UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                             REGION III
                          841 Chestnut Bundling
                      Philadelphia, Pennsylvania 19107
SUBJECT:  Region 3 Superfund Data Validation         DATE: MUU  •  6  ^95
         Policy1                                     -

FROM:    Abe Ferdas, Associate Director   /^b<£~'\^'
         Office of Superfund Programs  (3HW02)

TO:       Superfund Program Staff



Purpose:

     The Environmental Protection Agency makes consequential
decisions regarding public health and environmental conditions.
Analytical data are the cornerstone of this Agency's decision
making processes.  Thus, it is imperative that the data  used in
these processes be of known and documented quality.  The quality
of analytical data is determined through the data validation
process.  Specifically, data validation is a systematic  procedure
for reviewing analytical data against a set of established
criteria to determine its validity relative to the data's
intended use.  The purpose of this memo is to clearly define this
Region's data validation policy for the Superfund program.

Background:

     Each environmental data collection activity is different  due
to elements of variability which include site history, project
objectives, and the amount of historical data available.  The.
Site-specific procedures for data validation are specified in  the
individual Sampling and Analysis Plans developed for each site.
Organizations performing environmental data collection activities
should specify data validation requirements.  These requirements
should adequately support the intended use of the data.
     1   This policy and the procedures set out in this document
are intended for the use of U.S. EPA response personnel.   EPA
reserves the right to change this Policy at any time, without
prior notice, or to act at variance with this policy.  This
policy does not create any rights, duties or obligations,  implied
or otherwise, in any third parties.

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Implementation:

     Data review/validation procedures for this Region are
delineate'd in:

• Region III Modifications to the National Functional Guidelines
   for Organic Data Review

• Region III Modifications to the Laboratory Data Validation
  Functional Guidelines for Evaluating Inorganic Analyses.

These procedures provide the reader with instructions on how to
perform a full data validation.

     EPA Region III advocates full data review/data validation to
support quantitative Superfund Baseline Risk Assessments.  This
data validation is performed by an independent party other than
the laboratory that generates the analytical data.  The
validation is performed on all (100%)  of the data.  The
appropriate qualifiers should be applied to 100% of the data.

     There are various EPA national guidance documents that
address the objectives for data review/validation.  Risk
Assessment Guidance for Superfund. Volume 1 and the Guidance for
Data Useability in Risk Assessment include discussions of data
quality as a function of data use.  For quantitative risk
assessment, EPA National Guidelines indicate a preference for
full data review.

     For uses of data other than quantitative baseline risk
assessment, the degree or intensity of data validation may vary
based upon the intended use of the data.  Region Ill's
"Innovative Approaches to Data Validation" supports this concept.

     The Region's primary goal is to verify that the data quality
produced is adequate for the intended data use.  The "Innovative
Approaches to Data Validation" defines levels of data review
which are based on how data are to be used.  Each review level
contains data validation evaluation criteria which support the
data use category.  However, it is important to note that under
all circumstances the following conditions should be met:

     • The analytical deliverable requirement must contain all of
       the documentation listed in Appendix A of this memorandum.
     • Data qualifiers are applied to 100% of the data in all
       cases.
     • All data used to support quantitative baseline risk
       assessment should be reviewed using full Region III
       data validation procedures.

     The Region encourages dialogue between EPA and PRPs during
the scoping phase of a project to establish site-specific data

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quality objectives that will meet the needs of each data
collection activity.  It should be emphasized that the scoping
phase of the remedial process is the best time to present and
discuss the data validation objectives of the project.  An early
and comprehensive discussion of the data validation procedures of
the project will reduce the uncertainty during risk assessment.
The final decision regarding the appropriate level of review must
be approved by the EPA project manager.


Summary:

• Site specific data validation objectives are specified in the
  sampling and analysis plan for each site.

• Region III advocates 100% data validation to support
  any quantitative baseline risk assessment developed for the
  Superfund program.

• For data uses other than quantitative baseline risk assessment,
  Region III Innovative Approaches may be used with EPA project
  manager approval.

• Data validation procedures are provided in the Regional
  Guidelines as noted above.

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Appendix  A

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The contents of a data validation package are as follows:

Narrative

The narrative describes and summarizes the results of the
analytical process.  It is composed of:

     Overview - Describes the sample set (e.g. number of samples,
     matrices) and informs the user of the method of analysis.

     summary - Provide* a synopsis of the sample analysis and
     advises the user of any unsuccessful analyses.

     Xajor issues - Presents issues which directly affect data
     quality in an adverse manner.  Kay include statements
     regarding suspect and unusable data, or problems concerning
     sample integrity.

     Minor issues - Summarizes data qualifiers that have been
     applied to positive values or quantitation limits and
     informs tae user of the limitations of data use.

Attachments

Each report must have the following attachments:

     Appendix A - Glossary of data qualifiers

     Appendix B - Data Summary Forms (Regional data summary forms
     are available from the Quality Assurance Branch.)

