United States
               Environmental Protection
               Agency
Office of Solid Waste and
Emergency Response
(5102G)
EPA 542-R-01-015
October 2001
www.epa.gov
www.clu-in.org
V EPA   Current Perspectives in Site Remediation and Monitoring
               THE RELATIONSHIP BETWEEN  SW-846, PBMS, AND INNOVATIVE
               ANALYTICAL TECHNOLOGIES


               D. M. Crumbling1 and Barry Lesnik2
               Introduction

               This  summary  explains EPA's  position
               regarding testing methods used within waste
               programs, documentation of EPA's position,
               the reasoning behind EPA's position, and the
               relationship  between  analytical  method
               regulatory flexibility and the use of on-site
               measurements (also termed "field analytical
               methods") to improve the cost-effectiveness
               of contaminated site  cleanups.

               Although the flow of site cleanup work can be
               accelerated and  site cleanup can be more
               economical when on-site analytical methods
               are used, the adoption of field methods has
               been hindered  by misunderstandings about
               regulatory requirements for data quality and a
               traditional  reliance   on fixed  laboratory
               methods to provide nearly all of the data upon
               which site decisions are based. Contrary to
               widespread opinion [see Reference 1, Note 4],
               EPA policy does NOT "approve" (in a restric-
               tive sense) which specific analytical methods
               may be used to generate most of the analytical
               chemistry data  used   within the  "waste
               programs" (such as the RCRA, Superfund, or
               other contaminated site cleanup programs).
               However, to support the analytical needs of
               the RCRA program (and by extension, other
               waste/contaminated  site management prog-
               rams),  EPA has created and maintains  a
               methods compendium, entitled Test Methods
               for  Evaluating  Solid  Waste,  Physical/
         Chemical Methods  (also  known as "SW-
         846"). [EPA's SW-846 Manual and suppor-
         ting information are available on-line  at:
         http://www.epa.gov/SW-846/sw846.htm.]
         SW-846 is currently in its Third Edition, and
         Draft Update FVB has just been issued [see
         Reference 9].

         SW-846  is a guidance document meant to
         assist analytical chemists and other users by
         suggesting sampling and  analytical proce-
         dures that have undergone thorough evalua-
         tion to identify the strengths and weaknesses
         of the methods, and the expected analytical
         performance for the range of sample types
         evaluated [see Reference 1, Notes 1 and 3]. It
         is EPA's position that for the majority of
         methods  in SW-846 (which are not method-
         defined  parameters, as  discussed  further
         below):

           •  SW-846 is NOT the ONLY source of
             methods that can be used.

           •  Methods in SW-846 do NOT need to be
             implemented exactly as written in SW-
             846.

           •  Performance data presented in SW-846
             methods  should NOT  be  used  as
             regulatory  default  or  absolute  "QC
             requirements" [see  Reference  2, page
             TWO-land-2].
                1 EPA, Technology Innovation Office
                2 EPA, Office of Solid Waste, Economics, Methods, and Risk Analysis Division
                                                       1

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Causes of Confusion about "EPA-Approved
Methods"

Policies in other programs

One source of confusion about requirements for "EPA-
approved methods" within  the waste programs stems
from the fact that EPA's Water programs have regula-
tory  requirements  for  "EPA-approved  reference
methods" which are specifically written into their regu-
lations. If these reference methods are followed exactly,
by definition in these programs, the data generated using
these reference methods are automatically considered to
be  appropriate  for regulatory  compliance.  These
methods are mandatory and prescriptive. Because so
many U.S. commercial laboratories are set up to comply
with Water program requirements, and since discussions
about  "EPA methods" are rarely  explicit about the
specific regulatory program under discussion, many
people assume that the same policy  of prescriptive
methods applies to  all EPA programs. However, EPA's
Office of  Solid  Waste and Emergency  Response
(OSWER) which includes the programs responsible for
cleaning up contaminated sites operates under a very
different analytical paradigm than the Water programs.
There  are  a number of reasons for  this. The most
important  reason  is that  the   variety of  matrices
encountered in the waste  management and cleanup
programs, and the variety of decisions  involving those
matrices, are much too diverse to expect prescriptive,
one-size-fits-all sampling and analytical  methods to
produce scientifically defensible data across this entire
range of variables [see Reference 2, PREFACE-1].

