HAZARD EVALUATION DIVISION
STANDARD EVALUATION PROCEDURE
SPECIALTY APPLICATIONS
(I) CLASSIFICATION OF SEED TREATMENTS AND TREATMENT OF CROPS
GROWN FOR SEED USE ONLY AS NONFOOD OR FOOD USES
(II) MAGNITUDE OF THE RESIDUE: POSTHARVEST FUMIGATION OF CROPS
AND PROCESSED FOODS AND FEEDS
(III) MAGNITUDE OF THE RESIDUE: POSTHARVEST TREATMENT
(EXCEPT FUMIGATION) OF CROPS AND PROCESSED FOODS AND FEEDS
Prepared by
Michele Leparulo Loftus, Ph.D.
and
Michael S. Metzger
Standard Evaluation Procedures Project Manager
Orville E. Paynter
Hazard Evaluation Division
Office of Pesticide Programs
United States Environmental Protection Agency
Office of Pesticide Programs
Washington, DC 20460
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This Standard Evaluation Procedure (SE?) describes the procedures used by
EPA to evaluate residue studies on seed treatments, crops grown for seed,
post—harvest fumigation, and other post—harvest treatments. First, the
classification of seed treatments and treatments of crops grown for seed
as non—food or food use is examined. Requirements for a treatment to be
classified as a non—food use are described and include the availability of
a radiotracer study showing no uptake of radioactivity to aerial portions
or edible root portion o the growing crop, the seed itself not being a
raw agricultural commodity, no likelihood that there will be residues in
crops grown from, treated seeds, and subsequent to treatment, tall parts of
the crop must be unfit for human or livestock consumption. Second, post—
harvest fumjgation bf crops and processed foods and feeds is ekamined in
detail. A description of important parameters which should b considered
in evaluation of these studies is provided, as well as an Ap endix which
lists these considerations and others. Finally, post—harvest treatment
(except fumigation) of crops and processed foods and feeds is discussed.
Maj or treatments discussed include these made by dips, drenches,
i echanical foa.mers, spray and brush applications and -washes.
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STANDARD EVALUATION PROCEDURE
PREAMBLE
This Standard Evaluation Procedure (SEP) is one of a set
of guidance documents which explain the procedures used to
evaluate environmental and human health effects data submitted
to the Office of Pesticide Programs. The SEPs are designed
to ensure comprehensive and consistent treatment of major
scientific topics in these reviews and to provide interpretive
policy guidance where appropriate. The Standard Evaluation
Procedures will be used in conjunction with the appropriate
Pesticide Assessment Guidelines and other Agency Guidelines.
While the documents were developed to explain specifically
the principles of scientific evaluation within the Office of
Pesticide Programs, they may also be used by other offices in
the Agency in the evaluation of studies and scientific data.
The standard Evaluation Procedures will also serve as valuable
internal reference documents and will inform the public and
regulated community of important considerations in the
evaluation of test data for determining chemical hazards. I
believe the SEPs will improve both the quality of science
within EPA and, in conjunction with the Pesticide Assessment
Guidelines, will lead to more effective use of both public
and private resources.
Anne L. Barton, Acting Director
Hazard Evaluation Division
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TABLE OF CONTENTS
Page
(I) CLASSIFICATION OF SEED TREATMENTS AND TREATMENT
OF CROPS GROWN FOR SEED USE ONLY AS NONF000 OR
FOOD USES
I. INTRODUCTION
Purpose . . . . . . , . . . . . . 1
II. SEED TRE ATMENTS . 1
III. TREATMENT OF CROPS GROWN FOR SEED ONLY 1
IV. REVIEWER AID MATERIALS . . . . 3
(II) MAGNITUDE OF THE RESIDUE: POSTHARVEST FUMIGATION
OF CROPS AND PROCESSED FOODS AND FEEDS
I • INTRODUCTION
A. Purpose of the Standard Evaluation
Procedure 4
B. Objective of the Postharvest Fumigation
Trial. . . 4
II. INFORMATION TO BE SUPPLIED 4
III. THE DATA EVALUATION PROCESS
A. Prepare a Summary . . . . . . . • . 5
B. Identify Data Gaps 5
C. Assess the Appropriateness and Adequacy
o f the Da t a . • . • . . • 5
D. Determine the Need for Consultations with
Other HED Branches 6
E. Conclude if the Requested Action is
Sup p or table . • . • • . • • . . . 6
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TABLE OF CONTENTS (Cont’d)
Page
IV. APPENDICES
Appendix 1: Major Points to Consider in
Evaluating Residue Data from PostharvesL
Fumigation of Crops and Processed Foods
and Feeds . . . . . . . . . 8
ppendix 2: Reviewer Aid Materials . 14
(III) MAGNITUDE OF THE RESIDUE: POSTHARVEST TREATMENT
(EXCEPT F’UMIGATION) OF CROPS AND PROCESSED FOODS
AND FEEDS
I. INTRODUCTION 15
A. Purpose and Scope of the Standard
Evaluation Procedure . . . . . 15
B. Background 15
C. Objective of Trials for Postharvest
T r e a t men t s . . . . . . . . . 1 6
II. INFORMATION TO BE SUPPLIED 16
III. THE DATA EVALUATION PROCESS 17
A. Prepare a Summary . . . . . . . . . . . . . . . 17
B. Identify Data Gaps . . . . . . . 17
C. Assess the Appropriateness and Adequacy
of the Data . . . . . . . . . . 17
D. Determine the Need for Consultations with
Other HED Branches . . 18
E. Conclude if the Requested Action is
Supportable . . . . . . . . . . . . . . . . . . 18
IV. APPENDICES
Appendix 1: Major Points to Consider in
Evaluating Residue Data from Postharvest
Fumigation of Crops and Processed Foods
and Feeds . . . . . . . . . • • • • 19
Appendix 2: Reviewer Aid Materials . . . . . . . . 24
‘1
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HAZARD EVALUATION DIVISION
STANDARD EVALUATION PROCEDURE
SPECIALTY APPLICATIONS
(I) CLASSIFICATION OF SEED TREATMENTS AND TREATMENT OF CROPS
GROWN FOR SEED USE ONLY AS NONFOOD OR FOOD USES
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SPECIALTY APPLICATIONS
(I) CLASSIFICATION OF SEED TREATMENTS AND TREATMENT OF CROPS
GROWN FOR SEED USE ONLY AS NONFOOD OR FOOD USES
I • INTRODUCTION
Purpose
This Standard Evaluation Procedure is designed to aid
Residue Chemistry Branch (RCB) reviewers in evaluating whether
seed treatments and treatment of crops grown for seed use only
should be categorized as nonfood or food uses.
