&EPA
                           United Stales
                           Environmental Protection
                           Agency
                             Office of
                             Solid Waste and
                             Emergency Response
Publication: 9355.3-02FS-4
April 1991
Guide  to  Addressing  Pre-ROD
and  Post-ROD Changes
Office of Emergency and Remedial Response
Hazardous Site Control Division   OS-220W
                                                    Quick Reference Fact Sheet
           Section 117(b) of the Comprehensive Environmental Response, Compensation, and Liability Act
    (CERCLA) contains provisions for addressing and documenting changes to an alternative that occur between
    the time the alternative is proposed as the preferred cleanup approach for a site and the final selection of a
    remedy in a Record of Decision (ROD). In addition, sections 117(c) and (d) of CERCLA contain provisions
    for addressing changes to the remedy that occur after the ROD is signed. The National Oil and Hazardous
    Substances Pollution Contingency Plan (NCP) (55 FR 8666-8865, March 8, 1990) includes requirements for
    public information and community relations (§300.155), and the preparation and documentation requirements
    for remedial investigation/feasibility studies (RI/FSs) and remedy-selection documents (§300.430(c) and (f)(3)).
    It also addresses post-ROD information and public comment in sections 300.435(c)(2) and 300.825(b) and (c).
    This guide outlines the methods for categorizing pre- and post-ROD changes and the ways in which changes
    should be documented. More detailed guidance for pre-ROD changes and both significant and fundamental
    post-ROD changes (i.e., Explanations of Significant Differences (ESDs) and ROD amendments) can be found
    in  Chapters 5  and 8, respectively, of the Interim Final Guidance on Preparing Superfund Decision Documents
    (OSWER Directive 9355.3-02).
    I.  PRE-ROD CHANGES

       When a selected remedial  action reflects  a
    significant change(s) from the preferred alternative
    presented in the Proposed Plan for the remedial
    action, Section 117(b) of CERCLA requires that
    these  changes  be  documented.  A site-specific
    determination of what constitutes a significant (as
    opposed to minor) change, and,  therefore,  the
    extent of documentation required, is made after
    taking the following factors into  consideration: (1)
    the information previously made available  to the
    public;  (2)  the  original  description  of  the
    alternatives presented in the Proposed Plan (and
    outlined in detail in the RI/FS Report); and (3)
    the impact that the changes  may  have on  the
    alternative's scope, performance,  or cost.   (See
    NCP preamble, 55  FR 8772.)

       Minor changes are those that have little or no
    impact on the overall scope, performance, or cost
    of the alternative  originally  presented  in  the
    Proposed Plan as the preferred remedy for the site
    or operable unit. (See Highlight 1 for examples of
    minor changes).

       In  contrast to  minor  changes,  significant
    changes have a significant or fundamental effect on
                                           HIGHLIGHT 1
                                  EXAMPLES OF MINOR CHANGES
                              • Based on information received during the
                                public comment period, the lead agency
                                determines that the capital cost estimate in
                                the Proposed Plan was 10 percent too low.
                                Instead of a cost of $4.7 million the actual
                                capital cost of the remedy is $5.1  million.

                              • It was determined that a remedy will require
                                eight ground-water extraction wells,  rather
                                than six wells as estimated originally in the
                                Proposed Plan, to achieve cleanup objectives
                                within the desired time period.

                              • The volume of material to be excavated and
                                treated is actually 120,000 cubic yards, rather
                                than the 110,000 cubic yards estimated
                                originally in the Proposed Plan.
                           the  scope,  performance,  and/or  cost  of the
                           preferred alternative. They generally involve either
                           (1) selecting as the remedy an RI/FS alternative
                           other than the preferred alternative identified in
                           the Proposed Plan; or (2) substantially modifying

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a component of the previously identified preferred
alternative (e.g., addressing a substantially greater
or  lesser volume  of  waste;  addressing a  new
exposure   pathway;  or   by  encompassing   a
substantially  greater  physical area  of  the  site).
Changes in treatment technologies  or  processes
that substantially alter the long-term effectiveness
or the short-term effectiveness of the alternative
constitute significant changes  of the performance
of the  preferred  alternative.   If the capital  or
operation  and maintenance  costs for  the  final
alternative are  considerably  different  from  the
original estimates, this is considered a significant
change in the cost of the preferred alternative.

DOCUMENTING PRE-ROD CHANGES

   Minor changes to the Proposed Plan  should be
discussed in the Description of Alternatives section
of the ROD  Decision  Summary  and should  be
documented in the Administrative Record File.

