHORITY CITATION:
EPA Regs, are authorized by specific legislation of Congress: Clean Air Act Sec. 110,111(d), 202, 206, 208, 324, Clean
Water Act, Sec. 301, 402; Resource Conservation and Recovery Act (RCRA), Sec. 3011, Safe Drinking Water Act, Sec
1411,1412,1446, Noise Control Act, Sec 205, The Marine Protection, Research and Sanctuaries Act, Sec 102, 104(d)
CONTENT:
Background documents (scientific and technical), comments to regulatory actions, transcripts of public hearings,
correspondence
LOCATION:
EPA Headquarters Library
Office of Information Resources Management
Information Services Branch
Room 2904 on shelves B/01-13
SERVICE PROVIDED.
Responds to all public and government inquiries Most services provided are for walk-in visitors Open for inspecr-cn
and copying from 8 00AM to4 00PM
CONTACT:
oloris J Butler, (202) 382-5926
ADDRESS:
USEPA, PM-211D
401 "M- Street, SW, Rm. 2904
Washmgon, DC 20460
STAFFING:
1-Fulltime Employee
SECURrTY:
All records are available for public inspection. No security clearance is needed
AUTOMATION (INDEX):
Each record is indexed on an automated system (Lexitron)
AVERAGE MAINTENANCE TERM OF DOCKET BEFORE RETIRING TO FEDERAL RECORD CENTER (FRC):
Most are retained for 1-year after final ruling, then returned to Program for FRC arrangement. Others, such as Mobile
Sources, are retained indefinitely because earlier model cars are still available. Those records involved with RCRA are
retained for only the 30-day comment period, but can be retained longer if comment period is extended
FOIA REQUEST
All PIRU's requests for information are from walk-in visitors. All FOIA requests are forwarded to the FOIA Office for
processing.
1
-------
CENTRAL DOCKET
DESCRIPTION:
Central Docket, administratively, is in the Office of General Counsel. It provides public access to regulatory information
which supports the Agency's actions administered under the Dean Air Act. Program offices are required to provide
indexes to the regulations. Indexing of the comments is done by Central Docket. Documents are entered into the docket
in the appropriate category and given a sequential docket number as they become available. The docket consists of files
containing a series of file folders for each category of documents. Most of the records are on microfilm.
RULING, STATUTE AUTHORITY CITATIONS:
Clean Air Act, Section 307A 103,104. 105. 106, 108, 109,110, 111, 112, 113, 114, 118, 119, 120, 122, 123, 124, 126.
CONTENT:
Contains files: (1) related to Federal Register notices and rulemakings of Clean Air Act; and (2) mandated by Clean Air
Act Amendments of 1977 with rulemaking information consisting of comments, transcripts, and scientific and technical
reports developed by EPA contractors.
LOCATION:
Room 4, S. Conference Center
SERVICE PROVIDED.
Responds to all public and government inquiries Open to public for viewing and copying from 8 00 a m - 3 30 p m
CONTACT
Jacqueline Brown, (202)332-7548
ADDRESS.
USEPA, LE-131
401'M" Street, SW
Rcom 4, S Conference Center
Washington, DC 20460
STAFFING.
1 Fulltime Employee
SECURITY:
Records are available for public inspection. No security clearance is needed
AUTOMATION (INDEX):
Indexes are automated on Lexitron.
AVERAGE MAINTENANCE TERM OF DOCKET BEFORE RETIRING TO FEDERAL RECORD CENTER (FCR):
6-Months
FOIA REQUEST:
FOIA requests received by Central Docket are forwarded to FOIA Office for processing.
2
-------
RESOURCE CONSERVATION & RECOVERY ACT DOCKET
DESCRIPTION:
The Resource Conservation & Recovery Act (RCRA) Docket provides public access to regulatory information supporting
the Agency's actions under the Resource Conservation and Recovery Act (RCRA). Records support Federal Register
notices, Delisting Petitions and other Office of Solid Waste (OSW) publications. RCRA Docket publishes a semiannual
catalog of frequently requested documents.
RULING, STATUTE AUTHORITY CITATION:
Resource Conservation & Recovery Act (RCRA), Sec. 3011
CONTENT:
Background and support documents, RCRA Federal Register notices, comments to regulatory actions, correspondence/
memoranda transcripts of public hearings, Delisting Petitions, Administrative Records, policy directives, Health and
Environmental Effects Profiles (HEEPs), OSW publications and guidance documents
LOCATION:
RCRA Docket
LG-100 Mall
SERVICE PROVIDED:
Docket hours 9.00 A M -4.00 P M - appointments necessary Open to public for viewing and copying Assists in
distribution of OSW publications
CONTACT:
Carol Brock-Johnston, Kathy Bruneske, Mildred Tidwell, (202) 475-9327
ADDRESS
USEPA, RCRA Docket (WH-562)
401 "M* Street, SW
Washington DC 20460
STAFFING:
3-Fulltime Employees
SECURITY:
All records are available for public viewing No security clearance necessary
AUTOMATION (INDEX):
Automated inventory. No public access to automated system
AVERAGE MAINTENANCE TERM OF DOCKET BEFORE RETIRING TO FEDERAL RECORD CENTER (FRC).
No existing policy.
FOIA REQUEST:
Requests for RCRA Docket information are received in writing, and through telephone requests, walk-in requests and
the Superfund/RCRA HOTLINE (800) 424-9346. FOIA requests received by RCRA Docket are forwarded to the FOIA Office
for processing
3
-------
SUPERFUND DOCKET
DESCRIPTION:
The Superfund Docket provides public access to information supporting all regulatory decisions issued under the
Comprehensive Environmental Response, Compensation, Liability Act of 1980 (CERCLA), as amended. This includes
records of proceeding under the Emergency Planning and Community Right-to-Know Act of 1986, Title III of the
Superfund Amendments and Reauthorization Act (SARA) of 1986. The Docket also includes CERCLA guidance
documents and information supporting rulemaking under authority of Section 3012 of the Resource Conservation &
Recovery Act.
RULING, STATUTE AUTHORITY CITATION:
Clean Water Act, Sec. 311; Comprehensive Environmental Response, Compensation, Liability Act of 1980 as amended
by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 103, 104,105, 111, 112; Title III of SARA,
the Emergency Planning and Community Right-to-Know Act Of 1986, and the Resource Conservation and Recovery Act
(RCRA), Section 3012.
CONTENT:
Background data, comments on regulatory actions, Federal Register notices, transcnpts of public hearings, support
documents for regulatory decisions, correspondence/memoranda, Administrative Records, Superfund Program
directives Current Rulemakings* National Contingency Plans and Revisions, National Priority List (NPL) and Revisions,
Reportable adjustments and Revisions; Arbitration Procedures and Natural Resource Claims Procedures, Deletion of
States from NPL, Discharge Regulations, Emergency Planning Programs and Community Right-to-Know, Records of
Decision, Remedial Investigations and Feasibility Study Documents; Radionuclides Regulations, and Carcinogen
Regulations
LOCATION:
Superfund Docket
LG-100 Mall
SERVICE PROVIDED:
Responds to all inquiries; visits by appointment Open to public for viewing and copying from 9 00 A M to 4 30 P M
Superfund/RCRA HOTLINE. (800) 424-9346
CONTACT:
Tina Maragousis, Superfund Docket Clerk, (202) 382-3046
Deena Watson, Superfund Directives Clerk, (202) 382-3046
Dick Hyde, Project Manager, (202) 475-9334
ADDRESS:
USEPA Superfund Docket (WH-548D)
401 *M" Street, SW, Lower-Garage
Washington, DC 20460
STAFFING:
2 Fulltime Contractors
SECURITY:
All records available have had prior Office of General Counsel (OGC) approval and therefore are available to public for
viewing Docket room is locked. All documents are housed in lockable file cabinets No security clearance necessary
AUTOMATION (INDEX):
Lexitron Indexes updated daily Inventory automation proiected for 1988
4
-------
AVERAGE MAINTENANCE TERM OF DOCKET BEFORE RETIRING TO FEDERAL RECORD CENTER (FRC):
Retained indefinitely for support of pending related lawsuits.
FOIA REQUEST:
FOIA requests received by Superfund Docket are forwarded to the FOIA Office for processing
SUPERFUND
ERA'S Regional National Priority List (NPL) Docket Contacts
Tina Maragousis
Barry Nash
USEPA, Superfund Docket (WH-548D)
USEPA, Region 6
401 'M* St., SW, Rm LG-100
Allied Bank Tower
Washington, DC 20460
1445 Ross Ave
(202) 382-3046 (CML)
Dallas, TX 75202-2733
(8) 382-3046 (FTS)
(214) 655-6740 (CML)
(8) 255-6740 (FTS)
Peg Nelson
Constance McKenzie
USEPA, Region 1, Library
USEPA, Region 7, Library
JFK. Federal Bdg , Rm E121
726 Minnesota Ave
Boston, MA 02203
Kansas City, KS 66101
(617) 565-3000 (CML)
(913) 236-2828 (CML)
(8) 835-3000 (FTS)
(8) 757-2828 (FTS)
Carole Peterson
Dolores Eddy
USERA, Region 2
USEPA, Region 8, Library
Site Investigation & Compliance Branch
999 18th St., Suite 1300
26 Federal Plaza, 7th FL, Rm 737
Denver, CO 80202-2413
New York, NY 10278
(303) 293-1444 (CML)
(212) 264-8677 (CML)
(8) 564-1444 (FTS)
(8) 264-8677 (FTS)
Diane McCreary
Linda Sunnen
USEPA, Region 3, Library
USERA, Region 9, Library
841 Chestnut Bdg., 5th Fl.
215 Fremont St., 6th Fl
9th & Chestnut Sts.
San Francisco, CA 94105
Philadelphia, PA 19107
(415) 974-8082 (CML)
(215) 597-0580 (CML)
(8) 454-8082 (FTS)
(8) 597-0580 (FTS)
Gayle Alston
David Bennett
USERA, Region 4, Library
USEPA, Region 10
345 Courtland St, NE, Rm G-6
1200 6th Ave , 11th Fl
Atlanta GA 30355
Seattle, VUA 98101
(404) 347-4216 (CML)
(206) 442-2103
(8) 257-4216 (FTS)
(8) 399-2103
Jeanne Griffin
USERA, Emergency & Remedial
Response Branch, Region 5
230 South Dearborn St, 11th Fl
Chicago, IL 60604
(312) 886-3007 (CML)
(8) 886-3007 (FTS)
5
-------
DRINKING WATER DOCKET
DESCRIPTION:
The Drinking Water Docket currently contains information on the following regulatory phases: (1) Volatile Organic
Chemical (VOC) (Phase I); (2) Fluoride (Phase IIA); (3) Synthetic Organic Chemicals (SOC) (Phase II); (4) Surface Water
Treatment Rule (SWTR) and (5) Radionuclides (Phase III). Others will be developed as new Maximum Contaminant Level
Goals (MCLG) and Maximum Contaminant Levers (MCL) are proposed.
The above consists of supporting documentation used to develop each regulation These materials include appropriate
Federal Register notices, letters, public heanng transcripts, National Drinking Water Advisory Council materials, public
comments, technical support documents, and other matenaJs. An index to each record has been developed to facilitate
location and review of these matenals.
RULING, STATUTE AUTHORITY CITATION:
These regulations are developed under the authority of the Safe Drinking Water Act (SDW4), Section 1412
CONTENT:
These Dockets consist of all matenals used to develop MCLG and MCL regulations under the Safe Drinking Water Act
LOCATION:
Office of Drinking Water, WH 550-D
East Tower Basement, Room EB-49
SERVICE PROVIDED:
All materials may be reviewed at the above location It is advisable to call first to ensure access to the docket when you
arnve Materials may be copied for twenty cents per page Telephone and mail requests are accepted
CONTACT:
Patricia Minami, Docket Manager, (202) 475-9598
For access to Doteket Room, caii between 9 00 A M and 4 00 P M.
ADDRESS:
USEPA
Office of Drinking Water, WH-550D
401 *M* St., SW, Rm. EB-15
Washington, DC 20460
STAFFING:
1-Part-Time Employee
SECURITY:
All materials are available for public review in room EB-15. Security or Confidential Business Information (CBI) clearances
are not required.
AUTOMATION (INDEX):
There is a pnnted index to each area of the docket to facilitate the review and location of docket materials.
AVERAGE MAINTENANCE TERM OF DOCKET BEFORE RETIRING TO FEDERAL RECORD CENTER (FRC):
At the present time the Office of Drinking Water Dockets are not sent to the Federal Record Center
FOIA REQUESTS:
All FOIA requests are forwarded to the EPA FOIA Office for processing
6
-------
TOXIC SUBSTANCES DOCKET
DESCRIPTION:
The Office of Toxic Substances (OTS) Public Information Office houses the official copies of all OTS administrative
records supporting regulatory decisions promulgated under the Toxic Substances Control Act (TSCA) The Public
Information Office also maintains original matenals submitted by industry in compliance with TSCA regulations. All of
the records maintained in the office are available to the public for review and copying.
RULING, STATUTE AUTHORITY CITATION:
The Toxic Substances Control Act, 15 USC 2601, October 11, 1976.
CONTENT:
The contents of the dockets-vary according to the proposed regulation and the particular Section of the Act which is
being promulgated However, generally all dockets contain the following types of supporting documentation Federal
Register notices; vanous health, environmental and exposure assessment documents; published references,
communications; records/transcripts of public and informal meetings; records of informal hearings, public comments,
and test data.