Therefore, there are no "reference methods" (as defined
by EPA's Water program) included in SW-846. Within
the waste  programs, all SW-846  methods  or other
appropriate methods  must be demonstrated by the
analyst to generate  scientifically reliable data (i.e., data
of known quality)  for the analytes of concern, in the
matrices of concern, at the  concentrations of concern,
within the  context of the  intended application. EPA
policy in  the  waste  programs  is  that analyses are
required to "get the right answer" as demonstrated by
quality assurance mechanisms. If an accepted method
cannot "get the right answer" due to analytical difficul-
ties with the matrix, etc., selection of a different method,
or modification of a method is required. Having run a
method "as written" is no excuse for reporting faulty
data. These issues will be discussed in additional detail
below.
The CLP in the Superfundprogram

Another  cause for  confusion  is that the  Superfund
program  maintains the Contract Laboratory Program
(CLP), which has had a history of highly prescribed
methodologies, reporting limits,  and  QA/QC criteria.
The reason for the prescriptiveness of the CLP results
however, not from regulatory requirements, but from
contract requirements. The Contract Laboratory Prog-
ram is maintained by the Superfund program as a service
to provide Regional offices with ready access to contract
laboratory services. The CLP strives for consistency in
data reporting formats and  expected analytical  data
quality   [see  information  on  http://www.epa.gov/
superfund/programs/clp/aboutsrv.htm],  since   CLP
results are often relied upon for enforcement and other
sensitive  situations. This is done by having laboratories
that participate in this program  agree to the exact terms
of the contract in order to win a place on the list of
available CLP labs. Although many of the terms of past
contract mechanisms were planned with the expectation
that compliance with those terms would ensure consis-
tency in analytical quality, the realities of waste sample
types and  difficult analytes  have the potential  to
generate  inaccurate  or non-informative  data if needed
method  modifications, such as  changing extraction
procedures or adding cleanup steps, were not permitted
according to the terms of the contract. Fortunately, this
situation has changed substantially in recent years as the
CLP  explores new ways  to  permit  the  analytical
flexibility needed to ensure data quality on a sample-by-
sample basis, while still  accommodating the require-
ments  of a government contract mechanism  (for
additional information,  see  www.epa.gov/superfund/
programs/clp/methflex.htm).

It should  also be noted that use of CLP services by EPA
Regions is not required, but is  one  option open to site
managers to simplify their workloads. Obviously then,
compliance  with CLP contract  requirements is  not
incumbent upon entities  not governed  by those EPA
contracts. Nonetheless, because of the discomfort of
most environmental managers with selecting or evalua-
ting analytical chemistry methods, any mechanism that
seems to offer the ability to simply "check a box" when
choosing laboratory services and abdicate responsibility
for ensuring data quality to someone  else  (i.e.,  the
"government") possesses an irresistible attraction. This
has led many labs to market themselves to the private
sector as  CLP labs or equivalent in order to ride on the
coat tails of the CLP mystique, has fueled the miscon-
ception that prescriptiveness in analytical methodologies
can ensure consistently accurate data, and has furthered

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a misconception that CLP laboratories are certified or
accredited by EPA (which they are not). On the other
hand, where this has tended to promote consistency in
reporting formats  and enforcement expectations, there
has no doubt been benefit.