   The   type  of  documentation  required  for
significant changes depends on whether or not the
change  is a logical outgrowth of the information
available  to  the  public   for  comment  in  the
Proposed Plan and the RI/FS Report.  A logical
outgrowth occurs where  the public could  have
reasonably  anticipated  the  change,  based on
information available during the  public comment
period and the comments submitted.  A significant
change  would be considered to be  a logical
outgrowth where, based on the comments received
during  the public  comment period,  the Agency
selects,  from among the alternatives discussed in
the FS  and/or Proposed Plan, an alternative (or
parts  of  alternatives)   that  differs  from  the
preferred alternative in the Proposed  Plan.  A
significant change that  is a logical outgrowth of
information available to the public in the Proposed
Plan and RI/FS Report should be documented at
the end of the Decision Summary of the ROD in
the Documentation of Significant Changes section.
Additional public notice or comment on this type
of change is not  necessary.  Examples of types of
significant changes that are logical outgrowths are
presented in Highlight 2.

   In those limited situations in which a significant
change is not a logical outgrowth of the Proposed
Plan  and  its  supporting  information  (i.e.,  the
public could  not  reasonably have  anticipated the
                 HIGHLIGHT 2
       TYPES OF SIGNIFICANT CHANGES
      THAT ARE LOGICAL OUTGROWTHS

      • Changing a Component - In response to a
        commenter, a  change in  the preferred
        alternative's   cost,    timing,   level   of
        performance, or applicable or relevant and
        appropriate  requirements (ARARs)  that
        could have  been  anticipated  by  other
        members of the public.

     •  Combining Components of Alternatives --
        In response to comments, the final remedy
        combines one component of the preferred
        alternative   (e.g.,   for   ground-water
        remediation)   and  a  component  of  a
        different alternative  (e.g., soil  remediation)
        presented in the RI/FS Report.

     •  Selecting  a  Different  Alternative  - An
        alternative evaluated in the FS, other than
        the preferred alternative in the Proposed
        Plan,  is  determined to provide the most
        appropriate  balance of  tradeoffs  among
        alternatives, with respect to the nine criteria,
        in light of public comments.
change that is made) a revised Proposed Plan that
presents  the  new preferred alternative should  be
issued   for  public   comment   (NCP   section
300.430(f)(3)(ii)(B)).   The revised Proposed Plan
must  be  prepared   in  accordance  with  the
requirements of both  CERCLA section 117 and
the NCP.  Appropriate supporting material that
provides  the  necessary engineering, cost, and risk
information  for  the  new  alternative(s),  and
discusses how the new alternative(s) compares to
the other  alternatives with respect to the nine
evaluation  criteria,  should  be provided  in  the
revised Proposed Plan. (It may be appropriate to
provide this  information as a supplement to  the
RI/FS Report.)  In addition, significant changes to
the revised Proposed Plan must be documented at
the end of the Decision Summary of the ROD in
the Documentation of Significant Changes section.
Examples  of types  of significant changes that
require  a new Proposed  Plan, additional public
comment,  and documentation in the ROD  are
presented in  Highlight 3.

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                HIGHLIGHT 3
    TYPES OF SIGNIFICANT CHANGES THAT
      ARE NOT LOGICAL OUTGROWTHS

   • Selection of a new alternative that was not
     previously considered and discussed and is not
     a logical outgrowth ("e.g., combination) of
     considered alternatives.

   • Significant change to a component of the
     selected alternative resulting in fundamental
     changes to the remedy  - A previously
     unidentified ARAR now requires altering the
     remedy design, thus substantially altering the
     feasibility or performance of the alternative.
II.  POST-ROD CHANGES

   After a ROD is signed, new information may be
received  or generated during the RD/RA  that
could affect how the Agency believes the remedy
selected  in  the  ROD should be implemented.
Where information is submitted  by  a  PRP, the
public, or the support  agency after a ROD  is
signed,  the lead  agency should  consider  this
information when each of the following criteria are
met (NCP section 300.825(c)):

   • 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 alter significantly the response action.

   The lead agency may  also evaluate  whether a
change to the remedy is warranted on its initiative,
even  where the  requirements of NCP section
300.825(c) are not met.

   The lead agency's categorization of a change,
which will ultimately affect  the  documentation
procedure required, is a site-specific determination
and should consider the following factors:
   .  Does the change significantly alter the scope
     of the remedy (e.g., 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 and  depending on the
extent or scope of  modification being considered,
the lead agency  determines  that the post-ROD
change  is  (1)  non-significant  or  minor;   (2)
significant; or (3) fundamental. Examples of these
three types of post-ROD changes  are presented in
Highlight 4 (see also NCP preamble, 55 FR 8772).
Each category  is  associated  with  a  different
documentation procedure, as discussed below.