II. SEED TREATMENTS
This use includes cases where seed is treated either by the
seed company (and dyed according to the Seed Act) or by the
farmer (planting box or hopper treatments)
For a seed treatment to be considered a nonfood use, the
following is required:
o Data from a radiotracer study demonstrating no uptake cf
activity to the aerial portion and edible (for both
human and livestock consumption) root portion of zhe
growing crop.
If activity from a radiotracer study occurs ir. the aerial and
edible root portions of the crop or if no study is available,
seed treatments are considered to be food uses, requirir.g
tolerances and appropriate residue data in support of the
tolerances. In most cases where a tolerance is required, the
tolerance normally would be set at the limit of detection of the
analytical method.
III. TREATMENT OF CROPS GROWN FOR SEED ONLY
Three requirements must be met in order for uses on crops
grown for seed only to be considered nonfood uses. They are
listed below.
o The seed itself is not a raw agricultural commodity
(RAC)
Examples of crops where the seed itself is an RAC are
corn, sorghum, soybeans, small grains, and sunflowers.
For these crops, seeds from treated crops could not he
distinguished from those from untreated crops and coulo
be diverted to human and animal consumption. Thus,
cases where the seed itself is an RAC are considered to
be food uses. To determine whether the seed lt5elf is an
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RAC, the reviewer should consult Table II in the Residue
Chemistry Guidelines.
o There is no liI elihood of residues in crops growr. from
harvested seed.
Factors affecting this requirement include the systemicity
and the persistence of the pesticide, the expected level
of residues in/on the harvested seed, and the weight of
the seed in relation to that of the second generation
crop.
o Subsequent to treatment, all parts of the crop are not
fit for human consumption nor fed to livestock.
The requirement that the crop is not fed to livestock
can be met when no parts of this crop are livestock feed
items or palatable to livestock subsequent to treatment,
Or if a reasonable restriction can be imposed against
feeding the treated crop to livestock.
Examples of uses where the crop is not fit for human
consumption following treatment nor fed to livestock are
desiccant use on okra and postbloom applications to
leafy vegetables and Brassica (cole) leafy vegetables.
Since okra, following desiccation, and leafy and
Brassica (cole) leafy vegetables, following the bloom
stage of development, are not fit for human consumption
and since these crops are not livestock feed items,
desiccant use on okra and postbloocn applications to
leafy and Brassica (cole) leafy vegetables would be
considered nonfood uses, provide there is no likelihood
of residues in/on the harvested seed. A similar example
is use on table beet and carrot stecklings grown for
seed. Stecklings are plants of biennial root crops
which are dug and stored over winter and then replanted
the next season for seed production. A second season
use on table beet and Carrot stecklings grown for seed
production would be considered a nonfood use because
beets and carrots are not livestock feed items and
because 2 to 3 weeks after replanting the stecklir.gs a
flower stalk is produced, at which time the root becomes
fibrous and undesirable for human consumption.
Generally, alfalfa and clover grown for seed Cannot be
considered nonfood uses because of the economic
importance of alfalfa and clover hay. Subsequent
cuttings for hay would be taken regardless of label
restrictions. In addition, use on alfalfa grown for
seed only cannot be considered a nonfood use because of
the increasing importance of alfalfa sprouts as a human
food item. However, desiccant use on clover grown for
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seed can be a nonfood use because desiccation renders
the hay unfit for consurnptio.i oy livestock.
The above three requirements must be met .n order for
treatment of crops grown for seed only to be considered a nonfood
use. When the above three requirements are not met, the use is
consLdered to be a food use, requiring tolerances and the appro-
priate residue data in support of the tolerances. However, for
the purposes of a special local need [ 24(c ) ] registration, excep-
tions may be made on a case—by-case basis if only the third
requlreTner.t is not strictly met. Compelling reasons must be
provided by the registrant to consider the treatment a nonfood
use. Often the unique culture for the production of a seed crop,
as compared to the culture for the production of a food or feed
crop, results in a crop which is inedible, matures at a different
time than the normal food or feed crop, and/or is not commercially
viable as a food or feed crop. The 24(c) applications for these
uses should include the rationale as to why the proposed treatment
would be a nonfood use, as well as practical assurances by State
officials that the crop would not be diverted to food or feed.