     Appendix C - Results as reported by the laboratory  (Form 1
     or equivalent)

     Appendix D - Results of all Tentatively Identified Compounds
     which have been corrected to exclude blank contamination
     (Organics only)

     Appendix E - Support documentation which substantiates
     qualifiers placed on data during review (i.e. method blanX
     forms/ calibration forms, quantisation reports).

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                        Deliverables Listing
                         Metals Analyses
I.     Chain of Custody
II.    Narrative - Describe analyses performed and discuss any problems
      associated with the data reported.

III.    Sample Results (for each sample)

                  sample number
                  date received
                  matrix
                  % solids (for non-aqueous samples only)
                  concentration units
                  metal and determined concentration
IV.    QC Data (for those QC samples required by the method used to
      determine the  metals analyzed for)
                 .'
      0     Initial and Continuing Calibration Results

                  source of calibration standard(s)
                  concentration units
                  true value (for each analyte)
                  measured value (for each analyte)
                  percent recovery (for each analyte)

      0     CRDL Standard Recoveries for AA and ICP. (These analyses are
            required under the CLP protocols, other methods may or may
            not require that a standard at or near the detection limit of the
            instrument be analyzed to verify acceptable performance at that
            concentration level. If the method does not require such an
            analysis than this form  is omitted.)

                  same as listed for initial and continuing calibration

      0     Blanks

                  preparation blank matrix
                  instrument  and preparation blank units
                  initial calibration blank results
                  continuing calibration blank results
                  preparation blank results

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ICP Interference Check Sample (only needed if any analytes are
determined by ICP methods)

      ICP instrument ID (only if more than one ICP)
      concentration units
      true values (for each analyte and solution)
      found values (for each analyte and solution)
      percent recovery (for each analyte)

Matrix Spike Sample Recovery

      matrix
      concentration units
      control limit
    ^ spike sample result
     'unspiked sample result
      amount of spike added
      percent recovery

Post Digest Spike Sample Recovery. (These analyses are
required under the CLP protocols, other methods may or may
not require that a post digest spike sample analysis be
performed when the pre-digestion spike recovery is outside
acceptable limits.  If the method does not require such an
analysis than this form is omitted)

      same as for matrix spike recovery

Duplicates (note: for laboratory duplicate analysis results only)

      matrix
      percent solids for sample and duplicate (if non-aqueous
      matrix)
      concentration units
      control limit
      sample results
      duplicate results
      relative percent difference (% RPD)

Laboratory Control Sample
      matrix
      concentration units
      true value
      found value
      percent recovery
      control limits (if applicable)

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      0     Method of Standard Addition Results (for each analyte result
            determined by MSA)

                  sample no.
                  analyte
                  0 ADD ABS
                  1 ADD and ABS
                  2 ADD and ABS
                  3 ADD and ABS
                  final cone.
                  correlation coefficient

      0     ICP Serial Dilutions (only if ICP methods were used)

                  matrix
                  concentration units
                  initial sample result
                  serial dilution  result (corrected for dilution)
                  percent difference

      0     Instrument Detection Limits

                  instrument ID's
                  wavelength
                  type of background correction
                  instrument detection limit

      0     ICP Interelement Correction Factors (only if ICP methods were
            used)

                  wavelength
                  correction factor by analyte/interfering analyte

      0     ICP Linear Ranges (only if ICP methods were used)

V.    Raw Data

      For each reported value, the laboratory should include in the data
      package all raw data from  the instrument used to obtain the sample
      values and the QA/QC values reported (except for raw data for
      quarterly verifications of instrument parameters such as IDLs and
      interelement correction factors). Raw data must contain all
      instrument readouts used for the sample results,  including those
      readouts that may fall below the IDL. All AA and ICP instruments
      should provide a legible hard copy of the direct real-time instrument
      readout  (i.e., stripcharts, printer tapes, etc.).  A photocopy of the

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direct sequential instrument readout must be included.  A hardcopy of
the direct instrument readout for cyanide should be included if the
instrumentation has the capability.

All raw data should include intensities (ICP) and absorbances (AA)
with concentration units (unless instrument direct readout is in
concentration units).  All flame and furnace AA data should be
grouped by element.

To facilitate data validation, it is recommended that the raw data  be
identified to identify  the following:

0     Calibration standards, including source and prep date.

0     Initial and continuing calibration blanks and preparation blanks.

0     Initial and continuing calibration verification standards,
      interference check samples, and ICP serial dilution samples.

0     Diluted  and  undiluted  samples (by sample number) and all
      weights, dilutions and volumes used to obtain the reported
      values.  (If the volumes, weights and dilutions are consistent
      for all samples in a given data package,  a general statement
      outlining these parameters is sufficient).

0     Duplicates.

0     Spikes (indicating standard  solutions used, final spike
      concentrations, volumes involved).  If spike information (source,
      concentration, volume) is consistent for  a given data  package, a
      general statement outlining these parameters is sufficient).

0     Instrument used, any  instrument adjustments, data corrections
      or other apparent anomalies on the measurement record,
      including all data voided or  data not used to  obtain reported
      values and a brief written explanation.