DOCUMENTING POST-ROD CHANGES

   If non-significant or minor changes are made,
they should  be recorded in  the post-decision
document file. If the lead agency chooses, non-
significant changes can be documented  for  the
public in an optional Remedial Design Fact Sheet.
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 (BSD), as required by Section 117(c)
of CERCLA, If fundamental changes are made to
the overall remedy, they should be documented in
a ROD amendment.

EXPLANATION OF SIGNIFICANT
DIFFERENCES (ESDs)

   When documenting significant changes made to
a  remedy, the lead agency must  comply with the
procedures   specified   in   NCP    section
300.435(c)(2)(i). An BSD should be prepared to
provide the  public with an  explanation of the

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                HIGHLIGHT 4
      EXAMPLES OF POST-ROD CHANGES

     1)    Minor. Testing during remedial design
          shows that the volume of soil requiring
          treatment is 75,000 cubic yards rather
          than the 60,000  estimated in the ROD.
          However, the cost of the remedy will
          only increase by 5 percent because of
          economies of scale that can be realized.

     2)    Significant.  Residuals from a
          treatment operation were not expected
          to be hazardous and it was planned to
          dispose of them on site in a Subtitle D
          unit. However,  testing after treatment
          determines that  the residuals are
          hazardous wastes, and off-site disposal
          at a Subtitle C facility is required.

     3)    Fundamental. The in-situ soil washing
          remedy selected in the ROD proves to
          be infeasible to  implement after testing
          during remedial design.  A decision is
          made to excavate and thermally treat
          the waste instead.
nature of the changes made to the remedy,  to
summarize the information that led to making that
change, and  to  affirm that the revised remedy
complies  with  the  statutory  requirements  of
CERCLA section 121.   Generally,  a  new  nine
criteria analysis is not required; however, the ESD
should include a statement that the  ROD meets
ARARs identified at the time the  original ROD
was signed (NCP section 300.430(f)(l)(ii)(B)(l)
and (2)).

   It may  also be appropriate to prepare an ESD
document when the lead agency decides to exercise
a contingency remedy that was not sufficiently
described  in the ROD (see Guide to Developing
Superfund No   Action,  Interim  Action,  and
Contingency  Remedy RODs, Directive  #9335.3-
02FS-3, March 1991).

   During the period  when the ESD  is being
prepared and made available to the public, the lead
agency may 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 change, and the Agency
is not reconsidering the overall remedy.  The lead
agency should consult with the support agency, as
appropriate,  prior to issuing  an  ESD (see NCP
section 300.435(c)(2)).  Although not specifically
required  by  CERCLA  section 121 (f), it  is also
recommended for the lead agency to provide the
support agency the opportunity to comment and to
summarize the support agency's comments in the
ESD. The agency also should publish a notice of
availability and a brief description of the ESD in a
local newspaper of general circulation (as required
by CERCLA Section 117(c)), and make the ESD
available  to  the public  by  placing  it  in  the
administrative  record   file  and   information
repository. A formal public comment period is not
required  when issuing an  ESD.  The Office of
Emergency  and  Remedial Response  (OERR)
recommends issuing the ESD in a fact sheet format
as  outlined  in Highlight  5.   The  appropriate
Regional Manager may sign an ESD.  (NOTE:  In
some cases, an additional public comment period
or public meeting may  be held voluntarily on  a
planned ESD (see NCP  section 300.825(b)). This
may be useful where there is considerable public or
PRP interest in the  matter.)

ROD AMENDMENT

   In a few cases, new information  submitted by
the public post-ROD or  developed  by the lead
agency during the remedial design/remedial action
leads to the reconsideration of the hazardous waste
management approach selected in the ROD. Such
reconsideration  of  the  remedy  constitutes  a
fundamental  change. When fundamental changes
are made to  the remedy selected in a ROD,  the
lead agency should conduct the public participation
and documentation  procedures specified in NCP
section 300.435(c)(2)(ii).

   In  general, the  introductory sections  of  the
ROD  do  not  need  to be readdressed  in  the
amended  ROD.  The focus of the amendment
should be on:

   •  Documenting    the    rationale    for   the
     amendment;

   •  Evaluating the original selected remedy and
     the  new proposed remedy  using the nine
     evaluation criteria; and

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                                           HIGHLIGHT 5
                                   SAMPLE FORMAT FOR ESD

Introduction:  Begin with an introduction to the site and a statement of purpose for the ESD, including:
   Site name and location;
   Identification of lead and support agencies;
   Citation of CERCLA section  117(c) and NCP section 300.435(c)(2)(i);
   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 (NCP 300.825(a)(2)); and
•  Address of location where the File is available and hours of availability of the File.

