PESTICIDE ASSESSMENT GUIDELINES
SUBDIVISICN 0
RESIDUE CHEMISTRY
Series 171-4
Specialty Applications
(I) Classification of Seed Treatments and Treatment of
Crops Grown for Seed Use Only as Non-Food or Food Uses
(II) Magiitude of the Residue: Post-harvest Fumigation of
Crops and Processed Foods and Feeds
(III) Magiitude of the Residue: Post-harvest Treatment
(Except Fumigation) of Crops and Processed Foods and Feeds
ADDENDUM 5 ON DATA. REPORTING
Prepared fcy:
Michele Leparulo Loftus, Ph.D.
Residue Chemistry Branch
Hazard Evaluation Division
Project Manager:
Elizabeth M. K. Leovey, Ph.D.
Hazard Evaluation Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
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Subdivision O - Speciality Applications
Table of Contents of Addendum
Discussion
Introduction 3
Response to Public Ccmments 3
Guidelines
Part I: Classification of Seed Treatments and Treatment of 5
Crops Grown for Seed Use Only as Non-Food or Food Uses
Part II: Magnitude of the Residue: Post-harvest Fumigation of 12
Crops and Processed Foods and Feeds
Part III: Magnitude of the Residue: Post-harvest Treatment 19
(Except Fumigation) of Crops and Processed Foods and
Feeds
Table of Contents for Part I
Introduction 5
Guideline 6
Master Cover Page 6
Table of Contents 6
I. Introduction 6
II. Materials and Methods 6
III. Results and Conclusion 9
IV. Raw Data and Information on Individual Field Trials 10
V. Certification 11
VI. References 11
VII. Appendices 11
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Table of Contents for Part II
Introduction " 12
Guideline 12
Master Cover Page 12
Table of Contents 12
I. Introduction 13
II. Materials and Methods 13
III. Results and Conclusions 16
IV. Raw Data and Information on Individual Trials 17
V. Certification 18
VI. References 18
VII. Appendices 18
Table of Contents for Part III
Introduction 19
Guideline 19
Master Cover Page 19
Table of Contents 19
I. Introduction 20
II. Materials and Methods 20
III. Results and Conclusions 22
VI. Raw Data and Information on Individual Trials 23
V. Certification 24
VI. References 24
VII. Appendices 25
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PESTICIDE ASSESSMENT GUIDELINES
RESIDUE CHEMISTRY
Specialty Applications
Subdivision 0, Series 171-4
DATA REPORTING
FOREWORD
The Data Reporting Guidelines are addenda to the Pesticide Assessment
Guidelines (Subdivision O), designed primarily to aid the petitioner/registrant
in generating reports compatible with the Environmental Protection Agency's
review process. They were intended also to clarify ambiguities in the
interpretation of the existing Pesticide Assessment Guidelines.^/ The Data
Reporting Guidelines are not intended to introduce new data requirements or
revisions to the Pesticide Assessment Guidelines, nor are they intended for
use by Agency reviewers as a mere checklist. While following the Data Reporting
Guidelines is not mandatory, data submitters are encouraged to submit complete
reports which can be efficiently reviewed by the Agency. The Agency realizes
there are sections in the Data Reporting Guidelines which do not apply in all
cases. Therefore, registrants should exercise judgment in deciding vhich
portions are germane to a specific data submission.
This guidance pertains to the substance of the data report. PR Notice
86-5, effective on November 1, 1986 (available from the Registration Support
and Emergency Response Branch, Office of Pesticide Programs, US EPA), pertains
to the physical formating of reports (which are referred to as "studies")
and sutmittal packages. Some of the requirements in PR Notice 86-5 are
mandatory.
The Data Reporting Guideline on Specialty Applications is divided into
three parts: (I) Classification of Seed Treatments and Treatment of Crops
Grown for Seed Use Only as Non-Food or Food Uses; (II) Postharvest Fumigation
of Crops and Processed Foods and Feeds; (III) Post-harvest Treatment (Except
Fumigation) of Crops and Processed Foods and Feeds. Each part gives the
format/outline recommended by the Agency to be used by the petitioner/
registrant for reports on the particular specialty application study.
RESPONSE TO PUBLIC COMMENTS
The purpose of this section is to acknowledge and address the concerns
expressed in the letters of comments received by the Agency in response to
In addition. Residue Chemistry Standard Evaluation Procedures, designed to
aid Agency reviewers in their evaluations of pesticide residue data, are
available. They provide a more thorough clarification of the existing
Pesticide Assessment Guidelines.
