Environmental
MAY 2002
How the Environmental Laboratory
Accreditation Act Affects You
DO YOU
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Collect or analyze samples of air, water,
groundwater, soil, or other media in
Pennsylvania?
Operate monitoring equipment at your
facility (such as a continuous emission
monitoring system) that analyzes the quality
of your influent, emissions, or discharges?
Prior to enactment of Act 25, DEP only had authority to
regulate laboratories analyzing samples under the Pennsylvania
Safe Drinking Water Act (“SDWA”), the Oil and Gas Act, and
the Small Operators Assistance Program (“SOAP”) (which
provides laboratory assistance to small mine operators). With
this new legislation, DEP is required to establish a registration
and accreditation program for every “environmental
laboratory” that generates data or performs analyses to be used
to comply with any state environmental statute.
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Submit results of environmental analyses to
the Department of Environmental
Protection under any law?
WHAT IS AN
“ENVIRONMENTAL LABORATORY”?
If the answers to any of these questions are “YES,” then you
The term “environmental laboratory” is defined broadly to
need to understand how the new Environmental Laboratory
encompass the activities of many facilities that likely do not
Accreditation Act affects you, and prepare for its
view themselves as “environmental laboratories.” Section 2 of
implementation in the next few months.
the Act defines an “environmental laboratory” as any “facility
engaged in the testing or analysis of environmental samples.”
Adopted on April 2, 2002 as Act 25, the Pennsylvania
Environmental Laboratory Accreditation Act (the “Act”)
gives the Pennsylvania Department of Environmental
Protection (“DEP”) broad authority to regulate facilities
analyzing any environmental sample collected pursuant to a
Pennsylvania environmental statute. A copy of the Act is
available at http://www.dep.state.pa.us/dep/deputate/mts/bol/
“Environmental sample” includes any “solid, liquid, gas or
other specimen taken for the purpose of testing or analysis as
required by an environmental statute.” Finally, the term
“environmental statute” covers any “statue administered by the
Department of Environmental Protection relating to the
protection of the environment or of public health, safety and
welfare.”
Act25.htm.
Taken together, these definitions mean that any facility that
DEP sought this legislation to further its efforts in recent
years to step up regulation of environmental laboratories.
The result, however, is an Act that reaches far beyond
traditional testing laboratories, and which affects virtually
every business, municipality and facility that is required as
part of applications or monitoring to submit the results of any
environmental sample to DEP under any environmental law.
analyzes a “sample” collected pursuant to a Pennsylvania
environmental statute is operating an “environmental
laboratory.” As explained by DEP staff, one needs to think
broadly of the myriad of situations where such samples may
be collected and analyzed to comply with Pennsylvania
environmental laws. Included within the scope of these
terms are or may be:
Kirkpatrick & Lockhart LLP
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Samples of wastewater or stormwater collected to
whether you use a facility inside or outside of the
monitor compliance with NPDES effluent limits or
Commonwealth to perform analyses, that facility must hold the
“monitor only” requirements. This includes not only
required Pennsylvania accreditation or the data will be invalid.
samples sent to an off-site laboratory for chemical and
physical analysis, but also typical on-site testing and in-
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line analysis for simple parameters, such as pH and
REGISTRATION REQUIRED
BY OCTOBER 2, 2002
temperature.
Initially, Section 7(a) of the Act requires all “environmental
Samples collected and submitted as part of the
background information in applications for various
permits.
laboratories” to register with DEP by October 2, 2002. DEP
has developed a relatively simple registration form for this
purpose. That form is available electronically at http://
www.dep.state.pa.us/dep/deputate/mts/bol/1500-FM-
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The conduct of air quality stack tests.
LAB0101.doc. A $50.00 processing fee is required with the
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The operation of automated sampling and analysis
registration application.
equipment, such as air emission continuous emission
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monitoring systems (“CEMS”).
ACCREDITATION PROCESS TO BE
ESTABLISHED BY FUTURE REGULATION
Groundwater monitoring samples collected by solid
While the new statute has the potential to have far-reaching
waste facilities.
effects, the actual extent of its reach remains to be seen.
Drinking water well samples collected by mining and oil
Section 7(b) requires all environmental laboratories to “apply
and gas firms prior to initiation of activities.
for accreditation within six months after the Environmental
Collection and analysis of fish and benthic
macroinvertebrate samples as part of biological
monitoring, such as required under some water
withdrawal and NPDES permits.
