v>EPA
United States
Environmental Protection
Agency
Five-Year Review Process in the
Superfund Program
April 2003
EPA as required by statute and, as a matter of policy, reviews the remedies at certain sites every five
years. Section 121 of the Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA), as amended by the. Superfund Amendments and Reauthorization Act of 1986 (SARA),
requires that remedial actions which result in any hazardous substances, pollutants, or contaminants
remaining at the site be subject to a Five-Year Review. The National Oil and Hazardous Substances
Pollution Contingency Plan (NCP) defines this to mean contamination left at levels that do not allow for
unlimited use and unrestricted exposure. This fact sheet summarizes the guidance document,
Comprehensive Five-Year Review Guidance (EPA 540-R-01-007) that EPA issued in June 2001.
This document summarizes previously issued guidance to EPA personnel. It is not a regulation and does not create any legal obligations on any
person or entity. EPA will apply the guidance referenced in this document to any particular project only to the extent appropriate in light of the
facts EPA welcomes public comment on this document at any time.
TABLE OF CONTENTS
A. Overview " 1
B. When is a Five-Year Review conducted? 1
C. Who is responsible for conducting the Five-Year
Review? . . -: 2
D. What are the components of a Five-Year Review? 3
E. How does EPA assess the protectiveness of a
remedy? 4
F. How does EPA formulate its conclusions? 6
A. Overview
Under CERCLA §121(c), EPA is required to
review the remedies at Superfund sites
where hazardous substances remain at levels
that potentially pose an unacceptable risk.
Such reviews must be conducted every five
years or may be conducted more frequently
if necessary to ensure the protectiveness of
the remedy. The Five-Year Review
requirement applies to remedial actions
selected under CERCLA §121 upon
completion of which, hazardous substances,
pollutants, or contaminants will remain on
site. Five-Year Reviews are also conducted
as a matter of policy for other CERCLA
actions. Removal actions conducted under
CERCLA § 104 and Corrective Actions
conducted under the Resource Conservation
and Recovery Act (RCRA) are not subject to
the Five-Year Review requirement;
however, Regions may conduct Five-Year
Reviews for these or other remedies as a
matter of policy or at their discretion. In
June 2001, EPA issued the Comprehensive
Five-Year Review Guidance (EPA 54Q-R-
01-007) to aid Regions and other agencies
with responsibilities for conducting Five-
Year Reviews. This fact sheet was prepared
as a brief summary of that guidance
document.
B. When is a Five-Year Review
conducted?
A Five-Year Review may be required or
appropriate when a remedial action leaves
hazardous substances on the site at levels
that do not allow for unlimited use and
unrestricted exposure. Unlimited use and
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unrestricted exposure (UU/UE) means that
there are no restrictions placed on the
potential use of land or other natural
resources. In general, if the selected remedy
relies on restrictions of land, ground water,
or surface water use by humans or if any
physical or engineered barrier is part of the
remedy, then the use has been limited and a
Five-Year Review should be conducted.
There are two types of Five-Year Reviews,
statutory and policy. Statutory reviews are
required by CERCLA at post-SARA
remedial actions that upon completion of the
action leave hazardous substances,
pollutants or contaminants on site. Policy
reviews are performed, as a matter of policy,
for pre-SARA remedial actions that leave
hazardous substances, pollutants or
contaminants on site, and at removal-only
NPL sites where hazardous substances,
pollutants or contaminants were left on site
at levels that do not permit unlimited use
and unrestricted exposure. Policy reviews
are also conducted at other sites, including
pre- or post-SARA remedial actions, that
will take more than five years to complete.
The initiation, or trigger date, that starts the
Five-Year Review period depends upon
whether it is a statutory or policy review and
if the review is a first or subsequent review.
