PB86-247848
FIELD ACCUMULATION STUDIES ON ROTATIONAL CROPS
U.S. Environmental Protection Agency
Washington, DC
U.S. DEPARTMENT OF COMMERCE
National Technical Information Service
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EPA 540/9-86-149
PB86-247848
PESTICIDE ASSESSMENT GUIDELINES
SUBDIVISION N
ENVIRONMENTAL FATE
Series 165-2
Field Accumulation Studies on Rotational Crops
ADDENDUM 1 ON DATA REPORTING
Prepared by:
Samuel M. Creeger
Exposure Assessment 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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N 0 T I C E
THIS DOCUMENT HAS BEEN REPRODUCED FROM THE
BEST COPY FURNISHED US BY THE SPONSORING
AGENCY. ALTHOUGH IT IS RECOGNIZED THAT CER-
TAIN PORTIONS ARE ILLEGIBLE, IT IS BEING RE-
LEASED IN THE INTEREST OF MAKING AVAILABLE
AS MUCH INFORMATION AS POSSIBLE.
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Subdivision N — Field Acc mtulation Studies on Rotational Crops
Table of Contents of Pd ndurn
Discussion P e
Introduction i
Reslxrnse to Public Ca inents i
Guideline
Title/Cover P e 1
Table of Contents 1
I. Abstract 1
II. Introduction 1
III. Materials 2
IV. Test Method 3
V. Results/Discussion 4
V I. Conclusion 4
VII. Certification 4
VIII. Tables/ ’igures 5
IX. References 5
X. Apper ix(es) 5
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PESTICIDE ASSESSME ’tr GUIDELINES
ENI )N NtkL FATE
Field Acc inulation Studies on Rotational Crops
Subdivision N, Section 165—2
D A REPOR flJ3
IN’rI DD(JCr ION
A. Purpose
Information fraTt this study enables the Agency to determine if rotational
crops will take up pesticide residues under use ndit ions. The infor—
mation is used to establish plantir intervals for rotational cr s and
to determine if rotational crop tolerances st uld be cxnsidered.
B. Objective
This Data Reportir Guideline is designed to aid the petitioner/regis-
trant in generatir reports which are ccnpatible with the Agency’s
review process. hbile folla i’ing this Guideline is not mandatory, data
su itters are encouraged to sutinit ccxnplete reports which can be
efficiently reviewed by the Agency.
RES OI EE TO PUBLIC CQ1MEN S
There were 120 cat nts received frcin 13 ca mentors. The ccmtents re
grcuped into 35 general ca nents.
A caTulent cannon to nest of the canitentors was that the data subniss ion
guidelines are being used as a rrecthanism to impose new data requiremants.
This docurtent does not impose new data requiranents but mentior the types
of information su nitted by registrants in the past with their field accunu-
lation studies on rotational crt s. The purpose of this docunent is to
reca ntend the orqanizational format of that information. If the registrant
feels ne of the information will not aid in the efficient review of their
study, then they may decide not to include it with the study. Conversely, if
the registrant feels the information will aid in the efficient review of
their study, then it uld be to their advantage to include it with their
study based on this recatutended format.
After cor iderin all the cciiu ,ents, it was obvious that many cawientors
do not understand h sate information impacts heavily on the efficient
review of a study. Therefore, in addressir the caments, an attefipt has
been made to explain hcM the information does aid in the efficient review
of a study and that it will be in the registrant’s interest to include that
material with their study.
The caiunents are addressed bela ,.
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1. Garment - It is not important to know when the report was organized into
final form.
Response - The date in question as it will appear on the Title/Cover page
is described in FR 49, 37930.
2. Content - It is sufficient to ask for a single report number or other
specific indicator.
Response - The report identifier as it will appear on the Title/Cover page
is described in FR 49, 37930.
3. Comment - It is inappropriate to include a name and telephone number of
a contact person in the report since these may chanqe after the report
is submitted. In any case, questions frcm the Agency should be channeled
through the registrant's Registration Department or through established
Agency procedures.
Response - As known (and desired) by most pesticide manufacturers, it
is established Agency procedure for the Agency scientific reviewer to
directly call the registrant, without involving the Agency Product
Manager, to discuss technical aspects of the study. Therefore, to make
Agency review of the study proceed efficiently, it is reccntnended that
the name and telephone number of the contact person for that study (be
it the registrant's Product Manager or science personnel) be made
available.
4. Comment - There is no need for a list of figures and tables to appear
in the Table of Contents.
Response - Having this material in the Table of Contents will provide
additional organization for the Agency reviewer and will allow more
efficient review of the study.
