EPA
United States
Environmental Protection
Agency
Office of Emergency and
Remedial Response
Washington DC 20460
EPA/540/G-89/007
July 1989
Pre-Publication Copy
Superfund
Guidance on Preparing
Superfund Decision
Documents:
The Proposed Plan
The Record of Decision
Explanation of Significant
Differences
The Record of Decision
Amendment
Interim Final
-------
£ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
§ V^"^/ -
^-^MV- -' WASHINGTON. O.C. 20460
V PRC^
JUN 12
MEMORANDUM
SUBJECT: Interim Final Guidance on Preparing Superfund Decision
Documents (OSWER Directive 9355.3-02)
OFKICE OF
SOLID WASTE AND EMERGENCY RESPONSE
FROM: ./Jonathan Z.
^^cting Assistant Administr
TO: Regional Administrators
R«?gi
I am pleased to transmit to you the Interim Final Guidance on
Preparing Superfund Decision Documents, commonly known as the
"ROD Guidance." This document supersedes the original 1985
guidance on preparing Records of Decision (RODS) and the March
1988 draft revised guidance that you have been following during
the past year.
The ROD Guidance establishes procedures and standardized
formats for four important remedial documents: the Proposed Plan,
Record of Decision, Explanation of Significant Differences, and
ROD Amendment. These documents serve the legal function of
certifying that our decisions regarding remedy proposal,
selection or modification have been carried out in accordance
with CERCLA and the National Contingency Plan. These decision
documents also outline the technical parameters which form the
basis of remedial design. In addition, our decision documents
also perform the vital function of communicating the rationale
for Superfund remedy selection decisions to the public. As
^oituuunicacion tools, it is therefore essential that these
documents are logical, complete, and clear. In order to promote
consistency in our remedies and better public understanding of
these documents and consistency in presentation, I urge you to
adhere to the formats and approaches contained in the guidance.
In addition to establishing requirements for the necessary
contents and format for remedial decision documents, this guidance
specifies the roles and responsibilities of EPA, the States, and
other Federal agencies in developing and issuing Superfund
decision documents. The ROD Guidance also establishes procedures
for implementing CERCLA sections 117 (b) and (d) to document
significant changes made during the remedy selection process.
-------
Should you or your staff have any questions concerning this
guidance you should contact Sandra Panetta (FTS 475-9757) or
Betsy Shaw (FTS 382-4635) in the Site Policy and Guidance Branch
(OERR).
Attachment
cc: Directors, Waste Management Division, Regions I, IV, V, VI,
VIII
Director, Emergency and Remedial Response Division, Reg. II
Directors, Hazardous Waste Management Division, Regions III,
VII, IX
Director, Hazardous Waste Division, Region X
-------
EPA/540/G-89/007
July 1989
Pre-Publication Copy
Guidance on Preparing Superfund
Decision Documents:
The Proposed Plan
The Record of Decision
Explanation of Significant Differences
The Record of Decision Amendment
Interim Final
Office of Emergency and Remedial Response
U.S. Environmental Protection Agency
Washington, DC 20460
-------
OSWER Directive 9355.3-02
-11-
Notice
Development of this document was funded by the United States
Environmental Protection Agency in part under contract No. 68-W8-0098 to CH2M
HILL SOUTHEAST. It has been subjected to the Agency's review process and
approved for publication as an EPA document.
The policies and'procedures set out in this document are intended solely
for the guidance of response personnel. They are not intended, nor can they
be relied upon, to create any rights, substantive or procedural, enforceable
by any party in litigation with the United States. The Agency reserves the
right to act at variance with these policies and procedures and to change them
at any time without public notice.
-------
OSWER Directive 9355.3-02
-m-
Foreword
This Interim Final Guidance on Preparing Superfund Decision Documents was
issued in order to improve the quality and completeness of Records of Decision
and related documents. This guidance benefited from a review of past
Superfund Records of Decision and defines important items to be addressed in
documenting site remediation decisions.
This guidance does not cover the selection of remedy process itself.
This will be the subject of a separate guidance that will be developed in
concert with the final National Contingency Plan rulemaking.
-------
OSWER Directive 9355.3-02
Acknowledgments
This document was developed by EPA's Office of Emergency and Remedial
Response (OERR) in conjunction with the Record of Decision (ROD) Workgroup and
with assistance provided by ICF Incorporated. Darsi Foss was the EPA project
manager and co-chairperson of the ROD Workgroup along with Mary A. Gade,
Associate Division Director, Office of Superfund, EPA Region V. The ICF
project team included Gerald DiCerbo, Alice Whitfield, and Georgeann Morekas.
The ROD Workgroup contributed significantly to the development of this
document and included the following Regional, State, and Headquarters
personnel:
Jeremy Firestone, Region I
Bill Walsh-Rogalski, Region I
Robert McKnight, Region II
Beverly Houston, Region IV
Larry Kyte, Region V
Joan Tanaka, Region V
Mary Tyson, Region V
Laura demons, Region VIII
John Blevins, Region IX
Gary Pulford, Minnesota Pollution Control Agency
Bob Chapin, Texas Water Commission
Ed Putnam, New Jersey Department of Environmental Protection
Elizabeth Shaw, OERR
Sylvia Malm, OERR
Vanessa Musgrave, OERR
Deborah Lebow, Office of Waste Programs Enforcement (OWPE)
Tony Diecidue, OWPE
Ellen Spitalnik, Office of Enforcement and Compliance Monitoring
Joe Freedman, Office of General Counsel
Steve Nicholas, Office of Policy, Planning and Evaluation
-------
OSWER Directive 9355.3-02
-v-
Table of Contents
Page
Acknowledgements iv
Acronyms Used in this Guidance xiv
CHAPTER 1 INTRODUCTION 1-1
1.1 Purpose of this Guidance 1-1
1.2 Overview of the Superfund Remedial Process 1-2
1.2.1 The Pre-Remedial Stage 1-4
1.2.2 Determination of Lead and Support Agencies .... 1-4
1.2.3 Potentially Responsible Party(ies) (PRPs) 1-5
1.2.4 Remedial Investigation/Feasibility Study (RI/FS) . 1-6
1.2.5 Preferred Alternative 1-7
1.2.6 Proposed Plan 1-8
1.2.7 Record of Decision (ROD) 1-8
1.2.8 Remedial Design (RD) 1-8
1.2.9 Remedial Action (RA) 1-10
1.3 Outline of this Guidance 1-10
CHAPTER 2 THE PROPOSED PLAN 2-1
2.1 Purpose of the Proposed Plan 2-1
2.1.1 Statutory Requirements 2-2
2.2 Writing the Proposed Plan 2-4
2.3 Section-by-Section Description of the Proposed Plan. . . . 2-7
2.3.1 Introduction 2-7
2.3.2 Site Background 2-8
2.3.3 Scope and Role of Operable Unit or Response Action 2-8
2.3.4 Summary of Site Risks 2-9
2.3.5 Summary of Alternatives 2-10
2.3.6 The Evaluation of Alternatives 2-10
2.3.7 Community Participation 2-14
2.4 Formats for the Proposed Plan 2-15
2.4.1 Fact Sheet Format 2-15
2.4.2 Expanded Format 2-16
-------
OSWER Directive 9355.3-02
-vi-
Tabie of Contents (continued)
Page
CHAPTER 3 THE PROCESS FOR DEVELOPING THE PROPOSED PLAN 3-1
3.1 Overview 3-1
3.1.1 Preparing the Proposed Plan 3-1
3.2 Roles and Responsibilities of the Lead Agency and
Support Agency 3-3
3.2.1 Designation of Roles and Responsibilities 3-3
3.2.2 Lead and Support Agency Responsibilities 3-4
3.2.3 Management Review of the Proposed Plan 3-5
3.2.4 Support Agency Comment Period 3-6
3.3 Procedures for Resolving Disputes 3-7
3.4 Role of Other Federal Agencies 3-8
3.5 Role of Potentially Responsible Parties 3-9
CHAPTER 4 THE NEWSPAPER NOTIFICATION OF AVAILABILITY OF
THE PROPOSED PLAN AND THE PUBLIC COMMENT PERIOD 4-1
4.1 Statutory Requirements 4-1
4.2 Writing the Newspaper Notification 4-2
4.2.1 Section-by-Section Description of the
Newspaper Notification 4-2
4.3 Public Comment Period 4-4
CHAPTER 5 PRE-ROD SIGNIFICANT CHANGES 5-1
5.1 Overview 5-1
5.2 Requirement to Address Changes 5-2
5.3 Identifying Categories of Changes 5-2
5.3.1 Minor Changes 5-3
5.3.2 Significant Changes 5-3
-------
OSWER Directive 9355.3-02
-VTI-
Table of Contents (continued)
Page
5.4 Criteria for Analyzing Significant Changes 5-5
5.4.1 Significant Changes that may be Considered
Logical Outgrowths of the Information Available
to the Public 5-5
5.4.2 Significant Changes that may not be Considered
Logical Outgrowths of the Information Available
to the Public 5-7
5.5 Examples of Pre-ROD Changes 5-8
5.5.1 Minor Change 5-9
5,5.2 Significant Change Requiring Documentation
in the ROD 5-9
5.5.3 Significant Change Necessitating the Issuance of
a New Proposed Plan, of a New Public Comment
Period, and their Documentation in the ROD .... 5-10
CHAPTER 6 WRITING THE RECORD OF DECISION 6-1
6.1 Introduction 6-1
6.1.1 Purpose of the Record of Decision 6-1
6.1.2 Statutory Requirements to Issue the
Record of Decision 6-2
6.1.3 Major Components of the Record of Decision .... 6-2
6.2 Key Elements of the Declaration 6-3
6.2.1 Site Name and Location 6-6
6.2.2 Statement of Basis and Purpose 6-6
6.2.3 Assessment of the Site 6-6
6.2.4 Description of the Selected Remedy 6-7
6.2.5 Statutory Determinations 6-7
6.2.5.1 Sample Boilerplate Language for
Making Statutory Determinations 6-8
6.2.6 Signature and Support Agency Acceptance of
the Remedy 6-10
6.3 Key Elements of the Decision Summary 6-10
6.3.1 Site Name, Location, and Description 6-11
6.3.2 Site History and Enforcement Activities 6-12
-------
OSWER Directive 9355.3-02
-vm-
Table of Contents (continued)
Page
6.3.3 Highlights of Community Participation 6-12
6.3.4 Scope and Role of Operable Unit or
Response Action 6-13
6.3.5 Summary of Site Characteristics 6-14
6.3.6 Summary of Site Risks 6-15
6.3.6.1 Human Health Risks 6-15
6.3.6.2 Environmental Risks 6-19
6.3.7 Description of Alternatives 6-20
6.3.8 Summary of the Comparative Analysis of
Alternatives 6-23
6.3.9 The Selected Remedy 6-25
6.3.10 Statutory Determinations 6-28
6.3.11 Documentation of Significant Changes 6-33
6.4 The Responsiveness Summary 6-34
6.5 Submitting RODs to EPA Headquarters 6-36
CHAPTER 7 THE PROCESS FOR DEVELOPING THE RECORD OF DECISION 7-1
7.1 Overview 7-1
7.1.1 State Preparation of the ROD 7-1
7.1.2 Remedy Selection for State-Lead Enforcement
Actions 7-2
7.1.3 Roles and Responsibilities of Other Federal
Agencies 7-2
7.2 Roles and Responsibilities of Lead Agency and
Support Agency 7-3
7.2.1 Lead Agency 7-3
7.2.2 Support Agency 7-5
7.3 Dispute Resolution 7-6
7.4 Role of State and Other EPA Program Offices 7-6
7.5 Role of Potentially Responsible Parties 7-6
7.6 Issuing Notice of Availability of the ROD 7-7
7.6.1 Elements of the ROD Public Notice 7-7
-------
OSWER Directive 9355.3-02
-IX-
Table of Contents (continued)
Page
CHAPTER 8 POST-ROD SIGNIFICANT CHANGES 8-1
8.1 Overview 8-1
8.2 Requirements to Address Significant Changes 8-1
8.2.1 Analyzing Information Received or Generated. . . . 8-2
8.3 Consideration of Information Submitted by the Public,
PRPs, and the Support Agency 8-3
8.4 Standards for Consideration of Information Submitted
by the Public, PRPs, or Support Agency 8-4
8.5 Consideration of Information Generated by the Lead
Agency 8-6
8.6 Categories of Post-ROD Changes 8-7
8.6.1 Non-Significant Changes 8-8
8.6.2 Significant Changes to a Component of a Remedy . . 8-10
8.6.2.1 Preparing the ESD 8-14
8.6.3 Fundamental Changes to the ROD 8-16
CHAPTER 9 DOCUMENTING NO ACTION, INTERIM ACTION, AND
CONTINGENCY REMEDY DECISIONS 9-1
9.1 Documenting a "No Action" Decision 9-1
9.1.1 No Action is Necessary to Achieve Protection
of Human Health and the Environment 9-2
9.1.2 No CERCLA Authority to Take Action 9-3
9.1.3 No Effective Action 9-3
9.2 Documenting Interim Action Decisions 9-11
9.3 Decision Documents with Contingency Remedies 9-11
9.3.1 Innovative Technologies 9-15
9.3.2 Comparable Technologies 9-16
9.3.3 Documenting Contingency Remedy Decisions 9-17
-------
OSWER Directive 9355.3-02
-x-
List of Appendices
Appendix A: Sample Proposed Plan
Appendix B: Worksheets for the Summary Comparative Analysis of
Alternatives
Example of a Completed Comparative Analysis
Worksheet
Worksheets for the Summary Comparative Analysis
of Alternatives
Summary of Evaluation Worksheet
Appendix C:
Sample Description of an Alternative
Sample Summary of Site Risks Table
Appendix D: Sample Selected Remedy and Statutory Determinations
Discussion for the ROD
Appendix E: Helpful Hints: How to Prepare and Submit Decision
Documents to Headquarters
Appendix F: Sources of Information
-------
OSWER Directive 9355.3-02
-xi-
List of Exhibits
Exhibit
Number Exhibit Title Page
1-1 Expectations for Superfund Remedial Actions 1-9
2-1 Outline for the Proposed Plan 2-5
2-2 The Nine Remedial Evaluation Criteria 2-12
2-3 Hints for Preparing the Nine Criteria Analysis 2-13
2-4 Advantages and Disadvantages of the Fact Sheet Format 2-16
2-5 Advantages and Disadvantages of the Expanded Format 2-17
4-1 Sample Newspaper Notification of Availability of the
Proposed Plan 4-3
6-1 Outline for the Record of Decision 6-4
6-2 Sample Declaration for the Record of Decision:
Statutory Preference for Treatment as a Principal
Element is Met and Five-Year Review is not Required 6-5
6-3 Sample Declaration for the Record of Decision:
Statutory Preference for Treatment as a Principal
Element is not Met and Five-Year Site Review
is Required 6-9
6-4 Description of Details for Each Remedy 6-22
6-5 Federal ARARs that May Apply to Superfund Remedial Actions . . . 6-24
6-6 Example Cost Summary for the Selected Remedy 6-27
6-7 Examples of Federal and State ARAR Descriptions 6-30
6-8 Three Examples of Documentation of Significant Changes 6-35
7-1 Sample Newspaper Notification of Availability of the Record
of Decision 7-9
8-1 Examples of a Non-Significant Difference 8-9
8-2 Examples of a Significant Difference to a Component of a
Remedy 8-11
8-3 Outline for the Explanation of Significant Differences 8-15
8-4 Significant Change That Fundamentally Alters the Remedy
Requiring Amendment of the ROD 8-17
9-1 Documenting a No Action Decision: Action Not Necessary for
Protection Outline for the Proposed Plan 9-4
9-2 Documenting a No Action Decision: Action Not Necessary for
Protection Outline for the ROD 9-5
9-3 Documenting a No Action Decision: No CERCLA Authority to
Take Action Outline for the Proposed Plan 9-7
-------
OSWER Directive 9355.3-02
-X11-
List of Exhibits (continued)
Exhibit
Number Exhibit Title Page
9-4 Documenting a No Action Decision: No CERCLA Authority to
Take Action Outline for the ROD 9-8
9-5 Documenting a No Action Decision: No Effective Action
Possible Outline for the Proposed Plan 9-9
9-6 Documenting a No Action Decision: No Effective Action
Possible Outline for the ROD 9-10
9-7 Documenting Interim Action Decisions: Outline for the
Proposed Plan 9-12
9-8 Documenting Interim Action Decisions: Outline for the ROD. . . 9-13
9-9 Documenting Contingency Remedy Decisions: Outline for the
Proposed Plan 9-19
9-10 Documenting Contingency Remedy Decisions: Outline for
the ROD 9-20
-------
OSWER Directive 9355.3-02
-xm-
List of Figures
Figure
Number Figure Title Page
1-1 The Remedial Process 1-3
3-1 Preparation of the Proposed Plan by the Lead Agency 3-2
5-1 Pre-ROD Changes 5-4
6-1 Illustration of Components of Alternatives to be Described. . . 6-21
7-1 Lead Agency Responsibility in ROD Development Process 7-4
8-1 Process to Address Post-ROD Significant Changes 8-5
8-2 Process That Results in the Issuance of an Explanation of
Significant Differences: General Procedures 8-12
8-3 Process That Results in the Issuance of an Explanation of
Significant Differences: Changes Resulting From
Enforcement Activities 8-13
8-4 Process That Results in the Issuance of an Amended ROD:
General Procedures 8-19
8-5 Process That Results in the Issuance of an Amended ROD:
Changes Resulting from Enforcement Activities 8-20
-------
OSWER Directive 9355.3-02
-XIV-
Acronyms Used in this Guidance
AA - Assistant Administrator
ACL - Alternate Concentration Limit
ARAR - Applicable or Relevant and Appropriate Requirement
BOAT - Best Demonstrated Available Treatment Technologies
CA - Cooperative Agreement
CAA - Clean Air Act
CERCLA - Comprehensive Environmental Response, Compensation and
Liability Act of 1980
CFR - Code of Federal Regulations
CWA - Clean Water Act
EP - Extraction Procedure
EPA - Environmental Protection Agency
ESD - Explanation of Significant Differences
FR - Federal Register
FS - Feasibility Study
HRS - Hazard Ranking System
IAG - Interagency Agreement
LDR - Land Disposal Restrictions
LSI - Listing Site Investigation
MCLs - Maximum Contaminant Levels
MEP - Maximum Extent Practicable
MPRSA - Marine Protection Research and Sanctuaries Act
NCP - National Contingency Plan
NPDES - National Pollutant Discharge Elimination System
NPL - National Priorities List
OERR - Office of Emergency and Remedial Response
OSC - On-Scene Coordinator
OSWER - Office of Solid Waste and Emergency Response
OU - Operable Unit
OWPE - Office of Waste Programs Enforcement
PA - Preliminary Assessment
POTW - Publicly-Owned Treatment Works
PRP - Potentially Responsible Party
RA - Regional Administrator
RCRA - Resource Conservation and Recovery Act
RI - Remedial Investigation
RD/RA - Remedial Design/Remedial Action
ROD - Record of Decision
RPM - Remedial Project Manager
SARA - Superfund Amendments and Reauthorization Act of 1986
SDWA - Safe Drinking Water Act
SIP - State Implementation Plan
SMOA - Superfund Memorandum of Agreement
SSC - State Superfund Contract
SSI - Screening Site Investigation
SWDA - Solid Waste Disposal Act
TBC - To Be Considered
TMV - Toxicity, Mobility, or Volume
TSCA - Toxic Substance Control Act
-------
OSWER Directive 9355.3-02
CHAPTER 1
INTRODUCTION
1.1 PURPOSE OF THIS GUIDANCE
This "Guidance on Preparing Superfund Decision Documents" (commonly
referred to as the "ROD Guidance") has been developed to: (1) present
standard formats for documenting Superfund remedial action decisions; (2)
clarify the roles and responsibilities of the Environmental Protection Agency
(EPA), States, and other Federal agencies in developing and issuing decision
documents; and (3) explain how to address changes made to proposed and
selected remedies. The decision documents addressed by this guidance are the
Proposed Plan, the Record of Decision (ROD), the Explanation of Significant
Differences (ESD), and the ROD amendment.1 Section 117 of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as
amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA),
requires the issuance of these decision documents for remedial actions taken
pursuant to sections 104, 106, 120, and 122.2 The proposed National Oil and
Hazardous Substances Contingency Plan (NCP) incorporates the requirements and
provisions of SARA.3 This guidance has been prepared on the basis of SARA and
the existing NCP (1985) and is consistent with the proposed NCP.
The first purpose of the ROD guidance is to standardize the format of the
Proposed Plan, ROD, and other relevant decision documents. Standardized
formats for these documents are necessary because the remedies selected in the
Superfund program should be reviewed by the public on a national as well as a
local level. Standardizing these decision documents should:
Provide consistency among Regions, with respect to the
organization and content of decision documents;
This guidance replaces the February 27, 1985, memorandum: "Preparation of Decision Documents
for Approving Fund-Financed and Potentially Responsible Party Remedial Actions under CERCLA."
p
References made to CERCLA throughout this document should be interpreted as meaning
CERCLA, as amended by SARA.
3 "National Oil and Hazardous Substances Pollution Contingency Plan" Proposed Rule, (53 FR
51394), December 21, 1988.
-------
OSWER Directive 9355.3-02
1-2
Ensure that all statutory and regulatory documentation
requirements are met; and
Promote clear and logical presentations of rationales for
remedy selection decisions based on site-specific
information and supporting analysis.
In addition to the emphasis on providing a standard format to document
remedial action decisions, this guidance specifies the roles and
responsibilities of EPA, the States, and other Federal agencies in developing
and issuing Superfund decision documents. The emphasis on a larger State role
in the remedial process is contained in CERCLA section 121(f)(l), which
provides "for substantial and meaningful involvement of each State in the
initiation, development, and selection of remedial response actions to be
undertaken in that State." In addition, because Executive Order 12580
("Superfund Implementation," January 23, 1987) delegates authority for certain
CERCLA activities to other Federal agencies, this guidance also discusses the
roles and responsibilities of these other agencies (e.g., the Departments of
Defense, Energy, and the Interior) in the remedial process.
Finally, this guidance addresses the statutory requirement in CERCLA
sections 117(b) and (d) to document significant changes made during the remedy
selection process. For example, when significant changes are made to the
Proposed Plan after its publication, certain activities should be undertaken
to document these changes. In the event that significant changes are made to
the selected remedy after the ROD is signed, specific documentation and public
participation requirements should be met. Procedures to fulfill these
requirements are outlined in this guidance.
1.2 OVERVIEW OF THE SUPERFUND REMEDIAL PROCESS
This section describes the relationship between the decision documents
addressed in this guidance and the overall Superfund remedial response
process. Each stage of the remedial process is briefly summarized to show
the reader how the decision documents, including the Proposed Plan and the
ROD, fit into the overall Superfund remedial response process (see Figure 1-
1).
-------
1-3
FIGURE 1-1
The Remedial Process
Pre-Remedlaf :
- Preliminary Assessment
- Site Investigation
- MRS Evaluation
- NPL Listing
T
^
Remedial Investigation /Feasibility Study
-Scoping
Site Char " Devel°Pment
acterlzatlon a"d screening of
- Baseline alternatives *+
Risk - Detailed Analysis
Assessment of Alternatives
- Treatablllty
Studies
T
::: Selection of Remedy ! :',/.
Identification of
Preferred Alternative
i
Proposed Plan
T
Public Comment
f
Remedy Selection
i
T
Record of Decision {ROD)
i
I
t
^
-^
-^
.' : '!: ' ;-' /: . POSt-ROD V'"' '';;>''; ' :'
- Remedial Design
- Remedial Action
- Operation and Maintenance
- Deletion from NPL
Preliminary identification of site
hazards and evaluation of the need !
for action under Superf und
remedial program
i
i
Gather information sufficient to
support an Informed risk
management decision regarding
which remedy appears to be the
most appropriate for a given site
Make Initial Identification of preferred
alternative based upon preliminary
balancing of tradeoffs among
alternatives using the nine criteria
Present preferred alternative:
Minimum 21 day public comment
period held on the Proposed Plan,
RI/FS, and other contents of
the Administrative Record file
Make final determination on remedy
Certify lhat the remedy complies
with CERCLA, outline the technical
goals of the remedy* provide background
Information on the site, summarize
the analysis of alternatives, and
explain the rationale for the remedy
selected
' : .... .. I
Design and construct remedy utilizing
i
Information contained In the ROD
and other relevant documents
-------
OSWER Directive 9355.3-02
1-4
1.2.1 The Pre-Remedial Stage
The Pre-Remedial Stage encompasses the identification, investigation, and
listing of a site on the National Priorities List (NPL). The pre-remedial
stage consists of a three-part process for determining whether hazards at a
site justify performing a CERCLA remedial action or whether the site can be
cleaned up under some authority other than CERCLA. This process begins with a
Preliminary Assessment (PA), during which existing information on the site is
reviewed. If the results of the PA indicate that further investigation is
warranted, either a Screening Site Investigation (SSI) or a Listing Site
Investigation (LSI) is conducted. An LSI is performed to gather sufficient
information to "score" the site using the Hazard Ranking System (MRS). The
HRS is a site evaluation methodology that EPA uses to estimate the relative
hazards posed by different sites. Those sites that score above the HRS cut-
off score of 28.5 are eligible to be placed on the NPL.
1.2.2 Determination of Lead and Support Agencies
After a site is placed on the NPL, interagency negotiations are initiated
to determine which agency should act as the Lead Agency in the remedial
process and which as the Support Agency. These negotiations include EPA,
States, and other Federal Agencies. The lead agency, which is represented by
the Remedial Project Manager (RPM), has the primary responsibility for
coordinating a response action. Either EPA, a State environmental agency, or
another Federal agency (e.g., the Department of Defense for cases of hazardous
waste sites on military bases) can serve as the lead agency. The lead agency
RPM is responsible for overseeing all technical, enforcement, and financial
aspects of a remedial response.
. The support agency plays a review and concurrence role throughout the
remedial process. When EPA or another Federal agency acts as the lead agency,
the State in which the site is located usually serves as the support agency.
When the State is the lead agency, EPA usually serves as the support agency.
When EPA and a State are involved in remedial activities, the lead and
support agencies are identified in a Superfund Memorandum of Agreement, a
Cooperative Agreement, or a State Superfund Contract. A Superfund Memorandum
of Agreement (SMOA) is a general agreement that specifies the nature and
extent of interaction between EPA and the State for one or more sites. A
Cooperative Agreement (CA) is a site-specific agreement that establishes
-------
OSWER Directive 9355.3-02
1-5
Federal and State responsibilities for a specific CERCLA response action.4 A
State Superfund Contract (SSC) is an agreement that documents any required
cost shares and assurances necessary from a State but does not involve the
disbursement of Federal monies.5
A Federal agency other than EPA could also assume the roles and
responsibilities of the lead agency. These responsibilities include
coordinating and communicating with EPA and the State in their shared role as
support agencies. The division of authority and responsibility between the
Federal agency as lead and the support agencies, particularly in preparing the
Proposed Plan and the ROD, should be specified in an Interagency Agreement
(IAG). This agreement should be reached by considering the process and
activities outlined in this guidance, the CERCLA requirements, and the
proposed revisions to the National Oil and Hazardous Substances Pollution
Contingency Plan (NCP). Federal agencies conducting response actions are
expected to comply with this and other Agency guidance, as specified in CERCLA
section 120.
1.2.3 Potentially Responsible Party(ies) (PRPs)
Under CERCLA section 104, an individual or company identified as
potentially liable for a release of hazardous substances into the environment,
a Potentially Responsible Party (PRP), may also conduct CERCLA response
actions, if that party is qualified and otherwise capable. For a PRP-prepared
response action, either EPA or the State is the lead agency for overseeing the
PRP's work and for developing the Proposed Plan and the ROD. PRPs may
participate in the remedy selection process by recommending their own
preferred alternative to the lead agency at the conclusion of the feasibility
study and by submitting comments on the Proposed Plan and other information in
the administrative record during the formal public comment period that is held
before the final selection of a remedy for a site.
With a CA, EPA establishes an account to enable the State to use Trust Fund monies to finance
response actions.
5 Because a State may be either the lead agency or the support agency for most remedial activities,
this guidance often makes general reference to "lead" and "support" agency responsibilities, rather than
EPA or State responsibilities. Federal agencies (other than EPA) have lead responsibility at sites under
their jurisdiction; however, EPA has final authority regarding remedy selection at such sites.
-------
OSWER Directive 9355.3-02
1-6
1.2.4 Remedial Investigation/Feasibility Study (Rl/FS)
Once a site is listed on the NPL and a lead agency has been identified,
the lead agency performs a Remedial Investigation and Feasibility Study
(Rl/FS). During an Rl/FS, the lead agency gathers information sufficient to
support an informed risk management decision regarding which remedy appears to
be most appropriate for a given site or an operable unit within a site.
Operable Units (OUs) are discrete parts of an entire response action. An OU
can be defined as a certain geographic portion of a site or an environmental
medium at the site (e.g., alternative water supply, source control measures,
mitigation of contamination in off-site areas, or ground-water remediation).
Operable units may also be comprehensive but temporary remedies (e.g.,
temporary caps across a site) that can provide interim protection of human
health and the environment prior to final remediation.
The RI and the FS are usually conducted concurrently, in an interactive,
iterative manner. The data collected during the RI are used to develop
remedial alternatives in the FS, and the alternatives identified in the FS
determine the necessity of treatability studies or the collection of
additional data in the RI. In general, the RI consists of:
Collecting data to characterize site conditions;
Determining the nature and extent of contamination at the
site or operable unit;
Assessing risks to human health and the environment; and
Conducting treatability testing to evaluate the potential
performance and cost of the treatment technologies that
are being considered for the site.
In characterizing the site, the lead agency identifies the source of
contamination, potential routes of migration, and current and potential human
and environmental receptors. The baseline risk assessment conducted during
the RI identifies the contaminants of concern and exposure and toxicity
information that are used to determine the risks posed by the conditions at
the site to human health and the environment. Treatability studies are bench,
pilot, or full-scale tests of a particular technology on samples of actual
-------
OSWER Directive 9355.3-02
1-7
site wastes. Such studies are conducted to identify which technologies are
suitable for addressing the waste to be treated.
The FS involves the identification and detailed evaluation of potential
remedial alternatives. This process begins with the formulation of viable
alternatives, which involves defining remedial action objectives, general
response actions, volumes or area of media to be addressed, and potentially
applicable technologies. The alternatives should be screened, as appropriate,
down to a reasonable number that undergo a detailed analysis using the nine
evaluation criteria (for a discussion of this analysis, see Chapter 6). The
analysis profiles individual alternatives against the criteria and compares
them with each other to gauge their relative performance against each factor.
Each alternative, with the exception of the required no action alternative, is
designed and continually refined to ensure that it should be protective of
human health and the environment and that it should be compliant with its
respective Applicable or Relevant and Appropriate Requirements (ARARs).6
1.2.5 Preferred Alternative
The lead agency identifies a Preferred Alternative prior to holding a
formal public comment period on the proposed cleanup for a site. The detailed
analysis provides the lead and support agencies with sufficient information to
identify a preferred alternative. The preferred alternative is identified as
the protective, ARAR-compliant approach that is judged to provide the best
balance of tradeoffs with respect to the five primary balancing criteria.
This evaluation should also consider State (support agency) and community
acceptance of each alternative, when that information is available. The
preferred alternative and, ultimately, the selected remedy should be chosen
considering the Superfund program's "expectations." These are presented in
Exhibit 1-1.
ARARs include any Federal or State standards, requirements, criteria, or limitations that are
determined to be legally applicable or relevant and appropriate to a CERCLA site or action. These
requirements may include regulations promulgated under the Solid Waste Disposal Act (SWDA), the
Toxic Substances Control Act (TSCA), the Safe Drinking Water Act (SDWA), the Clean Water Act
(CWA), and other Federal environmental statutes or State laws. Applicable requirements are those
cleanup standards, standards of control, and other substantive environmental protection requirements,
criteria, or limitations promulgated under Federal or State law that specifically address a hazardous
substance, pollutant, contaminant, remedial action, location, or other circumstances at a CERCLA site.
Relevant and appropriate requirements are requirements that, while not "applicable" to circumstances at a
CERCLA site, address problems or situations sufficiently similar to those encountered at the CERCLA
site whose use is well suited for that particular site. Additional guidance on ARARs is provided in the
CERCLA Compliance with Other Laws Manual. Draft (OSWER Directive 9234.1-01, August 1988).
-------
OSWER Directive 9355.3-02
1-8
1.2.6 Proposed Plan
The preferred alternative for a site is presented to the public in a
Proposed Plan. The Proposed Plan provides a brief summary of all of the
alternatives studied in the detailed analysis phase of the RI/FS,
highlighting the key factors that led to the identification of the preferred
alternative. The Proposed Plan is made available for public comment, in
addition to the RI/FS and the other information, in the administrative record.
1.2.7 Record of Decision (ROD)
Following receipt of public comments and any final comments from the
support agency, a remedy is selected and documented in a ROD. The ROD, which
documents the remedial action plan for a site or operable unit, serves three
basic functions:
It certifies that the remedy selection process was carried
out in accordance with CERCLA and, to the extent
practicable, with the NCP;
It describes the technical parameters of the remedy,
specifying the treatment, engineering, and institutional
components, as well as remediation goals; and
It provides the public with a consolidated source of
information about the site and the chosen remedy,
including the rationale behind the selection.
1.2.8 Remedial Design (RD)
The ROD provides the framework for the transition into the next phase of
the remedial process, Remedial Design (RD). Remedial Design is an engineering
phase during which technical drawings and specifications are developed for the
subsequent Remedial Action. These specifications are based upon the detailed
description of the remedy and the cleanup criteria provided in the ROD.
-------
OSWER Directive 9355.3-02
1-9
EXHIBIT 1-1
Expectations for Superfund Remedial Actions
The following expectations guide the decisionmaker in determining what method (or combination of
methods of protection) is appropriate for a particular site or operable unit.
« The objective of the Superfund program is to select remedies that provide reliable, effective
protection over the long term. To meet this objective, remedies should either reduce all
wastes to health-based levels or manage contaminants to such an extent that there is a high
degree of certainty that future exposures will not harm human health or the environment.
« Treatment is the preferred means by which to address the principal threats posed by a site,
wherever practicable. Principal threats are characterized as areas contaminated with high
concentrations of toxic compounds, liquids, and other highly mobile materials. Principal
threats may include contaminated media (e.g., contaminated ground water, sediments, or
soil) that pose significant risk of exposure.
« The most appropriate remedy for a specific site frequently will be a combination of
treatment and containment.
Containment is more likely to be appropriate for low concentrations of materials and
immobile wastes that do not pose substantial long-term threats, for example:
- Wastes of which the contaminants are near health-based levels Or that are
substantially immobile or can otherwise can be reliably contained over long
periods of time;
" Wastes that are technically difficult to treat, such as mixed wastes of widely
varying composition or wastes dispersed over extraordinarily large sites, such as
municipal landfills or mining sites, where treatment is impracticable; and
Wastes with characteristics such that a treatment-based remedy would increase
overall risk to human health and the environment due to risks posed to
workers, the community, or the environment during implementation.
* Ground waters will be returned to their beneficial uses within a reasonable period of time,
wherever practicable.
Institutional controls (e.g., deed restrictions, prohibitions of well construction) are important
in controlling exposures during remedial action implementation and as supplements to long-
term engineering controls. Institutional controls alone should not substitute for more active
measures (treatment or containment) unless such active measures are found to be
impracticable.
-------
OSWER Directive 9355.3-02
1-10
1.2.9 Remedial Action (RA)
After completion of the RD> the Remedial Action (RA) begins, during which
the actual construction of the remedy, or implementation phase of site
cleanup, occurs. When all phases of remedial activity at a site have been
completed and no further remedial action is warranted, the site can be deleted
from the NPL. Completed cleanup results should be compared with the terms in
the ROD to determine whether remediation goals have been fulfilled such that
the site should be deleted from the NPL.
1.3 OUTLINE OF THIS GUIDANCE
While this guidance addresses only the preparation of Superfund decision
documents, other guidance documents that address other stages of the remedial
process are also available. Because preparation of the Proposed Plan and ROD
relies to a great extent on the information collected and analyzed during the
RI/FS process, the Guidance for Conducting Remedial Investigations and
Feasibility Studies under CERCLA (OSWER Directive 9355.3-01, October 1988) is
of particular importance. The ROD guidance and RI/FS guidance are
interrelated documents that should be used when conducting remedial actions
pursuant to CERCLA sections 104, 106, 120, and 122. Many portions of Proposed
Plans and RODs contain summaries of information that should have been
generated during the RI/FS. Additional sources of information on the remedy
selection process and other stages of the remedial process are listed in
Appendix F of this guidance.