A statutory review is triggered by the
initiation of the first remedial action that
leaves hazardous substances, pollutants or
contaminants on site at levels that do not
allow for unlimited use and unrestricted
exposure. In cases where there are multiple
remedial actions, the earliest remedial action
that leaves such substances on site should
trigger the initial review, even if it is an
interim remedial action.
A policy review is initially triggered by the
date that the construction phase for all
remedies is completed at a site. The date of
construction completion is generally the date
of the Preliminary Close Out Report
(PCOR) or the date of the Final Close Out
Report (FCOR) for sites that do not have a
PCOR.
After completion of the first statutory or
policy Five-Year Review, the trigger'for
subsequent reviews is the signature date of
the previous Five-Year Review report. Lead
agencies may choose to conduct a Five-Year
Review earlier or more frequently than
every five years to ensure protection of
human health and the environment.
Five-Year Reviews continue throughout the
life of the site until hazardous substances,
pollutants or contaminants no longer remain
on site at levels that do not allow for
unlimited use and unrestricted exposure.
The basis for this finding should be
documented in the final Five-Year Review
report.
C. Who is responsible for conducting the
Five-Year Review?
The lead agency, the agency providing the
remedial project manager, has primary
responsibility for conducting the Five-Year
Review, while the support agency provides
information and review support.
EPA also encourages appropriate State and
Tribal involvement for Fund-financed and
Enforcement-lead remedial actions. Where
the State or Tribe is the lead agency, the
NCP provides that EPA concurrence is
needed on the protectiveness determination
contained in the Five-Year Review. At
federal facilities, the Federal agency in
charge of the facility has the responsibility
to conduct the Five-Year Review. EPA
should provide concurrence with the
protectiveness determinations, or develop its
own independent determinations.
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D. What are the components of a Five-
Yea r Review?
The Five-Year Review process integrates
information taken from decision documents '
and operational data with the experiences of
those responsible for and affected by actions
at the site. There are six components to the
Five-Year Review process: 1) community
involvement and notification, 2) document
review, 3) data review and analysis, 4) site
inspection, 5) interviews and 6)
protectiveness determination as shown in
Figure 1. Together, the reviewer uses these
components to assess the remedy's
performance, and, ultimately, to determine
the protectiveness of that remedy.
Community Involvement and Notification
The reviewer begins working with the site's
Community Involvement Coordinator (CIC)
during the initial planning stages of the
Five-Year Review to determine the
appropriate level of community involvement
and to notify all potentially interested parties
that the Five-Year Review will be
conducted. This notification may include
States, Tribes, appropriate representatives of
the community, local officials, potentially
responsible parties (PRPs), Federal and/or
State Trustees for Natural Resources
(Trustees) and appropriate EPA offices. It
is recommended that EPA's community
involvement activities during the review
include notifying the community that the
Five-Year Review will be conducted,
notifying the community that the Five-Year
Review has been completed, and providing
the results of the review to the local site
repository.
Document Review
A review of documents is an early step in
the Five-Year Review process. All relevant
documents and data are reviewed to obtain
information to assess performance of the
response action. The lead agency reviews
various documents to obtain the necessary
information, including those for remedy
decisions (e.g., Records of Decision,
Explanation of Significant Differences),
enforcement decisions (e.g., Consent
Decrees, Administrative Orders on
Consent), site investigations, remedial
design and construction, and remedy
performance.
Data Review and Analysis
The lead agency also reviews sampling and
monitoring plans and results from
monitoring activities, operation and
maintenance (O&M) reports or other
documentation of remedy performance,
including previous Five-Year Review
reports. The data contained in these reports
form the primary basis for the technical
analyses and for the subsequent
protectiveness determination. The type and
quality of these data will have a significant
impact on findings and conclusions. In
some cases, the lead agency may also need
to conduct supplemental sampling or collect
other data.
Site Inspections
EPA or the lead agency conducts site
inspections to gather information about a
site's current status and to visually confirm
and document the conditions of the remedy,
the site, and the surrounding area. The
inspection should be recent, and be
conducted no more than nine months before
the expected signature date of the review.