5. Comment - The SUMMARY AND INTRODUCTION should be two separate sections.
Also, the word SUMMARY should be changed to the word ABSTRACT.
Response - These changes have been made.
6. Comment - Add "Age of Crop at Time of Sampling" and report residues in
terns of parts per million in the summary table in the ABSTRACT.
Response - These changes have been made.
7. Comment - Reporting "% parent and % products" goes beyond the require-
ments; total residues should be adequate.
Response - We disagree. The Subdivision N Guidelines clearly call for
analysis for residues of parent compound and degradates in the crops.
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8. Ccitr ent — If the I RDDUCTION contains a stat nt that the study is
designed to fulfill the EPA requirenent for crop rotation, then the
registrant will have to change this stat ent before using the same
study to support registration in another country.
Response — This Eata Su niss ion Guideline does not ask the registrant
to provide a statenent that the study is “to fulfill the EPA data re-
Quirement for crop rotation”. are sure the registrant can construct
a sentence that will describe the purpose of the study and what require-
ment it is intended to satisfy that will be useful to both the Agency
and other countries.
9. Car nent — Since “primary crop” is mentioned in the INT WCTION AND
SUMMARY, is bare soil application of the pesticide disallowed?
Response — The study sbould be conducted under actual use conditions.
If the pesticide is to be normally applied to bare soil, then this study
sFould involve a bare soil application. If the pesticide is to be
normally applied to a growing crop at a certain stage of growth, then
this study sbould involve application to a growing crop.
10. Ca rnent — Pesticide applications (for canpounds other than the test
canpound) sbould be described by nane, date applied and rate only.
Response — This clarification has been made.
11. Carrrent — A ten year history of daily rainfall and t nperature and how
it canpares to the daily rainfall and temperatures recorded during the
study is not feasible.
Response — Historical daily rainfall and temperature records fran the
nearest weather station are easily available and will be sufficient.
When this information is sutxnitted, it tells the Agency reviewer that
either typical or atypical weather conditions occurred during the study
and may impact on the study results. T lays may be encountered in the
review of a report lacking this data while the reviewer obtains it fran
other sources.
12. Conrent — It is not necessary to provide crc and pesticide use history
on the test plot for the five year period preceding the study.
Response — This information is not required t it s1x uld it be sutinitted,
it should be included in the materials section discussing the crop. It
is recanrrended that the available crop and pesticide use history be
sutrni tted.
13. Cctrment — The nount and quality of irrigation water is not necessary
and will be difficult to provide.
Response — The anount of irrigation water in terms of “gallons per acre”
or other units is needed so the reviewer can determine if the crop was
grown under typical use conditions. It will be adequate to describe
the quality of the irrigation water by providing a statement such as
“water typically used to irrigate crops at the study site was used”.
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14. Carrnent - Curies per gram is not a realisitic unit.
Resoonse — This has been corrected. Activity is to be expressed as
Curies/rrole and disintegrations per minute per gran (dpn/g).
15. Ccrm ent — The MATERIALS section is too excessive.
Response — Changes have been made based on sugqestions fran other
cannen tors.
16. Ca ent — It is not necessary to knc i weather conditions at time of
application.
Response — As with any field study, it is mandatory to knc i the weather
conditions, particularly at the tine of pesticide application.
17. Cc iitent — A map of the test plots is not necessary.
Response — In the past, req istrants have included maps (typically hand—
drawn) s1- ing the layout, topography and size of the test plot. The
Aqency reviewers have found these maps useful in reviewing the studies.
18. Courent — It is not necessary to include post—treath ent crop maintenance
information, such as use of fertilizers and other pesticides, as part
of this study.
Response — Inclusion of this infozrrtation allc ’is a better understanding
of the study. Since post-treatn nt crop maintenance is a normal part
of a rotational crop study, this cannot be construed to be a new data
re ujrenent and the information should be available.
19. Conrent — Mention of
regard to this field
end use product”.
Response - tinder special conditions, registrants have been able to
justify use of radiolabeled material when conducting a field accun.ilat ion
study in rotational crops (albeit in all, outdoor plots). Since this
approach is beccxning zrore prevalent, it is being discussed in this
document.
20. Corrnent — When radiolabeled material is used, a detailed analysis of
the formulation will not be needed. The results of the analysis of the
formulated product is not necessary.
Response — When radiolabeled material is used, the solvent and any other
adjuvants are to be identified. Therefore, sane analysis of this radio-
labeled for lation will be needed. In most instances, a typical
formulated end use product will be used. The analysis of the formulation
is to include the % by weight of the active ingredient in the formulation
and, for liquid formulations, the weight of active ingredient per unit
of liquid neasure. It is not necessary to ch nically reanalyze the
formulated product.