Interpretation of the term "approved method"

Another reason for confusion has to do with the use of
the word  "approved,"  and understanding what that
means. SW-846 methods are said to be "approved" for
use under the  RCRA regulatory program to  "comply
with the  requirements of subtitle C of the Resource
Conservation and Recovery Act (RCRA)" [see Refer-
ence 1, page 3089 and Reference 2, PREFACE-1]. To
support application  to  RCRA  programs,  "SW-846
analytical methods are written [in their most rigorous
form]  as quantitative trace [<1000  ppm] analytical
methods to demonstrate that a waste does not contain
analytes of concern that cause it to be managed as a
hazardous waste" [see Reference 2, page TWO-1 and
section 2.1.1]. This form of "EPA-approval," however,
not the same as that granted for methods in the Water
programs, where methods must be used and followed as
written. Approved methods for the RCRA program (i.e.
SW-846 methods) are methods that have been validated
for, and should be able to be used for, most RCRA
applications, but they are not requiredto be used (except
for the method-defined parameters-discussed below).

The application of "EPA-approved" methods is thus
neither exclusive or restrictive  [see Reference 2,
Disclaimer-1 page]. SW-846 generally offers several
alternative methods for the same class of analytes, any
of which might be selected to measure target analytes in
the context of a particular project or permit. Methods
that are not in SW-846 may also be selected. No matter
whether a waste generator uses an SW-846 method or
alternative method, the user must still demonstrate that
the method is applicable for its intended purpose, [see
Reference 1, Note 2]. If a method not published in SW-
846 is proposed,  and there  is also little or no perfor-
mance data published in any peer-reviewed forum, then
the amount of analytical documentation that will need to
be  submitted to  the  regulatory body for scientific
evaluation will be greater than when an established
method is used. But the regulatory body  should  not
rej ect any scientifically valid method that is proposed by
a regulated entity  simply because it does not appear on
the "SW-846  list."  As  long  as a method  can be
demonstrated to  achieve the needed  sensitivity and
accuracy for the target analytes in the matrix in question,
then that method should be  considered as  a viable
analytical option.

On the other hand, simply because a method from SW-
846 is selected does NOT mean that it can be assumed
that  implementing the method as written will  auto-
matically produce reliable data for a particular applica-
tion. Especially when unusual or complex matrices are
involved, SW-846 methods must still undergo a "demon-
stration of applicability" to establish adequate analytical
performance  in the context of that application [see
Reference 2, Section 2.1]. Modification of generalized
methods is often requiredto improve method performan-
ce for certain target analytes in  certain matrices.  It
should also be noted that SW-846 methods are  NOT
equivalent to Standard Operating  Procedures (SOPs),
and cannot be substituted for project-specific or labora-
tory-specific SOPs [see Reference  2, PREFACE-1].

Failure  to   distinguish  the  impact   of  sampling
considerations

One-size-fits-all approaches assign accountability based
on whether a certain procedure was followed, not on
whether work was performed correctly and accurately.
While  comforting in  the short-run because of their
simplicity, one-size-fits-all approaches are truly useful
only as stop gap measures until more reliable informa-
tion  or understanding becomes available. Reliance on
them after that becomes counter-productive, error-prone,
and wasteful in the long-run  as evidence of decision
errors (due to faulty underlying assumptions) accumu-
late. The expectation that  simply  regulating  how
analytical methods are used can guarantee sufficient data
quality is seductive to regulators and practitioners alike
because it avoids the much more difficult issues of
project planning,  sample representativeness, and the
integration of professional/technical competence and
scientific advancement into all levels of project imple-
mentation [see  Reference 2, PREFACE-1]. It is also
convenient to think that if project decisions are later
shown to be "wrong," the blame can be assigned to the
laboratory for generating the "wrong" results.

