United States

Environmental

Protection Agency

Office of Emergency

and Remedial

Response (5204G)

EPA 540-R-01-007

OSWER No. 9355.7-03B-P

June 2001

Superfund 

Comprehensive

Five-Year Review

Guidance

Office of Emergency and Remedial Response

U.S. Environmental Protection Agency

Washington, D.C. 20460

URL: http://www.epa.gov/superfund/pubs.htm

Superfund Information 1-800-424-9346
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OSWER No. 9355.7-03B-P

i

Preface

The U.S. Environmental Protection Agency (EPA) is issuing this “Comprehensive FiveYear Review Guidance” to assist EPA Headquarters (HQ), Regional staff, and support agencies

responsible for conducting five-year reviews under the Comprehensive Environmental Response,

Compensation, and Liability Act (CERCLA). This guidance generally is intended to promote

consistent implementation of the five-year review process. 

Section 121 of 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) further

provides that remedial actions which result in any hazardous substances, pollutants, or

contaminants remaining at the site above levels that allow for unlimited use and unrestricted

exposure be reviewed every five years to ensure protection of human health and the environment.

The Five-Year Review requirement applies to all remedial actions selected under

CERCLA §121. Therefore, sites with CERCLA remedial actions may be subject to a five-year

review. Consistent with Executive Order (EO) 12580, other Federal agencies are responsible for

ensuring that five-year reviews are conducted at sites where five-year reviews are required or

appropriate.

This guidance is designed and intended to:

C Provide an approach for conducting five-year reviews;

C Facilitate consistency across the ten EPA Regions;

C Clarify current policy; and

C Discuss roles and responsibilities of various entities in conducting or supporting

five-year reviews.

This guidance supersedes the following directives on five-year reviews:

C Office of Solid Waste and Emergency Response (OSWER) Directive 9355.7-02

(May 23, 1991), Structure and Components of Five-Year Reviews;

C OSWER Directive 9355.7-02FS1 (August 1991), Factsheet: Structure and

Components of Five-Year Reviews;
OSWER No. 9355.7-03B-P

ii

The policies and procedures established in this document are intended solely for the guidance of

government personnel. They are not intended, and cannot 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.

This document provides guidance to EPA Regions concerning how the Agency intends to exercise its

discretion in implementing one aspect of the CERCLA remedy selection process. The guidance is

designed to implement national policy on these issues. 

Some of the statutory provisions described in this document contain legally binding requirements. 

However, this document is not a substitute for those provisions or regulations, nor is it a regulation

itself. Thus, it cannot impose legally-binding requirements on EPA, States, or the regulated

community, and may not apply to a particular situation based upon the circumstances. Any decisions

regarding a particular remedy selection decision will be made based on the statute and regulations,

and EPA decision makers retain the discretion to adopt approaches on a case-by-case basis that

differ from this guidance where appropriate. EPA may change this guidance in the future.

C OSWER Directive 9355.7-02A (July 26, 1994), Supplemental Five-Year Review

Guidance; and

C OSWER Directive 9355.7-03A (December 21, 1995), Second Supplemental FiveYear Review Guidance.

In addition, this guidance updates and supersedes the text regarding five-year reviews in:

C OSWER 9200.1-23P (July 1999), A Guide to Preparing Superfund Proposed

Plans, Records of Decision, and Other Remedy Selection Decision Documents.

Questions or comments concerning this guidance should be directed to the appropriate

EPA Headquarters Regional Center.
OSWER No. 9355.7-03B-P

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Table of Contents

List of Acronyms ........................................................... vii

1.0 OVERVIEW ......................................................... 1-1

1.1 What is the purpose of a five-year review? ...................... 1-1

1.2 When are five-year reviews required or appropriate? .............. 1-1

1.2.1 When is a statutory review required? .......................... 1-2

1.2.2 When is a policy review appropriate? .......................... 1-3

1.2.3 When should five-year reviews be completed? ................... 1-4

1.2.4 When can five-year reviews be discontinued? .................... 1-4

1.3 When does the five-year review period begin? ................... 1-4

1.3.1 What actions first trigger a statutory review? .................... 1-4

1.3.2 What actions first trigger a policy review? ...................... 1-5

1.3.3 What are triggers for subsequent statutory and policy reviews? ...... 1-5

1.4 How do five-year reviews apply to a site with multiple operable units? 1-5

1.4.1 How is a multiple operable unit site categorized? ................. 1-5

1.4.2 When is it appropriate to conduct a separate five-year review for different

areas of a large and complex site? ............................ 1-6

1.4.3 How is a site with pre- and post-SARA RODs categorized? ......... 1-6

1.5 What are some other considerations for five-year reviews? ......... 1-6

1.5.1 Are five-year reviews required for a site that has been deleted or partially

deleted from the NPL? ...................................... 1-7

1.5.2 Are five-year reviews required for a site with a RCRA response? .... 1-7

1.5.3 How is a site that has an interim or early remedial action handled? . . 1-7

1.5.4 How is a site that has a no action or a no further action ROD handled?1-8

1.5.5 How is a ROD that includes monitored natural attenuation handled? . 1-8

1.5.6 How is a ROD that includes institutional controls handled? ........ 1-8

2.0 ROLES AND RESPONSIBILITIES FOR EPA, STATES, TRIBES, AND OTHER

FEDERAL AGENCIES ................................................ 2-1

2.1 What are the roles of the lead and support agencies? .............. 2-1

2.1.1 What are the roles of the lead agency? ......................... 2-2

2.1.2 What are the roles of the support agency? ...................... 2-2

2.2 Who conducts the review at a Fund-financed site? ................ 2-3

2.3 What if a site is an Enforcement-lead site? ...................... 2-3

2.4 What if site activities are led by a State or Tribe? ................. 2-3

2.5 What if site activities are led by another Federal agency or department? 2-4

2.5.1 What is the purpose of FFAs at other Federal agency NPL sites? .... 2-7

2.5.2 What is EPA’s role at NPL sites under the jurisdiction of another Federal

agency or department? ..................................... 2-8

2.5.3 What is EPA’s role at a non-NPL site under the jurisdiction of another

Federal agency or department? ............................... 2-8
OSWER No. 9355.7-03B-P

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2.5.4 What are States’ roles at non-NPL sites under the jurisdiction of a Federal

agency or department? ..................................... 2-9

2.5.5 What happens when Federal agencies or departments transfer real

property? ................................................ 2-9

3.0 COMPONENTS OF THE FIVE-YEAR REVIEW PROCESS ................ 3-1

3.1 Who is notified when planning the five-year review? .............. 3-1

3.2 How should I develop a review schedule? ....................... 3-1

3.3 How should I establish a review team? ......................... 3-1

3.4 How should I involve the community? ......................... 3-2

3.5 What data do I need to evaluate the remedy? .................... 3-3

3.5.1 How are documents reviewed? ............................... 3-4

3.5.2 How should I conduct interviews? ............................. 3-4

3.5.3 How should I conduct site inspections? ......................... 3-5

3.6 What should I include in Five-Year Review reports? .............. 3-5

3.7 How should I submit a Five-Year Review report? ................ 3-8

3.7.1 How is an EPA-lead report submitted? ......................... 3-8

3.7.2 How is a Federal facility-lead report submitted? ................. 3-8

3.7.3 How is a State or Tribal-lead report submitted? .................. 3-8

3.8 What are the annual reporting requirements to EPA Headquarters? ... 3-9

4.0 ASSESSING THE PROTECTIVENESS OF THE REMEDY ................ 4-1

4.1 Question A: Is the remedy functioning as intended by the decision

documents? .............................................. 4-2

4.1.1 How do I answer Question A for a remedial action that is under

construction? ............................................. 4-3

4.1.2 How do I answer Question A for a remedial action that is operating or 

completed? ............................................... 4-3

4.2 Question B: Are the exposure assumptions, toxicity data, cleanup levels,

and remedial action objectives used at the time of remedy selection still

valid? ................................................... 4-4

4.2.1 How should I check the impact of changes in standards and TBCs? . . 4-6

4.2.2 How should I check the impact of changes in exposure pathways? ... 4-7

4.2.3 How should I check the impact of changes in toxicity and other

contaminant characteristics? ................................. 4-7

4.2.4 How should I review RAOs and evaluate their impact? ............ 4-8

4.3 Question C: Has any other information come to light that could call into

question the protectiveness of the remedy? ...................... 4-9

4.4 How should I develop the conclusions of my five-year review? ..... 4-10

4.4.1 How should I identify issues? ............................... 4-10

4.4.2 When and how should I develop recommendations? .............. 4-11

4.5 How do I determine protectiveness? .......................... 4-13

4.5.1 How do I formulate protectiveness statements? ................. 4-21
OSWER No. 9355.7-03B-P

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Exhibits

Exhibit 1-1: Types of Actions Subject to Five-Year Reviews ........................ 1-3

Exhibit 2-1: Typical Roles in the Five-Year Review Process ........................ 2-4

Exhibit 2-2: Federal Responsibilities Under Executive Order 12580 .................. 2-6

Exhibit 2-3: Federal Facility Agreements and Five-Year Reviews .................... 2-7

Exhibit 3-1: Potential Members of the Five-Year Review Team ...................... 3-2

Exhibit 3-2: Notification Requirements for Five-Year Reviews ..................... 3-3

Exhibit 3-3: Contents of a Five-Year Review Report ............................. 3-6

Exhibit 4-1: Three Questions Used to Determine Whether a Remedy is Protective ....... 4-1

Exhibit 4-2: Example Questions to Determine if Assumptions Upon Which the Remedy 

was Based Have Changed ......................................... 4-5

Exhibit 4-3: Example Table for Listing Issues ................................... 4-11

Exhibit 4-4: Example Table for Listing Recommendations and Follow-up Actions ...... 4-13

Exhibit 4-5: Examples of Protectiveness Determinations .......................... 4-15

Exhibit 4-6: Protectiveness Statements ........................................ 4-21

Exhibit 4-7: Comprehensive Protectiveness Statements for Sites that Have Reached

Construction Completion ......................................... 4-22

Appendices

Appendix A: Community Involvement ......................................... A-1

Appendix B: Document Review ............................................... B-1

Appendix C: Five-Year Review Interviews ...................................... C-1

Appendix D: Five-Year Review Site Inspection Checklist .......................... D-1

Appendix E: Five-Year Review Report Template ................................. E-1

Appendix F: Sample Five-Year Review Report ................................... F-1

Appendix G: Methods and Examples for Evaluating Changes in Standards and Toxicity . . G-1
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OSWER No. 9355.7-03B-P

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List of Acronyms

AOC Administrative Order on Consent

ARARs Applicable or Relevant and Appropriate Requirements

CA Cooperative Agreement

CAG Community Advisory Group

CD Consent Decree

CERCLA Comprehensive Environmental Response, Compensation, and Liability Act 

CERCLIS Comprehensive Environmental Response, Compensation, and Liability

Information System

CFR Code of Federal Regulations

CIC Community Involvement Coordinator

CIP Community Involvement Plan

DOD Department of Defense

DOE Department of Energy

EO Executive Order

EPA United States Environmental Protection Agency

ESD Explanation of Significant Differences

FCOR Final Close Out Report

FFA Federal Facility Agreement

FFRRO Federal Facilities Restoration and Reuse Office

FR Federal Register

HASP Health and Safety Plan

IAG Interagency Agreement

IC Institutional Control

IRIS Integrated Risk Information System

LOAEL Lowest Observed Adverse Effect Level

MCLs Maximum Contaminant Levels

MNA Monitored Natural Attenuation

NCP National Oil and Hazardous Substances Pollution Contingency Plan

NOAEL No Observed Adverse Effect Level

NPL National Priorities List

O&M Operation and Maintenance

OECA Office of Enforcement and Compliance Assurance

OERR Office of Emergency and Remedial Response

OSHA Occupational Safety and Health Administration

OSWER Office of Solid Waste and Emergency Response

OU Operable Unit

PCOR Preliminary Close Out Report

PRP Potentially Responsible Party

RA Remedial Action

RAGS Risk Assessment Guidance for Superfund
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RAO Remedial Action Objective

RCRA Resource Conservation and Recovery Act

RD/RA Remedial Design/Remedial Action

RI/FS Remedial Investigation/Feasibility Study

ROD Record of Decision

RPM Remedial Project Manager

SARA Superfund Amendments and Reauthorization Act of 1986

SMOA Superfund Memorandum of Agreement

SPIM Superfund Program Implementation Manual

SSC Superfund State Contract

TAG Technical Assistance Grant

TBCs To Be Considereds

USACE United States Army Corps of Engineers

USCG United States Coast Guard

UU/UE Unlimited Use/Unrestricted Exposure

WasteLan The Regional database related to CERCLIS
OSWER No. 9355.7-03B-P

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1.0 OVERVIEW

This chapter covers the purpose of five-year reviews, when are reviews required or

appropriate, discontinuation of five-year reviews, and triggering actions for five-year reviews. 

This chapter also discusses the application of the Five-Year Review policy to sites with multiple

operable units (OUs), division of large complex sites, pre- and post-Superfund Amendments and

Reauthorization Act of 1986 (SARA) sites, Records of Decision (RODs), and deleted or partially

deleted sites. You will also find information on Comprehensive Environmental Response,

Compensation, and Liability Act (CERCLA) remedial actions (RAs), CERCLA remedial actions

at sites with Resource Conservation and Recovery Act (RCRA) response, and interim/early

remedial actions. Finally, the chapter discusses how no action or no further action RODs,

monitored natural attenuation (MNA), and institutional controls (ICs) impact five-year reviews.