Exceptions will not he made if the first two requirements are not
met; i.e., exceptions will not be made if the seed in question is
an RAC and if there is a likelihood of residues in crops grown
from harvested seed. Generally, exceptions will also not be made
for alfalfa and clover because of the economic importance of
alfalfa and clover hay.
IV. REVIEWER AID MATERIALS
In addition to the RCB file for nonfood uses, the reviewer
should consult Appendix 2 in the Standard Evaluation Procedure
for Magnitude of the Residue: Crop Field Trials.
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HAZARD EVALUATION DIVISION
STANDARD EVALUATION PROCEDURE
SPECIALTY APPLICATIONS
(II) £ AGNtTUDE OF TUE RESIDUE: POSTHARVEST FUMIGATION OF CROPS
AND PROCESSED FOODS AND FEEDS
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SPECIALTY APPLICATIONS
(II) MAGNITUDE OF THE RESIDUE: POSTHARVEST FUMIGATION OF’
CROPS AND PROCESSED FOOD AND FEEDS
I. INTRODUCTION
A. Purpose of the Standard Evaluation Procedure
This Standard Evaluation Procedure is designed to aid
RCB reviewers in their evaluations of postharvest fumigation
trial studies submitted by petitioners/registrants. It is meant
to be used as a supplement to the Standard Evaluation Procedure
for Magnitude of the Residue: Crop Field Trials (published in
FY ‘85).
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. In the case
of postharvest fumigation, both RACs and processed foods and
feeds may be treated.
This particular Standard Evaluation Procedure addresses
the magnitude of the first—generation residue in crop RACs and
processed food and feed commodities resulting from postharvest
fumigation of these commodities.
B. Objective of the Postharvest Fumigation Trial
Postharvest fumigation trial studies should answer the
followin 1 question: What is the maximum level of “total toxic
residue” ‘ that will likely result in or on the RAC or in or on
the processed food or feed commodity as a result of the postharvest
fumigation of these commodities with the pesticide formulated
product according to the proposed label directions for use?
II. INFORMATION TOBE SUPPLIED
The petitioner/registrant’s report on postharvest fumigation
trials or. RACs or processed food or teed commodities should include
all information necessary to provide a complete and accurate
description of the commodities (including bulk storage, container
information) and fumigation trial treatments and procedures; rate
of application; fumigation chamber (including construction materials,
geometry, and aLr tightness); temperature; pressure; exposure time;
1/The term “total toxic residue” is used to describe the sum of
the parent pesticide 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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aeration; sampling, handling, shipping, ano storage bf the RC;
storage stability validation of the test chemical (and
inetabolite(s) of special concer ); residue analyses of samples
for the “total toxic residue” (and for individual compone’ts of
special concern); validation (recovery studies) of the resicue
analytical methodology; reporting of the data and statistical
analyses; and quality control measures/precautions taken to
ensure the fidelity of these operations.
A Guideline of specific information that should e
included in the petitioner/registrant’s report of postharvest
fumigation trials is provided in the RCB Data Submission
Guideline on the Magr.itude of the Residue: Postharvest.
Fumigation Trials of Crops and Processed Foods and Feeds_”
that complements this Standard Evaluation Procedure. Related
information on Analytical Method(s) and Storage Stability are
found in the Standard Evaluation P ?cedures and Data Submission
Guidelines on those subject areas.
III. THE DATA EVALUATION PROCESS
A. Prepare A Summary
The initial step in the evaluation process of
postharvest fumigation trials on an RAC is for the reviewer to
carefully examine and summarize the information/data supplied by
the petitioner/registrant in his submission to the gency. ny
statistical treatments of the data should be independently
verified and the quality control precautions noted.
B. Identify Data Gaps
Using the Data Submission Guideline on Magnitude of the
Residue: Postharvest Fumigation Trials as a guide (in conjunction
with the related Guidelir.es on Analytical Method(s) and Storage
Stability), the reviewer should then look for data gaps — omissions
in the information supplied by the petitioner/registrant in his
report. A judgment should be made as to which are considered
significant enough to adversely affect the review process. Those
data gaps significant enough to adversely affect the review process
should be duly noted in the reviewer’s report. Those so identified
should be communicated back to the petitioner/registrant by the
Product Manager for corrective action.
C. Assess the Appropriateness and Adequacy of the Data
The data reviewer then considers the appropriateness
(vis—a—vis the intended use) and adequacy of the data/information
2/To be developed.
3/Concurrently in preparation.
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that has been supplied. The aforereferenced Data Submission
Guidelines are a useful guide to the various parameters that need
to be considered. Appendix 1 of this document discusses specific
aspects of those parameters that warrant consideration.
As an adjunct to these, the reviewer should draw upon
the technical guidance in the reviewer aids materials that are
available to him, such as the Residue Chemistry Guidelines
(Subdivision 0 of the Pesticide Assessment Guidelines). A listing
of some suggested source materials is located in Appendix 2 to
this document.
Any perceived deficiencies in the data/information
supplied should be identitied and explained, with a statement as
to what steps should be taken to resolve the deficiencies, so
that this information can be relayed back to the petitioner!
registrant by the Product Manager for appropriate action.
Note : Other aspects of the Magnitude of the Residue,
such as processed food/feed and meat/milk/poultry/eggs
considerations are to be addres çd in separate Standard
Evaluation Procedure documents.’ Those considerations are
applicable whenever an RAC (or parts thereof) or processed
commodity may be utilized as an item of livestock or poultry
feed, or whenever an RAC may be processed into feed items or
human foods.