But the unavoidable truth is that even //the most highly
accurate  laboratory  methods were  used  on  each
individual sample, the data will  be meaningless or
misleading if the sample collection procedures (proce-
dures implemented by field  personnel  over which
laboratories have no control) do not ensure the represen-
tativeness of the samples in the context of the project
decisions. In other words, does the sample selection
process ensure that data from  those  samples will
represent the parameter of interest? A sampling design

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that is supposed to determine whether spills or leaks
could have occurred at a site will be very different from
a sampling design that is supposed to  determine the
average concentration of contaminants across some risk-
based exposure unit. Sampling design must consider
where specimens  are  collected,  when  samples are
collected, and how samples are collected. "Where" is
frequently determined by  statistically-based sample
designs when quantitative estimates of decision certainty
are desired. "When" may also be governed by statistical
considerations, as well as by seasonal effects or other
time-sensitive factors.  "How" involves a consideration
of representative "sample support" (the dimensions and
orientation of specimens as they are extracted from the
parent material being tested), and the selection of the
sampling tools that will be used to extract the specimen
(spatulas, soil corers, drum samplers, etc.). [See EPA
guidances for statistics and sampling design available on
http://cluin.org/chartext_edu.htm#stats.  A   more
thorough discussion of the issue of representativeness in
regard to environmental  data  can be found in EPA
QA/G-5, Appendix H. See Reference 8.]

Failure to distinguish between determinative and
sample preparative methods

Non-chemists also show a strong tendency  to  focus
solely on determinative  analytical  methods  (the
instrumentation used to actually generate the analytical
result) to the exclusion of other very important aspects
of sample analysis,  such as  sample  preservation,
subsampling  in  the  laboratory, sample  preparative,
extraction, or digestion methods, and extract cleanup
methods. Yet, as with representative sample collection,
appropriate sample preparative methods can mean the
difference between data that are effective for defensible
decision-making and data that are completely unreliable,
irrespective of how much quality control is imposed on
the determinative method. Sadly, a great deal of time
and  money  is  spent to  micromanage  laboratory
determinative methodologies, while these other factors
are completely ignored. Huge gains in the reliability of
analytical results could  be attained by  refocusing
resources to ensure the representativeness of sample
collection, and by supporting the "mixing and matching"
of sample preparative, cleanup, and  determinative
methods  for the purpose of generating the appropriate
data needed to address specific project decisions [see
Reference 2, PREFACE-1, and Reference 3, page 3].
Prescriptive  SW-846  methods  for  method-defined
parameters

Yet another reason for confusion is that there are a few
specific requirements in regulations to use SW-846
methods exactly as written. EPA regulations state [see
Reference 1, Note 2] that  "Several of the hazardous
waste regulations under Subtitle C of RCRA require that
specific testing methods in SW-846 be employed for
certain  applications."  These requirements relate  to
testing used to determine a specific kind of property that
is termed a "method-defined parameter." The regulation
goes on to say that "Any reliable method may be used
to meet other requirements in 40 CFR parts 260 through
270" [emphasis added].

"Method-defined parameters" are characteristics  or
properties of waste materials that are defined  by the
outcome of a particular testing procedure. The test must
be performed exactly as written because the way the
method is  performed determines  the results, and
interpretation of the results has been standardized based
on implementing the testing procedure in the same way
every time. Where RCRA regulations are involved, a
method-defined parameter is a method that defines the
related regulation, and so it must be followed exactly as
written. Examples of these method-defined parameters
are the Toxicity Characteristic Leaching Procedure
(TCLP, SW-846 Method 1311), and tests to determine
the free liquid component of a waste (SW-846 Method
9095) or the  corrosivity of a waste material (SW-846
Method 1110).  If the method is  not performed  in the
exact manner as written (for  example, if the TCLP is
performed with a different leaching solution or for a
different time period), the result for the  measured
parameter cannot be used to interpret compliance with
the corresponding regulation [see Reference 2, page
TWO-1; and Reference 3, page 4].