0     All information including date for furnace analysis clearly and
      sequentially identified on the raw data, including sample
      number, sample and analytical spike data, percent recovery,
      coefficient of variation, full  MSA data, MSA  correlation
      coefficient, slope and y intercept of linear fit, final sample
      concentration  (standard addition concentration), and type of
      background  correction used.

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      0     Time and date of each analysis.  Instrument run logs can be
            submitted if they contain this information. If the instrument
            does not automatically provide times of analysis, these should
            be manually entered on all raw data for initial and continuing
            calibration verification and blanks, as well as interference check
            samples and linear range analysis.

      0     Integration times for AA analyses.

VI.    Digestion and Distillation  Logs

      Digestion and distillation logs for all samples analyzed should be
      submitted.  These logs should include:  (1) date, (2) sample weights
      and volumes, (3) sufficient information  to unequivocally identify which
      QC samples^i.e., laboratory  control sample, preparation blank)
      correspond to each batch digested, (4)  comments describing any
      significant sample changes or reactions which occur during
      preparation, and (5) indication of pH <2 or >12, as applicable.

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                       Deliverables Listing
                         Organic Analyses
.1.   Chain  of  Custody
II.  Narrative - Describe analyses performed and discuss any problems
     associated with the data reported.

III. Volatiles/Semi-Volatiles Data

           QC Summary
                - Surrogate Recovery Summary
                - Matrix Spike/Matrix Spike Duplicate Recovery Summary
                - Method Blank Summary (list associated samples for
                  each method blank)
                - Tuning Summary for BFB and DFTPP .
                  in chronological order by instrument

           Sample Data (for each sample)
                - Form I (from Org. SOW) or Lab Generated Reports
                  header must include the following:
                     sample no.
                     date received
                     matrix
                     units.reported
                     amount of sample
                     date extracted (Semi-VOA only)
                     % Moisture (soils only)
                     pH (waters only)

              .  - Reconstructed Ion Chromatogram (RIC)
                     label internal and surrogate standards
                     normalize to highest non-solvent peak
                  header must include to following:
                     sample no.
                     date and time of injection
                     instrument ID
                     lab file ID

                - Quantitation Reports
                  header must include:
                     same as for RIC
                     dilution factors
                     amount injected

                - Compound Identification (for all compds. detected
                  except surrogates and internal standards)
                  -  Raw mass spectra •
                  -  background subtracted mass spectra1
                  -  standard spectra  ,       •

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Standards
     - Initial Calibration Form
        include:
          date calibrated
          time calibrated
          applicable file IDs
          response factors for each compound at each level
          mean response factor
          Percent Relative Standard Deviation (%RSD)

     - RIC/Chromatogram and Quantitation report for each
        standard in initial calibration
        in chronological order by instrument

     - Continuing Calibration Form
        include:
          date and time calibrated
          mean response factor from initial calib.
          response factor from continuing calib.
          percent difference  (%D)

     *- Internal Standard Area Summary
        in order by instrument
        include:
          continuing calib. internal standard areas
          cont. calib. internal std. retention times
          internal standard areas and retention times for
          all samples quantitated against continuing calib,

Raw QC

     - Tuning BFB/DFTPP  ...
        bar graph spectrum
        mass listing

     - Blank Data
     - Form I or lab generated report forms
        for each method blank
     - RIC/Chromatogram
     - Quantitation report
     - Mass Spectrum of each positive result
           (above same header as samples)

     - Matrix Spike/Matrix Spike Duplicate Data
     - Form I or lab generated report forms
     - RIC/Chromatogram
     - Quantitation report
     - spectra not required

Copies of Sample Preparation/Extraction Logbooks
Run log/Injection  logbook
                                                           11

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IV.     Pesticide/PCB Data

        QC Summary
             - Surrogate Recovery Summary
             - Method Blank Summary
             - Matrix Spike/Matrix Spike Duplicate Recovery Summary

        Sample Data
             - Form I or lab generated report forms
             - Chromatogram
                header must include:
                  sample no.
                  volume injected
                  date and time of analysis
                  column
                  instrument identification
                  all positives labelled

             - Confirmation Chromatogram (if applicable)
                header same as above

             - GC integration report

             - GPC Chromatogram (if performed)

             - GC/MS Spectra (if confirmation on GC/MS performed)

        Standards Data

             - Pesticide Evaluation Standards Summary
             - Pesticide/PCB Standard Summary
                include:
                  calibration factors
                  percent difference (%D) for continuing and initial
                  calib.        ,

             - Pest/PCB standards data
             - Chromatogram and integration reports
                in chronological order  by instrument
                  label all peaks for individual compounds
                  list total ng injected
                  retention time and peak areas
                  date and time injected
                  GC column ID
                  GC instrument ID
                                                                 ii-i

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Raw Data
     Blank Data
       - Form I or lab generated result form
       - chromatogram
       - integration reports
         in chronological order

     Matrix Spike/Matrix Spike Duplicate
       - Form I or lab generated result form
       - chromatogram
       - integration reports
                                                          IV

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