1.1 What is the purpose of a five-year review?

The purpose of a five-year review is to evaluate the implementation and performance of a

remedy in order to determine if the remedy is or will be protective of human health and the

environment. Protectiveness is generally defined in the National Contingency Plan (NCP) by the

risk range and the hazard index (HI). Evaluation of the remedy and the determination of

protectiveness should be based on and sufficiently supported by data and observations.

1.2 When are five-year reviews required or appropriate?

Five-year reviews should be conducted either to meet the statutory mandate under

CERCLA §121(c) or as a matter of EPA policy. Consequently, five-year reviews are classified

in this guidance as either “statutory” or “policy.” The Five-Year Review requirement applies to

all remedial actions selected under CERCLA §121. Regions may also conduct other five-year

reviews at their discretion.

You should consider a number of factors when determining whether to conduct a fiveyear review, as discussed in the following two sections (see Sections 1.2.1 and 1.2.2). In general,

five-year reviews are required whenever a remedial action results in hazardous substances,

pollutants, or contaminants remaining on site. Under the Agency’s interpretation contained in

the NCP, the requirement in CERCLA §121(c) is triggered when remaining on-site hazardous

substances, pollutants, or contaminants are above levels that allow for “unlimited use and

unrestricted exposure.” See 40 CFR §300.430(f)(4)(ii).

CERCLA §121(c) states the following:

If the President selects a remedial action that results in any hazardous

substances, pollutants, or contaminants remaining at the site, the President shall

review such remedial action no less often than each five years after the initiation
OSWER No. 9355.7-03B-P

1

The general response authority of CERCLA §104(c)(4) applies to both removal and remedial actions.

104(c)(4). Also see 40 CFR §300.430(f)(4)(ii).

2

 Generally, SARA became effective the date it was passed (October 17, 1986). See Pub. L. 99-499, Oct.

17, 1986, 100 Stat. 1672.

1-2

of such remedial action to assure that human health and the environment are

being protected by the remedial action being implemented. In addition, if upon

such review it is the judgment of the President that action is appropriate at such

site in accordance with section [104] or [106], the President shall take or require

such action. The President shall report to the Congress a list of facilities for

which such review is required, the results of all such reviews, and any actions

taken as a result of such reviews.

The Agency interpreted this requirement further in the National Contingency Plan (NCP) 

(40 CFR §300.430(f)(4)(ii)) which states:

If a remedial action is selected that results in hazardous substances, pollutants, or

contaminants remaining at the site above levels that allow for unlimited use and

unrestricted exposure, the lead agency shall review such action no less often than

every five years after the initiation of the selected remedial action.

“Unlimited use and unrestricted exposure” (UU/UE) means that the selected remedy will

place no restrictions on the potential use of land or other natural resources. In general, if the

selected remedy relies on restrictions of land and/or groundwater use by humans and/or

ecological populations to be protective, then the use has been limited and a five-year review

should be conducted. For example, if a site is cleaned up to an industrial-use level, and/or other

types of uses are restricted (e.g., residential use), then, generally, UU/UE is not met. Exhibit 1-1,

“Types of Actions Subject to Five-Year Reviews,” provides examples of the types of remedial

actions subject to statutory and policy reviews.

1.2.1 When is a statutory review required?

CERCLA requires five-year reviews if both of the following conditions are true: 

• Upon completion of the remedial action, hazardous substances, pollutants, or

contaminants will remain on site1; and

• The ROD for the site was signed on or after October 17, 1986 (the effective date

of SARA2) and the remedial action was selected under CERCLA §121.
OSWER No. 9355.7-03B-P

1-3

Exhibit 1-1: Types of Actions Subject to Five-Year Reviews

If the action/site is . . . then a review is . . . and examples of actions or

components of actions include . . . 

a post-SARA remedial action that,

upon completion, will leave

hazardous substances, pollutants, or

contaminants on site above levels

that allow for unlimited use and

unrestricted exposure

required by statute – waste stabilization, fixation, or

encapsulation on site

– landfill cap or covers and slurry walls

– institutional controls

S sediment capping 

a pre- or post-SARA remedial

action that, upon completion, will not

leave hazardous substances,

pollutants, or contaminants on site

above levels that allow for unlimited

use and unrestricted exposure, but

requires five or more years to

complete

conducted as a matter of

EPA policy, until cleanup

levels are achieved,

allowing unlimited use and

unrestricted exposure

– long-term monitored natural

attenuation

– long-term groundwater pump and

treatment

– long-term bioremediation of

groundwater or soil

– other long-term remedies, such as soil

washing and land farming

S monitored natural recovery

(sediments)

a pre-SARA remedial action that will

leave hazardous substances,

pollutants, or contaminants on site

above levels that allow for unlimited

use and unrestricted exposure

conducted as a matter of

EPA policy

– waste stabilization, fixation, or

encapsulation on site

– landfill cap or covers and slurry walls

– institutional controls

a removal action that takes place

at a site on the NPL that leaves

hazardous substances, pollutants, or

contaminants on site above levels

that allow for unlimited use and

unrestricted exposure and where no

remedial action has or will take

place

conducted as a matter of

EPA policy

– excavation and treatment where

hazardous substances, pollutants, or

contaminants remain on site above

levels that allow for unlimited use and

unrestricted exposure

1.2.2 When is a policy review appropriate?

Five-year reviews generally should be conducted as a matter of policy for the following

types of actions:

• A pre- or post-SARA remedial action that, upon completion, will not leave

hazardous substances, pollutants, or contaminants on site above levels that allow

for unlimited use and unrestricted exposure, but requires five years or more to

complete;

• A pre-SARA remedial action that leaves hazardous substances, pollutants, or

contaminants on site above levels that allow for unlimited use and unrestricted

exposure; or
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• A removal-only site on the NPL where a removal action leaves hazardous

substances, pollutants, or contaminants on site above levels that allow for

unlimited use and unrestricted exposure and where no remedial action has or will

take place.

1.2.3 When should five-year reviews be completed?

The first five-year review generally should be completed and signed by the EPA Region

within five years of the initial trigger date (see Sections 1.3.1 and 1.3.2). As a matter of policy,

you should complete subsequent statutory or policy five-year reviews no later than five years

following the signature date of the previous Five-Year Review report. Five-year reviews may be

conducted earlier or more frequently than every five years, if needed, to ensure the protection of

human health and the environment.

1.2.4 When can five-year reviews be discontinued?

Five-year reviews may no longer be needed when no hazardous substances, pollutants, or

contaminants remain on site above levels that allow for unlimited use and unrestricted exposure. 

The basis for this finding should be documented in your final Five-Year Review report. When

you make this determination prior to the first five-year review, you should record it in a

document subject to public comment, such as a Proposed Plan or a Notice of Intent to Delete. 

When notice of five-year review discontinuation is given in a document other than a Five-Year

Review report, the Region should submit a memorandum, signed by the Regional Administrator

or his/her designee, to Headquarters. The memorandum should provide the reason for not

conducting five-year reviews and cite the document in which this decision was made and

supported.

1.3 When does the five-year review period begin?

The initiation or trigger date that starts the five-year review period depends upon whether

the review is categorized as statutory or policy. However, the review should be completed within

5 years of its trigger date regardless of its category. Lead agencies may choose to conduct a fiveyear review earlier, or more frequently, than every five years to ensure the protection of human

health and the environment. A discussion of the first and subsequent triggers for both statutory

and policy review is provided below.

1.3.1 What actions first trigger a statutory review?

In accordance with CERCLA §121 and the NCP, a statutory review is triggered by the

initiation of the first remedial action that leaves hazardous substances, pollutants, or

contaminants on site above levels that allow for unlimited use and unrestricted exposure. In

cases where there are multiple remedial actions, the earliest remedial action that leaves hazardous
OSWER No. 9355.7-03B-P

1-5

substances, pollutants, or contaminants on site should trigger the initial review, even if it is an

interim remedial action.

For the purpose of a five-year review, a remedial action typically is initiated on the date

of “actual RA on-site construction” or the “actual RA start” date for Federal facilities. The date

of actual RA on-site construction generally corresponds to the date the contractor begins work at

a site for the remedial action, typically the date of on-site mobilization. The definition of the

“actual RA start” varies as outlined in the Superfund/Oil Program Implementation Manual

(SPIM). For remedies where on-site mobilization may not occur, as a matter of policy, the date

of the first monitoring event following ROD signature or the ROD signature itself should be used

to trigger the five-year review period. 

1.3.2 What actions first trigger a policy review?

A policy review initially should be triggered by the date that construction 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. The PCOR or FCOR date also triggers the initial five-year review at NPL removal-only

sites.

1.3.3 What are triggers for subsequent statutory and policy reviews?

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. For reviews

led by other Federal agencies, States, or Tribes, and where EPA has a concurrence role, the

trigger for subsequent reviews corresponds to EPA’s concurrence signature date of the preceding

Five-Year Review report (see Sections 3.7.2 and 3.7.3).

1.4 How do five-year reviews apply to a site with multiple operable units?

Five-year reviews for sites with multiple OUs, as a matter of policy, should address all

OUs and remedial actions that have been initiated at the time of the review, except for situations

as described in Section 1.4.2. At the Regions’ discretion, the five-year review may also include

and consider areas of a site where no remedial action has been selected or initiated.

1.4.1 How is a multiple operable unit site categorized?

Five-year reviews for multiple OU sites can be categorized as either statutory or policy.

As a matter of policy, a site is subject to a statutory review if any one of its initiated remedial

actions is subject to a statutory review. A site is subject to a policy review if no initiated actions

are subject to a statutory review and at least one action is subject to a policy review.
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1.4.2 When is it appropriate to conduct a separate five-year review for different

areas of a large and complex site?

At some large and complex sites, individual OUs, or groups of OUs, may have been

treated as separate sites throughout the remedial process. Under these circumstances, Regions

may continue to treat these areas separately and conduct individual five-year reviews for each

area. Each five-year review should include the status and protectiveness determination of the

five-year reviews conducted for the other areas of the entire site. Regions may choose to

combine the separate reviews of different areas into a single five-year review prior to, or

following, construction completion for the entire site. However, no area should be reviewed later

than five years after its trigger date or previous review.

Actions within each area may trigger its respective statutory or policy review. However,

in cases where site-wide construction completion will not be achieved for an extended period of

time, the initial trigger date for a policy review should correspond to the date that physical

construction is complete at the area under consideration. The Region should establish this date

on a site-specific basis which should be based on the signature date of the Interim or Final RA

Report.

1.4.3 How is a site with pre- and post-SARA RODs categorized?

At sites where there are both pre- and post-SARA RODs, the pre-SARA remedial actions

are subject under this policy to post-SARA Five-Year Review procedures. For example, suppose

a pre-SARA remedial action initially is subject to a policy review because hazardous substances,

pollutants, or contaminants are permanently left on site above levels that allow for unrestricted

use and unlimited exposure. If a post-SARA ROD is signed for that same site, a five-year review

should be conducted, unless the post-SARA ROD selects a remedy that removes all on site

hazardous substances, pollutants, or contaminants including the hazardous substances, pollutants,

or contaminants left on site by the pre-SARA action. In such cases, the original five-year review

schedule should be maintained as a matter of policy. If no schedule has been established, the

post-SARA trigger should be utilized. 

1.5 What are some other considerations for five-year reviews?

This section discusses other considerations (i.e., deletions, RCRA responses, interim and

early remedial actions, no action or no further action RODs, monitored natural attenuation, and

institutional controls) that may affect the need for and conduct of five-year reviews.
OSWER No. 9355.7-03B-P

3

 In 1991, EPA clarified its policy on whether a site deleted from the NPL is subject to a five-year review. 

See “Notice of Policy Change,” 56 FR 66601 (December 24, 1991). In appropriate circumstances, a site does not

need to be kept on the NPL solely for the purposes of conducting five-year reviews (See 55 Fed Reg at p. 8699).

4

The memorandum “Coordination Between RCRA Corrective Action and Closure and CERCLA Site

Activities” was issued by Steven A. Herman, Assistant Administrator, Office of Enforcement and Compliance

Assurance, and Elliott P. Laws, Assistant Administrator, OSWER (September 24, 1996).

5

Interim and Early actions are defined in Chapter 8 in A Guide to Preparing Superfund Proposed Plans,

Records of Decision, and other Remedy Selection Decision Documents. EPA 540-R-98-031, OSWER 9200.1-23P

(July 1999)

1-7

1.5.1 Are five-year reviews required for a site that has been deleted or partially

deleted from the NPL?

It is EPA’s policy that the Five-Year Review requirement is independent of and

unaffected by the deletion process.3 Consistent with the NCP, a site can be deleted or partially

deleted from the NPL once the deletion criteria have been satisfied. If a site has been deleted or

is in the process of being deleted, your Five-Year Review report should address the status of any

deletion action. Five-year reviews continue as needed after deletion.

1.5.2 Are five-year reviews required for a site with a RCRA response?

In 1996, EPA established a policy to defer some CERCLA cleanup activities to the

RCRA program. The policy is outlined in the memorandum “Coordination Between RCRA

Corrective Action and Closure and CERCLA Site Activities.”4

 This policy allows site managers

to defer cleanup activities for all or part of a site from CERCLA to RCRA (or vice versa). If a

site is deferred to RCRA prior to being placed on the NPL, or is deleted from the NPL prior to

the selection of the remedy and deferred to RCRA for corrective action, you do not need to

conduct a five-year review.

