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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHING rON. D C 20460
Mpu o ioqc	EPA-540-F-98-042
NL - O ISftO	PB98-963259
MEMORAHDUM
SUBJECT J
OFFICE OF
SO. 10 WASTE *N0 EWE3G€KCv
RESPONSE
OSWER Directive # 924Q.0-29P
PROM:
Transmittal of "Office of Solid Waste and Emergency
Response Procedures for Contract Laboratory Program
Investigations"	.„
"V- f \ I £r-
Stephen D. Luftig, Director — pi	v.^r - t
Office of Emergency and Remedial Response (5I201O)
TO:
Addressees
Purpose: This memorandum restates for Superfund program
offices existing Office of Solid Waste and Emergency Response
(OSWER) procedures and program responsibilities during
investigations of Contract Laboratory Program (CLP} laboratories
and/or laboratory employees by the Office of Inspector General
(OIG) for alleged fraud or other corrupt practices. Potential
OSWER actions during any subsequent criminal, civil or
administrative actions are also discussed.
Baekgrou&dt The CLP consists of a nationwide community of
analytical laboratories. Environmental Protection Agency (EPA)
organizations, and associated contractors. It is managed from
EPA Headquarters in Washington, DC, by the Analytical Operations
Center (AOC) within the Office of Emergency and Remedial Response
(OERR). EPA support for implementing the CLP is provided by the
ten EPA Regional offices and the Sample Maragement Office
contractor.
The CLP generates data from analyses of approximately 50,000
samples per year which are collected from Superfund sites. It
provides Routine Analytical Services to analyze samples for the
presence of organic and inorganic compounds. The Superfund
program uses these data to determine the need for removal and
remedial response actions at those sites and to support Superfund
monitoring and enforcement activities. Superfund may also use
the data to support other site response actions, including
operation, maintenance, and closure activities. Each sample
which is processed by CLP laboratories must be documented
properly to ensure timely, correct, and complete analysis for all
parameters requested, and, most importantly, to support the
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potential use of sample data in Superfund response and
enforcement actions.
In accordance with the EPA OIG's mission to detect and
prevent fraud, wa3te, and abuse, the OIG has investigated, and
will continue to investigate, CLP contractors and individuals to
detect potential fraud and other corrupt practices that may
compromise the authenticity and reliability of CLP data.
Although the number of cases of fraud or other corrupt practices
in the CLP has not been great, no fraudulent activity will be
permitted to jeopardize the integrity of the Superfund program.
As a result of OIG investigations, and criminal and civil
actions initiated! by the Department of Justice, EPA has
suspended, prorosed for debarment, and debarred several CLP
laboratories and individuals from receiving new contracts and
from future participation in Federal non-procurement programs.
The Superfund program has discontinued use of existing CLP
contracts with suspended CLP laboratories and individuals pending
the completion of administrative and judicial actions.
In the May 20, 1992 Federal Register [57 FR 21576], EPA
published a notice proposing to amend the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP) (40 CFR
Part 300) by adding an Appendix E, OSWER Procedures for CLP
investigations. In the proposed Federal Register notice,
procedures Superfund employees are to follow when CLP
laboratories and individuals are under investigation for alleged
fraud or other corrupt practices were detailed.
Objective! In June 1995, OERR decided to reissue the
procedures as an OSWER directive instead of publishing it as a
Federal Register notice. Please note the procedures apply only
to CLP laboratory services contracted from private sector
analytical laboratories, and are not applicable to laboratory
services provided by contract to other EPA programs.
Three related procedures are also attached for your
information. On March 4, 1991, OBRR and the Office of Waste
Programs Enforcement (OWPE) issued a "Policy on the Use of
Allegedly Altered Data from Laboratories Under Investigations for
Fraud." This guidance discusses program requirements and site
considerations related to the use of environmental data generated
by laboratories subject to OIG investigations. The intent of the
guidance is to protect the integrity of EPA decisions based on
such laboratory data.
On July 18, 1991, OERR and the Office of Enforcement issued
"OSWER/OE Communication Procedures for Notification of Interested
Parties Regarding Administ ative, Civil and Criminal Actions
Against Contract Laboratories." These procedures implement the
notification Drovlsions of the guidance, "OSWER Procedures for
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CLP Investigations." The communications procedures detail
communications policies for affected Superfund program and legal
offices when a contract laboratory is under investigation by the
OXG; was suspended or debarred by the EPA; or bad civil or
criminal action taken against it. The ccmunications procedures
also explain when information concerning contract laboratory
fraud will be communicated outside the Federal government.
On June 22, 1992, OERR and OWPE issued 03WER Directive
9240.0-20, "Update on Proposed Rule and Procedures for CLP
Investigaticns". which summarized Superfund program practices
followed when "*Li? laboratory is investigated for fraud or other
potential ; induct.