LOCATION:
OTS Public Public Information Office,
Northeast Mall, Room G-004
SERVICE PROVIDED:
The Public Information Office is managed by the Public Information Section within the Chemical Information Branch
Information Management Division, Office of Toxic Substances Access to records is provided by Section staff upcn
request The Public Information Section maintains and operates a public reading room where EPA staff and Agency
visiters may review and copy records The reading room is equipped with a high speed photocopier, fiche to 'iche cco.e'
fiche viewers and reading tables for the convenience of the users. Section staff provide the responsive records upor
request and answer technical questions pertaining to the records in their possession The Reading Room is open to the
public be* -een the hours of 8 00 A M and 4 00 P M Monday-Friday Staff members are available to assist Agency
personnel between the hours of 7 30 A.M and 5 00 P M
CONTACT:
Deborah Williams, (202) 382-3587
ADDRSSS:
USEPA, TS 793
401 "M" Street, SW, Rm G-004
Washington, DC 20460
STAFFING:
B-Fulttime Employees
SECURITY-
All records located in the Public Information Office are of a nonconfidential nature However, only staff members are
permitted direct access to the record storage area.
AUTOMATION (INDEX):
An index is prepared for each docket established The index cites each document contained in the docket and constitutes
the official record of docket content An automated system for docket indexing is being deve'oced Evpeced svste—
oe'uery date December 1SS7
7
-------
AVERAGE MAINTENANCE TERM OF DOCKET BEFORE RETIRING TO FEDERAL RECORD CENTER (FRC):
No dockets are retired. Dockets from 1977 thru the present are available. Most 1977-1982 docket are available on
microfiche.
FOIA REQUEST:
All FOIA requests are forwarded to the FOIA Office for processing.
8
-------
PESTICIDES DOCKET
DESCRIPTION:
This Docket provides public access to documentation for each Registration Standard under development when the
Agency begins review of data for the Registration Standard or upon publication of a notice setting out the list and
sequence of Registration Standards. The docket also contains documentation of pre-special and special reviews of
pesticides.
RULING, STATUTE AUTHORITY CITATION:
The Federal Insecticide, Fungicide, and Rodentiade Act (FIFRA), Sec. 4, 40 CFR Part 155, Pesticide Registration
Standards; Docketing and Public Participation, Final Rule and 40 CFR Part 154; Special Reviews of Pesticides, Criteria
and Procedures; Final Rule.
CONTENT:
Memorandums describing each meeting between Agency personnel and any person or party outside of government
which concerns a pending pesticide regulatory decision. All comments, correspondence, or other materials concerning
a pending pesticide regulatory decision provided to the Agency by a person or party outside of government (other than
confidential business information) All documents, proposals, or other matenals concerning a pending pesticide
regulatory decision, provided by the Agency to any person or party outside of government (other than confidential
business information)
LOCATION:
Information Services Branch
Crystal Mall #2, Room 244
CONTACT:
Franklin D Rubis, (703) 557-4434
ADDRESS:
USEPA, TS-757-C
Information Services Branch
401 "M* St., SW
Washington, D.C. 20460
STAFFING:
1-Fulltime Employee
SECURITY:
Some records contain confidential business information that is not available to the public However, others are
non-confidential and are available for public review
AUTOMATION (INDEX):
An index is prepared for each docket established. The index ates each document contained in the docket and constitutes
the official record of docket content.
AVERAGE MAINTENANCE TERM OF DOCKET BEFORE RETIRING TO FEDERAL RECORD CENTER (FRC).
At the present time the Pesticides Dockets are not sent to the Federal Record Center
FOIA REQUEST-
All FOIA requests are forwarded to FOIA Office for processing
9
-------
UNDERGROUND STORAGE TANK DOCKET
DESCRIPTION:
The Underground Storage Tank (UST) Docket provides public access to regulatory information supporting the Agency's
regulatory actions on underground storage tanks As of October 1, 1987, there are five dockets: (1) UST Notification, (2)
Technical Standards; (3) Financial Responsibility Requirements; (4) State Program Approval; and (5) the Report to
Congress on Exempt Tanks.
RULING, STATUTE AUTHORITY CITATIONS:
Resource Conservation and Recovery Act Amendments of 1984, Subtitle I ("eye")
LOCATION:
UST Docket
LG-100 Mall
SERVICE PROVIDED:
Responds to inquiries regarding regulatory documents, visits by appointment only Open to public for viewing and
copying from 9:00 AM to 12 30 P M. and 1.30 to 5.00 P.M
For answers to specific questions, call the UST HOTLINE (800) 424-9346
CONTACT:
Karen Baker
UST Docket Clerk, (202) 475-9720
ADDRESS:
USEPA, UST Docket (WH-562A)
401 "M" Street, SW, Lower-Garage
Washington, DC 20460
STAFFING:
1 Fulltime Contractor
SECURITY:
All documents are available for public viewing No security clearance is necessary All documents are housed in locked
file cabinets
AUTOMATION (INDEX):
There is a printed index to each docket to facilitate the review and location of docket materials An automated system
is not currently available
AVERAGE MAINTENANCE TERM OF DOCKET BEFORE RETIRING TO FEDERAL RECORD CENTER (FRC):
There are no plans to retire dockets. Dockets will be retained as necessary to support the final regulations
FOIA REQUEST:
FOIA requests received by the UST Docket are forwarded to the FOIA Office for processing.
10
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D C 20450
FEB 2 7 1989
THE ADMINISTRATOR
MEMORANDUM FOR: All EPA Employees
SUBJECT:
Conduct of the Agency's Business
I look forward to meeting and working with many of you
as I take up my duties as Administrator of the Environmental
Protection Agency.
Together, as a team, we must tackle some of the most
pressing and vexing problems that confront our nation and, as
we have become acutely aware in recent years, our planet.
The very health and well-being of millions of people depend
on the decisions we make and the effectiveness with which we
pursue our mission. We at EPA, indeed the federal
government, cannot alone do all that is necessary. We must
continue to build strong working partnerships with state and
local agencies, with citizens and public interest groups, with
the environmental community, with business councils and trade
and professional associations, with scientists, and with many
others who have important roles to play in protecting public
health and the environment.
My immediate predecessors, Lee Thomas and William Ruckelshaus,
offered guidelines for EPA staff contacts with people outside
the Agency, and I wish to affirm them. The success of our
efforts at EPA directly depends on the trust of the public we
serve. We must seek at all times to earn and maintain that
trust, and we must conduct our business openly and fairly,
responding as best we can to the needs of the people we
serve. The guidelines below should maintain the fairness and
openness of our procedures and thus strengthen public
confidence in our decisions.
-------
-2-
General Principles
EPA must provide, in all its programs, for the fullest
possible participation by the public in our decisionmaking.
This requires not only that EPA staff remain open and
accessible to those representing all points of view, but also
that EPA employees responsible for decisions take affirmative
steps to seek out the views of those who will be affected by
the decisions. EPA will not accord privileged status to any
special interest, nor accept any recommendation or proposal
without careful, critical examination.
Appointment Calendars
To keep the public fully informed of my contacts with
interested parties, a copy of my appointment calendar for
each week will be placed in the Office of Public Affairs,
available to whomever is interested at the end of the week.
The Deputy Administrator, and all Assistant Administrators,
Associate Administrators, Regional Administrators, and Staff
Office Directors similarly shall make their appointment
calendars available.
Litigation and Formal Adjudication
EPA is engaged in a wide range of litigation, both
enforcement and defensive in nature. All communication with
parties in litigation must be through the attorneys assigned
to the case. Program personnel who receive inquiries from
parties in matters under litigation must immediately notify
the assigned attorney, and refer the caller to that attorney.
Formal adjudications, such as pesticide cancellation
proceedings, are governed by specific requirements concerning
ex parte communications, which appear in the various EPA rules
governing those proceedings. These rules are collected and
available in the Office of the General Counsel, Room 537 West
Tower. I will conduct myself in accordance with these rules,
and I expect all EPA employees to do the same.
Rulemaking Proceedings
In rulemaking proceedings under the Administrative
Procedure Act, EPA employees must ensure that the basis for
the Agency's decision appears in the public record.
Therefore, be certain (1) that all written comments received
from people outside the Agency (whether during or after the
comment period) are entered in the public record for the
rulemaking, and (2) that a memorandum summarizing any
significant new factual data or information likely to affect
the final decision received during a meeting or other
conversations also is placed in the public record.
-------
-3-
You are encouraged, consistent with statutory
responsibilities, to reach as broadly as possible for views
to assist you in arriving at final rules. You should do so,
however, in a manner that ensures that final decisions are
supported by the public.record and the Agency's rationale is
fully explained in the preamble to the final rule. This does
not mean that you may not meet with one special interest
group without inviting all other interest groups to the same
meeting, although all such groups should have an equal
opportunity to meet with EPA. It does mean, however, that
any oral communication regarding significant new factual data
or information affecting a rule, including a meeting with an
interest group, should be summarized in writing and placed in
the public record. In addition to these guidelines,
procedures have been established with OMB to ensure that
relevant material received by OMB from outside parties will
be placed in the EPA public record.
Communications Generally
I am confident that I can rely on EPA staff to use
common sense and good judgement in communicating with the
public. The openness and integrity with which we deal with
the public is essential to ensuring public trust in the Agency.
I firmly believe in developing and maintaining an
effective communications capability. The Agency has taken
important steps to strengthen these capabilities, and I want
to see continuing emphasis on communications planning,
including commitment by the programs and the regions of
appropriate personnel and other resources to achieve this.
In dealing with the press, EPA staff should be open and
accessible; none of our goals is well served by limiting
contact with the press. Those who speak to the press should
concern themselves only with their particular area of expertise.
Please inform your Assistant Administrator's office and the
EPA Press Office promptly about all such conversations with
the press.
Finally, all communications materials, written and audio-
visual, produced for public dissemination should be developed
in coordination with the Office of Public Affairs, which is
to assure they are done cost-effectively, done in-house or by
outside contractors as warranted, and are consistent with EPA
graphic standards and a number of OMB directives on such
materials.
-------
-4-
We have entered a new era in which I expect EPA to play
a leading role in developing solutions to complex
environmental problems and in strengthening our already firm
commitment to achieving steady, tangible environmental
progress. In my dealings with EPA staff to date, I have been
thoroughly impressed with the professionalism and dedication
of everyone. I find myself energized by the challenge ahead,
and look forward to working with you all to imppove-^he
quality of our environment. /
,1
is ^ Reilly^ J
Ls William K.
-------
WRITING A LEGALLY
DEFENSIBLE RULE
-------
XN !5H3
HOW TO WRITE A LEGALLY DEFENSIBLE RULE
I. Why is this important? People don't always agree with us.
II. How does someone challenge an EPA rule? By suing us in a
Federal Court. This is politely referred to as "seeking
judicial review."
III. How does judicial review work?
Under the Administrative Procedure Act generally, and most
of EPA's statutes specifically, people can challenge EPA's
actions in a Federal Court. Most of these challenges are
to EPA rules, and in most cases EPA's rules are reviewed in
a U.S. Court of Appeals by a panel of 3 judges.
Review of most agency actions in "on the administrative
record." In the case of a rule it is the rulemaking record
or docket. The challengers write briefs, EPA writes briefs,
and there is oral argument before the Court.
The Court can usually only consider what is in the administra-
tive record and must base its decision on that record.
There are no witnesses, no exhibits, no dramatic confessions.
EPA cannot come up with reasons or information in a brief
that it did not state in the record — this is referred to
as post hoc rationalization.
The Court can either uphold EPA's action or find it is flawed
and return it to the agency in some fashion, usually referred
to as a "remand."
IV. Standards for judicial review.
Many EPA statutes have their own standards for judicial
review, and the APA sets forth standards as well. In essence
courts can invalidate agency action if it is contrary to law,
if the action is arbitrary and capricious, or if the action
is not supported by substantial evidence in the administrative
record. The standards may be articulated in a variety of
ways, but they all boil down to proper legal interpretation,
proper procedure, and a reasonable basis for the action
taken.
-------
-2-
V. What does a Court consider in judicial review?
A. Statutory Interpretation
A Court looks at issues concerning whether the agency has
properly interpreted its statutory authority to do what it
did. As a general matter, courts defer to an agency's inter-
pretation of its own statute unless it is off the wall or
flies in the face of clear legislative history. Judges
feel comfortable with these "legal" issues.
B. Procedural errors.
The Administrative Procedure Act contains a number of
requirements for rulemaking, and EPA's statutes often add
procedural requirements. For rulemaking generally these
include notice and an opportunity for public comment and
can also include public hearings. There are exceptions
to these requirements, but they are narrowly construed.
Judges are usually lacking in technical background and thus
are most comfortable with procedural matters. Accordingly,
they are more likely to overturn EPA for procedural errors
or insufficiencies. These are pure "legal" issues.
Thus it is extremely important to go through the proper
procedures.
Many things are "rules" under the APA. For example, the
APA does not discuss "guidance" documents. A problem
arises when "guidance" is really a rule because of its
binding effect on others outside EPA. If the guidance has
not been adopted through notice and comment rulemaking
procedures, it may be thrown out.
If the action is a rule, make sure you have complied with
the APA notice and comment procedures. If an exception
applies, such as for procedural rules or rules which are
promulgated without comment based on a public interest
finding, make sure the reason is stated in the rule and
finding is properly supported. Remember that courts are
strongly biased in favor of notice and comment rulemaking.
EPA's own statutes add other requirements for hearings or
contents of the docket or rulemaking record. Make sure those
are followed as well.
It is embarrassing to have a rule overturned on strictly
procedural grounds, since all the work is essentially wasted.
C. Findings.
Many EPA statutes require that EPA make certain findings to
issue a rule. Courts can overturn a rule easily if EPA does
not make all the required findings.
-------
-3-
D. Support for the agency's action.
If the agency has properly interpreted its authority, has
followed the appropriate procedure, and has made all of the
required findings, the court can only look at whether there
is adequate support for the agency's action in the adminis-
trative record. This includes both the rationale and the
factual support for the action. As a general matter, in
complex technical matters, courts defer heavily the the
Agency's "expertise." This is only overcome when the agency
does not have a plausible rationale or factual support for
itself.
