v^0 sr^

I =_ *
33
5
b	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
|	I	WASHINGTON, D.C. 20460
%
*4 PRO^
OFFICE OF
SOLID WASTE AND
EMERGENCY RESPONSE
13 2012
OSWER 9200.2-111
MEMORANDUM
SUBJECT: Clarifying the Use of Protectiveness Determinations for Comprehensive Environmental
Response, Compensation, and Liability Act Five-Year Reviews
FROM: James E. Woolford, Director^ CJoTT^nfr*^.
Office of Superfund Remediation and Technology Innovation
Reggie Cheatham, Director /
Federal Facilities Restoration and Reuse Office
TO:
National Superfund Program Managers, Region 1-10
PURPOSE
The purpose of this memorandum is to clarify the use of protectiveness determinations in
Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Five-Year
Reviews (FYR). It provides general guidance for the use of specific protectiveness determinations and
recommends language to be used when drafting a protectiveness statement. The information provided in
this memorandum supplements, but does not supersede, the language in the "Comprehensive Five-Year
Review Guidance, " OSWER No. 9355.7-03B-P (June 2001).
BACKGROUND
An audit by the Office of Inspector General (OIG) entitled "Stronger Management Controls Will
Improve EPA Five-Year Reviews of Superfund Sites'" issued February 6, 2012 identified situations where
data provided in a FYR report did not fully support the region's protectiveness determination.
Specifically, the OIG identified situations where the regions did not follow agency guidance for making
protectiveness determinations for remedies under construction and concluded that short-term
protectiveness was not adequately defined in Agency guidance. As a result, the OIG recommended that
the Office of Solid Waste and Emergency Response (OSWER) clearly define the protectiveness
categories used in Agency guidance and ensure that protectiveness definitions are consistently applied
across the Agency.
Internet Address (URL) • http://www.epa.gov
Recycled/Recyclable • Printed with Vegetable Oil Based Inks on 100% Postconsumer. Process Chlorine Free Recycled Paper

-------
The purpose of a FYR 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 for carcinogens and the
hazard index (HI) for non-cancer effects. Evaluation of the remedy and the determination of
protectiveness should be based on and sufficiently supported by data and observations. Consistent with
the "Comprehensive Five-Year Review Guidance, " a discussion of this evaluation should be described
and presented in the FYR report, along with the protectiveness determination.
IMPLEMENTATION
To assess the protectiveness of the remedy, it is important to evaluate human health risks, ecological
risks, and the general performance of the selected remedy. To facilitate this evaluation, a technical
assessment of a remedy is conducted to answer the following questions. The answers to these questions
provide a framework for organizing and evaluating the FYR data and information:
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?
Evaluating Remedy Protectiveness
For CERCLA sites that require a FYR, a separate protectiveness statement is required for each operable
unit (OU) where the remedial action is currently underway or remedial construction is complete. If the
site is construction complete, a site-wide protectiveness determination is also required and will generally
be the same protectiveness determination as the least protective OU at the site.
The OSWER "Comprehensive Five- Year Review Guidance " defines five protectiveness categories:
protective, short-term protective, will be protective, protectiveness deferred, and not protective. The
following discussion provides general guidance for the use of the specific protectiveness determinations
and recommends language to be used when drafting the protectiveness statement for the FYR report.
Protective
A protectiveness determination of "protective" may be appropriate for remedies where:
•	Construction activities are complete and remedy is operating; or
•	Construction activities are complete, remedial action objectives (RAOs) have been achieved, and
operation and maintenance activities are occurring.
A protectiveness determination of "protective" is typically used when the answers to Questions A, B and
C provide sufficient data and documentation to conclude that the remedy is functioning as intended and
all human and ecological risks are currently under control and are anticipated to be under control in the