This OSWER Directive includes the attached
<~ui > ce as well as all previously referenced guidance issued to
date fcy the OERR or procedures for "LP Investigations. Please
ensure appropriate program office . sonnel receive copies of
OSWER Directive # 9240.0-29 and are cognizant of OSWER procedures
and program responsibilities.
Provisions of the procedures highlight the careful balance
between the due process and other legal rights of CLP
laboratories and individuals and the competing demands of EPA to
protect public health and the environment under the Superfund
program. These procedures are designed to mitigate potential
damage to the Government', protect the Government from harm, and
maintain due process and other legal rights of CLP laboratories
or individuals under investigation. The procedures protect the
authenticity and reliability of CLP-generated data and the
validity of EPA decisions based on such data.
For additional information or comment, please contact Hans
J. Crump-Wiesner, Director, Analytical Operation Center (Mailcode
5204G), OERR, EPA, 401 M Street, S.W., Washington, DC 20460.
He can also be reached at (703) 603-8821.
Attachments (4)
Addressees: Director, Office of Site Remediation and Restoration
Regions I
Director, Emergency and Remedial Response Division
Regior II
Director, Hazardous Waste Management Division
Regions III, IX
Director, Waste Management Division
Region IV
Director, Superfund Division
Regions V, VI, VII
Assistant Regional Administrator, Office of
Ecosystems Protection and Remediation
r>r> \f T T T
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Director, Environmental Cleanup Office
Region X
Director, Office of Environmental Measurement &
Evaluation
Region I
Director, Environmental Services Division
Regions II-IV, VI-VIII, X
Director, Environmental Sciences Division, Region V
Chief, Environmental Services Branch, Region IX
cc: Jerry Clifford, Director, Office of Site Remediation
Enforcement (2271)
Betfv Bailey. Director, Office cf Acquisition Management
(3801)
Mike Nortbridge, Regional Support Division, Office of Site
Remediation Enforcement (2272)
Regional Counsel, Regions I-X
Regional CLP Technical Project Officers, Regions I-X
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OSWER Procedures for Contract Laboratory Program
Inveatigationa
A.	Purpoam
This guidance describes the actions the Office of Solid
Waste and Emergency Response (OSWER), will take to protect the
authenticity and reliability of analytical data generated for
OSWER's Superfund programs by laboratories participating in the
Contract Laboratory Program (CLP). This guidance is intended to
aid the internal management of EPA. The procedures are not
intended to, nor do they, create any right or benefit enforceable
at law by any party against EPA or its officers or employees.
B.	Reporting mnd Coopmrmtion
1.	All alienations or suspicions of fraud, waste, or abuse
involving a CLP laLoratory and/or individual will be reported
immediately to the EPA OIG by any EPA employee or contractor
associated with the Superfund program.
2.	All EPA employees shall cooperate fully with the OIG
during the course of a preliminary inquiry and any subsequent
investigation. The cooperation includes, but is not limited to,
providing all relevant information associated with the CLP
laboratory and/or individual, fulfilling all information requests
by the OIG, providing technical assistance to the OIG, and making
on-site visits that may be required during the course of the
prelimir ry inquiry and any subsequent investigation.
3.	EPA employees will also cooperate with other Federal
authorities, including the Department of Justice (DOJ), in
matters related to preliminary inquiries, investigations, and
criminal and civil referrals and prosecutions.
C.	OSWER Actton* During 0X0 Xavmmtigmtionm
1. After reviewing a Notice of Scheduled Investigation
(NJLil) received from the OIG for a current CLP contractor and/or
individual, AOB will request EPA's Office of Acquisition
Management Division (OAM) to consider:
a.	issuing a Contracting Officer Stop Shipment (COSS)
notice informing the laboratory under investigation that EPA will
not order any sample analyses (including performance evaluation
(PE) samples) under the laboratory's CLP Routine Analytical
Services (RAS) contract(s) pending completion of the OIG
investigation; —d
b.	advising the Sample Management Office (SMO) to cease
sche.iuling RAS samples (including PE sample*) to the laboratory.
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2.	In cases where evidence of fraud or other corrupt
practices is found, OSWER will take action to protect the
Government's interest by referring the matter to the EPA Office
of Grants and Debarment (OGD) and Office of General Counsel
(OGC), Inspector General Division, to pursue suspension and/or
debarment of the laboratory and/or individual.
3.	OSWER may request that OAM discontinue the use of any
existing contracts with the laboratory and/or individual under
OSWER programs, concurrent with any suspension, debarment, or
other action that deems the laboratory and/or individual to be
ineligible. OSWER may also request that the Contracting Officer
(CO) consider terminating existing CLP contracts.
4.	OSWER will consult with OGC's Inspector General
Division about possible civil or administrative action to recover
monetary damages in connection with the alleged fraud or other
corrupt practices.
5.	EPA will consider all relevant investigative
information authorized for release by the OIG, and DOJ if
applicable, in EPA's review and approval of Superfund program
quality assurance project plans under the NCP.