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the public notice in the FEEERAL REGISTER of October 15, 1986 (51 FR 36753).
The only comment received concerning these guidelines was that the guidelines
should not contain technical details on why the test is necessary, how it should
be run and how the data will be evaluated; these should be covered by the
Pesticide Assessment Guidelines and Standard Evaluation Procedures (SEPs). The
Agency has included the introductory materials as a convenience to data
submitters and to clarify relevant sections in the Pesticide Assessment Guidelines
of difficulty for some registrants.
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Class! ficatdon of Seed Treatments and Treatment of Crops
Grown for Seed Only as Non-Food or Food Uses
1 ^atment of Crops Grown for Seed Use Only
the treatment of crops grown for seed use only to be classified as a
food use, the following requirements must be met: (1) the seed itself or
i js sprouts are not raw agricultural coimrdities ;£/ 2) there is no likelihood
c iresidues in crops grown from harvested seed; (3) subsequent to treatment,
a JL parts of the crop are not fit for human or animal consumption. Details of
t bse requirements and any exceptions are given in Part I of the Standard
E aluation Procedure for Specialty Applications .£/ If the treatment of the
c bp grown for seed use only is classified as a non-food use, no residue
s jidies are needed. If the treatment of the crop grown for seed use only is
c assified as a food use, metabolism and crop field studies are needed. The
f tmats for the metabolism and crop field studies^/ are addressed in separate
E La Reporting Guideline documents being developed concurrently, and the
r ijistrant/petitioner is referred to those Data Reporting Guidelines when the
t satment of crops grown for seed use only is classified as a food use.
S ad Treatments
i
| For seed treatments to be classified as a non-food use, data fron a
r aiotracer study are needed demonstrating no uptake of radioactivity to the
a rial portion and edible root (both human and livestock consumption) portion
c I the crop.£/ If the radiotracer study dertDnstrates that the particular seed
t patment is a non-food use, no further studies are needed. If the seed
t patment is classified as a food use, plant metabolism and crop field studies^/
a a needed, and the registrant is referred to the Data Reporting Guidelines
f r those studies.
40 CFR 180.l(e): Raw agricultural commodities include among other things
fresh fruits, whether or not they have been washed and colored or otherwise
i treated in their unpeeled natural form; vegetables in their raw or natural
i state, whether or not they have been stripped of their outer leaves, waxed,
prepared into fresh green salads, etc.; grains, nuts, eggs, raw milk, meats,
and similiar agricultural produce. It does not include foods that have been
, processed, fabricated, or manufactured by cooking, freezing, dehydrating, or
milling.
2/ The Standard Evaluation Procedure (SEP) for Specialty Applications is being
developed concurrently.
£/ See Data Reporting Guideline for Magnitude of the Residue: Crop Field
Trials; and Data Reporting Guideline for Nature of the Residue; Plants,
available from the National Technical Information Service (NTIS), PB86-248192
and PB87-208641 respectively.
5/ For additional details, see Part I of the SEP for Specialty Applications.
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The guideline given below in Part I of the Data Reporting Guideline for
Specialty Applications is a format/outline for the radiotracer study determining
whether or not the seed treatment results in uptake of radioactivity to the
aerial edible and root portions of the crop. The report for this study .
should include all information necessary to provide a complete and accurate
description of the study.
GUIDELINE
MASTER CDVER PAGE
Title page and additional documentation requirements (i.e., requirements
for data submission and procedure for claims of confidentiality of data) if
relevant to the study report should precede the content of the study
formatted below. These requirements are described in PR Notice 86-5.
TABLE CF CONTENTS
I. INTHDDUCTION
A. Background and Historical Information on the Pesticide
1. Brief summary of nature of the residue in plants, including
the structures of the parent and residues considered to be of
toxicolcgical concern;
2. Brief summary and references for residue data for the pesticide
active ingredient on this commodity and related caratodities
available from other sources; and
3. list of current and former section 3, 5, 24(c) registrations
and section 18 exemptions for the commodity under study and
related commodities.