-------
MAY 1988
RESPONDING TO PUBLIC COMMENTS
A. The Administrative Procedure Act states that the Agency must
provide an opportunity for public comment, and the Agency
has to consider those views. It also says that the rule
must have a concise statement o£ basis and purpose. Be sure
to lay out the thought process that resulted in the proposed
rule. The rationale in the preamble for why you did what
you did may be more important to a reviewing court than the
actual provisions of the rule. Discuss the problem, the
alternatives you considered, the one you chose, and why.
B. The question often arises whether certain changes from the
proposal can be made in the final rule in response to
comments or whether you have to allow the public to "comment
on the comments." The answer is generally "no"; such
changes are valid as long as they are a "logical outgrowth"
of the proposal.
C. Thus, in some ways, the proposal is even more important than
the final rule because a good proposal that lays out
alternative options, in addition to the proposed option,
will give you the latitude to make changes in the final rule
without having to repropose. Thus, a little extra time and
effort in preparing the proposal can often save time in the
long run by obviating the need to repropose. Don't just ask
for comment at the end of the proposal; identify specific
issues and alternatives where comment would be particularly
useful. Sometimes a supplemental notice, rather than a full
reproposal, is adequate to solicit comment on other
alternatives or new data.
D. What constitutes a reasonable comment period depends on
several factors, including the complexity of the issues and
time pressures created by statutory or judicial deadlines.
Make sure the record is complete at proposal so commenters
may review it. Try to accommodate late comments, if at all
possible.
E. The law requires-that the Agency to provide a written
response to all significant comments. What constitutes a
significant comment is a judgment call; however, it is
always better to err on the side of comments. Favorable
comments do not need a response. Responses should be
thoughtful, reflecting that you took the comment seriously;
it should indicate whether the Agency has changed the final
rule in response, and if not, why not.
-------
F. You should respond to major comments in the preamble to the
final rule. In fact, that is a good way to organize the
preamble: for each provision in the final rule, explain
what the Agency proposed, what kind of comments we received,
and what we did in the final rule to respond to those
comments.
G. For most rules of any size, the Agency usually prepares a
Response to Comments document that presents a more complete
response to the comments received. You should organize this
document carefully; otherwise you will find yourself
responding to the same comment over and over, or you will
neglect to respond to some comments. Cutting up the
comments and grouping them together by issue, and then
writing one response, often works best.
-------
SCIENTIFIC
INFORMATION
-------
ENFORCEMENT
-------
ENFORCEMENT
SIX POINT CHECKLIST
FOR WRITING ENFORCEABLE RULES
TERRELL HUNT
1. Have you included substantive standards in both the preamble AND the text?
2. Have you included the essential terms? Who is subject to this rule? What is being
regulated, and are terms clearly defined in the regulation?
3. Have you clearly defined the scope and applicability of the rule? Is it clearly tied
to a statutory authority that authorizes or requires the agency to promulgate the rule?
4. Have you set forth standards of performance?
5. Have you established and stated your monitoring requirements, inspection authority,
and reporting requirements?
6. Have you provided a means for demonstrating compliance with performance
standards?
-------
,U0
\ UNITED STATES ENVIRONMENTAL PROTECTION AGENC*
WASHINGTON, D.C. 20460
V»
AUG I 5 1985
OFFICE OF ENFORCEMENT
AND COMPLIANCE
MONITORING
MEMORANDUM
SUBJECT:
FROM:
Issuance of Enforcement Considerations for Drafting
and Reviewing Regulations and Guidelines for
Developing New or Revised Compliance and Enforcement
Strategies
and
Courtney M. Price
Assistant Administrator for Enforcement
Compliance Monitoring
TO:
Assistant Administrators
Office of General Counsel
Attached is a guidance package containing: 1) enforcement
considerations for drafting and reviewing regulations; and
2) guidelines for developing new or revised compliance and
enforcement strategies.
Staff members from both the compliance program offices
and the Associate Enforcement Counsel offices assisted with
developing the checklists. My staff interviewed legal and
technical enforcement personnel and incorporated their comments
into the guidance package as well as comments from the review
of draft checklists.
The guidance should encourage consistant consideration of
minimal enforcement requirements during regulation development.
In addition, the guidance may assi«t with initial enforcement
of a new or revised regulation by providing minimal considera-
tions for developing compliance and enforcement strategies
appropriate to the regulations.
To implement this guidance, I have requested all Associate
Enforcement Counsels to distribute copies of this guidance to
all enforcement attorneys responsible for the enforcement aspects
of regulation development. I encourage you to distribute copies
of this guidance to your national program managers and Associate
General Counsels and any staff who are responsible for regulation
development.
Attachment
-------
Part II Guidelines for Identifying the Need for and Developing
New or Revised Compliance and Enforcement Strategies
PURPOSE
This guidance provides a checklist for OECM and Program
Offices to evaluate the need for new or revised compliance and
enforcement strategies, assess the appropriate timing for
completing those strategies, and determine the scope of strategies
that need to be developed.
Work group members may use this checklist during the
options selection process of regulation development to ensure
that new or revised compliance and enforcement strategies are
developed concurrent with the regulation and that pertinent
issues are considered in developing the regulation. Because
each Agency program office or enforcement office identified in
a compliance and enforcement strategy has had a representative
on the work group developing the regulation, a new or revised
strategy should include a discussion of which office is respon-
sible for each part of the strategy.
This guidance amplifies the May 1984, "Strategy Framework
for EPA Compliance Program" and the October 1984 memorandum
from the Deputy Administrator on the strategic planning process
for compliance and enforcement within EPA.
APPLICABILITY
This auidance is limited to developing new or revised
compliance and enforcement strategies for:
1. New program initiatives within the Agency;
2. New statutory responsibilities delegated to the
Agency;
3. Revisions to existing regulations that a program
office determines will have a significant effect
on an ongoing program; and
4. Programs with existing strategies that are not
producing adequate environmental results.
A compliance and enforcement strategy or revisions in
selected components of an existing strategy would not be
necessary for every revision of an existing regulatory program.
For example, a compliance and enforcement strategy would not
be needed for each new or revised effluent guideline.
-------
I
CHECKLIST FOR IDENTIFYING THE NEED FOR AND DEVELOPING
A NEW OR REVISED COMPLIANCE AND ENFORCEMENT STRATEGY
I. Assessing the Need for New or Revised Strategies;
A. Does the new regulation significantly change any of
the components of existing compliance and enforcement
strategies? Does the new regulation require a clarifi-
cation of any of the elements of the existing compliance
and enforcement strategy?
B. Will the new regulation cause a readjustment in program
goals and priorities to achieve the environmental bene-
fits of the program?
C. Is the regulated community covered by the new regulations
sufficiently different from the existing regulated
community that a new strategy is needed to identify
the specific sources that are required to come into
compliance and tp maintain data on the compliance
status of those sources?
D. Is the requlated community or the nature of the require-
ments sufficiently different from the existing program
to require a new or revised strategy for promoting
compliance within the regulated community through
effective communication of the new requirements? Is
special technical assistance/guidance required to
assist facilities that wish to come into compliance?
E. Is the existing strategy producing adequate environmental
improvement as measured by reduced levels of pollution,
reduced threats to public health, or improved environ-
mental quality?
F. What methodologies has the program chosen to monitor
compliance?
1. Will these require a new or amended strategy for
implementation?
2. Are there new requirements for self-monitoring,
reporting and record keeping?
3. Will inspectors need new or different training to
assess compliance under the new regulations?
4. Will the program need to develop a new or revised
compliance assurance program for assessing performance
data on compliance?
-------
5. Is the program office clear about what type of inspec-
tions it expects and whether the existing levels
and types of commitments for inspections in the
existing strategy will include or accommodate the
new requirements?
G. Will the new regulations require a different enforcement
response than that specified in the existing compliance
and enforcement strategy?
1. Are there new statutory authorities or Agency
policies that are sufficiently different to require
an amendment to the current compliance and enforce-
ment strategy?
2. Has the program anticipated the need for a concerted
compliance and enforcement initiative timed with the
effective date of the regulation to establish the
credibility and integrity of the new requirement?
3. Is the role of the criminal enforcement office clear?
H. Has the program office considered coordination between
state and federal compliance and enforcement activities?
Will the states be prepared to pick up responsibility
for this program? Is the program adequately funded
and is its priority identified for purposes of grant
negotiations?
I. Do the agency management and evaluation systems have
adequate statistics to assess whether compliance is
being achieved with the new requirements? Do inspection
targets, definitions of significant noncompliance, and
other agency tracking systems need revision?
II. Assessing the Timing and Resources Requirements of any
Needed Compliance and Enforcement Strategy
Timing of any new or revised compliance and enforcement
strategy may be critical for implementing the regulation. The
questions below are formulated to help a work group assess
whether all or parts of the strategies need to be developed
concurrently with a regulation or shortly thereafter to develop
a schedule for completing the compliance and enforcement strategy.
A. Has the program office considered the implementation
and resource requirements of the compliance monitoring
strategies to assess whether the regulation will support
the compliance and enforcement strategy? Considerations
should include:
1. Ease of determining compliance;
-------
2.
Need for any special training for EPA or State
personnel;
3. Availability of instrumentation for monitoring
performance;
4. Availability of extramural contract funds or
equipment for on-site monitoring or test sampling
during inspections; and
5. Cost and time required for analyzing samples.
B. When does the regulated community need to know what it
is required to do? Based on the potential for confusion
and the timing of the requirements, when would a communi-
cations strategy be available for implementation?
Must a communications strategy and technical assistance
be available when the regulation is issued?
C. What specific implementation steps for the compliance
and enforcement strategy need to be taken at the time
the regulation is promulgated?
1. Should the strategy include a number ot inspections
EPA or authorized states need to perform within a
certain time frame after the etfective date of the
regulation?
2. Should the strategy target initial enforcement
actions to make maximum use of available resources
and to establish the program?
3. Are there resource constraints that need to be
addressed through the next budget cycle?
-------
POLLUTION
PREVENTION
-------
FEDERAL REGISTER
-------
FEDERAL REGISTER PUBLICATION
Purpose: The Federal Register publication system was established by Congress as a means of
informing the public of regulations that affect them. Publication in the Federal Register has certain
legal effects, including: providing official notice of a document's existence and content; creating a
rebuttable presumption that the text is a true copy of the original document; establishing that the
document was duly issued, prescribed, or promulgated; and providing evidence that is recognized by a
court of law.
Preparing the Document: When preparing a document for Federal Register publication, the lead
office should follow the formal requirements of the Office of the Federal Register (OFR), found in the
Federal Register Document Drafting Handbook The Federal Register package should include.
o the signed original of the preamble and regulation plus three copies
o the Federal Register Checklist, signed by the Steering Committee Representative or
other approving official,
o typesetting request (EPA form 2340-15); and
o EPA form 2340-1 if reprints are being ordered
OFR follows stnct publication requirements, so even minor problems can delay publication. The most
common problems causing delay are: errors in codification; unclear graphs, charts, and tables; too
few copies; unclear signatures; omitting a typesetting request or Federal Register Checklist.
Operation: If the package requires the Administrator's signature the lead office must submit the
Federal Register materials with the package for transmission to AX (See Fact Sheet 9). In any case,
direct all Federal Register packages to EPA's Federal Register Officer, Regulation Development Branch
(RDB), Room 409WT, 382-7204. RDB reviews documents for consistency with OFR requirements and
transmits them to OFR for publication. Documents usually appear in the Federal Register within four
days after RDB approves them. However, if a document is particularly long (250 pages or more), and
contains many tables, graphs, and figures, publication will take at lease one week RDB provides a
listing on E-Mail that describes all documents sent to the Federal Register or
published within the past five days. To access this system simply: 1) sign onto E-Mail, 2)
type PRPOST, when the prompt ">" appears, 3) type FED REG when "category:" appears, and 4) read
or scan the listing
See Also: Federal Register Document Draflinn Handbook, available from the Agency's supply store;
Federal Register Checklist, available from Steering Committee Representatives or the Regulation
Development Branch (382-5475).
Fact Sheet 10 (Rev. 5/90)
Regulation Management Series
-------
CHECKLIST FOR RULE ANO PROPOSED RUIE DOCUMENTS
Billing Code: Is the billing code at the top of firs! page? (See page 56.)
Qasslfication: Does it affect or relate to rules or proposed rules? Has the
preamble format been used? (See pages 6 through 8 and 12.)
Headings: Do the proper agency, CFR citation and subject headings pre-
cede the preamble? (See page 11.)
Preamble: Are all required elements of the preamble included? (See page
12.) Does the SUMMARY answer all three questions? (See page 14.)
List of Subjects: Are subject terms listed for each CFR part affected? Are
they placed at the end of the preamble? (See page 18.)
Authority citation: Is the U.S.C. cite included as either the first item of
amendatory language for each part affected or at the end of the table of
contents if a part is set out (See page 19.)
Amendatory language:
• Does it specify the exact unit being changed? (See page 28.)
• Does it use the correct term to describe the type of change? (See page
28.)
• Does it describe the change to the CFR accurately? Use the latest CFR
volume and the LSA. (See page 26.)
Table of contents: Include for each subpart or part being aet out in full.
(See page 38.) Do entries agree with the part subpart and section headings
as set out in the regulatory text?
Paragraph numbers: Are all paragraphs of CFR text lettered or numbered
correctly? (See page 23.)
OMB control numbers: Are OMB control numbers for information collec-
tion requirements included with the regulatory text? (See page 36.)
Signature and title:
• Is original signature (hand-signed in ink) included? (One person may
not sign for another or initial a signature.) (See page 61.)