In cases where full deferral is not appropriate, it is possible that both RCRA and

CERCLA authorities will be used to address a site. When a RCRA action is included as a part of

a CERCLA action, the RCRA action should be included in the five-year review as a matter of

policy, if a five-year review is required or appropriate. 

1.5.3 How is a site that has an interim or early remedial action handled?

Regions should conduct five-year reviews for interim or early actions selected under

CERCLA §121 consistent with Section 1.2 of this guidance.5 For instance, Regions should

conduct a review if an alternate water supply is installed and hazardous substances, pollutants, or

contaminants remain on site above levels that allow for unlimited use and unrestricted exposure. 

If a subsequent action reduces the hazardous substances, pollutants, or contaminants on site to
OSWER No. 9355.7-03B-P

6

 Regions should refer to OSWER 9355.0-74FS-P, dated September 2000, entitled Institutional Controls:

A Site Manager’s Guide to identifying, evaluating and selecting Institutional Controls at Superfund and RCRA

Corrective Action Cleanups for further information on institutional controls and remedy selection.

1-8

levels that allow unlimited use and unrestricted exposure, then reviews may be discontinued (see

Section 1.2.4).

1.5.4 How is a site that has a no action or a no further action ROD handled?

Consistent with Section 1.2, Regions should conduct a five-year review for a remedy

where a no action or no further action ROD leaves hazardous substances, pollutants, or

contaminants on site above levels that allow for unlimited use and unrestricted exposure. For

example, as a matter of policy Regions should conduct a review for an NPL site with a no action

ROD where a removal-only action leaves hazardous substances, pollutants, or contaminants on

site above levels that allow for unlimited use and unrestricted exposure, or where groundwater

monitoring or other types of monitoring of contamination above action levels is the only remedial

action selected. However, no five-year review may be needed when monitoring is used only to

verify absence of contamination. 

1.5.5 How is a ROD that includes monitored natural attenuation handled?

CERCLA §121 remedies relying on monitored natural attenuation or natural attenuation

may be subject to five-year reviews consistent with Section 1.2. If monitored natural attenuation

is included in a no action or a no further action ROD, then that ROD is not considered to be no

action or no further action and therefore, Regions may need to conduct a five-year review,

consistent with this guidance. 

1.5.6 How is a ROD that includes institutional controls handled?

Institutional controls may be part of remedies selected under CERCLA §121 and

consistent with Section 1.2 of this guidance may be subject to five-year reviews.6 If institutional

controls are included in a no action or a no further action ROD, and protectiveness relies on the

institutional control, then that ROD is not considered to be no action or no further action and

therefore, Regions may need to conduct a five-year review.
OSWER No. 9355.7-03B-P

7

Executive Order No. 12580 of January 23, 1987, as amended on August 28, 1996.

8As discussed in section 2.4, State enforcement-lead cleanups are not subject to this guidance.

9

See 40 CFR §300.5.

10Id.

2-1

2.0 ROLES AND RESPONSIBILITIES FOR EPA, STATES, TRIBES,

AND OTHER FEDERAL AGENCIES

This chapter discusses the roles and responsibilities of U.S. Environmental Protection

Agency (EPA), other Federal agencies, State agencies, and Tribes, in conducting five-year

reviews. As a general matter, for remedies selected under Comprehensive Environmental

Response, Compensation, and Liability Act (CERCLA) §121, except at non-NPL Federal facility

sites, EPA has the ultimate authority for determining whether a remedy subject to the Five-Year

Review requirements in CERCLA §121(c) is protective. The National Oil and Hazardous

Substances Pollution Contingency Plan (NCP) addresses, in general, the involvement of State

agencies and Tribes in CERCLA actions in 40 CFR §300.515 and §300.520. Finally, CERCLA

§120 and Executive Order (EO) 125807 address the responsibilities of Federal agencies in

carrying out CERCLA cleanups.8

2.1 What are the roles of the lead and support agencies?

Under the NCP, the lead agency provides for the remedial project manager (RPM) “to

plan and implement [the] response action;”9 a response action would include conducting a fiveyear review. A support agency “furnish[es] necessary data to the lead agency, reviews response

data and documents, and provides other assistance.”10 The NCP also encourages appropriate

State and Tribal involvement for Fund-financed and Enforcement-lead remedial actions (see 40

CFR §300.515 and §300.520). Where the State or Tribe is the lead agency, the NCP provides

that EPA concurrence is needed on remedy selection decisions (see 40 CFR §300.515(e) and

§300.520).

The relative roles and responsibilities for lead and support agencies can vary significantly

depending on ability, resources, and legal authorities. There are a number of documents that can

be used to specify roles and responsibilities of lead and support agencies. Some of these are

general in scope, while others are more narrow in scope and apply solely to a specific site. 

General instruments include Superfund Memoranda of Agreement (SMOAs), Cooperative

Agreements (CAs), and Superfund State Contracts (SSCs). Normally, SMOAs are general, nonsite-specific agreements that EPA uses to define roles and interactions in conducting a response

action. EPA uses CAs to transfer Superfund monies to States or Tribes for response activities. 

SSCs are used to identify EPA and State or Tribal roles and responsibilities required under
OSWER No. 9355.7-03B-P

2-2

CERCLA §104. Site-specific agreements include Consent Decrees, Administrative Orders on

Consent, and Federal Facility Agreements (FFAs). If no SMOA, SSC, or CA is available, a letter

of agreement should be written to define roles and responsibilities for the five-year review,

consistent with the NCP (see 40 CFR §300.515). Wherever possible, the specific roles and

responsibilities regarding the conduct of a five-year review should be detailed in a single

document to avoid confusion and disputes at a later date. 

2.1.1 What are the roles of the lead agency?

The lead agency conducts the five-year review, prepares the Five-Year Review report,

and submits the report to the support agency for review and comment. The lead agency is also

responsible for conducting community involvement activities and for ensuring that

recommendations and follow-up actions identified during five-year reviews are completed. 

Generally, funding for five-year reviews is provided by EPA for Fund-financed sites, Potentially

Responsible Parties (PRPs) for Enforcement-lead sites (through appropriate mechanisms), and by

other Federal agencies or departments for Federal facility sites. 

Where EPA is the lead agency pursuant to 40 CFR §300.515, the Region should submit a

copy of its final Five-Year Review report to EPA Headquarters (HQ) within 10 days of signature,

and provide copies to the support agency and site information repositories. Where the State or

Tribe is the lead agency, pursuant to 40 CFR §300.515, the State should submit a copy of the

final Five-Year Review report to the Region; once the Region has concurred, the Region should

provide a copy to EPA HQ within 10 days of signature, to any other support agencies, and to site

information repositories. Where another Federal agency or department is the lead agency,

pursuant to CERCLA §120 and EO 12580, the Federal agency or department should submit a

copy of the final Five-Year Review report to the Region; once the Region has concurred, the

Region should provide a copy to HQ within 10 days of signature, to any other support agencies,

and to site information repositories.

2.1.2 What are the roles of the support agency?

The role of the support agency is to participate in the review process, if requested, and 

review and comment on the Five-Year Review report. Where the State or Tribe is the lead

agency for a response action (such as conducting a five-year review), the NCP provides that it

must obtain EPA’s concurrence (see 40 CFR §300.515(e)).

The lead agency should give the support agency an adequate opportunity to participate in

the five-year review process and to review and comment on the draft Five-Year Review report

before it is finalized. When there is more than one support agency involved, time allowances for

review and comment should be the same for all support agencies who choose to participate in the

review process. The amount of time that a support agency will have to review the Five-Year

Review report should be documented in the SMOA, SSC, CA, or other agreement documents,
OSWER No. 9355.7-03B-P

2-3

but should not be less than review times for other remedy decision documents (see 40 CFR

§300.515(h)(3)). The goal should be to resolve any concerns of support agencies before drafting

the final report. In any case, the support agency or agencies may provide written comments on

the Five-Year Review report. Lead and support agencies should work together throughout the

five-year review process to ensure that concerns are resolved in a timely manner, and to the

extent practicable, prior to finalizing the Five-Year Review report.

2.2 Who conducts the review at a Fund-financed site?

At Fund-financed sites, the ultimate responsibility for the protectiveness determination

rests with EPA. As described in Section 2.1, EPA may be the lead or support agency.

Regions may acquire the services of a contractor or establish agreements with other

agencies (e.g., the U.S. Army Corps of Engineers) to perform studies, conduct investigations,

and/or develop draft Five-Year Review reports. In all cases, Regions should ensure the quality

and completeness of review activities and the content of the final Five-Year Review report. 

2.3 What if a site is an Enforcement-lead site?

At CERCLA Enforcement-lead sites, the ultimate responsibility for the quality and

completeness of review activities and the content and protectiveness determinations of the FiveYear Review report rests with EPA. As described in Section 2.1, EPA may be the lead or

support agency.

At sites in which EPA is the lead agency Regions may acquire the services of a contractor

or establish agreements with other agencies (e.g., the U.S. Army Corps of Engineers) to perform

studies, conduct investigations, and/or develop draft Five-Year Review reports.

PRPs or PRP-hired contractors may perform certain support activities (e.g., data

collection, studies or analysis) according to provisions of an enforceable agreement. 

2.4 What if site activities are led by a State or Tribe?

As described in Section 2.1, States and Tribes can be the lead agency in carrying out a

five-year review. In those cases, States or Tribes should ensure the quality and completeness of

review activities and the content of the final Five-Year Review report, prior to submitting the

report to the Region for EPA’s concurrence. When a State or Tribe provides EPA with a FiveYear Review report, EPA can choose to concur with the report and protectiveness statements or

make its own protectiveness determinations. 
OSWER No. 9355.7-03B-P

2-4

Where a State or Tribe conducts a cleanup using its own legal authorities (e.g., State

enforcement action under a CERCLA-equivalent State law), the remedy is not selected pursuant

to CERCLA §121 and is not subject to the Five-Year Review requirement.

Exhibit 2-1 provides an overview of the typical roles of different parties for each type of

response action. 

Exhibit 2-1: Typical Roles in the Five-Year Review Process*

If the

response

action is...

at... under... then conducting

the review is the

responsibility of...

with

funding

by...

and with the

EPA Region...

Fundfinanceda site CERCLA

§121,and

CERCLA §104

the lead agency;

when the lead agency

is a State or Tribe, EPA

concurs;

Superfund making or

concurring with the

protectiveness

determination.

Enforcement

-lead

a site CERCLA §104

and §121, along

with a Consent

Decree or other

enforcement

document

the lead agency; when

the lead agency is a

State or Tribe, EPA

concurs. (PRPs may

be allowed to provide

certain support for fiveyear reviews);

PRPs making or

concurring with the

protectiveness

determination.

Other

Federal

agency or

department

(e.g., led by

Department

of Defense,

Department

of Energy or

Department

of the

Interior)

a Federal facility

NPL site 

CERCLA §104,

§120 and §121, 

Executive Order

12580, and a

Federal Facility

Agreement

the respective Federal

agency or department

the

respective

Federal

agency or

department

making or 

concurring with 

the protectiveness

determination.

Other

Federal

agency

a Federal facility

non-NPL site

CERCLA §104

and §121, and

Executive Order

12580

the respective Federal

agency or department

the

respective

Federal

agency or

department

commenting on 

the protectiveness

determination 

(if requested).

Note: * The scenarios presented in the exhibit are not all inclusive. Regions should determine the respective

roles in the five-year review process when other circumstances exist. EPA does not have a role in fiveyear reviews at non-NPL Federal facility sites; however, EPA Regions may comment or be asked to

comment on a site-specific basis.

2.5 What if site activities are led by another Federal agency or department?

CERCLA §104, §120, and §121 identify functions and responsibilities vested in the

President for undertaking response efforts and coordinating all other efforts at the scene of a
OSWER No. 9355.7-03B-P

2-5

release on or from Federally-owned property (or vessels). The President, in EO 12580, delegates

some of these responsibilities to the respective Federal agencies and departments for Federallyowned or Federally-operated facilities over which these lead agencies have jurisdiction, custody,

or control.

Therefore, at sites where activities are led by another Federal agency or department, the

Federal agency or department has responsibilities for selecting remedies and implementing the

remedial actions, and for conducting all required five-year reviews. The Federal agency or

department is responsible for planning, coordinating, funding, and conducting five-year reviews

and for making protectiveness determinations upon conclusion of each five-year review. Federal

agencies or departments are encouraged to have EPA, States, and Tribes participate and comment

throughout the five-year review process, as appropriate. Federal agencies or departments are also

responsible for initiating resolutions to issues and following up on all recommendations that

result from these five-year reviews. Federal agencies or departments may not adopt or utilize

guidelines that are inconsistent with EPA’s Five-Year Review guidance or certain other EPA

guidance, as specified in CERCLA §120(a)(2).

C Federal facility sites that are listed on the NPL – EO 12580 paragraphs 2(d) and

(g) delegate remedial responsibilities to the Department of Defense (DOD) and

the Department of Energy (DOE), and to EPA, respectively. In addition, at all

Federal facility NPL sites, CERCLA §120 requires Federal agencies or

departments to perform remedial investigation and feasability studies (RI/FS) (see

CERCLA §120(e)(1)), to enter into Inter-Agency Agreements (IAGs) (frequently

called Federal Facility Agreements), and to initiate remedial actions, subject to

EPA concurrence. Therefore, five-year reviews are conducted by the Federal

agency or department that has jurisdiction, custody, or control, but EPA retains

final authority over whether the five-year reviews adequately address the

protectiveness of remedies. EPA will either concur with the final Federal agency

or department protectiveness determination, or EPA may provide independent

findings. Disputes which arise related to protectiveness determinations or

independent findings by EPA may be resolved on a site-specific basis through

formal dispute resolution procedures, typically established in FFAs. Exhibits 2-2

and 2-3 and Sections 2.5.1 and 2.5.2 discuss Federal facility NPL sites and FFAs

in more detail.

