EPA 540/09-88-050
PESTICIDE ASSESSMENT GUIDELINES
SUBDIVISION N
CHEMISTRY:
ENVIRDNMEWTAL FATE
Series 165-1
Confined Accumulation Studies on Rotational Crops
ADDENDUM 7 ON DftTA REPORTING
Prepared by:
E. Brinson Conerly
and
Samuel M. Creeger
Exposure Assessment Branch
Hazard Evaluation Division
Office of Pesticide Programs
Project Manager:
Elizabeth M.K. Leovey, PhD
Hazard Evaluation Division
Office of Pesticide Programs
US Environmental Protection Agency

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Subdivision N -
Confined Accumulation Studies on Rotational Crops
Table of Contents of Addendum
Page
Discussion
Introduction	-	2
Response to Public Comments	2
Guideline
Title/Cover Page	9
Table of Contents	9
I. Abstract	10
II. Introduction	10
III. Materials/Methods	10
IV. Results/Discussion	13
V. Conclusion	13
VI. Certification	13
VII. Tables/F igures	14
VIII. References	14
IX. Appendix(es)	14
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PESTICIDE ASSESSMENT GUIDELINES
ENVIRONMENTAL FATE
Confined Accumulation Studies on Rotational Crops
Subdivision N, Series 165-1
DATA REPORTING
INTRODUCTION
A.	Purpose
The confined accumulation study on rotational crops allows the Agency
to determine the uptake of a pesticide and its degradation products
when the pesticide is applied under use conditions. This confined
rotational crop study is required, in addition to the laboratory
environmental fate studies, in order to establish experimentally the
actual levels of residues to be expected in rotational crcps under
use conditions. These data are used to establish realistic crop rotation
restrictions or determine the need for crop tolerances.
B.	Objective
This Data Reporting Guideline (DRG) is provided to aid the petitioner/
registrant in generating reports which are compatible with the Agency's
review process. Data submitters are encouraged to use it to produce
complete reports for efficient review by the Agency. It pertains to
organizing and presenting the substance of the data report. PR
Notice 86-5, effective on November 1, 1986, available from the Office
of Pesticide Programs, US EPA, pertains to physical formatting of
reports (which are referred to as "studies") and submittal packages.
Sane of its requirements are mandatory.
RESPONSE TO PUBLIC COMMENTS
A common comment was that the Data Submission Guidelines are being used
as a mechanism to impose new data requirements. This document does not impose
new data requirements but mentions the types of information submitted by registrants
in the past with their crop accumulation studies. The purpose of this document
is to recanmend the organizational format of that information. If the registrant
feels some of the information will not aid in the efficient review of the study,
then he may decide not to include it with the study. Conversely, if the registrant
feels the information will aid in the efficient review of the study, then it
would be advantageous to include it with the study based on this reccnimended
format.
After considering all of the comments, it was obvious that many ccnimenters
do not understand how seme information impacts heavily on the efficient review
of a study. Therefore, in addressing the conments, an attempt has been made to
explain how the information does aid in the efficient review of a study and that
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it will be in the registrant's interest to include that material with the study.
The canments are addressed belcw:
1.	Comment:
The term "actual practice" is used throughout the document. It is
unclear what is intended by the use of this term.
Response;
The intended meaning is "usual practice" or "customary practice."
2.	Canment:
The term "significant" is used repeatedly, but not defined. This
addendum should define the level of residue that the Agency considers
significant and necessary for characterization. Hopefully, this
definition will cite a threshold level belcw which total residue is
insignificant as well as a proportion of the total radioactivity an
individual metabolite should represent to require identification.
Response:
Detectable residues should always be reported in these studies. In a
radiotracer study, the Agency would usually consider a metabolite
which comprised as much as 10% of the recovered material "significant."
3.	Garment:
.. .we would argue [that] the purpose [of the study] is "to establish
experimentally the actual levels of residues to be expected in rotational
crops under use conditions." In our view, a confined study is a
pass-fail test. If residues occur, then a field test is required.
Response:
The results from the confined study also provide information on type
and quantity of degradates thereby allowing for a better-designed
field study if one is necessary.
4.	Comment:
Inclusion of chemical structures for chemical and breakdown products
is redundant and unnecessary as they are contained in the main body of
the report. Chemical and/or common names should suffice for an Abstract.
Inclusion of structures should be optional.
Response:
Such information need only be included once in the report. We do strongly
encourage applicants to provide structures where possible.

