PB94-963311
 &EPA
                   United States
                   Environmental Protection
                   Agency
                            Solid Waste and
                            Emergency Response
EPA 540-F-94-028
OSWER 9285.7-14FS
PB94-963311
November 1996
Using  Qualified  Data  to  Document
an  Observed  Release  and  Observed
Contamination
 Office of Emergency and Remedfat Response C5204G)
                                                   Quick Reference Fact Sheet
 This fact sheet discusses the use of the U.S. Environmental Protection Agency's (EPA) Contract Laboratory Program
 (CLP) data and other sources of data qualified with a T, "IT, or "UF qualifier t: flag.  This guidance provides a
 management  decision tool for tbe optional use of qualified data to document  ar observed release and observed
 contamination by chemical analysis under EPA's Hazard Ranking System (HRS). The analyte and sample matrix (i.e.,
 soil or water) specific adjustment factors gwera intais feet siwetalfow biased CLP and oğ
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 CLP analytical data be reviewed, or validated by EPA or
 third party reviewers, to ensure the data are of known
 and documented quality and that the determination be
 discussed in a dat-  didation report that accompanies the
 analytical results.  Jased on this data validation, CLP
 data are classified into three categories: (1)  data for
 which all quality control (QC) requirements have passed
 contract-required acceptance criteria; (2) data for which
 at least one QC requirement has not met acceptance
 criteria;  and (3) data for which most  or  all  QC
 requirements have not met acceptance criteria.  Data in
 the first category typically are not qualified. Data in me
 second category are often qualified with a T  qualifier
 and, as discussed in mis fact sheet, are usually usable for
 HRS purposes.   Data in the third category are usually
 qualified by an "R" qualifier and are not usable for HRS
 purposes.

 Whether  data  are placed  into  the  second or  third
 category is determined by the amount of bias associated
 with the  analytical results.  Data validation evaluates
 biases resulting from laboratory analytical deficiencies or
 sample matrices to determine whether the data are
 usable. Bias indicates that the reported concentration is
 either higher or lower than the true concentration, and
 the data validation report identifies the direction of the
 bias or if the bias is unknown.

 The EPA CLP also sets imniirnim quantitation limits for
 all analytes;  the  Contract Required Quantitation Limit
 (CRQL) for organic analytes and the Contract Required!
 Detection Limit  (CRDL) for inorganic analytes.  For
 HRS purposes  and for this fact sheet, the term CRQL
 refers to both the contract required quantitation. limit and;
 the contract required detection limit. (40 CFR Part 300,
 App. A).  The CRQLs are substance specific levels that
 a CLP laboratory must be able to routinely and reliably
 detect  in  specific sample  matrices (i.e., soil, water,
 sediment).   The CRQLs are usually set above most
 instrument detection limits (DDLs) and method detection
 limits (MDLs).

 CONSIDERATIONS FOR NON-CLP DATA

 Because various laboratories and analytical methods may
 be used to develop non-CLP data, the  following list
 provides  the   general   information  sufficient  for
 determining whether non-CLP data are usable for HRS
purposes.
 (1)   Identification  of the  method  used for analysis.
      Methods include RCRA methods,  SW-846, EPA
      methods, etc.
 (2)   Quality control (QQ data. Check each method of
      analysis to determine if specific QC requirements
      are defined. If not, seek out another method.
 (3)   Instrument-generated data sheets for sample results.
      These data sheets would be the equivalent of Form
      I's in CLP data.
 (4)   MDLs and sample quantization Umits(SQLs). The
      analytical method should provide the MDL. The
      SQL is an adjusted MDL using sample specific
      measurements  such as percent   moisture and
      weight.
 (5)   Data validation report.

 USE OF BIASED QUALIFIED DATA

 In the past, all qualified data have been inappropriately
 perceived by some people as data of low confidence or
 poor quality and have not been used for HRS evaluation.
 With careful assessment of the nature of the analytical
 biases or QC deficiencies in the data on a case-by-case
 basis, qualified data can represent an additional resource
 of data for establishing an observed release.  Further, the
 D.C. District Court of Appeals in 1996 upheld EPA's
 case-by-case  approach  to  assess  data quality.   In
 reviewing  UK: use of qualified  data  to  identify an
 observed  release, die Court stated that if mere are
 deficiencies in die data, "...die appropriate response is
 lo review (he deficiencies on a 'case-by-case basis' to
 determine their impact on 'usability of the data.*" The
Court also stated with regards to  data quality that,
 "...EPA  does   not  face   a standard  of  absolute
perfection....Rather, it is statutorily required to 'assure,
to the marimnm extent feasible,'  that it  'accurately
 assesses Use relative degree of risk' posed by sites"
 IBoani of Regents of the University of Washington, et
aL, v. EPA, No. 95-1324, slip op.  at 8-10 (D.C. Cir.
June 25, !996).J

As  discussed in this fact  sheet,  the   application of
adjustment factors to "I" qualified data can serve as a
management  decision  tool to "adjust," or take into
account, the analytical uncertainty in the data indicated
by the qualifier, thereby making qualified data usable for
HRS evaluation.  The use of adjustment factors to
 account for me larger uncertainty in T* qualified data is
a  conservative   approach  enabling   a  quantitative
comparison of tne  data for use ia documenting an
observed release,  ft saould be sated tim the use of

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*
 adjustment factors only addresses analytical variability
 and does not take into account variabilities which may be
 introduced during field sampling. Some guidelines for
 using the adjustment factor approach are discussed in
 Exhibit 1.

