NTIS No. PB88-191713
EPA 540/09-88-049
PESTICIDE ASSESSMENT GUIDELINES
SUBDIVISION 0
RESIDUE CHEMISTRY
Series 171-3
Directions For Use
ADDENDUM 6 ON DATA REPORTING
Prepared by:
Alfred Smith
Residue Chemistry Branch
Hazard Evaluation Division
Project Manager:
Elizabeth M.K. Leovey, PhD
Hazard Evaluation Division
Office of Pesticide Programs
US Environmental Protection Agency
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Subdivision O - Directions for Use
Table of Contents of Addendum
Page
Introduction 2
Response to Public Garments 3
Guideline
Title/Cover Page 4
Directions for Use 4
Grope 4
Formulations 5
Application Directions 5
Field and Orchard Applications 5
Postharvest Applications 6
Animal Treatments 7
Aquatic Uses 7
Pood-Handling Establishments 8
Agricultural Premises 9
Use Restrictions 9
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PESTICIDE ASSESSMENT GUIDELINES
RESIDUE CHEMISTRY
Directions For Use
subdivision O, Series 171-3
DATA REPORTING
INTRODUCTION
A. Purpose
The Directions for Use are required Toy 40 CFR 162.10 to support the
registration of any pesticide intended for use on a food or feed
crop under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), as amended.
The Directions for Use form a part of the requirements for the
registration, reregistration, or amended registration of pesticides
intended for use on agricultural comodities under sections 408 and
409 of the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended.
Further regulatory support is provided in 40 CFR Parts 158.125, 162,
and 180.
B. Objective
The Directions for Use provide the user or pesticide applicator with
the appropriate methods for the treatment of soils, crops, water,
establishments, livestock, and livestock areas with the pesticide.
These uses are designed to provide effective and efficacious means
for treatments with pesticides. The Directions for Use are essential
to an adequate evaluation of the residue data. As a result, such
Directions must be clear and reflect those uses expected to be
effective against the target pest and result in residues in crops.
These data aid in the assessment of the exposure of the public to
pesticide chemicals. Consequently, the uses should be supported by
residue data Which reflect the proposed conditions of use.
This Data Reporting Guideline (DRG) is designed to aid the petitioner/
registrant in the data/information collection/organization process.
While other DRGs provide formats for study reports, this DRG provides
guidance on expressing use directions (for the readers' convenience,
the guidance has been presented in an outline format which addresses
the items/topics to be covered). Data submitters are strongly
encouraged to use this DRG to increase the efficiency of the registration
and reregistration processes. It pertains to the substance of the
data report. PR Notice 86-5, effective November 1, 1986 and available
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fron the Office of Pesticide Programs, pertains to physical formatting
of reports referred to as "studies" and submittal packages. Some of
its requirements are mandatory.
RESPONSE TO PUBLIC COMMENTS
The purpose of this section is to acknowledge and address the concerns
expressed in the letters of conment received by the Agency in response to the
public notice in the FEDERAL REGISTER of March 25, 1987 (52 PR 9536). Of the
seven responses received, two commented on the Directions for Use Data Reporting
Guideline.
This addendum to the Pesticide Assessment Guidelines [Subdivision O] is
to be considered an all-enccnpassing document. EPA recognizes there are
sections in the addendum which do not apply in all cases. Therefore, registrants
should exercise scientific judgment in deciding which portions are germane to
a specific data submission.
This DRG is not intended to introduce new data requirements or revisions
into the Pesticide Assessment Guidelines [Subdivision 01 nor is it intended
for use by Agency data reviewers as a mere checklist. It is intended to
clarify ambiguities in interpretation of those existing Guidelines, and to
organize the submission of data to facilitate the review process.
The Residue Chemistry Branch (RGB) has reviewed the comments submitted
by the registrants and/or committees in regard to the DRG. The cements
submitted are addressed as follows (the page numbers in the comments refer
to the page numbers in the document available for public comment and the
corresponding section in this document*has been provided in brackets):
Comment;
"The expression of formulations and inerts (page 2) [B.] is incorrect.
Formulation inerts are those inerts required to have the biologically
active material function effectively in field use. Adjuvants are materials
which may be added at the time of use."
Response;
The tern inert ingredient is defined under 40 CFR §162.3(t) as "all
ingredients which are not active ingredients . . . ." In order to avoid
any confusion in the use of the tern adjuvant, the last sentence has
been changed to read, "The inert ingredients are all ingredients which are
not active ingredients (40 CFR 162.3(t)] and serve such functions as
stickers or spreaders.11
Cciuuents:
"The paragraph at the top of page 3 1C. 1.1 and points 1 and 2 under use
restrictions on page 6 (D. 1. and 2.1 are nearly identical, we would
suggest that all be included under the Use Restrictions sections only.