The chapters included in this guidance address the following different
aspects of the Superfund remedy selection process that require specific
documentation:
Chapter 2 presents the purpose of and the statutory
requirements for the Proposed Plan and provides guidelines
for issuing the Plan;
Chapter 3 summarizes the roles and responsibilities of
lead and support agencies in developing the Proposed Plan;
-------
OSWER Directive 9355.3-02
1-11
Chapter 4 summarizes requirements for the newspaper
notification of availability of the Proposed Plan and
discusses the public comment period;
Chapter 5 describes the general framework for categorizing
minor and significant changes made to the preferred
alternative before issuance of the ROD and discusses
documentation and public information activities that may
be necessary;
Chapter 6 presents the standard format for the ROD and
discusses key elements to be included in each section;
Chapter 7 summarizes the roles and responsibilities of
lead and support agencies in developing the ROD;
Chapter 8 discusses the standards and procedures to follow
when Post-ROD significant changes occur; and
Chapter 9 examines the three types of remedial decisions
(no action, interim action, and contingency remedy
decisions) that should include modifications to the
standard ROD and Proposed Plan format.
-------
OSWER Directive 9355.3-02
CHAPTER 2
THE PROPOSED PLAN
This chapter presents the purpose of the Proposed Plan and the statutory
requirements for issuing the Plan pursuant to CERCLA sections 104, 106, 120,
and 122. In addition, this chapter provides a suggested outline and format
for writing the Proposed Plan.1
2.1 PURPOSE OF THE PROPOSED PLAN
The purpose of the Proposed Plan is to facilitate public participation in
the remedy selection process by:
Identifying the preferred alternative for a remedial
action at a site or operable unit and explaining the
reasons for the preference;
Describing other remedial options that were considered in
detail in the RI/FS report;
Soliciting public review and comment on all the
alternatives described; and
Providing information on how the public can be involved in
the remedy selection process.
The Proposed Plan is a public participation document and is expected to
be widely read. The Proposed Plan, therefore, should be written in a clear
and concise manner using non-technical language. In addition, the Proposed
Plan should direct the public to the RI/FS report as the primary source of
detailed information on the remedial alternatives analyzed, as well as other
site-specific information.
The Proposed Plan should present the lead agency's preliminary
recommendation concerning how best to undertake a cleanup action at the site
Chapter 9 should be consulted when preparing Proposed Plans for no action, interim action, and
contingency remedy decisions.
-------
OSWER Directive 9355.3-02
2-2
but should not select the final remedial action for a site or operable unit.
The Proposed Plan should make clear that the lead agency has "identified" a
preferred alternative based on available information, but has not "selected" a
remedy to implement. The Proposed Plan supports only preliminary decisions
for a site and should include observations and tentative recommendations. The
Proposed Plan should not make definitive findings or declarative statements
that would be difficult to revise later.
In emphasizing that the preferred alternative is only an initial
recommendation, the Proposed Plan should clearly state that changes to the
preferred alternative, or a change from the preferred alternative to another
alternative, may be made if public comments or additional data indicate that
such a change would result in a more appropriate solution. The final decision
regarding the selected remedy should be documented in the ROD after the lead
agency has taken into consideration all comments from both the support agency
and the public. An important function of the Proposed Plan is to solicit
public comment on all of the alternatives considered in the detailed analysis
phase of the RI/FS because the lead and support agencies may select a remedy
other than the preferred alternative.
2.1.1 Statutory Requirements
Three separate statutory requirements in CERCLA provide the basic
framework in the Proposed Plan and the process for developing this document.
These are CERCLA sections 113(k)(2)(B), 117(a), and 121(f)(l)(6).
Section 113(k)(2)(B) establishes the minimum procedures for public
involvement in selecting a response action. The specific procedures for the
Proposed Plan are to provide:
A notice to potentially affected persons and the public, which
shall be accompanied by a brief analysis of the [proposed]2
plan and alternative plans that were considered; and
A reasonable opportunity to comment and provide
information regarding the [proposed] plan.
] Denotes paraphrase.
-------
OSWER Directive 9355.3-02
2-3
Section 117(a) establishes the baseline public participation requirements
for remedial activities. The subsections relating to the Proposed Plan
require that the lead agency:
.(-1) -Publish a notice and brief analysis of the proposed plan
and make such plan available to the public;
(2) Provide a reasonable opportunity for submission of
written and oral comments and an opportunity for a public
meeting at or near the facility at issue regarding the
proposed plan and regarding any proposed findings under
section 121(d)(4) (relating to cleanup standards) [e.g.,
waivers]. The [lead agency] shall keep a transcript of
the meeting and make such transcript available to the
public; and
[Include in] the notice and analysis published under
paragraph (1) ... sufficient information ... as may be
necessary to provide a reasonable explanation of the
proposed plan and alternative proposals considered [in the
RI/FS report].
Section 121ff)(l)fG) specifies the minimum involvement EPA should afford
the State in the remedial decision process. The requirements specific to the
Proposed Plan are to provide:
[a] Notice to the State and an opportunity to comment on
the proposed plan for remedial action as well as on
alternative plans under consideration. The [EPA's]
proposed decision regarding the selection of remedial
action shall be accompanied by a response to the comments
submitted by the State including an explanation regarding
any decision on compliance with promulgated State
standards. A copy of such response shall also be provided
to the State.
-------
OSWER Directive 9355.3-02
2-4
2.2 WRITING THE PROPOSED PLAN
The Proposed Plan summarizes essential information from the RI/FS report.
At a minimum, the Plan should:
Summarize the environmental conditions at the site as
determined during the RI;
Describe the remedial alternatives evaluated in sufficient
detail to provide a reasonable explanation of each
alternative;
Identify the lead agency's preferred alternative;
Provide a general summary of the support agency comments,
if available (e.g., concurrence, nonconcurrence, or no
comments at present time) and the lead agency's response
to the comments;
Identify and provide a summary explanation of any proposed
waivers to the ARARs in CERCLA section 121(d)(4); and
Provide a brief analysis that supports the preferred
alternative, discussed in terms of the nine evaluation
criteria.
Exhibit 2-1 provides a recommended outline of the Proposed Plan. This
outline contains elements that are both specifically required by CERCLA and
others that are recommended for inclusion. Variations may be made as
appropriate.
The following subsections provide more specific guidance on the key
elements of the Plan. Chapter 9 provides additional guidance on modifications
to the Proposed Plan when the Plan calls for no action, interim action, or a
contingency remedy. A sample Proposed Plan is presented in Appendix A of this
Guidance for a hypothetical Superfund site.
-------
OSWER Directive 9355.3-02
2-5
EXHIBIT 2-1
Outline for the Proposed Plan
Introduction
Provide site name and location.
* Identify lead and support agencies.
Introduce document's purpose, which is to:
fulfill requirements of section H7(a);
describe alternatives analyzed;
identify preferred alternative and explain rationale for preference;
serve as companion to the RI/FS and administrative record file; and
solicit public involvement in selection of a remedy.
» Stress importance of public input on all alternatives.
Site Background
« Provide brief overview of site.
Describe site history.
Scope and Role of Operable Unit or Response Action
Describe scope of problem that the action will address.
Describe role of action within site strategy.
» Identify how action addresses principal threat(s).
Summary of Site Risks
Provide overview of baseline risk assessment, by describing the:
contaminated media;
chemicals of concern;
baseline exposure scenarios (e.g., routes of exposure - current and future land-use
scenarios); and
current and potential site risks (including both carcinogenic and noncarcinogenic
threats).
Discuss ecological risk(s), as appropriate.
Summary of Alternatives
Provide narrative description of alternatives evaluated in detailed analysis of FS (including
engineering components, treatment components, estimated present-worth cost, implementation
time, and the major ARARs associated with the alternative(s)).
-------
OSWER Directive 9355.3-02
2-6
EXHIBIT 2-1 (continued)
Outline for the Proposed Plan
Evaluation of Alternatives and The Preferred Alternative
» Identify the preferred alternative
* Introduce the nine evaluation criteria and discuss how they are utilized in the
Superfund program.
Provide the rationale for the preferred alternative by profiling it against the
nine criteria and highlighting how it compares to the other alternatives (major
advantages and disadvantages). State/support agency and community
acceptance should be addressed to the extent adequate information is available
at the time.
Discuss the lead agency's belief that the preferred alternative would satisfy the
statutory findings, including the preference for treatment as a principal
element.
When the support agency concurs with the preferred alternative, its
recommendation that the alternative meets the statutory findings also should be
included.
Community Participation41
Provide notice of public comment period (written comments are encouraged).
Note time and place for a public meeting(s) {if they are scheduled) or offer
opportunity for meeting.
Provide the location of administrative record files and information repositories.
* Community includes the general public and PRPs.
-------
OSWER Directive 9355.3-02
2-7
2.3 SECTION-BY-SECTION DESCRIPTION OF THE PROPOSED
PLAN
2.3.1 Introduction
This introductory section should include the site name and location, and
identify the lead and support agencies for the remedial action. The
introduction should state that the Proposed Plan is a document that the lead
agency is required to issue to fulfill CERCLA section 117(a).
The public should be informed of the function of the Proposed Plan in the
remedy selection process, specifically, that its fourfold purpose is to:
Identify the preferred alternative for remedial action at
a site or operable unit and explain the reasons for the
preference;
Describe the other remedial options considered in detail
in the RI/FS report;
Solicit public review of and comment on all the
alternatives described; and
Provide information on how the public can be involved in
the remedy selection process.
A clear statement should be made that the Proposed Plan highlights key
information from the RI/FS report but is not a substitute for that document.
The Plan should refer the reader to the RI/FS report and administrative record
file(s) as more complete sources of information regarding the remedial
action.3 The first section of the Proposed Plan should stress that public
input on all alternatives, and on the information that supports the
alternatives, is an important contribution to the remedy selection process.
The public should be encouraged to submit comments and should be informed that
their comments can influence the lead agency's preference. The point should
3 Subpart I of the proposed revisions to the National Contingency Plan (40 CFR Part 300) and the
Interim Guidance on Administrative Records for Selection of CERCLA Response Actions (OSWER
Directive 9833.3A, March 1989) provide detailed information on developing, maintaining, and providing
access to the Administrative Record for the selection of the CERCLA response action.
-------
OSWER Directive 9355.3-02
2-8
be made that the final remedial action plan, as presented in the ROD, could be
different from the preferred alternative, depending upon new information or
arguments the lead agency may consider as a result of public comments.
2.3.2 Site Background
The site background should include a site map and a brief description of
the site, including the history of waste generation or disposal that has taken
place there, the major contaminants of concern, the contaminated media, and
the extent of contamination.
2.3.3 Scope and Role of Operable Unit or Response Action
This section of the Proposed Plan should summarize the lead agency's
overall strategy for remediating the site and describe how the action being
considered in the Proposed Plan fits into that overall strategy.
If the response is being carried out in operable units, the purpose of
each operable unit and their sequence should be described. For example, the
following language could be included in this section. "This is the second of
three planned operable units for the site. The first operable unit provided
the community with an alternate water supply to prevent ingestion of
contaminated ground water. This operable unit addresses remediation of the
contaminated ground water, one of the principal threats posed by the site.
The third and final operable unit addresses the contaminated soil, which
represents the source of the ground-water contamination which is the other
principal threat posed by the site."
As the above example illustrates, the Proposed Plan's description of the
overall site strategy and the function of the proposed response action should
indicate how and through what action or series of actions the principal
threats posed by the site will be addressed. In general, an environmental
medium or physical area is identified as a principal threat when it is
contaminated with high concentrations of toxic compounds, liquids, or highly
mobile materials. Each site at which a Superfund remedial action is
undertaken has at least one, and often more than one, principal threat (e.g.,
contaminated soil and drinking water). This section of the Proposed Plan
should help establish the basis for the finding made in the ROD as to whether
or not the selected remedy satisfies the preference for using treatment as a
-------
OSWER Directive 9355.3-02
2-9
principal element which occurs when principal threats are addressed through
treatment.
2.3.4 Summary of Site Risks
This section of the Proposed Plan should summarize the extent of
contamination at the site and the risks posed to human health and the
environment using information developed during the RI. The summary of site
risks should include key findings made in the baseline risk assessment
conducted as part of the RI. This discussion should:
Identify contaminated media;
Identify contaminants of concern;
Describe exposure pathways (e.g., routes of exposure -
ground water, surface water, air, and soil);
Describe the potentially exposed population;
Discuss environmental risks as appropriate (ecological
receptors, potential exposures, and potential effects of
exposures); and
Describe how current risks compare to remediation goals
(e.g., current carcinogenic risks of 10~2 will be reduced
to 1CT6).
The description of site risks should not rely solely on standard numeric
risk representations (such as cancer risks of 10~3 or a hazard quotient value
of 22). These risk numbers should be accompanied by a discussion that
explains, for example, that a cancer risk level of 10"3 means that one
additional person out of a thousand is at risk of developing cancer if the
site is not cleaned up. Similarly, for noncarcinogenic effects, the
discussion of the hazard quotient and hazard index should state that a hazard
quotient (the ratio of the level of exposure to an acceptable level) greater
than 1.0 indicates that the exposure level exceeds the protective level for
that particular chemical. If the hazard quotients for individual chemicals
are less than 1.0 but the sum of the hazard quotients for all substances in an
-------
OSWER Directive 9355.3-02
2-10
exposure medium (i.e., the hazard index) is greater than 1.0, then there may
be a concern for potential health effects.
In addition, for proposed remedies other than "no action," this section
of the Proposed Plan should-conclude with the following statement.
Actual or threatened releases of hazardous substances from
this site, if not addressed by the preferred alternative
or one of the other active measures considered, may
present a current or potential threat to public health,
welfare, or the environment.
2.3.5 Summary of Alternatives
The Summary of Alternatives section should provide a brief narrative of
the alternatives studied in the detailed analysis phase of the RI/FS report.
This description should specify the treatment technology(ies), engineering
controls, institutional controls, quantities of waste handled, implementation
requirements, the estimated construction and operation and maintenance costs,
and the estimated implementation time frame associated with each remedy.
These descriptions also should incorporate the major ARARs associated
with each option. For example, ARARs associated with a source control remedy,
such as RCRA Subtitle C or D closure standards, should be incorporated into
the discussion, as appropriate. For treatment-based alternatives, the ARARs
associated with treating hazardous substances (e.g., RCRA land disposal
restrictions, RCRA incineration standards in Subpart 0, Clean Air Act
Standards, etc.) also should be described. The sample Proposed Plan in
Appendix A of this Guidance provides examples of the level of detail for these
discussions.
2.3.6 The Evaluation of Alternatives
This section should begin by identifying the preferred alternative.
Next, the nine criteria used to evaluate the alternatives in the detailed
analysis in the FS should be presented. The nine criteria encompass statutory
requirements and include other technical, economic, and practical factors that
assist in gauging the overall feasibility and acceptability of remedial
alternatives.
-------
OSWER Directive 9355.3-02
2-11
The nine criteria are categorized into three groups: threshold criteria,
primary balancing criteria, and modifying criteria. The threshold criteria
must be satisfied in order for an alternative to be eligible for selection.
The primary balancing criteria are used to weigh major tradeoffs among
alternatives. Generally, the modifying criteria are taken into account after
public comment is received on the Proposed Plan. Exhibit 2-2 presents
information on the organization of the criteria and the major points that
should be addressed under each criterion. Additional information on the nine
criteria and detailed analysis of alternatives are provided in the proposed
revisions to the NCP, and the Guidance for Conducting Remedial Investigations
and Feasibility Studies under CERCLA (OSWER Directive 9355.3-01, October
1988).
The Proposed Plan uses the nine criteria to profile the performance of
the preferred alternative, explaining the rationale for the preference by
briefly comparing the preferred alternative to the other alternatives under
each criterion. For example, under the long-term effectiveness and permanence
criterion, the quantity of residuals the preferred alternative leaves on-site
and the reliability of the long-term management controls used should be stated
and compared with the other alternatives. Additional information on the major
points to be addressed under each criterion are presented in Exhibits 2-2 and
2-3.
The discussion in this section of the Proposed Plan should develop the
initial rationale for the preferred alternative; however, it need not provide
a comprehensive analysis of each alternative in relation to each of the nine
criteria nor should it make conclusive, binding statements about an
alternative. For a more detailed explanation, the reader should be directed
to the comparative analysis contained in the RI/FS. Appendix B includes some
sample worksheets that could be used during the preliminary stages in
preparing this section of the Proposed Plan.
The conclusion of this section of the Proposed Plan should include a
summary by the lead Agency that says, based on information currently
available, the preferred alternative provides the best balance of tradeoffs
among the other alternatives with respect to the evaluation criteria. This
section should include a statement summarizing the support agency's
concurrence or nonconcurrence of the preferred alternative and should note
that the lead agency expects that the preferred alternative satisfies the
statutory requirements in CERCLA section 121(b) that the selected alternative:
-------
(.- it-
EXHIBIT 2-2
The Nine Remedial Evaluation Criteria
-\ ';;.:}" :
THRESHOLD CRITERIA
Overall Protection I L
of Human Health 1
and the Environment 1
Compliance with
ARARs
' How Alternative Provides Human
Health and Envtronmantal Protec-
tion
Comptance wttti Chemical Spe-
cmcARAR*
Compliance with Action-Specific
ARAR«
Comptance wtth Location-Spe-
cWcARAR*
Compliance wtth Other Criteria,
Advisories, and Outdances
(TBCa)
PRIMARY BALANCING CRITERIA
Long-term
Effectiveness
And Permanence
Reduction of Toxicity,
Mobility, or Volume
Through Treatment
Short-Term
Effectiveness
Implementability
Cost
Magnitude of Residual Risk
Adequacy and RcHaMltty of Con-
trol*
Treatment Process U»«d and Ma-
terials Treated
Amount of Hazardous Materials
Destroyed or Treated
Degree of Expected Reduction* In
Toxicity, MobMty, and Volume
Degree to Which Treatment la Ir-
reversfcle
Type and Quantity of Residuals
Remaining After Treatment
Protection of Community
During Remedial Actions
Protection of Workers Dur-
ing Remedial Actions
Environmental Impacts
Time Urrti Remedial Action
Objectives are Achieved
Ability to Construct and Operate
the Technology
Reliability of the Technology
Ease of Undertaking Additional
Remedial Actions, If Necessary
AbNty to Monitor Effectiveness of
Remedy
AMHty to Obtain Approvals from
Other Agencies
Coordination wtth Other Agen-
cies
AvalabWty of Offsile Treatment,
Storage, and Disposal Services
and Capability
Availably of Necessary Equip-
ment and Specialists
AvalabWty of Prospective Tech-
nologies
Capital Coats
Operating and Mainte-
nance Costs
Present Worth Cost
MODIFYING CRITERIA
State1 I
Acceptance 1
Community1
Acceptance
Features of the Alternative the State
Supports
Feature* of the Alternative About
Which the State has Reservations
Element* of the Alternative the Stale
Strongly Oppose*
Features of the Alternative the Com-
munity Supports
Features of the Alternative About
Which the Community has Reserva-
tton*
Elements of the Alternative the Com-
munity Strongly Opposes
'These criteria are assessed primarily following comment on the RI/FS report and the Proposed Plan.
S94106-1
-------
OSWER Directive 9355.3-02
2-13
EXHIBIT 2-3
Hints for Preparing the Nine Criteria Analysis
Overall Protection
In every FS, a "no action" alternative is developed for comparative analysis purposes. In most cases, this
alternative should not be selected because it does not adequately protect human health and the
environment based on the risks posed by the site or media. In such cases, the no action alternative can
be ruled out for further consideration under the protectiveness criterion and need not be discussed further
in the criteria analysis.
Compliance with ARARs
For an alternative to pass the screening process and thus become eligible for selection, it must comply
with its ARARs or a waiver should be identified and the justification for invoking it provided. An
alternative that cannot comply with ARARs, or for which a waiver cannot be justified, should not be
presented in the Proposed Plan or ROD.
Long-Term Effectiveness and Permanence
In addressing the long-term effectiveness and permanence of an alternative, the terms "effectiveness" and
"permanence" should be used carefully. Long-term effectiveness and permanence are viewed along a
continuum; an alternative can be described as offering a greater or lesser degree of either long-term
effectiveness or permanence.
Cost
The costs of remedies always should be qualified as estimates.
State/Support Agency Acceptance
Where there are major support agency comments, they should be summarized under the state (support
agency) acceptance criterion. The lead agency's response to those comments also should be summarized
here.
Community Acceptance
Because information available on the community acceptance criterion may be limited prior to the public
comment period for the Proposed Plan and the RI/FS report, the Proposed Plan should indicate that this
factor will be evaluated in the ROD or, if appropriate, the Proposed Plan should provide a preliminary
summary based on available information. Proposed Plans should not speculate on community acceptance
of the alternatives.
-------
OSWER Directive 9355.3-02
2-14
Be protective of human health and the environment;
Comply with ARARs (or justify a waiver);
Be cost-effective;
Utilize permanent solutions and alternative treatment (or
resource recovery) technologies to the maximum extent
practicable; and
Satisfy the statutory preference for treatment as a
principal element, or justify not meeting the preference.
2.3.7 Community Participation
The public should be informed of the following:
Dates of the public comment period (e.g., March 1-30);
Date, time(s), and location(s) of the public meeting(s) held
pursuant to CERCLA section 117(a), (offer to hold a meeting
upon request if one has not been scheduled);
Location of information repositories and administrative record
file(s), and hours of availability; and
Names, phone numbers, and addresses of the lead and
support agency personnel who will receive comments or
supply additional information.
-------
OSWER Directive 9355.3-02
2-15
2.4 FORMATS FOR THE PROPOSED PLAN
There are two basic formats available to the lead agency for preparing
the Proposed Plan. The first option is to issue the Proposed Plan in a fact
sheet format, similar to the community relations fact sheets that
traditionally have been issued by the Superfund program.
The second option for issuing the Proposed Plan is to prepare an
expanded, more detailed document that is similar to a draft ROD, yet less
lengthy and conclusive than a ROD. This latter option is more of a "stand
alone" document because it relies less on references to the RI/FS and other
documents in the administrative record file than does the briefer format.
While the fact sheet format is expected to be effective for most Proposed
Plans, there may be specific site circumstances (e.g., complexity, public
controversy) that warrant use of the expanded format. Regardless of the
format chosen, the Proposed Plan should be written so that the information
presented can be readily understood by the general public. After the Proposed
Plan is issued, a copy should be sent to Headquarters as soon as possible.
Appendix E, "Helpful Hints: How to Prepare and Submit Decision Documents to
Headquarters," describes the process for preparing and submitting the Proposed
Plan to Headquarters. Sections 2.4.1 and 2.4.2 summarize the advantages and
disadvantages associated with the two alternative formats for the Proposed
Plan.
2.4.1 Fact Sheet Format
EPA and the States currently distribute fact sheets as part of the
community relations activities for a site. Preparing the Proposed Plan in a
fact sheet format would fulfill the statutory requirements related to the
Plan. Because the Proposed Plan is issued to fulfill a statutory requirement,
the Plan may be organized differently or may discuss information not
traditionally contained in community relations fact sheets. Exhibit 2-4
discusses the advantages and disadvantages of the fact sheet format.
-------
OSWER Directive 9355.3-02
2-16
EXHIBIT 2-4
Ad vantages, and Disadvantages of the Fact Sheet Format
ADVANTAGES
« The fact sheet is an established tool used to communicate information to the public.
« Fact sheets can easily be distributed to the public.
* Fact sheets are already issued by EPA and States; Superfund personnel are familiar with
fact sheet production and distribution.
Some Regions and States already use the fact sheet format to announce a preferred
alternative.
DISADVANTAGES
The format may not be appropriate if the lead agency determines that the circumstances of
remedy selection at a particular site warrant a lengthier, detailed document that more
thoroughly describes the site conditions and the remedial alternatives.
2.4.2 Expanded Format
The lead agency may determine that the development of a more detailed
document is the most appropriate option for the site or operable unit. In
many instances, this document may be similar to a draft ROD. The use of an
expanded format for the Proposed Plan is more likely to occur when an in-depth
discussion of the alternatives in the RI/FS report is necessary (e.g., if the
site is technically complex, involves a series of operable units, or is the
subject of enhanced public concern). Documents following an expanded format
should include the same information specified in Exhibit 2-1, but in greater
detail. Exhibit 2-5 discusses the advantages and disadvantages of the
expanded format.
-------
OSWER Directive 9355.3-02
2-17
EXHIBIT 2-5
Advantages and. Disadvantages of the Expanded Format
ADVANTAGES
A document with an expanded format can provide an in-depth discussion of the lead
and support agencies' rationale for the initial preference of an alternative.
The document may provide a more direct basis for the ROD.
DISADVANTAGES
A lengthy discussion of the rationale may give the impression that a remedy has
already been selected.
Such a document could unintentionally divert attention from the RI/FS report.
Such a document may not encourage public participation due to its length and degree
of detail regarding the technical complexities of the site.
-------
OSWER Directive 9355.3-02
CHAPTER 3
THE PROCESS FOR DEVELOPING THE PROPOSED PLAN
3.1 OVERVIEW
This chapter summarizes the roles and responsibilities of the lead and
support agencies in developing the Proposed Plan. Agreement on the viable
alternatives for a site or operable unit is critical to the remedy selection
process. Therefore, personnel in the lead and support agencies should begin
discussions on the alternatives analyzed in the FS as early as possible. As
the RI/FS progresses, discussions between the lead and support agencies should
begin to focus on identification of a preferred alternative. These early
discussions should help prevent delays in the later stages of the remedy
selection process.
If PRPs conduct the RI/FS, the lead agency should be informed of the
alternatives developed, screened, and analyzed for the FS, because this
information constitutes the basis for the selection of the response action.
Early discussions on remedy selection should help prevent delays in the later
stages of the remedial process. The lead agency should ensure that the PRPs
and all support agencies are well informed of site activities by regularly
updating the administrative record file.1
3.1.1 Preparing the Proposed Plan
The general steps in preparing the Proposed Plan for public comment are
summarized in Figure 3-1. The sequence in which these steps are taken may
vary among Regions and States.
The lead agency should begin drafting the Proposed Plan upon completion
of the RI/FS report. If a PRP prepares the RI/FS, then the Proposed Plan
should be drafted by the lead agency after the lead agency approves the RI/FS.
The RI/FS report should be sent to the support agency as soon as the report is
available, but no later than when the draft Proposed Plan is transmitted to
the support agency for review and comment.
If a State has taken responsibility for an NPL site and is conducting the cleanup under the State's
own authority (i.e. a State-lead enforcement action), the State should keep EPA informed of the progress
at the site.
-------
3-2
FIGURE 3-1
Preparation of the Proposed Plan by the Lead Agency
Submits Draft
RI/FS to Support Agency
for Review & Comment
I Completes
RI/FS Report and Sends
Final Revision to
Support Agency
\
Management Briefed
on RI/FS and Proposed
Preferred Alternative
Note: framed boxes
denote statutory
requirements.
Prepares Draft
Proposed Plan
Receives
Support
Agency's
Comments
Decisionmaker Briefed
on Proposed Plan
J
Publishes Newspaper
Notice of Availability of
Proposed Plan and RI/FS
Makes the
the Proposed
Plan and RI/FS Report
Available to Public
Holds Public
Comment Period
-------
OSWER Directive 9355.3-02
3-3
A preferred alternative is identified tentatively on the basis of the
RI/FS report and ongoing discussions between the lead and support agencies.
To augment the regular flow of information to management, a formal briefing on
the RI/FS and the preferred alternative should be made to management at this
time. After thrs~ meeting,-a draft-Proposed Plan is written and submitted to
the support agency and lead agency management for review and comment. Other
intra-agency program offices should complete their review of the RI/FS report
if they haven't already during this period.
The lead agency should prepare the final Proposed Plan based on the
comments from the support agency and the results of the internal program and
management review process. This final version should include either a summary
of the support agency's agreement with the Plan or its dissenting comments.
If the State is the lead agency and EPA does not concur with the Proposed
Plan, then EPA could assume lead responsibility for the Proposed Plan if a
resolution cannot be reached (see Section 3.3 for more details). Finally, the
notice of availability of the RI/FS report and the Proposed Plan should be
published in a major newspaper, and both documents should be made available to
the public for comment.
3.2 ROLES AND RESPONSIBILITIES OF THE LEAD AGENCY AND
SUPPORT AGENCY
In order for the remedy selection process to be successful, lead and
support agencies should interact throughout the entire RI/FS and Proposed Plan
process. The goal of this continued interaction is to reach agreement on the
Proposed Plan and the RI/FS report before the public comment period.
Agreement by these agencies depends on the interaction and flow of information
that occurs during the RI/FS process.
3.2.1 Designation of Roles and Responsibilities
EPA and the State play specific roles throughout the remedial process.
These roles should be defined in the Superfund Memorandum of Agreement (SMOA),
Cooperative Agreement (CA), or State Superfund Contract (SSC).2 The SMOA
n
The SMOA is a procedural agreement that outlines cooperative efforts between States and EPA
Regions and defines the roles and responsibilities of each party in the conduct of a Superfund program in
a State. For more information on these, see Draft Guidance on Preparing a Superfund Memorandum of
Agreement (SMOA) (OSWER Directive 9375.0-01, September 1988). The CA is a contractual agreement
between EPA and the State, in which EPA appropriates money to the State to conduct remedial planning
-------
OSWER Directive 9355.3-02
3-4
and/or CA should designate the lead and support agency for conducting the
RI/FS, developing the Proposed Plan, and drafting the ROD. The SMOA, if
applicable, should describe the general procedures for oversight and
interaction between EPA and the State. Additionally, the SMOA should contain
site-specific'agreements between EPA and the State, such as which agencies are
designated to take the roles of the lead and support agencies at specific
sites. In the absence of a SMOA, a CA negotiated between EPA and the State
should provide this information for each specific site. The SSC, in contrast,
should be used when the State has no lead responsibilities for a particular
site or project and only when documentation of the cost-share is necessary.
3.2.2 Lead and Support Agency Responsibilities
The lead agency's responsibilities for developing the Proposed Plan are
to:
Draft the Proposed Plan;
Solicit comments on the Proposed Plan from the support
agency(ies);3
Respond in writing to comments from the support
agency(ies) and include both the comments and responses in
the administrative record file(s);
Summarize the comments received from the support
agency(ies) and present the lead agency's response in the
Proposed Plan;
Publish a newspaper notice announcing availability of the
RI/FS report and Proposed Plan; and
Make the RI/FS report and Proposed Plan available to the
public in the administrative record file.
activities and/or remedial action in compliance with the proposed NCP. The SSC documents any required
cost sharing between EPA and the State but does not involve disbursement of Federal monies.
3 If the State has taken responsibility for an NPL site and is conducting the cleanup under the State's
own authorities (i.e., as a State-lead enforcement site), the State should keep EPA informed about
progress at the site.
-------
OSWER Directive 9355.3-02
3-5
The support agency's primary responsibilities are to review and comment
in a timely fashion on (1) specific RI/FS deliverables, (2) the draft RI/FS
report(s), and (3) the Proposed Plan. The statute requires that this review
specifically address the preferred alternative, other remedial alternatives,
ARARs, and any proposed waivers to ARARs.
The role of other program offices within EPA and State agencies is to
provide specific comments on the alternatives analyzed in the RI/FS report.
EPA and the State should establish the appropriate procedures and time frames
for these intra-agency reviews. Review of the RI/FS report by other program
offices should be conducted at appropriate times during the RI/FS process to
ensure that alternatives in the detailed analysis phase of the RI/FS report
comply with other program requirements (e.g., ARARs). For EPA, this should
involve review by program offices such as the Water Program, the Resource
Conservation and Recovery Act Program, and the Toxic Substances Control Act
Program. If a draft Proposed Plan is available when the RI/FS report is ready
to be circulated, then the Plan should be circulated at the same time.
Alternatively, a cover memorandum indicating the preferred alternative and any
proposed waivers to ARARs should accompany the RI/FS report.
3.2.3 Management Review of the Proposed Plan
The lead and support agencies should determine the appropriate level of
managerial review for the draft Proposed Plan and, as appropriate, include
this in the SMOA, CA, or SSC. The Regional Administrator and State Director
should be briefed on the RI/FS report and the Proposed Plan by their
respective staffs prior to the release of these documents to the public. The
Assistant Administrator of the Office of Solid Waste and Emergency Response
(OSWER) should be briefed if the Proposed Plan and ROD for a site have not
been delegated to the Regional Administrator. Because the Proposed Plan
provides the first opportunity for the public to comment on the remedial
action identified as the preferred alternative by EPA and the State, the
Regional Administrator or State Director should be apprised of the contents of
both the RI/FS report and Proposed Plan, as well as of any unresolved or
potential issues. This is especially true if a waiver to an ARAR is involved
or if there are unresolved issues between the staffs of the lead and support
agencies.
-------
OSWER Directive 9355.3-02
3-6
3.2.4 Support Agency Comment Period
The support agency's comment period presents an important opportunity for
the lead and support agencies to reach agreement on the preferred alternative.
The lead agency should seek agreement from the support agency on the Proposed
Plan prior to making the Plan available to the public. The comment period
begins when the support agency receives the Proposed Plan from the lead agency
and should last at least five, but no more than ten, working days. If a
different time period for review is established in the SMOA, CA, or SSC, that
time period should be followed. As previously mentioned, the draft RI/FS
report could be given to the support agency before the Proposed Plan is ready
for review. The review period for the draft RI/FS report should last at least
15 working days, unless a different time period is established in the SMOA,
CA, or SSC, or by some informal arrangement between the lead and support
agencies.
During the review period, the support agency should provide written
comments on the preferred alternative and other components of the Proposed
Plan. These comments should specify one of the following:
Agreement, with or without comments;
Disagreement, with or without comments; or
No comment on the Plan at this time.
If the support agency does not respond to the lead agency's request for
comments or prefers to withhold its comments until the public comment period,
a copy of the written request for comments and a note documenting that the
support agency did not provide comments should be placed in the administrative
record file by the lead agency prior to the public comment period.
The lead agency should respond formally to the support agency's comments
that it receives prior to making the Proposed Plan available to the public.
The lead agency should address any unresolved issues with the support agency
through a written explanation sent to the support agency. The response should
address any concerns relating to the alternatives identified in the Proposed
Plan, the preferred alternative, ARARs, and any proposed ARAR waivers,
particularly any that relate to State standards. In addition to the formal
response (i.e., letter) sent to the support agency that addresses the points
-------
OSWER Directive 9355.3-02
3-7
raised, comments from the support agency should also be summarized in the
Proposed Plan under the State/support agency acceptance criterion in the
Evaluation of Alternatives section. These comments and the lead agency's
formal response to these comments should be included, in their entirety, in
the administrative record file.
3.3 PROCEDURES FOR RESOLVING DISPUTES
If a dispute should arise between the lead and support agencies during
any phase of the remedial process, the staffs of the lead and support agencies
should attempt to resolve these issues in a timely manner. In the event that
staff resolution is not possible, the issue(s) should be elevated promptly to
the attention of management for resolution.
The lead and support agencies should use the dispute resolution process
specified in the SMOA or CA, when these are appropriate. If Federal agencies
are involved, the dispute resolution process specified in the IAG should be
followed. Alternatively, the lead and support agencies could consider
utilizing the dispute resolution process specified in Subpart F of the
proposed NCP.
Subpart F, "State Involvement in Hazardous Substance Response," of the
proposed NCP (40 CFR Part 300) outlines a dispute resolution process that EPA
Regions and States should use to resolve disputes that arise during the RI/FS
and remedy selection process. This approach encourages the lead and support
agencies' Remedial Project Managers to resolve any disputes promptly. If this
cannot be accomplished, the issue could be referred to their supervisors for
further EPA/State consultation.* This supervisory referral and resolution
process should continue, if necessary, to the level of Director of the State
Agency and the Regional Administrator, respectively. If agreement still
cannot be reached, the dispute should be referred to the Assistant
Administrator (OSWER) who serves as final arbiter.
Regardless of the process utilized, the result should be an equitable
resolution of outstanding issues. There may be instances, however, in which a
final resolution cannot be achieved. If this should occur, there are two
alternatives for continuing effective action. First, if EPA is the lead
It is possible that one of the participants will choose to refer an unresolved issue to upper
management while the other participant chooses to maintain jurisdiction over the issue.
-------
OSWER Directive 9355.3-02
3-8
agency (pursuant to sections 104, 106, or 122), the Region should use its
discretion as to whether to proceed with publication of the Proposed Plan.