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5.	Comment:
Name and phone number of contact person should be placed on cover page.
Response;
Note that this information is optional. It may be placed on the cover
page.
6.	Comment:
It is recommended that use of millicuries per millimole (mCi/mmol) and
disintegrations per minute per microgram (dpm/ug) replace curies/mole
and dpm/g [since]...it is more representative of the range of concentration
used in studies...
Response:
Applicants may use these units if they so choose, however, units should
be clearly specified and used consistently throughout the report.
7.	Comment:
...Storage stability data on parent chemical and metabolites are normally
addressed in Residue Chemistry sections. Why are data required to support
radiolabeled studies?
Response:
Decomposition even of radioactive compounds may take place during
storage. These data provide insight into that possibility.
8.	Comment:
The request for method validation recovery and sensitivity data, quality
control procedures and results, would appear to relate to unlabeled
(i.e. "cold") methods of analysis involving GLC or HPLC. If so, it
should be so stated.
Response:
Appropriate method validation data would relate either to "cold" or
"hot" methods. The applicant should provide sufficient information to
demonstrate that whatever analytical results are provided are reliable.
9.	Comment:
...the inclusion of a "material balance" is not clearly understood and
needs further clarification....If included [it] would also be more
appropriately placed in RESULTS/DISCUSSION.

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Response:
Material balance, or "Recovery of Applied Material", allows the
reviewer to assess whether the starting material is properly accounted
for or was mostly lost during the experiment. It may be placed in
RESULTS/DISCUSSION. For further information, Subdivision N of the
Pesticide Assessment Guidelines should be consulted. It is also
available frcm the National Technical Information Service.
10.	Commenti
The statement "if conditions allow the use of radiolabeled material"
contradicts the current...guidelines which state, "This study shall
be conducted using the radioactively labeled analytical grade of the
active ingredient."
Response;
The canmenter is correct.
11.	Camnent:
The request for pan evaporation data for a confined crop rotation
studies [sic] appears totally irrelevant and should be eliminated. It
appears that more is being built into this test than necessary for making
the basic decision...
Response;
If the study is done under confined conditions in the field, such data
is relevant. Under other circumstances, it would not be required.
12.	Garment:
"Figures/photographs of specialized equipment used" is a reasonable
requirement. "Figures/photographs of the equipment used" is an excessive
requirement.
Response:
We agree.
13.	Comment:
Flow diagrams can be adequately placed in Section [TABLES/FIGURES] .
Inclusion [in Analytical Methods] should be optional.
Response:
This material may be placed in the report in the section which is most
advantageous for efficient review.

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14.	Ccmment:
Results of analyses of crop/soil samples would be placed in Results/
Tables/Figures sections.
Response:
We agree.
15.	Ccmment:
The request to place tables and figures [in RESULTS/DISCUSSION] is
confusing. A separate Section...has been set aside for this data.
Clarification is needed.
Response:
Brief tables and figures may be included in RESULTS if desired, longer
ones in the specially designated section.
16.	Comment:
Summaries of structures/chemical names are located in [TABLES/FIGURES] .
To include them in [RESULTS/DISCUSSION] would be redundant.
Response:
Material in the report need not be presented more than once.
17.	Ccmment:
A map of the site, describing the location of the test plot, is
requested... Seme indication as to what kind of map is expected
should be given.. .would a road map with the location circled be
considered sufficient?
Response:
A map with sufficient detail to allow precise location of the test
plot should be provided.
18.	Ccmment:
...the draft refers to "The composition of the formulated product
used..." The regulations and guidelines indicate that pure radiolabeled
material be used (PAIRA), not formulated product.
Response:
We agree.
19.	Ccmment:
...the draft states "Include here results of the analysis of the