C Non-NPL Federal facilities – EO 12580, paragraphs 2(d) and (e), give remedial

responsibilities, and therefore five-year review responsibilities, to the Federal

agency or department having jurisdiction, custody, or control. EPA may also be

asked to comment, to the extent practical, on five-year reviews or protectiveness

determinations at non-NPL Federal facilities. Section 2.5.3 discusses non-NPL

Federal facilities in more detail.
OSWER No. 9355.7-03B-P

2-6

Exhibit 2-2 below provides an overview of relevant EO 12580 sections and their

applicability.

Exhibit 2-2: Federal Responsibilities Under Executive Order 12580

In EO 12580

section(s)...

the President 

delegates to... 

certain remedial

functions and

responsibilities in 

CERCLA section(s)...

and those remedial functions

and responsibilities at Federal

facilities generally pertaining

to...

2(b) EPA (in consultation with

the National Response

Team)

121(f)(1) promulgation of regulations

assuring substantial and meaningful

State involvement (in initiation,

development, and selection of

remedial actions to be undertaken

in the State).

2(d) DOD, DOE, (subject to

the requirements

described in

CERCLA §120) 

104(a),

104(b),

104(c)(4),

and 121 selecting and taking NPL and nonNPL(1) (2) remedial actions, which

includes both conducting five-year

reviews and making protectiveness

determinations (with EPA

concurrence at NPL sites).

2(e) Federal Departments/

Agencies (for non-NPL

Federal facility sites.)

104(a),

104(b),

104(c)(4),

and 121 selecting and taking non-NPL

remedial actions, which includes

both conducting five-year reviews

and making protectiveness

determinations.

2(g) EPA (subject to the above

delegations) 

104(a),

104(b),

104(c)(4),

and 121 selecting and taking NPL remedial

actions, which includes conducting

five-year reviews and making

protectiveness determinations at

Fund-lead and Enforcement-lead

NPL sites.

Note: (1) EPA does not have a role in five-year reviews at non-NPL Federal facility sites; however, EPA Regions

may be asked to comment on a site-specific basis. 

 

 (2) In addition to the EO 12580 delegation of remedy selection and remedial action responsibilities to all

Federal agencies and departments for non-NPL Federal facility sites, CERCLA §120(e) establishes

remedy selection and remedial action responsibilities for Federal agencies and departments for all

Federal facility NPL sites, as well. For example, CERCLA §120(e)(2) requires Federal agencies and

departments to enter into NPL IAGs (frequently called FFAs) with EPA (States may participate.) 

CERCLA §120(e)(4) requires FFAs to address selection of remedies and completion of remedial actions

at Federal facility NPL sites. FFAs, where applicable, should specify the procedures to be followed with

respect to conducting five-year reviews at Federal facility NPL sites.  

The following subsections detail responsibilities for conducting five-year reviews at sites

led by other Federal departments and agencies.
OSWER No. 9355.7-03B-P

2-7

2.5.1 What is the purpose of FFAs at other Federal agency NPL sites?

CERCLA §120(e)(2) requires that EPA sign an IAG (frequently called an FFA) with

responsible Federal agencies or departments to detail respective roles and responsibilities for

remedial actions at NPL sites. CERCLA §120(e)(1) requires Federal agencies or departments to

conduct remedial investigations in consultation with EPA and appropriate State authorities at

Federal facility NPL sites. Most Federal facility NPL sites will have site-specific roles and

responsibilities specified in the FFA. CERCLA §120(e)(4) requires FFAs to include selection of

remedies, completion of remedial actions, and arrangements for long-term operation and

maintenance of the facility. Therefore, the procedures for conducting five-year reviews and

making protectiveness determinations fall within the scope of FFAs. FFAs should specify in

detail the procedures governing five-year reviews at Federal facility NPL sites. 

OSWER Directive 9320.0-75 (November 29, 1996), “Federal Facilities Streamlined

Oversight Directive” reiterates EPA’s responsibility for oversight of remedial activities at

Federal facility NPL sites. States and Tribes, as regulators, may also have an oversight role,

defined in the FFA, at a facility. Exhibit 2-3 describes the topics to be addressed in an FFA. 

Exhibit 2-3: Federal Facility Agreements and Five-Year Reviews

CERCLA § 120(e)(2) requires that the relevant Federal agency or department must enter into an FFA (IAG in the

statute) with EPA within six months after EPA’s review of the Remedial Investigation/Feasibility Study (RI/FS) is

completed. States may be signatories to the FFA and under CERCLA §120 (f) must be included in the decisionmaking process at Federal facility NPL sites. Whenever a Federal facility is located on Tribal lands, the

appropriate Tribal government should be involved. 

CERCLA §120(e)(4), in the case of schedules, requires that the EPA/DOD and EPA/DOE Model FFA contain

procedures for the submission and review of documents, schedules of cleanup activities, and provisions for

dispute resolution. Regions should examine FFAs with respect to the performance of five-year reviews to clarify:

• Roles, responsibilities, and milestones;

• Arrangements for long-term operation and maintenance of the facility; and

• Opportunities for public involvement.

For Federal facilities only, EPA considers Five-Year Review reports to be stand-alone

primary documents or part of another related primary document that should have an enforceable

schedule within the framework of the FFA. Where EPA enters into an FFA, the agreement

should include all site-specific Five-Year Review requirements, such as provisions for reviews,

public participation, and addressing or resolving issues.

Where the roles and responsibilities for conducting five-year reviews and making

protectiveness determinations are not specified in an FFA (for example, the FFA may not have

been signed, or it may be silent or unclear with respect to five-year reviews), then the parties

should rely on this guidance for fulfilling EPA’s obligations under CERCLA §120 and §121,

including making protectiveness determinations. Five-year review requirements should be
OSWER No. 9355.7-03B-P

2-8

identified early in the FFA process, so that the parties to the Agreement have clearly defined

roles and responsibilities for implementing CERCLA §121(c) with respect to five-year reviews. 

However, consistent with CERCLA §120(g), FFAs cannot re-delegate EPA’s final authority over

whether the five-year reviews adequately address the protectiveness of remedies.

2.5.2 What is EPA’s role at NPL sites under the jurisdiction of another Federal

agency or department?

CERCLA §120 and EO 12580 provide the basis for EPA’s oversight role at other Federal

agency NPL sites. This role includes the following:

C Assisting in the determination of cleanup remedies or potentially selecting the

remedies, in consultation with the lead agency and appropriate State authorities,

beginning at the commencement of remedial investigations and feasibility studies;

C Ensuring that Federal agencies or departments appropriately consider all relevant

guidance and policies that EPA determines are appropriate;

C Ensuring compliance with signed FFAs; and

C Determining that decisions protect human health and the environment and that

such decisions are adequately supported in the Five-Year Review report (whether

as a stand-alone primary document or part of a related primary document). 

EPA is not responsible for conducting five-year reviews at Federal facility NPL sites. 

However, EPA’s final remedy selection authority at Federal facility NPL sites requires that EPA

retain final authority to make protectiveness determinations. Accordingly, EPA will either

concur with any protectiveness determinations to ensure protection of human health and the

environment, consistent with EPA’s statutory and regulatory authorities or EPA may provide

independent findings. EPA Regions should review Federal facility NPL Five-Year Review

reports (whether as a stand-alone primary document or part of a related primary document) and

protectiveness determinations for consistency with this guidance and adequacy of the supporting

basis, and should participate or comment throughout the five-year review process, as appropriate. 

2.5.3 What is EPA’s role at a non-NPL site under the jurisdiction of another

Federal agency or department?

EO 12580 paragraphs 2(d) and (e)(1) delegates the authority in CERCLA §104 and §121

to the Federal agencies or departments for selecting and conducting remedial actions addressing

releases or threatened releases at sites that are not on the NPL. Consistent with CERCLA §121

and this guidance, Federal agencies or departments should conduct five-year reviews for all

CERCLA non-NPL remedial actions that require a review (discussed in Section 1.2.1 of this
OSWER No. 9355.7-03B-P

2-9

guidance). It is EPA’s expectation that Federal agencies or departments will also conduct fiveyear reviews as a matter of policy at sites that would be subject to policy reviews if they were on

the NPL (see Section 1.2.2). EPA does not have a statutorily defined role in five-year reviews at

non-NPL Federal facility sites. However, where EPA has had active and substantial involvement

at a non-NPL Federal facility, or where agencies, States, Tribes, or citizens seek EPA comment

on five-year reviews conducted at a non-NPL Federal facility, EPA may, to the extent practicable

on a site-specific basis, comment on five-year reviews and protectiveness determinations made

by other Federal agencies or departments at non-NPL Federal facilities, and/or provide

independent findings, where applicable. 

2.5.4 What are States’ roles at non-NPL sites under the jurisdiction of a Federal

agency or department?

Consistent with CERCLA §120(a)(4), at non-NPL Federal facilities sites, States generally

have remedial oversight responsibilities and should be provided with adequate opportunity to

participate in the five-year review process and to review the draft Five-Year Review document

before it is finalized. 

2.5.5 What happens when Federal agencies or departments transfer real

property?

In instances of Federal-to-Federal transfer of jurisdiction, custody, or control of real

property, the Federal agency or department having initiated CERCLA remedial actions generally

should conduct any required or appropriate five-year reviews. Alternatively, the lead agency may

assure that reviews are conducted by entering into reliable site-specific agreements with the

Federal agency or department gaining control of the property, where those arrangements remain

consistent with CERCLA and EO 12580. In instances of deed transfer of Federal property to

third parties, the Federal agency or department having initiated CERCLA remedial actions

generally should conduct any required or appropriate five-year reviews, unless other reliable sitespecific procedures are arranged with the transferee (or others), and those arrangements remain

consistent with CERCLA and EO 12580. Generally, however, the ultimate responsibility for

conducting five-year reviews should remain with the Federal agency or department that initiated

the CERCLA remedial actions.
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11

 OSWER Directive 9200.4-22A CERCLA Coordination with Natural Resource Trustees, dated July 31,

1997.

3-1

3.0 COMPONENTS OF THE FIVE-YEAR REVIEW PROCESS

This chapter discusses components of the five-year review process, including notifying

potentially interested parties, developing a review schedule, establishing a review team,

involving the community, and signing and submitting the Five-Year Review report. Data and

other site-specific information that form the foundation for the technical assessment of the

remedy at the time of the five-year review are discussed in this chapter, including data and

document review, site interview, site inspection, and components of a Five-Year Review report.

3.1 Who is notified when planning the five-year review?

In the initial planning stages of the five-year review, all potentially interested parties

should be notified that the five-year review will be conducted. This notification may include

States and/or Tribes, appropriate representatives of the community, local officials, Federal and/or

State Trustees for Natural Resources (Trustees)11, appropriate EPA offices, and the Community

Involvement Coordinator (CIC) for the site. Potentially responsible parties should be notified for

Enforcement-lead sites. 

3.2 How should I develop a review schedule?

You should develop a review schedule to meet the appropriate five-year review date of

completion. The review schedule should allow sufficient time for each component of the fiveyear review process, including document review, site inspection, interviews, the assessment of

the protectiveness of the remedy (see Chapter 4), and report development and final submission. 

You should incorporate into the five-year review schedule appropriate time for internal and interagency review and comment periods, community involvement activities, if needed, and finalizing

the report with all required signatures.

3.3 How should I establish a review team?

You should determine the appropriate level of assistance and team structure. For some

reviews, the project manager may be the only member of the team, consulting with technical

experts as necessary. For other reviews, a multi-disciplinary team may be needed to adequately

review the protectiveness of the remedy. Once team members are identified their roles should be

clearly defined. Communication among team members, agencies, and organizations is critical to

ensure that all parties remain informed throughout the entire five-year review process.
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Exhibit 3-1 below provides examples of potential team members for a five-year review.

Exhibit 3-1: Potential Members of the Five-Year Review Team

• Project Manager (EPA, State, Tribal, DOD, DOI)

• Regional Biological Technical Assistance Groups (BTAGs)

• Federal and State Natural Resource Trustees

• Community Involvement Coordinator (CIC)

• State and/or local regulatory agency representatives

• Tribal representatives

• TAG representatives and/or community representatives 

• Other Federal agency representatives (e.g., U.S. Army Corps of Engineers, U.S. Fish and Wildlife Service,

Agency for Toxic Substances and Disease Registry, U.S. Geological Survey, National Oceanic and

Atmospheric Administration) 

• Technical Experts

S Construction representative

S Engineers (e.g., civil, geo-technical, structural, chemical, process)

S Hydrogeologist

S Chemist

S Risk assessor

S Biologist

S Ecologist/ecological risk assessor 

S Attorney/legal advisor

S Environmental regulatory specialist

3.4 How should I involve the community?

You should begin working with the site’s CIC during the initial planning stages of your

five-year review to determine the appropriate level of community involvement. At a minimum,

your community involvement activities during the five-year review should include notifying the

community that the five-year review will be conducted, notifying the community that the fiveyear review has been completed, and providing the results of the review to the local site

repository (see Exhibit 3-2).

Together with the CIC, you should consider conducting additional community

involvement activities at high profile sites, those with significant public interest, and any other

sites for which the Region determines a need for additional community involvement activities. 