Second, in the event that the State is the lead agency (pursuant to section
104), EPA could elect to become the lead agency for the Proposed Plan, public
participation activities, and the ROD. (This applies only to Fund-financed,
State-lead projects.) It should be noted, however, that mutual acceptance by
EPA and the State of the preferred alternative and, ultimately, the selected
remedy by EPA and the State is crucial to effecting cleanup at the site.
3.4 ROLE OF OTHER FEDERAL AGENCIES
Executive Order 12580 delegates the authority for carrying out the
requirements of CERCLA sections 117(a) and (c) to Federal agencies with
Federal facilities under their jurisdiction. A Federal agency, therefore, has
the responsibility to issue the Proposed Plan. The lAGs between a Federal
agency, EPA, and, in many cases, the State should establish the
responsibilities for each party in preparing the Proposed Plan for Federal
facilities.
As the lead agency, a Federal agency's responsibilities for preparing the
Proposed Plan include those lead agency responsibilities specified in Chapters
2 and 3 of this guidance. As the support agency, EPA and/or the State should
have an adequate period of time prior to publication of the Proposed Plan to
comment on the RI/FS report and the draft Proposed Plan. The length of the
review period should be specified in the IAG. The Federal agency should
respond formally to comments made by EPA and the State. The formal response
to the comments should be sent to the support agency(ies) and included in the
administrative record file prior to the beginning of the public comment
period.
Support agency (i.e., EPA and/or the State) comments and Federal agency
responses to those comments should also be summarized in the Proposed Plan.
Under the State/support agency acceptance criterion in the Evaluation of
Alternatives section, the Federal agency should:
Explain whether the support agency agrees or disagrees
with the Proposed Plan (especially the preferred
alternative);
-------
OSWER Directive 9355.3-02
3-9
Indicate which alternative the support agency prefers when
there is a disagreement; and
Provide a summary of any outstanding support agency
comments.
3.5 ROLE OF POTENTIALLY RESPONSIBLE PARTIES
In accordance with the requirements of CERCLA sections 104 and 122, EPA
can provide PRPs with the opportunity to conduct the required response actions
(i.e., the RI/FS, remedial design, and remedial action). In the event that
the PRPs conduct the RI/FS, either EPA or the State will become the lead
governmental agency for general oversight of the RI/FS. EPA or the State
should prepare the Proposed Plan and the ROD, even if the PRP conducts the
RI/FS.5
PRPs could participate in the remedy selection process by commenting on
the Proposed Plan and on other publicly available information contained in the
administrative record file during the formal public comment period. The lead
agency, while not legally obligated to respond to comments submitted by PRPs
and members of the public prior to the formal public comment period, is
encouraged to do so.
5 At those sites for which the PRP conducts the RI/FS, the PRP should not indicate its preferred
alternative in the RI/FS report. If the PRP wants to communicate this information to the lead agency, it
should do so through some other mechanism, such as a memorandum.
-------
OSWER Directives 9355.3-02
CHAPTER 4
THE NEWSPAPER NOTIFICATION OF AVAILABILITY OF
THE PROPOSED PLAN AND THE PUBLIC COMMENT PERIOD
This chapter summarizes the requirements for the newspaper notification,
which announces the availability of the Proposed Plan, and presents guidance
on procedures for the public comment period.
4.1 STATUTORY REQUIREMENTS
CERCLA section 117 requires that upon completion of the Proposed Plan,
the lead agency shall notify the public of the availability of the Plan, the
RI/FS report, and the administrative record file. The statutory requirements
are as follows:
Section 117(a)(l) requires the lead agency to do the
following:
Publish a notice and brief analysis of the
Proposed Plan and make such Plan available to
the public; and
Include sufficient information in the notice and
analysis as may be necessary to provide a
reasonable explanation of the Proposed Plan and
alternative proposals considered.
Section 117(d) further specifies that:
Publication shall include, at a minimum,
publication in a major local newspaper of
general circulation. In addition, each item
developed, received, published, or made
available under this section to the public shall
be available for public inspection and copying
at or near the facility or site where the
remedial action is being considered.
-------
OSWER Directive 9355.3-02
4-2
4.2 WRITING THE NEWSPAPER NOTIFICATION
The lead agency's newspaper notification should include a brief abstract
of the Proposed Plan, which describes the alternatives analyzed and identifies
the preferred alternative. The notice should be published in a widely read
section of the newspaper, rather than in the classified advertisements or
legal notices. Key elements of the notification are summarized below.
Exhibit 4-1 provides a sample newspaper notification.
4.2.1 Section-by-Section Description of the Newspaper
Notification
The newspaper notification should consist of the following elements:
Site Name and Location. The notice should include the
proper site name and location.
The Date and Location of a Public Meeting (if scheduled).
If a meeting has not been requested or scheduled, the
notice should inform the public of its right to request
one.
Identification of Lead and Support Agencies. The notice
should identify which entities (i.e., EPA, State agency,
or other Federal agency) have served as lead and support
agencies for the response action.
Alternatives Evaluated in the Detailed Analysis. The
notice should list the remedial alternatives evaluated in
the detailed analysis phase of the FS.1
Identification of Preferred Alternative. A brief
statement of the major components of the preferred
alternative should be included.2
1 Statutory requirements of CERCLA section 117(a).
p
Statutory requirements of CERCLA section 117(a).
-------
OSWER Directive 9355.3-02
4-3
EXHIBIT 4-1
Sample Newspaper Notification
of Availability of the Proposed Plan
THE UNITED STATES
ENVIRONMENTAL PROTECTION AGENCY
Invites
PUBLIC COMMENT ON THE
PROPOSED CLEANUP OF THE EIO INDUSTRIAL SITE
at
129 FRANKLIN STREET, NAMELESS, TN
The U.S. Environmental Protection Agency (EPA) and the Tennessee Pollution Control Board
(TPCB) will hold a Public Meeting to discuss the Remedial Investigation/Feasibility Study Report (RI/FS)
and the Proposed Plan for the EIO site. The meeting will be held on October 17, 1989 at 7:30 p.m. in
the Community Hall, 123 Elm Road, Nameless, Tennessee,
EPA (the lead agency) and the TPCB (the support agency) evaluated the following options for
addressing the contaminated soil at the EIO site:
Capping the contaminated soils
Excavation and disposal in an off-site landfill
Excavation, treatment of organics (in a vaporization loop), stabilization of
residual metals, and disposal in an on-site landfill
Excavation and off-site incineration
Excavation, on-site incineration of soil (for organics), and stabilization of
residual metals
No action
Based on available information, the preferred option at this time is to excavate the 7,500 cubic
yards of contaminated soil at the site, treat the volatile organics in a vaporization loop, stabilize the soils
to immobilize metal contaminants, and dispose of them in an on-site landfill.
Although this is the preferred alternative at the present time, EPA and TPCB welcome the public's
comments on all alternatives identified above. EPA and TPCB will choose the final remedy after the
public comment period ends and may select any one of the options after taking those comments into
account.
The Proposed Plan has been mailed to all known interested parties. Also, complete documentation
of the analysis is presented in the RI/FS Report and in the Proposed Plan, which are available with the
rest of the administrative record file at the Nameless Public Library, 125 Elm Street.
The public may comment in person at the public meeting and/or may submit written comments
today and until October 31, 1989 to Joshua Doe at the EPA address below. For further information,
contact:
Joshua Doe
Community Relations Coordinator
U.S. Environmental Protection Agency
123 Peachtree Street
Atlanta, GA 00000
(555) 555-4640
Toll Free (800) 333-3333 between 8:30 a.m. and 4:30 p.m. Monday to Friday
-------
OSWER Directive 9355.3-02
4-4
Request for Public Comments. The notice should emphasize
that the lead agency is soliciting public comment on all
of the alternatives evaluated in the detailed analysis
phase of the FS, as well as on the preferred alternative.
It should include a clear statement that the preferred
alternative is only a preliminary determination and that
any of the other options presented could be selected as
the remedy based upon public comment, new information, or
a revaluation of existing information. The readers
should be referred to the RI/FS report and other contents
of the administrative record file for further information
on all of the remedial alternatives considered.
Public Participation. The notice should inform the public
of its role in the remedy selection process and provide
the following information:
The location of the information repositories and
administrative record file(s);
The methods by which the public may submit comments; and
The dates of the public comment period;
4.3 PUBLIC COMMENT PERIOD
This section provides guidance on the procedures the lead agency should
follow to satisfy the public participation requirements in section 117 of
CERCLA. Section 117(a)(2) requires that the lead agency do the following:
... [provide] a reasonable opportunity for submission of
written and oral comments and an opportunity for a public
meeting at or near the facility at issue regarding the
proposed plan and regarding any proposed findings [relating
to cleanup standards and any proposed waiver]... [and] keep
a transcript of the meeting and make such transcript
available to the public.
The lead agency is charged with making the relevant documents, such as
the Proposed Plan and the RI/FS report, available to the public at the time
-------
OSWER Directive 9355.3-02
4-5
the public comment period begins.3 In addition, the lead agency should ensure
that any information considered or relied upon in selecting the response
action is included as part of the administrative record file and is available
to the public during the public comment period.
CERCLA section 117(a)(2) also requires the lead agency to provide the
public with a reasonable opportunity to submit written and oral comments on
the Proposed Plan. Currently, the lead agency must allow the public a minimum
of 21 days to comment on the information contained in the RI/FS report
(including any proposed waivers relating to ARARs). Proposed revisions to the
NCP would increase the minimum period allowed for public comment to 30 days.
Longer time periods may be determined to be appropriate, depending on specific
site circumstances.
While the lead agency could respond to oral or written comments received
during the RI/FS process, prior to the public comment period, the lead agency
has no legal obligation to do so. To ensure that all comments are addressed,
the lead agency should ask individuals to resubmit comments that were
initially made during the RI/FS process during the formal public comment
period.
Further guidance on the public comment period and the lead agency's
responsibilities can be found in Community Relations in Superfund: A Handbook
(OSWER Directive 9230.0-3B, June 1988) and the draft Interim Guidance on
Administrative Records for the Selection of CERCLA Response Actions (OSWER
Directive 9833.3A, March 1989).
In addition to the newspaper notice, the notice of the Proposed Plan should be sent directly to the
PRPs via the community relations or enforcement mailing list for the site. (Although this is not a
statutory requirement, this may allow those PRPs, who may be outside the circulation area of the local
newspaper, to participate in a timely manner.)
-------
OSWER Directive 9355.3-02
CHAPTER 5
PRE-ROD SIGNIFICANT CHANGES
5.1 OVERVIEW
After the public comment period ends, a final remedial alternative is
selected for adoption in the ROD. The remedy is selected based on the
analysis presented in the Proposed Plan and RI/FS report, giving consideration
to the comments from the support agency and the public, as well as any other
new and significant information received or generated. The lead agency may
re-evaluate the preferred alternative in light of this information and may
change a component of the preferred remedy or choose to implement a remedy
other than the preferred alternative.
If a change is made, according to CERCLA section 117(b), the lead agency
should analyze these changes to determine if the modifications are
"significant". When the lead agency makes significant changes (such as a
change to the component of an alternative or a change from the preferred
alternative to another alternative presented in the Proposed Plan), these
changes should be explained in the ROD. In some instances, significant
changes may also warrant issuance of a revised Proposed Plan and additional
public comment. What constitutes a "significant" change is a site-specific
determination made by the lead agency, taking into consideration the
information available to the public, the original description of the
alternatives studied in detail in the Proposed Plan and RI/FS report, and the
impact that the changes may have on the scope, performance, or cost of the
remedy.
This chapter: (1) presents a general framework for categorizing minor
and significant changes made to the Proposed Plan after it is issued for
public comment; and (2) specifies documentation and communication activities
that may be necessary to inform the public of these changes. Because what
constitutes a significant change will vary depending upon site circumstances
and the manner in which the information was presented in the RI/FS and
Proposed Plan, "significant change" cannot be specifically defined in this
guidance.
-------
OSWER Directive 9355.3-02
5-2
5.2 REQUIREMENT TO ADDRESS CHANGES
CERCLA section 117(b) requires that the final remedial action plan (i.e.,
the ROD) be accompanied by:
a discussion of any significant changes (and the reasons for
such changes) in the proposed plan and a response to each
of the significant comments, criticisms, and new data
submitted [in the RI/FS report and the Proposed Plan].
Based on this requirement, the lead agency should document significant
changes that are identified and the reasons for these changes in the Decision
Summary of the ROD. In addition to complying with the statutory requirement
in CERCLA section 117(b), the lead agency should determine whether additional
public comment is necessary. If significant changes are made to the Proposed
Plan such that the public, through its review of the RI/FS report and Proposed
Plan, could not have reasonably anticipated these changes, then a revised
Proposed Plan should be issued for public comment before a ROD is prepared.
Section 5.4 provides criteria for determining whether or not a significant
change could reasonably have been anticipated by the public. Where such
changes could reasonably have been anticipated by the public, the lead agency
need not provide an additional opportunity for public comment.
5.3 IDENTIFYING CATEGORIES OF CHANGES
The lead agency has the discretion to make changes to the Proposed Plan
based either on new information received from the public or support agency or
on information generated by the lead agency itself during the remedial
process. In evaluating new information, the lead agency's initial focus
should be on whether the new information causes the lead agency either to
change a significant or minor aspect of the selected remedy or to choose a
remedy other than the alternative that was preferred in the Proposed Plan.
New information received during the public comment period typically will
relate to the scope, performance, or cost of the remedial approach. Typical
significant changes generally include the following:
Scope: Changes that alter the selected alternative by
addressing a substantially greater or lesser volume
-------
OSWER Directive 9355.3-02
5-3
of waste, a new environmental pathway, or by
encompassing a substantially greater physical area of
the site;
Performance: Changes in-treatment technologies or processes that
significantly alter the long-term effectiveness of
the remedy or that have significantly different
short-term effects.
Cost: Changes to any aspect of the selected alternative such
that the capital or operation and maintenance cost
estimates for the final alternative are significantly
altered.
Sections 5.3.1 and 5.3.2 elaborate on the distinction between minor and
significant changes and describe the documentation requirements specific to
each category of change. Figure 5-1 summarizes the process for analyzing and
documenting significant changes.
5.3.1 Minor Changes
Minor changes are those that have little or no impact on the overall
scope, performance, or cost of the alternative, as originally presented in the
RI/FS report or Proposed Plan. Such changes typically will be clarifications,
administrative changes, and minor technical or engineering changes that do not
significantly alter the overall scope, performance, or cost of the
alternative. Although the statute does not require documentation of these
minor changes, these should be noted in the Description of Alternatives
section of the ROD Decision Summary or in supporting information in the
administrative record file. Minor changes should not be discussed in the
significant changes section of the ROD Decision Summary.
5.3.2 Significant Changes
Prior to the final selection of a remedy, new information or public
comments may cause the lead agency to make significant changes to the Proposed
Plan that had been released for public comment. Modifying the selected
alternative or changing from the preferred alternative to another alternative
are examples of significant changes. When there are any proposed changes to a
component of an alternative, the changes should be analyzed to determine if
-------
5-4
FIGURE 5-1
Pre-ROD Changes
Public Comment On:
* Proposed Plan
Administrative Record
* RI/FS Report
Lead Agency
Analyzes Comments
Is
Lead Agency
Suggesting
Changes?
Does Change
Significantly Affect
* Scope
* Performance
Cost
of Selected
Alternative?
Could
Change Reason-
ably Have Been
Anticipated'?
Prepare ROD and
Document Changes
-------
OSWER Directive 9355.3-02
5-5
they significantly affect the scope, performance, or cost of the selected
remedy. The lead agency may decide, for example, to double the physical size
of the site; to change the remediation period from three years to six; or to
add an additional component of the long-term management controls that
increases-the operation and maintenance costs. When a significant change is
made, the lead agency should, at a minimum, document the change and the
reasons for such a change in the Decision Summary of the ROD. In some cases,
additional public comment may be necessary. The basis for determining which
significant changes warrant additional public comment is discussed in section
5.4 below.
5.4 CRITERIA FOR ANALYZING SIGNIFICANT CHANGES
Once it has been determined that a significant change is necessary, the
lead agency should decide whether the change warrants only documentation in
the ROD or additional public comment. To make this assessment, the lead
agency decides which of two categories the significant change(s) belongs: (1)
changes that are a logical outgrowth of the information and analysis already
presented to the public; or (2) changes that the public could not have
reasonably anticipated, based on information available during the public
comment period. If the lead agency determines that the significant change is
a logical outgrowth, the change should be documented in the ROD Decision
Summary. In those limited situations in which the public could not have
reasonably anticipated the changes, the lead agency should issue a revised
Proposed Plan for public comment. Additional means of classifying changes are
presented below.
5.4.1 Significant Changes that may be Considered Logical
Outgrowths of the Information Available to the Public
In analyzing significant changes, three broad scenarios of changes are
likely to be classified as logical outgrowths of the information on which the
public had the opportunity to comment. The significant changes in each of
these scenarios would only have to be explained in the ROD; additional public
comment is not necessary. The three scenarios are as follows:
(1) A Change to a Component of the Selected Alternative. The lead
agency may make a change to a component of the selected remedy (e.g., a change
in cost, timing, level of performance, or ARARs) that may result in a
-------
OSWER Directive 9355.3-02
5-6
significant alteration to the scope, performance, or cost of the remedy, while
the overall waste management approach represented by the alternative remains
the same. If the significant change to a component of the alternative could
have been reasonably anticipated by the public, taking into consideration the
inherent uncertainties associated with the waste management/engineering
process, the lead agency need only document the significant change in the ROD
Decision Summary.
(2) Selection of a Remedy Other than the one selected In the RI/FS and
Proposed Plan. The lead agency may determine, based on information received
during the comment period, that the preferred alternative in the Proposed Plan
no longer provides the most appropriate balance of tradeoffs among the
alternatives with respect to the evaluation criteria. Information available
to the lead agency may suggest that another alternative from the Proposed Plan
and RI/FS report provides the best balance of tradeoffs, and the lead agency
may select the other alternative. Such a change requires only documentation
in the ROD because the public has been apprised previously that that
alternative (or any other alternative in the detailed analysis) might be
selected as the remedy; thus, the public had adequate opportunity to review
and comment on it.
(3) Combining Components of Alternatives. In some instances, Proposed
Plans and RI/FS reports may recommend two or more alternatives (or
combinations of alternatives) for addressing different pathways at a site.
For example, an RI/FS report prepared for a site could develop two
alternatives, one to address contaminated soils and another to remediate the
ground water. In identifying the preferred alternative for each of these
media in the Proposed Plan, the lead agency did not make a conclusive
determination regarding the most appropriate combination of the source control
and ground-water alternatives for the site. Thus, if the lead agency chooses
to retain the preferred alternative for the ground water, but rejects the
preferred soil remediation alternative and chooses a different alternative
from among those presented in the Proposed Plan, the new selection would be
considered a logical outgrowth of the information on which the public already
had the opportunity to comment and a new comment period would not be required.
The change should, however, be documented in the ROD Decision Summary along
with the reasons for the change.
-------
OSWER Directive 9355.3-02
5-7
5.4.2 Significant Changes that may not be Considered
Logical Outgrowths of the Information Available to the
Public
Changes that are not logical outgrowths of the information presented in
the Proposed Plan and the RI/FS report should be documented by the lead agency
in a revised Proposed Plan and a new public comment period held. When issuing
a revised Proposed Plan to document a significant change that was not a
logical outgrowth, the revised document should be prepared in accordance with
the requirements of both CERCLA section 117 and the NCP. (These requirements
are discussed in Chapters 2 and 3 of this guidance.) Two changes that require
additional public comment are listed below.
(1) Selection of a New Alternative that was Not Previously Analyzed.
The lead agency may determine that an alternative that was not presented in
the Proposed Plan or detailed analysis phase of the RI/FS report should be
selected as the remedy. In this case, the public could not have reasonably
anticipated the lead agency making such a selection; therefore, the lead
agency should issue a revised Proposed Plan presenting the new preferred
alternative and provide appropriate supporting information for public comment.
The significant change should also be described in the ROD. This description
should note the initially preferred alternative, the new alternative, and the
reason for the change.
(2) Significant Change to a Component of the Selected Alternative. A
change to a component of the selected alternative (e.g., a newly discovered
ARAR, which, if complied with, would radically alter the feasibility of the
alternative, or a change in a portion of the treatment train to be used that
would alter significantly the alternative's ability to reduce the toxicity,
mobility, or volume of waste) requires additional public comment if making the
change will radically alter the overall remedy with regard to its scope,
performance, or cost in a manner that the public could not have reasonably
anticipated. Such changes could radically alter the volume of waste managed
or the physical scope of the action, as estimated in the Proposed Plan and the
RI/FS report.
-------
OSWER Directive 9355.3-02
5-8
5.5 EXAMPLES OF PRE-ROD CHANGES
The following text provides examples of the three types of changes that
can be made to the selected remedy (i.e., minor changes, significant changes
that should be explained in the ROD, and significant changes that should be
explained in both a revised Proposed Plan and a new public comment period).
At a hypothetical site, disposal of septic waste and some hazardous substances
has resulted in the contamination of 11,000 cubic yards of soil with volatile
organic compounds (VOCs) and metals. There are six alternatives identified in
the RI/FS report for controlling the source of contamination at the site:
(1) No action;
(2) Capping;
(3) Excavation and disposal in an off-site landfill;
(4) Excavation, vaporization of volatile organics,
and disposal in an on-site landfill;
(5) Off-site incineration; and
(6) On-site incineration and solidification.
The preferred alternative in the Proposed Plan was the fourth
alternative, which specifically calls for:
The excavation, vaporization, and disposal in an
on-site landfill of 11,000 cubic yards of
contaminated soil;
Capital cost: $4,666,000;
Annual O&M cost: $41,000;
Present worth cost: $5,050,150; and
Implementation time: 12 to 15 months.
NOTE: The examples presented here do not represent strict thresholds for
changes in cost, volume, and/or time. THIS GUIDANCE DOES NOT
ESTABLISH STANDARDS FOR SIGNIFICANT CHANGES.
-------
OSWER Directive 9355.3-02
5-9
5.5.1 Minor Change
Based on information received during the public comment period, the lead
agency determines that the capital cost estimate in the Proposed Plan was
about 10 percent too low; the actual capital cost of the remedy is $5,100,000.
The lead agency also identifies factors that would extend the implementation
time frame to 18 months. These changes do not significantly alter the scope,
performance, or cost of the remedy. Although the changes are not required to
be explained in the Significant Changes section of the ROD, they should be
discussed in the Description of Alternatives section of the ROD Decision
Summary, and the supporting information should be included in the
administrative record file(s).
5.5.2 Significant Change Requiring Documentation in the ROD
The lead agency receives new information during the public comment period
that prompts a change in the remediation goal for the soils; as a result, the
volume of contaminated soils that should be addressed is increased by 10,000
cubic yards more than the initial estimate. To incorporate this change, the
final remedial action plan specifications are modified as follows:
Excavation, vaporization, and disposal in an on-
site landfill of 14,600 cubic yards of
contaminated soil;
Capital cost: $5,366,000;
Annual O&M cost: $41,000;
Present worth cost: $5,750,150; and
Implementation time: 18 to 21 months.
To address the larger volume of contaminated soils, the lead agency
decides to implement the preferred alternative with some changes made to those
components presented in the Proposed Plan. The decision to increase the
volume of soils could be considered a logical outgrowth of the information,
even though doing so would impact the scope, performance, or cost of the
remedy. Although the volume of soils being addressed is increased by one-
third, there are economies of scale in the landfill construction and
-------
OSWER Directive 9355.3-02
5-10
volatilization process such that capital costs of the remedy are expected to
increase only by 15 percent, and O&M costs are not expected to increase at
all. The time required to implement the remedy is increased by approximately
six months. The changes in the specifications of the components of the remedy
are documented in the ROD Decision Summary, including an explanation of why
the changes were made. No additional public comment period is necessary.
5.5.3 Significant Change Necessitating the Issuance of a
New Proposed Plan, of a New Public Comment Period,
and their Documentation in the ROD
A remedy is selected that was NOT presented in the Proposed Plan or the
detailed analysis section of the FS. The selected alternative is:
In-situ vitrification of 11,000 cubic yards of
contaminated soil;
. Capital cost: $3,920,000 to $5,292,000;
Annual O&M cost: $33,000;
Present worth cost: $4,229,200 to $5,601,200;
and
Implementation time: 12 to 15 months.
This remedy is selected because new information is received indicating
that in-situ vitrification could be used effectively at the site. This new
remedy, however, is quite different in scope and performance from any other
alternative considered in detail in either the Proposed Plan or RI/FS report.
Because the public has not had an adequate opportunity to comment on the
technical, environmental, and human health aspects of the remedy or to
evaluate and compare its performance in terms of the nine evaluation criteria,
a revised Proposed Plan should be prepared and a new public comment period
should be held before the remedy is adopted in the ROD.
-------
OSWER Directive 9355.3-02
CHAPTER 6
WRITING THE RECORD OF DECISION
6.1 INTRODUCTION
This chapter presents a section-by-section discussion of the components
of a CERCLA Record of Decision (ROD). These components are the Declaration,
the Decision Summary, and the Responsiveness Summary. This chapter applies
specifically to decision documents prepared for final response actions that
are planned either for a site or an operable unit within a site. Final
response actions are those actions that address the principal threats posed by
the site or operable unit, that comply with statutory determinations, and that
address the statutory preference for treatment as a principal element.
Guidance on preparing a ROD that documents a no action or an interim (or
limited) action is presented in Chapter 9. A no action decision is made when
the lead agency determines that a response action is not necessary to control,
mitigate, or eliminate exposure. An interim action decision is made for those
actions of limited scope that will be followed by final response actions for
that operable unit. Chapter 9 outlines the modifications to the standard
format (as outlined in this chapter), which should be made when documenting
these two kinds of remedial decisions. In addition, the procedures in Chapter
9 should be consulted when a decision is being contemplated that includes both
a selected remedy and a contingency remedy which could be implemented in the
event that the primary remedy does not attain its performance specifications.
6.1.1 Purpose of the Record of Decision
The ROD documents the remedial action plan for a site or operable unit.
It is prepared by the lead agency in consultation with the support
agency(ies). The ROD has the following three purposes:
First, the ROD serves a legal function in that it
certifies that the remedy selection process was carried
-------
OSWER Directive 9355.3-02
6-2
out in accordance with the requirements of CERCLA and, to
the extent practicable, the NCR;1
Second, the ROD is a technical document that outlines the
engineering components and remediation goals of the
selected remedy; and
Third, the ROD is informational, providing the public with
a consolidated source of information about the history,
characteristics, and risks posed by the conditions at the
site, as well as a summary of the cleanup alternatives
considered, their evaluation, and the rationale behind the
selected remedy.
6.1.2 Statutory Requirements to Issue the Record of Decision
Sections 113 and 117 of CERCLA, as amended, require that the Agency issue
a final remedial action plan. The Superfund program commonly refers to this
plan as the Record of Decision (ROD). Section 113(k)(2)(B)(v) of CERCLA, as
amended, calls for "a statement of basis and purpose for the selected remedy
at a site." In addition, section 117(b) requires that:
notice of the final remedial action plan [ROD] adopted
shall be published and the plan shall be made available to
the public before commencement of any remedial action.
Such final plan shall be accompanied by a discussion of
any significant changes (and the reasons for such changes)
in the proposed plan and a response to each of the
significant comments, criticisms, and new data submitted
in written or oral presentations [Responsiveness Summary].
6.1.3 Major Components of the Record of Decision
The ROD consists of three basic components: a Declaration, a Decision
Summary, and a Responsiveness Summary (see Exhibit 6-1).
1 Section 121 (a) of CERCLA, as amended, provides that remedial actions should be carried out in
accordance with section 121 "and, to the extent practicable, the National Contingency Plan."
-------
OSWER Directive 9355.3-02
6-3
The Declaration functions as an abstract for the key
information contained in the ROD and is the section of the
ROD signed by the EPA Regional Administrator or Assistant
Administrator;
The Decision Summary provides an overview of the site
characteristics, the alternatives evaluated, and the
analysis of those options. The Decision Summary also
identifies the selected remedy and explains how the remedy
fulfills statutory requirements; and
The Responsiveness Summary addresses public comments
received on the Proposed Plan, RI/FS report, and other
information in the administrative record.
The key elements of each of these three components are described in the
following sections.
6.2 KEY ELEMENTS OF THE DECLARATION
The Declaration functions as an abstract for the information contained in
the ROD. It provides a brief description of the selected remedy for the site
and a formal statement explaining that the selected remedy complies with
CERCLA and is consistent, to the extent practicable, with the NCP. The
Declaration is the section of the ROD signed by the EPA Regional Administrator
or Assistant Administrator. The State Director or Federal facility
representative should co-sign the ROD when the State or other Federal Agency
is designated as the lead agency for preparing the ROD. Exhibit 6-2 is a
sample of the Declaration.
-------
OSWER Directive 9355.3-02
6-4
EXHIBIT 6-1
Outline for the Record of Decision
Declaration
Site Name and Location
Statement of Basis and Purpose
Assessment of the Site
Description of the Selected Remedy
Statutory Determinations
Signature and Support Agency Acceptance of the Remedy
Decision Summary
Site Name and Location
Site History and Enforcement Activities
Highlights of Community Participation
Scope and Role of Operable Unit
Site Characteristics
Summary of Site Risks
Description of Alternatives
Summary of Comparative Analysis of Alternatives
Selected Remedy
Statutory Determinations
Responsiveness Summary
Community Preferences
Integration of Comments
-------
OSWER Directive 9355.3-02
6-5
EXHIBIT 6-2
Sample Declaration for the Record of Decision
Statutory Preference for Treatment as a
Principal Element is Met
and Five-Year Site Review is not Required
SITE NAME AND LOCATION
Super Kleen Company Site
Dustbowl, AZ
STATEMENT OF BASIS AND PURPOSE
This decision document presents the selected remedial action for the Super Kleen Company site, in Dustbowl. Arizona,
chosen in accordance with CERCLA, as amended by SARA and, to the extent practicable, the National Contingency Plan. This
decision is based on the administrative record file for this site.
The State of Arizona concurs on the selected remedy.
ASSESSMENT OF THE SITE
Actual or threatened releases of hazardous substances from this site, if not addressed by implementing the response action
selected in this ROD, may present an imminent and substantial endangerment to public health, welfare, or the environment.
DESCRIPTION OF THE REMEDY
This operable unit is the final action of three operable units for the site. The first operable unit at this site involved
remediation of a municipal well. The second operable unit involved remediation of the ground water. This final operable unit
addresses the source of the soil and ground-water contamination. This action addresses the principal threat remaining at the site by
treating the most highly contaminated soils and waste material. Treatment residuals and soils contaminated at low levels will be
disposed of off-site, such that the site will not require any long-term management.
The major components of the selected remedy include:
- Excavation and treatment, via on-site thermal destruction, of approximately 10,000 cubic yards of contaminated soils
and waste materials from the former lagoon area; and
Disposal of treatment residuals and 2,000 cubic yards of contaminated soils at an off-site RCRA
Subtitle C disposal facility.
STATUTORY DETERMINATIONS
The selected remedy is protective of human health and the environment, complies with Federal and State requirements that
are legally applicable or relevant and appropriate to the remedial action, and is cost-effective. This remedy utilizes permanent
solutions and alternative treatment (or resource recovery) technologies to the maximum extent practicable and satisfies the statutory
preference for remedies that employ treatment that reduces toxicity, mobility, or volume as a principal element. Because this remedy
will not result in hazardous substances remaining on-site above health-based levels, the five-year review will not apply to this action.
Signature (Assistant Administrator/Regional Administrator) Date
Signature (State Director)
-------
OSWER Directive 9355.3-02
6-6
6.2.1 Site Name and Location
The proper site name (as listed on the National Priorities List) and
location (citing the town or county and State in which the site is located)
should be included in the Declaration.
6.2.2 Statement of Basis and Purpose
Section 113(k)(2)(B)(v) of CERCLA requires that "a statement of basis and
purpose of the selected remedy" be prepared. To comply with this requirement,
EPA must provide an explanation of the factual and legal basis upon which the
decision to select a particular remedy was made. The ROD serves as this
statement of basis and purpose, and the Declaration should make a statement to
that effect. In addition, another statement in this section of the
Declaration should say that the information supporting the lead and support
agencies' decisions on the selected remedy is contained in the administrative
record. [Note: The administrative record index need not be attached to the
ROD but should be placed in the administrative record file.]
6.2.3 Assessment of the Site
The Declaration should include a statement of the existence of an
imminent and substantial endangerment to public health, welfare, or the
environment. The following language should be added to all RODs (except where
the clean-up decision is to take "no further action"):
Required Language for Assessment of the Site:
Actual or threatened releases of hazardous substances from this site, if not
addressed by implementing the response action selected in this ROD, may
present a current or potential threat to public health, welfare, or the
environment.
-------
OSWER Directive 9355.3-02
6-7
6.2.4 Description of the Selected Remedy
The selected remedy should be identified and described briefly. This
description should be presented in bullet form and should specify the
treatment technologies and/or engineering controls that will be used, as well
as any institutional controls, such as deed or access restrictions. This
description should include the following elements:
A brief explanation of how this response action fits into
the overall site clean-up strategy, if the action is an
operable unit (e.g., "this is the second of three operable
units"); and
A statement as to how the selected response action does or
does not address the principal threat(s) posed by the
site.
6.2.5 Statutory Determinations
Finally, the ROD Declaration should conclude with the finding that the
selected remedy satisfies the statutory requirements of CERCLA section 121.
For the Declaration, this can be accomplished by making confirmatory
statements that the selected remedy attained the four statutory mandates (see
below) and the statutory preference for treatment.
The four mandates of CERCLA section 121 require that all remedial actions
taken pursuant to sections 104 or 106 must:
Be protective of human health and the environment;
Comply with ARARs (or justify a waiver);
Be cost-effective; and
Utilize permanent solutions and alternative treatment
technologies or resource recovery technologies, to the
maximum extent practicable.
In addition, the statutory preference for treatment in CERCLA section 121
should be addressed in all RODs including those documenting a selected remedy
-------
OSWER Directive 9355.3-02
6-8
that do not meet the statutory preference for treatment. Section 121 requires
that the lead agency provide an explanation whenever a remedy is chosen that
does not employ treatment that permanently and significantly reduces the
toxicity, mobility, or volume of hazardous substances as its principal
element.
Finally, the applicability of the five-year review required by CERCLA
section 121 should be addressed in this part of the Declaration. This review
is conducted to evaluate whether a remedy continues to provide adequate
protection of human health and the environment, and it should be conducted at
every site where the remedial action results in hazardous substances remaining
on-site above health-based levels.
6.2.5.1 Sample Boilerplate Language for Making Statutory
Determinations
Sample boilerplate language that addresses the aforementioned statutory
determinations is provided in Exhibits 6-2 and 6-3. The language in this
section of the Declaration will vary depending upon whether the statutory
preference for treatment is satisfied and whether the five-year review is
applicable. The sample Declaration in Exhibit 6-2 provides guidance for a
remedy that meets the statutory preference for treatment as a principal
element, with no required five-year review. The sample Declaration in Exhibit
6-3 provides guidance for a remedy that does not meet the statutory preference
for treatment and for which a five-year review is required.
If the remedy does not meet the statutory preference for treatment, then
the Statutory Determinations section of the Declaration should state this and
summarize the rationale for choosing a remedy that does not contain treatment
as a principal element. This rationale could be based on the specific factors
used to determine that the treatment is impracticable, such as technical
infeasibility, inadequate short-term protection of human health and the
environment, or unavailability of necessary capacity, equipment, or
specialists. In addition, a brief statement that past or future operable
units have met or will meet the statutory preference for treatment should be
included, when appropriate.
-------
OSWER Directive 9355.3-02
6-9
EXHIBIT 6-3
Sample Declaration for the Record of Decision
Statutory Preference for Treatment as a
Principal Element is not Met
and Five-Year Site Review is Required
SITE NAME AND LOCATION
Municipal Landfill Site
Nowhere, NY
STATEMENT OP BASIS AND PURPOSE
This decision document presents the selected remedial action for the Municipal Landfill site, in Nowhere, New York, developed in
accordance with CERCLA, as amended by SARA and, to the extent practicable, the National Contingency Plan. This decision is based on
the administrative record for this site.
The State of New York concurs on the selected remedy.
ASSESSMENT OF THE SITE
Actual or threatened releases of hazardous substances from this site, if not addressed by implementing the response action selected in
this ROD, may present an imminent and substantial endangerment to public health, welfare, or the environment.