• Is signer's name and title typed beneath actual signature? (See page
#1.)
Qoalttr
• Are original and copies clear and legible? (See page 71.)
• Is the document free of correction tape?
• Arc ink changes printed, dated and initialed on all three copies?
Page ¦»"¦"*»—! An all pages numbered consecutively? (See page 87.)
• Are the original and the copies identical? Are all pages included?
• Are the copies of the document properly signed or certified? (See page
61.)
-------
Revised 1/14/88
FEDERAL REGISTER CHECKLIST FOR
NOTICES, PROPOSED AND FINAL RULE DOCUMENTS
(Attached 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 (DDH).
SECTION ONE; NOTICE DOCUMENTS
(This section applies to Notices of public hearings, meetings,
and/or workshops, Correction Notices, Notices extending comment
periods, and Notices of Availabiity)
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
Intended 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
illustrat ions?
7. Are you submitting the original plus 3 copies? Do
your copies match? (DDH 62)
SIGNED
-------
FEDERAL REGISTER CHECKLIST FOR NOTICES,
PROPOSED AND FINAL RULE DOCUMENTS
SECTION TWO: PROPOSED AND FINAL RULES Yes NO
1. Does your document include the required preamble
elements: AGENCY, ACTION, SUMMARY, DATES, ADDRESSES,
FOR FURTHER INFORMATION CONTACT, SUPPLEMENTARY
INFORMATION? (DDH 12-18)
2. Does your Summary answer the three required questions:
What you're doing, Why 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? (DDH 18)
4. Is your Amendatory language clear and correctly
worded? (DDH 28-29)
5. Is your Authority C itat ion your first amendment (unless #7
applies in which case it follows the table of contents)?
(DDH 19-21)
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 or subpart that you are adding or
amending? Do headings in the regulatory text match
those in the table of contents? (DDH 36)
8. Are all CFR paragraphs given a letter or number in
correct sequence: (a), (1), (i), (A)? (DDH 23)
9. Is text of regulation displayed correctly (include
all section headings, and place the asterisks
appropriately)? (DDH 32-35)
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 the signer's name and title printed below the
signature? (DDH 61)
14. Are you preparing a prooosed 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)
S igned
-------
hyiOm$L£ Of htv\#/ Ku(\
41626 Federal Register / Vol. 52, No. 210 / Friday, October 30. 1987 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 763
[OPTS-62048E; FRL-326»-ei
Asbestos-Containing Materials In
School*
agency: Environmental Protection
Agency (EPA).
ACTION: Final rule.
summary: EPA is issuing a final rule
under section 203 of Title II of the Toxic
Substances Control Act (TSCA), IS
U.S.C. 2643, to require all local
education agencies ILEAs) to identify
asbestos-containing materials (ACMJ in
their school buildings and take
appropriate actions to control release of
asbestos fibers. The LEAs are required
to describe their activities in
management plans, which must be made
available to all concerned persons and
submitted to State Governors. This final
rule requires LEAs to use specially-
trained persons to conduct inspections
for asbestos, develop the management
plans, and design or conduct major
actions to control asbestos. Exclusions
are provided for LEAs which have
previously conducted inspections and
for LEAs subject to any state
requirement at least as stringent as the
comparable requirement in this final
rule.
DATES: In accordance with 40 CFR 23.5,
this rule shall be promulgated for
purposes of judicial review at t p.m.
Eastern Standard Time on November 13,
1987. This rule shall be effective on
December 14,1987. The incorporation by
reference in the rule is approved by the
Director of the Federal Register as of
December 14.1987.
FOR FURTHER INFORMATION CONTACT:
Edward A. Klein. Director, TSCA
Assistance Office (TS-799), Office of
Toxic Substances, Environmental
Protection Agency. Rm. E-543, 401M St,
SW„ Washington. DC 20460, Telephone:
(202-554-1404).
SUPPLEMENTARY INFORMATION:
I. Background
A. Description of the Enabling
Legislation
On October 22,1988, President
Reagan signed into law the Asbestos
Hazard Emergency Response Act
(AHERA) which enacted, among other
provisions. Title 11 of the Toxic
Substances Control Act (TSCA) 15
J.S.C. sections 2641 through 2854.
Section 203 of Title II,15 U.S.C. 2043,
requires EPA to propose rules by April
20.1987 (180 days after enactment), and
to promulgate final rules by October 17.
1987 (360 days after enactment),
regarding: (1) The.inspection of oil
public and private school buildings for
ACM; (2) the identification of
circumstances requiring response
actions: (3) description of the
appropriate response actions; (4) the
implementation of response actions; (5)
the establishment of a reinspection and
periodic surveillance program for ACM:
(6) the establishment of an operations
and maintenance program for friable -
ACM; (7) the preparation and
implementation of asbestos
management plans by LEAs and the
submission of the management plans to
State Governors, who may review the
planB and approve or disapprove them:
and (8) the transportation and disposal
of waste ACM from schools. This final
rule implements the Title II requirements
to issue the section 203 rules (except for
transportation and disposal, as
discussed further below).
Section 206 of TSCA Title II, 15 U.S.C.
2848, also requires EPA to issue by April
20,1967, a final model accreditation plan
for persons who inspect for asbestos,
develop management plans, and design
or conduct response actions. States are
required to adopt an accreditation
program at least as stringent as the EPA
model within 180 days after the
beginning of their next legislative
session. Accreditation oflabora lories
which analyze asbestos bulk samples
and asbestos air samples is also
required by TSCA Title II. The National
Bureau of Standards (NBS), US.
Department of Commerce, la required to
establish the bulk sampling
accreditation program by October 17,
1987, and the air sampling accreditation
program by October 12,1088.
States were required to notify LEAs
by October 17,1987, regarding where to
Bubmit management plans. LEAs must
submit those plans to their State no later
than October 12,1988. The plans must
include the results of Bchool building
inspections and a description of all
response actions planned, completed or
in progress. After receiving a
management plan. States are allowed 90
days to disapprove the plan. If the plan
is disapproved, the State must provide a
written explanation of the disapproval
and the LEA must revise the plan within
30 days to conform with the State's .
suggested changes. The 30-day period
can be extended to 90 days by the State.
LEAs are required to begin
implementation of their management
plans by July B. 1989, and to complete
implementation in a timely fashion.
Transport and disposal rules under
TSCA section 203(h) have not yet been
proposed. In accordance with TSCA
section 204(f), therefore, LEAs shall
provide for transportation and disposal
of asbestos in accordance with the most
recent version of EPA's "Asbestos
Waste Management Guidance."
Applicable provisions of that document
are included as Appendix D of this rule.
Regulations governing transport of
asbestos-containing waste, including
school waste already regulated by the
National Emission Standard for
Hazardous Air Pollutants (NESHAP) (40
CFR Part 61, Subpart M) under the Clean
Air Act (42 U.S.C. section 7401, et seq.),
were promulgated by the Department of
Transportation (DOT) (49 CFR Part, 173
Subpart J). The NESHAP and DOT rules
must be followed, according to the
"Asbestos Waste Management
Guidance." These rules will be sufficient
to ensure the proper loading and
unloading of vehicles and to ensure the
physical integrity of containers.
Section 203(1) requires Department of
Defense schools to carry out asbestos
identification, inspection and
management activities in a manner
comparable to the manner in which an
LEA is required to carry out such
activities. EPA interprets the language of
this section which states that such
activities shall be earned out "to the
extent feasible and consistent with the
national security" as recognition that
existing agreements with foreign
governments may make it difficult lo
carry out certain provisions of this
regulation.
Since this rule has been signed by the
EPA Administrator by October 17,1987,
the rule has been promulgated within
the statutory time frame required by
section 203 of TSCA Title II. In
accordance with 40 CFR 23.5, however,
solely for purposes of judicial review
deadlines under section 19 of TSCA
Title I, the rule is considered to be
promulgated at 1 p.m. eastern time, 14
days after publication in the Federal
Register. Thus. the period in which
petitions for review of this rule may be
tiled under section 19 commences 14
days after publication.
B. Previous EPA Asbestos Activities
EPA has undertaken a variety of
technical assistance and regulatory
activities designed to control ACMs in
buildings and minimize inhalation of
asbestos fibers.
1. Technical Assistance Program.
Since 1979. EPA staff have assisted
schools and other building owners in
identifying and controlling ACM in their
buildings. Through a cooperative
agreement with the American
Association of Retired Persons (AARP),
EPA has hired architects, engineers, and
-------
41846
Federal Register / Vol. 52. No. 210 / Friday. October 30. 1987 / Rules and Regulations
VI. References
1. USEPA. "Guidance for Controlling
• Asbestos-Containing Materials in
Buildings." EPA 560/5-85-024. Jufie 1985.
2. USEPA. "A Guide to Respiratory
Protection for the Asbestos Abatement
Industry." EPA 560/OPTS-66-001,
September 1086.
3. USEPA. "Asbestos in Buildings:
Simplified Sampling Scheme for Friable
Surfacing Materials," EPA 560/5-85-
030a. October 1985.
4. USEPA. Friable Asbestos-
Containing Materials in Schools, 40 CFR
Part 763, Subpart P.
5. USEPA. National Emission
Standards for Hazardous Air Pollutants,
40 CFR Part 61, Subpart M.
6. USDOL OSHA. Occupational
Exposure to Asbestos, 29 CFR 1926.58.
7. USEPA. Toxic Substances;
Asbestos Abatement Projects, 40 CFR - .
Part 763, Subpart G.
VII. Regulatory Assessment
Requirements
/4. Executive Order 12291
Under Executive Order 12291, EPA
has determined that this rule is a
"major" rule and has developed a
Regulatory Impact Analysis. EPA has
prepared an economic impact analysis
of the TSCA Title II regulations.
B. Regulatory Flexibility Act
EPA has analyzed the economic
impact of this rule on small businesses.
EPA's analysis of the economic
consequences of this rule appears in
Unit IV.
C. Paperwork Reduction Act
The reporting and recordkeeping
provisions in this rule have been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act. and has been assigned
OMB control number 2070-0091.
List of Subjects in 40 CFR Part 763
Asbestos. Environmental protection.
Hazardous substances. Incorporation by
reference. OccupaUonal health and
safety. Recordkeeping. Schools.
Dated: October 17,1987.
Lee M. Thomas,
Administrator.
Therefore, 40 CFR Part 763 is
amended as follows:
PART 763—(AMENDED]
1. The authority citation for Part 763
continues to read as follows:
Authority: IS U.S.C 2805 and 2807(c).
Subpart E also issued under 15 U.S.C. 2641.
2643.2846, and 2847.
2. By adding 9S 763.8Q through 763.99
and Appendices A. B, andp to Subpart
E to read as follows:
Subpart E—Asbestos-Containing Mateftat*
In Schoota
Sec.
783.80 Scope and purpose.
763.83 Definitions.
763.84 General local education agency
responsibilities.
783.85 Inspection and reinspections.
76338 Sampling.
76147 Analysis.
783.68 Assessment.
763.90 Response actions.
783.91 Operations and maintenance.
763.92 Training and periodic surveillance.
763.93 Management plans.
783.94 Recordkeeping.
763.95 Warning labels.
763.97 Compliance and enforcement
763 98 Waiver delegation to State.
763.99 Exclusions.
Appendix A to Subpart E—Interim
Transmission Electron Microscopy
Analytical Methods—Mandatory and
Nonmandatory—and Mandatory Section
to Determine Completion of Response
Actions
Appendix B to Subpart E—Work Practices
and Engineering Controls for Smali-
Scale, Short-Duration Operations
Maintenance and Repair (O&M)
Activities Involving ACM
• • • * «
Appendix D to Subpart E—Transport and
Disposal of Asbestos Waste
9 76X80 Scope and purpose.
(a) This rule requires local education
agencies to identify friable and
nonfriable asbestos-containing material
(ACM) in public and private elementary
and secondary schools by visually
inspecting school buildings for such
materials, sampling such materials if
they Are not assumed to be ACM, and
having samples analyzed by appropriate
techniques referred to in this rule. The
rule requires local education agencies to
submit management plans to the
Governor of their State by October 12,
1988, begin to implement the plans by
July 9,1989, and complete
implementation of the plans in a timely
fashion. In addition. local education
agencies are required to use persons
who have been accredited to conduct
inspections, reinspections, develop
management plans, or perform response
actions. The rule also includes
recordkeeping requirements. Local
education agencies may contractually
delegate their duties under this rule, but
they remain responsible for the proper
performance of those duties. Local
education agencies are encouraged to
consult with EPA Regional Asbestos
Coordinators, or if applicable, a State's
lead agency designated by the State
Governor, for assistance in complying
with this rule..
(b) Local education agencies mist
provide for the transportation, arid-
disposal of asbestos in accordance^th
EPA's "Asbestos Waste Management
Guidance." For convenience, applicable
sections of this guidance are reprinted
as Appendix D of this subpart There are
regulations in place, however, that affect
transportation and disposal of asbestos
waste generated by this rule. The
transportation of asbestos waste is
covered by the Department of
Transportation (49 CFR Part 173.
Subpart J) and disposal is covered by
the National Emissions Standards for
Hazardous Air Pollutants (NESHAP) (40
CFR Part 61. Subpart M).
S763J3 Definition*.
For purposes of this subpart
"Act" means the Toxic Substances
Control Act (TSCA). 15 U.S.C 2801, et
seq.
"Accessible" when referring to ACM
means that the material is subject to
disturbance by school building
occupants or custodial or maintenance
personnel in the course of their normal
activities.
"Accredited" or "accreditation" when
referring to a person or laboratory
means that such person or laboratory is
accredited in accordance with section
206 of Title D of the Act
"Air erosion" means the passage of
air over friable ACBM which may result
in the release of asbestos fibers.