This may include notifying local public officials, including the primary local health agency, and

the leadership of any relevant neighborhood and civic groups. (For ideas on notifying the public

see Publishing Effective Public Notices, which is part of the CIC Toolkit (Web address:

http://www.epa.gov/superfund/action/community/index.htm).)

In addition to this notification, you may also wish to interview several community

members, at least some of whom live or work near the site, to get their views about current site

conditions, problems, or related concerns. If there was or is a Community Advisory Group or a
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Technical Assistance Grant related to the site, representatives of these groups should be briefed

at the outset of the five-year review process, and, if requested, at other appropriate points. You

may also want to consider appropriate ways, such as public meetings or an opportunity for

submitting written comments, to get broader public involvement. For further information on

community involvement during the five-year review process, see Appendix A, “Community

Involvement.”

Exhibit 3-2: Notification Requirements for Five-Year Reviews

At the beginning: Your notice to the community that a five-year review will be conducted should identify:

• The site name, its location and web address (if available);

• The lead agency conducting the review;

• A brief description of the selected remedy;

• A summary of contamination addressed by the selected remedy;

• How the community can contribute during the review process;

• A contact name and telephone number for further information; and

• The scheduled completion date of the five-year review.

At the end: Your notice to the community that a five-year review has been completed should include:

• The site name, its location and web address (if available);

• The lead agency conducting the review;

• A brief description of the selected remedy;

• A summary of contamination addressed by the selected remedy as provided in the initial notice;

• A brief summary of the results of the five-year review;

• The protectiveness statement(s);

• A brief summary of data and information that provided the basis for determining protectiveness, issues,

recommendations, and follow-up actions directly related to the protectiveness of the remedy;

• Location(s) where a copy of the five-year review can be obtained or viewed (including site repositories);

• A contact name and telephone number where community members can obtain more information or ask

questions about the results; and

• The date of the next five-year review or a statement and supporting rationale that five-year reviews will

no longer be required.

3.5 What data do I need to evaluate the remedy?

Data and other pertinent site specific information that you should review include

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. These are the primary bases of the technical analyses and subsequent

protectiveness determination(s). The type and quality of data are essential to your five-year

review and its findings and conclusions. You may collect these types of data through a variety of

means, including document review, interviews, and a site inspection. You also may need to

conduct supplemental sampling or collect other data.
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3.5.1 How are documents reviewed?

A review of documents is one of the first steps in the five-year review process. You are

responsible for gathering all relevant documents, data, and other information in support of the

five-year review. Generally, for an initial five-year review, this may require you to evaluate

record keeping and the location of pertinent data and information. In cases where records are

difficult to obtain, you should establish appropriate record keeping procedures to minimize future

efforts needed to gather all necessary documents for subsequent five-year reviews. 

Documents should be reviewed to obtain relevant information and data concerning a

response action from which to base an assessment of its performance. The scope of the review is

dependent on the complexity of the remedy(s) and the stage of remedy construction. You may

need to review various documents to obtain the necessary information, including those for

remedy decisions (e.g., Records of Decision (RODs), Explanation of Significant Differences

(ESDs)), enforcement (e.g., Consent Decrees (CDs), Administrative Orders on Consent (AOCs)),

site investigations (e.g., remedial investigation/feasibility study (RI/FS)), design (e.g., remedial

design (RD)) and construction (e.g., Preliminary Closeout Reports (PCOR), remedial action (RA)

reports), and remedy performance and post-closure. (See Appendix B, “Document Review,” for

a more complete discussion of document review for the five-year review).

Your review team should be familiar with appropriate site-specific data and information

including the items listed below:

• Remedial action objectives and cleanup levels, as specified in the ROD and other

decision documents;

• Remedial action design and remedial action construction;

• O&M status;

• Implementation of institutional controls;

• Changes that affect the validity of cleanup levels (e.g., standards identified as

Applicable or Relevant and Appropriate Requirements (ARARs), “to be

considereds” (TBCs), assumptions about contaminant characteristics and potential

exposure); and

• Data supporting the effectiveness of the remedy in meeting cleanup levels and

remedial action objectives.

3.5.2 How should I conduct interviews?

Interviews should be conducted, if necessary, to provide additional information about a

site’s status. The scope of interviews should be tailored to the remedy evaluation on a sitespecific basis. Those interviewed may include the site manager; site personnel; Federal, State,

and Tribal regulatory authorities; local officials; community action groups or associations;
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residents and businesses located near the site; and other pertinent organizations or individuals. 

At an Enforcement-lead site, the lead agency should conduct the interviews. A Potentially

Responsible Party (PRP) generally should not conduct interviews because there is a potential for

a conflict of interest (see Appendix C, “Five-Year Review Interviews,” for additional

information). For Federal facility sites, a State and/or EPA representative may wish to be present

at and/or participate in conducting interviews.

3.5.3 How should I conduct site inspections?

Your five-year review should include a recent site inspection. For purposes of conducting

site inspections for five-year reviews, “recent” generally means no more than nine months from

the expected signature date of the review. The review should be performed by objective parties

without bias or preconceived views or conclusions about the remedy and conditions at the site. 

Site inspections are conducted to provide information about a site’s status and to visually confirm

and document the conditions of the remedy, the site, and the surrounding area. 

At an Enforcement-lead site, the lead agency should conduct the site inspection. A PRP 

generally should not conduct the site inspection because of the potential for a conflict of interest. 

At Federal facility sites, a State and/or EPA representative may wish to be present and/or

participate in conducting site inspections. 

Appendix D, “Five-Year Review Site Inspection Checklist,” may serve as your guide for

planning and documenting a site inspection for containment, groundwater, and surface water

remedies. Using this checklist should aid you in the planning and documentation of the site

inspection. Therefore, you may adapt this checklist for other types of remedies or use other site

inspection tools and checklists that have been developed by others for this purpose. You can find

other checklists by accessing the web site: http://www.frtr.gov/optimization/general/ and clicking

on “ USACE Remediation System Evaluation Checklists.”

3.6 What should I include in Five-Year Review reports?

In your Five-Year Review report, you should present the findings and conclusions of the

review, including recommendations, follow-up actions to issues, and protectiveness

determination(s). The report should also contain the data and information necessary to support

all findings and conclusions. 

 Where your review only addresses a portion of a site, the report should provide a

summary of the status of other operable units (OUs) and/or the remainder of the site. Similarly,

for sites where you conduct a separate five-year review for different areas of a large or complex

site (see Section 1.4.2), you should provide a summary of the status of the other areas of the site

in your Five-Year Review report. Additionally, if you receive written comments on the FiveYear Review report from support agencies and/or the community (e.g., States, Tribes, other
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Federal agencies or departments, local governments, citizens, PRPs, other interested parties), you

should attach a copy of these comments to the report.

A suggested “Five-Year Review Report Template” and “A Sample Five-Year Review

Report” are provided in Appendices E and F, respectively. Exhibit 3-3 summarizes the

recommended contents of a Five-Year Review report.

Exhibit 3-3: Contents of a Five-Year Review Report

The following report 

sections...

should include these topics when appropriate: 

I. Introduction – the purpose of the review

– who conducted the review 

– when the review was initiated and completed

– whether it is the first review or a subsequent review at the site

– status of other five-year reviews, OUs, and/or areas of the entire site

II. Site Chronology – dates of major events (such as the initial discovery of contamination, NPL

listing, decision and enforcement documents, start and completion of remedial

and removal actions, construction completion, and prior five-year reviews)

III. Background – physical characteristics

– land and resource use

– history of contamination

– initial response

– summary of basis for taking action

IV. Remedial Actions – remedy selection

– remedy implementation

– system operations/O&M

V. Progress Since Last

Review (as applicable)

– protectiveness statements from last review

– status of recommendations and follow-up actions from last review

– results of implemented actions, including whether they achieved the intended

purpose

– status of any other prior issues 

VI. Five-Year Review

Process

– notification of potentially interested parties of start of review

– identification of five-year review team members 

– components and schedule of your five-year review

– document review

– data review and evaluation

– community notification

– other community involvement activities

– site inspection 

– site interviews
OSWER No. 9355.7-03B-P

Exhibit 3-3: Contents of a Five-Year Review Report

The following report 

sections...

should include these topics when appropriate: 

3-7

VII. Technical

Assessment 

Question A: Is the remedy functioning as intended by the decision documents?

– remedial action performance and monitoring results

– system operations/O&M

– costs of system operations/O&M 

– opportunities for optimization

– early indicators of potential remedy problems

– implementation of institutional controls and other measures

Question B: Are the exposure assumptions, toxicity data, cleanup levels, and

remedial action objectives (RAOs) used at the time of the remedy still valid?

– changes in exposure pathways 

– changes in land use 

– new contaminants and/or contaminant sources

– remedy byproducts

– changes in standards, newly promulgated standards, and TBCs

– changes in toxicity and other contaminant characteristics

S expected progress towards meeting RAOs

– risk recalculation/assessment (as applicable)

Question C: Has any other information come to light that could call into question

the protectiveness of the remedy? 

– ecological risks 

– natural disaster impacts 

– any other information that could call into question the protectiveness of the

remedy

 

Summary of Technical Assessment

– summary of findings and conclusions related to Questions A, B, and C 

VIII. Issues – issues that were identified during the technical assessment and other five-year

review activities (e.g., site inspection)

– a determination of whether issues affect current or future protectiveness

– a discussion of unresolved concerns or items raised by support agencies and

the community (States, Tribes, other Federal agencies or departments, local

governments, citizens, PRPs, other interested parties)

IX. Recommendations

and Follow-up

Actions

– list of any recommendations, including follow-up actions to ensure

protectiveness

– parties responsible for implementation 

– agencies with oversight authority

– schedule for completion

X. Protectiveness

Statement(s)

– protectiveness statement(s) developed at the OU level 

– protectiveness statement developed for the site as a whole at construction

complete sites 

XI. Next Review – statement of when the next review is to be completed, or explanation of why no

further five-year reviews are needed
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3.7 How should I submit a Five-Year Review report?

The procedures for submitting reports to EPA Regions and Headquarters are described

below. This process takes place after all reviews of draft reports, and other interagency reviews

are completed, appropriate concurrences and signatures are obtained, and, to the extent

practicable, issues are resolved. 

3.7.1 How is an EPA-lead report submitted?

A report prepared by EPA is complete when it is signed by the EPA Regional

Administrator or his/her designee. The Region should submit one copy of the signed Five-Year

Review report to EPA Headquarters within ten days of the signature date. The Region should

also place a copy of the report in each site information repository.

3.7.2 How is a Federal facility-lead report submitted?

When a Federal agency or department other than EPA conducts a five-year review, the

report should be submitted to the Region for review pursuant to the terms of the Federal Facility

Agreement or other authorized agreement. The Region should review the report for accuracy,

protectiveness determination/statement, and the basis/support for such determination and

consistency with this guidance. The EPA Regional Administrator or his/her designee should

issue a memorandum that documents any unresolved items or concerns and either concurs with

the report findings or provides EPA’s own independent findings and protectiveness

determination. Within ten days of the signature date of the memorandum, the Region should

forward a copy of the report, with the memorandum attached, to EPA Headquarters, and a copy

should be placed in each site information repository.

In some cases, EPA may have minimal involvement at the site or in the development of

the Five-Year Review report or protectiveness statements. In such cases, Regions should

determine whether to rely solely on the information presented by the other Federal agency or

department without independent verification. When the Region relies solely on the

representations of another Federal agency or department, the Regional Administrator or his/her

designee should note this in the memorandum. It is important to consider who signed the FiveYear Review report at the other Federal agency or department. EPA expects that a Five-Year

Review report generally will be signed by the other Federal agency or department at the senior

management level.

3.7.3 How is a State or Tribal-lead report submitted?

When a State or Tribe conducts a five-year review, the report should be submitted to the

respective Region for review of accuracy, protectiveness determination/statement and the

basis/support for such determination and consistency with this guidance. The EPA Regional

Administrator or his/her designee should issue a memorandum that documents any unresolved
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3-9

items or concerns and either concurs with the report findings and protectiveness statement(s) or

provides EPA’s own independent findings and protectiveness determination. Within ten days

after the memorandum is signed, the Region should forward a copy of the report, with the

memorandum attached, to EPA Headquarters and a copy should be placed in each site

information repository. 

3.8 What are the annual reporting requirements to EPA Headquarters?

Each EPA Region should report annually to EPA Headquarters on the progress of the

five-year reviews for each of their sites. At a minimum, at the end of each fiscal year each

Region should provide to EPA Headquarters the following:

• A list of sites that had five-year reviews due for that fiscal year;

• If a five-year review due date changes for any site, or a site no longer needs a fiveyear review, identify the sites and the basis for the change or discontinuation;

• A list of those sites where five-year reviews were completed;

• For each completed five-year review, a summary of the protectiveness

determination(s), issues that impact protectiveness, follow-up actions, and the

schedule and entity responsible for implementing such actions;

• Status of protectiveness when Five-Year Review reports from previous fiscal

years made a “not protective” determination or “needed further information”

before making a protectiveness determination, or deferred protectiveness; and 

• Status of follow-up actions identified in Five-Year Review reports from previous

fiscal years. 

The exact date for submitting the annual report should be provided at the work planning

sessions at the beginning of each fiscal year or through your Headquarters Regional Center

contact.
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4.0 ASSESSING THE PROTECTIVENESS OF THE REMEDY

A five-year review should determine whether the remedy at a site is or upon completion

will be protective of human health and the environment. The level of effort necessary to conduct

a five-year review is site-specific and should be tailored appropriately for the remedial action and

its stage of implementation. In general, five-year reviews of remedial actions under construction

are narrower in scope than five-year reviews of remedies that have been constructed. 