B. Purpose of Study
C. Abstract of Study
1. Brief summary of application and field procedures;
2. Results, including unexpected problems; and
3. Conclusions.
II. MATERIALS AND METHODS
A. Test substance
1. Identification of the test pesticide active ingredient (a.i.),
including chemical name, common name (ANSI, BSI, ISO), registrant
developmental/experimental name and chemical structure;
2. Description of the radiolabeled test material;
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Identify the radiolabel and the site of the label. A rationale
should be provided for selection of a radiolabel other than
l^c and for the site of the label (where possible the ring
position should be labeled). The purity, specific activity in
Curies /mole and disintegrations per minute per gram (dpm/g) " '
should be reported here.
3. Identification of the pesticide formulated product(s) in which
the radiolabeled pesticide active ingredient was applied,
including trade name, type (EC, WP, G, etc.), pounds of active
ingredient per gallon, percent a.i. by weight, EPA registration
number, and manufacturer; and
4. Physical state and nature of the solvent, carrier, bait,
adjuvant or other matrix in which the pesticide was applied.
B. Test Crop
Note: If more than one trial is carried out using different
varieties, sites, etc., the registrant may prefer to
include the following in Chapter IV, R£W DATA AND
INFORMATION ON INDIVIDUAL FIELD TRIALS.
1. Identification of the test crop including variety and crop
group classification according to 40 CFR §180.34(f), as revised
June 29, 1983; 48 FR 29855;
2. Identification of specific crop part(s) harvested and subjected
to analysis for radioactivity; and
3. Developmental stage(s), general condition (immature/mature,
green/ripe, fresh/dry, etc.), size(s) of the test crop at time
of harvest.
C. Test Site
Note: If more than one trial is carried out using different
varieties, sites, etc., the registrant may prefer to
include the following in Chapter IV, R2W DATA AND
INFORMATION ON INDIVIDUAL FIELD TRIALS.
1. Description of test site;
Overall testing environment (outdoor test plots, greenhouse,
plant growth dhamber); location (county and state); environmental
conditions (temperature, rainfall, sunlight); soil type;
2. Location (county, state); and
3. Cooperator.
D. Field Trial Methods
Note: If more than one trial is carried out using different
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varieties, sites, cultural practices, etc., the
registrant may prefer to include this in Chapter IV,
R2W DATA flND INFORMATION ON INDIVIDUAL FIELD TRIALS.
1. Detailed description of application of radiolabeled pesticide
to seeds:
Information to be reported includes dose rate, pounds active
ingredient and formulated product per pounds seed, concentration
of treatment solution, volume of application solution per
pounds seed, formulation, physical state in vihich pesticide is
applied, diluent, additives, etc., method of application
(hopper box, commercial equipment). The pesticide should be
applied at the maximum proposed application rate.
2. Field trial lay-out:
Information to be reported includes size of plots/pots, number
of plants per plot/pot, number of plots/pots, number of plants
per unit area, length of rows and row spacing.
3. Farming practice:
Information on practices such as cultivation, irrigation, and
treatments with other pesticides should be included here.
4. Harvest procedures, including the number of days between
planting and harvesting.
E. Sampling, Handling and Storage
1. Dates of sampling, shipping, storage, and analyses;
2. Description of sampling procedure and size of samples; and
3. Handling, pre-shipping, shipping, post-shipping storage conditions,
including storage times .^/
F. Analytical Procedures/Instrumention^/
1. Description of sample preparation (i.e., dissection, grinding,
lyophilization, number of plants contained in one sample,
etc.) prior to analyses of radioactivity; and
2. Details of analytical method to measure radioactivity,
including descriptions of equipment and instrument parameters.
£ Refer to the Data Reporting Guideline on Storage Stability available frcm
NTIS, PB86-248192.
2J Also refer to the Data Reporting Guideline on Analytical Methods available
fron NTIS, PB86-248192.
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G. Quality Control
Description of control measures and precautions ffollowed to
ensure the fidelity of the field tests, samples and measurement
of the residue.
H. Other Pertinent Information on Materials and Methods
III. RESULTS WD CONCLUSIONS
A. Brief Summary of Study Procedures
The summary of the study procedures should include the number of
field trials, descriptions of the application of the radiolabeled
pesticide to the seed (dose rate, method, formulation), the site
(greenhouse, outdoors, plant growth chamber), number of days
between planting and harvest, number of plants sampled, parts of
the plant analyzed for radioactivity, and the method of detection.