D. Determine the Need for Consultations with Other BED
Branches
In considering the appropriateness and adequacy of the
data/information that has been supplied, the data reviewer must
also determine if consultations with other BED Branches are
needed to reach that decision.
If so, the specific nature of the issue(s) in question
should be clearly and succinctly stated and directed to the
specific Branches whose input is sought.
E. Conclude if the Requested Action is Supportable
As the last step in the data evaluation process, the
data reviewer makes a judgment as to whether the submitted data!
information support the requested action (tolerance/registration)
of the data submitter.
If the data are not supportive, possible alternative
action(s) that may be taken by the petitioner/registrant are
suggested.
4/Concurrently in preparation.
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If deficiencies/omissions exist in the submitted data
base, the reviewer may have to defer judgment ur ti1 such time as
appropriate corrective action has been taken by the petitioner!
reg istrant.
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APPENDIX I
MAJOR POINTS TO CONSIDER IN EVALUATING R SIDUC DATA FROM
POSTHARVEST FUMIGATION OF CROPS AND PROCESSED FOODS AND FEEDS
A. The Cornmooit
- Has the commodity been adequately identified in all the
postharvest. fumigation trials?
— Is the commodity an RAC or a processed food or feed?
- For RACs, are an adequate number of types and varieties
represented and are the commercially important varieties
represented?
— For RACs, is it clear what specific plant part(s) were
harvested and then fumigated?
— Is it clear what specific processed commodity was treated
(e.g., hulls, meal, or flour)?
— Has the general condition (e.g., green/ripe, fresh/dry,
etc.) of the commodity at time of fumigation been specified?
— Are there livestock or poultry feed items associated with
the RAC or processed commodity? If so, are animal
metabolism and feeding studies available? (Note: these
concerns will be addressed in separate Standard Evaluation
Procedures, concurrently in preparation.)
— Is the RAC normally processed into feed or food items? If
so, have processing studies been conducted? (Ref. Footnote
1, page 4, this document.)
— Is supplementary information available for the pesticide in
other reports by the petitioner/registrant on this
commodity or related commodities that can be translated to
support the data base, if needed?
— Are data for the pesticide under similar use conditions
available on the representative RACs of the crop group to
which this RAC belongs and, if so, should a crop group
action be considered?
— Have there been experimental use permits/temporary tolerances,
section 18 exemptions, or section 24(c) registrations for
the commodity treated with this pesticide? Permanent
tolerance petition requests?
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- Are there Codex/FAO Monograph data available for this
commodity or related commodities treated with this
pesticide?
— Are there International Residue Limits (IRLs) established
for use of this pesticide on this commodity and, if so,
upon what use(s) were they established and what components
of the residue are regulated? What would be required tor
harmonization with any such IRLs?
— Is there any other unpublished or published information
known to us about this pesticide and commodity use that
must be taken into consideration?
— Are all the important dates relative to the treating and
sampling of the commodity reported?
B. The Pesticide
Refer to Appendix I, section (AH2) in the Standard
Evaluation Procedure for Magnitude of the Residue: Crop Field
Trials (published in Fl ‘85).
C. The Fumigation Chamber, Application of the Pesticide,
Aeration of the Commodity
— Do the fumigation trials reflect the intended use (proposed
labeling) of the fumigant on the RAC or processed commodity?
— What type of fumigation chamber (e.g., grain elevator and
flat storage, tarpaulin covering, shiphold, fumigation
vault, vacuum chamber) was used for the trial?
— Are the size and geometry of the fumigation chamber reported?
— Were fumigation trials carried out in the fumigation
chamber(s) listed on the proposed label?
— What is the overall airtightness of the fumigation chamber?
This question is important because leakage reduces the
concentration of pesticide released in the fumigation
chamber.
— What materials (e.g., frame, metal, cement block, concrete,
asphalt, plastic tarpaulins) were the fumigation chambers
constructed of and were they porous or absorbent? Metal,
asphalt, and concrete surfaces are less porous than wood
and cement blocks. For instance, the porous nature of
cement blocks allows leakage.
— Were chamber surfaces covered with a material which reduces
leakage (e.g., covering the chamber surfaces with asphalt
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paper or plastic tarpaulins [ often not practical on large
operations] or pair.t)?
— What measures were taken to seal t e fumigation chamber?
Were all vents, chimneys 1 etc. closed or sealed with
polyethylene bags? Were doors, wLndows, cracks, etc.
sealed with masking tape?
— What were the wind conditions outside tne fumigation
chamber? Were there any drafts inside the chanber? Drafts
can cause escape of the fumigant from the chamber.
— Was there a large temperature differential between the
space inside the chamber and the enviror.ment outside the
chamber, aiding escape of the fumigant?
— What was the relative size of the fumigation chanber as
compared to the commodity load? The smaller the relative
size of the commodity load, the higher the expected
residues because less material is available to absorb the
fumigant.
— How were the commodities arranged during the fumigation?
What size were the stacks of commodities? Can the fumigant
penetrate to the middle of the stack of a given commodity?
— What kind of material were the containers holding the
commodities made of? Were the containers permeable (e.g.,
untreated kratt paper, burlap, containers of slatted wood)?
If not, were the packages or containers opened? Examples
of relatively nonpermeable containers are cellophane,
plastic, waxed, laminated, polyethylene, waterproof paper,
and tight wooden packing cases. Nor.perrneable containers
hinder both absorption of the chemical during the
fumigation period and desorption of the chemical durir.j the
aeration period. What is the affinity of the container
material for the fumigant? During aeration, the container
can provide a secondary fumigation for the commodity if the
container material, has a high affinity for the fumigant.