Your technical assessment of a remedy should examine the following three questions,

which provide a framework for organizing and evaluating data and information and ensure that

all relevant issues are considered when determining the protectiveness of the remedy:

• Question A – Is the remedy functioning as intended by the decision documents?

• Question B – Are the exposure assumptions, toxicity data, cleanup levels, and

remedial action objectives (RAOs) used at the time of the remedy

selection still valid?

• Question C – Has any other information come to light that could call into

question the protectiveness of the remedy?

The following sections present Questions A, B, and C in more detail. Exhibit 4-1

summarizes a number of items that you should consider in answering questions A, B, and C in

your evaluation of a remedial action. 

Exhibit 4-1: Three Questions Used to Determine Whether a Remedy is

Protective

When you ask... you should consider whether...

Question A: Is the remedy

functioning as intended by the

decision documents? 

• performance standards (e.g., cleanup levels, plume containment,

pumping rates) are or will likely be met;

• there are problems with the remedy that could ultimately lead to the

remedy not being protective or suggest protectiveness is at risk (e.g.,

shrubs or bushes growing on a landfill cap that was designed to have a

grass vegetative cover, extent of plume not fully delineated);

• access (e.g., fencing, security guards) and institutional controls

needed at the particular stage of the remediation are in place and

prevent exposure;

• other actions (e.g., removals) necessary to ensure that there are no

exposure pathways that could result in unacceptable risks have been

implemented; and 

• maintenance activities (e.g., pumping and treating, monitoring slurry

walls, mowing cap), as implemented, will maintain the effectiveness of

response actions. 
OSWER No. 9355.7-03B-P

Exhibit 4-1: Three Questions Used to Determine Whether a Remedy is

Protective

When you ask... you should consider whether...

4-2

Question B: Are the exposure

assumptions, toxicity data, cleanup

levels, and remedial action

objectives used at the time of the

remedy selection still valid?

• there are changes in standards identified as Applicable or Relevant

and Appropriate Requirements (ARARs) in the ROD, newly

promulgated standards, and/or changes in TBCs identified in the ROD,

that could call into question the protectiveness of the remedy;

• there are changes in land use or the anticipated land use on or near

the site;

• new human health or ecological exposure pathways or receptors have

been identified;

• new contaminants or contaminant sources have been identified;

• there are unanticipated toxic byproducts of the remedy not previously

addressed by the decision documents;

• there are changes in the physical site conditions; and

• there are changes in the toxicity factors for contaminants of concern.

Question C: Has any other

information come to light that could

call into question the

protectiveness of the remedy?

• ecological risks have been adequately addressed at the site, and/or

there is a plan to address them through a future action; and

• the site is/was subject to natural disasters, such as a 100-year flood.

4.1 Question A: Is the remedy functioning as intended by the decision

documents?

In general, to determine if the remedy is functioning as described in the decision

documents, you should first consider its implementation status, (e.g., whether the remedy is

under construction, operating, or completed). You should also look for available information

about the remedy and compare it to the requirements in the decision documents and remedial

design/construction specifications. For purposes of this guidance, definitions of remedial actions 

under construction, operating remedial actions, and completed remedial actions are as follows: 

C Remedial actions under construction are those actions where physical

construction has been initiated, but is not yet complete.

C Operating remedial actions are those actions that are ongoing, but where cleanup

levels have not yet been achieved. Such actions typically have remedial

components requiring several years to reach cleanup levels (e.g., groundwater and

surface water restoration, monitored natural attenuation, soil vapor extraction, and

bioremediation). 

C Completed remedial actions are those actions where construction is complete and

cleanup levels have been achieved.
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4.1.1 How do I answer Question A for a remedial action that is under

construction?

In the case where a remedy is under construction, the focus of your review should be 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. In addition, you should confirm that access controls (e.g., fencing, security guards)

necessary at this stage of the remediation are in place and successfully prevent exposure. If the

remedial action includes institutional controls (ICs), then your five-year review should also

consider the implementation status of those controls. For example, answer the following

questions: Have specific ICs been identified? Are there ICs needed at this stage of remediation

to prevent exposure? Who is responsible for implementing ICs? What is the plan, schedule, and

current status for IC implementation? 

4.1.2 How do I answer Question A for a remedial action that is operating or 

completed?

Your review of an operating or completed remedial action generally will address more

aspects of the remedy implementation than a review of a remedial action under construction. In

general, you should assess the following:

C Remedial action performance – Determine whether the remedial action continues

to operate and function as designed (e.g., extent of groundwater plume is well

defined and updated plume maps confirm containment), and has achieved, or is

expected to achieve, cleanup levels.

C System operations/operation and maintenance (O&M) – Determine whether

maintenance procedures, as implemented, will maintain the effectiveness of

response actions. This evaluation might include, but is not limited to, visual

inspection of the system and the review and evaluation of monitoring reports (e.g.,

groundwater data from extraction and monitoring wells, biological monitoring

data, discharge requirements, wetland monitoring data, leachate monitoring for

containment remedies).

C Costs of system operations/O&M – Review and consider system operations/O&M

costs if they are available. Compare actual/current annual O&M costs to the

original cost estimate; large variances from the original cost estimate might

indicate potential remedy problems. (Note: This information may not be readily

available at Enforcement-lead sites, but should be requested.)

C Implementation of institutional controls and other measures – Determine

whether access controls (e.g., fencing, security guards) and ICs that are needed at

this stage of the remediation are in place and successfully prevent exposure. If
OSWER No. 9355.7-03B-P

12 Note that risk parameters in EPA publications such as the Integrated Risk Information System (IRIS)

(see http://www.epa.gov/IRIS) are guidance only, and should be applied only as appropriate for the remedy being

reviewed.

4-4

ICs are not in place, determine why not, and obtain the schedule for

implementation; determine whether other actions (e.g., removals) necessary to

ensure that exposure pathways that could result in unacceptable risks have been

implemented.

C Monitoring activities – Determine whether monitoring activities required to

ensure the effectiveness of the remedy (e.g., performance and environmental data

collected and results evaluated) are being conducted and whether they are

adequate to determine the protectiveness and effectiveness of the remedy. 

C Opportunities for optimization – If readily apparent during the course of

conducting five-year review activities, identify any opportunities to improve the

performance and/or reduce the costs of sampling and monitoring activities and

operating treatment systems. If changes in these activities are recommended in

the Five-Year Review report, you should also provide the rationale/basis for such

changes. If appropriate, your report can also recommend that an optimization

study be conducted.

C Early indicators of potential remedy problems – Investigate and identify

problems that could lead to the remedy being not protective or suggest

protectiveness is at risk unless changes are made. Problems could include

frequent equipment breakdowns or replacement, or large variances in operating

costs (if cost data are available). Some examples of indicators of potential remedy

problems could include erosion and/or subsidence of a cap, trend analysis of

sampling data showing no decrease in contaminant levels, monitoring data

showing evidence of leachate migration, or that the extent of the groundwater

contamination plume exceeds the outer reaches of the monitoring network.

4.2 Question B: Are the exposure assumptions, toxicity data, cleanup levels,

and remedial action objectives used at the time of remedy selection still

valid?

In conducting your five-year review, you should evaluate the effects of significant

changes in standards and assumptions that were used at the time of remedy selection. Changes in

the promulgated standards or “to be considereds” (TBCs) may impact the protectiveness of the

remedy. Similarly, you should investigate the effect of significant changes in the risk parameters

that were used to support the remedy selection, such as reference doses, cancer potency factors12,

and exposure pathways of concern. Finally, you should evaluate whether the original

assumptions regarding current and future land/groundwater uses and contaminants of concern are
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4-5

still valid, and whether any physical features (or understanding of physical sites conditions) have

changed (e.g., changes in anticipated direction or rate of groundwater or identification of a new

groundwater divide). All of these factors may have a bearing on the validity of the remedial

action objectives and may affect the protectiveness of the remedy.

Exhibit 4-2 presents a series of example questions that you should consider in

determining whether the exposure assumptions and toxicity data used at the time of remedy

selection are still valid and, if you determine that they are no longer valid, whether they call into

question the protectiveness of the remedy. Exhibit 4-2 also groups the questions according to the

type of assumption. 

Exhibit 4-2: Example Questions to Determine if Assumptions Upon Which the

Remedy was Based Have Changed

For an assumption based on ... an example question may be...

standards and TBCs Are there changes in the standards identified as ARARs in the ROD that

bear on the protectiveness of the remedy? Are there newly promulgated

standards that might apply or be relevant and appropriate to the site and

that bear on the protectiveness of the remedy? Are there changes in

TBCs identified in the ROD that bear on the protectiveness of the

remedy?

cleanup levels What is the basis for each cleanup level identified in the ROD (e.g., riskbased or promulgated standards as ARARs)? Have there been changes

to the basis of the cleanup levels? (See sample questions for “standards

or TBCs” above, and for “toxicity and other contaminants characteristics”

below.) 

exposure pathways Has land use or expected land use on or near the site changed (e.g.,

industrial to residential, commercial to residential)?

exposure pathways Have any human health or ecological routes of exposure or receptors

changed or been newly identified (e.g., dermal contact where none

previously existed, new populations or species identified on site or near

the site)?

exposure pathways Are there newly identified contaminants or contaminant sources?

exposure pathways Are there unanticipated toxic byproducts of the remedy not previously

addressed by the decision documents (e.g., byproducts not evaluated at

the time of remedy selection)?

exposure pathways Have physical site conditions changed such that protectiveness may be

affected (e.g., changes in anticipated direction or rate of groundwater

flow)? Has understanding of physical site conditions changed (e.g.,

identification of a new groundwater divide)?

toxicity and other contaminant

characteristics

Have toxicity factors for contaminants of concern at the site changed 

(e.g., Integrated Risk Information System (IRIS) evaluations? (See

http://www.epa.gov/IRIS) Have other contaminant characteristics

changed? Have ecological toxicity reference values and/or ecological

“no observed adverse effect levels/lowest observed adverse effect”

(NOAELs/LOAELs) levels changed. 
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4-6

4.2.1 How should I check the impact of changes in standards and TBCs?

Cleanup levels or actions may be based on ARARs identified in the Record of Decision

(ROD) (as opposed to calculated site-specific risk, as discussed in Section 4.2.3). For example,

the cleanup levels for a groundwater remedy may be based on the Safe Drinking Water Act

maximum contaminant levels (MCLs) if these were identified as ARARs in the ROD. 

In the preamble to the final National Contingency Plan (NCP), EPA states its policy that

it will not reopen remedy selection decisions contained in RODs (i.e., ARARs are normally

frozen at the time of ROD signature) unless a Anew or modified requirement calls into question

the protectiveness of the selected remedy.@ 55 FR 8757 (March 8, 1990). The preamble goes on

to state that “a policy of freezing ARARs at the time of ROD signing will not sacrifice protection

of human health and the environment because the remedy will be reviewed for protectiveness

every five years, considering new or modified requirements at that point, or more frequently, if

there is reason to believe that the remedy is no longer protective of health and environment.” 55

FR 8758 (March 8, 1990). The preamble also states that a remedy would not necessarily need to

Abe modified solely to attain a newly promulgated or modified requirement,@ but that “newly

promulgated or modified requirements contribute to [the] evaluation of protectiveness.” 55 FR

8758 (March 8, 1990).

Therefore, although ARARs generally are “frozen” at the time of ROD signature, in

conducting a five-year review, you should determine the effect of a newly promulgated or

modified standard on the protectiveness of the remedy originally selected in the ROD. You

should evaluate the newly promulgated or modified requirement to determine if the cleanup level

established in the ROD remains protective. TBCs may also have been used to select cleanup

levels. Therefore, you should also review any new or modified TBCs to ensure that any changes

will not impact the protectiveness of the remedy.

Generally, you should only consider changes in standards that were identified as ARARs

in the ROD, newly promulgated standards for chemicals of potential concern, and TBCs

identified in the ROD that bear on the protectiveness of the remedy. As such, you should review

any newly promulgated standards, including revised chemical-specific requirements (such as

MCLs, ambient water quality criteria), revised action and location-specific requirements, and

State standards if they were considered ARARs in the ROD. 

In evaluating a change in a standard that was identified as an ARAR in the ROD, or a

newly promulgated standard or TBC, you should establish whether the new requirement indicates

that the remedy is no longer protective. You should recommend a follow-up action when the

remedy is not protective. For example, based on revised risk information for a specific chemical,

a new standard (e.g., more stringent MCL for a chemical) may result in a situation where the

cleanup level to be achieved by the original remedy would pose a 10-3 cancer risk. In that

circumstance, the five-year review could recommend that a new cleanup level based on the new
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4-7

standard be adopted and, if necessary, that the remedy be modified. However, a change in a

standard may not necessarily result in a change in the resulting risk and therefore may not always

impact protectiveness. An illustration of a method and an example for evaluating changes in

standards is provided in Appendix G, “Methods and Examples for Evaluating Changes in

Standards and Toxicity,” Exhibit G-1, “Evaluating Changes in Standards,” Exhibit G-2,

“Hypothetical Scenario for a Change in a Standard,” and Exhibit G-3, “Decision Process for a

Hypothetical Change in Standard.” 

4.2.2 How should I check the impact of changes in exposure pathways?

You should consider changes in site conditions that could result in increased exposure. 