-------
future.
Recommended Language for a Protectiveness Determination of "Protective"
"The remedy at OUX is protective of human health and the environment, "
The Remedial Project Manager should briefly describe in a separate paragraph below the protectiveness
statement the elements of the remedy that protect human health and the environment and how the RAOs
have been met or are being met.
Short-Term Protective
A protectiveness determination of "short-term protective" may be appropriate for remedies where:
•	Construction activities are complete and remedy is operating; or
•	Construction activities are complete, remedial action objectives have been achieved, and
operation and maintenance activities are occurring.
A protective determination of "short-term protective" is typically used when the answers to Questions
A, B and C provide sufficient data and documentation to conclude that the human and ecological
exposures are currently under control and no unacceptable risks are occurring. However, the data and/or
documentation review also raise issues that could impact future protectiveness or remedy performance
but not current protectiveness. Examples of scenarios that may result in a short-term protectiveness
determination may include:
•	No exposure is occurring but institutional controls have not been fully implemented;
•	Future land use assumptions may have changed;
•	Engineering performance issues related to the operation of the remedy; or
•	Monitoring data indicates that remedy will not achieve goals in the anticipated time frame
Recommended Language for a Protectiveness Determination of "Short-Term Protective"
"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 protectiveness.
Will be Protective
A protectiveness determination of "will be protective" may be appropriate for remedies where:
•	Construction activities are ongoing
A protective determination of "will be protective" is typically used when the answers to Questions A, B
and C provide sufficient data and documentation to conclude that the human and ecological exposures
are currently under control and no unacceptable risks are occurring in those areas. In addition, answers
3

-------
to Questions A, B and C also indicate that the remedy under construction is anticipated to be protective
upon completion and no remedy implementation or performance issues have been identified.
Recommended Language for a Protect!veness Determination of "Will Be Protective"
"The remedy at OUX is expected to be protective of human health and the environment upon
completion. In the interim, remedial activities completed to date have adequately addressed all
exposure pathways that could result in unacceptable risks in these areas. "
Protectiveness Deferred
A protectiveness determination of "protectiveness deferred" may be appropriate for remedies where:
•	Construction activities are ongoing;
•	Construction activities are complete and remedy is operating; or
•	Construction activities are complete, remedial action objectives have been achieved, and
operation and maintenance activities are occurring.
This protective determination is generally used when the available information to answer Questions A,
B and C does not provide sufficient data and documentation to conclude that all human and ecological
risks are currently under control and no unacceptable exposures are occurring. Examples of scenarios
that may result in a "protectiveness deferred" determination include:
•	A new exposure pathway (e.g., vapor intrusion) has been identified and additional data are
required to determine if an unacceptable risk is occurring;
•	An emerging contaminant is present and the current risk has not been evaluated;
•	An ecological risk assessment has never been adequately addressed at the site; or
•	The toxicity value has changed and it unclear whether the current remedy at a site is protective or
whether the selected remedy can achieve the new risk-based cleanup level.
When a protectiveness deferred determination is made, the protectiveness statement generally discusses
the actions needed to collect the missing information and the timeframe anticipated to complete these
actions. Once the necessary data and/or information are obtained, a Five-Year Review addendum is
typically completed that documents the protectiveness determination for the OU(s) where the
protectiveness had been deferred.
Recommended Language for a Protectiveness Determination of "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. "
Not Protective
A protectiveness determination of "not protective" may be appropriate for remedies where:
4

-------
•	Construction activities are ongoing;
•	Construction activities are complete and remedy is operating; or
•	Construction activities are complete, remedial action objectives have been achieved, and
operation and maintenance activities are occurring.
A protectiveness determination of "not protective" is generally used when the answers to Questions A, B
and C provide adequate data and documentation to conclude that the human and/or ecological risks are
not currently under control. Examples of scenarios that may result in a "not protective" determination
include:
•	An immediate threat is present (ex. new exposure pathway identified and it is reasonably likely
to assume that unacceptable exposures are occurring)
•	Migration of contaminants is uncontrolled and poses an unacceptable risk to human
health and the environment; or
•	Potential or actual exposure is clearly present or there is evidence of exposure
Recommended Language for a Protectiveness Determination of "Not Protective"
"The remedy at OU X is not protective because of the following issues(s) (describe each issue). The
following actions need to be taken (describe the actions needed) to ensure protectiveness. "
CONCLUSION
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.
If you have any questions, please contact David Cooper at (703) 603-8763 or at
cooper.davide@epa.gov.
Barnes Johnson, OSWER/OSRTI
Phyllis Anderson, OSWER/OSRTI
Bruce Means, OSWER/OSRTI
David Cooper, OSWER/OSRTI
John Michaud, OGC
David Kling, FFEO
Construction and Post Construction Management Branch, OSWER/OSRTI
Regional Five-Year Review Coordinators, Regions 1-10
NARPM Co-Chairs
5

-------