 CLP QA/QC PROCEDURES

 CLP qualifiers are applied to analytical data based on the
 results of  various Quality Assurance/Quality Control
 (QA/QC) procedures used  at the laboratory.   EPA
 analytical methods use a number of QA/QC mechanisms
 during sample analysis in order to assess qualitative and
 quantitative accuracy (Contract  Laboratory Program
 Statement of Work for Inorganic Analyses, Document
 No. ILM02.0; Contract Laboratory Program Statement
 of Work for Organic Analyses, Document No. OLM1.8;
 Quality   Assurance/Quality   Control  Samples,
 Environmental  Response   Team Quality  Assurance
 Technical  Information  Bulletin; Test  Methods for
 Evaluating  Solid  Waste   (SW-846): Physical  and
 Chemical Methods^ Document No. SW-846). To assess
 data quality,  the laboratory uses  matrix spikes, matrix
 spike duplicates, laboratory control samples, surrogates,
 blanks,   laboratory  duplicates,  and  quarterly  blind
 performance  evaluation (PE) samples.  The  Agency
 assumes that if biases are found in the QA/QC samples,
 the  field sample concentrations may also be biased.

 Surrogates  are  chemically similar to the analytes of
 interest.   They  are  added or "spiked"  at a known
 concentration into the  field samples before analysis.
 Also, selected target analytes are "spiked" into samples
 at a specified frequency to assess potential interferences
 from the sample matrix.   These samples are called
 matrix spikes. Comparison of the known concentration
 of the surrogates and matrix spikes  with their actual
 analytical   results  reflects  the  analytical  accuracy.
 Because the surrogates are expected to behave similarly
 to the target analytes, they may indicate bias caused by
 interferences from the sample matrices. These types of
 interferences  from the  sample matrix are known  as
 matrix effects (CLP National Functional Guidelines for
 Inorganic Data Review, Publication 9240.1-05-01; CLP
 National  Functional Guidelines for Organic  Data
 Review,  Publication 9240.1-05;  Test  Methods  for
 Evaluating  Solid  Waste   (SW-846):  Physical  and
 Chemical Methods, Document No. SW-846).

 Laboratory controfsamples are zero blind samples which
 contain known concentrations of specific analytes and are
 analyzed in the same batch as field samples.  Their
 results are used to measure laboratory accuracy. Blanks
 are analyzed to detect any extraneous  contammarion
 introduced either in the field or in the laboratory.

 Laboratory duplicates are  created when one sample
 undergoes two separate analyses.  The duplicate results
 are compared  to determine  laboratory  precision.
 Quarterly blind PE samples are single blind samples that
 evaluate the laboratory's capability  of performing the
 specified analytical protocol.

 CLP and other  EPA  analytical  methods  include
 specifications for acceptable aaalyte identification, target
 analytes, and minimum and tnarimnm percent recovery
 of the QA/QC compounds. Data are validated according
 to guidelines  which  set  performance  criteria  for
 instrument  calibration,  analyte  identification,  and
 identification and recovery of QA/QC compounds (CLP
 Statement  of Work  and SW-846).   The National
 Functional Guidelines far Data Review, used in EPA
 validation, was  designed for the assessment of data
 generated  under  the  CLP  organic  and  inorganic
 analytical protocols (CLP Statement  of Work; National
 Functional Guidelines for Data Review). The guidelines
 do not preclude die validation of field and  other non-
 CLPdata.  Thus, many EPA Regions have also adapted
 the National Functional Guidelines for Data Review to
 validate aon-CLP data.  Data which do not meet the
 guidelines' performance criteria are qualified to indicate
 bias or QA/QC deficiencies.  The data validation report
 usually  explains why the data  were  qualified and
 inrffcafeg the bias direction when it can be determined.
 Validated data  that are not qualified are considered
 unbiased and can be used at their reported numerical
 value for HRS evaluation.

 QUALIFIER DEFINITIONS

 Most EPA validation guidelines use  the data qualifiers
 presented in Exhibit  2 (CLP  National  Functional
 Guidelines for Data Review). Olher qualifiers besides
 these may be used; the validation report should always
be checked for me exact list of qualifiers and their
 meanings.

 It should be emphasized that not meeting one or some of
the contract required QA/QC acceptance criteria is iwten
 an indication that the sample was difficult to analyze, not
that there is low confidence in the analysis (i.e., the

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                                                 EXHIBIT 1
                         GUIDELINES FOR THE USE OF ADJUSTMENT FACTORS
        The use of adjustment factors identified in this fact sheet is a management tool for the optional use of "J"
        qualified data generated under CLP or other sources of data to document an observed release.
        Adjusted qualified data should be used with non-qualified data whenever possible.
        EPA maintains a "worst sites first" policy for placing sites on the NPL (Additional Guidance on "Worst
        Sites" and "NPL Caliber Sites' to assist in SACM Implementation, OSWER Directive 9320.2-07).
        EPA Regions should use adjustment factors with discretion on a case-by-case basis and should always
        carefully consider the use of qualified data in borderline cases.
        Resampling and/or reanalysis may be warranted if qualified data do not appear adequate to document an
        observed release.
        EPA Regions may substitute higher adjustment factors based on documented, justifiable reasons but may
        never use a lower adjustment factor vafue.
        The adjustment factors should only be applied to anafytes listed in the tables. These adjustment factors
        should not be interpolated or extrapolated to develop factors for analytes not listed in the tables.
   •    The adjustment factors apply only to T qualified data above the CRQL.
        Detection below the CRQL is treated as non-quantifiable for HRS purposes.
   *    "UJ" data may be used under strict circamstances as explained in this fact sheet.
       The adjustment factors only apply to biased T qualified data, not to other "J" qualified data.
       The adjustment factors do not apply to "N", "HP, or "R" qualified data. These data can not be used to
       document an observed release for HRS purposes.
analysis is "under control" and can be adopiafe for HRS
decision making).  Often "J", "IT, and "UJ" qualified
data fall into this category.