DESCRIPTION OF THE REMEDY
This operable unit is the first of two that are planned for the site. The first operable unit addresses the source of the contamination
by containing the on-site wastes and contaminated soils. The function of this operable unit is to seal off the Municipal Landfill site as a
source of ground-water contamination and to reduce the risks associated with exposure to the contaminated materials. While the remedy
does address one of the principal threats at the site, the second operable unit will involve continued study and possible remediation of the
downgradient contaminant plume.
The major components of the selected remedy include:
- Installing a security fence around the landfill site;
Capping the 65-acre landfill in accordance with Resource Conservation and Recovery Act Subtitle D requirements;
Installing surface water controls to accommodate seasonal precipitation;
- Conducting environmental monitoring to ensure the effectiveness of the remedial action; and
Preparing a supplemental remedial investigation and feasibility study to identify the extent of ground-water contamination and
to develop and evaluate appropriate remedial alternatives.
DECLARATION
The selected remedy is protective of human health and the environment, complies with Federal and State requirements that are legally
applicable or relevant and appropriate to the remedial action, and is cost-effective. This remedy utilizes permanent solutions and
alternative treatment technologies to the maximum extent practicable for this site. However, because treatment of the principal threats of
the site was not found to be practicable, this remedy does not satisfy the statutory preference for treatment as a principal element of the
remedy. The size of the landfill and the fact that there are no on-site hot spots that represent the major sources of contamination
preclude a remedy in which contaminants could be excavated and treated effectively.
Because this remedy will result in hazardous substances remaining on-site above health-based levels, a review will be conducted within
five years after commencement of remedial action to ensure that the remedy continues to provide adequate protection of human health
and the environment.
Signature (Assistant Administrator/Regional Administrator) Date
Signature (State Director)
-------
OSWER Directive 9355.3-02
6-10
6.2.6 Signature and Support Agency Acceptance of the
Remedy
All ROD Declarations are signed and dated by the Assistant Administrator
of OSWER or the Regional Administrator. When the State is the lead agency for
developing the ROD, the State Director should sign the ROD. When the State is
the support agency, the State's signature on the ROD is optional (i.e., the
SMOA, CA, or SSC may or may not provide for such signature). At a minimum, a
letter specifying concurrence or nonconcurrence from the State should always
be included in the administrative record. In situations where a Federal
agency other than EPA is the lead agency, that agency should co-sign the ROD
with EPA.
Although the goal of the interactions between the lead and support
agencies is to reach mutual agreement on the ROD, there may be limited
instances in which this is not achieved. In such an event, the procedures for
selecting and implementing the remedy are dependent upon whom has the lead
responsibility for the ROD. If EPA has the lead, and the State nonconcurs on
the selected remedy, then EPA has the discretionary authority to sign the ROD
and continue through the remedial design stage. EPA cannot proceed beyond the
remedial design stage, however, without the State's cost-share.
In the event that the State is the lead and EPA does not concur on the
selected remedy, EPA can assume the lead for the ROD and proceed through the
design stage. In either case, all information pertaining to the disagreement
should be included in the administrative record.
6.3 KEY ELEMENTS OF THE DECISION SUMMARY
The Decision Summary, the second and main component of the ROD, should
provide an overview of the site-specific factors and analysis that led to
selection of the remedy for the operable unit or site. In general, this
section of the ROD should describe the following:
The history of and contamination at the site;
The alternatives evaluated;
The analysis leading to the final remedy selection; and
-------
OSWER Directive 9355.3-02
6-11
How the selected remedy satisfies the statutory
requirements.
Although some of the information presented in the Decision Summary is similar
to that presented in the Declaration, this section discusses the topics in
greater detail and provides the rationale for those "declarations."
The Decision Summary, to a great extent, should summarize information
that is already in the administrative record for a site, particularly the
RI/FS report. However, when information is either not available or is not
satisfactorily addressed in the administrative record, then the discussion in
the ROD Summary may need to be more thorough. The one completely original
section of the Decision Summary is the final section which identifies the
selected remedy and explains how the statutory requirements are satisfied by
that remedy.
6.3.1 Site Name. Location, and Description
This section should be a brief description of basic information about the
site location and the actual or potential threat from the site. The site
description should include the following information:
Location and address at which the response action is
occurring, including the town or county, the State in
which the site is located, and the site's distance from
significant locations, such as an intersection or
geographical boundary; and
A general overview of the site, summarizing geographical
and topographical information such as natural resource
use, adjacent land use, distance to nearby populations,
location in a floodplain, general surface-water and
ground-water resources, and surface and subsurface
features (e.g., number and volume of tanks, lagoons,
structures, and drums at the site).
Inclusion of maps and charts in this section is encouraged.
-------
OSWER Directive 9355.3-02
6-12
6.3.2 Site History and Enforcement Activities
This section should provide background information on the site's history
and enforcement actions taken to date. Factors that should be addressed
include the following:
The history of activities at the site that have led to the current
problems, such as manufacturing activities or disposal of hazardous
substances (e.g., a key piece of information may be whether a site
operated prior to or after the effective date(s) of the Resource
Conservation and Recovery Act, i.e., November 19, 1980, or July 26,
1982; and
The history of site investigations or remedial actions conducted to
date under CERCLA, as well as under other environmental authorities,
such as RCRA, the Clean Water Act (CWA), the Clean Air Act (CAA), or
State authorities.
The history of CERCLA enforcement activities at the site, such as
whether a special notice has been issued to PRPs or whether a law
suit has been filed regarding cleanup of the site.
6.3.3 Highlights of Community Participation
CERCLA establishes a number of public participation activities that the
lead agency must conduct during a remedial action. This section should
briefly note how the public participation requirements in CERCLA section
113(k)(2)(B)(i-v) were met. These requirements are established to provide:
Notice to potentially affected persons and the public, which shall
be accompanied by a brief analysis of the plan and alternative plans
that were considered [in the RI/FS report and Proposed Plan];
A reasonable opportunity to comment and provide information
regarding the [proposed] plan [and RI/FS report] (i.e., public
comment period);
An opportunity for a public meeting held in the affected area, in
accordance with section 117(a)(2) (relating to public
participation);
-------
OSWER Directive 9355.3-02
6-13
A response to the significant comments, criticisms, and new data
that were submitted in either written or oral presentations; and
A statement of the basis and purpose of the selected action (e.g.,
the ROD).
Although this description should be brief, the lead agency may also
include a description of any other major public participation activities.
Community response to the selected remedy should not be included in this
section; the community's response to the selected remedy should be addressed
under the community acceptance criterion in the comparative analysis section
of the ROD and specific comments responded to in the Responsiveness Summary.
The following is an example of the length and type of information that should
be included in this section.
Sample Language for Community Participation Activities:
The RI/FS and Proposed Plan for the EIO Industrial site were released to the
public in September 1988. These two documents were made available to the
public in both the administrative record and an information repository maintained
at the EPA Docket Room in Region 4 and at the Nameless Public Library. The
notice of availability for these two documents was published in the Nameless
Advocate on September 28, 1988. A public comment period was held from
October 3, 1988 through November 5, 1988. In addition, a public meeting was
held on October 17, 1988. At this meeting, representatives from EPA and the
Tennessee Pollution Control Board answered questions about problems at the site
and the remedial alternatives under consideration. A response to the comments
received during this period is included in the Responsiveness Summary, which is
part of this Record of Decision. This decision document presents the selected
remedial action for the EIO Company Site, in Nameless, Tennessee, chosen in
accordance with CERCLA, as amended by SARA and, to the extent practicable,
the National Contingency Plan. The decision for this site is based on the
administrative record.
6.3.4 Scope and Role of Operable Unit or Response Action
This section should discuss how the operable unit or response action
addressed by the ROD fits into the overall site strategy (e.g., "This ROD
addresses the second of three planned activities at the site: the first
addressed alternative water supply; this one addresses contaminated ground
water; and a third will deal with contaminated soils"). This section should
focus on how the response action fits into the overall strategy for addressing
the principal threat(s) posed by the conditions at the site. The following
-------
OSWER Directive 9355.3-02
6-14
provides sample language for describing the scope and role of an operable unit
or response action.
Sample Language for Operable Unit:
As with many Superfund sites, the problems at the EIO Company Site are
complex. As a result, EPA organized the work into three operable units
(OUs). These are:
OU One: Contamination in the municipal well..
OU Two: Contamination of the ground-water aquifer.
OU Three: Contamination in the soils.
EPA has already selected remedies for OUs One and Two (the municipal well
and the contaminated ground water). The contaminated ground water is a
principal threat at this site because of the direct ingestion of drinking water
from wells that contain contaminants above health-based levels. Both of these
actions are in the remedial design stage. Actual construction is planned to
begin in March 1990.
The third OU authorized by this ROD addresses the contaminated soils in the
lagoon and tank farm area. This area of the site poses the principal threat to
human health and the environment because of the risks from possible ingestion
or dermal contact with the soils. Also, there is the threat of contaminant
migration from the soil into the underlying ground water that is a source of
drinking water for the local residents. The purpose of this response is to
prevent current or future exposure to the contaminated soils and to reduce
contaminant migration into the ground water. This third operable unit will be
the final response action for this site.
6.3.5 Summary of Site Characteristics
This section should provide an overview of site contamination and the
actual and potential routes of exposure posed by the conditions at the site.
This can be accomplished by describing the assessments made during the RI that
characterized the site, its environment, and the extent of contamination.
Site characteristics should include general information about the contaminants
at the site, potential routes of contaminant migration and routes of exposure,
population and environmental areas that could be affected by the contaminants
at the site, and any site-specific factors (e.g., fractured bedrock) that may
affect the remedial actions at the site. The following factors should be
highlighted in this section:
All known or suspected sources of contamination;
-------
OSWER Directive 9355.3-02
6-15
Types of contamination and affected media (including description of
the quantity, types, and concentration of hazardous substances
present and their mobility, carcinogenicity or noncarcinogenicity,
and volume; the lateral and vertical extent of contamination, and
-potential surface-and subsurface pathways of .migration); and
All known current risks and potential routes of human and
environmental exposure.
The discussion in this section should present a brief, comprehensive
overview of the site. The use of maps illustrating the location of
contaminant sources and tables listing the types of contaminants and
concentrations in various media are recommended.
6.3.6 Summary of Site Risks
The summary of the baseline risk assessment in the ROD should provide an
indication of the risks to human health and the environment that are or may be
posed by the conditions at the site. The information necessary to write this
summary should be available in the risk assessment chapter of the RI/FS
report. Appropriate summary paragraphs or tables in the RI/FS report may be
used directly to serve as the basis for the ROD discussion of the baseline
risk assessment. The RI/FS chapter describing the risk assessment (or the
risk assessment document, if presented separately) should be referenced.
The information presented in the summary of site risks should support the
decision to take remedial action when there is an actual or potential threat
of release. Alternatively, when no action will be taken, the data and
narrative discussion should support that decision. (See Chapter 9 for writing
no action RODs.) The baseline risk assessment should also describe the
exposure pathways and risks, so that the ROD clearly specifies how risk
reductions resulting from the remedial alternatives are related directly to
the exposure pathways and baseline risks (see section 6.3.8, "Summary of the
Comparative Analysis of Alternatives").
6.3.6.1 Human Health Risks
Only a brief summary of the information developed in the risk assessment
should be presented in the ROD. Information should be presented in such a
manner that individuals who are not familiar with the site can understand the
-------
OSWER Directive 9355.3-02
6-16
basis for undertaking remedial action. A mixture of (1) text format (e.g.,
for describing the exposure pathways and the risks), (2) table format (e.g.,
for presenting lists of chemicals and risk numbers), and (3) graphics (e.g.,
for illustrating changes in risks over time) may be used in the summary.
Further guidance-on the summary and presentation of-carcinogenic risk and the
potential for noncarcinogenic effects is currently being developed in the
revisions to the Superfund Public Health Evaluation Manual, which is scheduled
for publication in the fall of 1989.
The discussion of risks in the ROD should parallel the major areas that
are discussed in the sections of the risk assessment: contaminant
identification, exposure assessment, toxicity assessment, and risk
characterization. The primary focus should be on those exposure pathways and
contaminants found to pose actual or potential threats to human health and the
environment.
Contaminant identification information should include brief descriptions
of the following :
The media of concern (e.g., soils, ground water);
The contaminants of concern in each medium; and
The concentrations of the chemicals of concern on which the risk
assessment was based (e.g., mean, maximum, and minimum).
Exposure assessment information should include brief discussions of the
following:
The exposure pathways (e.g., ingestion of contaminated ground water,
inhalation of volatiles);
The potentially exposed population(s) (e.g., adults living on-site,
children playing on-site);
The monitoring or modeling data and assumptions used to characterize
exposure point concentrations; and
-------
OSWER Directive 9355.3-02
6-17
The major assumptions about exposure frequency and duration that
were included in the exposure assessment (e.g., 180 days/year, 70
years).
In many cases, the. exposure assessment-in ihe RI/FS report includes reasonable
maximum estimates for both current and future exposure scenarios. When this
information is available, descriptions of current and future exposures should
be included in the ROD.
Toxicity assessment information should include the following:
The cancer potency factors for contaminants of concern that are
carcinogens;
The reference doses for the contaminants of concern that have
noncarcinogenic effects; and
A brief explanation of the toxicity information.
The sample language in this guidance should be included in the ROD to
explain the derivation and use of the cancer potency factors and reference
doses.
Risk characterization information should include the following for each
land-use scenario (e.g., current and future land use):
The quantified carcinogenic risks of each containment of concern in
each exposure medium for each exposure pathway;
The combined carcinogenic risks reflecting all contaminants and
pathways reasonably expected to affect a given population (e.g.,
children playing at a residence who may be exposed through soil
ingestion and through drinking local ground water);
The potential for noncarcinogenic effects as identified by the
hazard quotient for each contaminant of concern in each exposure
medium for each exposure pathway;
-------
OSWER Directive 9355.3-02
6-18
Sample Language for Toxicity Assessment Summary:
Cancer potency factors (CPFs) have been developed by EPA's Carcinogenic
Assessment Group for estimating excess lifetime cancer risks associated with
exposure to potentially carcinogenic chemicals. CPFs, which are expressed hi
units of (mg/kg-day) , are multiplied by the estimated intake of a potential
carcinogen, in mg/kg-day, to provide an upper-bound estimate of the excess
lifetime cancer risk associated with exposure at that intake level. The term
"upper bound" reflects the conservative estimate of the risks calculated from
the CPF. Use of this approach makes underestimation of the actual cancer
risk highly unlikely. Cancer potency factors are derived from the results of
human epidemiological studies or chronic animal bioassays to which animal-to-
human extrapolation and uncertainty factors have been applied.
Reference doses (RfDs) have been developed by EPA for indicating the
potential for adverse health effects from exposure to chemicals exhibiting
noncarcinogenic effects. RfDs, which are expressed in units of mg/kg-day, are
estimates of lifetime daily exposure levels for humans, including sensitive
individuals. Estimated intakes of chemicals from environmental media (e.g.,
the amount of a chemical ingested from contaminated drinking water) can be
compared to the RfD. RfDs are derived from human epidemiological studies
or animal studies to which uncertainty factors have been applied (e.g., to
account for the use of animal data to predict effects on humans). These
uncertainty factors help ensure that the RfDs will not underestimate the
potential for adverse noncarcinogenic effects to occur.
The combined potential for noncarcinogenic effects, as expressed by
hazard indices (HI), reflect reasonable contaminant and exposure
pathway combinations for specific population groups;
A brief explanation of the meaning of both the risk characterization
number and qualitative statements;
A discussion of significant sources of uncertainty inherent in this
risk assessment; and
Risk assessment conclusions, based on data presented and any other
facts that the decisionmaker should be made aware of that may affect
risk to human health and the environment at sites (e.g., the
presence of B2 carcinogens without quantitative toxicity numbers for
risk characterization).
The following language should be included in the ROD to explain how
cancer and noncancer risks are characterized in the baseline risk assessment.
-------
OSWER Directive 9355.3-02
6-19
Sample Language for Risk Characterization Summary:
Excess lifetime cancer risks are determined by multiplying the intake level with
the cancer potency factor. These risks are probabilities that are generally
expressed in scientific notation (e.g., 1x10 or 1E-6). An excess lifetime
cancer risk of 1x10 indicates that, as a plausible upper bound, an individual
has a one in one million chance of developing cancer as a result of site-related
exposure to a carcinogen over a 70-year lifetime under the specific exposure
conditions at a site.
Potential concern for noncarcinogenic effects of a single contaminant in a
single medium is expressed as the hazard quotient (HQ) (or the ratio of the
estimated intake derived from the contaminant concentration in a given
medium to the contaminant's reference dose). By adding the HQs for all
contaminants within a medium or across all media to which a given population
may reasonably be exposed, the Hazard Index (HI) can be generated. The HI
provides a useful reference point for gauging the potential significance of
multiple contaminant exposures within a single medium or across media.
As discussed previously, a combination of textual, tabular, and graphic
presentations of risk information is encouraged.
6.3.6.2 Environmental Risks
In addition to human health risks, the risks to the environment that were
considered in the RI/FS should also be addressed in the ROD. Procedures for
addressing environmental risks are not as standardized as they are for human
health risk assessment. Consequently, the appropriate level of detail to
describe the environmental evaluation in the ROD is also less standardized.
In summary, the level of detail of the environmental evaluation should be the
guide for the amount of information that should be included in the ROD. The
rule of thumb is to include only the information from the environmental
evaluation that is necessary to help the decisionmaker address environmental
concerns at the site. At the very least, the following points should be
addressed:
Are any critical habitats affected by site contamination?
Are any endangered species or habitats of endangered species
affected by site contaminants?
-------
OSWER Directive 9355.3-02
6-20
The Risk Assessment Guidance for Superfund Environmental Evaluation
Manual (OSWER Directive 9285.7-01, March 1989} provides additional information
about the environmental evaluation.
In addition, for^all RODs except-those selecting "no action," the
"Summary of Site Risks" section of the Decision Summary should conclude with
the same statement contained in the "Assessment of the Site" section of the
Declaration, which states the following:
Actual or threatened releases of hazardous substances from
this site, if not addressed by implementing the response
action selected in this ROD, may present an imminent and
substantial endangerment to public health, welfare, or,
the environment.
6.3.7 Description of Alternatives
This section provides a concise description of how each alternative would
address the contamination at the-site or operable unit from the beginning of
the remedy to the completion of site activities. This description should
explain the treatment and/or engineering (e.g., containment) components of
each alternative as they logically occur in the proposed remediation process.
When describing a particular treatment or containment alternative, the general
treatment family or containment objectives could be described. Specific
process options within those categories should be described if there is
confidence that the options will be used. For example, an alternative should
be described as employing thermal destruction rather than rotary kiln
incineration or infrared incineration. In the same way, a containment option
that employs a RCRA Subtitle C cap should specify the objectives of the cap
(e.g., reducing the permeability by covering the site with an impermeable
layer), rather than the specific type of liner that could achieve that
objective (e.g., synthetic liner, PVC).
The flow chart in Figure 6-1 provides an illustration of the details
outlined in Section 6.3.8 that should be included in these descriptions, and
Exhibit 6-4 lists the details that should be described for each remedy.
Appendix C contains a sample write-up of a remedial alternative that
-------
6-21
FIGURE 6-1
Illustration of Components of Alternatives to be Described
11,000yd'
Contaminated
Soil
In
Lagoon/Tank
Farm Area
^^
^^
Excavation
of 7.500 yd'of
VOC-
Contamlnated
hot spots
^^
P»-
Low
Temperature
Volatilization
toll
^^
^*"
1
Stabl
h
Lagoo
Farnr
7,500 yd VOC-
Contamlnated
Hot Spots
TCE. 140 ppm
Benzene: 40 ppm
3
3,500 yd heavy
metal- contaminated
Soils
Pb: 30 ppm
Cd: 17 ppm
3
Cr: 12 ppm
-3
10 carcinogenic
risk level
Amount determined
by fate and
transport modeling
and
Sampling and
analysis during
excavation process
VoUIII*
Org *!«
Activated
Carbon
Canisters
I
(Illolxwy
Air
Emissions
Off-Site
Subtitle C
Disposal
Landfill
Closure of
Lagoon/Tank
Farm Area
Long-Term O&M
Cap Integrity
-- GW Monitoring
Exposure Level at 10
Deed Restrictions
Capital Costs $4.7M
Annual O&M $41,000
-------
OSWER Directive 9355.3-02
6-22
EXHIBIT 6-4
Description of Details for Each Remedy
Treatment components. Describe the following, as appropriate:
- contaminated media addressed;
treatment technologies (e.g., thermal destruction) that will be used;
type and volume of waste treated;
process sizing; and
primary treatment levels (e.g., BDAT, percentage or order of magnitude of reductions
expected).
Containment or storage components. Describe the following, as appropriate:
~ type of storage (e.g., landfill, tank, surface impoundment, containers);
type of closure that will be implemented (RCRA Subtitle C clean closure, landfill closure,
Subtitle D solid waste closure);
~ type and quantity of waste to be treated or stored; and
quantity of untreated waste and treatment residuals to be left in place and degree of risk
posed by such waste (prior to and following containment).
Ground-water component. Describe the following, as appropriate:
- ground-water classification (e.g., Class I, II, or III);
~ cleanup levels;
area of attainment; and
restoration timeframe.
General components. Describe the following, as appropriate, for each of the three previous
components:
- contaminated media addressed (and physical location at the site);
initial risk;
-- risk reduction;
whether treatability testing has been or will be conducted;
implementation requirements;
institutional controls;
residual levels (e.g., delisting, BDAT); and
~ assumptions, limitations, uncertainties.
The major ARARs. risk-based levels, and other "to be considereds" (TBCs^ being met/utilized
for the specific components of the waste management process.*
The description should summarize how the specific components of the waste management
approach will comply with the major ARARs, as well as briefly describe why the standard
is applicable or relevant and appropriate (e.g., placing a RCRA characteristic waste, thus
RCRA closure is applicable).
TBCs are non-promulgated advisories, criteria, or guidance issued by Federal or State governments that are not
legally enforceable standards. TBCs may also include proposed regulations. Before the lead agency proposes to utiliz
a TBC, it should obtain the support agency's agreement on the appropriateness of the TBC(s).
-------
OSWER Directive 9355.3-02
6-23
illustrates the level of detail appropriate for this section.2 In particular,
it should be noted that the description should incorporate the major ARARs
associated with a remedial alternative in laying out exactly how the waste
will be handled. Exhibit 6-5 lists the major Federal ARARs that typically may
apply to Superfund remedies and may need to be discussed in describing
alternatives.
By providing a comprehensive description of the alternatives in this
section, the comparative analysis of alternatives (which is the next section
of the ROD) can focus on highlighting the differences or similarities among
alternatives with respect to the nine evaluation criteria (see Section 6.3.8,
"Summary of Comparative Analysis of Alternatives"). In addition, this initial
description of the selected remedy should provide engineering details that
will support the remedial design phase.
The description also should outline the performance parameters of each
alternative, such as the concentration levels of contaminants that will remain
on site without management, the types of long-term management controls that
will be used (e.g., permeable cap), and the MCLs or other levels to be
attained in remediated ground water.
6.3.8 Summary of the Comparative Analysis of Alternatives
This section should provide the basis for determining which alternative
provides the "best balance" of tradeoffs with respect to the following nine
evaluation criteria:
Threshold Criteria 1) Overall protection of human health and the
environment; and
2) Compliance with applicable or relevant and
appropriate requirements.
o
A ROD will often contain descriptions of separate remedies for addressing the contaminated
ground water and the source of contamination at the site. An effective way of presenting the alternatives
for each of these pathways would be to discuss the ground-water alternatives separately from the source-
control alternatives. By organizing the description of alternatives in this manner, a more comprehensive
understanding can be gained of the options analyzed for remediating each of these pathways. Where
there are components of the ground-water alternatives that are interrelated with a specific source-control
alternative, these should be noted.
-------
OSWER Directive 9355.3-02
6-24
EXHIBIT 6-5
Federal ARARs that May Apply
to Superfund Remedial Actions
Safe Drinking Water Act (SDWA)
~ Maximum Containment Levels (MCLs)
- MCL Goals (MCLGs)
» Resource Conservation and Recovery Act (RCRA) Subtitle C (Hazardous Waste
Requirements)
~ Closure (i.e., landfill or clean closure)
Subpart F Ground-Water Monitoring (including post-closure care)
~ Location Standards
Minimum Technology
~ Subpart O Incineration
Land Disposal Restrictions
~ Unit-Specific Design and Operating Standards (e.g., for tanks, containers)
RCRA Subtitle D (Solid Waste Requirements)
Clean Water Act
- Federal Water Quality Criteria (FWQC)
- Publicly-Owned Treatment Works (POTW) standards
-- Effluent Limitations and Guidelines
~ Requirements for Dredge and Fill Activities
Toxic Substances Control Act (TSCA)
Polychlorinated biphenyls (PCB) standards
Clean Air Act (CAA)
National Ambient Air Quality Standards (NAAQs)
-- State Implementation Plan (SIP)
State ARARs.
-------
OSWER Directive 9355.3-02
6-25
Primary Balancing Criteria 3) Long-term effectiveness and permanence;
4) Reduction of toxicity, mobility, or volume
through treatment;
5) Short-term effectiveness;
6) Implementability; and
7) Cost.
Modifying Criteria 8) State/support agency acceptance; and
9) Community acceptance.
This analysis should summarize the comparative analysis of alternatives
presented in the detailed analysis section of the RI/FS report. The RI/FS
guidance contains additional information on the subfactors included in each of
the nine criteria. (These subfactors are also reflected in Exhibit 2-2 in
this guidance and in Appendix B.) These factors should be addressed, when
appropriate, in describing and evaluating alternatives. The comparative
analysis provides the basis for explaining how the selected remedy satisfies
the statutory requirements described in section 6.3.10 (specifically, the
cost-effectiveness and utilization of permanent solutions and treatment to the
maximum extent practicable ["MEP"] findings).
The major objective of this section of the ROD is to evaluate the
relative performance of the alternatives with respect to the criteria so that
the advantages and disadvantages associated with each cleanup option are
clearly understood. The most effective way of organizing this analysis is to
present a series of paragraphs headed by each criterion. Under each
criterion, the alternative that performs best in that category is discussed
first, with the other options discussed in sequence from most to least
advantageous.3 The worksheets in Appendix B may be used to assist in
preparing the comparative analysis summary.
6.3.9 The Selected Remedy
The remainder of the Decision Summary focuses on the selected remedy.
This section of the ROD should identify and summarize the major treatment
components of the selected remedy, as well as any engineering controls (e.g.,
A symbolic ranking method without an accompanying narrative, such as a "+" for the "best"
alternative and a "-" for the lower ranking alternative, is discouraged. Although this could be used in a
table, the symbols are not substitutes for the narrative comparison.
-------
OSWER Directive 9355.3-02
6-26
containment) or institutional controls that will be part of the remedy. In
addition, this section of the ROD should briefly discuss the following:
The remediation goals and corresponding risk level(s) to be attained
at the conclus-ion of ttie response action and the points of
compliance for the media being addressed (e.g., ground water); and
The lead agency's basis for the remediation goals (e.g., ARARs, risk
calculation).
Where remediation goals specify carcinogenic risk levels (e.g.,
1 x 10"6), the basis for the selection of that level (e.g., technical,
uncertainty, or exposure factors) should be explained briefly. If more than
one area at the site is being addressed (e.g., treatment and landfill ing of
residuals), this section of the ROD should identify the remediation goals for
each area. A table may be included in this section of the ROD to summarize
the remediation goals for each area or medium.
The discussion of the selected remedy in this section of the ROD should
expand upon the details of the remedy from the Description of Alternatives
discussed in section 6.3.7 of this guidance. One aspect of the selected
remedy that should be described in detail is the estimated costs of the
remedial action. The capital costs of each major treatment and containment
component of the selected remedy should be identified, along with an
indication of the volume of material that each component will address and the
estimated unit costs. Contingencies should also be listed. Operation and
maintenance cost should be stated in terms of annual costs, and the total net
present value should be presented. Exhibit 6-6 illustrates the type of cost
information to be included for the remedy outlined in Figure 6-1. This
section of the ROD should mention that some changes may be made to the remedy
as a result of the remedial design and construction processes. The ROD should
include a clear statement that such changes, in general, reflect modifications
resulting from the engineering design process.
-------
OSWER Directive 9355.3-02
6-27
EXHIBIT 6-6
Example Cost Summary for the Selected Remedy
Estimated Costs of
Selected Remedy
7,500
11,500
11,000
Capital Costs;
Treatment Component
1. Low temperature volatilization/
stabilization
2. Treatment/disposal of off-gases
Containment Component
1. Landfill closure of residuals
Contingencies @ 20%
Operation and Maintenance Cost:
1. Landfill maintenance and ground
water monitoring around unit
TOTAL COSTS
(Net Present Value calculated using a 5% discount value)
Estimated
Cubic Yards Cost per CY Cost
$360
$ 60
$50
$2,700,000
660,000
550.000
$3,910,000
790.000
$4,700,000
Annual Cost
$41,000
$5,320,780
-------
OSWER Directive 9355.3-02
6-28
In addition to the elements recommended in the Description of
Alternatives section, the following elements of the selected remedy should be
addressed, as appropriate, for ground-water remedies: expected pumping and
flow rates; number of extraction wells; treatment processes; methods of
control for cross-media impacts; gradient control system; and performance
evaluations and schedule.
6.3.10 Statutory Determinations
Once the selected remedy has been identified, the ROD Decision Summary
should conclude with a description of how the selected remedy meets the
statutory requirements of CERCLA section 121. The remedy selected by the lead
agency, in consultation with the support agency, must:
Be protective of human health and the environment;
Comply with ARARs (or justify an ARAR waiver);
Be cost-effective;
Utilize permanent solutions and alternative treatment technologies
or resource recovery technologies to the maximum extent practicable;
and
Satisfy the preference for treatment that reduces toxicity,
mobility, or volume as a principal element, OR provide an
explanation as to why this preference is not satisfied.
A brief, site-specific description of how the selected remedy satisfies
each of the statutory requirements should be provided in this section of the
ROD. The statutory requirements and the key information that should be
summarized for each finding are highlighted in Appendix D of this guidance.
Protection of Human Health and the Environment: This section of the ROD
should describe how the selected remedy will provide adequate protection of
human health and the environment through treatment, engineering controls,
and/or institutional controls. Specifically, the remedy should be described
in terms of how the existing or potential risks posed by the site or operable
unit through each pathway will be eliminated, reduced, or controlled by the
response action. This discussion should also indicate that exposure levels
-------
OSWER Directive 9355.3-02
6-29
will be reduced to within the 10~A to 10"7 range within which EPA manages
carcinogenic risk and that the Hazard Indices for non-carcinogens will be less
than one. Finally, this discussion should reflect that the implementation of
the selected remedy will not pose unacceptable short-term risks or cross-media
impacts.
Compliance with Applicable or Relevant and Appropriate Requirements
(ARARs):* This section of the ROD should:
State whether the selected remedy will comply with all Federal and
any more stringent State ARARs or whether any ARAR waiver will be
used. If a waiver is invoked, it should be identified and a
justification provided;
List and briefly describe the ARARs that will be attained by the
selected remedy. This list should be organized according to
chemical-specific, location-specific, and action-specific ARARs.
Also, applicable requirements should be distinguished from the
relevant and appropriate requirements for the RCRA land disposal
restrictions and closure requirements, SDWA MCLs, and other
requirements, as necessary; and
List and briefly describe the TBCs (e.g., advisories, criteria, and
guidances) being utilized and the reason for their use.5
Exhibit 6-7 illustrates the level of detail in which Federal and State
ARARs should be described for documentation of the selected remedy.
Other available information that does not constitute an ARAR (e.g., advisories, criteria, and
guidance) may be considered in the analysis if it helps to ensure protectiveness or is otherwise appropriate
for use in a specific alternative. These To-Be-Considered materials should be included in the description
if the lead and support agencies agree that their inclusion is appropriate.
5 CERCLA Compliance With Other Laws Manual (OSWER Directive 9234.1-01, August 1988).
-------
OSWER Directive 9355.3-02
6-30
EXHIBIT 6-7
Examples of Federal and State ARAR Descriptions
Safe Drinking Water Act (SDWA)
SDWA MCL for benzene (5.0 x 10"3 mg/1) in the ground-water aquifer.
Resource Conservation and Recovery Act (RCRA)
40 CFR 264.111 Subpart G (Closure Performance Standards) for closure
with no post-closure care (i.e., clean closure).
40 CFR 264.91 - 100 Subpart F, which specifies ground-water
monitoring requirements for closure of a unit with waste in place.
40 CFR 264.18(b), which specifies that hazardous waste treatment,
storage, or disposal facilities constructed within the 100-year
floodplain must be designed, constructed, operated, and maintained
to avoid washout.
RCRA design and operating requirements in Subpart N 40 CFR
264.301, which specify minimum technology for construction of a new
unit, including a double liner and leachate collection system.
RCRA Subpart O requirements for incineration of hazardous waste in
40 CFR 264.340 through 264.34 and 264.35.
RCRA Land Disposal Restrictions in 40 CFR 268 are applicable and
will be achieved by using BOAT (rotary kiln incineration and
stabilization), which is specified in the requirements for nonwastewaters
containing K001 waste. Treatment levels specified for the constituents
pyrene and toluene will be achieved.
Clean Water Act (CWA)
CWA Ambient Water Quality Criteria for Protection of Human Health
with Water and Fish Ingestion of 3.5 mg/1 for phenol in the receiving
stream.
Sound County Sanitary Authority Pretreatment Standard of .005 ppb for
xylene in the discharge to the sanitary sewer system.
CWA requirement for Best Available Technology will be achieved using
hydroxide precipitation and sedimentation for treatment of metal waste.
Discharge limits will be established using BPJ during remedial design.
CWA 404 requirements for discharge of dredged material, which specify
minimization of adverse impacts.
-------
OSWER Directive 9355.3-02
6-31
The following is an example of how TBCs can be summarized.6
Sample Language for TBCs:
In implementing the selected remedy, EPA and the State have agreed to
consider a number of procedures that are not legally binding. These include
the guidance on designing RCRA caps (Draft RCRA Guidance Document.
Landfill Design, Liner Systems and Final Cover, issued June 1982) and posting
of a deed notice at the site after the remedial action has been completed.
The guidance on designing RCRA caps includes specifications to be followed
in constructing and maintaining a RCRA cap. Deed restrictions are
institutional controls that will be enforced by the local government to ensure
that the RCRA cap is not disturbed.
For some remedies, more lengthy discussion of a statute or regulation is
necessary. For example, the selected remedy could be one that complies with
the relevant and appropriate requirements of both clean closure and landfill
closure under RCRA to fashion an "alternate" closure or a remedy for which
land disposal restrictions are applicable and a treatability variance is being
obtained.
Cost-Effectiveness: In this section, the lead agency should verify that
the selected remedy affords overall effectiveness proportional to its costs.
This section should state briefly how the selected remedy appears to be cost-
effective, when the overall relationship between cost and effectiveness is
compared to the cost/effectiveness relationship among the other alternatives.
Utilization of Permanent Solutions and Alternative Treatment (or Resource
Recovery) Technologies to the Maximum Extent Practicable (MEP): This section
describes the rationale for the remedy selected, explaining how the remedy
provides the best balance of tradeoffs among the alternatives with respect to
the evaluation criteria, particularly the five primary balancing criteria.
The summary worksheets for conducting the comparative analysis, included in
Appendix B of this guidance, could be used in discussing this determination.
Key TBC's (those fundamental to the selected remedy) should be justified in the ROD. If the
validity of TBCs is challenged, the justification for use of the TBC should also be provided in the
Responsiveness Summary (see Section 6.4).
-------
OSWER Directive 9355.3-02
6-32
The final remedy is selected among the protective, ARAR-compliant (or
waiver-worthy) alternatives. The selection is based on a determination of
which option best balances the tradeoffs among the alternatives as they relate
primarily to: long-term effectiveness and permanence; reduction in toxicity,
mobility, or volume through treatment; short-term effectiveness;
implementability; and cost. Those criteria that distinguish the alternatives
will be the major tradeoffs to be balanced in the selection decision. To the
extent that alternatives are comparable with respect to a particular criterion
(e.g., all options provide similar degrees of long-term effectiveness), that
criterion is not a decisive factor in the selection process. The degree to
which each alterative has State/support agency and community acceptance also
is a factor considered in the decision, along with the primary tradeoffs.
This section of the ROD should discuss why the selected remedy is
believed to best meet the evaluation criteria, compared to the other
alternatives, and why it is the most appropriate solution for the site. In
identifying the alternative that provides the best balance of tradeoffs, the
decisionmaker also is judging the alternative to be the one that utilizes
permanent solutions and treatment technologies to the maximum extent
practicable for that site.