— Was the commodity raised on pallets for fumigant circulation
underneath the load? Was the air space above the load
unobstructed for proper circulation?
— What kind of fumigant dispensing system was used and where
were the discharge points? How was the fumigant volatilized?
Were vaporizers used to hasten vaporization?
— What measures were taken to maximize gas circulation?
Where were fumigant dispensers and circulating fans/blowers
positioned?
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— Was the application equipment and procedure similar to that
used in commercial practice?
— Are dose rates reported in a manner (e.g., lb ai/l000 ft 3 )
that is consistent with normal practice and with the
directions on the proposed labeling?
— Were temperature and pressure reported?
— Are the dates, number and timing of the application(s)
given?
— What was the aeration time prior to sampling? For the
purpose of worker safety, at the completion of the
fumigation period, the fumigant will be evacuated from the
sheltered area. Often, additional aeration is needed to
prever.t damage to the fumigated commodity or excessive
chemical residues.
— Is the minimum aeration time specified on the proposed label
and is it a practical one?
— How was the aeration carried out (removal of seals and
covers, opening doors and windows, use of exhaust fans, use
of air suction systems)? Was additional aeration performed
outside the confines ot the fumigation chamber? Was the
aeration procedure similar to that on the proposed label
and similar to that used in commercial practice?
— Are exaggerated rate data available?
— Are residue decline data (residue . versus aeration time)
available, includln9 that past the proposed minimum
aeration time specified on the label?
— Are data available on the aeration time necessary for
residues to fall below tolerance? Below detectable levels?
— Are data available reflecting the maximum proposed use
conditions (e.g., maximum dose rate(s), maximum exposure
time, maximum temperature, airtight fumigation chambers,
minimum aeration time, maximum number of treatments with
the pesticide, minimum intervals between treatments)? If
not, are the available data sufficient to allow for
extrapolation?
— Are label restrictions needed?
— Were there a sufficient number of trials conducted on the
commodities to support the requested action of the data
submitter?
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(Note: This is a judgment call ar.d is influenced by the
importance of the RAC or processed commodity, the range of
conditions under which it is fumigated, the number of types
of fumigation chambers listed on the proposed label, how
closely the trials corresponded with the intended use
pattern(s), whether exaggerated rate and residue decline
data are available, whether a minor ctop or minor use is
involved, the data and established tolerances already
available on related commodities treated with the pesticide
under similar conditions of use, the nature of the
requested action of the data submitter, and the general
concern over the toxicity of the pesticide.)
0. Sampling, Conditions of Handling Between Storage and Analysis
— How soon after the fumigation period were samples taken?
The time between the fumigation period and sampling is
usually the aeration time, unless measures were taken to
prevent desorption prior to the sampling of commodities.
— Is the sampling procedure described — i.e., the point of
sampling, size (weight) of samples, and handling of
samples?
— Where was the commodity sampled (e.g., top, bottom, or
side; outer layer, center of stack; side or middle of
chamber)?
- Given the treatment and aeration procedure, the description
of the fumigation chamber, and properties of the fumigant,
would residues be expected to be relatively low or high at
a particular sampling point? For example, higher residues
would be expected at lower sampling positions when the
fumigant is more dense than air.
- How were samples stored prior to shipping, during shipping,
and between shipping and analysis? WHat quality assurance
measures were taken to ensure the fidelity of samples?
Were samples immediately stored in packaging to ensure the
integrity of the samples? If not, how were the samples
stored? Given the volatile nature of fumigants, immediate
proper packaging of samples is necessary.
— Was additional aeration performed after sampling? Should
any of the time between sampling and analysis be considered
as additional aeration time?
— What were the method(s) of packaging samples between
sampling and analysis (container type(s)/size(s); sample
sizes; temperature; labeling/dating/coding)?
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- How long betweer. sampling and shipping? how long were
samples kept. in storage? Were the dates of aeration,
sampling, entry into storage before shLpplr.g, storage, an.:i
analysis given?
— Was any sample compositing or subsampl.ing done at these
stages? If so, were details given?
E. Storage Stability Validation Testing
Refer to the 5 tar .dard Evaluation Procedure on Storage
Stability Tests._ In addition, given the volatile nature of
the fumigants, emphasis may also be needed or. studying the
stability (degradation) of residues during the time between
sampling and storage.
F. Residue Method(s) and Instrumentation
Refe ,to the Standard Evaluation Procedure on Analytical
Methods.
G. Results of Postharvest Fumigation Trials on Crops and
Processed Food and Feeds
Refer to Section E of Appendix 1 in the Standard Evalua on
Procedure for Magnitude of the Residue: Crop Field Trials.’
However, an additional point should he made.
When evaluating postharvest residue data for the purpose of
setting a tolerance, the reviewer must also take into
- consideration preharvest uses; the maximum “total toxic residue”
expected from postharvest uses should be added to the maximum
“total toxic residue” expected from preharvest uses.
H. Quality Control
Refer to Appendix 1 in the Standard Evalu ion Procedure for
Magnitude of the Residue: Crop Field Trials._
5/Concurrently in preparation.
6/Published in F? ‘85.
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APPENDIX 2
REVIEWER AID MATERIALS
The following is a listing of useful aids for evaluating
residue data from postharvest fumigation trials. This listing is
a supplement to the reviewer aids listed in Append ,2 of the
Standard Evaluation Procedu 91 ,for Crop Field Trials_’ and
Processed Food/Feed Studies._
1. Plant Protection and Quarantine ProQrams Treatment
Manual , United Stated Department of Agriculture (1976)
2. Feeds and Feeding, Abridged , F.B. Morrisor., Morrison
Publishing Company, Clinton, IA (1961).