"Asbestos" means the asbestiform
varieties of: Chrysotile (serpentine);
crocidolite (riebeckite); amosite
(cummingtonitegrunerite); anthophyllite;
tremolite; and actinolite.
"Asbestos-containing material"
(ACM) when referring to school
buildings means any material or product
which contains more than 1 percent
asbestos.
"Asbestos-containing building
material" (ACBM) means surfacing
ACM, thermal system insulation ACM,
or miscellaneous ACM that is found in
or on interior structural members or
other parts of a school building.
"Asbestos debris" means pieces of
ACBM that can be identified by color,
texture, or composition, or means dust
if the dust is determined by an
accredited inspector to be ACM.
"Damaged friable miscellaneous
ACM" means friable miscellaneous
ACM which has deteriorated or
sustained physical injury such that the
internal structure (cohesion) of the
material is inadequate or, if applicable,
which has delaminated such that its
bond to the substrate (adhesion) is
-------
Federal Register / Vol. 52, No. 210 / Friday, October 30, 1987 / Rules and Regulations
41857
program determined to be inadequate,
and specifies the facts that underlie the
findings of inadequacy.
9 763.99 Exclusion*.
(a) A local education agency shall not
be required to perform an inspection
under { 763.85(a) in any sampling area
as defined in 40 CFR 763.103 or
homogeneous area of a school building
where:
(1) An accredited inspector has
determined that based on sampling
records, fnable ACBM was identified in
that homogeneous or sampling area
during an inspection conducted before
December 14.1987. The inspector shall
sign and date a statement to that effect
with his or her State of accreditation
and if applicable, accreditation number
and, within 30 days after such
determination, submit a copy of the
statement to the person designated
under § 763-84 for inclusion in the
management plan. However, an
accredited inspector shall assess the
friable ACBM under g 763.88.
(2) An accredited inspector has
determined that based on sampling
records, nonfriable ACBM was
identified in that homogeneous or
sampling area during an inspection
conducted before December 14,1987.
The inspector shall sign and date a
statement to that effect with his or her
State of accreditation and if applicable,
accreditation number and, within 30
days after such determination, submit a
copy of the statement to the person
designated under I 763.84 for inclusion
in the management plan. However, an
accredited inspector shall identify
whether materia] that waB nonfriable
has become fnable since thai previous
inspection and shall assess the newly-
friable ACBM under J 763.88.
(3) Based on sampling records and
inspection records, an accredited
inspector has determined that no ACBM
is present in the homogeneous or
sampling area and the records show that
the area was sampled, before December
14,1987 in substantial compliance with
S 763.65(a), which for purposes of this
section means in a random manner and
with a sufficient number of samples to
reasonably ensure that the area is not
ACBM.
(i) The accredited inspector shall sign
and date a statement with his or her
Slate of accreditation and if applicable,
accreditation number that the
homogeneous or sampling area
determined not to be ACBM was
sampled in substantial compliance with
S 763.85(a).
(ii) Within 30 dayB after the
inspector's determination, the local
education agency shall submit a copy of
the inspector's statement to the EPA
Regional Office and shall include the
statement in the management plan for
that school.
(4) The lead agency responsible for
asbestos inspection in a State that has
been granted a waiver from $ 763.85(a)
has determined that, based on sampling
records and inspection records, no
ACBM is present in the homogeneous or
sampling area and the records show that
the area was sampled before December
14,1987, in substantia] compliance with
{ 763.85(a). Such determination shall be
included in the management plan for
that school.
(5) An accredited inspector has
determined that, based on records of an
inspection conducted before December
14.1987. suspected ACBM identified in
that homogeneous or sampling area is
assumed to be ACM. The inspector shall
sign and date a statement to that effect
with his or her State of accreditation
and if applicable, accreditation number
and. within 30 days of such
determination, submit a copy of the
statement to the person designated
under { 763.84 for inclusion in the
management plan. However, an
accredited inspector shall identify
whether material that was nonfriable
suspected ACBM assumed to be ACM
has become friable since the previous
inspection and shall assess the newly
friable material and previously
identified friable suspected ACBM
assumed to be ACM under 8 763.88.
(6) Based on inspection records and
contractor and clearance records, an
accredited inspector has determined
that no ACBM is present in the
homogeneous or sampling area where
asbestos removal operations have been
conducted before December 14,1987,
and shefU sign and date a statement to
that effect and include his or her State of
accreditation and, if applicable,
accreditation number. The local
education agency shall submit a copy of
the statement to the EPA Regional
Office and shall include the statement in
the management plan for that school.
(7) An architect or project engineer
responsible for the construction of a
new school building built after October
12.1986, or an accredited inspector signs
a statement that no ACBM was
specified as a building material in any
construction document for the building,
or, to the best of his or her knowledge,
no ACBM was used as a building
material in the building. The local
education agency shall submit a copy of
the signed statement of the architect
project engineer, or accredited inspector
to the EPA Regional Office and shall
include the statement in the
management plan for that school.
(b) The exclusion, under paragraph (a)
(1) through (4) of this section, from
conducting the inspection under
J 763.85(b) shall apply only to
homogeneous or sampling areas of a
school building that were inspected and
sampled before October 17,1987. The
local education agency shall conduct an
inspection under S 763.85(a) of all areas
inspected before October 17,1987, that
were not sampled or were not assumed
to be ACM.
(c) If ACBM is subsequently found in
a homogeneous or sampling area of a
local education agency that had been
identified as receiving an exclusion by
an accredited Inspector under
paragraphs (a) (3). (4), (5) of this section,
or an architect project engineer or
accredited inspector under paragraph
(a)(7) of this section, the local education
agency shall have 180 days following the
dale of identification of ACBM to
comply with this Subpart E.
Appendbc A lo Subpart E—Interim
Transmission Electron Microscopy
Analytical Methods—Mandatory and
Nonmandatory—and Mandatory Section
to Determine Completion of Response
Actions
J. Introduction
The following appendix contains three
units. The first unit is the mandatory
transmission electron microscopy (TEM)
method which all laboratories must
follow; it is the minimum requirement
for analysis of air samples for asbestos
by TEM. The mandatory method
contains the essential elements of the
TEM method. The second unit contains
the complete non-mandatory method-
The non-mandatory method
supplements the mandatory method by
including additional steps to improve
the analysis. EPA recommends that the
non-mandatory method be employed for
analyzing air filters; however, the
laboratory may choose to employ the
mandatory method. The non-mandatory
method contains the same minimum
requirements as are outlined in the
mandatory method. Hence, laboratories
may choose either of the two methods
for analyzing air samples by TEM.
The final unit of this Appendix A to
Subpart E defines the steps which must
be taken to determine completion of
response actions. This unit is
mandatory.
//. Mandatory Transmission Electron
Microscopy Method
A. Definitions of Terms
1. "Analytical sensitivity"—Airborne
asbestos concentration represented by
each fiber counted under the electron
-------
Federal Register / Vol. 52, No. 210 / Friday, October 30. 1987 / Rules and Regulations
41859
FIGURE I—SAMPLING CASSETTE CONFIGURATION
Inlet Plug
Cassette Cap
Extension Cowl
or
Retainer Ring
£ 0.4 iim pore PC filter or
£ 0.45 |im pore MCE filter
5 (im MCE Diffuse?
Support Pad
Cassette Base }
Outlet Plug
BiLUNO CODE «MO-W-C
-------
41876
Federal Register / Vol. 52. No. 210 / Friday. October 30. 1987 / Rules and Regulations
TABLE 1-—NUMBER OF 200 MESH EM GRID OPENINGS
10.0057 MM^) THAT NEED TO BE ANALYZED TO
MAINTAIN SENSITIVITY OF 0.005 STRUCTURES/CC
BASED ON VOLUME AND EFFECTIVE FILTER AREA
Effective Filler Area
385 sq mm
Volume (liters)
# of and ooeninas
. 560
24
600
23
700
19
800
17
900
15
1.000
14
1,100
12
1
1,200
1 1
1
1,300
1 0
Recommended
1.400
1 0
Volume
1,500
9
Range
1,600
•
1
1
1,700
•
1,800
•
1,900
7
2,000
7
2,100
6
2,200
6
2,300
6
2,400
6
2,500
5
2,600
5
2,700
5
2,800
5
2,900
5
3.000
5
3,100
4
3.200
4
3.300
4
3.400
4
3.500
4
3.600
4
3.700
4
3.800
4
Effective FBter Area
855 sq mm
Volume (liters)
* of arid ooeninas
1,250
24
1.300
23
1.400
21
1.600
19
1.800
17
2.000
15
2.200
14
2.400
13
2,600
12
2,800
1*1
1
3,000
1 0
1
3,200
•
Recommended
3,400
9
Volume
3,600
9
Range
3,800
9
1
4,000
8
1
4.200
7
4.400
7
4.600
7
4,800
6
6,000
6
5.200
6
5.400
6
5.600
5
5.800
5
6.000
5
6.200
5
6.400
5
6,600
5
6.800
4
7,000
4
7.200
4
7.400
4
7.600
4
Note minimum vollines ivquired:
2Smm :560Hers
37 mm : 1250 Hers
Filter tfameter of 25 mm - effective area of 38S aq mm
FBter (Sameter of 37 mm ¦effective area of 855 sq mm
B1LUHQ COOC 6S60-S0-C
-------
Federal Register / Vol. 52. No. 210 / Friday. October 30, 1987 / Rules and Regulations
41879
FIGURE 3—SAMPLE RECEIVING FORM
Date of package delivery Package shipped from
Carrier Shipping bill retained
•Condition of package on receipt
~Condition of custody seal
Number of samples received Shipping manifest attached
Purchase Order No. Project I.D.
Comments
Sampling Sampled
Medium Volume Receiving
Ho* Description ££ MCE Liters ID# Assigned#
2
4
5
6
7
8
9
10
11
12
13 ,
(Use as many additional sheets as needed.)
Comments
Date of acceptance into sample bank
Signature of chain-of-custody recipient
Disposition of samples
*Note: If pwlrfly hx ynctahmrf «nhct
-------
41894
Federal Register / Vol. 52, No. 210 / Friday, October 30, 1987 / Rules and Regulations
be comparable with contamination/
background levels of blank Tillers. The
decision is based, in part on Poisson
statistics which Indicate that four
structures must be counted on a filter
before the Tiber count is statistically
distinguishable from the count for one
structure. As more information on the
performance of the method is collected,
this criterion may be modified Since
different combinations of the number
and size of grid openings are permitted
under the TEM protocol, the criterion is
expressed in structures per square
millimeter of Tiller to be consistent
across all combinations. Four structures
per 10 grid openings corresponds to
approximately 70 t/rnm1.
B. Sample Collection and Analysis
1. A minimum of 13 samples is
required: five samples collected inside
the abatement area, five samples
collected outside the abatement area,
two field blanks, and one sealed blank.
2. Sampling and TEM analysis must
be done according to either the
mandatory or nonmandatory protocols
in Appendix A. At least 0.057 mm1 of
filter must be examined on blank filters.
C. Interpretation of Results
1. The response action shall be
considered complete if either
a. Each sample collected inside the
abatement area consists of at least 1,199
L of air for a 25 mm filter, or 2.799 L of
air for a 37 mm filter, and the arithmetic
mean of their asbestos structure
concentrations per square millimeter of
filter is less than or equal to 70 s/mm*;
or
b. The three blank samples have an
arithmetic mean of the asbestos
structure concentration on the blank
filters that is less than or equal to 70
s/mm*and the average airborne
asbestos concentration measured inside
the abatement area is not statistically
higher than the average airborne
asbestos concentration measured
outside the abatement area as
determined by the Z-test. The Z-test is
carried out by calculating
2 = ~ %
O.8(l/n, + U0),/2
where Y( is the average of the natural_
logarithms of the inside samples and Y0
Is the average of the natural logarithms
of the outside samples. n( is the number
of inside samples and no is the number
of outside samples. The response action
is considered complete if Z is less than
or equal to 1.05.
(Note.—When no fibers are counted, the
calculated detection Unit for that analysis is
inserted for the concentration.)
2. If the abatement site does not
satisfy either (1) or (2) above, the site
must be recleaned and a new set of
samples collected.
D Sequence for Analyzing Samples
It is possible to determine completion
of the response action without analyzing
all samples. Also, at any point in the
process, a decision may be made to
terminate the analysis of existing
samples, reclean the abatement site, and
collect a new set of samples. The
following sequence is outlined to
minimize the number of analyses
needed to reach a decision.
1. Analyze the inside samples.
2. If at least 1.199 L of air for a 25 mm
filter or 2,799 L of air for a 37 mm filter is
collected for each inside sample and the
arithmetic mean concentration of
structures per square millimeter of filter
is less than or equal to 70 s/mm*, the
response action is complete and no
further analysis is needed.
3. If less than 1.199 L of air for a 25
mm filter or 2,799 L of air for a 37 mm
filter is collected for any of the inside
samples, or the arithmetic mean
concentration of structures per square
millimeter of filter is greater than 70
s/mm1. analyze the three blanks.
4. If the arithmetic mean
concentration of structures per square
millimeter on the blank filters is greater
than 70 s/mm1, terminate the analysis,
identify and correct the source of blank
contamination, and collect a new set of
samples.
5. If the arithmetic mean
concentration of structures per square
millimeter on the blank Alters is less
than or equal to 70 s/mm*. analyze the
outside samples and perform the Z-test.
6. If the Z-statistic is less than or
equal to 1.05. the response action is
complete. If the Z-statistic is greater
than 1.65, reclean the abatement site
and collect a new set of samples.
Appendix B to Subpart E—Work
Practices and Engineering Controls for
Small-Scale. Short-Duration Operations
Maintenance and Repair (O&M)
Activities Involving ACM
This appendix is not mandatory, in
that LEAs may choose to comply with
all the requirements of 40 CFR 763.121.