B. Results
1. Total recovered (i.e., combustible) radioactivity on seeds at
time of planting, if measured:
The radioactivity should be reported as:
a. disintegrations per minute (dpm)
b. dpm/ug
c. ppm equivalents (expressed as parent ccmpound).
2. The distribution of radioactivity in the treated crop at the
time of harvest or sampling:
The data to be reported are the total recovered (i.e., ccmbustible)
radioactivity remaining at time of sampling or harvest on the
whole plant and on the plants parts of interest? i.e., the
aerial and edible root portions of the plant. The radioactivity
for the whole plant and the plant parts should be reported in
tabular format as:
a. dpm
b. dpm/ug
c. ppm equivalents (expressed as parent ccmpound).
For the plant parts, the radioactivity should also be expressed
as:
d. The percentage of the total recovered radioactivity
in the whole plant.
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3. Graphs and figures of the results:
Graphs, if provided, should be accompanied by tables of actual
values from vhich graphs were constructed.
4. Narrative of results:
Narrative should include a discussion of the quantitative
accountibility for a majority of the total radioactivity recovered
from the aerial and edible root portions of the plant and a
discussion of unexpected problems, the way in vhich they were
resolved, and explanations for apparently aberrant, atypical
values.
C. Conclusions
The registrant's conclusion on whether or not the results of this
study and any other relevant studies support a non-food use
classification for the seed treatment in question should be given.
IV. PAW DATA AND INFORMATION CM INDIVIDUAL FIELD TRIALS
A. Details of Radioactive Counting Data for Selected Representative
Samples
Details should include counting times, total counts recorded,
corrected counts, counting efficiencies, other raw data (sample
sizes, ppm equivalents found, sensitivity, limit of detection) and
other pertinent information needed to check the registrant's
calculations.
B. Description of Calculations, Including Examples
C. Description of Statistical Tests, Including Examples
D. Representative Raw Data Figures
As applicable, printout sheets, chromatograms, spectra, etc.
E. Detailed Descriptions of Each Field Trial
Note: Some of this information is the same included under
Chapter II, MATERIALS AND METHODS. It is not necessary
to include this in nore than one location in the report.
The registrant may decide where to report this information.
1. Information to be reported for each field trial includes:
a. Test crop (see chapter II.B of this guideline);
b. Test site (see chapter II.C of this guideline);
c. Field trial methods (see chapter II.D of this guideline);
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d. Dates (treatment of seeds, planting, sewing, transplanting,
sampling/harvest, receipt in laboratory, storage, analysis,
etc.);
e. Length of storage of samples; and
f. Sample identification.
F. Other
Any additional information the registrant considers appropriate and
relevant to provide a complete and thorough description of the
study.
V. CERTIFICATION
Certification of authenticity by the Study Director (including signature,
typed name, title, affiliation, address, telephone number and date).
VI. REFERENCES
VII. APPENDICES
A. Reprints of published and unpublished literature, ccmpany reports,
letters, etc., not expected to be in GPP files, but which the
registrant feels vail aid the review of the study.
B. Other pertinent information vfaich does not fit in any other section
of this outline.
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II
Magnitude of the Residue: Post-harvest Fumigation of
Crops and Processed Foods and Feeds
Part II of the Data Reporting Guideline for Specialty Applications is an
outline/format for a report on a study to determine the magnitude of the
residue vfaich will result on raw crops and processed foods and feeds as a
result of post-harvest fumigation. Other post-harvest treatments are the
subject of Part III of this Eata Reporting Guideline. Fumigation may be defined
as the act of releasing and dispersing a toxic chemical so that it reaches
the organism wholly or primarily in the gaseous or vapor state. Both the raw
agricultural ccmmodities and its processed products may be treated post-harvest
by fumigation.
The report for a study on the post-harvest fumigation of raw crops and
processed foods and feeds should include all information necessary to provide
a complete and accurate description of the study. The study should answer the
following question: vihat is the maximum level of "total toxic residue"^/
that will result in or on the raw food or feed or processed food or feed from the
proposed post-harvest fumigation of the raw or processed canmodity with the
pesticide formulated product? Actual residue data on commodities as consumed
should be provided in oases where tolerance level residues lead to unreasonable
risks. Crop group considerations should also be addressed, and an effort
should be made to achieve harmonization with applicable International Residue
Limits (Codex).