Summary of Site History, Contamination Problems, and Selected Remedy:  Summarize the following aspects
of the site or  operable unit:

•  The contamination problems and site history, including the date on which the ROD was signed; and
•  The selected remedy, as originally described in the ROD.

Description of the  Significant Differences and  the Basis for those Differences:  Summarize the significant
changes to the remedy and the basis for making those changes, including:

•  Information that gave rise to significant differences from the selected remedy as it was originally specified,
   which could include the following: (1) the results of treatability studies; or (2) other information developed
   or provided during the remedial design process that supports the change. Reference 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, or cost
   between the original and  modified remedies, as nece_ssary.  For example:
          Original Remedy

    Excavation and incineration of 7,500
    cubic yards of contaminated soil.

    Air stripping and ground-water
    restoration.
Modified Remedy

Excavation and incineration of 11,500
cubic yards of contaminated soil.

Carbon adsorption for ground-water
restoration.
Support Agency Comments: Include a summary of support agency comments on the ESD.

Affirmation of the Statutory Determinations: Affirm that the modified remedy continues to satisfy the
requirements of CERCLA section 121 by including a statement such as the following:

"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 were identified  [(1) in the ROD/(2) in
this ESD] as applicable or relevant and appropriate to this remedial action (at the time  [(1) the original
ROD/(2) this ESD] was signed), 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.'1

Public Participation Activities:  Document compliance with the appropriate public participation requirements:

•  That notice has been issued that the contents of the Administrative Record File are available for public
   review and comment; and
•  The date of planned public information meetings, if applicable. (EPA is not required  to hold public
   meetings on  ESDs but may choose to do so  if warranted by public interest.)

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   • Providing  assurances   that  the   proposed
     remedy satisfies the statutory requirements.

The format for a ROD amendment is presented in
Highlight 6.

   If the ROD to be amended 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.
Under SARA §121, for the  portion  of  the ROD
being amended,  a  new  nine  criteria  analysis,
including a  new ARARs analysis, will  be necessary.
Portions of the analysis in the original ROD can
be cross-referenced, where appropriate. Therefore,
the amount of information  included in a ROD
amendment is a function of the type  of change
made to the remedy and the rationale for  that
change.   RD/RA  activities  being conducted on
other portions  of  the site or operable  units not
proposed for changes may  continue during the
amendment process.

   When there are fundamental changes proposed
to the ROD, the lead agency should conduct the
public participation and documentation procedures
conducted  for the  original ROD (e.g.,  Proposed
Plan,  public comment  period,   Responsiveness
Summary).  (See NCP section 300.435(c)(2)(ii)(A)-
(H).)  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 a change is made after a consent decree
has been entered, involvement of the  court may be
required.  Site managers should  check with their
regional   counsel   on   how   this   may   be
accomplished.)   ROD amendments should be
signed by the Regional Administrator.
                HIGHLIGHT 6
   SAMPLE FORMAT FOR ROD AMENDMENT

Introduction

•  Site Name and Location;
•  Identify lead and support agencies;
.  Cite CERCLA §117 and NCP 300.435(c)(2)(ii);
•  Date of ROD signature;
•  Summarize circumstances that led to the need for a
   ROD amendment;
•  State that ROD amendment will become part of
   the Administrative Record File (NCP section
   300.825(a)(2)); and
•  Provide address where File is available for public
   review and hours of availability.

Reasons for Issuing the ROD Amendment

•  Identify remedy selected in ROD; and

•  Summarize rationale for changing  remedy selected
   in the ROD.

Description of the New Alternatives

•  Describe the original selected remedy and the new
   proposed remedies in the same manner requested
   in a standard ROD, highlighting the:

•  Treatment components;

•  Containment or storage components;

•  Ground-water components;

•  General components;  and

•  Major ARARs.

Evaluation of Alternatives

•  Profile the original selected remedy and the new
   proposed remedies against the nine criteria.

Statutory Determinations

•  Provide a statement that the modified remedy
   satisfies CERCLA §121.

NOTE:  See guidance on preparing RODs for scope
and detail of subjects to be addressed under each
point.
  NOTICE:  The policies set out in this memorandum are intended solely as guidance. They are not intended, nor can
  they be relied upon, to create any rights enforceable by any party in litigation with the United States.  EPA officials
  may decide to follow the guidance provided in this memorandum, or to act at variance with the guidance, based on
  an analysis of specific site circumstances.  The Agency also reserves the right to change this guidance any time
  without public notice.

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