7/Published in F? ‘85.
8/Concurrently i r. preparation.
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HAZARD EVALUATION DIVISION
STANDARD EVALUATION PROCEDURE
SPECIALTY APPLICATIONS
(III) MAGNITUDE OF THE RESIDUE: POSTHARVEST TREATMENT (EXCEPr
FUMIGATION) OF CROPS AND PROCESSED FOODS AND FEEDS
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SPECIALTY APPLICATIONS
(III) MAGNITUDE OF THE RESIDUE: POSTE-JARVEST TREATMENT
( EXCEPT FUMIGATION) OF CROPS AND PROCESSED FOODS AND FEEDS
I. INTRODUCTION
A. Purpose and Scope of the Standard Evaluatior. Procedure
This Standard Evaluation Procedure is designed to aid
RCB reviewers in their evaluations of ials for postharvest
treatment of crops (except fumigations_’ ) and processed foods
and feeds submitted by petitioners/registrants. It is meant to
be used as a supplement to the Standard Evalu? on Procedure for
Magnitude of the Residue: Crop Field Trials._’
This particular Standard Evaluation Procedure addresses
the magnitude of the first-generation residue in foods and feeds
(either RACs or processed commodities) resulting from postharvest
treatments.
B. Background
Postharvest treatment of foods and feeds are applied by
various means, including dips, drenches, mechanical foamers, and
spray and brush applicators. Often, postharvest treatments
involve the application of a wax coating. The application of wax
coatings are accomplished by diluting the formulated pesticide
with wax prior to treatment of the RAC, inclusion of wax in the
pesticide formulation, or by application of the wax coating after
treatment. Waxes may require warming prior to application (unless
the ambient temperature is high, vegetable wax usually requires
heating). Postharvest treatments may also include a detergent
wash procedure, either prior to, during, or following treatment.
Use directions for postharvest treatments sometimes call for an
aqueous rinse following treatment. Since detergent is always
rinsed off the crop, use directions calling for a detergent wash
step during or following treatment necessitates a rinse step
following treatment with a pesticide.
For dips, typically a forklift places bulk bins into a
tank containing the treatment solution. A heavy lid is often
placed over the tank to ensure that the commodities stay submerged.
The bin is then removed and drained. In drench treatment, bulk
bins are flooded, then allowed to drain. Excess solution is
recovered and recycled for immediate reuse. Postharvest
9/The magnitude of the residue from postharvest fumigation is
addressed in a separate section of this Standard Evaluation
Procedure.
10/Published in F l ‘85.
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treatment by spray or brush applicators is generally accomplished
as the commodities progress down a conveyor belt. For treatment
using mechanical foamers, the treatment solution also contains a
detergent. The treatment solution is “foamed” with a mechanical
foarner and allowed to spill onto the commodity to be treated.
Following treatment by foamer, the commodity is rinsed with water.
Typically, dip and drench operations are perEori ied outdoors, and
spray, brush, and wax operations are located inside the
pack inghouse.
C. Objective of Trials for Postharvest Treatments
Trial studies of postharvest treatment of foods and
feeds should answer the follow g question: what is the maximum
level of “total toxic residue”_’ that will likely result in
or on the food or feed commodity as a result of the postharvest
treatment(s) with the pesticide formulated product according to
the proposed ].ahel directions for use,
II. INFORflATION TO BE SUPPLIED
The petitioner/registrant’s report on trials for postharvest
treatments on foods and feeds should include all information
necessary to provide a complete and accurate description of trial
treatments and procedures; sampling, handling, shipping, and
storage of the commodity; storage stability validation of the test
chemical (and metabolite(s) of special concern); residue analyses
of samples for the “total toxic residue” (and for individual
components o special concern); validation (recovery studies) of
the residue analytical methodology; reporting of the data and
statistical analyses; and, quality control measures/precautions
taken to ensure the fidelity of these operations.
A Guideline of specific information that should be included
in the petitioner/registrant’s report of trials for postharvest
treatments is provided in the Residue Chemistry Branch Data
Submission Guideline on the Magnitude of the Residue: Postharvest.
Tt-e tT 9t (Except Fumigation) of Crops and Processed Foods and
Feeds_’ that complements this Standard Evaluation Procedure.
Related information on analytical Method(s) and Storage Stability
are found in the Standard Evaluati? ,Procedure and Data. Submission
Guidelines on those subject areas.
11/The term “total toxic residue” is used to describe the sum of
the parent pesticide and its degradation products, metabolites
(free and bound), and impurities that are considered to be of
toxicological significance, and therefore warrant regulation.
12/To be developed.
13/To be developed.
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III. THE DATA EVALUATION PROCESS
A. Prepare A Summary
The initial step in the evaluation process for trials
for postharvest treatments of foods and feeds is for the reviewer
to carefully examine and summarize the information/data supplied
by the petitioner/registrant in his submission to the Agency.
Any statistical treatments of the data should be independently
verified and the quality control precautions noted.
B. Identify Data Gaps
Using the Data Submission Guideline on Magnitude of the
Residue: Postharuest Treatment (Except Fumigation) of Crops and
Processed Foods and Feeds as a guide, in conjunction with the
related Guidelines on Analytical Method(s) and Storage Stability,
the reviewer should then look for data gaps — omissions in the
ir.Eormat.ion supplied by the petitioner/registrant in his report.