The discussion in this section should be organized as follows:
Provide a general statement that the selected remedy utilizes
permanent solutions and treatment technologies to the maximum extent
practicable;
Highlight tradeoffs among alternatives related to the five primary
balancing criteria, which should be discussed in this order:
long-term effectiveness and permanence,
reduction of toxicity, mobility, or volume through treatment,
short-term effectiveness,
implementability, and
cost;
Discuss which of the five criteria were the most decisive factors in
the selection decision; and
-------
OSWER Directive 9355.3-02
6-33
Describe how State and community acceptance were factored into the
decision making process.
The ROD should always make the affirmative finding that the selected
remedy meets the statutory requirement to utilize permanent solutions and
treatment technologies to the maximum extent practicable, even if it is a
containment remedy. In this situation, the extent of treatment found to be
practicable is no treatment at all. Therefore, where the selected remedy does
not employ any treatment or resource recovery technologies, the explanation of
the rationale used in the decision should include the reasons for finding
treatment to be impracticable.
Preference for Treatment as a Principal Element: In addition to the four
statutory mandates discussed previously, the statutory preference for
treatment as a principal element also should be addressed. In writing the
ROD, the manner in which the preference is addressed will depend upon whether
the selected remedy uses treatment to address the principal threat(s) posed by
the site. A discussion of whether the selected remedy satisfies the statutory
preference should be included. This summary should describe the principal
threats posed by the site (e.g., hot spots in a landfill or a contaminated
ground-water plume) and the treatment methods that will be used to address
these.
If the remedy selected does not satisfy the statutory preference, the ROD
should explain why it does not do so. In some cases, this explanation will
involve a statement of why treatment of the principal threat(s) is not
practicable. In the case of operable units of very limited scope (e.g.,
control of plume migration), the discussion should include a statement that
the operable unit will not definitively address any of the principal threats
posed by the site and demonstrate how past actions did, or future actions
will, address those threats.
6.3.11 Documentation of Significant Changes
To fulfill the requirements of CERCLA section 117(b), the ROD should
document and discuss the reasons for any significant changes made to the
selected remedy from the time the Proposed Plan and RI/FS report were released
for public comment to the final selection of the remedy (see Chapter 5 for a
complete discussion on pre-ROD significant changes).
-------
OSWER Directive 9355.3-02
6-34
The documentation of significant changes can be organized in the ROD in
one of two ways, depending upon the nature of the changes. Where the
significant change affects a feature of the preferred alternative (the
selected remedy in the ROD), the documentation should appear at the end of the
ROD. Where the significant change entails changing from the preferred
alternative to another alternative discussed in the Proposed Plan, this should
be documented prior to he description of alternatives.
This section of the ROD should identify the preferred alternative from
the Proposed Plan and should indicate whether any significant changes were
made. If significant changes were made, the reasons for those changes should
be explained. If a significant change was made that required the issuance of
a revised Proposed Plan and the announcement of a new public comment period,
the activities performed in compliance with these requirements should be
summarized as well.
Exhibit 6-8 includes examples of the three different types of discussions
that generally could be included in this section of the ROD. These examples
were developed from information presented in the sample Proposed Plan in
Appendix A of this guidance. The first example is a case in which no
significant changes are made. The second is a case in which a significant
change is made that is a logical outgrowth of the information originally
presented in the Proposed Plan and the RI/FS report. In this second case, the
only procedural requirement is to discuss the change in this section of the
ROD. The final example is a case in which a significant change is made that
is not a logical outgrowth of the information in the RI/FS and the Proposed
Plan. This third example describes the additional public participation
activities that should be conducted after the first Proposed Plan has been
released for public comment.
6.4 THE RESPONSIVENESS SUMMARY
The Responsiveness Summary is the third component of the ROD, and it
serves several purposes. First, it provides the lead agency decisionmakers
with information about community preferences regarding both the remedial
alternatives and general concerns about the site. Second, it demonstrates how
public comments were integrated into the decision-making process. Third, it
allows EPA to respond to comments "on the record." This means that a court
reviewing the remedy will look to see whether EPA has provided a reasonable
response to comments in the record, and will not allow new presentation of
-------
OSWER Directive 9355.3-02
6-35
EXHIBIT 6-8
Three Examples of Documentation
of Significant Changes
Example One: No Significant Changes
The Proposed Plan for the EIO site was released for public comment in September 1988. The
Proposed Plan identified Alternative 4, excavation and on-site volatilization of VOCs, as the preferred
alternative. EPA reviewed all written and verbal comments submitted during the public comment period.
Upon review of these comments, it was determined that no significant changes to the remedy, as it was
originally identified in the Proposed Plan, were necessary.
Example Two: Significant Change Requiring Only Documentation in the ROD
The Proposed Plan was released for public comment in September 1988. The Proposed Plan
identified Alternative 4, excavation and on*site volatilization of VOCs, as the preferred alternative. One of
the other alternatives (Alternative 6) presented in the Proposed Plan and the RI/FS involved on-site
incineration and solidification of wastes. The original preference for Alternative 4 was based in part on
the fact that a mobile incinerator was not readily available to implement Alternative 6. During the public
comment period, however, a mobile incinerator became available. As a result, EPA, in consultation with
the Tennessee Pollution Control Board, decided to select the on-site incineration remedy. On-site
incineration is a more comprehensive, reliable treatment-based remedy for the particular waste at the EIO
site than is the volatilization remedy originally preferred.
Example Three; Significant Change Requiring a New Public Comment Period
A Proposed Plan for the EIO site was released for public comment in June 1988. The Plan
identified Alternative 4, excavation and on-site volatilization of VOCs, as the preferred alternative. During
the public comment period, the results of remedial activities at another site with contamination problems
similar to those at the EIO site indicated that an alternative treatment technology, in-situ vitrification,
could be used successfully on contaminants similar to those at the EIO site. Further analysis of the
vitrification alternative indicated that fewer short-term risks would be associated with it than with the
volatilization alternative, and that the long-term effectiveness of vitrification would be greater, as the
solidified matrix is expected to have a longer effective life than a RCRA landfill. The information
supporting this determination is available in the administrative record file.
As a result of this new information, EPA decided to select in-situ vitrification as the new preferred
alternative for cleaning up the EIO site. The Tennessee Pollution Control Board concurred with this
decision. In compliance with statutory requirements for ensuring the public has the opportunity to
comment on major remedy selection decisions, a new Proposed Plan was prepared presenting in-situ
vitrification as the preferred alternative. The second Plan was made available to the public in September
1988. No significant comments were received during the second public comment period, and no significant
changes have been made to the selected remedy.
-------
OSWER Directive 9355.3-02
6-36
evidence on those issues. An adequate responsiveness summary is essential in
defending RODs in judicial proceedings.
To serve these purposes, the Responsiveness Summary should be a concise
and complete summary of significant comments received from the public,
including PRPs, during the public comment period that is required by CERCLA
section 117. The summary should be accompanied by the lead agency's responses
to these comments. Responses should be clear, accurate, and carefully written
by the OSC or RPM, and/or by any other persons, as necessary, to ensure the
best response. For example, if the validity of a key TBC is challenged during
public comment, EPA Headquarters should be consulted to aid in preparing the
justitification for use of the TBC in the Responsiveness Summary.
When general policy matters are discussed in the Responsiveness Summary,
it is recommended that they be brought to management's attention prior to the
release of the ROD. If the lead agency determines that a point-by-point
response to a set of comments is warranted, the comment response document
should be prepared as a separate document. In this situation, a summary of
these comments with the lead agency's response should be included in the
Responsiveness Summary as well.
Guidance on preparing Responsiveness Summaries is available in "Community
Relations in Superfund: A Handbook," (OSWER Directive 9230.0-3B, June 1988).
This Handbook details the process of preparing the Summary and includes a
sample Responsiveness Summary.
6.5 SUBMITTING RODS TO EPA HEADQUARTERS
It is important that all signed RODs be sent to Headquarters as soon as
possible after they are signed. A completely assembled, clear, legible copy
of the ROD with a signed signature page should be forward by the RPM, or other
designated individual to:
Chief, Remedial Planning and Response Branch
Hazardous Site Control Division (OS-220)
Office of Emergency and Remedial Response, OSWER
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
-------
OSWER Directive 9355.3-02
6-37
This process may be more efficient if one individual coordinates this effort
in the Regional office (e.g., the administrative record coordinator).
Appendix E describes the process of submitting RODs and other decision
documents to Headquarters.
-------
OSWER Directive 9355.3-02
CHAPTER 7
THE PROCESS FOR DEVELOPING THE RECORD OF DECISION
This chapter describes the roles and responsibilities of the lead and
support agencies in developing the ROD. In this chapter procedures to
facilitate timely preparation, review, and final approval of the ROD are
presented, as well as dispute resolution procedures and the role of other
Federal agencies in cleanup activities at Federal facilities.
7.1 OVERVIEW
As with the Proposed Plan, the lead agency has the responsibility for
preparing the ROD and coordinating with the support agency(ies) and other lead
agency program offices to attain concurrence on the selected remedy.
Typically, the lead agency that prepares the RI/FS report and the Proposed
Plan will prepare the ROD, although this may vary from site to site. In many
cases, EPA is the lead agency and prepares the ROD; however, the State can
prepare the ROD either when the State is designated the lead agency in the
SMOA, CA, or SSC or when there is a State-lead enforcement action at an NPL
site. Federal agencies should prepare RODs for Federal facilities under their
jurisdiction, consistent with the terms of their lAGs.
Although the roles of EPA, the State, and other Federal agencies may vary
from site to site, EPA retains the final authority for selecting all response
actions pursuant to CERCLA sections 104, 106, 120, and 122.
7.1.1 State Preparation of the ROD
The. State should recommend a remedy for EPA concurrence and adoption for
cases in which EPA and the State designate that State as the lead agency in
the SMOA. Through the annual planning process, EPA and the State should
designate those sites for which the State should prepare the ROD for EPA
concurrence and adoption.
As indicated in the proposed revisions to the NCP, EPA intends to
implement selectively the process of State preparation of RODs, giving the
State the lead when both of the following conditions are met:
-------
OSWER Directive 9355.3-02
7-2
The circumstances at a particular site warrant less EPA
and more State involvement; and
The State has demonstrated its ability to conduct remedial
actions in an effective and responsible manner.
When the State is the lead agency for developing the RI/FS at a Fund-financed
site, if agreed to by EPA, the State should prepare the Proposed Plan, publish
the notice of availability, prepare the Responsiveness Summary, and develop
the ROD. When the State has the responsibility for preparing the ROD, the
State should recommend a remedy to EPA. EPA and the State then sign the ROD.
In cases such as this one, EPA retains final authority over remedy selection
although the State prepared the ROD.
7.1.2 Remedy Selection for State-Lead Enforcement Actions
Not every remedial activity taken at NPL sites are conducted under the
authority of CERCLA sections 104, 106 or 122. The State may take action at an
NPL site under its own remedial authority. This kind of action is commonly
referred to as a State-lead enforcement action.
The degree of EPA involvement in the remedy selection process at these
sites is discretionary and should be established between EPA and the State in
the SMOA, CA, or SSC. EPA may choose to concur or nonconcur with a remedy
selected for such a site only when the SMOA, CA, or SSC specified such a role
for EPA. Further guidance on State-lead enforcement actions will be available
in the forthcoming Interim Final Guidance Package on Funding CERCLA State
Enforcement Actions at NPL Sites.
7.1.3 Roles and Responsibilities of Other Federal Agencies
Executive Order 12580 delegates the authority for carrying out the
requirements of CERCLA sections 117(a) and (c) to Federal agencies with
Federal facilities under their jurisdiction. A Federal agency, therefore, can
issue the Proposed Plan. The agreement among the Federal agency, EPA, and, in
many cases, the State should establish the responsibilities of each party for
preparation of the ROD.
For sites under its jurisdiction, a Federal agency has the lead
responsibility for preparing the draft ROD in accordance with Chapters 6 and,
-------
OSWER Directive 9355.3-02
7-3
when appropriate, Chapter 9 of this guidance, and for carrying out the lead
agency responsibilities specified in this chapter. The Federal agency should
prepare the draft ROD, taking into consideration new information and comments
received during the public comment period, and should submit the draft ROD to
EPA (and, where designated in the IAG, the State) for EPA's written approval.
The Regional or Assistant Administrators' signatures constitute final EPA
"adoption" of the ROD.
The Federal agency should publish a notice of availability pursuant to
CERCLA section 117(d) and make the ROD available to the public before
beginning the response action. In a limited number of cases, the Federal
agency, EPA, or the State involved in a remedial action will not be able to
reach agreement on the remedial approach for a site. If the parties are
unable to reach agreement on the draft ROD even after a dispute resolution
process has been followed, EPA should select the remedial action.
7.2 ROLES AND RESPONSIBILITIES OF LEAD AGENCY AND
SUPPORT AGENCY
The responsibilities outlined below for the lead and support agency apply
to EPA, the State, or another Federal agency except where specifically noted.
7.2.1 Lead Agency
The lead agency's responsibilities in the ROD development process include
the following (see Figure 7-1):
Preparing the draft ROD;
Briefing lead agency upper management on the ROD;
Submitting the draft ROD to other lead agency program
offices for their review;
Submitting the ROD to the support agency to obtain that
agency's formal concurrence on the selected remedy;
Reviewing and addressing the support agency's comments and
modifying the selected remedy, as appropriate;
-------
7-4
FIGURE 7-1
Lead Agency Responsibility in ROD Development Process
Prepare Draft ROD
Brief Lead Agency
Management
on ROD
Submit
ROD to
Program
Offices
Submit
ROD to
Support
Agency
Receive
Concurrence
from Support
Agency
Revise
ROD for
Signature
Brief the following:
* Regional Administrator/
Assistant Administrator
* Support Agency
Obtain Appropriate
Signatures
Publish Notice and
Make ROD Available
to the Public
-------
OSWER Directive 9355.3-02
7-5
Revising the draft ROD for signature;
Briefing the Regional Administrator and the Assistant
Administrator of OSWER, as well as the designated
personnel in the support agency;
Submitting the ROD to the Regional Administrator and the
Assistant Administrator of OSWER for signature (if a State
or a Federal agency is the lead agency, that lead agency
and EPA should sign the ROD); and
Publishing the newspaper notice of availability of the ROD
and making the ROD available to the public.
7.2.2 Support Agency
The support agency's responsibilities in the ROD development process
include:
Reviewing and commenting on the draft ROD;
Briefing support agency upper management on the ROD;
Coordinating review of the ROD by other support agency
offices;
Providing EPA with a letter stating whether it concurs
with the ROD (this letter becomes part of the
administrative record file when the State is the support
agency); and
Participating in briefing the upper management of the lead
agency, as necessary.
The support agency should have an adequate opportunity to review the
draft ROD prior to its adoption. Unless otherwise specified in the SMOA, CA,
or SSC, 10 working days is recommended as the average amount of time that
should be established in the support agency's schedule for review of the draft
ROD. For more complicated sites, a goal of 15 working days is the suggested
guideline.
-------
OSWER Directive 9355.3-02
7-6
7.3 DISPUTE RESOLUTION
Continuous interaction between the lead and support agencies throughout
the remedy selection process should ensure that final agreement on the
selected remedy is accomplished in a timely manner. There could be instances,
however, where outstanding issues may arise between the lead and support
agencies. The draft guidance on preparing SMOAs, Draft Guidance on Preparing
a Suoerfund Memorandum of Agreement (SMOA) (OSWER Directive 9375.0-01,
September 1988) specifies a dispute resolution process that could be utilized
by EPA and the State if conflicts should arise. Chapter 3 of this guidance
discusses the dispute resolution process presented in the proposed revisions
to the NCP (Subpart F, "State Involvement in Hazardous Substance Response," 40
CFR Part 300). Those resolution procedures should be used if none are
specified in the SMOA.
7.4 ROLE OF OTHER EPA AND STATE PROGRAM OFFICES
Each agency should establish appropriate procedures and time frames for
intra-agency review of RODs. An agency may need to coordinate with a number
of program offices to ensure that technical and legal aspects of the ROD are
defensible. Concurrence from EPA's Regional Counsel should be sought prior to
presenting the ROD to the Regional Administrator or Assistant Administrator,
unless outstanding issues exist that must be resolved by the Regional
Administrator or Assistant Administrator. Regional and State legal counsel
should be involved early in the remedy selection process to assist in the
identification of ARARs, to ensure that all enforcement-sensitive issues are
presented properly, and to ensure that the ROD is legally defensible.
7.5 ROLE OF POTENTIALLY RESPONSIBLE PARTIES
When the PRP conducts the RI/FS, the lead agency, as designated by the
SMOA, CA, or SSC, is responsibile for writing the Proposed Plan and ROD. If
the PRPs are not conducting the RI/FS, they should be kept informed of
remedial activities just as any other member of the public, through the
community relations process and the administrative record file.
The lead agency could conduct negotiations with the PRPs concerning RD/RA
activities during the time the ROD is being written. These negotiations
should be separate from any ROD-related activities. Generally, documents that
-------
OSWER Directive 9355.3-02
7-7
result from these negotiations are not part of the administrative record
unless they are submitted by the PRP as information that the lead agency
should consider in selecting the response action.
At Federal lead sites, after the ROD is signed, the consent decree for
RD/RA is signed and then filed for a 30-day public comment period. After the
comment period ends, a Responsiveness Summary is compiled by the Department of
Justice, in consultation with the lead agency, which provides a discussion of
the procedures to follow when changes contained in the consent decree differ
from the remedy in the ROD.
7.6 ISSUING NOTICE OF AVAILABILITY OF THE ROD
The ROD should be added to the administrative record files after it is
signed. In addition, to comply with CERCLA, the lead agency should publish a
notice of the availability of the ROD in a local newspaper. CERCLA section
117(b), states that:
Notice of the final remedial action plan adopted shall be
published and the plan shall be made available to the
public before commencement of any remedial action...
The public notice of availability of the ROD should be brief and factual.
It need not be as extensive as the newspaper notification of availability of
the RI/FS and Proposed Plan, which are described in Chapter 4 of this
guidance. The notice should use a display advertisement format and should be
published in a widely read section of the newspaper.
7.6.1 Elements of the ROD Public Notice
The ROD newspaper notification should include the following elements:
The site name and notice of availability of the ROD;
The date on which the ROD was signed;
A brief summary of the major elements of the selected
remedy;
-------
OSWER Directive 9355.3-02
7-8
Details on the location and hours of availability of the
administrative record file and/or the information
repository; and
The name and telephone number of the tndtvidual(s) to
contact for further information about the site and the
remedy selected.
The lead agency may find it appropriate to provide information in the
newspaper notification about support agency concurrence or non-concurrence on
the ROD. When preparing a ROD notice for a Federal facility, the announcement
should specify that the ROD has been prepared by the relevant Federal agency
and approved by EPA. Exhibit 7-1 is an example of a newspaper notification
announcing the availability of the ROD for public review.
-------
OSWER Directive 9355.3-02
7-9
EXHIBIT 7-1
Sample Newspaper Notification
of Availability of the Record of Decision
THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
ANNOUNCES THE AVAILABILITY OF THE
RECORD OF DECISION FOR THE
EIO INDUSTRIAL SUPERFUND SITE
IN NAMELESS, TENNESSEE
On March 31, 1989, the U.S. Environmental Protection Agency (EPA) signed the Record of Decision
(ROD) that formally selects the cleanup plan for the soil contamination at the EIO Industrial site. The ROD
outlines EPA's decision for selecting the cleanup remedy for the site. The Tennessee Pollution Control Board
concurs with the findings in the ROD.
EPA has decided to excavate contaminated soils, treat the organic compounds in the soils using a low-
temperature volatilization loop, stabilize the remaining wastes, and dispose of the treated soils in an on-site
landfill.
The administrative record file for the site, which includes the ROD and all documents that formed the
basis for EPA's selection of the cleanup remedy, is available for public review at the locations listed below.
Nameless Public Library U.S. EPA Docket Room, Region 4
125 Elm Street Federal Building, 10th Floor
Nameless, TN 00000 Atlanta, GA 00000
(101) 9994099 (555) 555-1212
Hours: Hours:
Mon.-Sat.: 9 a.m. to 9 p.m. Mon.-Fri.: 8:30 a.m. to 4:30 p.m.
Questions about EPA's decision or other activities at the EIO Industrial Superfund site should be
directed to:
Joshua Doe
Community Relations Coordinator
U.S. Environmental Protection Agency
123 Peachtree Street
Atlanta, GA 00000
(555) 555-4640
Toll-free: 1 (800) 333-1515
between 8:30 a.m. and 4:30 p.m.
-------
OSWER Directive 9355.3-02
CHAPTER 8
POST-ROD SIGNIFICANT CHANGES
8.1 OVERVIEW
After a ROD is signed, new information may be generated during the RD/RA
process that could affect the remedy selected in the ROD. The lead agency
should analyze this new information to determine if changes should be made to
the selected remedy. Three types of changes could occur: (1) non-significant
changes; (2) significant changes; and (3) fundamental changes. If non-
significant or minor changes are made, they should be recorded in the post-
decision document file; if significant changes are made to a component of the
remedy in the ROD, these changes should be documented in an Explanation of
Significant Differences (ESD); and if fundamental changes are made to the
overall remedy, these changes should be documented in a ROD amendment. This
chapter provides procedures to review and document changes when new
information is provided by the public, PRPs, or the support agency, or when
new information is generated by the lead agency that affects the selected
remedy. Definitions of significant changes are presented and the
documentation procedures associated with them are summarized. This chapter
also provides an outline of an ESD, an amended ROD, and examples of
documenting non-significant and significant differences.
8.2 REQUIREMENTS TO ADDRESS SIGNIFICANT CHANGES
The lead agency may determine that a significant change to the selected
remedy, as described in the ROD, is necessary after the ROD is signed. CERCLA
section 117(c) requires the lead agency to address post-ROD significant
changes:
After adoption of a final remedial action plan (1) if any
remedial action is taken [under sections 104 or 120], (2) if
any enforcement action under section 106 is taken, or (3) if
any settlement or consent decree under section 106 or section
122 is entered into, and if such action, settlement or decree
differs in any significant respects from the final plan [ROD]
the [lead agency] shall publish an explanation of the
significant differences and the reasons such changes were made.
-------
OSWER Directive 9355.3-02
8-2
The statute's emphasis on "significant" differences indicates that not
all differences between the remedy specified in the ROD and the remedial
design, remedial or enforcement action, and settlement or consent decree are
required to be addressed in an ESD. A review of the legislative history
indicates that the significant differences provision in CERCLA section 117(c)
was not intended to be unreasonably burdensome on the lead agency. As a
result, a threshold for defining significant changes (or differences) has been
established, which is intended to reduce the paperwork burden on the lead
agency without compromising the public's right to be kept informed.
Therefore, only changes that significantly alter the scope, performance, or
cost of a component of the remedy as presented in the ROD should be addressed
in an ESD.
The proposed revisions to the NCR incorporate this statutory requirement
for the lead agency to address significant changes that arise after the ROD is
signed. In addition, the proposed revisions to the NCR incorporate for the
first time EPA's policy of amending a ROD (or other decision document) if a
significant change is made to a remedy that fundamentally alters the hazardous
waste management approach presented in the ROD.
8.2.1 Analyzing information Received or Generated
The information that provides the basis for making a significant change
to a remedy could come from a number of sources including the public, PRPs,
the support agency, or the lead agency itself. The proposed revisions to the
NCR specify criteria for the lead agency to follow in determining the extent
to which it should formally "consider" (i.e., formally respond to) new
information submitted by the public, PRPs, and the support agency after the
ROD is signed. These procedures are presented in Section 8.3. The procedures
that the lead agency should follow in evaluating information it develops
during the RD/RA process and the subsequent effects of that information on the
selected remedy are presented in Section 8.4. Section 8.5 defines three
categories of post-ROD changes and the documentation procedures that should be
followed for each.
-------
OSWER Directive 9355.3-02
8-3
8.3 CONSIDERATION OF INFORMATION SUBMITTED BY THE
PUBLIC, PRPS, AND THE SUPPORT AGENCY
EPA and the States have general procedures for responding to comments or
information received throughout the remedial process. CERCLA ensures that the
public, PRPs, and the support agency have the opportunity to participate in
the remedy selection process prior to adoption of the ROD. Once the lead
agency has selected the response action, however, its obligation to respond to
comments on the remedy is limited to special circumstances (see Section 8.4,
below) so that implementation of the selected remedy can be expedited.
The support agency's role in the RD/RA process after the ROD is signed is
different from the public's role because the support agency has a uniquely
defined role in the RD/RA process (see CERCLA section 121(f) for the role of
the State). In general, the support agency has an opportunity to be involved
in reviewing the engineering design and other reports relating to
implementation of the remedy. The support agency is also notified of
negotiations with PRPs and given the opportunity to participate in those
negotiations. Given these specific roles, information submitted by the
support agency during RD/RA will typically be in the form of comments it has
received. In most instances, it is expected that these comments could be
addressed through the normal communications process between the lead and
support agencies. The comments and any lead agency responses should be
documented in the post-decision document file.
The public, including PRPs, may submit information to the lead agency
after the ROD is signed that serves as the basis for their request that a
component of the remedy be changed (e.g., increase the boundaries of the
site). Similarly, there may be instances in which the support agency submits
new information or makes a significant comment on the RD/RA that falls outside
the standard review and comment process in which the support agency
participates throughout the entire remedial process. For example, the support
agency may request that the lead agency incorporate into the remedy a newly-
passed State regulation or an advisory that it determines is necessary to
achieve adequate protection of human health and the environment.
When information is received from the public or support agency after the
ROD is signed, the information should be analyzed to determine if it should be
"considered" by the lead agency. Consideration refers to the lead agency's
obligation to respond formally, in writing, to information received and to
-------
OSWER Directive 9355.3-02
8-4
document this response in the administrative record. The types of information
typically received from the public and support agency are described in the
next section, along with the lead agency's obligation to respond to this
information.
8.4 STANDARDS FOR CONSIDERATION OF INFORMATION
SUBMITTED BY THE PUBLIC, PRPs, OR SUPPORT AGENCY
EPA recommends a four-part standard for determining which comments
submitted by the public or support agency after the ROD is signed warrant
formal consideration.1 Formal consideration, as specified in the proposed
revisions to the NCR and depicted in Figure 8-1, requires a written response
to the comments and the inclusion of the comments in the administrative record
file. Comments received from the support agency or public should be
considered by the lead agency when each of the following criteria are met:
The comments contain significant information;
The information is not contained elsewhere in the
administrative record file;
The information could not have been submitted during the
public comment period; and
The information substantially supports the need to
significantly alter the response action.
In most cases (particularly in light of the fourth criterion),
information that meets this four-part standard warrants a significant change
to the remedy. Depending upon how significant the change is, the lead agency
should prepare either an ESD or a ROD amendment following the guidance in
Section 8.5 below. The ESD or amended ROD represent the lead agency's formal
written response to the information submitted.
1 The basis for establishing the "consideration" standard relates back to the public's and support
agency's statutory opportunity to participate in the remedy selection process prior to adoption of the
ROD. Once the lead agency has selected the response action, the obligation to respond to comments on
the remedy is limited. Additionally, it is in the best interest of the public for the lead agency to proceed
with the implementation of the selected remedy in an expeditious manner. The lead agency's ability to
accomplish this would be compromised if it were under the obligation to formally respond to every
comment submitted after the ROD is signed.
-------
8-5
FIGURE 8-1
Process to Address Post-ROD Significant Changes
INFORMATION RECEIVED
FROM PUBLIC OR
SUPPORT AGENCY
YES I-
DOES
INFORMATION
LEAD TO
SIGNIFICANT
CHANGES?
DOES IT
WARRANT FORMAL
"CONSIDERATION"
BY LEAD
LEAD AGENCY MUST
ISSUE EITHER:
EXPLANATION OF
SIGNIFICANT
DIFFERENCES; OR
NEW PROPOSED PLAN
AND ROD AMENDMENT
N0|
LEAD AGENCY PLACES
INFORMATION IN
POST-DECISION
DOCUMENT FILE
NO
LEAD AGENCY MUST:
* FORMALLY RESPOND;
AND
* PLACE DOCUMENT IN
ADMINISTRATIVE
RECORD FILE
** NOTE:
* DO THE COMMENTS CONTAIN SIGNIFICANT INFORMATION?
* IS THE INFORMATION NOT AVAILABLE IN THE ADMINISTRATIVE RECORD?
* COULD THE COMMENTS HAVE BEEN SUBMITTED DURING THE COMMENT PERIOD?
* DOES THE INFORMATION SUBSTANTIALLY SUPPORT THE NEED TO ALTER
THE RESPONSE ACTION?
-------
OSWER Directive 9355.3-02
8-6
There may be limited situations in which the information submitted by the
support agency or the public meets the four-part standard for formal
consideration, but the significant change to the remedy cannot be undertaken.
For example, information that supports the use of in-situ vitrification at a
site may be submitted to the lead agency when 90 percent of the construction
of the previously selected thermal destruction remedy already has been
completed. In this case, the lead agency may determine that implementation of
in-situ vitrification is not practicable or cost-effective, even though the
new information supports the use of that remedy. Because no change is made to
the remedy, the lead agency would not prepare an ESD or amended ROD. Instead,
the lead agency would prepare a written explanation of why a significant
change to the remedy will not be made and include this in the administrative
record file. This process is shown in Figure 8-1.
8.5 CONSIDERATION OF INFORMATION GENERATED BY THE
LEAD AGENCY
During the RD/RA process, the lead agency itself could generate
information that supports making a significant change to the remedy selected
in the ROD. This information could be developed through additional
investigations at the site. The lead agency may determine, for example, that
a pilot-scale test is necessary on a particular technology to further define
the design specifications of a particular treatment technology.
Alternatively, the lead agency may take additional samples during
remedial design to define more accurately the volume and type of waste to be
treated. This new information will typically support the implementation of
the remedy presented in the ROD. There will be instances, however, in which
such information results in the lead agency initiating a significant change to
the remedy.
Additional information and changes can also occur during RD/RA through
the process of value engineering. The remedy described in the ROD may be
subject to modifications and changes in the design and construction process
intended to enhance the cost-effectiveness of the remedy. The Superfund
program routinely uses value engineering to analyze remedies with respect to
equipment, facilities, services, and supplies associated with the system.
This analysis is conducted with the specific intent of designing and
constructing the lowest-cost remedy consistent with the performance, scope,
and reliability of the remedy selected in the ROD. The goal of this process
-------
OSWER Directive 9355.3-02
8-7
is to lead to decisions during design and construction that optimize the cost-
effectiveness and performance of the remedy. There will be instances,
therefore, in which these value engineering decisions result in significant
changes to the remedy.
Unlike the public, PRPs, and the support agency, who are subject to the
consideration standard discussed in Section 8.3, the lead agency has the
discretion to make decisions regarding the post-ROD information it generates.
As previously mentioned, the intent of the consideration standard is to
determine what public or support agency information the lead agency should
respond to and document in the administrative record file. The intent of this
standard does not apply to information the lead agency generates itself, since
there is no need to respond to that information.
The lead agency's initial analysis should focus on whether the new
information generated during RD/RA prompts the lead agency to initiate a
change to the remedy. The change may be either a non-significant or a
significant change to the ROD. If the lead agency determines a significant
change is warranted, then the lead agency should consult with the support
agency to determine the appropriate procedures for documenting that
significant change (e.g., an ESD or ROD amendment). The procedures for
evaluating the magnitude of the changes made to a remedy and, therefore, the
documentation procedures that should be followed, are presented in the next
section.
8.6 CATEGORIES OF POST-ROD CHANGES
Once the lead agency determines that a change to the remedy is warranted
based on the information submitted by the public, PRPs, the support agency, or
simply generated through the RD/RA process, the change should be evaluated to
determine whether it is one of the following:
A non-significant or minor change;
A significant change to a component of the remedy; or
A fundamental change to the overall remedy.
-------
OSWER Directive 9355.3-02
8-8
The lead agency's categorization of a change is a site-specific determination.
In making this determination, the lead agency should consider the effect the
change has on the scope, performance, or cost of the remedy as described in
the ROD. The lead agency should consider the following factors:
Does the change significantly alter the scope of the remedy (i.e.,
the physical area of the response, remediation goals, type and
volume of wastes)?
Would the change alter the performance (e.g., treatment levels to be
attained) and thus raise concerns about the protectiveness or long-
term effectiveness of the remedy that could not have been
anticipated based on information in the ROD?
Are the changes in costs of such a nature that they could not have
been anticipated based on the estimates in the ROD and the
recognized uncertainties associated with the hazardous waste
engineering process selected?
Based on this evaluation, the lead agency determines that the change is
non-significant, significant, or fundamental in nature. Each category is
discussed below along with the associated documentation procedures.
8.6.1 Non-Significant Changes
Non-significant (i.e., minor) changes fall within the normal scope of
changes occurring during the RD/RA engineering process. These minor changes
typically are the result of value engineering conducted during remedial design
and construction. Through the value engineering process, modifications are
made to functional specifications of the remedy to optimize performance and
minimize costs. This may result in minor or non-significant changes to the
type and/or cost of materials, equipment, facilities, services, and supplies
used to implement the remedy. When such changes do not significantly affect
the scope, performance, or cost of a remedy, they should be considered minor
or non-significant. Exhibit 8-1 presents examples of non-significant changes.
The lead agency need not prepare an ESD for minor changes. However,
minor changes should be documented in the post-decision document file, which
is equivalent to the RD/RA case file for a remedial action. The documentation
-------
OSWER Directive 9355.3-02
8-9
EXHIBIT 8-1
Examples of a Non-Significant Difference
Specific examples of a non-significant difference have been developed using the
following hypothetical remedy. The major components of the remedy include:
Excavation of 11,000 cubic yards of contaminated soil; treatment by thermal
destruction; disposal in an on-site landfill;
Restoration of ground water through air stripping/reinjection;
Provision of an alternate Water supply;
Capital cost: $42,463,300;
Annual O&M: $26,200; Present worth: $42,708,780; and
Implementation time: 12 to 15 months.
Example 1; In conducting engineering design and costing procedures, the lead
agency refines the original cost and time estimates for the selected remedy in the ROD.
The actual cost of implementing the remedy rises from $4.7 million to $5,3 million, and
the implementation time increases six months. Such refining of the time and cost
estimates of remedies occurs through the usual course of remedial design at most sites.
These changes are not significant differences; the lead agency is not required to prepare
an BSD. Such changes should be documented in a post-decision document file and may
be summarized in the RD/RA fact sheet.
Example 2; The lead agency determines that the contaminant plume has migrated
1,500 feet outside the original boundaries of the site. As a result of the migration, the
boundaries of the site are enlarged to incorporate the plume. This is a non-significant
difference. Explanation of the boundary change should be included in the post-decision
document file and may be summarized in the RD/RA fact sheet.
All of the examples in the exhibits in Chapter 8 are hypothetical; the numbers do
not represent Agency standards.
-------
OSWER Directive 9355.3-02
8-10
of non-significant differences should not be part of the administrative record
file for the ROD. If the lead agency chooses, non-significant changes can be
documented for the public in an optional Remedial Design Fact Sheet. These
fact sheets generally are used to inform citizens of the lead agency's
schedule for public participation activities as well as progress being made in
the design and implementation of the remedy. These fact sheets also can be
used to notify the public of any minor changes made to the remedy.
8.6.2 Significant Changes to a Component of a Remedy
As a result of information submitted by the public, PRPs, the support
agency, or generated by the lead agency through its own activities during the
RD/RA process, the lead agency may make a significant change to a component of
a remedy. Significant changes to a component of a remedy generally are
incremental changes to the hazardous waste approach selected for the site
(i.e., a change in timing, cost, or implementability). These changes do not
fundamentally alter the overall approach intended by a remedy. Significant
changes to a component of a remedy also may result from an enforcement action
taken pursuant to CERCLA section 106 or a settlement or consent decree entered
into pursuant to sections 106 and 122 after adoption of the ROD. When
significant changes are made to a component of a remedy, an ESD should be
prepared. Exhibit 8-2 presents examples of changes that warrant an ESD.
When the settlement or consent decree proposes to make a significant
change to a component of the remedy, the ESD should be prepared and issued
concurrently with the consent decree. Where the negotiations result in a
fundamental change being proposed to the overall remedy in the ROD (e.g., from
incineration to bioremediation) and not just a component of the remedy, the
lead agency should initiate the process for amending the ROD (see section
8.6.3 for more information on amending RODs). The consent decree should
reflect, to the extent possible, the remedy described in the ROD.
During the period when the ESD is being prepared and then made available
to the public, the lead agency should proceed with the pre-design, design,
construction, or operation activities associated with the remedy. The remedy
can continue to be implemented in this case because the ESD represents only a
notice of a change, and is not a formal opportunity for public comment since
the Agency is not reconsidering the overall remedy. The flow charts in
Figures 8-2 and 8-3 illustrate the remedial and enforcement processes that
could lead to issuance of an ESD.