There are instances when qualified  data cannot be used
since the uncertainty of the results is unknown.  For
example, violations of laboratory instrument calibration
and tuning requirements, and gross violations of holding
times reflect the  possibility that  the results  are of
unknown quality (i.e., the analysis  is "out of control").
Most often these data would be qualified with an "R" or
an "N" (not usable for HRS purposes).

USING "U" QUALIFIED DATA

The  "U" qualifier simply  means that the reported
concentration of the analyte was at or below the CRQL-
there can be confidence that the true concentration is at
or below the  quantitation  limit.    Therefore,  "U"
qualified data can be used for establishing background
levels. If the release sample concentration is above this
level, as specified in the HRS, an observed release can
be established.  The quantitation limit for that analyte
could be used as a maximum background concentration
if a  more conservative background  level  seems
appropriate.

USING ĞS" QUALIFIED DATA

As discussed previously, some "J" qualified data can be
used in establishing an observed release if the uncertainty
in the reported values is documented. Qualified data
should always be carefully examined by the Regions to
determine the  reasons for qualification before use in
HRS evaluation. Resampling and/or reanalysis may be
warranted if qualified data only marginally document an
observed release.   Whenever possible, qualified data
should be used in conjunction with non-qualified data.

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 As described in Exhibit 2, T qualified data indicates
 that bias has been detected in the sample analysis and
 although the analyte is definitively present, the reported
 concentration is art estimate.  Depending on the reasons
 and the direction of bias, with the use of adjustment
 factors,  "J"  qualified data can represent data of known
 and documented quality sufficient for use in establishing
 an observed release  and observed contamination under
 the HRS.

 USING "UJ" QUALIFIED DATA

 A combination of the "U" and "J" qualifiers indicates
 that the reported value may not accurately represent the
 concentration necessary to positively detect the analyte in
 the sample.  Under  limited conditions, "UJ" qualified
 data can be used to represent background concentrations
 for establishing an observed release. These conditions
 are:  instances when there  is   confidence that the
 background  concentration is  not detectable above the
 CRQL, the background concentration is biased high, and
 the  sample  measurement establishing  the observed
 release equals or exceeds the CRQL.

 DIRECTION OF BIAS IN "J" QUALIFIED DATA

 It is  important to  understand the direction of bias
 associated with "J" qualified data before using the data
 to document an observed release.  Qualified data may
 have high, low, or unknown bias.  A low bias means
 that the reported concentration is likely an underestimate
 of die true concentration.  For example, data may be
 biased low  when sample holding times  for volatile
 organic compounds (VOCs) are moderately exceeded or
 when recovery of QA/QC compounds is  significairdy
 less than the amount introduced into the sample.  Low
 surrogate recovery would also indicate a low bias.  A
 high bias means the reported concentration is likely an
 overestimate  of the true  concentration.  For example,
 data may be biased  high when recovery  of QA/QC
 compounds is significantly higher than the amount in the
 sample.  A bias is unknown  when it  is impossible to
 ascertain whether the  concentration is an overestimate or
 an underestimate.  For example, an unknown bias could
 result when surrogate  recoveries exceed method recovery
 criteria   and  matrix  spike/matrix  spike duplicate
compounds  below method recovery criteria fail the
relative percent difference (RPD) criteria in the same
sample.

Despite the bias,  certain qualified data may be  used
without application of adjustment factors for determining
 an observed release under certain circumstances.  The
 following  are  examples of using  "J" qualified data
 without adjustment factors:

 •    Low  bias  release samples   are  likely  to' be
      underestimates  of true concentrations.   If the
      reported concentration of a low bias release sample
      is three times above unbiased  background levels,
      these release samples would still meet the HRS
      criteria.   The true concentrations would still be
      three times above the background level.

 •    High bias background samples  are likely to be
      overestimates  of  true concentrations.    If  the
      reported concentration of unbiased release samples
      are three  times  above the reported  background
      concentration, they would still meet  the HRS
      observed release criteria because they would still
      be  three  times   above   the  true  background
      concentration.

 The above examples show that both low  bias "J"
 qualified release samples at their reported concentrations
 and high bias "J" qualified background samples may be
 used at their reported concentrations in these situations.

 High bias  release samples  may not be used at then-
 reported concentrations because they are an overestimate
 of true concentrations in this situation; resampling and/or
 re-analysis of the release samples should be considered.
 The true  difference  in the background and  release
 concentrations may be less than the HRS criteria for
 establishing an  observed  release.    The  reported
 concentration for low bias  background concentrations
 may not be compared to release samples because it is
 most  likely  an underestimate of background level; the
 release sample  concentration  may  not  significantly
exceed the true background concentration. However, in
lieu of re-sampling and/or re-analysis, high bias release
data, anrf low bias background data may be used with
adjustment  factors which compensate for the probable
uncertainty in the  analyses.