A judgment should be made as to which are considered significant
enough to adversely affect the review process. Those data gaps
significant enough to adversely affect the review process should
be duly noted in the reviewer’s report. Those so identified
should be communicated back to the petitioner/registrant by the
Product Manager for corrective action.
C. Assess the Appropriateness and Adequacy of the Data
The data reviewer then considers the appropriateness
(vis—a-vis the intended use) and adequacy of the data/information
that has beer. supplied. The aforereferenced Data Submission
Guidelines are a useful guide to the various parameters that need
to be considered. Appendix 1 of this document discusses specific
aspects of those parameters that warrant consideration.
As an adjunct to these, the reviewer should draw upon
the technical guidance in the reviewer aids materials that are
available to him, such as the Residue Chemistry Guidelines
(Subdivision 0 of the Pesticide Assessment Guidelines) . A listing
of some suggested source materials is located in Appendix 2 to
this document.
Any perceived deficiencies in the data/information
supplied should be identified and explained, with a statement as
to what steps should be taken to resolve the deficiencies, so
that this ir.formation can be relayed back to the petitioner!
registrant by the Product Manager for appropriate action.
Note : As stated in Footnote 1, other aspects of the
Magnitude of the Residue, such as second—generation residues in
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processed food/feed/and meat/milk/poultry/eggs considerations are
to be addressed in separate Standard Evaluation Procedure
documents. Those considerations are applicable whenever a
treated RAC (or parts thereof) or processed commodity may be
utilized as an item of livestock or poultry feed, or whenever a
treated RAC may be processed into feed items or human foods.
D. Determine the Need for Consultations with Other HED
Branches
In considering the appropriateness and adequacy of the
data/information that has been supplied, the data reviewer must
also determine if consultations with other HED Branches are
needed to reach that decision.
IC so, the specific nature of the issue(s) in question
should be clearly and succinctly stated and directed to the
specific Branches whose input is sought.
E. ç _ onç1 de. if the Requested Action is Supportable
As the last step in the data evaluation process, the
data reviewer makes a judgment as to whether the submitted
data/information support the requested action (tolerance/
registration) of the data submitter.
If the data are not supportive, possible alternative
action(s) that may be taken by the petitioner/registrant are
suggested.
If deficiencies/omissions exist in the submitted data
base, the reviewer may have to defer judgment until such time as
appropriate corrective action has been taken by the petitioner/
registrant.
14/Concurrently in preparation.
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APPENDIX I
MAJOR POINTS TO CONSIDER IN EVALUATING RESIDUE DATA FROtI
POSTHARVEST TREATMENT OF RAW AGRICULTURAL COMMODITIES
In addition to the concentration of the treatment solution,
the magnitude of the residue from postharvest treatments is
affected by many other factors. Some of these factors are:
exposure time, method of application, temperature, type of
diluent (e.g., water, wax), use of waxes, the particular wax, use
of washed, chemical or detergent used for wash, use of rinses,
length (volume) of rinse, brush speed, type of bristles, dump
rate (bins dumped/hour), number of stops and starts on the line,
measures taken to maintain solution strength, and the size,
variety, maturity, and health of the fruit.
A. The Commodity
— Has the commodity beer. adequately identified in all
postharvest treatment trials? Is the commodity an RAC or
is it a processed commodity?
— Is it clear what specific plant part(s) were harvested
and then treated?
— Are an adequate number of types and varieties represented
and are the commercially important varieties represented?
Has the general condition (e.g., maturity, health, size,
etc.) of the commodity at time of treatment beer. specified?
— Are there livestock or poultry feed items associated with
the commodity? If so, are animal metabolism and feeding
studies available? (Note: these concerns will be addressed
in separate Standard Evaluation Procedures, concurrently in
preparation.)
- Is the commodity normally processed into feed or food items?
If so, have processing studies been conducted? (Ref. Foot-
note 1, page 14, this document.)
- Is supplementary information available for the pesticide in
other reports by the petitioner/registrant on this commodity
or related commodLties that can be translated to support
the data base, if needed?
— Are data for the pesticide under similar use conditions
available on the representative commodities of the crop
grouping, and, if so, should a crop group action be
considered?
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— Are there any reharvest uses registered under review for
this pesticide on the commodity in question? If preharvest
uses are registered, what is (are) the tolerance(s)?
— Have there been experimental use permits/temporary tolerances,
section 18 exemptions, or section 24(c) re istratior.s for
the commodity treated with this pesticide? Permanent
tolerance petition requests?
— Are Codex/FAO Monograph data available for this commodity
or related commodities treated with this pesticide?
— Are there International Residue Limits (IRLs) established
for use of this pesticide on this commodity and, if so,
upon what use(s) were they established and what components
of the residue are regulated? What would be required for
harmonization with any such IRLs?
— Is there any other unpublished or published information
known to us about this pesticide and commodity use that
must be taken into consideration?
— Are all the important dates relative to the treating and
sampling of the commodity reported?
— Is this commodity considered a “minor crop” (i.e., limited
acreage and low exposure)?
B. The Pesticide
For parameters concerning the pesticide, the reviewer should
refer to Appendix I, section (A)(2) in the Standard Evaluation
Procedure for Magnitude of the Residue: Crop Field Trials. In
addition, several other parameters should also be considered for
postharvest treatments. They are listed below.
— Do the label directions indicate that the formulation is to
be diluted with water or wax prior to treatment, or is wax
already contained in the formulation as a carrier (diluent)
for the pesticide?