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control plots." Control plots are inappropriate for radiolabeled
studies and since radiolabeled materials must be used, this is not
appropriate to include.
Response:
The applicant must, at minimum, demonstrate that the test soil does
not contain radioactivity from some previous source. Further, control
crops, if grown, may be used for field spiking recovery tests.
20.	Comment:
Characterization of Radioactivity: ...Rf (TLC) and Rt (HPLC) values
should be provided for parent chemical and metabolites - but only if
the techniques are utilized in the study.
Response;
We agree.
21.	Canment:
Characterization of Radioactivity: The requirement for metabolites
comprising 10% of the total terminal residue to be identified should
also be accompanied by concentration limits (e.g., 0.100 ppn equivalent
to parent chemical). Often a 10% level of radioactive residue may
equate to a level of mass which is beyond the limits of the analytical
chemist to identify.
Response:
An applicant is not required to identify undetectable levels of residues.
Levels of detectability will vary with each different parent compound.
22.	Comment:
We recommend the statement that, "the registrant should take note
that the crop and soil samples are to be analyzed for the [laboratory
soil metabolism] degradation products...and possibly...products
found...in...hydrolysis studies and photolysis studies" be replaced
with the following: "The registrants should note that crop samples
are to be analyzed for levels of radiolabeled residues. Significant
radiolabeled residues in crops should be characterized further. The
relationship to [sic] the products found in the rotation crop(s) to
the degradation products found from other plant metabolism and environ-
mental fate studies (soil metabolism, hydrolysis and photolysis)
should be presented if such information is known at the time of the
writing of the confined crop rotation report."
Response:
A variation of the suggested text has been incorporated.

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23.	Garment:
...the phrase "and toxicological significance" should be deleted. A
residue study is not designed to address the toxicological questions
nor would the study director of this type of study generally be qualified
to make such an assessment. Further, toxicological significance of
any residue would be largely unknown until all of the required toxico-
logical evaluations have been completed.
Response:
This information is highly useful to environmental fate reviewers and
others. It should be provided if possible.
24.	Comment;
Toxicological significance of the residues is beyond the scope of this
study. Instead, the conclusions section of this study report should
provide a short summary of the significant findings, including the
identification and levels of residues, and a brief comparison of these
findings to those which were found or expected based on previous plant
metabolism studies.
Response:
The applicant should provide the information suggested by the cammenter
above, and whatever toxicology information is available.
25.	torment:
In confined rotational crop studies, the identity of the metabolites
present in the commodity is unknown. Thus it is not possible to
conduct reliable storage stability studies as can be done for residue
studies. A sentence indicating that samples should be kept frozen
until analysis is suggested. It should also be recommended that
efforts should be made to analyze the samples as rapidly as feasible
after harvest.
Response:
Use of standard recovery techniques such as analysis of experimental
samples in parallel with appropriate "field-spiked" samples may be
helpful. Holding samples in the frozen state, and analyzing as soon
as feasible are certainly recommended as good techniques.
26.	Comment:
The implication...is that retention of samples need not be discussed
if the registrant plans no further work. Clarification of this would
be helpful.

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Response:
The statement has been revised.
27.	Canment:
It...seans irrelevant to provide a description of what is done to the
plot after it is harvested.
Response:
The applicant should describe plot (or container) treatment through-
out the experimental period. This includes a period after harvest
of the treated crop.
28.	Garment;
A discussion of utility or adequacy of proposed enforcement methodology
for handling metabolites [should be] addressed...in Residue Chemistry
reports. [It] should be optional in Metabolism studies.
Response:
Accuracy and precision of any analytical method(s) used in the study
should be described in the report. They may incidentally also be
enforcement methods.
29.	Camient:
The need for inclusion of tables and figures [in the APPENDIX] seems
redundant.
Response:
Material need only be included once per report.
GUIDELINE
TITLE/COVER PAGE
Title page and additional documentation requirements (i.e., requirements
for data submission and statement of data confidentiality claims), if
relevant to the study report, must precede the content of the study
formatted below. These requirements are described in PR Notice 86-5.
TABLE OF CONTENTS
This page should indicate the overall organization of the study, including
tables and figures. The Table of Contents must follow the title, data
confidentiality, and GLP (if appropriate) pages.