GUIDELINE
MASTER COVER PAGE
Title page and additional documentation requirements (i.e., requirements
for data submission and procedure for claims of confidentiality of data) if
relevant to the study report should precede the content of the study
formatted below. These requirements are described in PR Notice 86-5.
TABLE OF CONTENTS
The term "total toxic residue" is used to describe the sum of the parent and
its degradation products, metabolites (free or bound), and impurities that are
considered to be of toxicological significance, and therefore warrant
regulation.
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I. INTRDDUCTTON
A. Background and historical information on the pesticide
1. Brief summary of nature of the residue in plants, including the
structures of the parent and the residues considered to be of
toxicological significance;
2. Brief summary and references for residue data for the pesticide
active ingredient on this cantiodity and related coraiDdities,
available fron other sources; and
3. List of current or former section 3, 5, 24(c) registrations and
section 18 exemptions for the pesticide active ingredient on the
commodity under study or related camodities.
B. Purpose of Study
C. Abstract of Study
1. Brief summary of application procedures;
2. Results, including unexpected problems; and
3. Conclusions.
II. MATERIALS AND METHODS
A. Test Substance
1. Identification of the test pesticide active ingredient (a.i.),
including chemical name, cannon name (ANSI, BSI, ISO), registrant
developmental/experimental name and chemical structure;
2. Identification of the pesticide formulated product(s) in which
the pesticide active ingredient was applied, including trade
name, type (EC, WP, G, etc.)f pounds of active ingredient per
gallon, percent a.i. by weight, EPA registration number and
manufacturer;
3. Information on the matrix in which the formulated pesticide was
applied and on any additives; and
4. Physical/chemical parameters on the test substance.
B. Test Raw or Processed Conmodity
Note: If more than one trial is carried out using different
varieties, fumigation chambers, conditions, etc., the
registrant may prefer to include the following in Chapter
IV, RAW DATA AND INFORMATION ON INDIVIDUAL TRIALS.
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1. Identification of the raw or processed test commodity, including
variety and crop group classification according to
40 CFR §180.34(f), as revised June 29, 1983; 48 FR 29855;
2. Identification of specific crop part(s) harvested, fumigated-and
analysed;
3. Developmental stage(s), general condition (immature/mature,
green/ripe, fresh/dry, etc.)/ size(s) of the test commodity at
time of fumigation;
4. Size and kind of containers holding the connodity (e.g. wood
burlap, etc.); and
5. Information on whether the raw or processed commodity, or its
storage container, had been treated prior to the test post-harvest
treatment, including application rates, FHI's and the residue
prior to the test post-harvest treatment.
C. Test Site
Note: If more than one trial is carried out using different
varieties, sites, etc., the registrant may prefer to
include the following in Chapter IV, RfiW DATA AND
INFORMATION ON INDIVIDUAL TRIALS.
1. Description of fumigation chamber
Information to be reported includes:
a. Type of fumigation chamber (grain elevator and flat storage,
tarpaulin covering, shophold, fumigation, vault, vacuum
chamber, etc.);
b. Size and geometry of fumigation chamber;
c. Measures taken to seal the fumigation chamber (e.g., covering
surfaces with asphalt paper or plastic tarpaulins, sealing of
vents, windows, cracks, etc.);
d. Drafts inside the chamber;
e. Temperature inside the chamber; and
f. The relative size of the chamber as compared to the
commodity load.
2. location of fumigation chamber
Information to be reported includes:
a. County and state;
b. Environmental conditions (temperature, wind, temperature); and
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c. Cboperator.
D. Application of the Pesticide
Note: If more than one trial is carried cut using different
varieties, fumigation chambers, conditions, etc., the
registrant may prefer to include the following in Chapter
IV, RAW DATA. AND INFORMATION ON INDIVIDUAL TRIADS.