There are only a few method-defined parameter methods
in SW-846. The vast majority of SW-846 methods (and
much, if not all, of the testing done during hazardous
waste site characterization)  are  not  method-defined
parameters.  That  means  the  analytical method  is
measuring a parameter that is real physical matter, such
as the total amount of arsenic (As) in a kilogram of soil.
The amount of total arsenic is an independent, verifiable
quantity that is at theoretically and conceptually possible
to measure  exactly, even  if that measurement is a
technological challenge. Such methods are proper candi-
dates for method  modifications or  for selection  of
alternative  methods  that  permit  improvement  of
analytical performance for specific sample types, or to

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improve   the   cost-effectiveness  of  environmental
monitoring  programs  while still  ensuring that the
"correct" regulatory decisions are being made. The goal
of the RCRA methods program is not to arbitrarily
require specific procedures (which is a command-and-
control  mechanism),  but to allow  members  of the
environmental  community freedom  to  achieve  their
regulatory objectives in ways that make both scientific
and economic sense within their particular context. This
is  called  a performance-based,  or results-oriented,
approach.

The development of regulation-defined testing proce-
dures should be considered carefully. Where there are
regulatory requirements for certain testing procedures to
be  implemented  as  written in the regulation, the
responsibility for the accuracy or realism of the results
is assumed by the regulating entity.  For example, the
purpose of the TCLP is to estimate the likelihood that
waste deposited in a landfill will leach toxic constituents
into groundwater.  If the TCLP  test predicts that  no
leaching will occur, and the waste is placed in a landfill,
but then leaching does occur in the real world, the blame
for faulty real-world predictability does not lie with the
regulated  entity, but with the regulator/regulation for
requiring  a  test that  does not always  yield reliable
results. Yet  developing a prescriptive test that will be
reliable across multiple impacting variables is extremely
difficult, if not impossible.

Writing regulations that require prescriptive methods for
actual physical quantities (such  as the  amount  of
benzene in a liter of groundwater) turns these measure-
ments into method-defined parameters from a regulatory
perspective, and ceases to recognize benzene concentra-
tions as real  molecules whose accurate quantification is
continually improved  with experience and technology
advancement. If a regulating entity relies on prescriptive
methods, it is then under continual pressure to update its
regulations to keep pace with improvements in analytical
chemistry technology. This has proven to be an impos-
sible task. A more technologically, economically, and
scientifically feasible  approach  is the  Performance-
Based Measurement  System  approach  (discussed
below).

Performance-Based Measurement Systems (PBMS)

Why  a performance-based  approach  to  analytical
methods is advantageous

As discussed above, prescriptive regulation of analytical
methods is not wise for several reasons:
1. Eliminating analytical flexibility forces some testing
to be done  inappropriately because site- or sample-
specific issues (such as matrix complexities, recovery
issues, or interferences) cannot be addressed to ensure
accurate analytical results.

2. For some site decisions, rigorous quantitative data
may not be needed-only a semi-quantitative or "go or
no-go" result is required to make the correct decision. It
is wasteful to pay for high levels  of analytical data
quality that are not  relevant to project needs; yet
regulatory programs that prescribe specific methods
seldom permit a graded approach to  selecting methods
or so that analytical performance can be tailored to
match specific project needs. However,  it is  well
established that as long as adequate planning  and
QA/QC protocols ensure that the data quality will be
known and appropriate to the intended data use, it is
frequently possible to use less expensive analytical
methods  for some or all of the data collection efforts,
while achieving a  higher  level  of overall decision
certainty if amore representative number of samples can
be tested [see Reference 7].

3. Regulatory analytical rigidity damages the ability of
the  environmental laboratory community to grow in
expertise  and advance technologically.  Prescriptive
methods  prohibit the  use  of  professional analytical
chemistry skills that could otherwise select the most
appropriate  methods  or  modify  and   troubleshoot
methods to ensure that the "right answer" is obtained.
Discussions  with experienced environmental chemists
and  skilled laboratory auditors reveal  a common
consensus that years  of  prescriptive  methods  has
atrophied the competence of U.S. commercial environ-
mental laboratories,  and is a contributing factor to
laboratory fraud.  These observers  have seen highly
trained and experienced professional chemists replaced
by technicians who mindlessly operate equipment while
lacking the technical understanding and critical thinking
abilities  needed to guarantee the  analytical quality
needed to support environmental decisions (see WTQA
references regarding laboratory and data quality issues).