These changes could include changed or new land uses, including zoning changes, changed or

new routes of exposure or receptors, changed physical site conditions that may affect the

protectiveness of the remedy, new contaminants, or a new understanding of geological

conditions. In evaluating this information, you should work closely with a risk assessor to

establish the impact that such changes may have on the estimated risk associated with your site. 

Depending on the significance of the changes, it may be necessary for you to recalculate human

health risk and re-examine ecological risks. Generally, your human health determination should

be based on whether the cancer risk could now be greater than 10-4 and/or the hazard index could

be greater than 1 for non-carcinogenic effects. 

In some cases, it may be necessary to revise or expand the previous risk assessment as

part of your five-year review. For example, you may need to revise the risk assessment when

there is a new exposure pathway, a new potential contaminant of concern, or an unanticipated

toxic byproduct of the remedy. In all cases, you should evaluate whether the remedy can mitigate

any unacceptable risk or whether additional actions may need to be taken. Your five-year review

can also recommend further investigation to determine whether an additional response action is

needed. 

4.2.3 How should I check the impact of changes in toxicity and other

contaminant characteristics?

Cleanup levels at a site may be based on the calculated risk for chemicals and/or media

where there are no promulgated standards (e.g., site-specific soil and sediment action levels) or

existing standards are not sufficiently protective for site-specific conditions. If the remedy is

intended to meet a site-specific, risk-based cleanup level, you should check to see whether

toxicity or other contaminant characteristics used to determine the original cleanup level have

changed. In addition to toxicity, you should examine other contaminant characteristics that

determine the nature and extent of contaminant migration and effects on receptors (e.g. sorption

characteristics, ability to bioaccumulate, bioavailability). If there have been changes in the

understanding or in our knowledge of these physical/chemical characteristics, you may need to

recalculate risk using the original cleanup level or using the current concentration if it has not

been identified as a contaminant of concern. An increase in the cancer slope factor, for example,
OSWER No. 9355.7-03B-P

4-8

may suggest that the risk from a chemical concentration is above the generally acceptable cancer

risk range (10-4 to 10-6). You should also consider changes in toxicity and other contaminant

characteristics relating to ecological receptors.

You may work with your Region’s risk assessor to determine whether there have been

changes in toxicity or other contaminant characteristics and whether further investigation is

needed. The risk assessor is also familiar with efficient use of the Superfund Technical Support

Center and its hotline. One preferred resource for checking changes in toxicity information is

EPA’s Integrated Risk Information System (IRIS) (http://www.epa.gov/IRIS). However, many

contaminants found at Superfund sites are not found in IRIS. You may find it useful to refer to

the Superfund Risk Assessment Tools of the Trade page for databases and additional links and

pointers (http://www.epa.gov/superfund/programs/risk/tooltrad.htm#gp). Beginning in the

summer of 2001, this page should link risk-based concentration tables which provide screening

levels for specific exposure scenarios, a risk calculation tool, and should identify recent toxicity

data and their sources.

The flowchart presented in Appendix G, Exhibit G-4, “Evaluating Changes in Toxicity

and Other Contaminant Characteristics,” shows the process you should use to evaluate the

significance of changes in toxicity values and other contaminant characteristics when conducting

a five-year review. You should first identify any site-specific, risk-based, cleanup levels and

investigate relevant changes in contaminant characteristics. If the estimated risk for a

contaminant has not changed, your analysis on this point should be complete.

If the estimated risk has increased, then you should determine whether the new estimated

risk is acceptable. In most cases, you should base this determination on whether the risk is

within or below the generally acceptable risk range of 10-4 to 10-6 for carcinogenic risk and the

hazard index is below 1 for non-carcinogenic effects. If the estimated risk is not protective, you

should determine what actions need to be taken to achieve an acceptable level of risk. Appendix

G, Exhibit G-5, “Hypothetical Scenario for a Change in Toxicity,” and Exhibit G-6, “Decision

Process for a Hypothetical Change in Toxicity,” provide an example of the evaluation process

when there are changes in toxicity and other characteristics. Note: Future guidance will address 

the appropriateness of using various statistical methods in making the determination about when

remedial action objectives (RAOs) have been attained. 

4.2.4 How should I review RAOs and evaluate their impact?

As part of the five-year review, you should conduct an evaluation of the RAOs stated in

the ROD to determine whether the remedy is meeting or will meet RAOs. Depending on the

outcome of the evaluation, you may find it necessary to modify the RAOs, modify the remedy, or

conduct further response actions. For example, an RAO phrased in terms of “achieving the

drinking water standard in ten years” may be significantly affected by a new MCL that

establishes a more stringent standard. Conversely, an RAO may be general enough to

accommodate a new or modified requirement. 
OSWER No. 9355.7-03B-P

4-9

If your evaluation of data indicates that the remedy is not meeting and will not be able to

meet the RAO stated in the ROD, then you may need to determine if the remedy is protective

and, if not protective, what additional actions are needed. For example, if the risk associated

with the cleanup levels currently being achieved by the remedy are within EPA’s acceptable risk

range, the remedy generally should be considered protective. However, if the remedy will not be

able to meet the RAOs, further actions may be needed, depending on the specificity of the

original RAOs in the ROD. Your Five-Year Review report should identify such further actions

as recommendations and/or follow-up actions.

New site conditions, such as discovery of new contaminants, can also impact the RAOs

and remedy protectiveness. During your five-year review, you should evaluate whether the

RAOs in the ROD are sufficiently comprehensive to cover any new or changed conditions at a

site. If a new condition at the site is not covered by the RAOs, you should recommend further

investigation in the Five-Year Review report to determine whether additional response actions

are needed.

Further response actions may not necessarily involve additional physical construction

activities but could include sampling, studies, and/or investigations. For example, modifying

RAOs will require a ROD Amendment, but does not require a physical site activity.

4.3 Question C: Has any other information come to light that could call into

question the protectiveness of the remedy?

You should consider any other information that comes to light that could call into

question the protectiveness of the remedy. It is expected that most considerations related to the

protectiveness of the remedy will be covered by Questions A and B. However, in some

instances, there may be other factors about the remedy or the site that you should consider during

the review. 

Situations to watch for include the following:

C Ecological risks have not been adequately addressed at a site, and there is not a

plan to address them through a future action; 

C The site, although located entirely above the 500-year flood boundary, was

partially inundated by a 100-year flood (which now may require a flood plain

redesignation of the region); and

C Land use changes that are being considered by local officials. 

If ecological risks have not been adequately addressed at a site, and there is not a plan to

address them through a future action, then you may need to address them by conducting a

screening ecological risk assessment as part of the Five-Year Review using Final Guidance: 

Ecological Risk Assessment and Risk Management Principles for Superfund Sites, OSWER
OSWER No. 9355.7-03B-P

4-10

Directive 9285.7-28P (October 7, 1999). The ecological risk assessor on your team can help

streamline the process appropriately.

4.4 How should I develop the conclusions of my five-year review?

The conclusions of your five-year review should include: 1) an identification of issues; 2)

recommendations and follow-up actions; and 3) a determination of whether the remedy is, or is

expected to be, protective of human health and the environment. You should arrive at these

conclusions through a technical assessment of the information collected during the document

review, data collection, interviews, site inspection, and other activities. Your evaluation should

focus on the information collected through answering the three questions shown in Exhibit 4-1. 

(See Sections 4.1, 4.2, and 4.3, above, for a detailed discussion of how to assess the remedy by

answering these three questions.) These conclusions should be documented in the Five-Year

Review report as a technical assessment summary. 

4.4.1 How should I identify issues?

You should identify all issues that currently prevent the response action from being

protective, or may do so in the future. You should document all such issues and follow-up

actions needed to ensure the proper management of the remedy in your Five-Year Review report. 

You should also identify early indicators of potential remedy problems. Early indicators of

remedy problems may include operating costs that are greater than originally anticipated. For

instance, excessive replacement of pumps or other equipment may indicate the need to reconsider

system design or re-evaluate aquifer conditions. 

Examples of issues that may be identified in a Five-Year Review report include the

following:

C Inadequate access controls (e.g., fencing has been breached, or fencing is not

adequate to restrict access);

C Incomplete response action, including ICs (e.g., environmental easements or well

restrictions are not in place);

C Inadequate ICs (e.g., well restrictions are in place but are not preventing

exposure);

C Response action is not expected to achieve cleanup levels; plume containment has

not been confirmed or achieved;

C Cleanup levels are not protective due to changes in chemical characteristics;

C Discharge requirements are exceeded;

C Inadequate operation and maintenance of physical remedial structures (e.g.,

vegetative cover of cap mowed infrequently);
OSWER No. 9355.7-03B-P

4-11

C Differences found in actual or proposed land use other than those assumed in the

selection of the response action;

C RAOs will not be achieved; 

C Monitoring is not being completed in a timely manner; and

C Inadequate monitoring activities to determine the protectiveness of the remedy

(e.g., the number and location of monitoring wells are not appropriate for

monitoring remediation progress of the groundwater contamination plume).

You should describe each issue in sufficient detail so that EPA can appropriately track the

progress to resolution. For each issue, you should determine if it currently affects the

protectiveness of the remedy or may do so in the future.

Exhibit 4-3 provides an example of a tabular format that you can use to list issues in your

Five-Year Review report. 

Exhibit 4-3: Example Table for Listing Issues 

Issues

Affects

Protectiveness

(Y/N)

Current Future

4.4.2 When and how should I develop recommendations?

For each issue identified, the Region should document and ensure implementation of

recommendations to resolve those issues. These recommendations should be identified along

with follow-up actions in your Five-Year Review report. Follow-up actions should be completed

to ensure long-term protectiveness of the remedy, or to bring about protectiveness of a remedy

that is currently not protective. You may also have follow-up actions where a protectiveness

determination cannot be made at the time of the five-year review. In addition, you may wish to

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.
OSWER No. 9355.7-03B-P

4-12

 The following are types of recommendations that generally are considered appropriate as

part of a five-year review:

C Provide additional response actions – For example, additional response actions

may be necessary to ensure protectiveness if new risk information indicates that a

remedy is not protective (e.g., a treatment process will not be able to achieve soil

cleanup levels). EPA may implement such further response any time pursuant to

CERCLA §104 or §106 authority. In your Five-Year Review report, you can

recommend further investigation and the implementation of further response

actions.

C Improve O&M activities – For example, when a cap’s vegetative cover is not

mowed on a regular basis and/or vegetation other than that specified in the

remedial construction contract specifications is present, you may recommend that

actions be taken to improve compliance with the O&M Manual/Plan. The lack of

O&M activities can lead to more serious remedy problems if not addressed. Your

Five-Year Review report should recommend that O&M activities be conducted if

they currently are not being performed or inadequately conducted and, if needed,

expanded, reduced, or terminated. The report should also provide the

rationale/basis for any of these recommendations.

C Optimize remedy – For example, when the limits of a groundwater plume have

contracted due to pumping, and some monitoring wells no longer register

contamination levels above cleanup levels, it may be appropriate to revise the

sampling plan to eliminate these wells from the sampling routine or reduce the

frequency of their sampling. It may also be possible to remove specific

groundwater extraction wells from service and increase or reduce the pumping

rate on others to optimize groundwater remediation. Similarly, it may be possible

to remove treatment units that no longer contribute to the achievement of remedial

goals.

C Enforce access controls and ICs – For example, when repeated site trespassing

has been observed, you could recommend repair of the fence and an evaluation of

the need for additional security measures. When you have evidence that

groundwater wells continue to be installed despite well restrictions that are

currently in place, you can recommend an evaluation of the need for further

enforcement of institutional controls (e.g., prohibit well drilling). 

C Conduct additional studies or investigations – For example, after reviewing and

evaluating all available data and information it is apparent that contaminant levels

have not decreased as expected in the estimated time frame. Additional

information will be needed to determine if the remedy, as is, will be able to

achieve remediation goals within the estimated time frame. Other studies may

include, but are not limited to, site characterization, ecological assessment,
OSWER No. 9355.7-03B-P

4-13

focused feasibility studies, groundwater modeling, treatability studies, and/or

sampling. 

For each recommendation, you should identify the party responsible for implementation,

the agency with oversight authority, a recommended schedule for implementation and

completion, and the impact, if any, on current or future protectiveness. Exhibit 4-4 provides an

example of a table that you can use in your Five-Year Review report for documenting both

recommendations and follow-up actions.

Exhibit 4-4: Example Table for Listing Recommendations and Follow-up Actions

Recommendations/

Follow-up Actions

Party

Responsible

Oversight

Agency

Milestone

Date 

Follow-up Actions: 

Affects

Protectiveness (Y/N)

Current Future

Regions should track the progress and completion of recommendations and/or followup

actions with documentation in the site file, and upon completion update the administrative record

in the site information repository. See Section 3.8 for annual reporting responsibilities to EPA

Headquarters. 

4.5 How do I determine protectiveness?

After addressing Questions A, B, and C, you should be ready to determine the

protectiveness of the remedy or remedies at a site and to document the rationale for your

determination(s). You should make a protectiveness statement for each OU and an additional,

comprehensive site-wide protectiveness statement for those sites that have reached construction

completion. 

Your determination of whether the remedy remains protective of human health and the

environment generally should 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), your 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 your technical analysis and evaluation, if the answers to Questions A, B,

and C are yes, yes, and no, respectively, then your remedy normally should be considered 
OSWER No. 9355.7-03B-P

4-14

protective. However, if the answers to the three questions are other than yes, yes, no, depending

on the elements that affect each question, your remedy may be one of the following:

C Protective; 

C Will be protective once the remedy is completed;

C 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;

C Not protective, unless the following action(s) are taken in order to ensure

protectiveness; or 

C Protectiveness cannot be determined until further information is obtained. (A

time frame should be provided when a protectiveness determination will be made. 

