United States
         Environmental Protection
            Prevention, Pesticides
            And Toxic Substances
April 1995
Pesticide Reregistration
Rejection Rate Analysis
Environmental Fate

Follow-up Guidance for:
         Submission of Raw Data
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                   f Guidance on Submission of Raw Data

Raw data, in the sense used here, are not the detailed laboratory
records required for a GLP audit.  The "raw data1!1 required for an
EFGWB review is the uninterpreted factual information that formed
the basis for the study report.   Enough data should be provided so
that the EFGWB reviewer  is  able  to understand how the experiment
was performed and reconstruct the development of the study results.

As pointed out in the Environmental Fate "Rejection Rate Analysis"
document, the need for additional raw data does not normally result
in  the  rejection  of a  study,  and is usually corrected by the
submission of the required data.  It is generally most efficient to
provide a well-organized presentation  of all potentially necessary
data, rather than respond to requests for data during the study
review.  The data requirements listed below may not apply to all
reviewers or all studies, but should provide a general outline of
the kind of information necessary in order to make a reliable data


     Data presenting results from soil  and/or water physicochemical

     Data supporting the nominal test substance application rate,
     with calculations, where applicable.

     All dates (not just intervals) associated with the study: site
     preparation, test substance preparation,  dosing or
     application, sampling,  extraction, analysis, etc.  Tabulation
     with calculated intervals would be helpful.

     The registrant should ensure that description of any
     referenced SOP's or standard methods  must be| available to the
     Agency at the time of the review.  If these SOP's have been
     previously submitted to the Agency,  the registrant may
     reference the documents by MRID or Accession number.

     Information on reference substance characterization (as
     required by GLP's).

     Techniques used for preparation of aliquots or subsamples.

     If automated data  calculation methods are usied,  some
     discussion/examples of the calculation techniques,  such as
     spreadsheet formulae, calculation parameters from a commercial
     system, etc.

     The quantitative data which form the basis for calculating the
     reported concentrations of radioactivity in 
     radioactivity may be verified.  Data should be provided 'for
     control and treated samples.  Background data for solvents
     should be included as well.

     Supporting chromatograms, mass spectra, NMR spectra, IR
     spectra, UV-Vis spectra, and any other data used to
     characterize or identify degradation products.  This would
     include chromatograms or spectra which demonstrate the
     absence of any proposed metabolites.

     Quantitative data associated with chromatograms,
     autoradiograms, spectra, etc., so quantitative assessment of
     metabolite identification can be confirmed.  This would
     include the amount of radioactivity (in dpm) used in the
     analysis and the amount recovered.  A complete set of sample
     calculations should be included with formulae and variables
     defined in generally understood terms, using data from the
     submitted report.

     Chromatograms of standards and controls.

     Information on sample storage including conditions,  sample
     form (extract or homogenized) and sample container.   Often a
     range of temperatures is provided, which account for
     temperature spikes; information should also be included about
     the condition of samples during temperature spikes.   Reports
     should detail how samples are handled and stored prior to
     receipt by the analyzing lab.  In particular, the time
     between taking the sample and freezing the sample should be

Analytical methods

     Schematic diagram(s) of the analytical approach for the
     separation, identification, and quantitation of the test
     substance and its degradates.

     Supporting validation data associated with all methods
     submitted for each matrix  (soil, water, air, biological
     tissue, etc.).  This would include not only final results
     but also sample weights, extraction volumes, final volume
     of extracts, peak heights/areas, injection volumes,  and any
     other data which would allow the reviewer to reproduce the
     results.  These data can be summarized in a table, and may
     be reported along with analytical data for treated samples.

     Chromatograms for each matrix of interest at all spiking
     levels, including the claimed limit of quantitation.  A
     minimum of ten chromatograms is suggested for each matrix
     including both spiked and control samples, particularly in
     those instances where tolerances are proposed at or near
     the limit of quantitation.  There is a need for control and
     method blank chromatograms so reviewers can assess the

  reported limits of detection and quant itat ion.
  provided.   If there are more than 10 samples,  at least 10
  chromatograms should be provided.      «PAe*,  at least 10

  A minimum of three chromatograms each of control and fortiori
  samples in  order to assess the limit of wntita?fon?      d

  A sample calculation should be presented wh<-re a treats
  sample  and  fortified control are taken  through ?he Int ire

       a°n £r°Cedure-  A reviewer should be Ible to ?ie ?his

             t0 ' Chr°mato^am «* quantitative data° included

                                        .     ,

 corrected values are reported for trea?ed sampfls*  thfn
 apparent values should be reported as well?   P'

 Notes  on any  technical communications between the studv

'JUSH^  ?°teS °n the difficulties  of the method and
modifications to facilitate method implementation?

All appropriate manufacturer and lot numbers if or
chromatography columns, chemicals, and equipment.

Field data

     Field notes and/or reports on application,  harvest, plot
     preparation and maintenance.

     Procedure and results for calibration of application

     A specific description as to how and where (within the field
     plot) samples were taken.  What was done to insure that the
     sample was representative?

     Daily wind, rain, and temperature data is required to
     determine the relationship between environmental conditions
     and pesticide dissipation.

     Irrigation data,  including date, quantity, and application
     method is required.

     Soil series of test plots, with SCS description of a typical
     profile for that  soil type.

     Description of terrain, including percentage and direction of
     slope, and depth  to the water table.

Additional considerations

     No data should be included  from analyses  aborted due to
     equipment failure or other circumstances.  The registrant is
     required to keep  such data  in accordance  with GLP standards,
     but  such data should not  be submitted with the final study

     Information should be provided in a manner which is complete
     and  legible.  It  should be organized so that the reviewer can
     easily  find the desired  information, and not have to look in
     many different places  in  a  report to find the dates or
     analytical results.