At Federal facility sites, a State and/or EPA
representative may wish to be present and/or
participate in site inspections.
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Community
Involvement j
and
Notification
Document
Review
Figure 1: Components of the Five-Year Review Process
Interviews
As necessary, interviews may be conducted
to provide additional information about a
site's status and/or identify remedy issues.
Individuals who may be interviewed
include: the site manager; site personnel;
Federal, State, and Tribal regulatory
authorities; and people who live or work
near the site.
E. How does EPA assess the
protectiveness of a remedy?
The purpose of a Five-Year Review is to
determine whether the remedy at a site is, or
upon completion will be, protective of
human health and the environment. EPA's
technical assessment of a remedy examines
the three questions shown in Figure 2.
These questions provide a framework for
organizing and evaluating data and ensure
that all relevant issues are considered when
determining the protectiveness of the
remedy.
Question A: Is the remedy functioning as
intended?
When answering Question A, the reviewer
focuses on the technical performance of the
remedy, whether that remedy is related to a
single Operable Unit (OU) or the entire site.
Data on monitoring, system performance
and operation and maintenance of the
remedy plays an important role in the
determinations. In addition, EPA confirms
that access and institutional controls (ICs)
are in place and successfully prevent
exposure. In answering Question A, the
reviewer should consider the
implementation status of the remedy.
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Q uestion A : Is th e
remedy functioning as
intended by the decision
documents?
Question B: Are the
exposure assumptions,
toxicity data and Remedial
Action Objectives used at
the tim e o:f fern edy
selection still valid?
•
Question C : Has any other inform a tion
come to light that could call into
question the protectiveness of the
remedy?
Figure 2: Three Questions for Assessing Protectiveness
When the Remedy is under Construction
The focus of the review is to determine if
the remedy is being constructed in
accordance with the requirements of the
decision documents and design
specifications, and if the remedy is expected
to be protective when it is completed.
When the Remedy is Operating or
Completed
Additional aspects of remedy
implementation are addressed. In general,
the following will be assessed:
• Remedial action performance,
« System operations/operation and
maintenance (O&M),
• Costs of system opef ations/O&M,
• Implementation of institutional controls
and other measures,
• Monitoring activities,
» Opportunities for optimization, and
• Early indicators of potential remedy
problems.
Question B: Are the exposure assumptions,
toxicity data, cleanup levels, and Remedial
Action Objectives still valid?
In answering Question B, the lead agency
should review all the risk parameters on
which the original remedy decision was
based. This assessment should test the
validity of all assumptions that underlie the
original risk calculation. To reach its
conclusions, the lead 'agency will generally
consider changes in:
• Target populations,
• Exposure routes,
• Site characteristics and land use,
• Reference doses and slope factors,
• Applicable or Relevant and Appropriate
Requirements (ARARs) and To Be
Considereds (TBCs), and
• Remedial Action Objectives (RAOs).
EPA generally will not reopen remedy
selection decisions contained in RODs
unless a new or modified requirement calls
into question the protectiveness of the
selected remedy.
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Question C: Has any other information
come to light that could call into question
the protectiveness of the remedy?
The reviewer considers any other
information that comes to light that could
call into question the protectiveness of the
remedy. Situations of interest to EPA may
include the following:
• Ecological risks had not been adequately
evaluated or addressed at a site, and
there is no plan in place to address these
risks through a future action;
• The site, although located entirely above
the 500-year flood boundary, was
partially inundated by a 100-year flood;
and
• Land use changes that are being
considered by local officials.
F. How does the lead agency formulate its
conclusions?
The conclusions of the Five-Year Review
should include:
• Identification of issues,
• Recommendations and follow-up
actions, and
• A determination of whether the remedy
is, or is expected to be, protective of
human health and the environment.
The reviewer arrives at these conclusions
through a technical assessment of the
information collected during the document
review, data collection, interviews, site
inspection, and other activities.