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I. ABSTRACT
This section should contain the overall summary of the study addressing
the following points:
A.	The chemical (use the name used throughout the report and indicate
the formulation) was applied according to customary practice to the
treatment site. Structures of the chemical and primary breakdown
products may be included here.
B.	The treatment area was maintained according to customary practice.
C.	A table similar to the following with an appropriate title:
Days after 	Residues (ppm)	
Application Total Parent Products
[may need to name
plant tissue	and quantify
products singly]
D.	A discussion of unexpected problems (such as technical difficulties or
unusual weather) which necessitated deviations frcm the intended test
protocol and a description of the effects of these deviations on the
results of the study; and
E.	Provide a name and a phone number of a contact person in the event the
reviewer has technical questions about the study. [This is optional.
Provision of this information will facilitate efficient review in case
of questions.]
II. INTRODUCTION
This section should open with a description of the purpose of the study,
what requirement it is intended to satisfy and (if applicable) how it
supports the position of the registrant. Background and historical
information relative to the study should be placed in this section.
hi. materials/Methods
The applicant may elect to describe materials and methods in separate
sections or combine into a single section. The following format combines
the two into one section.
This section should be in narrative form. All details with regard to the
materials, equipment, experimental design, test plots or containers,
procedures used in conducting the study, and drawings and photographs of
the plot or container, of equipment and of different phases of the study
should be placed in this section. In addition, the following are to be
included, when appropriate:
A. Chemical
Provide the purity of the material, its activity in Curies/mole,

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disintegrations per minute per gram (dpm/g), and the site of radio-
labeling.
B.	Site
1.	If test plots are used:
a.	Provide a map describing location, topography and size, and
location and size of any control plots in relation to the
test plots; and an indication of whether the test plot contains
a subsurface drainage system;
b.	Describe the means by which the test material is confined in
the areas surrounding the test plantings—e.g. aluminum pipe
sunk in the ground;
c.	Provide the soil characteristics (% sand, % silt, % clay,
% organic matter, pH, cation exchange capacity, and moisture
capacity) of the plot;
d.	Provide also a complete record of daily temperature, daily
rainfall and pan evaporation data throughout the study and
how they compare to temperature and rainfall over the past
10 years at the test site based on records from the nearest
weather station; and
e.	Include crop and pesticide use history on the plot for the
three year period preceding the study.
2.	If test containers are used, provide information on the size of
the containers; amount of soil, its type and characteristics as
detailed in "1." above, its pesticide use history if kncwn, and
other distinctive details.
C.	Test Method
1. General
a.	The date and technique of plot or container preparation
prior to pesticide application; and the identity of the
treated crop, if applicable;
b.	A description of how and when the treated crop was planted;
c.	A description of how and when the pesticide was applied;
the ambient conditions at the time of application; the
application rate and the application technique; also, similar
descriptions for each of any additional applications made;
information on how much pesticide was applied in comparison
to actual use rates; and if application technique differed
from label recommendations;
d.
A description of any post-treatment crop maintenance such

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as use of fertilizers and other pesticides, irrigation
(when applied and hew much), tilling, weeding, watering,
etc.;
e.	A description of the crop sampling technique, procedure and
devices used; and the date of harvest of the treated crop;
f.	A description of the soil sampling technique, depth of
sampling, procedure and devices used and the pre- and
post-application soil sampling schedule; the date of harvest
of the treated crop; and the description of what was done to
the plot after harvest of the treated crop before planting
of the rotational crop, during planting of the rotational
crop, and during its growth;
g.	Identity of the rotational crops planted should be placed
in this section. Also, provide a description of the
procedure used in planting the rotational crops; the number
of days between treatment of the initial crop with the
pesticide and planting of the rotational crop; and a
description of all procedures used in the maintenance of
the rotational crcps (as done for the treated crop), sampling
method and how many samples/replicates were taken. All
dates should be provided in terms of "days from pesticide
application."
h.	A description of the source of irrigation water, where
applicable;
i.	A description of the handling of the crop and soil samples
from the time of taking of the samples until analysis with
special attention to the conditions under which they were
stored and the thawing procedure (if frozen); in addition,
the storage stability data to be used in determining if the
pesticide residues are stable under the storage conditions;
and the dates the samples were frozen, thawed and analyzed.
j. Information on how long samples will be retained and under
what conditions they will be retained (in the event additional
analytical work is necessary); and
k. An elaboration on any difficulties or special problems that
arose during the study which necessitated deviation from the
intended test protocol and on the effects the deviations
had on the results.
2. Analytical Method(s)
a. The full description of each method used in this study
should be placed in this section. Note that methods for
degradation products, when appropriate, are included. This
section should also include the method validation data,
recovery and limit of detection data, quality control
procedures and results, sample chromatograms, sample