4. In addition, prescriptive requirements inhibit the
development of new and better analytical methods for
the environmental laboratory because of the great time
lag between the introduction of an innovative, improved
technology and the regulatory acceptance that would
allow it to be freely used  in the marketplace. While
analytical science  is  making  great strides in other
industries,  application of  improved,   cost-effective
analytical technologies in the environmental arena lags

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behind. Statements from instrument makers and vendors
reveal their reluctance to develop and  market new
equipment for  environmental  applications  because a
near-term return on their investment appears unlikely no
matter how much promise the technology may offer in
lower analytical costs or improved analytical quality.

PBMS'within EPA 's waste programs

Although the Methods Team responsible for maintaining
SW-846  has  worked  under  a  performance-based
approach since the inception of SW-846, this fact is
seldom recognized. Despite the many efforts of the
Methods Team to counteract disturbing trends toward
analytical micromanagment, SW-846 has been misap-
plied in a prescriptive manner in the implementation of
many federal and  state programs [see Reference 3, page
2]. In another attempt to combat analytical prescriptive-
ness, EPA has formally adopted an agency-wide policy
called the  Performance-Based Measurement  System
(PBMS)  approach, as announced in an October 6, 1997
Federal Register Notice [see Reference 4]. Although the
policy addresses  all agency programs, this  discussion
will  only involve  the application of PBMS to RCRA-
related programs  (and by extension,  to all programs
relying on SW-846 methods), as announced in a May 8,
1998 Federal Register Notice [see Reference 5].

As discussed in Section II.A, page 25431 of the May 8,
1998 Federal  Register  Notice,  a PBMS  approach
"conveys 'what'  needs to be accomplished, but not
prescriptively 'how' to do it... [T]he regulating entity
will specify questions to be answered by the monitoring
process,  the decisions to  be  supported by the data, the
level of uncertainty acceptable for making the decisions,
and the documentation to be generated to support the
PBMS approach...Data producers will demonstrate that
a proposed sampling and  analytical approach meets the
monitoring criteria specified in the Quality Assurance
Project Plans or Sampling and Analysis Plans for the
individual projects or applications."

This means that any analytical method may be used to
generate  data (whether or not it is currently published in
SW-846) as long as it can be demonstrated to:

 •  measure the constituent of concern,
 •  in the matrix of concern,
 •  at the concentration level of concern,
 •  at the degree of accuracy as identified as necessary
    to address the site-decision.
number and placement of specimen collections) interact
with the analytical consideration and the decisions to be
made in an integrated fashion to generate a specified
level of overall certainty in a decision. For example,
contrast  two  scenarios wherein a given waste stream
contains constituents subj ect to regulatory monitoring to
ensure to some specified degree of statistical certainty
that the true constituent concentration is indeed less than
a given regulatory threshold. In Scenario l,the regulated
analytes tend to occur  at levels very close to  the
regulatory threshold. Statistical calculations determine
that a certain number of samples and a certain level of
analytical method accuracy (i.e., precision and bias) will
be  required  to establish  regulatory compliance. In
contrast, for Scenario 2, the same regulated analytes in
the same waste stream tend to occur at concentrations
significantly  less than the regulatory threshold, but all
other conditions (such as the desired degree of statistical
confidence) are the same. For Scenario 2, demonstrating
that regulatory compliance is achieved would require
few er sample s and less stringent analytical accuracy than
those required in Scenario 1.