ADJUSTMENT  FACTORS FOR  BIASED "J"
QUALIFIED DATA

Applying adjustment factors to "J"  qualified data will
enable EPA to  be more confident that the increase in
contaminant concentrations between the background and

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                                                 EXHIBIT 2
   EPA CLP DATA QUALIFIERS AND THEIR USABILITY FOR DOCUMENTING AN OBSERVED RELEASE
                        Usable*
                   Not Usable
   "U"   The substance or analyte was analyzed for, but
         no quantifiable concentration was found at or
         above the CRQL (CLP National Functional
         Guidelines for Data Review).
"N"  The analysis indicates the presence of an analyte
      for which there is presumptive evidence to make
      a "tentative identification'' (CLP National
      Functional Guidelines for Data Review).
   "J"   The analyte was positively identified-the
         associated numerical value is the approximate
         concentration of the analyte in the sample. The
         "J" Qualifier indicates that one or more QA/QC
         requirements have not met contract required
         acceptance criteria, but the instrumentation was
         functioning properly during the analysis.  For
         example, a "J" qualifier may indicate that the
         sample was difficult to analyze or mat the value
         may lay near the low end of the linear range of
         the instrument. " J" data are considered biased,
         but provide definitive analyte identification (CLP
         National Functional Guidelines for Data
         Review),
"R"  The sample results are rejected due to serious
      deficiencies in the ability to analyze the sample
      and meet QC criteria.  The presence or absence
      of the analyte can not be verified and the result
      has been rejected. A sample result may be
      qualified with an "R" qualifier when the
      instrument did not remain "in control" or the
      stability or sensitivity of the instrument were not
      maintained during the analysis (CLP National
      Functional Guidelines for Data Review).
   "UJ"  The analyte was not quantifiable at or above the
         CRQL.  In addition to not being quantifiable,
         one or more QA/QC requirements have not met
         contract acceptance criteria (CLP National
         Functional Guidelines for Data Review).
"NJ" The analysis indicates the presence of the
      analyte that has been "tentatively identified" and
      the associated numerical value represents its
      approximate concentration (CLP National
      Functional Guidelines far Data Review).
   Usable under certain circumstances as explained in this fact sheet.
release samples is due to a release.  The adjustment
factors are applied as "safety factors" to compensate for
analytical uncertainty, allowing biased data to be used
for determining an observed release. Dividing the high
bias result by an adjustment factor ueflates it from the
high end of the acceptable range towards a low bias
value.   Multiplying a low bias  concentration  by an
adjustment factor inflates it to the high end  of the
acceptable range.

Tables 1  through 4 (pages 11-18) present analyte and
matrix-specific  adjustment  factors  to  address  the
analytical uncertainty when determining an observed
release using high bias release samples and low bias
background data. The factors are derived from percent
recoveries of matrix spikes, surrogates, and laboratory
control samples in the CLP Analytical Results Database
  (CARD) from January 1991 to March 1996. A total of
  32,447  samples were  reviewed for volatile organic
  analytes;  32,913  samples for  semivolatile  organic
  analytes; 59,508 samples for pesticides/PCB analytes;
  and 5,954 samples for inorganic analytes.

  The range of CARD data for each analyte includes 97
  percent  of  all percent recoveries  in the database,
  discarding outliers. The adjustment factors are ratios of
  percent recovery values at the 98.5 and 1.5 percentiles.
  The ratios generally show a consistent pattern.

  Adjustment factors have been determined for all analytes
  in the CLP Target Compound List (organic analytes) and
  Target Analyte List (inorganic  analytes).   A tiered
  approach was used to derive the organic adjustment
  factors.    Percent  recoveries  for  surrogates  were

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 examined first,  followed by matrix spike recoveries.
 When both  matrix spike  and surrogate data  were
 available for the same analyte, the larger adjustment
 factor (representing more extreme high and low percent
 recoveries) was used.  Laboratory control samples were
 used  to  calculate  the inorganic  adjustment factors.
 Quarterly blind sample data were not used to determine
 adjustment  factors because of the small  data set
 available. A default adjustment factor of 10 was used
 for  analytes  when   percent   recovery  data   were
 unavailable.

 Adjustment  factors do not  correct the biased sample
 concentration to  its true value,  as such "correction" is
 not possible.   CARD data do not differentiate and
 quantify  individual sources  of  variation.  Instead, the
 ratio  of percentile used to develop adjustment factors
 represents a "worst-case" scenario.  Adjustment factors
 either inflate background values to the nigh end of the
 range or deflate release data to the low end. Therefore,
 adjustment factors compensate or adjust for the apparent
 analytical variability when comparing a high bias value
 to a low bias value (see Exhibit 3).

 USING THE ADJUSTMENT FACTORS

 This  section  of the  fact  sheet  demonstrates  how
 adjustment factors can be used with UJ" qualified data
 for HRS scoring purposes, including documentation and
 detection  limit issues.

 Documentation Reauirements for Using Qualified Data
 In using  "J" qualified data  to  determine an  observed
 release, include a discussion of  "J" qualifiers  from the
 data validation report and cite it as a reference in the site
 assessment report or HRS documentation record. If
 adjustment factors  are  applied  to  "J"  qualified  data.
 reference  and cite  this fact sheet.   These steps  will
 ensure that the direction of bias is documented and will
 demonstrate how  biases have been adjusted.

 Detection Limit Restrictions
 Adjustment factors may only be applied to T  qualified
 data with concentrations above  the CLP CRQL for
 organics or CRDL for  inorganics.   "J"  qualified  data
with concentrations below the CRQL can not be used to
document an observed release except as specified in the
previous section entitled "Using  "UJ" Qualified Data."

Application of Factors
Exhibit 3 shows how to apply the factors to "J"  qualified
data.  Multiply low bias background sample results by
 the analyte-specific adjustment factor or the default factor
 of 10 when an analyte-specific adjustment factor is not
 available.    The  resulting new  background  value
 effectively becomes a high bias value that may be used
 to determine an observed release.  Divide high bias
 release sample data by the analyte-specific adjustment
 factor or the default factor of  10 when an  analyte-
 specific adjustment factor is not available.  The resulting
 new release sample value effectively becomes a low bias
 value that may be used to determine an observed release.