-------
OSWER Directive 9355.3-02
8-11
EXHIBIT 8-2
Examples of a Significant Difference
to a Component of a Remedy
Specific examples of a significant difference have been developed using the following
hypothetical remedy which calls for:
Excavation of 11,000 cubic yards of contaminated soil; treatment by thermal
destruction; disposal in an on-site landfill;
Restoration of ground water through air stripping/reinjection;
Provision of an alternate water supply;
Capital cost: $42,463,300;
Annual O&M: $26,200; Present worth: $42,708,780; and
Implementation time: 12 to 15 months.
Example 1; In the process of implementing the remedy, the lead agency conducts
additional sampling and determines that the volume of soil to be incinerated is 50 percent
greater than the volume estimated in the ROD. As a result, a proportional increase in capital
costs of the remedy is realized. The capital cost increases from $4,6 to $7 million, and the
amount of time necessary to incinerate the additional soils adds three years to the
implementation time frame estimated in the ROD.
Because the scope and cost of the remedy have changed substantially from the
specifications of the remedy in the ROD, an BSD is prepared to inform the public of the
changes. Remedial design continues, because the lead agency determines the public already
has had an adequate opportunity to comment on the overall approach the remedy represents
(i.e., incineration and disposal in an on-site landfill). No public comment period is necessary.
Example 2; The lead agency reaches a settlement with the PRPs for a site, who agree
to implement the remedy selected in the ROD but delay the ground-water restoration
procedures for three years. The lead agency determines that this is a significant difference
that alters the performance (i.e,, short-term effectiveness) of the remedy. The lead agency
prepares an BSD documenting the significant difference from the ROD and the specific
reasons for the change. The Consent Decree is issued for public review and comment. The
ESD is issued at the same time for public review.
Example 3: The lead agency decides to use carbon adsorption rather than air
stripping to conduct the ground-water restoration activities. Because further investigation
revealed that the volatile organics in the waste stream at the site are of low solubility and
polarity, carbon adsorption will provide better removal efficiency on this waste stream than
would air stripping. The basic pump and treat remedy remains unaltered, and the
performance level specified in the ROD will still be met by the new technology. The lead
agency prepares an ESD to notify the public that the new technology is to be used. No
amendment to the ROD is necessary, and remedial design can continue.
-------
8-12
FIGURE 8-2
Process That Results in the Issuance
off an Explanation of Significant Differences:
General Procedures
information received
from public or
support agency or
generated by lead agency
CO
LJJ
8
o
CC
Lead agency determines:
Information should be
considered; and
A significant change to a
component of the remedy
would result
Lead agency:
* Prepares ESD; and
* Gives support agency
opportunity to
comment
Lead agency:
Publishes newspaper
notice; and
Places ESD and relevant
information In
administrative record file
-------
8-13
FIGURE 8-3
Process That Results in the Issuance of an Explanation
of Significant Differences:
Changes Resulting From Enforcement Activities
oc
o
oc
o
o>
o
o.
oc
0.
Consent Decree Is signed
which Includes significant
changes to a component
of the selected remedy
Lead agency:
' Prepares ESD; and
1 Gives support
agency opportunity
to comment
Lead agency:
* Publishes newspaper
notice:
* Makes ESD and appropriate!
Information available In thej
administrative record file;
and
* Gives public the
opportunity to
comment on
Consent Decree
Lead Agency:
* Responds to comments;
and
* Motions to enter Into
Consent Decree
Consent Decree
Is entered with
U.S. District Court
-------
OSWER Directive 9355.3-02
8-14
8.6.2.1 Preparing the ESD
The ESD can be prepared using one of two formats: a fact sheet format or
a more general and expanded decision document format. The complexity of the
changes undertaken should be considered when deciding which format to use. In
either format, the ESD should include the information presented in Exhibit 8-
3.
The lead agency should conduct the following activities when issuing an
ESD:
Provide the support agency with a reasonable opportunity
to comment on the ESD prior to publication (a maximum of
15 working days is recommended, unless otherwise specified
in the SMOA, CA, or SSC);
Summarize the support agency's comments in the ESD;
Publish a notice of availability and brief description of
the ESD in a local newspaper of general circulation, as
required by CERCLA section 117(c);
Make the ESD available to the public by placing it in the
administrative record file and information repository; and
Place the information supporting the change in the
administrative record file, as well as the lead agency's
response to any comments. A Responsiveness Summary is not
required.
Although the lead agency may choose to conduct these activities, a formal
public comment period, public meeting, and Responsiveness Summary are not
required when issuing an ESD.
Role of the Support Agency. Although the lead agency has the discretion
to determine if a change should be undertaken, the support agency should be
given the opportunity to comment on the proposed significant change. The
interaction and flow of information between the lead and support agencies
during RD/RA is fundamental to ensuring that the remedial process proceeds in
a timely manner. Therefore, the support agency should be given the
-------
OSWER Directive 9355.3-02
8-15
EXHIBIT 8-3
Outline for the Explanation
of Significant Differences
Introduction
i '
Site name and location.
Identification of lead and support agencies.
Citation of CERCLA section 117(c) that requires the ESD.
Summary of the circumstances that gave rise to the need for an ESD.
Statement that the ESD will become part of the administrative record file.
Address of location where the file is available and hours of availability of the file.
Summary of Site History, Contamination Problems, and Selected Remedy
Summary of contamination problems and site history, including the date the ROD was
signed.
Summary of the remedy as originally described in the ROD.
Description of Significant Differences and the Basis for those Differences
Summary of the information that gave rise to significant differences from the selected
remedy as it was originally specified. This summary information could include the results
of treatability studies or other information developed or provided to the lead agency during
the remedial design process. In this discussion, reference should be made to any
information in the administrative record file that supports the need for the change.
Description of the significant differences between the remedy as presented in the ROD
and the* action'now proposed". As appropriate, this description should summarize the
differences in scope, performance (e.g., technology, ARARs, and timing), or cost between
the original and modified remedy.
Support Agency Comments
Summary of support agency comments on proposed ESD.
Affirmation of the Statutory Determinations
Affirmation that the modified remedy continues to satisfy statutory requirements. The
ESD should include a statement such as: "Considering the new information that has been
developed and the changes that have been made to the selected remedy, the [lead and
support agencies] believe that the remedy remains protective of human health and the
environment, complies with Federal and State requirements that are applicable or relevant
and appropriate to this remedial action, and is cost-effective. In addition, the revised
remedy utilizes permanent solutions and alternative treatment (or resource recovery)
technologies to the maximum extent practicable for this site."
Public Participation Activities
Notice that administrative record is available for comment.
Date of any planned public information meeting.
(NOTE: EPA is not required to hold public meetings on ESDs but may choose to if
warranted by public interest.)
-------
OSWER Directive 9355.3-02
8-16
opportunity to comment on the ESD prior to the lead agency making the ESD
available to the public. These time frames should be specified in the SMOA,
CA, or SSC. It is recommended that 15 working days be the maximum review
period, unless otherwise specified in the SMOA, CA, or SSC.
The lead and support agencies generally will reach agreement on the
proposed significant change. However, there may be situations in which
outstanding issues cannot be resolved by the respective staffs of the lead and
support agencies. In this event, the dispute resolution process discussed in
Chapter 3 of this guidance can be utilized. In the event that a mutually
acceptable resolution cannot be reached, the support agency's comments should
be summarized in the ESD and placed in the administrative record file along
with the lead agency's response to those comments. EPA must concur on the ESD
in the case of Fund-financed RODs.
8.6.3 Fundamental Changes to the ROD
In a few cases, new information submitted by the public, PRPs, the
support agency, or developed by the lead agency during RD/RA may cause the
lead agency to reconsider the hazardous waste management approach selected in
the ROD. For example, the lead agency may determine that the innovative
technology originally selected in the ROD did not perform satisfactorily
during the pilot scale testing conducted during design. Based on this
information, the lead agency could decide to switch to thermal destruction,
rather than use the innovative technology, a move that would represent a
fundamental change to the remedy. Alternatively, the lead agency, as a result
of negotiations with PRPs, may choose to change the remedy in the ROD from
thermal destruction to a biological treatment process -- also a fundamental
change. When such fundamental changes are made to a remedy, the lead agency
should repeat the ROD process in accordance with the requirements of CERCLA
section 117 by issuing a revised Proposed Plan and an amended ROD.2
Additional examples of cases in which a ROD amendment would be necessary are
presented in Exhibit 8-4.
Procedures for Issuing the ROD Amendment. When there are fundamental
changes proposed to the ROD, the lead agency should conduct the public
participation and documentation procedures specified in CERCLA section 117
t)
If the lead agency is amending a pre-SARA ROD (i.e., a decision document signed prior to
October 17, 1986), the amended remedy will have to satisfy the requirements of section 121 of CERCLA.
-------
OSWER Directive 9355.3-02
8-17
EXHIBIT 8-4
Significant Change
That Fundamentally Alters the Remedy
Requiring Amendment of the ROD
Specific examples of significant differences that fundamentally alter a remedy requiring
amendment of the ROD have been developed using the following hypothetical remedy. The
major components of the remedy include:
Excavation of 11,000 cubic yards of contaminated soil; treatment by thermal
destruction; disposal in an on-site landfill;
Restoration Of ground water through air stripping/reinjection;
Provision of an alternate water supply;
Capital cost: $42,463,300;
Annual O&M: $26,200; Present worth: $42,708,780; and
Implementation time: 12 to 15 months.
Example 1: The lead agency determines that incineration capacity cannot be secured
in the time period necessary for remediating the site. The lead agency proposes to use
bioremediation rather than the thermal destruction originally selected to address the
contaminated soil. This new remedy is fundamentally different from the remedy selected in
the ROD, and an amended ROD must be prepared. Remedial design for the source control
remedy is halted because the thermal destruction remedy is no longer implementable. Data
collection to support the design of the bioremediation option and RD/RA on the ground-water
remedy may proceed.
Example 2: The lead agency negotiates a consent decree with the PRPs that proposes
to implement a remedy other than the one selected in the ROD. The PRPs propose in-situ
vitrification rather than thermal destruction, which was the selected remedy in the ROD.
Because the public has not had an opportunity to comment on the proposed remedy in the
consent decree, a Proposed Plan is prepared proposing the ROD amendment. Remedial
design cannot commence until the consent decree and amended ROD are legally enforceable.
The comment periods for the Proposed Plan and consent decree are held concurrently. An
amended ROD and Responsiveness Summary are prepared. The Proposed Plan, consent
decree, and amended ROD are included in the administrative record file.
-------
OSWER Directive 9355.3-02
8-18
which are outlined in Chapters 3 and 7 of this guidance. When a fundamental
change is proposed as a result of negotiations with a PRP, the Proposed Plan
for the ROD amendment should be released for public comment concurrently with
the consent decree. If the proposed amended ROD addresses the entire response
action for the site or a series of operable units (e.g., soil, surface water,
and ground water), only that portion of the remedy being changed (e.g., ground
water) requires an amendment. RD/RA activities in the other operable units
not proposed for changes may continue during the amendment process. Figures
8-4 and 8-5 summarize the processes that could lead to an amended ROD.
Key Elements of the ROD Amendment. When issuing a ROD amendment
(preceded by a revised Proposed Plan), the amount of information to include in
these documents will be a function of the type of change made to the remedy
and the rationale for that change. In general, the introductory sections of
the Proposed Plan and ROD (e.g., site history, community relations, and site
risks) do not need to be readdressed in these amended documents. The focus
should be on documenting the reasons for the ROD amendment, evaluating the
existing and proposed remedies in terms of the nine criteria, and providing
assurances that the proposed remedy satisfies the statutory requirements.
-------
OSWER Directive 9355.3-02
CHAPTER 9
DOCUMENTING NO ACTION, INTERIM ACTION,
AND CONTINGENCY REMEDY DECISIONS
This chapter presents guidance on preparing the Proposed Plan and ROD for
three unique types of remedial actions:
No action;
Interim action; and
Contingency remedies.
This chapter defines these decisions and outlines the modifications that
should be made to the standard Proposed Plan and ROD formats described in
Chapters 2 and 6, respectively, when preparing the decision documents in
support of these special types of decisions.
9.1 DOCUMENTING A "NO ACTION" DECISION
EPA may determine that "no action" is warranted for a site or operable
unit within a site under three general circumstances:
A site or operable unit is already in a protective state (i.e., the
site or operable unit poses no current or potential threat to human
health or the environment);
CERCLA does not provide the appropriate authority to take any or
complete remedial action; or
No effective action can be taken using currently available
technology.
These three circumstances are described below, along with the special
documentation procedures that should be followed for both the Proposed Plan
and ROD.
-------
OSWER Directive 9355.3-02
9-2
9.1.1 No Action is Necessary to Achieve Protection of
Human Health and the Environment
In limited situations, the baseline risk assessment conducted during the
RI provides the basis for concluding that the conditions at a site or a
portion of a site pose no current or potential threat to human health or the
environment. The lead agency, therefore, may determine that its authority
under CERCLA sections 104 or 106 to undertake a remedial action to ensure
adequate protection need not be invoked. Under such circumstances, the
statutory cleanup standards of CERCLA section 121 (e.g., compliance with
ARARs, cost-effectiveness) are not triggered and these requirements need not
be addressed in documenting the determination that a "no action" decision is
appropriate for a site or a portion of the site.
Examples of sites at which a "no action" decision could be made include:
(1) a site where a previous removal action mitigated the threat; and (2) a
site at which the threat no longer exists because of natural environmental
processes (e.g., natural attenuation of a ground-water contaminant plume).
While no action decisions may authorize monitoring to verify that no
unacceptable exposures occur, such response decisions should not include any
additional measures to eliminate, reduce, or control threats beyond the
mitigative measures previously taken. Therefore, a remedy including any
treatment controls, engineering controls (e.g., containment), or institutional
controls would not be considered a "no action" remedy.
The finding that "no action" is necessary to ensure adequate protection
of human health and the environment should be supported by the baseline risk
assessment or other information in the administrative record file. The
finding should take into account both the current and reasonable maximum
exposure scenarios using appropriate health and environmental criteria and
standards that relate directly to the media and hazardous substances being
addressed. Sites or site areas at which EPA has determined that no action is
necessary should allow for unrestricted use of, or unlimited access to, the
area or have in place appropriate exposure controls from a previous action to
ensure that no unacceptable exposures will occur (i.e., exposures greater than
10"4 for carcinogens). If EPA has determined that no action is necessary for
an entire site, that site is eligible for deletion from the NPL once the no
-------
OSWER Directive 9355.3-02
9-3
action decision is codified in a ROD. Exhibits 9-1 and 9-2 present outlines
of the Proposed Plan and ROD for documenting "no action" decisions.1
9.1.2 No CERCLA Authority to Take Action
There are a few circumstances in which the results of the RI and/or FS
indicate that CERCLA does not provide the appropriate legal authority to
undertake a remedial action at a site. One possible example is off-site
contamination that is not attributable to an NPL site. In this case, EPA
would not have the authority to respond using Superfund resources until the
release is traced and its source is listed on the NPL. Alternatively, the
results of the RI may show that the contaminants of concern at the site are
exempt from remedial action under CERCLA section 101. For example, releases
involving only petroleum wastes are excluded from CERCLA remedial action. In
preparing the Proposed Plan and ROD for this type of "no action" decision, the
documentation should support this determination. Exhibits 9-3 and 9-4 present
outlines for the Proposed Plan and ROD, respectively, for this category of a
"no action" decision.
9.1.3 No Effective Action
t
The Agency may determine that no effective remedial action is possible at
a site or operable unit due to the site conditions or the nature of the
contamination at the site. For example, it is possible that the process of
remediating a wetland would result in greater environmental harm than if the
contamination were left in place. Another possible example is where the
removal of the contamination, such as white phosphorus submerged in an
estuary, would be technologically infeasible, due to the risks to the workers,
community, and environment that would result from the use of current
technology. The Proposed Plan and ROD should indicate that the five-year
review will be performed for sites in such instances where "no action" is
possible. Exhibits 9-5 and 9-6 present outlines of the Proposed Plan and ROD,
respectively, for documenting this type of a "no action" decision.
1 All of the Exhibits in Chapter 9 are based upon either the Outline for the Proposed Plan (Chapter
2) or the Outline for the ROD (Chapter 6). A line through the text indicates a deletion and bold text
indicates a change to the existing section or a "new" section.
-------
OSWER Directive 9355.3-02
9-4
EXHIBIT 9-1
Documenting a No Action Decision:
Action Not Necessary for Protection
OUTLINE FOR THE PROPOSED PLAN
A Proposed Plan to document the decision that no action is necessary to achieve
protection of human health and the environment at a site or operable unit should follow the
guidance in Chapter 2 with the special modifications outlined below.
1. Introduction
2. Site Description
3. Scope and Role of Operable Unit - Specify in this section any relationship this
"no action" decision has to other past and future site activities, particularly any
removal or interim actions under which exposure controls may have been
implemented.
4. Summary of Site Risks The information presented in this section will provide
the primary basis for the "no action" decision. The discussion should support
the determination that remedial action is not necessary to ensure protection of
human health and the environment. This can be accomplished by demonstrating
bow the current and reasonable maximum exposure scenarios considered under
the baseline risk assessment indicate that unacceptable exposures will not occur.
Any exposure controls implemented as part of previous actions that contribute
to protection of human health and the environment should be discussed.
5-. Summary of Alternatives
o. J-^y
-------
OSWER Directive 9355.3-02
9-5
EXHIBIT 9-2
Documenting a No Action Decision:
Action Not Necessary for Protection
OUTLINE FOR THE ROD
The preparation of a ROD to document a decision that no action is necessary to ensure
protection of human health and the environment should follow the guidance presented in
Chapter 6 with the special modifications noted below.
1. Declaration
Site Name and Location
Statement of Basis and Purpose
« - Assessment of the Site
Description of the Selected Remedy: No Action
Declaration Statement - None of the Section 121 statutory determinations
are necessary in this section. Instead, a brief statement should be made
noting that no remedial action is necessary to ensure protection of human
health and the environment. It should also be noted whether a five-year
review is required. A five-year review will be necessary under a "no action"
ROD when previous removal or remedial actions at the site result in the
implementation of engineering or institutional controls to prevent
unacceptable exposures from hazardous substances and when these controls
will remain over the long-term.
Signature and Support Agency Acceptance of the Remedy
2. Decision Summary
Site Name, Location, and Description
Site History and Enforcement Activities
Highlights of Community Participation
Scope and Role of Operable Unit or Response Action
Site Characteristics
Summary of Site Risks - The information presented in this section provides
the primary basis for the "no action" decision. The discussion should
support the determination that no remedial action is necessary to ensure
protection of human health and the environment. This can be
accomplished by demonstrating how the current and reasonable maximum
exposure scenarios considered under the baseline risk assessment indicate
that unacceptable exposures will not occur. Any exposure controls
implemented as part of previous actions that contribute to protection of
human health and the environment should be discussed.
-------
OSWER Directive 9355.3-02
9-6
EXHIBIT 9-2 (continued)
Documenting a No Action Decision:
Action Not Necessary for Protection
OUTLINE FOR THE ROD
Decision .Summary (continued)
Summary ef Comparative. Analysis ef Alternatives
Selected Remedy
* Statutory Determinations
* Description of the "No Action" Alternative
* Explanation of Significant Changes
Note: The ROD should not include the "Description of Alternatives" or "Summary
of the Comparative Analysis of Alternatives" sections. If alternatives were
developed in the FS, the RI/FS report should be referenced.
3. Responsiveness Summary
-------
OSWER Directive 9355.3-02
9-7
EXHIBIT 9-3
Documenting a No Action Decision:
No CERCLA Authority to Take Action
OUTLINE FOR THE PROPOSED PLAN
The preparation of a Proposed Plan for this category of "no action" decision should follow
the guidance in Chapter 2 with the special modifications noted below.
1. Introduction
2. Site Description
3. Scope and Role of Operable Unit or Response Action
4. Summary of Site Risks
-)» vjUUUUAry Ol AltCi TimlVCit
G. lJ.VdlUdtiQU OI AitCi JldUVCiS dltu U1G 1 TCIC1 JC-u AitCf .nAtlVC
5. Statutory Authority Finding This section should explain that the EPA does not
have authority under CERCLA section 104 to address the site or operable unit
The statement also should note that the "no action" decision does not constitute
a finding by the Agency that adequate protection has been achieved at the site.
Rather, the statement should identify the statutory or regulatory authority that
does have or potentially could have jurisdiction over the problem. If the site has
been referred to the proper authorities, this should be explained in the Proposed
Plan.
6. Community Participation - This section should provide standard information about
how the public can participate in the remedy selection process. It will not,
however, solicit comment on all alternatives, since only one option is being
proposed.
-------
OSWER Directive 9355.3-02
9-8
EXHIBIT 9-4
Documenting a No Action Decision:
No CERCLA Authority to Take Action
OUTLINE FOR THE ROD
The ROD to document a "no action" decision based on the lack of statutory authority
under CERCIA should be prepared following the guidance presented in Chapter 6 with the
special modifications outlined below.
1. Declaration
» Site Name and Location
Statement of Basis and Purpose
* - Assessment of the Site
* Description of the Selected Remedy: No Action
"» ti r o tftiuiGry " i-/ ct C-TwiinACiofls
* Declaration Statement » No Section 121 statutory determinations are
necessary in this section. This section should explain that EPA does not
have authority under CERCLA section 104 to address the site or operable
unit. The statement should note that the "no action" decision does not
constitute a finding by the Agency that adequate protection has been
achieved at the site. Rather, the statement should identify who has or
who potentially has the statutory or regulatory authority over the site. If
the site has been referred to other authorities, this should be explained.
* Signature and Support Agency Acceptance of the Remedy
2. Decision. Summary
Site Name, Location, and Description
Site History and Enforcement Activities
Highlights of Community Participation
Scope and Role of Operable Unit or Response Action
Site Characteristics
Summary of Site Risks
l)tlOl^ Ot yVltCmAtlVC-S
y oi t^oiiip
-------
OSWER Directive 9355.3-02
9-9
EXHIBIT 9-5
Documenting a No Action Decision:
No Effective Action Possible
OUTLINE FOR THE PROPOSED PLAN
The preparation of a Proposed Plan for a "no action" decision based on a determination
that remedial action would not be feasible or would cause adverse environmental impacts should
follow the guidance in Chapter 2 with the special modifications noted below.
L Introduction
2. Site Description
3. Scope and Role of Operable Unit or Response Action
4. Summary of Site Risks
0. : i"ri ' - rrr- - -^yjiH^rtiOfl// Oi.y.AI^
5. Summary Rationale for No Action Decision - This section should explain the basis
for the "no action" decision. The basis will be related to the fact that greater
adverse impacts would result from undertaking remedial action than from leaving
the waste in place or that the problem is technically infeasible to remediate. The
remedial alternatives that were considered, and the impact associated with them
or their infeasibility, should be summarized in this discussion as necessary. A
detailed comparative analysis need not be included. A statement also should be
included to the effect that this "no action" decision does not constitute a finding
that the remedy ensures adequate protection of human health or the environment
The need for a five-year review should be noted.
6. Community Participation
-------
OSWER Directive 9355.3-02
9-10
EXHIBIT 9-6
Documenting a No Action Decision:
No Effective Action Possible
OUTLINE FOR THE ROD
The preparation of a ROD to document this category of "no action" decision should
follow the guidance in Chapter 6 with the special modifications noted below.
1. Declaration
Site Name and Location
Statement of Basis and Purpose
* Assessment ot tuc uitc
Description of the Selected Remedy
Declaration Statement - This declaration should state that it has been
determined that no effective remedial action is possible at tbe site. The
declaration should also explain that the "no action" decision does not
constitute a finding that the remedy ensures adequate protection of human
health or the environment. A statement that a five-year review will be
conducted should be included.
Signature and Support Agency Acceptance of the Remedy
Decision Summary
Site Name, Location, and Description
Site History and Enforcement Activities
Highlights of Community Participation
Scope and Role of Operable Unit or Response Action
Site Characteristics
Summary of Site Risks
3.
£ "ot&iiitui*y~ j-xtccriiiiiiciLAuiis
Summary of Basis for "No Action" Decision - The rationale for the "no
action" decision should be provided. The remedial alternatives that were
considered, and the impact associated with them or their feasibility, should
be summarized in this discussion. A detailed comparative analysis using
the nine evaluation criteria need not be included. A statement also should
be included to the effect that this "no action" decision does not constitute
a finding that adequate protection of human health and the environment
has been achieved at the site.
Explanation of Significant Changes
Responsiveness Summary
-------
OSWER Directive 9355.3-02
9-11
9.2 DOCUMENTING INTERIM ACTION DECISIONS
During scoping or at other points in the RI/FS process, the lead agency
may determine that it is appropriate to implement an interim action at a site.
Interim actions, which may be removal or remedial actions, can be taken to
respond to an immediate site threat or to take advantage of an opportunity to
significantly reduce risk quickly. Interim actions are limited in scope and
are followed by other operable units that complete the steps to provide
definitive protection of human health and the environment for the long-term.
Examples of interim actions include: constructing a fence to restrict access
to the site, pumping a ground-water aquifer to restrict migration of a
-contaminant plume, providing an alternative source of drinking water,
'providing bottled water, or constructing a temporary cap.
Proposed Plans and RODs prepared to support interim remedial action
decisions are generally more streamlined than decision documents for more
comprehensive response actions. The documentation of interim action decisions
should be tailored to the limited scope and purpose of the interim action. In
particular, the "Summary of Site Risks" discussion may be very brief,
providing information to support the need to take action but usually not
specifying final acceptable exposure levels for the site; the complete
findings of the baseline risk assessment should be included in the decision
documents for future, final operable units. The number of alternatives
considered for interim actions should generally be limited to three or fewer
options, and the nine-criteria evaluation limited to addressing factors
pertinent to the scope and purpose of the interim action. Likewise, the
section 121 statutory determinations should not be made definitively for the
site as a whole; rather, the ROD should discuss how the interim action
fulfills those requirements within its limited scope. Further details on
preparing Proposed Plans and RODs for interim action decisions are presented
in Exhibits 9-7 and 9-8.
9.3 DECISION DOCUMENTS WITH CONTINGENCY REMEDIES
In general, the lead agency identifies a preferred alternative in the
Proposed Plan and selects a single remedy in the ROD. When selecting a
treatment technology to address the source of contamination, this typically
involves selection of a treatment class or family, such as thermal
destruction, rather than a specific technology process option, such as a
-------
OSWER Directive 9355.3-02
9-12
EXHIBIT 9-7
Documenting Interim Action Decisions
OUTLINE FOR THE PROPOSED PLAN
The Proposed Plan should include all of the sections outlbed in Chapter 2, with the followbg
modifications.
\. Introduction
2. Site Description - This section should focus on site characteristics addressed by
the limited action.
3. Scope and Role of Operable Unit - This section of the document should specify
how the interim response action fits into the overall site strategy. The point
should be made that, to the extent possible, the interim action will be consistent
with any planned future actions.
4. Summary of Site Risks - This section should provide the rationale for taking a
limited action. This should be supported by facts that indicate the action is
necessary to stabilize the site, prevent further degradation, or that the action can
accomplish significant risk reduction quickly. The information should relate only
to the limited scope of the action. Qualitative risk information may be presented
if quantitative details are not yet available, which will often be the case.
5. Summary of Alternatives - A very limited number of alternatives should be
analyzed for interim actions; in some cases, only one plan of action will be
appropriate to consider. The alternative descriptions should reflect the pertinent
ARARs associated with the action. ARARs are important for the following aspects
of an interim action: any portion of the remedy that is final, materials that are
treated or managed off-site, and any release that will occur during
implementation. Requirements are not applicable or relevant and appropriate if
they are outside the scope of the interim action.
6. Evaluation of Alternatives and the Preferred Alternative - The comparative analysis
should be conducted in relation to the limited role and scope of the remedy.
Criteria that are not pertinent to the selection of interim actions (e.g., long-term
effectiveness of a temporary cap) need not be addressed in detail. Rather, their
irrelevance to the remedy decision should be noted.
7. Statutory Findings The findings should be discussed in terms of the limited
scope of the action.
8. Community Participation
-------
OSWER Directive 9355.3-02
9-13
EXHIBIT 9-8
Documenting Interim Action Decisions
OUTLINE FOR THE ROD
The guidance for preparing RODs in Chapter 6 should be followed for preparing a ROD
documenting the selection of an interim action remedy, with the following modifications.
1. The Declaration
* Site Name and Location
Statement of Basis and Purpose
« Assessment of the Site
Description of Selected Remedy
Declaration - The declaration statement should read as follows:
This interim action is protective of human health and the
environment, complies with Federal and State applicable or relevant
and appropriate requirements directly associated with this action,
and is cost-effective. This action utilizes permanent solutions and
alternative treatment (or resource recovery) technologies to the
maximum extent practicable, given the limited scope of the action.
Because this action does not constitute the final remedy for the
[site/operable unit], the statutory preference for remedies that
employ treatment that reduces toxicity, mobility, or volume as a
principal element [will not be satisfied by this interim action (or)
will be addressed at the time of the final response action].
Subsequent actions are planned to address fully the principal
threats posed by this [site/operable unit].
Signature and Support Agency Acceptance of the Remedy
Decision Summary
Site Name, Location, and Description
Site History and Enforcement Activities
Highlights of Community Participation
Scope and Role of Operable Unit This section provides the rationale for
taking the limited action. To the extent that information is available, the
section should detail how the response action fits into the overall site
strategy. The point should be made that the interim action will be
consistent with any planned future actions, to the extent possible.
Site Characteristics - This section should focus on the description of Site
characteristics to be addressed by the interim remedy.
-------
OSWER Directive 9355.3-02
9-14
EXHIBIT 9-8 (continued)
Documenting Interim Action Decisions
OUTLINE FOR THE ROD
2. Decision Summary (continued)
Summary of Site Risks This section should focus on risks addressed by
the interim action and should provide the rationale for the limited action.
This could be supported by facts that indicate that action is necessary to
stabilize the site, prevent further degradation, or achieve significant risk
reduction quickly. Qualitative risk information may be presented if
quantitative risk information is not yet available, which will often be the
case.
Description of Alternatives This section should describe only the limited
alternatives that were considered for the interim action. The ARARs
discussion should be incorporated, as appropriate, given the limited nature
of the action.
» Summary of Comparative Analysis of Alternatives - The comparative
analysis should be presented in light of the limited scope of the action.
Criteria not relevant to the evaluation of interim actions need not be
addressed in detail. Rather, their irrelevance to the decision should be
noted briefly.
Statutory Determinations - The interim action should protect human health
and the environment from the exposure pathway or threat it is addressing,
any releases generated, or the waste material that is managed. The ARARs
discussion should focus only on those ARARs specific to the interim action
those related to any final disposition of waste, off-site treatment or
disposal, or releases caused during implementation. An interim remedy
waiver may be necessary in some situations. However, if an interim waiver
is needed, the final remedy must comply with the requirement The
discussion of the use of treatment should indicate that the selected remedy
represents the best balance of tradeoffs with respect to pertinent criteria,
given the limited scope of the action. The discussion under the preference
for treatment section should note that the preference will be addressed in
the final decision document for the site or operable unit.
Explanation of Significant Changes
3. The Responsiveness Summary
-------
OSWER Directive 9355.3-02
9-15
rotary kiln. Selection of a treatment class affords the lead agency
flexibility during the remedial design to procure the most cost-effective
process through competitive bidding.2
There are limited situations, however, in which additional flexibility
may be required to ensure implementation of the most appropriate treatment
remedy for a site. In such situations, the lead agency may determine that a
decision document with a selected remedy accompanied by a contingency remedy
is appropriate.
The Agency developed this option for two purposes. The first is to
promote the use of innovative technologies. An innovative treatment
technology may appear to be the most appropriate remedy for a site or operable
unit during the RI/FS, but more testing is needed during remedial design to
verify the technology's expected performance potential. If there are
uncertainties about an innovative treatment technology, then the lead agency,
in consultation with the support agency, may elect to include a proven
technology as a contingency remedy in the Proposed Plan and ROD. The second
situation that may be appropriate for contingency remedies is where two
different technologies under consideration appear to offer comparable
performance on the basis of the five primary balancing criteria such that both
could be argued to provide the "best balance of tradeoffs." Under such
circumstances, the Proposed Plan and ROD may identify one as the selected
remedy and the other as a contingency remedy and specify the criteria whereby
the contingency remedy would be implemented.
9.3.1 Innovative Technologies
Treatability testing of a technology generally should be conducted during
the RI/FS. However, it may not always be feasible to conduct sufficient
treatability testing during the RI/FS to address all of the significant
uncertainties associated with an innovative technology. Therefore, the
analysis of alternatives in the FS, which typically examines specific
differences between cleanup options with respect to the five primary balancing
criteria, should be significantly less definitive for innovative technologies.
t\
Similarly, when selecting containment technologies, the type of system should be described in terms
of basic characteristics, such as permeable, impermeable, double or single liner, without specifying what
materials will be used in the system (e.g., clay, synthetic).
-------
OSWER Directive 9355.3-02
9-16
The evaluation should focus instead on the expected performance potential and
uncertainties associated with these less proven technologies. Based on
performance potential, an innovative technology may appear to provide the best
balance of tradeoffs from among the options considered, despite its
uncertainties. Congress provided support for selecting innovative
technologies in such instances in CERCLA section 121(b)(2), which states:
The President may select an alternative remedial action meeting
the objectives of this subsection whether or not such action
has been achieved in practice at any other facility or site
that has similar characteristics. In making such a selection,
the President may take into account the degree of support for
such remedial action by parties interested in the site.
Parties "interested in the site" include the lead agency, support agency,
local community, PRPs, and other members of the public.
Where an innovative technology is selected and its performance potential
is to be verified through additional testing conducted during RD/RA, a proven
treatment technology may be included in the Proposed Plan and ROD as a
contingency remedy. In the event that test results indicate that the
innovative technology will not fulfill its performance expectations at that
site or operable unit, the contingency remedy could be implemented.
9.3.2 Comparable Technologies
It is possible that two alternatives could emerge from the FS that appear
to offer comparable performance with respect to the five primary balancing
criteria such that either one could provide the "best balance of tradeoffs."
This situation could only occur when two alternatives represent the same
overall cleanup approach (i.e., they would treat and contain the same
materials on the site) but vary in the particular type of treatment technology
employed as the treatment component (e.g., bioremediation vs. soil washing).
The alternatives could appear comparable either by offering identical
performance with respect to each of the five balancing criteria or, more
likely, the overall combination of tradeoffs they provide are very similar.
In such cases, one of the alternatives may be the selected remedy and the
other the contingency remedy that could be implemented after additional
-------
OSWER Directive 9355.3-02
9-17
testing, PRP negotiations, and the competitive bidding process indicate that
the contingency remedy would be a more favorable option.
In the Proposed Plan, the alternative proposed for selection and the
contingency alternative ideally should both be discussed in the Preferred
Alternative section and discussed in relation to the evaluation criteria in
the Evaluation of Alternatives section. Also, the criteria that would prompt
implementation of the contingency remedy should be identified.
In the ROD, the Comparative Analysis of Alternatives section should
discuss both alternatives in equal detail and the Selected Remedy section
should establish the parameters of each and provide the criteria by which the
contingency remedy would be implemented. The Statutory Determinations section
should demonstrate how either remedy would meet CERCLA section 121
requirements.
9.3.3 Documenting Contingency Remedy Decisions
In documenting selection decisions involving a contingency remedy, the
Proposed Plan should and the ROD must identify the preferred alternative or
selected remedy and the contingency remedy. Ideally, the Proposed Plan should
identify the alternative proposed for selection and the contingency
alternative in the Preferred Alternative section along with the criteria that
would prompt implementation of the contingency alternative. Both options
should also be featured in the Evaluation of Alternatives section and
indicated as being able to fulfill the statutory requirements of CERCLA
section 121. If a contingency remedy is not contemplated at the time of the
Proposed Plan, it may still be possible to select a contingency remedy in the
ROD provided that the contingency is a logical outgrowth of the information
presented in the Proposed Plan (see Chapter 5 on Pre-ROD significant-changes).
Whenever a contingency remedy is likely, the Proposed Plan should inform the
public of that possibility.
In the ROD, the Comparative Analysis of Alternatives section should
discuss both remedies in similar detail and the Selected Remedy section should
establish the parameters of each and provide the criteria by which the
contingency remedy would be implemented. The Statutory Determinations section
should demonstrate how either remedy would fulfill section 121 requirements.