1. Type of fumigant dispensing system and method of fumigant
volatilization;
2. Measures taken to hasten gas circulation;
3. Dose rate, exposure time, temperature, and pressure;
4. Layout of the fumigation (i.e., discharge points and positioning
of circulating fans/blowers in relation to arrangement of
ccrnrtDdities, size of stacks of commodities, etc.);
5. Number and date(s) of application^); and
6. Formulation.
E. Aeration of the Oomodities
1. The aeration time and the dates of the aeration;
2. Description of aeration procedures inside (e.g., removal of
seals and covers, opening of doors and windows, use of ejdiaust
fans and air suction systems) and outside the fumigation
chamber; and
3. Description of any aeration following sampling.
F. Sampling, Handling, and Storage
1. Dates of sampling, shipping, storage and, analyses;
2. Description of sampling procedure, including the location of
the sampling (e.g., top, bottom or side outer layer or center
of stack; side or middle of chamber), size of the samples, and
measures taken to prevent desorption of the fumigant during
sampling; and
3. Handling, pre-shipping, shipping, and post-shipping storage
conditions, including storage times£/, special measures taken to
prevent desorption of the fumigant during the time between sampling
and analysis, and description of sample containers and storage
temperature.
See Data Reporting Guideline on Storage Stability available fron NTIS,
PB86-248192.
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G. Analytical Procedures/Instrumenticai^Q/
1. Description of sample preparation (compositing, subsampling,
grinding, extraction, etc.) and measures taken to prevent
desorption of the fumigant during sample preparation? and
2. Details of analytical method to measure residue, including
descriptions of equipment/instrumentation and instrument
parameters.
H. Quality Control
Description of control measures and precautions to ensure the
fidelity of the field test, samples and measurement of the residue.
I. Any Other Pertinent Information on Material and Methods
III. RESULTS AND CONCLUSIONS
A. Brief Summary of the Study Procedures
The summary of the study procedures should include the number of
trials, the commodities, vihether the cannodities had been previously
treated with the test active ingredient, descriptions of the
fumigations and fumigation chambers, the formulation, aeration
time, and the method of detection.
B. Results of Analyses of Treated and Control Samples and Fortified
Samples
1. Tables of the results
Residue data should be given in a tabular format, providing the
following information:
a. Commodity;
b. Plant part;
c. Type of fumigation chamber;
d. Dose;
e. Exposure time;
f. Temperature;
g. Aeration time; and
Refer to the Data Reporting Guideline on Analytical Methods available
fron NTIS, PB86-248192.
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h. Residue; residue testing should extend beyond sampling
immediately after the label specified aeration to include
studies to follow the rate of residue decline that could be
expected under various shipping and storage conditions and
temperature.
2. Graphs and Figures of the Results:
Graphs, if provided, should be accompanied by tables of actual
values frcm which graphs were constructed.
3. Narrative on the results:
Narrative should include a discussion of unexpected problems
and ways in which they were resolved and explanations for
apparently aberrant, atypical values.
E. Conclusions on the Appropriate Tolerance(s) for the Proposed Use(s)
IV. RAW DATA AND INFORMATION ON INDIVIDUAL TRIALS
A. Raw Data Tables for Residue Analyses of Treated, Control and
Fortification Recovery Samples and Standards
B. Representative Raw Data Figures
1. As applicable, printouts, spectra, chronatogranis of treated
samples, control samples, fortified samples and standards, etc.;
and
2. Calibration curves.
C. Description of Calculations, Including Examples
D. Description of Statistical Tests, Including Examples
E. Detailed Descriptions of Each Trial
Note: Some of this information is the same included under
MATERIALS AND METHODS (Chapter II of the format). It
is not necessary to include this information in more
than one location in the report. The registrant may
decide where to report this information.
1. Information should be reported for each trial on:
a. Test raw or processed eximiodity (see Chapter II.B of this
guideline);
b. Test site (see Chapter II.C of this guideline);
c. Application of the pesticide (see Chapter II.D of this
guideline);
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d. Aeration of the oaimodities (see Chester II.E of this
guideline);
e. Dates (fumigation, aeration, sampling, receipt at laboratory,
analyses, etc.); and
f. Sample identification.
F. Other
Any additional information the registrant considers appropriate and
relevant to provide a complete and thorough description of the study.
V. CERTIFICATION
Certification of authenticity by the Study Director (including signature,
typed name, title, affiliation, address, telephone number and date).
VI. REFERENCES
VII. APPENDICES
A. Reprints of published and unpublished literature, company reports,
letters, etc., not expected to be in CPP files, but vhich the
registrant feels will aid the review of the study.
B. Other pertinent information which does not fit in any other section
of this outline.
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Ill
Magnitude of the Residue: Pest-harvest Treatment
(Except Fumigation) of Crops and Processed Foods and Feeds
Part III of the E&ta Reporting Guideline for Specialty Applications is
an outline/format for a report of a study to determine the magnitude of the
residue vihich will result on raw crops and processed foods and feeds as a
result of post-harvest treatments, except fumigation. Post-harvest fumigation
is the subject of Part II of this E&ta Reporting Guideline.