 Note: High bias background data, low bias release data,
 and  unbiased data  may be used  at  their  reported
 concentrations.

 Note: Adjusted release and background values must still
 meet HRS criteria (e.g., release concentration must be
 at least three times above background level) to determine
 an observed release.

 Examples Using Trichloroethene in  Soil and Water
 1.  Release water  sample is unbiased,  background
     water sample is unbiased but all data are qualified
     with  a "J" due to an contractual laboratory error
     not analytical error.

 Background sample value:  12 /tg/L (J) no bias
 Release sample value:     40 pg/L (J) no bias

 The CRQL for trichloroethene is 10 pg/Kg for soil and
 10 /tg/L for water.

 In this example, the qualification of the  data is not
 related to bias in the reported  concentrations.   Thus,
 using adjustment factors is not needed and an observed
 release is established if all other criteria are  met.

 2.  Release soil sample data is biased low, background
    soil .'fflnple data is biased high.

 Background sample value: 12  ngfKg  (J)  high  bias
 Release sample value:     40 /*g/Kg (J) low bias

 In this example, the direction of bias indicates that the
true   release  value  may be  higher  and the  true
background value may be lower than reported  values.
The   release  sample  concentration   still  exceeds
background by more than three times, so an observed
release is established, provided all other HRS criteria are
met.  Using adjustment factors is not needed.

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EXHIBIT 3
USE OF ADJUSTMENT FACTORS FOR M" QUALIFIED DATA
Type of Sample
Background
Sample
Release
Sample
Type of Bias
No Bias
Low Bias
High Bias
Unknown Bias
No Bias
Low Bias
High Bias
Unknown Bias
Action Required
None: Use concentration without faaor
Multiply concentration by factor
None: Use concentration without factor
Multiply concentration by factor
None: Use concentration without factor
None: Use concentration without factor
Divide concentration by factor
Divide concentration by factor
3.   Release soil sample data is unbiased, background
     soil sample is biased law.

Background sample value:  12 jtg/Kg (J) low bias
Release sample value:      30 fig/Kg  no bias

In this example, the true background value is assumed to
be less than the reported value; however, an observed
release may still be possible. To use the data to establish
an observed  release, multiply the background sample
data  value  by  the  adjustment  factor  given  for
trichloroethene in soil  (2.11).  No adjustment factor is
needed for the release sample.

New background sample value:
(12 jug/Kg) x (2.11) = 25.32 /tg/Kg (J) high bias

The  release  sample concentration  does  not meet or
exceed the new background level by three times, so an
observed release is not established.

4.  Release  -water sample  data  is  biased  high,
    background water sample data is unbiased.

Background sample value:  15 ^g/L no bias
Release sample value:      70 pgfL (J) high bias

In this example,  the true release  value may be lower
than the reported value;  however,  an  observed release
may  still be possible.  To  use tne data to establish an
observed  release, divide the release sample  by the
adjustment factor for trichloroethene  in water (1.66).
No adjustment factor  is needed for the background
sample.

New release sample value:
(70 /tg/L) -*- (1.66) = 42.17 /tg/L (J) low bias

The new release sample concentration does not meet or
exceed the  background level  by three times,  so an
observed release is not established.

5.  Release  soil  sample  data has  unknown  bias;
    background soil sample data has unknown bias.

The following  example  is   the  most  conservative
approach to using adjustment factors with qualified data.
Background sample value:
Release sample value:
325 pg/Kg (J) unknown bias
m mis example, it is not possible to determine from the
reported values if an observed release is possible.  To
use the data to establish an observed release, divide the
release  sample value  and multiply  the  background
sample  value by the  adjustment factor given  for
tricbloroethene in soil (2.11).

New release sample value:
(325 /%/Kg) * (2.11) = 154.03 /ig/Kg (J) low bios

New background sample value:
(20 jig/Kg) x (2.11) = 42.2 pg/Kg (J) high bios

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 The new release sample is at least three times the new
 background concentration,  so  an observed release is
 established, provided all other HRS criteria are met.

 ISSUES wrra USING ADJUSTMENT FACTOR
 APPROACH

 Some issues were raised regarding  the application of
 adjustment factors to qualified data during the Agency's
 internal review process.

 One issue is that "J" qualifiers are added to analytical
 results for many reasons that may or may not affect the
 accuracy and precision of the analytical result.  The
 application of an adjustment factor to "J" qualified data
 in which bias is not affected could be considered overly
 conservative.

 All  qualified data  should  be carefully evaluated to
 determine if the data are biased.  Based on the reasons
 for bias, the use of an adjustment factor should 01% be
 considered as a management tool that provides a quick
 screening of the data for site assessment, not a means for
 correcting the biased value to a true value. Application
 of adjustment factors are intended for use with qualified
 data reported at or above the CRQL and may not be
 applicable to data which are qualified but technically
 sound.   As stated  previously, qualified data should
 always be carefully reviewed on a case-by-case basis
 prior to use in HRS evaluation.

 Another  issue  is  the  validity  of "10"  as a default
 adjustment factor.  A default adjustment factor of 10 was
 a  policy decision based on the  range  of adjustment
 factors and an  industry approach.   The default was
 chosen in order to account for the maximum' variability
 regardless of the direction of the bias.  Therefore, the
 default value of 10 is generally considered to be a
 conservative adjustment factor.  EPA reviewed the use
 of the default value of 10 and determined mat this "alue
 was conservative.