The reviewer identifies all issues that
currently prevent or may prevent the
response action from being protective.
Examples of issues that may be identified in
a Five-Year Review report include the
following:
• Inadequate ICs,
• Cleanup levels are not protective due to
changes in chemical characteristics, and
• Remedial Action Objectives will not be
achieved.
Section 4.4.1 of the Guidance contains
additional examples.
The reviewer documents all such issues and
follow-up actions needed to ensure the ,
proper management of the remedy in the
Five-Year Review report. The reviewer
should also identify early indicators of
potential remedy problems.
For each issue identified, the reviewer
documents and ensures implementation of
recommendations to resolve those issues.
These recommendations are linked to
follow-up actions in the Five-Year Review
report. In addition, the reviewer may make
additional recommendations that do not
directly relate to achieving or maintaining
the protectiveness of the remedy, such as
activities related to O&M of the remedy and
coordination with other public and
government authorities. The following are
the types of additional recommendations
that may be included in the report:
• Provide additional response actions,
• Improve O&M activities,
• Optimize remedy,
• Enforce access controls and ICs, and
• Conduct additional studies or
investigations.
After addressing Questions A, B, and C, the
reviewer determines the protectiveness of
the remedy or remedies at a site and
documents the rationale for its
determination(s). The reviewer should
make a protectiveness determination for
each OU. For sites that have reached
construction completion, it is recommended
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the review include an additional,
comprehensive site-wide protectiveness
statement.
The determination of whether the remedy
remains protective of human health and the
environment generally will be based on the
answers to Questions A, B, and C and the
information obtained in the process of
answering them. Although protectiveness
generally is defined by the risk range and
hazard index (HI), the answers to Questions
A, B, and C may identify other factors and
issues that may impact the protectiveness of
a remedy.
At the end of the technical analysis and
evaluation, if the answers to Questions A, B,
and C are yes, yes, and no, respectively, then
the remedy normally will be considered
protective. However, if the answers to the
three questions are other than yes, yes,, and
no, depending on the elements that affect
each question, the remedy may be one of the
following:
• Protective,
• Will be protective once the remedy is
completed,
• Protective in the short-term; however, in
order for the remedy to be protective in
the long-term, follow-up actions need to
be taken,
• Not protective, unless the following
action(s) are taken in order to ensure
protectiveness, or
• Protectiveness cannot be determined
until further information is obtained.
If a protectiveness statement cannot be
made, a time frame should be provided
when a protectiveness determination will be
made. This is done through an addendum.
If this is the case, the next Five-Year
Review is due five years from the date that
the report is signed, not from the signature
date of the addendum.
Even if there is a need to conduct further
actions, it does not mean that the remedy is
not protective. Normally, the remedy may
be considered not protective when the
following occur:
• An immediate threat is present (e.g.
exposure pathways that could result in
unacceptable risks are not being
controlled);
• Migration of contaminants is
uncontrolled and poses an unacceptable
risk to human health or the
environment;
• Potential or actual exposure is present or
there is evidence of exposure (e.g.,
institutional controls are not in place or
not enforced and exposure is occurring);
or
• The remedy cannot meet a new cleanup
level and the previous cleanup level is
outside of the risk range.
Once the Five-Year Review report is signed
and placed in the local site repository, the
lead agency should notify community
members that the review is complete and the
report is available.
As discussed in Section 1.3.3, the date EPA
signs the report is the official completion
date for the Five-Year Review, and this date
becomes the trigger date for subsequent
reviews. This date should be entered into
WasteLan as soon as possible.
FOR MORE INFORMATION
For additional information on the Five-Year
Review process, please contact your
Regional or Headquarters Five-Year Review
Coordinator.
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Office of Solid Waste and Emergency Response OS WER 9355.7-08FS
Washington, D.C. 20460 EPA 540-F-02-004
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