-------
OSWER Directive 9355.3-02
9-18
If the lead agency determines that the contingency remedy should be
implemented, an "Explanation of Significant Differences" should be issued in
accordance with Chapter 8 of this guidance. In addition, the appropriate
Regional Coordinator at EPA Headquarters should be contacted if a contingency
remedy is being contemplated. The outlines in Exhibits 9-9 and 9-10,
respectively, should be followed to prepare the Proposed Plan and ROD to
document selection of a contingency remedy.
-------
OSWER Directive 9355.3-02
9-19
EXHIBIT 9-9
Documenting Contingency Remedy Decisions
OUTLINE FOR THE PROPOSED PLAN
The preparation of a Proposed Plan to document the decision to select a contingency
remedy should be based on the following outline. All of the sections listed in Chapter 2 should
be included, with the following modifications:
1. Introduction
2. Site Description
3. Scope and Role of Operable Unit or Response Action
4. Summary of Site Risks
5. Summary of Alternatives - This section should identify any uncertainties that exist
with the technologies being considered, and to what extent additional testing is
needed.
6. Evaluation of Alternatives and the Preferred Alternative - All contingency options
should be identified and analyzed fully with respect to the nine criteria. The
discussion should address any uncertainties involved with innovative technologies.
In the discussion of community (and support agency) acceptance, the support of
the interested parties should be discussed in light of the CERCLA provisions
supporting selection of innovative technologies in section 121(b)(2). If comparable
alternatives exist, this section should support the finding that the contingency
alternative provides similar tradeoffs with respect to the evaluation criteria. The
preferred alternative and any contingency alternative should be described, and
performance expectations and any uncertainties concerning use of the technology,
identified. If comparable alternatives are selected, the contingency alternative
should be described, focusing on how its performance is similar to that of the
preferred alternative in terms of the combination of tradeoffs they offer with
respect to the evaluation criteria.
7. Statutory Determinations - This section should assert that the preferred and
contingency alternatives are both expected to meet the statutory requirements
based on currently available information.
8, Community Participation
-------
OSWER Directive 9355.3-02
9-20
EXHIBIT 9-10
Documenting Contingency Remedy Decisions
OUTLINE FOR THE ROD
The preparation of a ROD for decisions involving any type of contingency remedy should
be based on the following outline. The ROD should include all of the sections Usted in Chapter
6, with the following modifications:
1. Declaration
Site Name and Location
« Statement of Basis and Purpose
Assessment of the Site
Description of the Selected Remedy - Both the selected remedy and any
contingency remedies should be described in bullet form.
oi.-
Declaration - The Declaration should be modified to indicate that both the
selected remedy and the contingency remedy will meet the statutory
findings.
Signature and Support Agency Acceptance of the Remedy
2. Decision Summary
Site Name, Location, and Description
Site History and Enforcement Activities
Highlights of Community Participation
Scope and Role of Operable Unit or Response Action
Site Characteristics
Summary of Site Risks
Description of Alternatives - This section should identify any uncertainties
concerning use of the technologies being considered and to what extent
additional testing is needed. The selected remedy and contingency remedy
must be fully described.
Summary of Comparative Analysis The selected remedy and any
contingency alternative should be evaluated fully against the nine criteria.
The uncertainties should be noted, as well as the expectations for
performance. In the discussion of community (and support agency)
acceptance of an innovative technology, the support of the interested
parties should be discussed in light of the CERCLA provisions in section
121(b)(2). Where alternatives are cbosen because of their comparability,
this analysis should provide support for that finding.
-------
OSWER Directive 9355.3-02
9-21
Exhibit 9-10 (continued)
Documenting Contingency Remedy Decisions
OUTLINE FOR THE ROD
2. Decision Summary (continued)
Selected Remedy - The selected and contingency remedy should be
identified. If an innovative technology is identified as the preferred
alternative, this section should describe what will happen if further testing
determines that the preferred alternative is not effective or implementable.
If comparable alternatives are selected, all should be described in detail.
Statutory Determinations «The statutory determinations discussion should
demonstrate that both remedies fulfill CERCLA section 121 requirements.
Explanation of Significant Changes
3. Responsiveness Summary
-------
APPENDIX A
SAMPLE PROPOSED PLAN
-------
Superfund Program
Proposed Plan
Region IV
EIO Industrial Site
Nameless, Tennesse
September 1988
EPA ANNOUNCES PROPOSED PLAN
This Proposed Plan identifies the pre-
ferred option for cleaning up the contami-
nated soils at the EKD Industrial Site. In
addition, the Plan includes summaries of
other alternatives analyzed for this site.
This document is issued by the U.S. En-
vironmental Protection Agency (EPA), the
lead agency for site activities, and the
Tennessee Pollution Control Board (TPCB),
the support agency for this response action.
EPA, in consultation with the TPCB, will
select a final remedy forthe site only after
the public comment period has ended
and the information submitted during this
time has been reviewed and considered.
EPA is issuing this Proposed Plan as
part of its public participation responsibili-
ties under section 117(a) of the Compre-
hensive Environmental Response, Com-
pensation and Liability Act (CERCLA).
This document summarizes information
that can be found in greater detail in the
Remedial Investigation and Feasibility
Study (RI/FS) report and other docu-
ments contained in the administrative
record file for this site. EPA and the State
encourage the public to review these other
documents in order to gain a more com-
prehensive understanding of the site and
Superfund activities that have been con-
ducted there. The administrative record
Figure 1
EIO Industrial Site and Surroundings
Closed Lagoons
Area
Q
n n a
TCE-Contaminated Soil
Metals-Contaminated Soil
Private Wells
Site Boundary
Municipal Well
* NOT TO SCALE
file, which contains the information upo
which the selection of the response ac
tion will be based, is available at th
following locations:
Nameless Public Library
125 Elm Street,
Nameless, TN 00000
(101)999-1099
Hours: Mon-Sat, 9 a.m.-9 p.m.
and
U.S. EPA Docket Room,
Region IV
Federal Building, 10th Floor,
Atlanta, GA
(555)555-1212
Hours: Mon-Fri, 8:30 a.m.-
4:30 p.m.
EPA, In consultation with the TPCB,
may modify the preferred alterna-
tive or select another response
action presented In this Plan and
the RI/FS Report based on new In-
formation or public comments.
Therefore, the public Is encour-
aged to review and comment on
all the alternatives identified here.
Dates to remember:
MARK YOUR CALENDAR
October 3-24,1988:
Public comment period on remedies
to control contaminated soils.
October 12,1988:
Public meeting at Nameless Com-
munity Hall, 123 Market Road,
Nameless, Tennessee at 7:30 p.m.
-------
SITE BACKGROUND
A HISTORY OF SEPTIC
WASTE DISPOSAL
In 1947, the EIO Industrial Company
began disposing of septic waste at its
plant located at 129 Franklin Street in
Nameless, Tennessee. In the late 1960s,
the company also began to accept ship-
ments of hazardous waste. Wastes were
stored in thirteen storage tanks at the
site. The wastes subsequently were
pumped to eight unlined lagoons. The
site ceased operation in August of 1980,
prior to enactment of the Resource Con-
servation and Recovery Act (RCRA).
During site operations, soils at the 5-
acre tank farm area were contaminated
by wastes spilled during pumping and
from leaking tanks. Although the lagoons
were emptied and backfilled with clean
soil by the EIO Company in 1981, the
subsurface soils in that 5-acre area were
contaminated. In addition, both the
municipal well, located a mile from the
site, and several residential wells, located
within a half-mile, have been contami-
nated by wastes from the site.
The site was placed on the National
Priorities List (NPL) in 1982. Between
1984 and 1986, the EIO Industrial Com-
pany conducted an RI/FS underthe guid-
ance of the TPCB, with EPA's oversight.
The RI/FS was conducted to identify the
types, quantities, and locations of con-
taminants and to develop ways of ad-
dressing the contamination problems. The
results of the RI/FS are as follows:
On-site surface sorts in the former lagoon
and tank farm area are contaminated
with varying levels of lead, chromium,
and cadmium;
On-site subsurface soils in the former
lagoon and tank farm area are
contaminated with trichloroethylene
(TCE), other chlorinated aliphatic and
polynudear aromatic hydrocarbons, and
lead;
A nearby municipal weU is contaminated;
and
A plume of contaminated ground water
extends from the site to the XYZ River.
SCOPE AND ROLE OF
ACTION
The problems at the EIO site are com-
plex. As a result, EPA has divided the
work into three manageable components
called "operable units (OUs)." These are
as follows:
OU One: Contamination in the
municipal well.
OU Two: Contamination of the
ground-water aquifer.
OU Three: Contamination in the soils.
EPA has already selected cleanup
remedies for OUs One and Two (the
municipal well and the contaminated ground
water). The contaminated ground water
is a principal threat at this site because of
the potential for direct ingestion of con-
taminants through drinking water wells.
Both of these actions are in the Remedial
Design stage, which means that the
engineers are developing specific plans
for implementation of the remedy. Actual
construction is planned for March 1990.
The third OU addresses the contami-
nated soils in the lagoon and tank farm
area. This contiguous area was deter-
mined to be a principal threat at the site
because of the potential threat of direct
contact with the soils and the soil's impact
on ground water. The clean up objectives
f orthis OU are to prevent current or future
exposure to the contaminated soils through
treatment and/or containment, and to re-
duce the migration of contaminants from
the soil to groundwater.
SUMMARY OF SITE RISKS
During the RI/FS, an analysis was
conducted to estimate the health or envi-
ronmental problems that could result if
the soil contamination at the EIO site was
not cleaned up. This analysis is com-
monly referred to as a baseline risk as-
sessment. In conducting this assess-
ment, the focus was on the health effects
that could result from direct exposure to
the contaminants as a result of the soil
coming into contact with the skin, or from
direct ingestion of the soil by a child
playing in the area. The analysis focused
on the major contaminant of concern,
TCE. TCE is a volatile organic compound
that is known to cause cancer in labora-
tory animals and thus is classified as a
carcinogen. TCE is a highly mobile con-
taminant that typically migrates through
the soil into the ground-water.
EPA's sampling of the soil at the site
found that the average concentration of
TCE in the soils was 140 parts per million.
This concentration level is associated with
an excess lifetime cancer risk of 1Q-3.
This means that if no cleanup action is
taken by EPA, one additional person per
one thousand has a chance of contract-
ing cancer as a result of the exposure to
TCE-contaminated soil. This estimate
was developed by taking into account
various conservative assumptions about
the likelihood of a person being exposed
to the soil and the toxicity of TCE.
EPA and the State have determined
that in cleaning up the contaminated soil
at the EIO site to a concentration of 13
ppm of TCE, the excess lifetime cancer
risk posed by the site following remedia-
tion will be reduced to 104. This cleanup
target would reduce the probability of
contracting cancer as a result of expo-
sure to the contaminants in the soil to one
additional person in one million. Because
there are no Federal or State cleanup
standards for contamination in soil, this
cleanup target was established for this
site as part of the risk assessment con-
ducted during the RI/FS. The cleanup
target was established to reduce direct
contact exposure to an acceptable level,
as well as to ensure that the migration of
the TCE into the ground water is mini-
mized.
Actual or threatened releases of
hazardous substances from this site.
if not addressed by the preferred alterna-
tive or one of the other active measures
considered, may present an imminent
and substantial endangerment to public
health, welfare, or the environment.
-------
SUMMARY OF ALTERNATIVES
The alternatives analyzedforOU Three
are presented below. These are num-
bered to correspond with the numbers in
the RI/FS Report. The alternatives forthe
soil cleanup are the following:
Alternative 1:
Alternative 2:
Alternative 3:
Alternative 4:
Alternative 5:
Alternative 6:
No Action.
Capping.
Excavation and Disposal
in an Off-site Landfill.
Excavation, Treatment
of Volatile Organic
Compounds in a
Vaporization Loop, Lime
Stabilization of Sols, and
Disposal On-site
Excavation and Off-site
Thermal Destruction.
Excavation, On-site
Thermal Destruction,
and Solidification.
Common Elements. Except for the
"No Action" alternative, all of the alterna-
tives now being considered for the site
would Include a number of common
components. Alternatives 3 through 6
include removal and/or treatment of the
storage tanks, 7,500 cubic yards (yd3) of
VOC-contaminated soils and 3,500 yd3 of
metal-contaminated soils from the lagoon/
tank farm area. Each alternative also in-
cludes long-term ground-water monitor-
ing in compliance with requirements of
RCRA Subpart F, 40 CFR § 264.100.
These monitoring activities will be con-
ducted to gauge the effectiveness of the
selected remedy. In addition, the State
will place a deed restriction on the site to
prohibit soil excavation and construction
of buildings at the site. It also should be
noted that the wastes at the EIO site were
found to be neither RCRA-listed wastes
nor RCRA-characteristic wastes.
Alternative 1:
NO ACTION
Capital Cost: 0'
Annual Operation and Maintenance
(O&M) Costs: 0'
Present Worth (PW): 0'
Months to Implement: None
The Superfund program requires that
the "no action" alternative be evaluated
at every site to establish a baseline for
comparison. Under this alternative, EPA
would take no further action at the site to
prevent exposure to the soil contamina-
tion.
Alternative 2:
CAPPING
Capital Cost: $740,485*
Annual O&M Costs: $18,120"
PW: $910,260'
Months to Implement: 5*
The contaminated soil would be ieft in
place and a 24-inch compacted cap would
be installed over the entire 10 acres of
contaminated surface soils in the tank
f ami and lagoon areas. The cap would be
designed to meet the relevant and appro-
priate requirements of RCRA landfill
closure in 40 CFR §264.310, which, among
other things, specify that the permeability
of the cap must be less than or equal to
the permeability of the natural underlying
soils at the site.
Alternative 3:
EXCAVATION AND DISPOSAL
IN AN OFF-SITE LANDFILL
Capital Cost: $18,188,000'
Annual O&M Costs: $26,200'
PW: $18,433,480'
Months to Implement: 7'
All 11,000 yd3 of contaminated soils
from the 10-acre tank farm and lagoon
area would be excavated and hauled to
an off-site, permitted RCRA Subtitle C
landfill, and the excavated area would be
regraded and backfilled with clean soil.
This process would be conducted i n com-
pliance with the RCRA requirements for
clean closure of a landfill. Under these re-
quirements, all contaminants would be
excavated and the need for long-term
monitoring and maintenance of the tar
farm and lagoon area would be elirr
Aiternative 4:
EXCAVATION,
VOLATILIZATION,
STABILIZATION, AND
DISPOSAL ON-SITE
Capital Cost: $4,666,000'
Annual O&M Costs: $41,000'
PW: $5,050,150'
Months to Implement: 12-15'
The 7,500 yds of VOC-contaminatei
soils from the tank f anrrvlagoon area wouk
be excavated. To remove the highl;
mobile VOCs, a low-temperature volatili
zation step would be inserted into the
cleanup process between excavation an<
landlilllng. Granular activated career
(GAC) canisters would separate the vola
tile contaminants from the soils teavinc
only the less mobile organic and meta
compounds in the soil to be landfllled on
site. Approximately 99 percent of the
VOCs would be removed by this treat
ment process. The used carbon canis-
ters would be shipped off-site to be re-
generated.
The treated soils would then be re-
turned to the lagoon/tank farm area anc
stabilized with the 3.500 yd3 of metal-
contaminated soils not excavated. The
lagoon/tank farm area would be regraded
and revegetated and capped in accor-
dance with the relevant and appropriate
requirements of RCRA landfill closure in
40 CFR §264.310.
THE PREFERRED ALTERNATIVE: NUMBER 4
EXCAVATION, TREATMENT, ON-SITE DISPOSAL
Excavation
of 7.500 yd'ol
VOC-
Centamlnat*d
hot spot*
Temperature
Volatilization
Lagoon/ Tan*
FarmAroa
7.500 yd'voc-
Cantamln«t«d
Hoi Spotn
TCE- 140 ppm
Banian* 40 ppm
>
3 500 yd heavy
7
metal* contaminated
Soil*
Pb 30 ppm
Cd 17 ppm
Cr' 12 ppm
TO carclno0anlc
risk I*V«I
Amount d«t»rmln*d
by f ! and
uantport motiving
and
«»mp«rtfl»n«
analyst during
xoavatlon precoaa
1
F
Activated
CanliUrt
Off-SIU
Subtitle C
Otiposal
LandfM
ClOflur* !
Laqoon/Tank
Farm Area
Lontf-Torm OftM
Cap Integrity
- QW Monitoring
Expoturo Lovol »t 1 0 '
* 0««d tattrtettom
capital Co*t«S4 7M
Annual 0*M $4 t.000
' All costs and implementation times are estimated.
-------
Alternative 5:
EXCAVATION AND OFF-SITE
THERMAL DESTRUCTION
Capital Cost: $39,056,421'
Annual O&M Costs: $26,200'
PW: $39,301,905"
Months to Implement: 36 to 72'
All 11,000 yd3 of contaminated soils
would be excavated, transported, and
destroyed in an off-site thermal destruc-
tion unit. This thermal destruction proc-
ess would address the VOCs in the soil;
however, metals would remain in the ash
and would require proper disposal. The
excavation process would leave the site
"clean," consistent with the relevant and
appropriate requirements of RCRA
closure, and requiring no long-term man-
agement controls. The off-site thermal
destruction unit would comply with tech-
nical standards for incinerators, which
include having stack scrubbers and other
recovery mechanisms to ensure that no
untreated hazardous substances are
released Into the environment. The in-
cinerator would destroy 99 percent of the
VOCs in the contaminated soils. The re-
sulting ash would be properly handled
and disposed of by the operators of the
thermal destruction unit. The RCRA facil-
ity must be in compliance with the Super-
fund off-site policy before waste could be
transported there.
Alternative 6:
EXCAVATION, ON-SITE
THERMAL DESTRUCTION,
AND SOLIDIFICATION
Capital Cost: $42,463,300'
Annual O&M Costs: $26,200'
PW: $42,708,780'
Months to Implement: 30'
A mobile, thermal destruction unit would
be brought to the site, and 11,000 yd3 of
contaminated soils would be excavated
and destroyed on-site. This thermal
destruction process would address the
VOCs, but the metals in the soil would re-
main in the ash. The excavation and
backfilling process would comply with the
relevant and appropriate requirements of
RCRA closure. The on-site thermal de-
struction unit would comply with technical
standardsforincinerators. Off-gases and
scrubber wastes from the thermal de-
struction unit would be collected and dis-
posed of. This incinerator would destroy
99 percent of the VOCs in the soil. Resid-
ual metals and ash would be solidified
and disposed off-site in a RCRA Subtitle
C facility.
'All costs and implementation times are
estimated.
EVALUATION OF ALTERNATIVES
The preferred alternative for clean-
Ing up the soil* (the source control
operable unit) at the EK> sits Is Alter-
native 4 - Excavation, Volatilization,
Stabilization, and Disposal On-sHs.
Based on current Information, this alter-
native would appear to provide the best
balance of trade-offs among the alterna-
tives with respect to nine criteria that EPA
uses to evaluate alternatives. This sec-
tion profiles the performance of the pre-
ferred alternative against the nine crite-
ria, noting how it compares to the other
options under consideration. A glossary
of the evaluation criteria is noted below.
GLOSSARY OF EVALUATION CRITERIA
> Overall Protection of Human Health
and Environment addresses whether
or not a remedy provides adequate
protection and describes how risks posed
through each pathway are eliminated,
reduced, or controlled through treatment
engineering controls or institutional
controls.
Compliance with ARARs addresses
whether or not a remedy will meet all of
the applicable or relevant and appropriate
requirements of other Federal and State
environmental statutes and/or provide
grounds for invoking a waiver.
Long-term sffsctivsnsss and
permanence refers to the magnitude
of residual risk and the ability of a
remedy to maintain reliable protection
of human health and the environment
over time once cleanup goals have
been met.
Reduction of toxleKy, mobility, or
volume through treatment is the
anticipated performance of the treatment
technologies that may be employed in
a remedy.
Short-term effectiveness refers to the
speed with which the remedy achieves
protection, as well as the remedy's
potential to create adverse impacts on
human health and the environment that
may result during the construction and
implementation period.
Implementablllty is the technical and
administrative feasibility of a remedy,
including the availability of materials
and services needed to implement the
chosen solution.
Cost includes capital and operation
and maintenance costs.
Stats Acceptance indicates whether,
based on its review of the RI/FS and
Proposed Plan, the State concurs with,
opposes, or has no comment on the
preferred alternative.
Community Acceptance will be
assessed in the Record of Decision
fotowing a review of the public comments
received on the RI/FS report and the
Proposed Plan.
Analysis
Overall Protection. All of the alterna-
tives, with the exception of the "no action*
alternative, would provide adequate pro-
tection of human heath and the environ-
ment by eliminating, reducing, or control-
ling risk through treatment, engineering
controls, or institutional controls. The
preferred alternative would treat the vola-
tile organic contaminants in the soils, sta-
bilize the remaining wastes, and cap the
remaining residuals to reduce the risks
associated with direct contact, and mini-
mize the migration of contamination from
the ground water.
Because the "no action" alternative is
not protective of human health and the
environment, it is not considered further
in this analysis as an option for this site.
Compliance with ARARs. All alterna-
tives would meet their respective appli-
cable or relevant and appropriate require-
ments of Federal and State environmental
laws. Although the preferred alternative
would involve the excavation and place-
ment of waste, thus making the land
disposal restrictions (LDR) potential
ARARs, TCE-contaminated soil at this
site is not a RCRA hazardous waste and
therefore these requirements are not ap-
plicable. The U.S. EPA is undertaking an
LDR rulemaking that will specifically ap-
ply to soil and debris. Until that rulemak-
ing is completed, the CERCLA program
will not consider the land disposal restric-
tions to be relevant and appropriate to soil
and debris that does not contain RCRA-
restricted wastes. All options would in-
volve meeting the relevant and appropri-
-------
ate RCRA closure requirements. No waiver
from ARARs is necessary to implement
any of the active cleanup options.
Long-term effectiveness and perma-
nence. The preferred alternative would
reduce the inherent hazards posed by the
volatile organic compounds in the con-
taminated soils. The treated soils would
still be contaminated with other organic
and metal compounds; however, the long-
term risks of exposure to the remaining
contaminants in the soils would be re-
duced by stabilizing and sealing the soils
in the capped area, which would prevent
migration of the contaminants to ground
water, surface water, air, and other soils.
A ground-water monitoring system would
be installed around the lagoon/tank farm
area to assess the effectiveness of the
treatment and disposal in the closed area.
Alternatives 5 and 6 would permanently
destroy most of the organic soil contami-
nation (TCE, PAHs). The ash generated
by the thermal destruction units, how-
ever, would be contaminated by those
metal compounds not destroyed by this
process. Under Alternative 5, the ash
would be disposed of in an off-site landfill
to protect against risks of future human
contact. Under Alternative 6, the con-
taminated ash would be solidified to pre-
vent the possibility of human contact. The
solidified waste would be stored in a newly
constructed on-site RCRA Subtitle C landfill
Alternative 6 would remove all waste to
a permitted, off-site landfill, thereby elimi-
nating the long-term risks of exposure at
the EIO site. As with all landfills, the long-
term effectiveness of the containment
system may need to be retrofitted or re-
placed. While the off-site disposal option
eliminates on-site risks, off-site disposal
without treatment is the least preferred
option under CERCLA
The cap that would be implemented in
Alternative 2 would provide long-term re-
ductions in the amount of water that oth-
erwise would pass through the contami-
nated soils. This would reduce the gen-
eration of contaminated leachate that could
migrate to the groundwater. Because the
highly-mobile VOCs will not be treated,
the contaminated soils that constitute a
principal threat would remain at the site
and would pose potential long-term risks
of exposure. The cap's effectiveness
would be evaluated through long-term
monitoring. The cap would require long-
term maintenance, and portions of It might
need to be replaced in the future.
Reduction of Toxlclty, Mobility, or
Volume of the Contaminants Through
Treatment Only three of the alternatives
would treat the wastes to reduce the
toxicity, mobility, or volume of the organ-
ics. Alternative 4 would involve treatment
of the most mobile contaminants, the
volatile organic compounds. The treated
soils would still be co ntaminated with less-
mobile organic and metal compounds.
These soils would be stabilized with the
metal-contaminated soils in the lagoon/
tank farm area and the area would then
be capped.
Alternatives 5 and 6 both would involve
incineration processes that would perma-
nently destroy the organic contaminants.
The contaminated ash would be disposed
of in a RCRA landfill. Alternatives 2 and 3
achieve no reduction in toxicity, mobility,
or volume.
Short-term effectiveness. Alterna-
tive 4 would contain the treated soils and
reduce the possibility of direct human
contact with contaminants in the least
amount of time, compared with the other
alternatives, except Alternative 2 (i.e.,
capping). Under the preferred alterna-
tive, onca the volatile organic compounds
have been collected in canisters, there is
some minor, short-term risk of exposure
to the community during transportation of
the canisters to a treatment facility. All of
the alternatives that include excavation
wouid pose some short-term risks of
exposure to VOCs during the excavation
process.
Because the capacity of on-site and
off-site thermal destruction units is lim-
ited, under Alternatives 5 and 6, contami-
nated soils would be stockpiled for up to
six years. Under these two alternatives,
the risks of direct contact with stockpiled,
contaminated soils would be increased
until incineration has been completed
because of dust. In addition, there are
some risks of exposure to air emissions
from the incinerators and the piles.
Implementabillty. Alternatives 2, 3,
and 4 have few associated administrative
difficulties that could delay implementa-
tion. The remedies have been used suc-
cessfully to address similar contaminants
at other Superfund sites, and the skilled
workers needed to construct the reme-
dies are readily available in the area. The
long-term monitoring that would be re-
quired to establish the continued viability
of the preferred alternative would be less
extensive than would be necessary for
Alternative 2. The activated carbon can-
isters that are part of the vaporization
step used in the preferred alternative are
available in the area. In contrast, there is
uncertainty about the availability of ade-
quate capacity at an off-site incinerator.
This could lead to delays of up to six years
in implementing Alternative 5. Because
there is only one mobile incinerator that
could be used at the site, the implemen-
tation of Alternative 6 may take over two
years to complete.
THE COMMUNITY'S ROLE IN THE SELECTION PROCESS
EPA solicits input from the community on the cleanup methods proposed for each Superfund response action. EPA has
set a public comment period from October 3 through November 5,1988, to encourage public participation in the selection
process. The comment period includes two public meetings at which EPA, with the TPCB, will present the RI/FS Report and
Proposed Plan, answer questions, and accept both oral and written comments.
A public meeting is scheduled for 7:30 p.m., October 2,1988, and will be held at the Nameless Community Hail, 123 Mar-
ket Road, In Nameless, TN.
Comments will be summarized and responses provided in the Responsiveness Summary section of the Record of Decision
(ROD). The ROD is the document that presents EPA's final selection forcleanup. To send written comments or obtain further
information, contact:
Jane Doe
Community Relations Coordinator,
U.S. Environmental Protection Agency
123 Peachtree Street, Atlanta, GA 00000
(555) 555-4640. Toll-free 1 (800) 333-1515
between 8:30 a.m. and 4:30 p.m. (Monday - Friday)
-------
Cost The present-worth cost of the
preferred alternative is $5,050.150. The
lowest-cost alternative is Alternative 2 at
$910,260. The highest-cost alternative is
Alternative 6 at $42.708,780. Alternative
3 has a present-worth cost of $18,433,480
and Alternative 5 has a cost of $39,301,905.
State acceptance. The State of Ten-
nessee supports the preferred alternative
without comment.
Community Acceptance. Commu-
nity acceptance of the preferred alterna-
tive will be evaluated after the public com-
ment period ends and will be described in
the Record of Decision for the site.
SUMMARY OF THE
PREFERRED ALTERNATIVE
In summary, Alternative 4 would achieve
substantial risk reduction through treat-
ment of the principal threat remaining at
the site (i.e., the mobile lagoon waste)
and by providing for the safe manage-
ment of other materal that will remain at
the site. Alternative 4 achieves this risk
reduction more quickly and at substan-
tially less cost than any of the other
treatment options. Therefore, the pre-
ferred alternative Is believed to provide
the best balance of trade-offs among
alternatives with respect to the evaluation
criteria. Based on the information avail-
able at this time, EPA and the State of
Tennessee believe the preferred alterna-
tive would be protective of human health
and the environment, would comply with
ARARs, would be cost effective, and would
utilize permanent solutions and alterna-
tive treatment technologies or resource
recovery technologies to the maximum
extent practicable. Because it would
treat the VOC contaminants in the soil,
the remedy also would meet the statutory
preference for the use of a remedy that
involves treatment as a principal ele-
ment.
THE WORD NOTEBOOK
Specialized terms used elsewhere in
this Proposed Plan are defined below.
activated carbon canister* (ACCa) --
a treatment system in which contami-
nants are removed from air as it passes
through canisters containing activated
carbon.
Applicable or R»t*vant and Appropri-
ate Requirement* (ARARa) - the Fed-
eral and State requirements that a se-
lected remedy will attain. These require-
ments may vary among sites and alter-
natives.
chlorinated aliphatic hydrocarbon*
(CAM*) - organic compounds composed
of carbon, hydrogen, and chlorine that
may vaporize easily. Those CAHs typi-
cally found at hazardous waste sites
have been used as degreasers and sol-
vents. Some CAHs can cause cancer,
and some depress the central nervous
system. Trichloroethylene (TCE) is a
CAM.
contaminant plume ~ A column of
contamination with measurable horizon-
tal and vertical dimensions that Is sus-
pended in and moves with ground water.
ground water- underground waterthat
fills pores in soils or openings In rocks to
the point of saturation. Unlike surface
water, ground water cannot clean itself
by exposure to sun or filtration. Ground
water is often used as a source of drink-
ing water via municipal or domestic wells.
leachate -- a liquid that has passed
through wastes and contains some com-
ponents of the wastes.
lead -- an element that is used in the
manufacture of batteries and pigments.
It Is also still added to some types of
gasoline to improve octane ratings.
Exposure to low levels of lead over long
periods can cause brain, bone, and neuro-
logical damage. It also can cause learn-
ing disabilities in children.
monitoring- ongoing collection of infor-
mation about the environment that helps
gauge the effectiveness of a cleanup
action. Monitoring wells drilled at differ-
ent levels at the EIO Industrial site would
be used to detect any leaks in the landfill
liners.
organic compound* - carbon com-
pounds, such as solvents, oils, and pesti-
cides, none of which tend to dissolve
readily in water. Some organic com-
pounds can cause cancer.
polynuclear aromatic hydrocarbons
(PAH*) - organic chemical compounds
that are composed of carbon and hydro-
gen, including materials such as oil, pes-
ticides, and solvents. Some PAHs are
carcinogenic.
revegetate - to replace topsoil, seed,
and mulch on prepared soil to prevent
wind and water erosion.
source control - a remedy that ad-
dresses contamination problems at their
source, rather than at some other point
along the chain of exposure. At the EIO
Industrial site, for example, the source of
potential ground-water and air contami-
nation is lodged in the soils at the site.
solidification - a process used to re-
duce the mobility of contaminants by mixing
the waste with a material such as cement
kiln dust. Solidification allows for Im-
proved handling of the waste and makes
the contaminants less likely to leach.
thermal destruction- high temperature
burning of materials to destroy hazard-
ous compounds.
volatile organic compound* (VOC*) -
organic compounds that vaporize easily.
Some VOCs have been shown to cause
leukemia; some are toxic to the kidney
and liven and some depress the central
nervous system, causing drowsiness.
-------
MAILING LIST
K you did not receive this Proposed Plan in the mail and wish to be placed on the mailing list for future publications pertaining to
this site, please fill out, detach, and mail this form to:
Jane Doe
Community Relations Coordinator
U.S. Environmental Protection Agency
123 Peachtree Street
Atlanta, GA 00000
Name.
Address.
Affiliation
Phone( ).
-------
APPENDIX B
WORKSHEETS FOR THE SUMMARY COMPARATIVE
ANALYSIS OF ALTERNATIVES
This appendix includes worksheets (Exhibit B-2) that could be used to
assist in preparing the "Evaluation of Alternatives" section of the Proposed
Plan and the "Comparative Analysis of Alternatives" section of the ROD. These
worksheets are optional tools.* Worksheets are included for each of the nine
evaluation criteria. Separate formats have been developed for the two
threshold criteria, the five balancing criteria, and the two modifying
considerations.** In general, each worksheet includes: the relevant
questions that should be addressed under each criterion; space for listing
each alternative; and additional space for notes. The first Exhibit B-l, is
an example of a completed comparative analysis worksheet for the primary
balancing criterion long-term effectiveness and permanence. The last exhibit
in this appendix, B-3, presents a format for summarizing the results of the
comparative analysis for the ROD.
In preparing the Proposed Plan, these worksheets could be used to outline
how all alternatives compare to the preferred alternative. In preparing the
ROD, the worksheets can assist in identifying the most significant advantages
and disadvantages among alternatives. This will facilitate a logical
presentation of the comparative analysis in which alternatives are discussed
under each individual criterion, beginning with the alternative that performs
best in that category and continuing through the other options in sequence.
The individual notes and summary exhibit at the end of this Appendix may also
prove a useful tool for briefing the Regional Administrator or the State
Director on the findings in support of the Proposed Plan or the ROD.
If they are used, the worksheets should not be included in the administrative record file.
The two threshold criteria are overall protection of human health and the environment and
compliance with ARARs. The five balancing criteria are: long-term effectiveness and permanence;
reduction of toxicity, mobility or volume through treatment; short-term effectiveness;
implementability; and cost. The two modifying considerations are state/support agency acceptance
and community acceptance.
-------
EXHIBIT B-l
EXAMPLE OF A COMPLETED
COMPARATIVE ANALYSIS WORKSHEET
CRITERION: Long-term Effectiveness and Permanence
Analysis Factor
Specific Factor Considerations
Magnitude of residual risks
o
o
o
Adequacy and reliability of controls o
o
o
o
o
What is the magnitude of the remaining risks?
What remaining sources of risk can be identified? How much is
due to treatment residuals, and how much is due to untreated
residual contamination?
Will a five-year review be required?
What is the likelihood that the technologies will meet required
process efficiencies or performance specifications?
What type and degree of long-term management is required?
What are the requirements for long-term monitoring?
What operation and maintenance functions must be performed?
What difficulties and uncertainties may be associated with long-
term operation and maintenance?
What is the potential need for replacement of technical
components?
What is the magnitude of the threats or risks should the remedial
action need replacement?
What is the degree of confidence that controls can adequately
handle potential problems?
What are the uncertainties associated with land disposal of residuals
and untreated wastes?
ALTERNATIVE
NOTES
Incineration of TCE-
contaminated Soil, Ground-
Water Pump and Treat,
In-situ Fixation of Lead-
contaminated Soil, Cap
In-situ Soil Vapor Extraction
of TCE-contaminated Soil, In-situ
Fixation of Lead-contaminated
Soil, Cap, Ground-Water Pump and
Treat
Risks of direct contact eliminated.
Current and future risks from ground-water ingestion reduced to
10"6.
If metals are present, ash will be disposed in RCRA landfill.
O&M required for ground-water treatment and cap. Failure of
cap would have little effect because soil would be fixed.
Current and future risk of direct contact eliminated. Current and
future risk from ingestion of contaminated ground water reduced
to 1(T6.
May need additional controls if fixation process does not meet
performance specifications.
O&M needed for cap and ground-water controls. Failure of cap
would have little effect on ground water because of soil fixation,
although direct contact may be a concern.
-------
EXHIBIT B-l (continued)
CRITERION: Long-term Effectiveness and Permanence
3.
In-situ Soil Vapor Extraction
of TCE-contaminated Soil, Cap
of Lead-contaminated Soil,
Ground-Water Pump and Treat
4.
Cap of TCE- and Lead-
contaminated Soils, Natural
Attenuation of Ground Water
5. No Action
Risk of direct contact with soil is controlled. Inherent hazards of
of TCE-contaminated material reduced to health-based levels.
Current and future risk of exposure to ground water reduced to
10"6 cancer risk level.
May need additional controls if metals are present in the TCE-
contaminated area because vapor extraction would not remove
metals. Such as yet unidentified metals could leach to ground
water.
O&M required for ground-water treatment for 25-40 years. Long-
term maintenance of cap required. Potential failure of cap would
result in longer ground-water restoration timeframe.
Risks of direct contact eliminated as long as cap maintained.
However, inherent hazard of waste remains. There is a potential
for cap to fail. Cap will need maintenance and replacement in
future.
Current risk of exposure from ground-water ingestion eliminated
by providing alternative water supply. Institutional controls used
to control future use of ground water.
Potential failure of institutional controls may result in exposure to
contaminated ground water during attenuation period.