 Even if using adjustment factors  is  sometimes overly
 conservative, this approach is preferable to not using the
 data at all.  EPA maintains a "worst sites first" policy
 that only the sites considered most harmful' to human
 health  and/or the environment should be listed.  EPA
 considers the use of adjustment  factors appropriate as a
inanageme^: decision tool.   However,  discretion  is
needed when applying adjustment factors.  The use of
adjustment factors may not be appropriate in all cases.
 USE OF OTHER ADJUSTMENT FACTORS

 EPA Regions may substitute higher, but never lower,
 adjustment factor values for the ones listed in this fact
 sheet on a case-by-case basis when technically justified.
 For example, other adjustment factors may be applied to
 conform  with site-specific Data Quality Objectives
 (DQOs) or with Regional Standard Operating Procedures
 (SOPs) {Data Quality Objectives Process for Superfiatd,
 Publication 9355.9-01).

 SUMMARY

 For site assessment purposes, EPA Regions should not
 automatically discard "J" qualified data. However, site-
 specific data usability Determinations may result hi the
 data's not being used.

 Data  qualified  under me  EPA's  CLP or from  other
 sources of validated data may be used to demonstrate an
 observed release if certain measures are taken to ensure
 mat the bias of die data qualifier  is adjusted using the
 factor approach specified in this fact sheet.  (This fact
 sheet provides a management decision tool for making
 qualified  data  usable  for  documenting  an observed
 release.)  The  analyte and matrix-specific adjustment
 factors provided in Tables 1 through 4 of this fact sheet
 present these adjustment factors.

 The scope of mis fact sheet is limited to the situations
 described in Exhibit 1.  The use of qualified analytical
 data without me adjustment factors presented in ibis fact
 sheet  is limited.   Higher adjustment factors may be
 substituted by EPA Regions on a  case-by-case  basis
when tecnmcaHy  justified  by she-specific DQOs or
SOPs.

-------
REFERENCES

1.  U.S. Government Printing Office, FederalRegister,
    Part H, Environmental Protection Agency, 40 OFR
    Pan 300, Hazard Ranking System, Final Rule,
    December 14, 1990.

2.  U.S.  Environmental  Protection Agency, Hazard
    Ranking System Guidance Manual, Office of Solid
    Waste and Emergency  Response, PB92-963377,
    November 1992.

3.  U.S.  Environmental  Protection Agency,  1995.
    Establishing an Observed Release.   Office  of
    Emergency and Remedial Response. PB94-9633I4.

4.  U.S.  Environmental  Protection Agency,  1995,
    Establishing Areas of Observed,  Contamination.
    Office of Emergency and  Remedial  Response.
    PB94-963312.

5.  U.S.  Environmental  Protection Agency,  1995.
    Establishing Background  Levels.    Office  of
    Emergency and Remedial Response. PB94-9633J3.

6.  U.S. Environmental Protection Agency, 1994. CLP
    National Functional Guidelines for Inorganic Data
    Review. Office  of Solid Waste and  Emergency
    Response. Publication 9240.1-05-01.

7.  U.S. Environmental Protection Agency, 1993. CLP
    National Functional Guidelines for Organic Data
    Review.  Office of Solid Waste and  Emergency
    Response. Publication 9240.1-05.

8.  U.S.  Environmental  Protection Agency,   1991.
    Contract Laboratory Program Statement of Work
    for Inorganic Analysis. Document No. ILM02.0.

9.  U.S.  Environmental  Protection Agency,   1991.
    Contract Laboratory Program Statement of Work
    for Organic Analysis.  Document No. OLM1.8.

10.  U.S.  Environmental  Protection Agency,   1993.
    Additional Guidance on "Worst Sites" and "NPL
    Caliber Sites" to Assist in SACM Implementation.
    Office  of Emergency  and  Remedial  Response.
    PB94-963206.
11. Board of Regents of the University of Washington,
    etal., v. EPA, No. 95-1324, slip op. at 10 (D.C.
    Cir. June 25, 1996). 10.

12. U.S. Environmental  Protection  Agency,  1991.
    Guidance for Performing Preliminary Assessments
    Under  CERCLA.  Office of  Solid Waste  and
    Emergency Response.  Publication 934S.O-01-A.

13. U.S. Environmental  Protection  Agency,  1992.
    Guidance for Performing Site Inspections  Under
    CERCLA.  Office of Solid Waste and Emergency
              PB92-963375.
14. U.S. Environmental Protection Agency,  1992.
    Quality  Assurance/Quality  Control  Samples,
    Environmental Response Team Quality Assurance
    Technical Information Bulletin.

15. U.S. EmaroDmental Protection Agency, 1986. Test
    Methods for Evaluating Solid  Waste (SW-846):
    Physical and Chemical Methods.  Office of Solid
    Waste and Emergency Response.  Document No.
    SW-846.

16. U.S. Environmental Protection Agency, 1993.
    Data Quality Objectives Process for Superfund.
    Office of Emergency and Remedial Response.
    Publication 9355.9-01.
                                                  10

