UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
FEB 12 2)09
OFFICE OF
SOLID WASTE AND EMERGENCY
RESPONSE
OSWER Directive No. 9200.1-85
MEMORANDUM
SUBJECT: Guidance for Labeling Externally Validated Laboratory Analytical Data for Superfund
Use
1, DirectorJ*^- €4^r~"~
FROM: James Woolford,
Office of Superfund Rerrfed-fation and Technology Innovation
TO: Superfund National Policy Managers, Regions 1-10
Regional Science and Technology Directors, Regions 1-10
Purpose
The purpose of this memorandum is to transmit the final Office of Solid Waste and Emergency
Response Directive entitled Guidance for Labeling Externally Validated Laboratory Analytical Data
for Superfund Use. This guidance will help increase national consistency, and improve
communication and understanding about the nature of validation procedures conducted on laboratory
analytical data developed for Superfund use.'
Background
Each year, well over $25 million are spent through Superfund contracts to analyze soils, water,
sediments, and other media for the presence of contaminants of potential concern. Additional
resources are often used by U.S. Environmental Protection Agency (EPA) to review (i.e., verify and
validate) the resulting laboratory analytical data packages. These reviews are conducted in part to
ensure that data produced in support of EPA's environmental decision making are of adequate quality
1 This guidance will provide information to the public and to the regulated community on how EPA intends to
exercise its discretion in implementing its regulations at contaminated sites. It is important to understand,
however, that this document does not substitute for statutes EPA administers or their implementing
regulations, nor is it a regulation itself. Thus, this document does not impose legally binding requirements on
EPA, states, or the regulated community, and may not apply to a particular situation based upon the specific
circumstances. Rather, the document suggests approaches that may be used at particular sites as
appropriate, given site-specific circumstances. This guidance may be modified in the future.
Internet Address (URL) • http://www.epa.gov
Recycled/Recyclable • Printed with Vegetable OH Based Inks on Recycled Paper (Minimum 30% Postconsumer)
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and usability for their intended purpose. Since there are often different procedures used to evaluate
laboratory data quality by different Superfund stakeholders (e.g., EPA regions. Federal facilities, state
organizations, potentially responsible parties (PRPs). supporting contractors), the manner in which
these reviews are communicated to decision-makers may also vary. Such variability can create
problems when data sets developed by different organizations or contractors are evaluated together in
support of a particular site activity (e.g., when data are gathered over long periods of time, or when
data are gathered quickly by multiple groups in support of a time-critical response action). Because
of this potential variability, and because of the complex nature of commonly used analytical data
verification and validation procedures, it is important to minimize ambiguity in communicating the
nature of these procedures to data users.
The attached guidance recommends the use of consistent terminology by external data reviewers2 in
describing the scope and content of verification and validation conducted on laboratory analytical
data packages developed in support of Superfund response actions. Through the use of this guidance,
EPA decision makers should be readily able to determine what data verification or validation
procedures have been performed on each laboratory analytical data package regardless of which
region, program office, or contractor provided the review.
Implementation
Effective immediately, the attached guidance should be included among those instructions provided
to entities responsible for the verification and validation of laboratory data developed for Superfund
use. More specifically, this directive recommends the following:
• EPA Quality Assurance experts should use this guidance (among other relevant guidance and
guidelines) when performing external review (i.e.. verification and/or validation) of laboratory
deliverables.
• Contract Laboratory Program and other national analytical service/quality assurance contract
deliverables should include the appropriate terminology and labels presented in the attached
guidance to describe the nature of data verification and validation work conducted prior to
delivery to regional customers.
• EPA personnel that administer data review contracts (e.g., Response Action Contracts,
Superfund Technical Assessment and Response Team. Environmental Services Assistance
Team. Regional Oversight Contracts) and Intcragency Agreements (lAs) should incorporate
this guidance into all appropriate contractor instructions (e.g.. Statements of Work (SOW).
Work Assignments. Task Orders) for laboratory analytical data verification and validation
activities.
• EPA personnel responsible for oversight of Potentially Responsible Party (PRP) analytical
activities should incorporate this guidance into all appropriate instructions (e.g.. Consent
Decrees) for PRPs that may review laboratory anahtical data, and for PRP oversight
contractors (e.g., SOWs, Work plans) that may perform laboratory data verification and
validation activities.
2 For the purposes of this guidance, external parties are defined as organizations (including Governmental
entities, contractors, or vendors) that conduct analytical data review, verification, and validation activities and
that are not part of the immediate laboratory that generates the subject analytical data.
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• EPA personnel responsible for the oversight of Federal facilities analytical activities should
incorporate this guidance into all appropriate instructions (e.g., lAs) for Federal facilities that
may review laboratory analytical data, and for Federal facilities oversight contractors (e.g..
SOWs) that may perform data verification and validation activities.
This guidance does not require specific levels (or tiers) of verification or validation for EPA or
contractor products. Generally, these questions are addressed on a project-specific basis in Quality
Assurance Project Plans and/or other project-specific documents.
This document can be found on the internet at htto://www.epa.qov/suDerfund/policv/pdfs/EPA-54Q-R-
08-005.pdf. Please direct any questions to Eric Reynolds of my staff at 703-603-9928
(reynolds.eric@epa.gov).
Attachment
cc: Barry Breen. OSWER
Renee Wynn. OSWER
Debbie Dietrich, OEM
John Reeder. FFRRO
David R. Lloyd, OBLR
Matt Hale. ORCR
Brigid Lowery. CPA
Cliff Rothenstein. OUST
Barbara Hostage. OPM
Lora Culver, OM1S
Marcia Mulkey, OS RE
Dave Kling, FFEO
John Michaud. OGC
Molly O'Neill, OEI
Wendy Lubbe, Superfund Lead Region Coordinator, US EPA Region 7
Cheryl Overstreet, RS&T Lead Region Coordinator, US EPA Region 6
NARPM Co-Chairs
OSC Task Force
Regional QA Managers
OSRTI Managers
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