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Quality Board establishes an accreditation requirement by
regulation for a type of laboratory.” The Environmental
Quality Board must establish regulations further defining and
governing an accreditation program under Section 5 of the
Act. An 11-member Laboratory Accreditation Advisory
Samples of soil, groundwater, or surface water collected
Committee will participate in development of those rules.
to demonstrate compliance with cleanup standards under
The rules will include provisions relating to:
the Pennsylvania Land Recycling and Environmental
Remediation Standards Act.
Consider further that in many cases, facilities have submitted
plans to DEP for industrial waste treatment, sewage treatment,
and air pollution control units that included process sampling
devices or procedures. Under typical Water Quality
Management Part II permits and Air Quality Plan Approvals,
(1) Testing or analysis to be conducted by an environmental
laboratory.
(2) Allowable fees for environmental laboratories.
(3) Requirements for education, training and experience of
laboratory supervisors.
(4) Criteria and procedures to be used by DEP to accredit
the plans submitted as part of such applications (including
environmental laboratories, which may include
presumably the sampling and monitoring systems described in
proficiency test samples and on-site audits.
those applications) are viewed as incorporated by reference
into the final permits. Hence, some might argue that operation
The Act also allows the Board to “adopt regulations that
of such sampling and monitoring systems that test the physical
establish a general certificate of accreditation program or
or chemical characteristics of solids, liquids, or gases is
certificates of accreditation by rule” and requires the Board to
“required” under an environmental statute, and the facility that
“establish requirements and procedures that address the
operates such a system is an “environmental laboratory.”
unique needs of small businesses, municipalities, municipal
authorities and in-house laboratories.”
2
USE OF ACCREDITED
LABORATORIES MANDATED
Since these regulations will dictate the requirements
After the effective date of the accreditation requirements
laboratories, the regulated community should carefully
(discussed below), facilities may only submit sample data to
scrutinize the rules as they are proposed and provide
DEP that has been analyzed by an accredited laboratory. Thus,
comments, as appropriate, to the Department.
associated with DEP’s accreditation of environmental
KIRKPATRICK & LOCKHART LLP ENVIRONMENTAL ALERT
While the specific parameters of the accreditation program
Laboratories must provide the Department with access to
will need to be established through regulations, Section 6 of
inspect records and data maintained under the Act and to
the Act sets forth several broad principles that will guide the
conduct tests and sampling related to inspections. The
process. In general, an environmental laboratory must have
importance of recordkeeping is underscored in Section 10(d)
the staff, management structure, equipment, quality assurance
which states: “Failure of an environmental laboratory or
and quality control procedures and recordkeeping procedures
laboratory supervisor to maintain adequate records or
necessary to ensure that the laboratory generates valid and
proficiency test samples as required creates a rebuttable
accurate test results meeting all conditions for accreditation.
presumption that the test or analysis was not conducted as
The regulated community should pay particular attention to
required” (emphasis added). Given this provision, a
proposed regulations that set forth the specific procedures
laboratory or lab supervisor could face substantial civil
that need to be followed to implement this general
penalties even though environmental samples were analyzed in
requirement. DEP may seek rules that continue to use broad
accordance with proper protocols if the laboratory fails to
language similar to that found in the Act in order to afford the
properly maintain records of the analyses.
Department considerable discretion. Such an approach was
used by DEP in establishing standards of performance for
NELAP ACCREDITATION
laboratories and laboratory officers as part of the laboratory
While laboratory accreditation is not mandated under the Act
certification process under the Pennsylvania Safe Drinking
until the Environmental Quality Board adopts implementing
Water Act. As many drinking water laboratories have
regulations, Section 7(c) of the Act allows environmental
discovered, DEP has used this broad language to justify
laboratories to voluntarily seek accreditation under the
citations for alleged violations of a wide range of
National Environmental Laboratory Accreditation Program
requirements found in Department and EPA guidance
(“NELAP”) through the Department after the Department is
documents, even though the guidance in such documents is
approved as an accrediting authority by NELAP. The
not mandatory and does not bear the force of law.
processing fee associated with application for NELAP
Two additional prerequisites for a certificate of accreditation
accreditation is $5,000.00.
concern the role of the laboratory supervisor and access to
NELAP is a program administered by the U.S.
records and data.