“rad iolabeled material” creates conf us ion with
study since it is to be conducted with “typical
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21. Carment — Soil characteristics in one—foot increrrents to four feet and
the depth to the water table should not be required especially since
the field study is being nducted in a typical use area. Taking soil
cores to four feet may not be possible due to clay. For non—leachers,
a soil profile to 12 inches should be adequate.
Response — Conducting the study in a sandy soil may result in lower
uptake of residues due to leaching of the pesticide residues below the
root zone. Although a crop may be normally grown in a sandy soil, the
same crop is probably grown in less sandy soils also. Therefore, to
interpret the field rotational crop study, it is important to know the
characteristics of the soil in which the study wes conducted. If the
infoi:mat ion is not provided, then efficient review of the study may be
ca prQnised. If the thforniation is sut nitted, then it should be included
in the study according to this format. It is realized that soil samples
may not be taken to four feet due to a hard clay layer. % agree with
the canrrent regarding limiting soil sampling to 12 inches for non—leathers.
Howe er, the registrant’s designation of their pesticide as a non—leacher
may be in contradiction to the Agency’s assessi ent.
22. Ccitn nt — Soil, climate and rainfall data are irrelevant to a rotational
crop study.
Response — These paraireters have great impact on the results of a field
rotational crop study. The study cannot be evaluated in the abeence of
this information.
23. Q rti nt — Requesting information on the effects of other pesticides on
degradation and uptake of the subject pesticide is similar to asking
for tank mix data which the Agency is not currently requiring.
Response — agree. The request for this information has been deleted.
24. Conrent — Storage stability data for every rotational crop is not neces-
sary; data on only the parent crop should suffice. The paper by Fili
(J. Ag. Food Ch ., 30, (1982), o. 861) relatir hydrolytic stability
to stability in frozen crop samples should be o nsidered. Why does the
Agency have to know lx v long the samples will be kept in frozen storage?
Response — disagree. Consideration of the cited paper by the Residue
Ch nistry Branch indicates that residue stability in basic and acidic
crops was not studied. Therefore, an indication of how long samples
were kept frozen before analysis and how long they will be kept frozen
for further rk rTuist be supported with storage stability data indicating
the pesticide residues will be stable for the desired stor je period.
25. CaiTnent — In a non—radiolabeled field study, it is not practicable to
provide a material balance.
Response — We agree. Mention of the subuiss ion of this information has
been deleted.
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26. Cczment — A description of the thawing procedure and dates of freezing
arEl thawing are new requir t nts.
Response — The ! gency is not asking the registrant to thaw or freeze
anything. Therefore, it is not a new requiren nt! nat the Agency is
asking is should the registrant freeze or thaw sarr les that the proce-
dures and dates of such be provided.
27. Can nt - There is no need to provide soil saT pling techniques.
Response — This information will provide the revie r a better under-
standing of the study and allcM for a more efficient review. If this
information is sukxnitted, it should be done so according to this format.
28. Ca inent — It is not necessary to express residues in terms of dry and
fresh ight. This information can only be provided if the registrant
can rely on tables of water content of crops. This information should
only be provided for those ccziiricxiities sold in both dry and fresh
forms.
Response - Residues in terms of fresh and dry weight are needed only
for those crops that enter caimerce in both dry and fresh forms.
29. Cor ent — Rotational crops should be analyzed only for products of toxi-
cological significance and not all degradation products. The radio-
labeled rotational crop study will identify degr ation products that
occur under field conditions.
Response — We disagree. Products of toxicological significance cannot
be identified until all products (toxic ar i non—toxic) are first identi-
fied. Therefore, the rotational crop study must include an analysis of
all products in the crop. This information is then provided to toxicol-
ogists for an asses nent of the toxicity of those products. If the
radiolabeled rotational crop study is conducted under conditions si.mula—
ting field conditions then the rotational crop will take up any ca tpounds
it uld normally take up under field conditions.
30. COitu nt — The Agency se ns to be requiring a radiolabeled field rotational
crop study.
Response — The Agency is not requiring such a study but recognizes there
are cases when a registrant can do a radiolabeled rotational crop field
study that uld satisfy the require ent to do both (1) the radiolabeled
confined [ 165—U and (2) the field [ 165—2] rotational crop studies. If
a raijolabeled rotational crop field stt y results in no detectable
uptake of residues by rotational crops, then it may satisfy the require-
ments for both 165—1 and 165—2. However, if the radiolabeled rotational
crop field study does sh i uptake of residues by rotational crops, then
165—2 will be needed but the only ccxripounds that will have to be analyzed
for in 165—2 will be those detected in the radiolabeled rotational crop
field study.