For this reason, regulations should serve only to set a bar
for  overall  statistical   certainty  in  environmental
decisions, but should not attempt to prescribe sample
numbers or  to  limit analytical  technologies.  When
regulated  entities  are  given  clearly  defined  (and
consistently enforced) compliance goals and the freedom
to customize their processes and monitoring programs to
match their particular circumstances, industry quickly
discovers the most cost-effective means to achieve the
goals of environmental regulation, including the creation
of innovative technologies. Flexibility can also encour-
age  regulated  entities to  exceed the environmental
protection goals desired by regulatory requirements, if
the cost of  lowering the  absolute  concentration of
discharged regulated analytes in the waste stream can be
offset by savings in the monitoring costs (as exemplified
in Scenario 2). If  appropriate technical expertise is
incorporated by the  regulatory body, it is not difficult to
develop oversight programs that discourage "cheating"
while permitting this kind of flexibility.

When sampling and analytical considerations  are
allowed to  be co-variables in an equation whose output
is the overall confidence (statistical certainty) desired in
a regulatory decision, a much more cost-effective and
protective monitoring program can be developed than is
possible under  programs  built  on  a foundation of
prescriptive, one-size-fits-all assumptions.
This  also means  that sampling considerations  (the    A PBMS is consistent with Agency-wide EPA policies

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                                                     Performance-based approaches are the foundation of the
                                                     paradigm  shift  away  from  command-and-control
                                                     regulatory structures (which are very expensive  and
                                                     unsatisfactory in  other ways) toward more results-
                                                     driven,  economical,  market-based  approaches  to
                                                     environmental protection. Adopting a PBMS policy is a
                                                     first step toward accepting newly available analytical
                                                     tools and the work  strategies they  support so that
                                                     management of contaminated sites can be made more
                                                     affordable and more defensible. The triad approach to
                                                     site cleanup (i.e., the integration of systematic planning,
                                                     dynamic work plans, and on-site analysis) is based on
                                                     PBMS  principles.  It  has  consistently demonstrated
                                                     savings up to 50%  over the  life of a project when
                                                     compared to the costs of more traditional cleanups,
                                                     while maintaining or improving confidence inprotective
                                                     site decisions. The dynamic work plan approach using
                                                     on-site (i.e., field) analytical methods has been described
                                                     in the informative video entitled, "Field Analytics: The
                                                     Key to Cost Effective Site Cleanup" [Reference 6].
                                                     More  information about  the  triad  approach and its
                                                     implications  for the  management of hazardous waste
                                                     sites can be found  in Reference 7.
regarding quality management and the implementation
of quality systems. EPA quality policies do not require
that specific procedures or analytical technologies be
required or designated. Rather, EPA's Agency-wide
Quality Manual requires  the  use of  "a systematic
planning process based on the scientific method [and
based on] a common-sense graded approach to ensure
that the level of detail in planning is commensurate with
the  importance and  intended use of the work and the
available resources" [see section 3.3.8 of Reference 10].
Quality policies require that whatever methods are used,
they must  be  adequately  documented in  order to
demonstrate that the data quality will be known and be
adequate to defensibly support achievement of the stated
project objectives [see sections 5.3.1  and  5.3.3 of
Reference 10].

Implications of PBMS for contaminated site cleanup

Integration of new analytical technologies for characteri-
zation  and monitoring,  and new remediation technolo-
gies for cleaning up  sites, offer "smarter solutions" for
managing the environmental issues related to hazardous
waste. When hazardous waste practice clings tenacious-
ly to the familiar habits developed during its infancy,
everyone loses.

References

Reference 1: Federal Register, Vol.  60, No. 9, Friday, January 13, 1995, Rules and Regulations, pages 3089-3095.
    Item is retrievable at http://www.access.gpo.gov/su_docs/aces/aces 140.html. Search using the following entries:
    1995 Federal  Register; Final Rules and Regulations; On  01/13/1995;  Search Term = "Hazardous Waste
    Management System"

Reference 2: Pages  from the body of SW-846. These pages can be viewed or downloaded from the following
    websites:
    page "DISCLAIMER-1" from http://www.epa.gov/SW-846/disclaim.pdf
    pages "TWO-1 and TWO-2" from http://www.epa.gov/SW-846/chap2.pdf
    pages PREFACE-1 and PREFACE-2 from http://www.epa.gov/SW-846/preface.pdf