This should be done through an addendum. If this is the case, your next five-year

review should be due five years from the date this report is signed, not 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 should be considered as not protective when the following

occur:

C An immediate threat is present (e.g. exposure pathways that could result in

unacceptable risks are not being controlled);

C Migration of contaminants is uncontrolled and poses an unacceptable risk to

human health or the environment; 

C Potential or actual exposure is clearly present or there is evidence of exposure

(e.g., institutional controls are not in place or not enforced and exposure is

occurring); or

C The remedy cannot meet a new cleanup level and the previous cleanup level is

outside of the risk range.
OSWER No. 9355.7-03B-P

Question A – Is the remedy functioning as intended by the decision documents?

Question B – Are the exposure assumptions, toxicity data, cleanup levels, and remedial action objectives (RAOs) used at the time of the remedy selection still valid?

Question C – Has any other information come to light that could call into question the protectiveness of the remedy?

4-15

Exhibit 4-5 presents examples of protectiveness determinations. These examples cover only some of the possible situations you may

observe at your site but should serve to guide your decision-making.

Exhibit 4-5: Examples of Protectiveness Determinations

1. Remedies Under Construction

If the remedy involves... and you observe in your five-year review

that...

then your answers to

Questions A, B and

C should be...

and...

any remedial action under construction • no changes to site conditions or any other

parameters would impact protectiveness

A - Yes

B - Yes

C - No

the remedy will be protective.

a groundwater pump-and-treat system

expected to operate for 30 years with

institutional controls to restrict well

drilling of groundwater wells

• an MCL for one of the contaminants of

concern (COCs) has become more

stringent since the ROD was signed; and

the risk associated with the previous MCL

is now outside of the risk range; 

• the remedy cannot meet the new standard

(even with design modifications); and

• ICs are in place,

A - Yes

B - No

C - No

the remedy is not protective because

the remedy is not able to meet the new

standard (ARAR) and the previous

MCL is outside of the risk range. 

However, since ICs are in place there

are no current exposures. 

Recommend that follow-up actions be

taken to address the new MCL (ARAR)

issue. 

rerouting of contaminated surface

runoff from tailings

• remedy in the ROD did not address

ecological risks;

• sediment sampling data from adjacent

wetlands indicate high levels of heavy

metals;

• there were dead fish, and land animals

with physical abnormalities; or

• an ecological risk assessment was not

previously conducted,

A - Yes

B - Yes

C - Yes

defer protectiveness because more

information is needed to make a

protectiveness determination. 

Recommend that follow-up actions be

taken to address inadequate

ecological risk data.
OSWER No. 9355.7-03B-P

Exhibit 4-5: Examples of Protectiveness Determinations

Question A – Is the remedy functioning as intended by the decision documents?

Question B – Are the exposure assumptions, toxicity data, cleanup levels, and remedial action objectives (RAOs) used at the time of the remedy selection still valid?

Question C – Has any other information come to light that could call into question the protectiveness of the remedy?

4-16

2. Operating Remedies

If the remedy involves... and you observe in your five-year review

that...

then your answers to

questions A, B and

C should be...

and...

any operating remedy • no changes to site conditions or any

parameters under Questions A, B, and C

occurred,

A - Yes

B - Yes

C - No

the remedy is protective.

groundwater pump-and-treat system

expected to operate for 15 years with

ICs to restrict well drilling

• no well drilling restriction in place as

required by ROD;

• there is no known current exposure to

groundwater, based on site visits,

interviews with local officials and residents,

A - No

B - Yes

C - No

the remedy is considered protective in

the short-term, because there is no

evidence that there is current

exposure. However, in order for the

remedy to remain protective in the

long-term, ICs restricting well drilling

must be put in place.

groundwater pump-and-treat for 20

years; ICs restricting well drilling; RAO: 

restore groundwater to drinking water

standards

• based on data and current groundwater

modeling, the RAOs will not be met;

• ICs are in place;

• the system has been operating for ten

years;

• there are no changes in standards or

contaminant characteristics for COCs;

• there are no new standards;

• contaminant levels of COCs have leveled

off in the last five years;

• optimization efforts have not been effective

in further decreasing COC levels;

• current levels of contamination are within

EPA’s risk range, however, RAOs have not

yet been achieved,

A - No

B - No

C - No 

the remedy is considered protective in

the short-term because ICs are in

place, and therefore, there is no

current or potential exposure. Followup actions are necessary to address

long-term protectiveness because

RAOs are not expected to be met. 

Recommend that the remedial action

objectives may need to be reevaluated

and other potential actions be further

evaluated.
OSWER No. 9355.7-03B-P

Exhibit 4-5: Examples of Protectiveness Determinations

Question A – Is the remedy functioning as intended by the decision documents?

Question B – Are the exposure assumptions, toxicity data, cleanup levels, and remedial action objectives (RAOs) used at the time of the remedy selection still valid?

Question C – Has any other information come to light that could call into question the protectiveness of the remedy?

4-17

If the remedy involves... and you observe in your five-year review

that...

then your answers to

questions A, B and

C should be...

and...

groundwater pump-and-treat for 10

years; ICs on well drilling; RAO:

groundwater restoration to beneficial

use

• ICs are in place;

• there is a new State MCL for one of the

COCs;

• the standard (ARAR) in the original ROD is

still protective because it is within the

same order of magnitude as the new State

MCL and remains within EPA’s risk range;

• there is no current exposure - residents

with private wells in the area are on

alternate water supply;

• the State considers all groundwater to be a

potential source of drinking water

(However, there is no Comprehensive

State Groundwater Protection Plan

[CSGWPP]); and

• the existing remedy (system) can achieve

the new MCL,

A - Yes

B - No

C - No

the remedy is considered protective

because the cleanup levels are still

within EPA’s risk range and there is no

current or potential exposure. 
OSWER No. 9355.7-03B-P

Exhibit 4-5: Examples of Protectiveness Determinations

Question A – Is the remedy functioning as intended by the decision documents?

Question B – Are the exposure assumptions, toxicity data, cleanup levels, and remedial action objectives (RAOs) used at the time of the remedy selection still valid?

Question C – Has any other information come to light that could call into question the protectiveness of the remedy?

4-18

If the remedy involves... and you observe in your five-year review

that...

then your answers to

questions A, B and

C should be...

and...

groundwater pump-and-treat for 20

years; ICs restricting well drilling; RAO:

groundwater restoration to drinking

water standards

• ICs are in place;

• new Federal standard for one of the COCs;

• the standard (ARAR) in the original ROD is

still protective, within EPA’s risk range;

• no current or potential exposure to

groundwater; and

• existing remedy can remediate

groundwater to the new standard,

A - Yes

B - No

C - No

the remedy is considered protective

because cleanup levels are still within

the risk range and there is no current

or potential exposure. However, if the

new MCL is not met, the groundwater

will not meet the RAO of restoration to

drinking water standards. 

Recommend consideration of followup actions to address the new

standard and the issue of not

achieving the RAO. However, in this

case, the remedy can meet the new

standard, and therefore, another

option is to recommend that the new

standard be adopted as the new

cleanup level, which would then allow

you to achieve the original RAOs. 

Adopting a new cleanup level would

have to be done through the remedy

decision process with a ROD

Amendment or Explanation of

Significant Differences (ESD).
OSWER No. 9355.7-03B-P

Exhibit 4-5: Examples of Protectiveness Determinations

Question A – Is the remedy functioning as intended by the decision documents?

Question B – Are the exposure assumptions, toxicity data, cleanup levels, and remedial action objectives (RAOs) used at the time of the remedy selection still valid?

Question C – Has any other information come to light that could call into question the protectiveness of the remedy?

4-19

3. Completed Remedies

If the remedy involves... and you observe in your five-year review

that...

then your answers to

questions A, B and

C should be...

and...

any remedy that is complete with a fiveyear review requirement• there were no changes to site conditions or

parameters under questions A, B, and C,

A - Yes

B - Yes

C - No

the remedy is protective.

capping of 30-acre landfill with ICs to

prevent disturbance of cap

• ICs were never put in place; 

• mowing and cap maintenance activities

are ongoing and adequate;

• there is no cracking, sliding, settlement of

cap or other indicators of cap breaches;

and

• there is no evidence of an exposure

(human or ecological),

A - No

B - Yes

C - No

the remedy is considered protective in

the short-term because there is no

evidence of a cap breach and thus no

current exposure. However, in order

for the remedy to remain protective in

the long-term, ICs must be put in

place.

groundwater pump-and-treat for 10

years; ICs restricting well drilling; RAO:

restore groundwater to drinking water

standards; cleanup goals were

achieved and RAOs were met (third

five-year review is being conducted as

a matter of policy in order to facilitate

the deletion process)

• there is a new standard for one of the

COCs;

• Standard in original ROD (ARAR) is now

outside of the risk range (due to a change

in toxicity); and

• ICs are no longer in place because RAOs

were met last year,

A - Yes

B - No

C - No

the remedy is not protective because

the standard in the ROD is no longer

within the risk range and therefore no

longer protective. In addition, the RAO

is no longer being met. Recommend

follow-up actions necessary to make

remedy protective and deletion should

not occur until this issue is resolved.
OSWER No. 9355.7-03B-P

Exhibit 4-5: Examples of Protectiveness Determinations

Question A – Is the remedy functioning as intended by the decision documents?

Question B – Are the exposure assumptions, toxicity data, cleanup levels, and remedial action objectives (RAOs) used at the time of the remedy selection still valid?

Question C – Has any other information come to light that could call into question the protectiveness of the remedy?

4-20

If the remedy involves... and you observe in your five-year review

that...

then your answers to

questions A, B and

C should be...

and...

excavation and disposal of top two feet

of contaminated soil; ICs prohibiting

residential and recreational use of the

property; RAO: cleanup site to allow for

industrial use; site was deleted three

years ago

• ICs are still in place;

• the remedy is intact, no physical

disturbances, top two feet of clean soil

remain undisturbed; and

• the local government is considering

changing the zoning of the property to

allow for recreational use,

A - Yes

B - Yes

C - No

the remedy is considered to be

currently protective. However, should

the zoning of the property change to

recreational use, the remedy may no

longer be protective. Recommend

follow-up actions with local officials to

ensure that in the event that zoning

changes the remedy will remain

protective.
OSWER No. 9355.7-03B-P

4-21

4.5.1 How do I formulate protectiveness statements?

You should develop a protectiveness statement for each OU at which a remedial action

has been initiated. For sites that have reached construction completion and have more than one

OU, you should develop an additional comprehensive site-wide protectiveness statement

covering all of the remedies at the site. You should not include this additional protectiveness

statement until construction completion because, until then, all remedies at the site may not

necessarily have been selected and constructed.

In order to promote consistency, you are strongly encouraged to model your

protectiveness statements on the sample protectiveness statements provided in Exhibits 4-6 and

4-7. Your Five-Year Review report should present the protectiveness statements at the beginning

of a discussion that should explain and provide the supporting rationale of the protectiveness

determination. 

Exhibit 4-6: Protectiveness Statements

If the remedial action at the OU is: then use this statement ...

under construction and...

protective or will be protective “The remedy at OU X is expected to be protective of human health

and the environment upon completion, and in the interim, exposure

pathways that could result in unacceptable risks are being controlled.”

not protective “The remedy at OU X is not protective because of the following

issue(s) (describe each issue). The following actions need to be

taken (describe the actions needed) to ensure protectiveness.”

protectiveness deferred “ A protectiveness determination of the remedy at OU X cannot be

made at this time until further information is obtained. Further

information will be obtained by taking the following actions (describe

the actions). It is expected that these actions will take approximately

(insert time frame) to complete, at which time a protectiveness

determination will be made.”
OSWER No. 9355.7-03B-P

4-22

Exhibit 4-6: Protectiveness Statements

If the remedial action at the OU is: then use this statement ...

operating or completed and...

protective “The remedy at OU X is expected to be protective upon completion or

is protective of human health and the environment, and in the interim,

exposure pathways that could result in unacceptable risks are being

controlled.”

protective in the short-term “The remedy at OU X currently protects human health and the

environment because (describe the elements of the remedy that

protect human health and the environment in the short term). 

However, in order for the remedy to be protective in the long-term, the

following actions need to be taken (describe the actions needed) to

ensure long-term protectiveness.”

not protective “The remedy at OU X is not protective because of the following

issue(s) (describe each issue). The following actions need to be

taken (describe the actions needed) to ensure protectiveness.

protectiveness deferred “ A protectiveness determination of the remedy at OU X cannot be

made at this time until further information is obtained. Further

information will be obtained by taking the following actions (describe

the actions). It is expected that these actions will take approximately

(insert time frame) to complete, at which time a protectiveness

determination will be made.”

Exhibit 4-7: Comprehensive Protectiveness Statements for Sites That Have

Reached Construction Completion

If the remedy(ies)

is/are ...

then use this statement:

protective “Because the remedial actions at all OUs are protective, the site is protective of human

health and the environment.” 

not protective “The remedial actions at OUs X and Y are protective. However, because the remedial

action at OU Z is not protective, the site is not protective of human health and the

environment at this time. The remedial action at OU Z is not protective because of the

following issue(s) (describe each issue). The following actions need to be taken

(describe the actions needed) to ensure protectiveness.”