Existing risk remains. Future risk greater as plume migrates to
residents. Eventually natural attenuation may decrease risk.
No controls over remaining contamination. No long-term
management employed.
-------
EXHIBIT B-2
WORKSHEET FOR THE SUMMARY
COMPARATIVE ANALYSIS OF ALTERNATIVES
THRESHOLD CRITERION : Overall Protection of Human Health and the Environment
QUESTIONS TO ADDRESS*.
o Bow does the remedy eliminate, reduce or control risks posed through each pathway through
treatment, engineering controls, or institutional controls?
o Are there any unacceptable short-term or cross-media impacts associated with the remedy?
o For carcinogens, will exposure levels be brought within the risk range?
PROVIDES
ADEQUATE
ALTERNATIVE NOTES PROTECTION?
(Y/N)
-------
EXHIBIT B-2 (continued)
THRESBOLD CRITERIOH: Overall Protection of Human Health and the Environment
ALTERHATITE NOTES
-------
EXHIBIT B-2 (continued)
THRESHOLD CHITERIOH: Compliance with ARARs
QUESTIONS TO ADDRESS:
o Compiles with chemical-specific, location-specific, or action-specific ARARs?
o If necessary, can a waiver be justified?
o Compliance with other guidance, criteria, or advisories lead and support agencies have
agreed are "to be considered" for the action.
ALTEBHATIVE NOTES ATTAINS ARARs?
(Y/N)
-------
EXHIBIT B-2 (continued)
THRESHOLD CRITERIOH: Compliance with ARARs
ALTERHATIVE NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALANCING CRITERION: Long-term Effectiveness and Permanence
Analysis Factor
Magnitude of residual risks
Adequacy and reliability of controls o
Specific Factor Considerations
o What is the magnitude of the remaining risks?
o What remaining sources of risk can be identified? How much is
due to treatment residuals, and how much is due to untreated
residual contamination?
o Will a 5-year review be required?
What is the likelihood that the technologies will meet requirec
process efficiencies or performance specifications?
o What type and degree of long-term management is required?
o What are the requirements for long-term monitoring?
o What operation and maintenance functions must be performed?
0 What difficulties and uncertainties may be associated with long-
term operation and maintenance?
o What is the potential need for replacement of technical
components?
o What is the magnitude of the threats or risks should the remedial
action need replacement?
O What is the degree of confidence that controls can adequatel;
handle potential problems?
o What are the uncertainties associated with land disposal of residuals
and untreated wastes?
ALTERNATIVE
NOTES
-------
EXHIBIT B-2 (continued)
FBOUBX BALAHCIHG CHITERIOH: Long-term Effectiveness and Permanence
ALTERKATIVE NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALAHCIBG CRITERION: Reduction of Toxicity, Mobility, or Volume Through Treatment
Analysis Factor
Treatment process and remedy
Amount of hazardous material
destroyed or treated
Reduction in toxicity, mobility,
or volume
frreversibility of the treatment
Type and quantity of treatment
residual
Statutory preference for treatment
as a principal element
o
o
o
o
0 '
o
0
0
o
o
o
0
0
Specific Factor Considerations
Does the treatment process employed address the principal threats?
Are there any special requirements for the treatment process?
What portion (mass, volume) of contaminated material is
destroyed?
What portion (mass, volume) of contaminated material is
treated?
To what extent is the total mass of toxic contaminants
reduced?
To what extent is the mobility of toxic contaminants reduced?
To what extent is the volume of toxic contaminants reduced?
To what extent are the effects of treatment irreversible?
What residuals remain?
What are their quantities and characteristics?
What risks do treatment residuals pose?
Are principal threats within the scope of the action?
Is treatment used to reduce inherent hazards posed by prbcipa
threats at the site?
ALTERNATIVE
NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALAKIBG CRITERION: Reduction of Toxicity, Mobility, or Volume Through Treatment
ALTERNATIVE NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALANCING CRITERION: Short-term Effectiveness
Analysis Factor
Specific Factor Considerations
Protection of community during
remedial actions
Protection of Workers during
remedial actions
Environmental impacts
Time until remedial response
objectives are achieved
o What are the risks to the community that must be addressed?
o How will the risks to the community be addressed and mitigated?
o What risks remain to the community that cannot be readily
controlled?
o What are the risks to the workers that must be addressed?
o What risks remain to the workers that cannot be readily controlled?
0 How will the risks to the workers be addressed and mitigated?
o What environmental impacts are expected with the construction
and implementation of the alternative?
o What are the available mitigation measures to be used and what
is their reliability to minimize potential impacts?
o What are the impacts that cannot be avoided should the alternative
be implemented?
o How long until protection against the threats being addressed
by the specific action is achieved?
o How long until any remaining site threats will be addressed?
o How long until remedial response objectives are achieved?
ALTERNATIVE
NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALAHCIHG CRITERION: Short-term Effectiveness
ALTERNATIVE NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALANCING CRITERION: Implementability - Technical Feasibility
Analysis Factor
Technical Feasibility
Ability to construct and operate
technology
Reliability of technology
Ease of undertaking additional
remedial action, if necessary
Monitoring considerations
Specific Factor Considerations
o What difficulties may be associated with construction?
O What uncertainties are related to construction?
o What is the likelihood that technical problems will lead to schedul
delays?
o What likely future remedial actions may be anticipated?
o How difficult would it be to implement the additional remedia
actions, if required?
o Do migration or exposure pathways exist that cannot be monitoret
adequately?
o What risks of exposure exist should monitoring be insufficient tc
detect failure?
ALTERNATIVE
NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALAHCIHG CRITERION: Implementability - Administrative Feasibility
Analysis Factoi;
Administrative Feasibility
Coordination with other agencies
Specific Factor Considerations
o What steps are required to coordinate with other agencies?
o What steps are required to set up long-term or future coordination
among agencies?
o Can permits for offsite activities be obtained if required?
ALTERNATIVE NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALANCING CRITERION: Implementability - Availability of Service and Materials
Analysis Factor
Availability of Services and Materials
Availability of treatment, storage
capacity, and disposal services
Availability of prospective
technologies
o
o
o
Availability of necessary equipment o
and specialists o
o
o
o
o
o
Specific Factor Considerations
Are adequate treatment, storage capacity, and disposal services
available?
How much additional capacity is necessary?
Does the lack of capacity prevent implementation?
What additional provisions are required to ensure the needec
additional capacity?
Are the necessary equipment and specialists available?
What additional equipment and specialists are required?
Does the lack of equipment and specialists prevent implementation?
What additional provisions are required to ensure the needed
equipment and specialists?
Are technologies under consideration generally available and
sufficiently demonstrated for the specific application?
Will technologies require further development before they can be
applied full-scale to the type of waste at the site?
When should the technology be available for full-scale use?
Will more than one vendor be available to provide a competitive
bid?
ALTERNATIVE
NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALANCING CRITERION: Cost
QUESTIONS TO ADDRESS:
o What are the estimated capital and operation and maintenance costs?
ALTERNATIVE NOTES
-------
EXHIBIT B-2 (continued)
PRIMARY BALAHCIUG CRITERIOH: Cost
ALTERNATIVE NOTES
-------
EXHIBIT B-2 (continued)
MODIFYIHG CRITERION: State/Support Agency Acceptance
QUESTIONS TO ADDRESS;
o Does the State or Support Agency concur on the selected remedy?
ALTERHATIVE NOTES
-------
EXHIBIT B-2 (continued)
MODIFYIHG CRITERION: State/Support Agency Acceptance
Alternative Notes
-------
EXHIBIT B-2 (continued)
MODIFYING CRITERIOH : Community Acceptance
QUESTIONS TO ADDRESS:
o Does the community accept the alternative?
ALTERNATIVE NOTES
-------
EXHIBIT B-2 (continued)
MODIFYIHG CRITERION: Community Acceptance
ALTERNATIVE NOTES
-------
SUMMARY OF EVALUATION WORKSHEET
CRITERION
ALTERNATIVES
The exhibit below summarizes the relative ranking of the alternatives in terms of the primary balancing criteria. For
purposes of clear, consistent presentation, the alternatives can be discussed in order of most to least in the
"Comparative Analysis" section of the ROD.
1) Long-term Effectiveness and Permanence 1)
Most |
A«5' -Alt3 !
- Alt 1 |
Alt 4 - i
- Alt 2 |
Least i
:
-^ ,, ,
2) Reduction of Toxicity, Mobility, and Volume 2)
Through Treatment
Most ^
Alt 5 " - Alt 3 |
- Alt 2 i
Alt 1 - :
Ait 4 - ;|
Least 1
- '&,' ^ *" ^ *-»V« c^'/^iS ' -.'-",>.>"<.' x" '- -i ' A f'i&s'^''^'
3) Implementability 3)
*
Most 1
Alt 3- 1
Alt 1 - |
Alt 5- I
Art 4 - 1
Alt 2 - 1
Least *
- '<. " \ ,,'<- " '"« '' i " '"- ' , ^ ' .«' "% . "> x &y- -' --*
4) Short-term Effectiveness 4)
Most |
Art 1 - 3
- Alt 4 |
- Alt 5 |
Alt 3 - |
Alt 2 - |
Least %^
- *&/ -; "*>f ^fy- 'st, ^*y - **/& &f? »/ - **>£ *- ""- - ^ "t»"' ^^ , ^ ^ , * c ^%^^*.< - ;
5) Cost 5)
, , , *>v
Most 3
-Alt5 |
- Alt 1 |
- Alt 3 1
- Alt 2 1
- Alt 4 |
Least |
i'~ ^ -V , i , - ^2^*^.^1», v^^^, i
S94106-1
-------
OSWER Directive 9355.3-02
APPENDIX C
Sample Description of an Alternative
Sample Summary of Site Risks
Table
-------
OSWER Directive 9355.3-02
APPENDIX C
EXHIBIT C-l
SAMPLE DESCRIPTION OF A REMEDIAL ALTERNATIVE
The sample below describes a remedial alternative with approximately 11,000 cubic yards
of contaminated soil in a former lagoon/tank farm area. Approximately 3,500 cubic yards of
the soil are contaminated with heavy metals, with average concentrations of cadmium at 17
parts per million (ppm), chromium at 12 ppm, and lead at 30 ppm. Hot spots of volatile
organic compounds (VOCs) also are present in approximately 7,500 cubic yards of the soils,
including TCE at 140 ppm and benzene at 40 ppm. These levels in the soil pose a cumulative
carcinogenic risk level of 10" .
Alternative 3: Excavation. Thermal Destruction of Contaminated Soils. Stabilization, and On-
site Disposal of Residuals
Major Components of the Remedial Alternative. The major features of this alternative
include excavation of 7,500 cubic yards of VOC-contaminated soil from hot spots in the
lagoon/tank farm area, on-site thermal destruction of the VOC-contaminated soil, stabilization
of the treated residuals with metal-contaminated soils remaining in the lagoon/tank farm area,
and landfill closure of the lagoon/tank farm area.
The amount of VOC-contaminated soil to be excavated in the lagoon/tank farm area was
determined using fate and transport modeling to estimate the potential ground-water
contamination that could result from the migration of soil contaminants remaining in the
lagoon/tank farm area. The VOC-contaminated soils would be treated on-site in accordance
with RCRA Subpart O standards using a thermal destruction unit. The specific type of
process (e.g., rotary kiln) would be determined in the Remedial Design phase through
engineering design and analysis and the competitive bidding process. The unit would be
mobilized, operated, and closed according to the requirements of RCRA Subpart O, 40 CFR
264.340. These requirements, though not applicable because the hazardous substances to be
treated are neither RCRA-listed nor RCRA-characteristic waste, have been determined to be
relevant and appropriate. Specific operating practices necessary to meet the performance
objectives, including a 99.99 percent destruction and removal efficiency (DRE) of stack
emissions as required by Subpart O of RCRA, would be determined through a trial burn at
the site after the installation of the thermal destruction unit. Although this alternative involves
the excavation and placement of hazardous substances, those substances are not RCRA-
regulated waste; therefore, the RCRA land disposal restrictions are not applicable
requirements. EPA is undertaking a Land Disposal Restriction (LDR) rulemaking that will
specifically apply to soil and debris. Until that rulemaking is completed, the CERCLA
program will not consider LDRs to be relevant and appropriate to soil and debris that do not
contain RCRA-regulated wastes.
-------
OSWER Directive 9355.3-02
C-2
EXHIBIT C-1 (Continued)
Management of Residuals. The thermal destruction unit would be equipped with an
appropriate dry emission control system, which would eliminate the need for wastewater
treatment. Any water from emission control and from decontamination procedures would be
treated in an on-site ground-water treatment system, which is already operating as part of a
previous operable unit at the site.
The residual ash and treated soils would be stabilized with the heavy metal contaminated
soils in the lagoon/tank farm area. This 10-acre area would be capped and closed as a
landfill in accordance with the requirements specified in 40 CFR 264.310 for landfill closure,
which require a cap to have a permeability less than or equal to the permeability of the
natural underlying soil. Because the facility ceased operation in August 1978 prior to the
effective date of RCRA (November 19, 1980) and the remedy does not involve the disposal of
RCRA-regulated waste, the RCRA Subtitle C closure standards are not applicable to the tank
farm. However, the standards have been determined to be relevant and appropriate to the
type of wastes being managed and the circumstances of the release. Closure of the area also
will comply with the State's more stringent RCRA requirements.
The cap would be designed and constructed to promote drainage, minimize erosion of
the cover, and provide long-term minimization of migration of liquids through the underlying
contaminated soils. Consistent with the requirements of RCRA 264.117, long-term operation
and maintenance (O&M) would be conducted to monitor the ground water around the landfill
and to ensure the integrity of the cap. The RCRA minimum technology requirements are not
ARARs because the stabilized soils would not be placed in a new RCRA unit, a lateral
expansion of an existing unit, or a replacement unit.
At the completion of the remedial action, health risks posed by direct contact with soils
would be no greater than 1 x 10" . Meeting this target cleanup level for TCE-contaminated
soil would protect against exposure by direct contact and ingestion, as determined by the risk
assessment. The estimated capital cost of this component of the remedy is $14,666,000, with
annual O&M costs estimated to be $14,400. The estimated time to implement this remedy
and to meet the cleanup goals is approximately 34 months.
-------
APPENDIX C
EXHIBIT C-2
SAMPLE SUWARY OF SITE RISKS
BASED ON CURRENT LAND-USE*
Chronic Daily Cancer Noncancer
Total Exposure Point
Nearby Residential
Population
Distant Public
Water Supply
Users
Chemical Intake (GDI) CPF Risk RfD Hazard Index
Exposure Pathway of Concern (mg/kg-day) (mg/kg-day)"1 (CDI x CPF) (mg/kg-day) (CDI/ RfD)
(1) Ground-water Benzene 0.00025 0.052 1 x 10~^ 0.002
Ingestion Lead 0.00015 - - 0.00043
(wells) Chlordane 0.00008 1.61 1 x 10~4
PATHWAY TOTAL 1 x 10" 4
(2) Home Grown MEK 0.0009 - - 0.008
Produce Lead 0.000035 - - 0.00043
Ingestion Chlordane 0.00015 1.61 2 x 10~A
PATHWAY TOTAL 2 x 10~4
TOTAL FOR NEARBY RESIDENTIAL POPULATION 3 x 10~4
(1) Ground-water [Table should continue for each total exposure point, pathway of exposure,
Ingestion chemical of concern.]
0.1
0.3
0.4
0.1
0.08
0.2
0.6
and
* Values for illustration only.
CPF = Cancer Potency Factor.
RfD = Reference Dose.
MEK = Methyl ethyl ketone.
-------
OSWER Directive 9355.3-02
APPENDIX D
Sample Selected Remedy and Statutory Determinations
Discussion for the ROD
THE SELECTED REMEDY
Based upon consideration of the requirements of CERCLA, the detailed
analysis of the alternatives, and public comments, both EPA and the State have
determined that Alternative 9: Excavation, Volatilization, Stabilization, and
On-site Disposal is the most appropriate remedy for the EIO Industrial Site in
Nameless, TN.
Seventy-five hundred cubic yards of volatile organic compound (VOC)-
contaminated soil hotspots will be excavated from the lagoon/tank farm area.
The VOCs in the soil will be treated using a volatilization technology.
Approximately 99 percent of the VOCs will be removed by this treatment
process. The treated soils will be returned to the lagoon/tank farm area and
stabilized with the estimated 3,500 cubic yards of metal-contaminated soils
not excavated from that area. The lagoon/tank farm area will be regraded,
revegetated, and capped in accordance with Federal and State requirements for
RCRA landfill closure.
Remediation Goals
The purpose of this response action is to control risks posed by direct
contact with soils and to minimize migration of VOCs to ground water.
Existing conditions at the site have been determined to pose an excess
lifetime cancer risk of 10~3 from direct contact with contaminated soils and
ingestions of contaminated ground water. This risk relates to the VOC
concentrations (primarily TCE) in soil which average 140 mg/kg. This remedy
will address all soils contaminated with VOCs in excess of 5 ppm. VOC
contamination remaining in soils at 14 mg/kg corresponds to an excess lifetime
cancer risk of 10"6 through each route of exposure. Since no Federal or State
ARARs exist for soil, the action level for the VOCs in soil was determined
through a site-specific analysis. This analysis used fate and transport
modeling to determine levels to which VOCs in soils should be reduced in order
to ensure no leaching of contaminants to ground water above MCL levels
-------
OSWER Directive 9355.3-02
D-2
(5 mg/kg). Levels protective of ground water will also ensure protection from
exposure through direct contact to soils above a 10"5 excess cancer risk.
The excavated VOC-contaminated soils will be treated using low-
temperature volatilization that will remove 99 percent of the VOCs from the
soil. The granular activated carbon canisters used to capture the VOCs will
be shipped offsite to be regenerated.
The treated soil, which will still contain less mobile organic compounds
and metals, will be combined with the 3,500 cubic yards of metal-contaminated
soils not excavated. This material will be stabilized and then covered with
an impermeable cap.
STATUTORY DETERMINATIONS
Under its legal authorities, EPA's primary responsibility at Superfund
sites is to undertake remedial actions that achieve adequate protection of
human health and the environment. In addition, section 121 of CERCLA
establishes several other statutory requirements and preferences. These
specify that when complete, the selected remedial action for this site must
comply with applicable or relevant and appropriate environmental standards
established under Federal and State environmental laws unless a statutory
waiver is justified. The selected remedy also must be cost-effective and
utilize permanent solutions and alternative treatment technologies or resource
recovery technologies to the maximum extent practicable. Finally, the statute
includes a preference for remedies that employ treatment that permanently and
significantly reduce the volume, toxicity, or mobility of hazardous wastes as
their principal element. The following sections discuss how the selected
remedy meets these statutory requirements.
Protection of Human Health and the Environment
The selected remedy protects human health and the environment through
volatilization of VOC-contaminated soil, stabilization of the treated soil
with the metal-contaminated soil, and capping the stabilized soils in the
lagoon/tank farm area. The area will be capped and closed in accordance with
RCRA landfill closure requirements to reduce the likelihood of contaminant
migration.
-------
OSWER Directive 9355.3-02
D-3
Volatilization of the VOC-contaminated soil also will eliminate the
threat of exposure to the most mobile contaminants from direct contact with or
ingestion of contaminated soil. The current risks associated with these
exposure pathways is 3.5 x 10"3. By excavating the hotspots of contaminated
soil and treating them in a volatilization unit, the cancer risks from
exposure will be reduced to less than 2.7 x 1CT6. This level is within the
range of acceptable exposure levels of between 10'* and 10"7. By stabilizing
the residuals and the unexcavated metal-contaminated soils and closing the
lagoon/tank farm area as a landfill, the risks of exposure through direct
contact will be further reduced. There are no short-term threats associated
with the selected remedy that cannot be readily controlled. In addition, no
adverse cross-media impacts are expected from the remedy.
Compliance With Applicable or Relevant and Appropriate
Requirements
The selected remedy of excavation, on-site thermal treatment, and
stabilization will comply with all applicable or relevant and appropriate
chemical-, action-, and location-specific requirements (ARARs). The ARARs are
presented below.
Action-specific ARARs:
RCRA requirements for landfill closure in 40 CFR 264.111 Subpart G, which
specify a cap with a permeability less than or equal to the permeability
of any bottom liner or natural sub-soils present at the site.
40 CFR 264.117(a)(l) Subpart G Post-Closure and Monitoring requirements
for thirty years or another period determined by the Regional
Administrator.
Rules 4-2, 4-3, and 5-3 of the State Regulations for Control and
Abatement of Air Pollution that affect actions that generate air
emissions and odors.
Chemical-specific ARARs:
None
-------
OSWER Directive 9355.3-02
D-4
Location-specific ARARs:
None
Other Criteria, Advisories or Guidance To Be Considered for This
Remedial Action (TBCs)
EPA and the State have agreed to incorporate a non-promulgated local deed
restriction to prohibit excavation at the site after the remedial action is
complete.
Cost-Effectiveness
The selected remedy is cost-effective because it has been determined to
provide overall effectiveness proportional to its costs, the net present worth
value being $5,050,154. The estimated costs of the selected remedy are within
an order of magnitude of (less than five times) the costs associated with on-
site capping of the contaminated soils, and yet the selected remedy assures a
much higher degree of certainty that the remedy will be effective in the long-
term due to the significant reduction of the toxicity and mobility of the
wastes achieved through volatilization of the VOCs and stabilization of the
metal-contaminated soils prior to capping. While the selected remedy
effectively reduces the hazards posed by all of the contaminants at the site,
its costs are only 12 percent of the alternatives involving incineration.
Utilization of Permanent Solutions and Alternative Treatment
Technologies (or Resource Recovery Technologies) to the Maximum
Extent Practicable
EPA and the State of Tennessee have determined that the selected remedy
represents the maximum extent to which permanent solutions and treatment
technologies can be utilized in a cost-effective manner for the final source
control operable unit at the EIO site. Of those alternatives that are
protective of human health and the environment and comply with ARARs, EPA and
the State have determined that this selected remedy provides the best balance
of tradeoffs in terms of long-term effectiveness and permanence, reduction in
toxicity, mobility, or volume achieved through treatment, short-term
effectiveness, implementability, cost, also considering the statutory
preference for treatment as a principal element and considering State and
community acceptance.
-------
OSWER Directive 9355.3-02
D-5
While the selected remedy does not offer as high a degree of long-term
effectiveness and permanence as the incineration alternatives, it will
significantly reduce the inherent hazards posed by the contaminated soils
through volatilization of the VOCs and stabilization of the metals such that
the residual material that remains to be managed can be contained with a high
degree of certainty over the long term. Since the remaining material will be
bound up, the impact on human health and the environment would be minimal if
the containment system were to fail. Additionally, the incineration options,
while resulting in fewer residuals requiring long-term management, would
nonetheless involving capping of the metal-contaminated ash.
The selected remedy treats the principal threats posed by the soils,
achieving significant VOCs reductions (99 percent) only slightly less
effective than incineration. The selected remedy is more effective than all
other treatment options in the short-term, requiring only 12-15 months to
implement as compared to the six years potentially required for incineration.
The implementability of the selected remedy is comparable to the nontreatment
alternatives and significantly better than the incineration options. The
selected remedy is also the least costly treatment option and also less
expensive than off-site disposal.
The selection of treatment of the contaminated soil is consistent with
program expectations that indicate that highly toxic and mobile waste are a
priority for treatment and often necessary to ensure the long-term
effectiveness of a remedy. Since all three treatment options are reasonably
comparable with respect to long-term effectiveness and the toxicity and
mobility reductions achieved, the major tradeoffs that provide the basis for
this selection decision are short-term effectiveness, implementability, and
cost. The selected remedy can be implemented more quickly, with less
difficulty and at less cost than the other treatment alternatives and is
therefore determined to be the most appropriate solution for the contaminated
soils at the EIO site.
Preference for Treatment as a Principal Element
By treating the VOC-contaminated soils in a thermal destruction unit and
stabilizing the residuals with the metal-contaminated soils, the selected
remedy addresses one of the principal threats posed by the site through the
use of treatment technologies. Therefore, the statutory preference for
remedies that employ treatment as a principal element is satisfied.
-------
OSWER Directive 9355.3-02
8-4
document this response in the administrative record. The types of information
typically received from the public and support agency are described in the
next section, along with the lead agency's obligation to respond to this
information.
8.4 STANDARDS FOR CONSIDERATION OF INFORMATION
SUBMITTED BY THE PUBLIC, PRPs, OR SUPPORT AGENCY
EPA recommends a four-part standard for determining which comments
submitted by the public or support agency after the ROD is signed warrant
formal consideration.1 Formal consideration, as specified in the proposed
revisions to the NCR and depicted in Figure 8-1, requires a written response
to the comments and the inclusion of the comments in the administrative record
file. Comments received from the support agency or public should be
considered by the lead agency when each of the following criteria are met:
The comments contain significant information;
The information is not contained elsewhere in the
administrative record file;
The information could not have been submitted during the
public comment period; and
The information substantially supports the need to
significantly alter the response action.
In most cases (particularly in light of the fourth criterion),
information that meets this four-part standard warrants a significant change
to the remedy. Depending upon how significant the change is, the lead agency
should prepare either an ESD or a ROD amendment following the guidance in
Section 8.5 below. The ESD or amended ROD represent the lead agency's formal
written response to the information submitted.
1 The basis for establishing the "consideration" standard relates back to the public's and support
agency's statutory opportunity to participate in the remedy selection process prior to adoption of the
ROD. Once the lead agency has selected the response action, the obligation to respond to comments on
the remedy is limited. Additionally, it is in the best interest of the public for the lead agency to proceed
with the implementation of the selected remedy in an expeditious manner. The lead agency's ability to
accomplish this would be compromised if it were under the obh'gation to formally respond to every
comment submitted after the ROD is signed.
-------
FIGURE 8-1
Process to Address Post-ROD Significant Changes
INFORMATION RECEIVED
FROM PUBLIC OR
SUPPORT AGENCY
YES
DOES
INFORMATION
LEAD TO
SIGNIFICANT
CHANGES?
DOES IT
WARRANT FORMAL
"CONSIDERATION"
BY LEAD
LEAD AGENCY MUST
ISSUE EITHER:
* EXPLANATION OF
SIGNIFICANT
DIFFERENCES; OR
* NEW PROPOSED PLAN
AND ROD AMENDMENT I
NO j
LEAD AGENCY PLACES
INFORMATION IN
POST-DECISION
DOCUMENT FILE
NO j
LEAD AGENCY MUST:
FORMALLY RESPOND;
AND
PLACE DOCUMENT IN
ADMINISTRATIVE
RECORD FILE
** NOTE:
* DO THE COMMENTS CONTAIN SIGNIFICANT INFORMATION?
* IS THE INFORMATION NOT AVAILABLE IN THE ADMINISTRATIVE RECORD?
* COULD THE COMMENTS HAVE BEEN SUBMITTED DURING THE COMMENT PERIOD?
* DOES THE INFORMATION SUBSTANTIALLY SUPPORT THE NEED TO ALTER
THE RESPONSE ACTION?
-------
8-19
FIGURE 8-4
Process That Results in the Issuance of an Amended ROD:
General Procedures
1
a
s
I
INFORMATION RECEIVED OR
GENERATED BY LEAD AGENCY
o
LEAD AGENCY DETERMINES:
* INFORMATION SHOULD BE CONSIDERED; AND
A FUNDAMENTAL CHANGE
TO THE REMEDY RESULTS
LEAD AGENCY:
PREPARES AMENDED PROPOSED PLAN; AND
GIVES SUPPORT AGENCY
OPPORTUNITY TO COMMENT
a
o
LEAD AGENCY:
PUBLISHES NEWSPAPER NOTICE; AND
PLACES PROPOSED PLAN AND RELEVANT
INFORMATION IN ADMINISTRATIVE
RECORD FILE
LEAD AGENCY:
GIVES PUBLIC OPPORTUNITY TO COMMENT; AND
PROVIDES OPPORTUNITY FOR PUBLIC MEETING
1
J
LEAD AGENCY:
RESPONDS TO COMMENTS;
PREPARES ROD AMENDMENT; AND
* REGIONAL OR ASSISTANT ADMINISTRATOR
SIGNS ROD AMENDMENT
J
LEAD AGENCY:
PUBLISHES NEWSPAPER NOTICE; AND
* PLACES ROD AMENDMENT INTO
ADMINISTRATIVE RECORD FILE
-------
8-20
FIGURE 8-5
Process That Results in the Issuance of an Amended ROD:
Changes Resulting from Enforcement Activities
CONSENT DECREE:
* l» SIGNED; AND
INCLUDES SIGNIFICANT CHANGE
THAT WOULD FUNDAMENTALLY
CHANGE THE REMEDY.
CONSENT DECREE FILED WITH
U.S. DISTRICT COURT
i
J
LEAD AGENCY:
* PREPARES AMENDED PROPOSED PLAN; AND
* GIVES SUPPORT AGENCY OPPORTUNITY
TO COMMENT.
Q
CC
cc
o
UL
(/>
o
<
o
o
1U
z
LEAD AGENCY:
* PUBLISHES NEWSPAPER NOTICE;
* PLACES PROPOSED PLAN AND RELEVANT
INFORMATION IN ADMINISTRATIVE RECORD |
FILE; AND
MAKES CONSENT DECREE AVAILABLE.
LEAD AGENCY:
* GIVES PUBLIC OPPORTUNITY TO
COMMENT ON PROPOSED PLAN; AND
* PROVIDES OPPORTUNITY FOR
PUBLIC MEETING,
DOJ PROVIDES OPPORTUNITY TO COMMENT
ON CONSENT DECREE.
i
LEAD AGENCY:
* RESPONDS TO COMMENTS;
» PREPARES ROD AMENDMENT; AND
* REGIONAL OR ASSISTANT ADMINISTRATOR
SIGNS ROD AMENDMENT
DOJ RESPONDS TO COMMENTS ON
CONSENT DECREE.
1
LEAD AGENCY:
* PUBLISHES NEWSPAPER NOTICE; AND
* PLACES ROD AMENDMENT IN
ADMINISTRATIVE RECORD FILE.
J
LEAD AGENCY:
* RESPONDS TO COMMENTS; AND
* MOTIONS TO ENTER INTO CONSENT DECREE.
i
J
CONSENT DECREE IS ENTERED
WITH U.S. DISTRICT COURT.
J
-------
OSWER Directive 9355.3-02
8-7
is to lead to decisions during design and construction that optimize the cost-
effectiveness and performance of the remedy. There will be instances,
therefore, in which these value engineering decisions result in significant
changes to the remedy.
Unlike the public, PRPs, and the support agency, who are subject to the
consideration standard discussed in Section 8.3, the lead agency has the
discretion to make decisions regarding the post-ROD information it generates.
As previously mentioned, the intent of the consideration standard is to
determine what public or support agency information the lead agency should
respond to and document in the administrative record file. The intent of this
standard does not apply to information the lead agency generates itself, since
there is no need to respond to that information.
The lead agency's initial analysis should focus on whether the new
information generated during RD/RA prompts the lead agency to initiate a
change to the remedy. The change may be either a non-significant or a
significant change to the ROD. If the lead agency determines a significant
change is warranted, then the lead agency should consult with the support
agency to determine the appropriate procedures for documenting that
significant change (e.g., an ESD or ROD amendment). The procedures for
evaluating the magnitude of the changes made to a remedy and, therefore, the
documentation procedures that should be followed, are presented in the next
section.
8.6 CATEGORIES OF POST-ROD CHANGES
Once the lead agency determines that a change to the remedy is warranted
based on the information submitted by the public, PRPs, the support agency, or
simply generated through the RD/RA process, the change should be evaluated to
determine whether it is one of the following:
A non-significant or minor change;
A significant change to a component of the remedy; or
A fundamental change to the overall remedy.
-------
OSWER Directive 9355.3-02
APPENDIX E
HELPFUL HINTS:
HOW TO PREPARE AND SUBMIT DECISION DOCUMENTS
TO HEADQUARTERS
After a decision document -- Proposed Plan, Record of Decision (ROD),
Explanation of Significant Differences (ESD), or ROD Amendment -- is issued, a
copy should be sent as soon as possible to the following office in
Headquarters:
Chief, Remedial Planning and Response Branch
Hazardous Site Control Division (OS-220)
Office of Emergency & Remedial Response
U.S. EPA
401 M Street, S.W.
Washington, D.C. 20460
The following procedures should be followed in preparing and submitting
decision documents to Headquarters.
1. FORMAT
One clear, LEGIBLE copy of the document (Proposed Plan, ROD, ESD, or
ROD Amendment) should be provided to Headquarters. In addition, a
computer file of the ROD and/or ROD Amendment should be provided on
a diskette.
All documents should follow the format described in this guidance.
All RODs and ROD Amendments should be single spaced.
All documents should come to Headquarters completely assembled and
legible. Do not send sections separately.
For RODs and ROD Amendments, THE SIGNED AND DATED SIGNATURE PAGE
SHOULD ALWAYS BE INCLUDED.
-------
OSWER Directive 9355.3-02
E-2
2. ATTACHMENTS. CHARTS. TABLES, MAPS, AND EXHIBITS
All columns and text should be displayed completely.
Computer printouts should be LEGIBLE, especially cost sheets. Dot
matrix printouts do not copy well.
Try to avoid including reduced documents (tables and texts), because
these documents tend to be illegible.
3. COST TABLES
All columns and figures in the cost tables should be LEGIBLE,
especially those that apply to the selected alternative.
Costs should be broken down into capital, operation and maintenance
and present-worth costs.
4. ENFORCEMENT CONFIDENTIAL INSERTS
Enforcement confidential pages should be labeled clearly and
CONSPICUOUSLY.
-------
OSWER Directive 9355.3-02
APPENDIX F
SOURCES OF INFORMATION
The following is a list of additional guidance documents that may be
useful in preparing Superfund decision documents or are pertinent to the
remedial decisionmaking process.
-------
OSWER Directive 9355.3-02
F-2
10. State Participation in the Suoerfund Program Manual. Volume I. U.S. EPA,
OSWER Directive 9375.1-04, March 1986.
11. State Participation in the Suoerfund Program. Volume II. U.S. EPA, OSWER
Directive 9375.1-05, March 1986.
12. Interim Guidance on State Participation in Pre-Remedial and Remedial
Response. U.S. EPA, OSWER Directive 9375.1-09, July 1987,
-------
OSWER Directive 9355.3-02
APPENDIX F
SOURCES OF INFORMATION
The following is a list of additional guidance documents that may be
useful in preparing Superfund decision documents or are pertinent to the
remedial decisionmaking process.
1. Comprehensive Environmental Response, Compensation, and Liability Act of
1980 (CERCLA) (P.L. 96-510) as amended by the Superfund Amendments and
Reauthorization Act of 1986 (SARA) (P.L. 99-499).
2. National Oil and Hazardous Substances Pollution Contingency Plan,
Proposed Rule (40 FR 51394), December 21, 1988.
3. Guidance for Conducting Remedial Investigations and Feasibility Studies
under CERCLA (Interim Final), U.S. EPA, OSWER Directive 9355.3-01,
October 1988.
4. CERCLA Compliance with Other Laws Manual, Draft, U.S. EPA, OSWER
Directive 9234.1-01, August 1988.
5. Community Relations in Suoerfund: A Handbook. U.S. EPA, OSWER Directive
9230.0-3B, June 1988.
6. Suoerfund Remedial Design and Remedial Action (RD/RA) Guidance. U.S. EPA,
OSWER Directive 9355.0-4A, June 1986.
7. Guidance on Remedial Actions for Contaminated Groundwater at Suoerfund
Sites (Interim Final), U.S. EPA, OSWER Directive 9283.1-2, December 1988.
8. Guidance on Administrative Records for Selection of CERCLA Response
Actions (Interim), U.S. EPA, OSWER Directive 9833.3, March 1989.
9. Superfund State-Lead Remedial Pro.lect Management Handbook. U.S. EPA,
OSWER Directive 9355.2-01, December 1986.
-------
OSWER Directive 9355.3-02
F-2
10. State Participation In the Superfund Program Manual, Volume I. U.S. EPA,
OSWER Directive 9375.1-04, March 1986.
11. State Participation in the Simerfund Program. Volume II. U.S. EPA, OSWER
Directive 9375.1-05, March 1986.
12. Interim Guidance on State Participation in Pre-Remedial and Remedial
Response. U.S. EPA, OSWER Directive 9375.1-09, July 1987.
13. Superfund Federal-Lead Remedial Pro.lect Management Handbook. U.S. EPA,
OSWER Directive 9355.1-1, December 1986.
14. Guidance on Developing a Superfund Memorandum of Agreement. U.S. EPA,
OSWER Directive 9375.0-01, Fall 1988.
------- |