Post-harvest treatments of foods and feeds are applied by various means,
including dips, drenches, mechanical reamers, and spray and brush applicators.
The pesticide may be applied directly (to the conrtDdity) or indirectly (to
the storage bin). Often, the application of a wax coating on the comtDdity
is involved. Both the raw agricultural caraiDdity and its processed product
may be treated post-harvest. Additional details on post-harvest treatments
are given in Part III of the Standard Evaluation Procedure for Specialty
Applications .1]-/
The report for a study on the post-harvest treatment of raw crops and
processed foods and feeds should include all information necessary to provide
a complete and accurate description of the study. The study should answer the
following question: what is the maximum level of "total toxic residue" that
will result in or on the raw food or feed or processed food or feed fron the
proposed post-harvest treatment of the raw or processed conmodity with the
pesticide formulated product? Actual residue data on commodities as consumed
should be provided in cases where tolerance level residues lead to unreasonable
risks. Crop group considerations should also be addressed, and an effort
should be made to achieve harmonization with applicable International Residue
Limits (Codex).
GUIDELINE
MASTER COVER PAGE
Title page and additional documentation requirements (i.e., requirements
for data submission and procedure for claims of confidentiality of data) if
relevant to the study report should precede the content of the study
formatted below. These requirements are described in PR Notice 86-5.
TABLE OF CONTENTS
To be published.
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I. INTRODUCTION
A. Background and Historical Information on the Pesticide
1. Brief sunnary of nature of the residue in plants, including
the structures of the parent and the residues considered to be
of toxicological significance;
2. Brief sunmary and references for residue data on this conmodity
and related coimodities available from other sources; and
3. List of current or former section 3, 5, 24(c) registrations
and section 18 exemptions for the commodity under study or
related commodities.
B. Purpose of Study
C. Abstract of Study
1. Brief sunnary of application procedures;
2. Results, including unexpected problems; and
3. Conclusions.
II. MATERIALS AND METHODS
A. Test Substance
1. Identification of the test pesticide active ingredient (a.i.),
including chemical name, common name (ANSI, BSI, ISO), registrant
developmental/experimental name and chemical structure;
2. Identification of the pesticide formulated product(s) in vihich
the pesticide active ingredient was applied, including trade
name, type (EC, WP, G, etc.), pounds of active ingredient per
gallon, percent a.i. by weight, EPA registration number and
manufacturer; and
3. Information on the matrix (e.g., water, wax) in which the
formulated pesticide was applied and on any additives.
Trade and chemical names for the matrix substance and additives
should be provided.
B. Test Raw or Processed Commodity
Note: If more than one trial is carried out using different
varieties, application procedures, conditions, etc.,
the registrant may prefer to include the following in
Chapter IV, RAW DATA AND INFORMATION ON INDIVIDUAL
TRIALS.
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1. Identification of the raw or processed test connodity,
including variety and crop group classification according to 40
CFR §180.34(f), as revised June 29, 1983; 48 FR 29855;
2. Identification of specific crop part(s) harvested, treated, and
analysed;
3. Developmental stage(s), general condition (immature/nature,
green/ripe, fresh/dry, etc.), size(s) of the test conriDdity at
time of treatment; and
4. Information on whether the cannDdity or storage container had
been treated with the test active ingredient prior to the test
post-harvest treatment, including application rates, PHI's, and
the residue prior to the test post-harvest treatment.
C. Test Site
Note: If more than one trial is carried out using different
varieties, application procedures, conditions, etc.,
the registrant may prefer to include the following in
Chapter IV, RAW DATA. AND INFORMATION ON INDIVIDUAL
TRIALS.
1. Description of test site;
Overall testing environment (outdoor, indoor, climate controlled
packinghouse, etc.), temperature;
2. Location (county, state); and
3. Cboperator.
D. Application of the Pesticide
Note: If more than one trial is carried out using different
varieties, application procedures, conditions, etc.,
the registrant may prefer to include this in Chapter
IV, RAW DATA AND INFORMATION ON INDIVIDUAL TRIALS.