6.	Notwithstanding EPA review and approval of any Superfund
program quality assurance project plans under the NCP, if other
Federal agencies, States, prime contractors, or Potentially
Responsible Parties (PRPs) submit data from samples shipped to a
laboratory during the time period that is the focus of the
investigation, the EPA Superfund program reserves the right to
exclude or limit the use of these data in its decision-making, in
the absence of satisfactory evidence that the date are not
compromised.
D. OSWER Actions Following Suspension# and Dmbmxmmntm
1.	In consultation with OGD and OAM, Superfund program
employees may take actions pursuant to the applicable regulations
with respect to a laboratory and/or individual that has been
suspended, proposed for debarment, debarred, or otherwise deemed
to be ineligible.
2.	Under the terms and conditions of settlement
agreements, consent decrees, or administrative orders with PRPs,
Superfund program employees may direct PRPs not to use
laboratories and/or individuals that are suspended, debarred, or
otherwise deemed tc be ineligible. In addition, cuperfund
program employees shall request that COs for the Superfund
program use the information available to them, consistent with
applicable law, to make responsibility determinations, consent
determinations on proposed subcontracts, and contract. ' ermination
decisions.
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3.	OSWER will request that the EPA Regions not accept or
approve work plans submitted by PRPs that propose to ship samples
to a laboratory that is suspended, debarred, or otherwise deemed
to be ineligible.
4.	Except as otherwise provided in this subsection, OSWER
and Regional employees in the Superfund program will not
recommend or direct any action by other Federal agencies, States,
prime contractors (including the SMO contractor), or Potentially
Responsible Parties (PRPs) with regard to their existing or
future contracts with a laboratory and/or individual under
investigation.
5.	It i 9 c.PA'8 position that other Federal agencies,
States, and prime contractors are to take actions that are
consistent wi'.h EPA's actions regarding laboratories and/or
individuals that have been suspended, debarred, or otherwise
deemed to be ineligible. These parties are to make contractor
responsibility determinations and contract administration and
termination decisions based on the information available to them,
in accordance with applicable regulations.
I. Notification
1.	When the OIG issues an NSI regarding a CLP laboratory
and/or individual, it routinely sends a copy to OGC's Inspector
General Division, the AGB, and the Regional Administrator of the
Region in which the laboratory is located. OGC's Inspector
General Division will be responsible for forwarding a copy of all
PSIs on CLP laboratories and/or individuals to the DOJ Civil
Division and to the Director, Regional Support Division, Office
of Site Remediation Enforcement, Office of Enforcement and
Compliance Assurance (OECA). OSWER will notify appropriate EP*
offices when a CLP laboratory and/or individual is issued a COSS
notice, suspension, debarment, contract discontinuance or
termination, cr is otherwise deemed to be ineligible. Zn
addition, it is OSWEP.' s policy to provide the EPA Regions, OECA,
and the DOJ Environmental Enforcement Section (EES) with a list
of potentially affected sites that have had samples analyzed by
the laboratory. If investigative information is authorized for
release by the OIG, and DOJ if applicable, OSWER will provide
that information to the EPA Regions, OECA, EES, and to COs for
use in making contractor responsibility determinations for new
awards, subcontract consent determinations, and contract
termination decisions.
2.	Headquarters and Regional employees of the Superfund
program will notify other tederal agencies, States, prime
contractors, and PRPs when a CLP laboratory and/or individual is
issued a suspension, debarment, contract discontinuance or
termination, or is otherwise deemed to be ineligible. In
general, Superfund eaployees will not notify these parties of any
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COSS notice or NSI; however, AOB will notify the SMO contractor
of any COSS notice. When or.G, and DOJ if applicable, authorize
the release of investigative information, Superfund employees
will notify other Federal agencies, States, prime contractors,
and PRPs of th%t information for contractor responsibility
determinations, subject to the recipient's agreement not to
further disclose such information.
3.	Other Federal agenciea, States, prime contractors, or
PRPs may consult the laboratory and/or individual to determine
whether EPA or any other organization has taken any action with
regard to that laboratory and/or individual that may affect the
determination of the responsibility of the laboratory and/or
individual or the adequacy of the datz generated by the
laboratory and/or individual.
4.	EPA will reiprnd to requests for information consistent
with the requirements and exemptions of the Freedom of
Information Act (FOIA), 5 U.S.C. S52.
5.	Inquiries from outside EPA to employees of the Superfund
program regarding the existence of an investigation of a CLP
laboratory and/or individual will be referred to the OIG.
Inquiries regarding contract discontinuance or termination will
be referred to OAM. Inquiries regarding suspensions, debarments,
or other actions under which a CLP laboratory and/or individual
is otherwise deemed to be ineligible will be referred to OGD.
6.	The Superfund program should ensure that all parties
that were previously notified are informed when an investigation
is closed, or when a CLP laboratory has been indicted, convicted,
the subject of a civil fraud judgment, suspended, debarred, or is
otherwise deemed to be ineligible.
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