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31. Carrnent — There is no need to provide a degradation scheme of the rota—
tiona]. crc residues.
Response — Registrants often submit diagr ns shc ir g to what products
their pesticide degrades. The revie r finds these helpful in evalua—
tiri the study. More canplicated diagra is (st h as those sh ing
involv nent of plant enzymes or biochemical cycles) will not provide
useful information.
32. nrnent - A canpiete quality assurance package should not be required
for this study.
Response — We agree. This section reiterates the Guidelines.
33. Cam ent — Pdopt the American Che nica1 Society method of arabic n m ra1s
for figures ard ronan numerals for tables.
Response — This is a good s .z gest ion. Registrants are encouraged to
adopt any acceptable method but use it consistently since reviewers
becate confused when they review submissions containir different
methods.
34. Cati rent — What is meant by “ ‘relevant’ material should be placed in the
appendices” ?
Response — Relevant material is any material cited by the registrant
that the registrant feels will aid in the review of the study but is
not part of the study proper.
35. Cc ment — There is no need to resubmit studies cited in the appendix
if those studies re previously submitted. Raw data, which is often
voluminous, should not be necessary to submit. Standard analytical
methods should be referenced and not described in detail. Only departures
fran stardard methods should be discussed in detail.
Response - Although it is not necessary to resubmit those studies and
material, it will be to the registrant’s advantage to have a hard copy
of that referenced/cited material in the sul:xniss ion under review in the
event the revie r needs to refer to it. If the registrant elects to
submit such hard copy, then it should be placed in the appendix.
ss S
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GUI DELINE
TITLE/CWER P? GE
Title page and ditional doQmuentation requir nents (i.e., requirenents
for data sul:rrtission and pr edures for claims of confidentiality of data)
if relevant to the study report should precede the content of the study
formatted below. These currently proposed requirements are described in
49 FR (188) 37596 (9/26/85).
TABLE OF C NTEN S
This page should indicate the overall organization of the study and
what material is on which page(s). Tables and figures should be
included in the Table of Contents on an individual basis.
I • ABSTRACT
This section should also contain an overall simnary of the study and
mantion, at least, the following points:
A. The di nical (use the name used throughout the report and indicate
the formulation) was applied according to actual practice to the
primary (treated) crop;
B • The primary crop and rotational crops were maintained according to
actual practice;
C. Provide narrative or a table (with an appropriate title) that pro-
vides the following information:
%ys between
treatment of
and planting C -cp at
Crop! of rotational Time of Rate Residues (pç n)
Crop part crop San ling lb ai/A Total Parent Products
D. Indicate unusual prthlems (suth as technical difficulties or unusual
weather) resulting in necessary deviations fran the intended test
protocol. E scribe the effects of these deviations on the results
of the study; and
E. Provide a n and a phone rn.m ber of a contact person in the event
the reviewer has technical questions about the study. (This is
optional. bwever, provision of this information will facilitate
efficient review in case of questions.)
II. tNT D XTION
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
infor’nation relative to the study should be placed in this section.
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III. I’ERThLS
This section and the methods section should be in narrative form and
in the following order and should contain all details with regard to
the materials, equipt nt, experimental design, field plots and pro-
cedures used in conducting the study. The registrant is encouraged
to include drawings and photcçraphs of the plot, equi nt and of
different phases of the study.
In this section, the follc iing should be included:
A. Chenical
1. If radiolabeled material is used, provide the p.irity of the
material, its activity in Curies/nole and disintegrations per
minute per gra n (dpn/g) and the site of radiolabeling; and
2. The caTipc ition of the product to be used in determining if it
contains the claimed anount of active ingredient. Include the
% (by ight) of the active ingredient and for liquid formula—
tior , the weight of active ingredient per unit of liquid
maasure.
B. Site
1. A map of the test plots indicating their location, topography
and size, and location arid size of the control plots in relation
to the test plots; an indication of whether the test plot
contains a subsurface drainage syst n; the soil characteristics
(% sand, % silt, % clay, % oz anic matter, pH, cation exchange
capacity, noisture capacity) of the plot in one foot incr nts
to a depth of four feet; the depth to the water table; arid
2. A ccxnplete record of daily temperature arid daily rainfall
throughout the study arid how they canpare to temperature and
rainfall over the past 10 years at the test site.