Section 763.91(b) extends the protection
provided by EPA in its 40 CFR 763.121
for worker protection during asbestos
abatement projects to employees of
local education agencies who perform
small-scale, short-duration operations,
maintenance and repair (O&M)
activities involving asbestos-containing
materials and are not covered by the
OSHA asbestos construction standard
at 29 CFR 1926.58 or an asbestos worker
protection standard adopted by a State
as part of a State plan approved by
OSHA under Bection 18 of the
Occupational Safety and Health Act.
Employers wishing to be exempt from
the requirements of S 763.121 (e)(6) and
(f)(2)(i) may instead comply with the
provisions of this appendix when
performing small-scale, short-duration
O&M activities.
Definition of Small-Scale, Short-
Duration Activities
For the purposes of this appendix,
small-scale, short-duration maintenance
activities are tasks such as, but not
limited to:
1. Removal df asbestos-containing
insulation on pipes.
2. Removal of small quantities of
asbestos-containing insulation on beams
or above ceilings.
3 Replacement of an asbestos-
containing gasket on a valve.
4. Installation or removal of a small
section of drywall.
5. Installation of electrical conduits
through or proximate to asbestos-
containing materials.
Small-scale, short-duration
maintenance activities can be further
defined, for the purposes of this subpart,
by the following considerations:
1 Removal of small quantities of
asbestos-containing materials (ACM)
only if required in the performance of
another maintenance activity not
intended as asbestos abatement.
2. Removal of asbestos-containing
thermal system insulation not to exceed
amounts greater than those which can
be contained in a single glove bag
3. Minor repairs to damaged thermal
system insulation which do not require
removal.
4. Repairs to a piece of asbestos-
containing wallboard.
5. Repairs, involving encapsulation,
enclosure or removal, to small amounts
of friable asbestos-containing material
only if required in the performance of
emergency or routine maintenance
activity and not intended solely as
asbestos abatement. Such work may not
exceed amounts greater than those
which can be contained in a single
prefabricated minienclosure. Such an
enclosure shall conform spatially and
geometrically to the localized work are."
in order to perform its intended
containment function.
-------
OMB REVIEW
-------
OMB REVIEW UNDER E.O. 12291
Purpose: Under Executive Order (E.O.) 12291, each proposed and final rule (including some policy
documents and guidelines) which the agency issues must be sent to OMB for review before the
Administrator signs it. The Order defines two categories of rules: major and non-major. Major rules
are those having a very large impact on society, either in terms of costs (over $100m annually), or in
terms of effects on an industrial sector, employment, or international trade. 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 associated with each. OMB has exempted certain
high-volume classes of rules with limited impacts (e.g., pesticide tolerances) from E.O. 12291 review.
Participants: The lead office responds to OMB issues or questions on its rule. The Steering
Committee Representative for that office takes the lead in arranging all OMB meetings and in
coordinating the office's response to OMB. The lead program office should include OPPE and OGC in any
meetings with OMB, and confer with other affected offices on the appropriate response before making
substantive changes OPPE tracks and reports on the status and current issues of rules under OMB
review for senior management.
Operation: Except for the exempted rules -- and those in certain special categones (e.g. TSCA 8(a)
Rules) - all rules are sent to OMB's Office of Information and Regulatory Affairs (OIRA) before they
are signed by the Administrator or a designated official. OMB review normally follows Red Border
review. If this sequence of review would cause EPA to miss a statutory or court-order deadline, the
Steering Committee may authorize concurrent OMB and Red Border review.
To initiate the E.O 12291 review, the lead office must submit five copies of the preamble and rule along
wilh a single copy of a SF-83 form signed by their Steering Committee Representative to the Regulation
Development Branch 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.
The period for OMB review cited in the Order varies according to the type of action: major rules have
a 60-day review at proposal and 30 days at final; non-major proposed and final rules have a 10-day
review If OMB does not complete its review within the specified review period the OIRA desk officer
calls the RDB desk officer to extend the review. In virtually all cases, rules do not go forward for final
signature in EPA until the program office addresses OMB concerns and resolves outstanding issues
Court-ordered deadlines and stringent statutory deadlines may occasionally require that EPA publish a
rule before OMB has finished its analysis and comment. After OMB review is completed the lead office
prepares the package for AX (Administrator's Correspondence Control) and the Administrator's
signature. The package includes two copies of the preamble and rule, the signed action memo,
communications strategy, Federal Register typesetting request (EPA Form 2340-15), and request for
reprints, if desired (EPA Form 2340-1). The lead office should deliver the package to RDB for
transmission to AX. Obtaining the Administrator's signature usually takes a week to ten days.
See Also: Fact Sheet #8, "Red Border Review*, available from the Regulation Development Branch
(382-5479) Steering Committee Representatives can advise on exemptions from E.O. 12291 review.
Fact Sheet 9 (Rev. 5/90)
Regulation Management Series
-------
OMB REVIEW
I. WHO REVIEWS RULES AT OMB
Desk Officer
Why is gov't, action necessary?
Does the rule "maximize net benefits to society?"
Does the rule require interagency coordination-'
Budget Examiner
What's the effect
on Federal outlays?
Economist
how reliable are tne
agency "s benef ft\cost
est t mates?
II. WHAT DOES "MAXIMIZING NET BENEFITS TO SOCIETY" MEAN?
Getting the most for your money
Getting the best value
Shooting for the point at which the benefits of
additional regulation are equivalent to the harm caused
by additional regulation.
R
Getting Here
P
Reduction in Pollution
Line RR* describes
the marginal value
to receptor of
reducing pollution.
Line PP1 describes
the marginal cost of
reducing pollution.
III. MAKING OMB REVIEW EASIER
A. Consider what policies may "maximize net benefits
to society" early on.
B. Ask questions of OMB staff early in the policy
making process.
-------
EXECUTIVE ORDER 12291
BASIC PRINCIPLES
the extent permitted by law:
Decisions shall be based on adequate information concerning
the need for and consequences of proposed government action;
and,
Regulatory objectives and alternatives shall be chosen to
maximize net benefits to society.
-------
Thursday
February 19, 1981
Part III
The President
Executive Order 12291—
Federal Regulation
-------
13193
Federal Register
Vol 46. No 33
Thurtday February 19. 1981
Presidential Documents
The President
Title 3—
Executive Older 12291 of February 17, 1981
Federal Regulation
By the authority vested is me as President by the Constitution and laws of the
United States of America, and in order to reduce the burdens of existing and
future regulations, increase agency accountability for regulatory actions, pro-
vide for presidential oversight of the regulatory process, minimize duplication
and conflict of regulations, and insure well-reasoned regulations, it is hereby
ordered as follows:
Section 1. Definitions. For the purposes of this Order.
(a) "Regulation" ot "rule" means an agency statement of general applicability
and future effect designed to implement interpret, or prescribe law or policy
or describing the procedure or practice requirements of an agency, but does
not include:
(1) Administrative actions governed by the provisions of Sections 556 and 557
of Title 5 of the United States Code;
(2) Regulations issued with respect to a military or foreign affairs function of
the United States; or
(3) Regulations related to agency organization, management, or personnel.
(b) "Major rule" means 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
(3) Significant adverse effects on competition, employment, investment, pro-
ductivity, innovation, or on the ability of United States*based enterprises to
compete with foreign-based enterprises in domestic or export markets.
(c) "Director" means the Director of the Office of Management and Budget.
(d) "Agency" means any authority of the United States that is an "agency"
under 44 U.S.C. 3502(1). excluding those agencies specified in 44 U.S C.
3502(10).
(•) 'Task Force" means the Presidential Task Force on Regulatory Relief.
Sec. 2. General Requirements. In promulgating new regulations, reviewing
existing regulations, and developing legislative proposals concerning regula-
tion, all agenoes, to the extent permitted by law, shall adhere to the following
requirements:
(a) Administrative decisions shall be based on adequate information concern-
ing the need for and consequences of proposed government action;
(b) Regulatory action shall not be undertaken unless the potential benefits to
society for the regulation outweigh the potential costs to society;
(c) Regulatory objectives shall be chosen to maximize the net benefits to
society;
(d) Among alternative approaches to any given regulatory objective, the
alternative involving the least net cost to society shall be chosen: and
(e) Agencies shall set regulatory priorities with the aim of maximizing the
aggregate net benefits to society, taking into account the condition of the
-------
13194 Federal Register / Vol. 46, No 33 / Thursday. February 19. 1981 / Presidential Documents
particular industries affected by regulations, the condition of the national
economy, and other regulatory actions contemplated for the future.
Sec 3. Regulatory Impact Analysis and Review.
(a) In order to implement Section 2 of this Order, each agency shall, in
connection with every major rule, prepare, and to the extent permitted by law
consider, a Regulatory Impact Analysis. Such Analyses may be combined with
any Regulatory Flexibility Analyses performed under 5 U S.C. 603 and 604.
(b) Each agency shall initially determine whether a rule it intends to propose
or to issue is a major rule, provided that, the Director, subject to the direction
of the Task Force, shall have authority, in accordance with Sections 1(b) and 2
of this Order, to prescribe criteria for making such determinations, to order a
rule to be treated as a major rule, and to require any set of related rules to be
considered together as a major rule.
(c) Except as provided in Section 8 of this Order, agencies shall prepare
Regulatory Impact Analyses of major rules and transmit them, along with all
notices of proposed rulemaking and all final rules, to the Director as follows:
(1) If no notice of proposed rulemaking is to be published for a proposed major
rule that is not an emergency rule, the agency shall prepare only a final'
Regulatory Impact Analysis, which shall be transmitted, along with the pro-
posed rule, to the Director at least 60 days prior to the publication of the major
rule as a final rule;
(2) With respect to all other major rules, the agency shall prepare a prelimi-
nary Regulatory Impact Analysis, which shall be transmitted, along with a
notice of proposed rulemaking, to the Director at least 60 days prior to the
publication of a notice of proposed rulemaking, and a final Regulatory Impact
Analysis, which shall be transmitted along with the final rule at least 30 days
prior to the publication of the major rule as a final rule;
(3) For all rules other than major rules, agencies shall submit to the Director, at
least 10 days prior to publication, every notice of proposed rulemaking and
final rule.
(d) To permit each proposed major rule to be analyzed in tight of the
requirements stated in Section 2 of this Order, each preliminary and final
Regulatory Impact Analysis shall contain the following information:
(1) A description of the potential benefits of the rule, including any beneficial
effects that cannot be quantified in monetary terms, and the identification of
those likely to receive the benefits:
(2) A description of the potential costs of the rule, including any adverse
effects that cannot be quantified in monetary terms, and the identification of
those likely to bear the costs;
(3) A determination of the potential net benefits of the rule, including an
evaluation of effects that cannot be quantified in monetary terms;
(4) A description of alternative approaches that could substantially achieve
the same regulatory goal at lower cost, together with an analysis of this
potential benefit and costs and a brief explanation of the legal reasons why
such alternatives, if proposed, could not be adopted; and
(5) Unless covered by the description required under paragraph (4) of this
subsection, an explanation of any legal reasons why the rule cannot be based
on the requirements set forth in Section 2 of this Order.
(e) (1} The Director, subject to the direction of the Task Force, which shall
resolve any issues raised under this Order or'ensure that they are presented to
the President is authorized to review any preliminary or final Regulatory
Impact Analysis, notice of proposed rulemaking, or final rule based on the
requirements of this Order.
(2) The Director shall be deemed to have concluded review unless the Director
advises an agency to the contrary under subsection (f] of this Section:
-------
Federal Register / Vol 46. No 33 / Thursday. February 19. 1981 / Presidential Documents 13195
(A) Within 60 days of a submission under subsection (c)(1) or a submission of
a preliminary Regulatory Impact Analysis or notice of proposed rulemaking
under subsection (c)(2);
(B) Within 30 days of the submission of a final Regulatory Impact Analysis
and a final rule under subsection (c)(2). and
(C) Within 10 days of the submission of a notice of proposed rulemaking or
final rule under subsection (c)(3)
(f) (1) Upon the request of the Director, an agency shall consult with the
Director concerning the review of a preliminary Regulatory Impact Analysis
or notice of proposed rulemaking under this Order, and shall, subjpct to
Section 8(a)(2) of this Order, refrain from publishing its preliminary Regulatory
Impact Analysis or notice of proposed rulemaking until such revipw is con-
cluded
(2) Upon receiving notice that the Director intends to submit views with
respect to any final ReguTatory Impact Analysis or final rule, the agoncy shall,
subject to Section 8(a)(2) of this Order, refrain from publishing its final
Regulatory Impact Analysis or final rule until the agency has responded to the
Director's views, and incorporated those views and the agency's response in
the rulemaking file.
(3) Nothirc in this subsection shall be construed as displacing the agencies
responsib./ues delegated by law.
(g) For every rule for which an agency publishes a notice of proposed
rulemaking, the agency shall include in its notice:
(1) A brief statement setting forth the agency's initial determination whether
the proposed rule is a major rule, together with the reasons underlying that
determination: and
(2) For each proposed major rule, a brief summary of the agency's preliminary
Regulatory Impact Analysis.
(h) Agencies shall make their preliminary and final Regulatory Impact Analv-
ses available to the public.
(i) Agencies shall initiate reviews of currently effective rules in accordance
with the purposes of this Order, and perform Regulatory Impact Analyses of
currently effective major rules. The Director, subject to the direction of the
Task Force, may designate currently effective rules for review in accordance
with this Order, and establish schedules for reviews and Analyses under this
Order.
Sec. 4. Regulatory Review. Before approving any final major rule, each agency
shall:
(a) Make a determination that the regulation is clearly within the authority
delegated by law and consistent with congressional intent, and include in the
Federal Register at the time of promulgation a memorandum of law supporting
that determination.