1. Physical state in which the pesticide was applied;
2. Description of method/equipment for pesticide application; e.g.,
direct (applied to controdity) or indirect (applied to storage
container), dips, drenches, mechanical foamers, spray applicators,
brush applicators, wax applicators;
3. Pounds active ingredient and formulation per pounds treated
° commodity, concentration of treatment solution, volume of treatment
solution per pounds treated cannDdity, exposure time, number of
treatments, temperature of solution;
4. Description of post-harvest practices accompanying the post-harvest
treatment such as application of wax coatings after treatment,
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detergent washes, and rinses, including number, timing, and
volume;
5. Date(s) of application(s); and
6. Formulation.
F. Sampling, Handling and Storage
1. Dates of sampling, shipping, storage and analyses;
2. Description of sampling procedure and size of the samples; and
3. Handling, pre-shipping, shipping, and post-shipping storage
conditions, including storage times££/.
G. Analytical Procedures/Instrumention^^/
1. Description of sample preparation (conpositing, subsampling,
grinding, extraction, etc.); and
2. Details of analytical method to measure residue, including
descriptions of equipment/instrumentation and instrument
parameters.
H. Quality Control
Description of control measures and precautions to ensure the
fidelity of the field test, samples and measurement of the residue.
I. Any Other Pertinent Information on Material and Methods
III. RESULTS AND CONCLUSIONS
A. Brief Sunmary of Study Procedures
The summary of the study procedures should include the number of
trials, the cannrdities, whether the commodities had been previously
treated with the test active ingredient, description of the
post-harvest treatment (e.g., concentration, exposure time,
temperature), the formulation, and the method of detection.
B. Results of Analyses of Treated and Control Samples and Fortified
Samples
12/ See Data Reporting Guideline on Storage Stability available from NTIS,
PB86-248192.
13/ See Data Reporting Guideline on Analytical Methods available fron NTIS,
PB86-248192.
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1. Tables of the results
Residue data should be given in a tabular format, providing
the following information, as applicable:
a. Commodity;
b. Plant part;
c. Method/equipment for pesticide application;
d. Pounds active ingredient per pounds ccmtodity;
e. Concentration of treatment solution;
f. Volume treatment solution per pounds canrrodity;
g. Exposure time;
h. Number of treatments;
i. Other pertinent information affecting the level of residue
(e.g., use of wax, rinse, volume and time of rinse);
j. Formulation; and
k. Residue; residue testing should provide information on the
rate of residue decline that could be expected under various
shipping and storage conditions and temperature.
2. Graphs and figures of the results:
Graphs, if provided, should be accompanied by tables of actual
values frcm vihich graphs were constructed.
3. Narrative on the results:
Narrative should include a discussion of unexpected problems
and ways in which they were resolved and explanations for
apparently aberrant, atypical values.
C. Conclusions on the Appropriate Tolerance(s) for the Proposed
Use(s)
IV. Raw DATA AND INFORMATION ON INDIVIDUAL TRIALS
A. Raw Data Tables for Residue Analyses of Treated, Control and
Fortification Recovery Samples, and Standards
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B. Representative Raw Data Figures
1. As applicable, printouts, spectra, chronatograms of treated
samples, control samples, fortified samples and standards,
etc.; and
2. Calibration curves.
C. Description of Calculations, Including Examples
D. Description of Statistical Tests, Including Examples
E. Detailed Descriptions of Each Trial
Note: Some of this information is the same included in
Chapter II, MATERIALS AND METHODS. It is not necessary
to include this information in more than one location
in the report. The registrant may decide where to
report this information.
1. Information to be reported for each trial includes:
a. Test raw or processed ccmmodity (see chapter II.B of this
guideline);
b. Test site (see chapter II.C of this guideline);
c. Application of the pesticide (see chapter II.D of this
guideline);
d. Dates (treatment, sampling, shipping, receipt in laboratory,
storage, analyses, etc.);
e. Length of storage of samples; and
f. Sample identification.
F. Other
Any additional information the registrant considers appropriate
and relevant to provide a complete and thorough description of
the study.
V. CERTIFICATION
Certification of authenticity by the Study Director (including signature,
typed name, title, affiliation, address, telephone number and date).
VI. REFERENCES
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VII. APPENDICES
A. Reprints of published and unpublished literature, company reports,
letters, etc., not expected to be in CPP files, but which the
registrant feels will aid the review of the study.
B. Other pertinent information which does not fit in any other
section of this outline.
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