— Does the label give directions for dilution of the
formulation (e.g., x parts formulation to y parts diluer’.t;
x ounces formulation to y gallons diluent) to the treatment
concer.trat ion?
— If label directions recommend the addition of a specific
wax to the formulation, are the constituents of the recom-
mended wax exempt from the requirements of a tolerance
under 40 CER 180.1001 or generally recognized as safe under
21 CFR 184?
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- Do the directions for use recommend the addition of any
detergents to be added to the formulation? I! a specific
detergent or any other additives are to adaed, is the
detergent (additive) exempt from the requirements of a
tolerance under 40 CPR 180.1001 or generally recoynized as
safe under 21 CFR 184?
— Are there any restrictions for this use on trie proposed
label? Are any label restrictions needed? Are the
restrictions practical? A restriction against postharvest
treatments if the RAC was treated prior to harvest is not
practical since the prior treatment history of the crop is
generally not known at the packinghouse.
C. Application of the Pesticide
— Do the the trials for postharvest treatments of foods and
feeds reflect the intended use (proposed labeling)?
Residue data should include that from tr].a].s reflecting the
maximum concentration of the treatment solution and maximum
exposure time and/or quantity pesticide applied per unit
weight commodity, as specified on the proposed label. In
the case of postharvest dips, the specification of a
maximum exposure time is a practical label restriction and
should be included on the label. For other methods of
application, label directions restricting the maximum
exposure time and/or quantity pesticide per unit weight
commodity may not be practical and, often, restrictions
regarding the maximum exposure of the commodity with the
treatment solution is not specified on the label. Thus,
the reviewer may need to make a judgment as to whether the
submitted studies include trials reflecting maximum
exposure with the treatment solution.
Trials should be carried Out using the diluent (e.g.,
water, wax) specified on the label. When the use of a
particular wax coating is indicated on the label, residue
data should include trials using the particular wax when
the wax is applied by diluting the pesticide formulation
with the wax. Generally, though, labels only indicate the
use of “wax.” Then, trials using different waxes are
preferable to those using the same wax.
Trials should reflect the methods of application (e.g.,
dips, drenches, mechanical toamers, spray applicators,
brush applicators, wax applicators) specified on the label,
as commercially practiced. Trials should also reflect the
proposed use for application of wax coatings, detergent
washes, and rinses with respect to number, method, timing
(in relation to other steps in the procedure), and volume
(or concentration, where applicable.), particularly when the
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proposed use for waxes, washes, and rinses is expected to
have an effect on the magnitude of the residue. For
example, the number and volume of rinses following
pesticide application will have a critical effect on the
magnitude of the residue. Although label directions
usually do not specify a minimum volume of rinse water, the
volume of rinse water used for the trials should reflect
the extremes of the dictates of commercial practice.
Residue data for trials carried out at temperatures
reflecting commercial practice storage conditions should
be submitted. Residue data for storage at more than one
temperature may be required. Variations in temperature for
commercial postharvest treatments car . depend on weather,
climate control (or lack thereof) in the packinghouse, the
particular requirements of the commodity, and the
temperature requirements of the wax.
— Were there a sufficient number of trials conducted on the
commodities to support the requested action of the data
submitter?
(Note: This is a judgment call and is influenced by the
importance of the commodity, the range of conditions under
which it is treated, the number of postharvest methods of
application listed on the proposed label, the number of
diluents, waxes, and other additives listed on the proposed
label, how closely the trials corresponded with the intended
use pattern(s), whether trials from exaggerated treatments
are available, whether a minor crop or minor use is involved,
the data and established tolerances already available on
related commodities treated with the pesticide under similar
conditions of use, the nature of the requested action of
the data submitter, and the general concern over the toxicity
of the pesticide.)
D. Sampling and Storage of Samples
Refer to Appendix 1 in the Standard Evalu ,on Procedure for
Fvldgnitude of the Residue: Crop Field Trials._
S. Storage Stability Validation Testing
Refer to the Standard Evaluation Procedure on Storage
Stability Tests.
15/Published in F? ‘85.
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F. Analytical Methods
Refer tO the Standard Evaluation Procedure for Analytical
Methods. However, one additional point should be made.
For RACs having skins or shells, registrants occasionally
analyze only the skin or shell of RACe treated postharvest, and
then calculate the residue on the basis of the whole fruit.
Residue data for the skin or shell only is acceptable only when
additional residue data are available for the particular RAC
demonstrating that detectable residues are found in the skin and
detectable residues are not found in the flesh. However, since
tolerances are set on the basis of the whole fruit, analysis of
the whole fruit is preferable to analysis of the skin only.
G. Results of Postharvest Treatments of RACe
Refer to Section E of Appendix 1 in the Standard Evalua 9n
Procedure for Magnitude of the Residuez Crop Field Trials._’
However, an additional point should be made.
When evaluating postharvest residue data for the purpose of
setting a tolerance, the reviewer must also take into
consideration preharvest uses; the maximum ‘total toxic residue’
expected from postharvest uses should be added to the maximum
‘total toxic residue’ expected from preharvest uses.
H. Quality Control
Refer to Appendix 1 in the Standard Evalu on Procedure for
Magnitude of the Residue: Crop Field Trials.
16/Published in FY ‘85.
17/Published in p1 ‘85.
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APPENDIX 2
REVIEWER AID MATERIALS
Refer to Appendix 2 in the Standard Eva1 g ion Procedure for
Magnitude of the Residue: Crop Field Trials._
18/Published in FY ‘85.
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