(b) Make a determination that the factual conclusions upon which the rule is
based have substantial support in the agency record, viewed as a whole, with
full attention to public comments in general and the comments of persons
directly affected by the rule in particular.
Sec. 5. Regulatory Agendas.
(a) Each agency shall publish, in October and April of each year, an agenda of
proposed regulations that the agency has issued or expects to issue, and
currently effective rules that are under agency review pursuant to this Order
These agendas may be incorporated with the agendas published under 5
U.S.C. 602, and must contain at the minimum:
(1) A summary of the nature of each major rule being considered, the
objectives and legal basis for the issuance of the rule, and an approximate
-------
13196 Federal Register / Vol. 48. No. 33 / Thursday. February 19. 1981 / Presidential Documents
schedule for completing action on any major rule for which the agency has
issued a notice of proposed rulemaking;
(2) The name and telephone number of a knowledgeable agency official for
each item on the agenda: and
(3) A list of existing regulations to be reviewed under the terms of this Order,
and a bnef discussion of each such regulation.
(b) The Director, subject to the direction of the Task Force, may. to the extent
permitted by law:
(1) Require agencies to provide additional information in. an agenda; and
(2) Require publication of the agenda in any form.
Sec. 8. The Task Force and Office of Management and Budget.
(a) To the extent permitted by law, the Director shall have authonty, subject
to the direction of the Task Force, to:
(1) Designate any proposed or existing rule as a major rule in accordance with
Section 1(b) of this Order
(2) Prepare and promulgate uniform standards for the identification of major
rules and the development of Regulatory Impact Analyses;
(3) Require an agency to obtain and evaluate, in connection with a regulation,
any additional relevant data from any appropriate source;
(4) Waive the requirements of Sections 3, 4, or 7 of this Order with respect to
any proposed or existing major rule;
(5) Identify duplicative, overlapping and conflicting rules, existing or pro-
posed. and existing or proposed roles that are inconsistent with the policies
underlying statutes governing agencies other than the issuing agency or with
the purposes of this Order, and. in each such case, require appropriate
interagency consultation to minimize or eliminate such duplication, overlap, or
conflict:
(6) Develop procedures far estimating the annual benefits and costs of agency
regulations, on both an aggregate and economic or industrial sector basis, for
purposes of compiling a regulatory budget:
(7) In consultation with interested, agencies, prepare for consideration by the
President recommendations for changes in the agencies' statutes; and
(8) Monitor agency compliance with the requirements of this Order and advise
the President with respect to such compliance.
(b) The Director, subject to the direction of the Task Force, is authorized to
establish procedures for the performance of all functions vested in the Direc-
tor by this Order. The Director shall take appropnate steps to coordinate the
implementation of the analysis, transmittal, review, and clearance provisions
of this Order with the authorities and requirements provided for or imposed
upon the Director and agencies under the Regulatory Flexibility Act. 5 U S.C.
801 et seq., and the Paperwork Reduction Plan Act of 1980, 44 U S C. 3501 et
seq.
Sec. 7. Pending Regulations.
(a) To the extent necessary to permit reconsideration in accordance with this
Order, agencies shall, except as provided in Section 8 of this Order, suspend
or postpone the effective dates of all major rules that they have promulgated
in final form as of the date of this Order, but that have not yet become
effective, excluding:
(1) Major rules that cannot legally be postponed or suspended;
(2) Major rules that, for good cause, ought to become effective as final rules
without reconsideration. Agencies shall prepare, in accordance with Section 3
of this Order, a final Regulatory Impact Analysis for each major rule that they
suspend or postpone.
-------
Federal Register / Vol 46. No. 33 / Thursday. February 19. 1981 / Presidential Documents 13197
(b) Agencies shall report to the Director no later than 15 days prior to the
effective date of any rule that the agency has promulgated in final form as of
the date of this Order, and that has not yet become effective, and that will not
be reconsidered under subsection (a) of this Section:
(1) That the rule is excepted from reconsideration under subsection (a)
including a brief statement of the legal or other reasons for that determination,
or
(2) That the rule is not a major rule.
(c) The Director, subject to the direction of the Task Force, is authorized, to
the extent permitted by law, to:
(1) Require reconsideration, in accordance with this Order, of any major rule
that an agency has issued in final form as of the date of this Order and that
has not become effective; and
(2) Designate a rule that an agency has issued in final form as of the date of
this Order and that has not yet become effective as a major rule in accordance
with Section 1(b) of this Order.
(d) Agencies may, in accordance with the Administrative Procedure Act and
other applicable statutes, permit major rules that they have issued in final
form as of the date of this Order, and that have not yet become effective, to
take effect as intenm rules while they are being reconsidered in accordance
with this Order, provided that, agencies shall report to the Director, no later
than 15 days before any such rule is proposed to take effect as an interim rule,
that the rule should appropriately take effect as an interim rule while the rule
is under reconsideration.
(e) Except as provided in Section 8 of this Order, agencies shall, to the extent
permitted by law, refrain from promulgating as a final rule any proposed
major rule that has been published or issued as of the date of this Order until
a final Regulatory Impact Analysis, in accordance with Section 3 of this Order,
has been prepared for the proposed major rule.
(f) Agencies shall report to the Director, no later than 30 days prior to
promulgating as a final rule any proposed rule that the agency has published
or issued as of the date of this Order and that has not been considered under
the terms of this Order
(1) That the rule cannot legally be considered in accordance with this Order,
together with a brief explanation of the legal reasons barring such considera-
tion: or
(2) That the rule is not a major rule, in which case the agency shall submit to
the Director a copy of the proposed rule.
(g) The Director, subject to the direction of the Task Force, is authorized, to
the extent permitted by law, to:
(1) Require consideration, in accordance with this Order, of any proposed
major rule that the agency has published or issued as of the date of this Order;
and
(2) Designate a proposed rule that an agency has published or issued as of the
date of this Order, as a major rule in accordance with Section 1(b) of this
Order.
(h) The Director shall be deemed to have determined that an agency's report
to the Director under subsections (b), (d), or (f) of this Section is consistent
with the purposes of this Order, unless the Director advises the agency to the
contrary:
(1) Within 15 days of its report, in the case of any report under subsections (b)
or (d). or
(2) Within 30 days of its report, in the case of any report under subsection (f).
-------
13198
Federal Register / Vol. 46. No. 33 / Thursday. February 19. 1981 / Presidential Documents
(i) This Section does not supersede the President's Memorandum of )anuary
29, 1981. entitled "Postponement of Pending Regulations", which shall remain
in effect until March 30.1881.
(j) In complying with this Section, agencies shall comply with all applicable
provisions of the Administrative Procedure Act. and with any other proce-
dural requirements made applicable to the agencies by other statutes
Sec. 8. Exemptions
(a) The procedures prescribed by this Order shall not apply to:
(1) Any regulation that responds to an emergency situation, provided that, any
such regulation shall be reported to the Director as soon as is practicable, the
agency shall publish in the Federal Register a statement of the reasons why it
is impracticable for the agency to follow the procedures of this Order with
respect to Buch a rule, and the agency shall prepare and transmit as soon as is
practicable a Regulatory Impact Analysis of any such major rule: and
(2) Any regulation for which consideration or reconsideration under the terms
of this Order would conflict with deadlines imposed by statute or by judicial
order, provided that, any such regulation shall be reported to the Director
together with a brief explanation of the conflict, the agency shall publish in
the Federal Register a statement of the reasons why it is impracticable for the
agency to follow the procedures of this Order with respect to such a rule, "and
the agency, in consultation with the Director, shall adhere to the requirements
of this Order to the extent permitted by statutory or judicial deadlines.
(b) The Director, subject to the direction of the Task Force, may. in accordance
with the purposes of this Order, exempt any class or category of regulations
from any or all requirements of this Order.
Sec. 9. Judicial Review. This Order is intended only to improve the internal
management of the Federal government and is not intended to create any
right or benefit, substantive or procedural, enforceable at law by a party
against the United States, its agencies, its officers or any person. The determi-
nations made by agencies under Section 4 of this Order, and any Regulatory
Impact Analyses for any rule, shall be made part of the whole record of
agency action in connection with the rule.
Sec. 10. Revocations. Executive Orders No. 12044, as amended, and No. 12174
are revoked.
THE WHITE HOUSE.
February 17, 1981.
|FR Doc 81-5790
Filed 2-17-ftl 3 19 pm|
Billing a>de 319S-01-M
-------
Tuesday
January 8, 1985
Part III
The President
Executive Order 12498—Regulatory
Planning Process
-------
1036
Ftdnl Regis tar
Vot. 5a No. 8
Tuasday. January & 1BU
Presidential Documents
Title 3—
The President
Executive Ordar 12488 of )uuiy i tttS
Regulatory Planning Procaaa
By the authority vested in me a» President by the Constitution and laws of the
United States of America, and in order to create a coordinated process for
developing on an annua] basis the Adatinistration's Regulatory Program,
establish Administration regulatory priorities increase the accountability of
agency heads for the regulatory action* of their agencies, provide for Presides
tial oversight of the regulatory process, reduce the burdens of existing and
future regulations, minimiza duplication and conflict of regulations, and en-
hance public and Congressional understanding of the Administration's regula-
tory objectives, it is hereby ordered a a follows:
Section 1. General Requirements, (a) There is hereby established a regulatory
planning process by which the Administration will develop and publish a
Regulatory Program for each year. To implement this process, each Executive
agency subject to Executive Order No* 12291 shall submit to the Director of the
Office of Management and Budget (OMB) each year, starting in 1985. a
statement of its regulatory policies, goals, and objectives for the coming year
and information concerning alt significant regulatory actions underway or
planned: however, the Director may exempt from this Order such agencies or
activities as the Director may deem appropriate in order to achieve the
effective implementation of this Order
(b) The head of each Executive agency subject ta this Order shall ensure that
all regulatory actions are consistent with the goals of the agency and of the
Administration, and will be appropriately implemented.
(c) This program i» intended to complement the existing regulatory planning
and review procedures of agencies and the Executive branch, including the
procedures established by Executive Order No. 12291.
(d) To assure consistency with the goals of the Administration, the head of
each agency subject to this Order shall adhere to the regulatory principles
stated in Section 2 of Executive Order No. 12291. including those elaborated
by the regulatory policy guidelines set forth in the August 11. 1983. Report of
the Presidential Task Force on Regulatory Relief, "Reagan Administration
Regulatory Achievements."
Sec. 2. Agency Submission of Draft Regulatory Program, (a) The head of each
agency shall submit to the Director an overview of the agency's regulatory
policies, goals, and objectives for the program year and such information
concerning all significant regulatory actions of the sgency, planned or under-
way, including actions taken to consider whether to initiate rulemaking;
requests for public comment: and the development of documents that may
influence, anticipate, or could lead to the commencement of rulemaking
proceedings at a later date, as the Director deems necessary to develop the
Administration's Regulatory Program. This submission shall constitute the
agency's draft regulatory program. The draft regulatory program shall be
submitted to the Director each year, on a date to be specified by the Director,
and shall cover the period from April 1 through March 31 of the following year
-------
Federal Register / Vol. SO. No. 3 / Tuesday. January 8. 1965 / Presidential Documents
1037
fb) The overview portion of the agency's submission should discuss the
agency's broad regulatory purposes. rxplam how they are consistent with the
Administration's regulatory principles, and Include a discussion of the signifi-
cant regulatory actions, as defined by the Director, that it will take. The
overview should specifically discuss the significant regulatory actions of the
agency to revise or rescind existing rules.
(c) Each agency head shall categorize and describe the regulatory actions
described In subsection (a) in such format as the Director shall specify and
provide such additional information as the Director may request: however, the
Director shall, by Bulletin or Circular, exempt from the requirements of this
Ocder any class or category of regulatory action that the Director determines
is not necessary to review la order to achieve the effective implementation of
the program.
Sec. 3. Review, Compilation, and Publication of the Administration's Regula-
tory Program, (a) In reviewing each agency's draft regulatory program, the
Director shall (i) consider the consistency of the draft regulatory program with
the Administration's policies and priorities and the draft regulatory programs
submitted by other agencies; and (ii) identify such further regulatory or
deregulatory actions as may, in his view, be necessary in order to achieve
such consistency. In the event of disagreement over the content of the
agency's draft regulatory program, the agency head or the Director may raise
issues for further review by the President or by such appropriate Cabinet
Council or other forum as the President may designate.
fb) Following the conclusion of the review process established by subsection
(a), each agency head shall submit to the Director, by a date to be specified by
the Director, the agency's final regulatory plan for compilation and publication
as the Administration's Regulatory Program for that year. The Director shall
circulate a draft of the Administration's Regulatory Program for agency com-
ment review, and interagency consideration, if necessary, before publication.
(c) After development of the Administration's Regulatory Program for the year,
if the agency head proposes to take a regulatory action subject to the
provisions of Section 2 and not previously submitted for review under this
process, or if the agency head proposes to take a regulatory action that is
materially different from the action described in the agency's final Regulatory
Program, the agency head shall immediately advise the Director and submit
the action to the Director for review in Buch format as the Director may
specify. Except in the case of emergency situations, as defined by the Director,
or statutory or judicial deadlines, the agency head shall refrain from taking the
proposed regulatory action until the review of this submission by the Director
is completed. As to those regulatory actions not also subject to Executive
Order No. 12291. the Director shall be deemed to have concluded that the
proposal is consistent with the purposes of this Order, unless he notifies the
agency head to the contrary within 10 days of its submission. As to those
regulatory actions sub|ect to Executive Order No. 12291, the Director's review
shall be governed by the provisions of Section 3(e) of that Order.
(d) Absent unusual circumstances, such as new statutory or judicial require-
ments or unanticipated emergency situations, the Director may. to the extent
permitted by law, return for reconsideration any rule submitted for review
under Executive Order No. 12291 that would be subject to Section 2 but was
not included in the agency's final Regulatory Program for that year, or any
other significant regulatory action that is materially different from those
described in the Administration's Regulatory Program for that year.