C. Crop
1. Crop and pesticide use history on the plot for the 5 year period
preceding this study;
2. The date arid technique of plot preparation prior to pesticide
application;
3. The identity of the treated crop; a description of how arid
when the treated crop s planted; how and when the subject
pesticide was applied; the weather (tei perature, rainfall,
windspeed and direction) arid condition of the field at time of
application; the formulation of the pesticide applied, adjuvants
or other ccxnpounds added to the spray/application mixture; the
application rate and the application technique. Also, provide
a similar description for each of any additional applications
made of the subject pesticide. Indicate how much pesticide
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was applied in tt arison to actual use rates and if application
technique differed fran label recc.i iendations.
4. A description of any opst—trea nent crop maintenance such as
use of fertilizers and other pesticides’, irrigation (when
applied and how much), tilling, weeding, etc.; and
5. A description of the source of irrigation water.
IV. TEST METhOf)
A. General
1. A description of the soil s npling technique, depth of sampling,
procedure and devices used and provide the pre- and pc t-
application soil sampling schedule; provide the date of harvest
of the treated crop and describe what is done to the plot after
harvest in preparation for planting of the rotational crops;
2. The identity of the rotational crops planted in the study; a
description of the procedure used in planting the rotational
crops and the number of days between when the crops were planted
in relation to when the plot was treated with the pesticide;
a description of all procedures used in the maintenance of the
rotational crops (as done for the treated crop), the sanpling/
harvest met od and how many samples/replicates were taken;
All dates should be provided in terms of “days fran pesticide
application.
3. A description of the handling of the samples fran the tine of
taking of the samples until analysis with special attention to
the conditions under which the sampled rotational crops were
stored and the thawing procedure (if frozen); in addition,
stor e stability data to be used in determining if the pesticide
residues are stable under the storage conditions; also, the
dates the samples were frozen, thawed and analyzed;
4. If pesticide residues in the crop are stable when frozen, then
indicate how long samples will be retained in the event additional
analytical ork is needed; and
5. Elaborate on the difficulties or special probl ns that arcee
during the study that necessitated deviation fran the intended
test protocol and on the effects the deviations had on the
results.
B. Analytical Method
1. Each metbod used in this study is to be described fully and
include mett d validation data, recovery and met)od sensitivity
data, sample chranatcçrams and sample calculations. Preparation
and handling of the sample throughout the met!ul s ould be
described in detail. Note that metbods for degradation products
may also be needed.
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2. Identify the instrumentation, equi nt and reagents used and
the operating conditions of the instr inentation. If the
extractioWclean—up procedure is ccmplex, then a fl i diar i
of it should be sutznitted.
3. Identify the plant fractions analyzed in the study, stxh as
grain, chaff and straw in the case of nall grains and root
and aerial (leafy) portions in the case of root crops.
V. RE JLTS/DISQJSSION
A. This section should contain the scientific results of the study.
narrative and tables describing the steps taken in determining the
pesticide residues in the soil and crop sanples should be presented.
All graphical presentations of the data should be acccznpanied with
tables of the actual values frcm which the graph was constructed.
Include results of the analysis of the control plots.
B. This section should contain a table of structures and ch nical
nai es/desiqnations for the parent ccinpound and degr 1ation products
discussed in the study.
C. The registrant should be s e that the rotational crops are analyzed
for the degradation products found in the radiolabeled rotational
crop study. It may be necessary to also analyze the rotational
crops for other degradation products found and identified in the
hydrolysis, photolysis and aerobic soil metaboli n studies if the
radiolabeled rotational crop study was not conducted under conditions
simulating field conditions.
0. I sidues found in the rotational crops are to be reported in terms of
crop fresh ight and in terms of crop dry ight (if the crop enters
cani rce in dry form).
E. If the parent oesticide or its degradation products are metabolized
by the rotational crop, then the identity of those products is to be
provided.
VI. (t)NCUSION
Provide discussion as to the significance of the residues (if any)
taken up, at what intervals residues are taken up by rotational crops
(in which crop fractions and at what levels) and at what interval no
residues can be expected to be taken up by rotational crops.
VII. ( RTIFICATION
A. Signatures of each of the senior scientific personnel responsible
for the study; and
B. Certification by the applicant that the report is a ca lete and
unaltered copy of the report provided by the testing facility.
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VIII. TABLES/FIGURES
It is re xt nded that tables and figures be nt nbered usir arabic
nuri rals for figures and ranan n rals for tables.
I x. R FERE tES
X. APPENDIX(ES)
Reprints of
(raw data),
not fittir
case should
met1 ds and other studies cited, actual results of analyses
copies of relevant letters and mencs and other material
in any of the other sections and that support the petitioner’s
be placed here.
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