Environmental Protection Agency (“EPA”) to oversee state
As to laboratory supervisors, the Act requires that testing,
and federal accrediting authorities. See http://www.epa.gov/
analysis and reporting of data by an accredited laboratory be
ttn/nelac/backgrnd.html. The NELAP program was
under the direct supervision of a “laboratory supervisor.” This
developed in response to complaints from the laboratory
applies equally to the off-site testing lab and on-site sampling
community regarding the burden of multiple accreditations
and monitoring operations – and means that many industrial
due to lack of a nationally-recognized accreditation program.
facilities will need to identify, designate and train on-site
In 1990, EPA’s Environmental Monitoring Management
personnel to serve as their “laboratory supervisor” for purposes
Council established an internal work group to consider the
of certifying sampling conducted on-site. The designated
feasibility and advisability of such a program. The National
supervisor, in turn, must certify that each test or analysis is
Environmental Laboratory Accreditation Conference
accurate and valid and that the test or analysis was performed
(“NELAC”) was subsequently organized as a voluntary
in accordance with all conditions of accreditation. DEP may
association of state and Federal agencies formed to establish
disqualify a laboratory supervisor who is responsible for the
and promote mutually acceptable performance standards for
submission of inaccurate test or analysis results. Individuals
the inspection and operation of environmental laboratories.
serving as laboratory supervisors face personal liability for
NELAC has established standards through a consensus
substantial criminal and civil penalties for failure to properly
process based primarily on two guidance documents that
represent that “a test or an environmental sample is accurate or
originated with the International Organization for
was performed in accordance with procedures authorized
Standardization (“ISO”), a body that develops consensus
pursuant to this act.” Thus, proposed rules detailing the
standards for technical fields. The documents are entitled
“conditions of accreditation” should be carefully scrutinized to
General Requirements for the Competence of Calibration
ensure that the responsibilities of laboratory supervisors are
and Testing Laboratories (ISO/IEC Guide 25-1990) and
clearly established.
Calibration and Testing Laboratory Accreditation System-
MAY 2002
Kirkpatrick & Lockhart LLP
General Requirements for Operation and Recognition (ISO/
may now seek authority to certify NELAP accreditation for
IEC Guide 58). The most current version of the NELAC
additional program areas.
standards are incorporated by reference into Pennsylvania’s
Environmental Laboratory Accreditation Act. Copies of
A listing of NELAP accredited laboratories is available at
www.epa.gov/ttn/nelac/accreditlabs.html.
these standards are available at EPA’s website: http://
www.epa.gov/ttn/nelac/2001standards.html.
A FINAL THOUGHT
Although NELAP is a national program, states serve as the
Although this Act was enacted without controversy, its
primary accrediting authorities. States can elect to operate a
potentially far-reaching effects merit the continued attention of
comprehensive program that includes analyses under
the regulated community. Virtually every regulated entity is
multiple federal environmental statutes or operate a program
affected, in one manner or another, by this Act.
that covers a single program area. To be an accrediting
authority, reciprocity with other NELAP accrediting
authorities is mandatory.
KIMBERLY A. HUMMEL
Currently, eleven states, including Pennsylvania, have been
717.231.4807
khummel@kl.com
approved as accrediting authorities. Pennsylvania is
currently authorized to certify NELAP accreditation for
R. TIMOTHY WESTON
analyses performed only for certain programs, although DEP
717.231.4504
tweston@kl.com
intends to seek broader accreditation authority in the near
future. Given the broad scope of the Act, the Department
FOR MORE INFORMATION about this Alert, Kirkpatrick & Lockhart’s environmental practice or
criminal enforcement of environmental laws, please contact the authors or one of the K&L office
contacts lised below. You may also visit our webpage at www.kl.com/PracticeAreas/Environmental.
Roger C. Zehntner
Boston
617.261.3149
rzehntner@kl.com
Stephen A. Kennedy
R. Timothy Weston
Dallas
214.939.4917
skennedy@kl.com
Harrisburg
717.231.4504
tweston@kl.com
Kimberly A. Hummel
Harrisburg
717.231.4807
khummel@kl.com
Paul W. Sweeney, Jr.
Los Angeles
310.552.5055
psweeney@kl.com
Daniel A. Casey
Miami
305.539.3324
dcasey@kl.com
Anthony P. La Rocco
Newark
973.848.4014
alarocco@kl.com
Warren H. Colodner
New York
212.536.3912
wcolodner@kl.com
Richard W. Hosking
Pittsburgh
412.355.8612
rhosking@kl.com
Edward P. Sangster
San Francisco
415.249.1028
esangster@kl.com
Barry M. Hartman
Washington
202.778.9338
bhartman@kl.com
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This publication/newsletter is for informational purposes and does not contain or convey legal advice. The information herein
should not be used or relied upon in regard to any particular facts or circumstances
without&first
consulting
lawyer.
KIRKPATRICK
LOCKHART
LLPaENVIRONMENTAL
ALERT
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© 2002 KIRKPATRICK & LOCKHART LLP.
ALL RIGHTS RESERVED.