-------
io3a
Federal Register / Vol. SO. No. 5-/ Tuesday, January 8, 1985 / Presidential Docnmentv
(FR Doc. as-azs
Filed 1 < ffilf 4DB pn)
Billing cod# 319B-91-M
Sec. 4. Office, of Management and Budget. The Director of the Office of
Management and Budget la authorized, to the extent permitted by law. to take
such actions aa may be- necessary to carry out the provisions of this Order.
Sec. 3. Judicial Review. This Order'Is intended only to improve the internal
management of the Federal government, and is not intended to create any
nght or benefit, substantive or procedural, enforceable at law by a party
agauist the United States, its ageaciea. its officers or any person.
THE WHITE HOUSE.
January 4. 1985.
Ediloriai oota: Th» Preaident'a memorandum of Jan. 4. 1903. for the head* of executive depart-
ment* *nd agenciaa on the development of the admuuatration't regulatory program is pnnted in
the Weakly Compilation of PretidenuaJ Documents (vol. 21. no 1).
-------
ECONOMIC
INFORMATION
-------
May 3, 1989
THE USE OF ECONOMIC ANALYSIS IN RULEMAKING
Michael Shapiro, Director
Economics and Technology Division
Office of Toxic Substances
Overview of Presentation
1. Why economic analysis has become a required part of most rulemaking
activities.
2. Types of economic analysis used to support rulemaking.
3. Factors that govern the use of economic analysis in rulemaking.
4. Some thoughts on how to incorporate economic analysis into the
rulemaking in the most productive way possible.
Why Economics?
1. Environmental control can be a costly enterprise. Moreover, it is likely
to become more costly in the future as we tackle more complex problems,
such as the control of materials that can be toxic at very low
concentrations.
2. Although many of us feel that such expenditures are fully justified, given
the magnitude of the costs, it is natural to ask a number of questions:
a) Are we getting the most environmental protection for the resources
we are expending?
b) Are we accomplishing our environmental objectives in the most
efficient manner?
c) As we exert tighter and tighter controls on particular sources of
pollution, at greater and greater expense, at some point do we decide
that the additional pollution reduction is no longer worth the cost7
d) Is the distribution of costs and benefits of environmental programs
across companies, workers, the general public considered fair?
3. As it turns out, these are the kinds of questions that economics can help
answer. As a result over the past 15 years or so there has been a steady
increase in the use of economic analysis in the Agency's rulemaking
process.
Types of Economic Analysis
Various types of analysis can fall under the general rubric of economic analysis.
Some explanations are therefore needed to understand what kinds of studies are
appropriate in different circumstances.
-------
2
1. Cost analysis
This type of analysis simply answers the question "How much will the
regulation cost?" It is a basic building block for more sophisticated types of
analysis, but is seldom done alone except for relatively minor rulemakings.
Costs are usually estimated in a fairly straightforward manner. For
example, engineering estimates might be employed to'evaluate the costs of
a particular wastewater treatment requirement. However, there can be some
tricky economic problems involved at this stage. For example, accounting
definitions of cost often do not coincide with economic definitions.
2.. Cost-effectiveness analysis
Cost-effectiveness analysis attempts to examine different regulatory options
from the standpoint of how much each will cost to achieve a particular
objective. For example, what is the,least expensive, way to achieve a
desired level of particulates in the air? Alternatively, a cost-effectiveness
analysis might ask the question: what is the most that can be achieved at a
particular cost? Cost effectiveness analysis is frequently used where the
benefits of a regulation can not easily be evaluated in dollar terms (or
because we prefer not to evaluate benefits that way, even if we could).
This is frequently the case in environmental regulations.
,3. Cost-effectiveness ratios
This is a variation of cost-effectiveness analysis involving^ comparison of
the costs and benefits of a regulation through a simple ratio. For example,
if a particular regulation will result in a decrease of 100' cancer cases, at a
cost of 100 million dollars, then the cost-effectiveness ratio would be one
million dollars per life saved. From a purely economic standpoint such a
regulation would be preferable to an alternative that would avoid 100 cases
at a cost of 400 million dollars, for a ratio-of 4 million dollars per life
saved.
Although this type ration calculation seems .straightforward, there are a
couple of different approaches for doing the calculation, and interpreting
the results can be tricky, especially where the results of different studies
are being compared.
4. Benefit-cost analysis is the most complete form of economic assessment.
It involves a comparison of the costs of a regulation with the benefits,
converted to monetary terms. The net benefits of a regulation are the
difference between the benefits and the costs. According to economic
theory, a regulation would not be worth doing (from the perspective of
economic efficiency) unless the net benefits are positive, i.e. the benefits
exceed the costs. In choosing among alternative regulatory approaches, the
one that results in the greatest net benefits would be preferred. As
discussed below, many of EPA's statutes would preclude making a decision
solely on the basis of a benefit-cost, calculation, if we would want to.
Some types of benefits, for example, the damage to agricultural crops from
air pollution, are amenable to the calculation of monetary values; others,
such as the value attributable to reduced pain and suffering from disease
are difficult to estimate and may entail considerable controversy. Because
-------
3
attaching a monetary value to environmental benefits can be quite
difficult, and often controversial, full benefit-cost analyses are not all that
common. However, there are number of good examples of this approach,
particularly jp. analyses performed for the Air Program.
5.. Impact Apalysis
This is .a general .term ttbat is applied to a variety of • different types of
analyses that examine hojyrvarious groups or interests might be affected by
a regulation. These include impacts on small business, x»n employment, on
ilow income groups, on the balance of trade, plant closings, innovation,
energy..use^etc. Theilocus of these analyses may vary with the nature of
the regulation and the likelihood that significant impacts could be
triggered. Economic analysis at EPA began with a focus oh impacts,
because the initial use of economic analysis arose out of the Agency's need
to address .concerns that its'actions would have severe adverse impacts on
certain companies or industries. However, at present this'type of analysis,
while'Still important, tends to be less so that the cost-effectiveness or
benefit-cost calculations.
D. Factors Influencing the Use of Economic Analysis'
The use oF'econoihic analysis in the Agency's decision and rulemaking processes
varies across pre/grams. To some degree this variation reflects differences in
organizational culture and traditions over what factors are important in reaching
decisions. Within EPA, OPPE has been an advocate for the use off economic
analysis to support decisions. However, a number of external factors impose
significant' 'cons/trailits on what is done.
1. OMB
Under E<6cutive Order 12291 OMB reviews proposed" and final regulations
before they'-can lie'issued. For "major" regulations, EPA must prepare a
Regulatory impact Analysis (RIA) for both the proposed dnd final
regulations. OMB has issued guidelines for the preparation' of RIAs; these
have been supplemented by EPA guidance. Basically an RIA is a full
benefit-cost analysis of the Agency's preferred approach, together with
alternatives. In addition, the distribution of benefits and' costs must be
evaluated.
a) EO 12291 indicates when a regulation is considered major. One
criterion is that it would result in annual oosts'iri excess of $100
million. But in practice, any regulatory action that poses significant
public policy issues will probably be considered 'major. OMB has the
final say on this determination.
b) According to EO 12291 EPA is supposed to 0ick1,thfe alternative that
yields the greatest net-benefits or is the most cost-effective, where
the statutory authority" permits. The qualification i4 important, given
the way many 'of 'our statutes are written.
2. Statutory Considerations
EPA administers a variety of diffefeht statutes: the-Crean Air Act, Clean
Water Act, Safe Drinking Water Act, Resource Conservation and recovery
Act, etc. Each'statute Hafs'its'owri criteria for the Agehcy to consider in
-------
4
reaching regulatory decisions. Some tend to encourage the use of economic
analysis, others discourage it. Exhibit 1 pTpvides some interpretation of
what economic factors can be considered under the different statutes.
a)- At one extreme, certain statutes would appear to preclude direct
consideration of cost-benefit balancing. For example, in setting
ambient air quality standards under this Clean Air Act, EPA has to
set primary standards to protect human health with an adequate
margin of safety.
b) Other provisions are driven by the availability of technology, but
allow some scope for consideration of economic factors in evaluating
the affordability or efficiency of technological approaches. Terms
such as "Best Available Technology Economically Achievable" for
example reflect this type of'approach.
c) TSCA and FIFRA represent the other end of the spectrum. They do
not only permit, but to a certain degree mandate the use of a
benefit-cost type framework to reach regulatory decisions. Both
statutes incorporate the concept of an "unreasonable risk" finding to
justify regulation. Such a finding requires, in essence, a comparison
of the benefits of regulation with the costs of the action.
3. Other Laws
The Regulatory Flexibility Act requires that EP/t determine whether a
proposed regulatory action would have significant adverse impacts on a
substantial number of small entities - which might include small businesses
or small governments. If such an impact is projected, then the Agency must
prepare a Regulatory Flexibility Analysis (RFA). The RFA is an analysis
of options for mitigating the impacts on small entities. The Agency is not
required to select an option that eliminates or minimizes adverse impacts,
but it must explain its rationale for making its final decision. The RFA
requirement does not override the applicable-statutory mandate which the
Agency is acting under.
Although the RFA can be a separate document, it is frequently folded into
the Regulatory Impact Analysis, where an RIA is being prepared for a
major rule. The EPA has prepared guidelines for determining what
constitutes a "significant adverse impact on a substantial number of small
entities" and on complying with the RFA requirements.
E. Using Economics (and Economists) to Support a Regulation
1. Normally, consideration of economic issues should begin long before the
formal Agency rule development process begins. It should be factored into
the internal processes used by an office to decide whether to initiate
formal regulatory action and the general' scope of that action.
a) For reasons noted below, this will help yield better decisions (or at
least better informed decisions). But even if you don't believe that,
it will smooth the rulemaking process.
b) Economic analyses for major regulations are frequently difficult,
expensive and time consuming. By starting work early you will
reduce the likelihood that completion of the RIA will delay issuance
-------
5
of the final rule. Moreover, the economist will be in a better
ppsition to anticipate data needs and identify where data gaps need
to be filled in order to defend the regulation.
2. By^ts nature the, economic, analysis is an integrative piece. It has to bring
together .most of theseparate analyses that go jn.to supporting a regulation.
It is a good mechanism to p^qmote consistency iq assumptions and data use,
and to identify >v,here pieces may not "fit together."
3. Economists think funny. Believe it or not, this can be an advantage. By
actively participating in-the early stages of option development, economists
can,. help, generate appj-pac^hes that might not be identified otherwise.
CoinverseJyt jbyt participat,ipjj- in the analysis $it an early stage, the economist
will get ^psetter feel for the range of approaches that may ultimately need
to be considered inth,e RIA. As a result, he or she can design a flexible
analytical approach that is responsive to the various twists and turns that a
rule may; take .during its evolution. There's nothing more frustrating than
to come up with £ ;grea1t new regulatory approach, only to find out that it
will take a completely new economic model to handle the analysis of that
approach!
4. Work closely with the,economists supporting your workgroup. Make sure
that they know what the latest thinking is and that you have access to
their study design and interim results. Too often rule writers are Surprised
by the final RIA, when it's too late they find out that the results don't
actually support the arguments in favor of the selected regplatory
approac^.
5. yse the economic analysis as a topi to identify areas, where more
information -may be.needejd. There are always data -gaps'knowledge gaps
that must (benfiiled by assumptions or extrapolations.'Which-of these
assumptions ,are most critical to the decision? By running the economic
analysis underjdifferent assumptions (sensitivity analysis) you can
d^ermine iwhethejr, any of these assumptions are critical to the final
decision. In some cases these critical assumptions ,can be [Supported by
additional data gathering. In others it is not feasible to fill the information
gap, but the decision maker should be made aware of thp critical nature of
the assumption and ^he uncertainties surrounding the particular choice
made.
6. Work closely with the-;economist Jo determine the best way ito summarize
and present the economic information for decision makers and reviewers.
7. Don't take the numbers too seriously! Decisions often focus too readily on
the bottom line numbers such as dollars per cancer case ^voided. While
these are obviously'.useful numbers (at least from an economists
perspective) most economists arri .only too well awar.e of the limitations of
the analysis. What htaportant qualitative factors should .afXeqt the decision?
For example, are there ecosystem effects that could not' be quantified for
the benefits analysis? Are tjieir long term effects on innovation or
industrial competitiveness that couldn't be captured quantitatively? Are
particular groups heavily impacted?
-------
EXHIBIT-1
ANALYSES SPECIFIED IN EPA's ENABLING LEGISLATION
Benefits
Costs
Act/Regulation
Clean Air Act
NAAQS - Primary
NAAQS - Secondary
Hazardous Air Pollutants
New-Source Standards
Motor Vehicle Standards***
Aircraft Emissions
Fuel Standards***
Pollution Welfare/
Reduction Health Envrnmnt
X
X
X
X
X
*
X
X
X
*
X
X
X
Compliance Cost-
Costs Effctv
Economic
Impacts
**
X
X
X
X
**
X
X
Clean Water Act
Private Treatment Works
Public Treatment Works
X
X
****
X
X
Safe Drinking Water Act
Max. Contaminant Level Goals
Maximum Contaminant Levels
Toxic Substances Control Act
Resource Conservation and
Recovery Act
Comprehensive Environmental
Response. Compensation and
Liability Act
Reportable Quantities
National Contingency Plan
Federal Insecticide. Fungicide
and Rodenticide Act
Data Requirements
Minor Uses
Atomic Energy Act
Radioactive Wastes
Uranium Mill Tailings
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
* Includes non-air-quality health and environmental impacts only.
** Statute refers only to "cost."
*** Type of analysis depends on grounds for control.
**** Includes non-water-quality environmental impacts only.
------- |