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TABLE 1
FACTORS FOR VOLATILE ORGANIC ANALYTES
VOLATILE
ORGANIC
ANALYTES
1,1, i-TRICHLOROETHANE
1, 1,2,2-TETRACHLOROETHANE
1 , 1 ,2-TRICHI-OROETHANE
1 , 1-DICHLOROETHANE
1 , 1-DICHLOROETHENE
1 .2-DICHLOROETHANE-D4
1,2-DICHLOROETHENE (TOTAL)
1 ,2-DICHLOROPROPANE
2-BUTANONE
2-HEXANONE
4-METHYL-2-PENTANONE
ACETONE
BENZENE
BROMODICHLOROMETHANE
BROMOFORM
BROMOFLUOROBENZENE
BROMOMETHANE
CARBON DISULFEDE
SOIL MATRIX
Number of
CARD
Samples
Reviewed
—
—
—
—
7,031
32,446
—
—
—
—
—
—
7,024
—
—
32,444
—
—
Factor
10.0
10.0
10.0
10.0
2.71
152
10.0
10.0
10.0
10.0
10.0
10.0
1.97
10.0
10.0
1.7
10.0
10.0
WATER MATRIX
Number of
CARD Samples
Reviewed
—
—
_.
—
5,015
25,516
—
—
—
—
.Ğ
—
5,001
—
—
25,518
—
—
Factor
10.0
10.0
10.0
10.0
2.35
1.38
10.0
10.0
10.0
10.0
10.0
"10.0
1.64
10.0
10.0
1.26
10.0
10.0
11

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TABLE 1
FACTORS FOR VOLATILE ORGANIC ANALYTES
VOLATILE
ORGANIC
ANALYTES
CARBON TETRACHLORIDE
CHLOROBENZENE
CHLOROETHANE
CHLOROFORM
CH1X)ROMETHANE
CIS-1 ,3-DICHLOROPROPENE
DEBROMOCHLOROMETHANE
ETHYLBENZENE
METHYLENE CHLORIDE
STYRENE
TE rRACHLOROETHENE
TOLUENE-D8
TRANS-1 ,3-DICHLOROPROPENE
TRICHLOROETHENE
VINYL CHLORIDE
XYLENE (TOTAL)
SOIL MATRIX
Number of
CARD
Samples
Reviewed
—
7,018
—
—
—
—
—
—
—
—
—
32,447
—
6,988
—
—
Factor
10.0
2.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
1.63
10.0
2.11
10.0
10.0
WATER MATRIX
Number of
CARD Samples
Reviewed
—
5,015
—
—
—
—
—
—
—
—
—
25,526
—
4,938
—
—
Factor
10.0
1.54
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
1.21
10.0
1.66
10.0
10.0
12

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TABLE 2
FACTORS FOR SEMIVOLATILE ORGANIC ANALYTES
SEJWIVOLAT1LE
ORGANIC
ANALYTES
1 ,2,4-TRICHLOROBENZENE
1 .2-DICHLOROBENZENE-D4
1 ,3-DICHLOROBENZENE
1 ,4-DICHLOROBENZENE
2,2'-OXYBIS(l-CHLOROPROPANE)
2,4,6-TRIBROMOPHENOL
2,4,5-TRICHIjOROPHENOL
2,4,6-TRICHLOROPHENOL
2,4-DICHLOROPHENOL
2,4-DIMETHYLPHENOL
2,4-DINITROPHENOL
2,4-DINITROTOLUENE
2,6-DINITROTOLUENE
2-CHLORONAPHTHALENE
2-CHLOROPHENOL-D4
2-FLUOROBIPHENYL
2-FLUORPHENOL
2-METHYLNAPHTHALENE
2-METHYLPHENOL
2-NITROANILINE
2-NITROPHENOL
3,3'-DICHLOROBENZIDINE
3-NITROANILINE
^,6-DINITRO-2-METHYLPHENOL
4-BROMOPHENYL-PHENYLETHER
SOIL MATRIX
Number of CARD
Samples Reviewed
6,792
32,848
—
6,796
—
32,605
—
—
_.
—
—
6,798
—
__
32,798
32,913
32,781
—
~
—
—
—
—
_
__
Factor
4.83
4-22
10.0
6.0
10.0
9.38
10.0
10.0
10.0
10.0
, 10.0
4.88
10.0
10.0
4.08
3.38
5.05
10.0
10,0
10.0
10.0
10.0
10.0
10.0
10.0
WATER MATRIX
Number of CARD
Samples
Reviewed
4,605
21,506
—
4,599
—
21,509
—
—
—
—
—
4,623
—
—
21,506
21,532
21,511
—
—
—
—
—
—
—
—
Factor
3.71
3.0
10.0
3.85
10.0
3.57
10.0
10.0
10.0
10.0
10.0
3.52
10.0
10.0
2.92
2.84
3.34
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
13

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TABLE 2
FACTORS FOR SBVKVOLATILE ORGANIC ANALYTES
SEMJVOLATILE
ORGANIC
ANALYTES
4-CHLORO-3-METHYLPHENOL
4-CHLOROANOJNE
4^HLOROPHENTiTv-PHENYLETHER
4-METHYLPHENOL
4-NITROANEJNE
4-NITROPHENOL
ACENAPHTHENE
ACENAPHTHYLENE
ANTHRACENE
BENZO(A)ANTHRACENE
BENZO(A)PYRENE
BENZO(B)FLUORANTHENE
BENZO(G,H,I)PERYLENE
BENZO(K)FLUORANTHENE
BIS(2-CHLOROETHOXY)METHANE
BIS(2-CHLX>ROETHYL)ETHER
BIS(2-ETHYLHEXYL)PHTHALATE
BUTYLBENZYLPHTHALATE
CARBAZOLE
CHRYSENE
DI-N-BUTYLPHTHALATE
DI-N-OCTYLPHTHALATE
DffiENZ(A,H)ANTHRACENE
DEBENZOFURAN
DIETmTPHTHALATE
SOIL MATRIX
Number of CARD
Samples Reviewed
6J15
—
—
—
—
6,627
6,773
—
__
—
—
— .
—
—
—
_
—
—
—
—
—
—
—
—
—
Factor
6.26
10.0
10.0
10.0
10.0
9.33
4.68
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10,0
10.0
10.0
10.0
10.0
10.0
10.0
WATER MATRIX
Number of CARD
Samples
Reviewed
4,609
—
—
—
—
4,586
4,600
—
_
—
—
—
—
—
—
—
—
—
—
—
—
—
—
—
__
Factor
4.46
10.0
10.0
10.0
10.0
5.96
3.63
10.0
10.0
10.0
10.0
10.0
10.0
10.0
iO.O
10.0
10.0
10.0
10.0
3.0.0
10.0
10.0
10.0
10,0
10.0
14