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calculations and a material balance. The detailed descrip-
tion of the procedures used in preparation and handling of
the sairple throughout the method should also be placed
here.
2.	The identity of the instrumentation, equipment and reagents
used and the operating conditions of the instrumentation;
3.	Figures/photographs of any special equipment used in the
methods; and flow diagrams of particularly complex extraction/
clean-up procedures are to be included here; and
4.	The results of analyses of all crop and soil core samples or
composites.
IV. RESULTS/DISCUSSION
A. This section should contain the scientific results of the study,
for instance;
1.	Narrative and tables describing the steps taken in determining
the pesticide residues in the crop and soil samples should be
presented here in addition to the graphical presentations of the
data (accompanied by the tables of the actual values fran which
the graphs were constructed).
2.	Include here results of the analysis of any control plots. The
registrant should note that the crop and soil samples for both
control and treated plots and/or containers are to be analyzed
for levels of radioactive residues.
3.	Significant residues should be characterized further, with
special attention to known degradates from plant metabolism,
soil metabolism, hydrolysis and photolysis.
B . This section should contain the table of structures and chemical names/
designations for the parent compound and degradation products discussed
in the study.
V. CONCLUSION
This section should contain the discussion of the magnitude and toxicological
significance of the residues of parent and degradates found in the rotational
crcps.
VI. CERTIFICATION
A. Signatures of each of the senior scientific personnel responsible for
the study; and
3. Certification by the applicant that the report is a complete and
unaltered copy of the report provided by the testing facility
(except for title page changes required by PR Notice 86-5).
t

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VII. TABLES/FIGURES
It is recommended that tables and figures be numbered using arabic numerals
for figures and roman numerals for tables.
VIII. REFERENCES
IX. APPENDIX(ES)
At the registrant's option, reprints of methods and other studies, raw
data, copies of relevant letters/memos and material which will help
support the registrant's conclusions, but do not fit in any of the other
sections, should be placed in an appendix.

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50272-101
REPORT DOCUMENTATION »• REPORT no. 2.
PAGE
IS
4. Title and Subtitle
ADDENDUM 7 ON DATA REPORTING TO PESTICIDE ASSESSMENT GUIDELINES
Confined Accumulation Studies on Rotational Crops
3. nepon un*
March 1988
6.
7. Author(s)
E. Brinson Conerly and Samuel M. Creeger
8. Performing Organization Rept. No.
9. Performing Organization Name and Address
U.S. Environmental Protection Agency
0PP/HED (TS-769C)
401 M St. S.W.
Washington, D.C. 20460
10. Project/Task/Work Unit No.
11. Contract(C) or Grant(G) No.
(C)
(G)
12. Sponsoring Organization Name and Address
Same as #9
13. Type of Report & Period Covered
14.
15. Supplementary Notes
ADDENDUM 7 to Pesticide Assessment Guidelines, Subdivision N, Chemistry: Environmental
Fate (EPA-540/9-82-021 and NTIS Order Number PB83-153973), October, 1982
16. Abstract (Limit: 200 words)
The Data Reporting Guideline (DRG) for Confined Accumulation Studies on Rotational
Crops, Series 165-1, gives guidance to pesticide registrants on the format
for their study report so that the Agency can review it efficiently. This
guidance clarifies sections in the existing Pesticides Assessment Guidelines,
Subdivision N, on data reporting. It provides an outline for the study
report and describes the topics which should be addressed such as a description
of the test plots or containers used, soil characteristics, weather, pesticide
use history, post-treatment crop maintenance, sampling or harvesting techniques,
soil sampling, the analytical method, and the handling and analysis of samples
and provides guidance on the presentation of the results of the study. Data
submitters can use the DRG in preparing their reports for submission to EPA
to meet 40 CFR 158 requirements for the registration of pesticides.
,The DRG for Series 165-1, Confined Accumulation Studies on Rotational Crops,
is only one of a number of DRG's published by the National Technical Information
Service as an addendum to Subdivision N of the Pesticide Assessment Guidelines.
17. Document Analysis a. Descriptors
b. identifiers/Open-Ended Terms
c. COSATI Field/Group
18. Availability Statement
Unclassified and freely available
19. Security Class (This Report)
Unclassified
21. No. of Pages
17
20. Security Class (Jhj< Page)
Unclassifiea
22. Price
(See ANSI—Z39.18)	See Instructions on Reverse	OPTIONAL FORM 272 (4—77)
(Formerly NTIS-35)
Department of Commerce

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