Reference 3: Article entitled "An Update of the  Current Status of the RCRA Methods Development Program,"
    available from http://www.epa.gov/SW-846/rcra.pdf

Reference 4: Federal Register, Vol. 62, No. 193,  Monday, October 6, 1997, Notices, pages 52098-52100. Item is
    retrievable at http://www.access.gpo.gov/su_docs/aces/acesl40.html. Search using the following entries: 1997
    Federal Register; Notices; On 10/06/1997; Search Term = "Performance Based Measurement System"

Reference 5: Federal Register, Vol. 63, No. 89, Friday,  May 8,1998, Notices, pages 25430-25438. Item is retrievable
    at  http://www.access.gpo.gov/su_docs/aces/acesl40.html.  Search using the following entries: 1998 Federal
    Register; Proposed Rules; On 05/08/1998; Search Term = "RCRA-Related Methods"
Reference 6: Tufts University video, Field Analytics: The Key to Cost Effective Site Cleanup. 18 minutes in length.
    The video is available for viewing or ordering through the following website: http://cluin.org/video/Hanscom.htm

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Reference 7: Access the issue paper, Current Perspectives in Site Remediation and Monitoring: Using the Triad
   Approach  to Improve  the  Cost-Effectiveness of Hazardous Waste Cleanups  (EPA 542-R-01-016) from
   http: //cluin. org/tiopersp/

Reference 8:  Access the document, EPA Guidance for Quality Assurance Project Plans  (EPA  QA/G-5),  at
   http ://www .epa.gov/quality/qs-docs/g5 -final .pdf

Reference 9: Federal Register, Vol. 65, No. 228, Monday, November 27,2000, Proposed Rules, pages 70679-70681.
   Item is retrievable at http://www.access.gpo.gov/su_docs/aces/aces 140.html. Search using the following entries:
   2000 Federal Register; "Proposed Rules"; On 11/27/2000; Search Term = "IVB"

Reference 10: AccessEPA Quality Manual for Environmental Programs (5360 Al), athttp://www.epa.gov/qualityl/
   qs-docs/5360.pdf

Additional information regarding laboratory and data quality issues can be found in the following Waste Testing and
   Quality Assurance Symposium papers, available at http://cluin.org/products/dataquality

Selected papers from WTQA '97 - 13th Annual Waste Testing and Quality Assurance Symposium Proceedings:
 •  "Options in Data Validation: Principle for Checking Analytical Data Quality" by Shawna Kennedy (pp. 169-172)
 • "Laboratory Analyst Training in the 1990's and Beyond" by Roy-Keith Smith (pp. 172-182)
 • "Investigation versus Remediation: Perception and Reality" by Emma P. Popek (pp. 183-188)
 • "Performance-Based Evaluation of Laboratory Quality Systems: An Objective Tool to Identify QA Program
   Elements that Actually Impact Data Quality" by Sevda K. Aleckson and Garabet H. Kassakhian (pp.  195-199)
 • "The Method Detection Limit: Fact or Fantasy?" by Richard Burrows (pp. 200-203)

Selected papers from WTQA '98 - 14th Annual Waste Testing and Quality Assurance Symposium Proceedings:
 •  "Techniques for Improving the Accuracy of Calibration in the Environmental Laboratory" by Dennis A. Edgerley
   (pp.181-187)
 • "Interpretation of Ground Water Chemical Quality Data" by G. M. Zemansky (pp. 192-201)

Selected papers from WTQA '99 - 15th Annual Waste Testing and Quality Assurance Symposium Proceedings:
 • "Lessons Learned from Performance Evaluation Studies" by Ruth L. Forman (pp. 38-46)
 • "Questionable Practices in the Organic Laboratory: Part II" by Joseph Solsky (pp.  121-125)
 •  "The Role of a Compliance Program and Data Quality Review Procedure under PBMS" by Ann Rosecrance (pp.
   231-235)

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