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                TABLE 2
FACTORS FOR SEMIVOLATILE ORGANIC ANALYTES
SEMIVOLATILE
ORGANIC
ANALYTES
DIMETHYLPHTHALATE
FLUORANTHENE
FLUORENE
HEXACHLOROBENZENE
HEXACHLOROBUTADffiNE
HEXACHLOROCYCLOPENTADffiNE
HEXACHLOROETHANE
INDENOC1 ,2,3-CD)PYRENE
ISOPHORONE
M-NITROSO-DI-N-PROPYLAMINE
N-NITROSODIPHENYLAMINE(1)
NAPHTHAJJENE
NimOBENZENE-DS
PENTACHLOROPHENOL
PHENANTHRENE
PHENOL-D5
PYRENE
TERPHENYL-D14
SOIL MATRIX
Number of CARD
Samples Reviewed
—
—
—
—
—
—
— .
—
—
6,725
—
—
32,867
6,59?
—
32,855
6,543
32,899
Factor
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
4.92
10.0
10.0
3.96
12,5
10.0
3.85
11.86
435
WATER MATRIX
Number of CARD
Samples
Reviewed
—
—
—
—
—
—
—
—
—
4,513
—
—
21,533
4,550
—
21,489
4,612
21,541
Factor
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
1C.O
4.0
10.0
10.0
.2.73
10.12
10.0
3.53
5.67
6.32
                  15

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TABLE 3
FACTORS FOR PESTICIDES/PCB AMALYTES
VOLATILE
ORGANIC
ANALYTES
4,4'-DDD
4,4'-DDE
4,4'-DDT
ALDRIN
ALPHA-BHC
ALPHA-CHLORDANE
AROCLOR-1016
AROCLOR-1221
AROCLOR-1232
AROCLOR-1242
AROCLOR-1248
AROCLOR-1254
AROCLOR-1260
BETA-BHC
DECACHLOROBIPHENYL
DELTA-BHC
DIELDREN
SOIL MATRIX
Number of
CARD
Samples
Reviewed
—
—
5,343
5,526
—
—
—
—
__
—
—
—
—
—
57,315
—
5,539
Factor
10.0
10.0
12.82
14.26
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
17.79
10.0
11.93
WATER MATRIX
Number of
CARD Samples
Reviewed
—
—
3,850
3,829
—
—
—
—
—
—
—
—
—
—
33,592
—
3,861
Factor
10.0
10.0
7.14
6.63
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
10.0
4.87
16

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             TABLE 3
FACTORS FOR PESTICIDES/PCB ANALYTES
VOLATILE
ORGANIC
ANALYTES
ENDOSULFAN !
ENDOSULFAN H
ENDOSULFAN SULFATE
ENDRIN
ENDRIN ALDEHYDE
ENDRIN KETONE
GAMMA-BHC (LINDANE)
GAMMA-CHLORDANE
HEPTACHLOR
HEPTACHLOR EPOXIDE
METHOXYCHLOR
TETRACHLORO-M-XYLENE
TOXAPHENE
SOIL MATRIX
Number of
CARD
Samples
Reviewed
—
—
_
5,521
—
—
5,545
—
5,548
_
—
59,508
—
Factor
10.0
10.0
ib.o
14.13
10.0
10.0
11.79
10.0
7.88
10.0
10.0
8.5
10.0
WATER MATRIX
Number of
CARD Samples
Reviewed
—
—
—
3,850
—
—
3,832
—
3,836
—
—
33,787
—
Factor
10.0
10.0
10.0
5.33
10.0
10.0
10.0
10.0
5.26
10.0
10.0
5.29
10.0
               17

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TABLE 4
FACTORS FOR INORGANIC ANALYTES
INORGANIC
ANALYTES
ALUMINUM
ANTIMONY
ARSENIC
BARIUM
BERYLLIUM
CADMIUM
CALCIUM
CHROMIUM
COBALT
COPPER
CYANIDE
IRON
LEAD
MAGNESIUM
MANGANESE
MERCURY
NICKEL
POTASSIUM
SELENIUM
SILVER
SODIUM
THALLIUM
VANADIUM
ZINC
SOEL MATRIX
Number of
CARD
Samples
Reviewed
5387
5392
5675
5360
5399
5385
5383
5389
5392
5394
3281
5391
5982
5397
5395
5954
5400
3874
:S2Q
5392
5024
5621
5393
5404
Factor
1.66
1.98
1.74
3.99
1.28
1.41
1.28
1.29
1.25
1.22
1.55
1.34
1.44
1.23
1.24
1.83
1.35
17.49
228
L74
25,43
1M
1.34
1.50
WATER MATRIX
Number of
CARD
Samples
Reviewed
6208
6170
6303
6201
6208
6166
6201
6210
6212
6205
225
6216
6384
6210
6214
256
6210
6175
6278
6215
6195
6253
6212
6224
Factor
1.30
1.27
1.35
1.25
1.25
1.29
1.24
1.30
1.27
1.25
1.36
1.27
1.31
1.24
1.28
1.50
1.29
1.24
1.41
1.42
1.26
1.37
1.25
1.29
18

-------