Listing restrictions in more than one place on the report may be confusing
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in that each list may not be complete. The minimun interval between
successive applications/ if relevant, could appear in the general application
information as well."
"On page 3, the first sentence of the last paragraph under 'Full-coverage
sprays' [C. 1. b.] may cause sane confusion. Vie suggest it be changed to
'. . . should include the spray concentration or active ingredient per
acre and the spray volume per acre.1"
Responsei
We agree that the paragraph at the top of page 3 [C. 1.] and points 1 and 2
under Use Restrictions on page 6 [D. 1. and 2.] are similar. The paragraph
at the top of page 3 is a general statement to help explain the Application
of Pesticides [Application Directions] introduced on page 2 [C. l.J.
The use restrictions on page 6, points 1 and 2
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The crop groupings represent exceptions to the foregoing discussion
(see 40 CPR 180.34). A tolerance may be proposed for a collection
of related crops (crop group) without Use Directions for each individual
crop in the group. Representative crops from the crop group may be
provided as a minimum requirement for data purposes. Hawever, the
Use Directions for all crops in the group must be similar before the
specific crop(s) is (are) registered under FIFRA.
B. Formulations
The pesticide chemicals Which are to be used are formulated as
dusts, liquids, or granular forms. The formulation to be used must
be expressed quantitatively in terms of its active ingredient and
its inert ingredients. The inert ingredients are all ingredients
which are not active ingredients [40 CFR 162.3(t)] and serve such
functions as stickers or spreaders.
C. Application Directions
1. Field and Orchard Applications
The application of dusts, sprays, and granular formulations are
to be expressed in terms of pounds of active ingredient per acre
(lb ai/A). For band or row treatments, the use should indicate
if the pounds per acre rate refers to the area treated or to the
entire field.
The maximum number of applications permitted per growing season
or per year should be provided. Additionally, the minimum
interval between successive applications and the minimum interval
between the last application and harvest should be provided.
a. Orchard Treatments
The application of pesticides to orchards generally requires
more attention than other crops due to the variations in tree
size. The various modes of application are discussed below.
i. Full-Coverage Sprays
For full-coverage sprays to orchards, the dosage should
be expressed as pounds active ingredient per 100 gallons
spray solution to runoff. The dosage is expressed in
this manner because of the variation in the quantity of
active ingredient applied per acre as a result of the
variation in the size of the trees.
ii. Concentrated Sprays
In the case of concentrated orchard sprays, the amount
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of active ingredient applied per acre should also be
related to tree size. Usually this can be achieved by
specifying the same or less active ingredient per acre
as the amount which would be applied using a full
coverage spray.
iii. Options
In order to lessen the possibility of excess treatment,
some options include information on the label which
indicate that smaller trees should be treated with less
volume of solution and thus less active ingredient per
acre. Alternatively, data could be provided to show
the maximum likely residues to be expected due to
treatment with the most concentrated spray on the
smallest mature fruit-bearing tree in ccaroercial production.
Additionally, methods of adjusting for tree size as
reflected in agricultural practices should be provided.
Some examples as recommended by the Extension Service
will be provided in the next revision of the Residue
Chemistry Pesticide Assessment Guidelines (Subdivision
0: Residue Chemistry, 40 CFR §158.125).
b. Special Modes
For special modes of application (aircraft, ultra low volume
[ULV], mist sprays), the Use Directions should include the
spray concentration, the active ingredient per acre, and the
spray volume per acre. This is necessary since the volumes
of solutions used in these cases are generally much less
than the usual spray solutions.
2. Postharvest Applications
a. Fumigation
Fumigation generally involves the chemical treatment
of crops which have been harvested and are being stored or are
already in storage. The dosages may be expressed in terms of
weight of fumigant per volume of storage space (i.e., pounds
active ingredient per 100 cubic feet), or weight of fumigant
per unit weight of conmodity treated (pounds active ingredient
per 1000 pound grain) or weight of fumigant per unit area
and depth of preplant field treatment. Other factors should
also be considered. The factors include time of exposure,
temperature, pressure, geometry and airtightness of containers,
and aeration procedures which include tine of aeration.
b. Miscellaneous
The general standards for the Directions for Use are
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not applicable to certain specialized processes. For example,
such processes include the manufacture of impregnated fruit
wraps to control fungus diseases, or processes in Which
pesticides are applied postharvest to fruits, such as in a
wax coating. A complete description of the process, including
quality control measures and directions for disposal of
spent dip solutions or runoff, should be included in the
Proposed Use Section of a petition.
3. Animal Treatments
The uses on animals occur in the form of tags, backrubs, dusts,
dips, and wetting sprays. The concentration of the pesticide in
the treatment solution is the primary consideration. The Use
Directions for dips should include instructions for recharging
and maintaining a constant solution strength in the dip tank and
for the disposal of spent dip solutions. Factors Which may
affect the deposition of residues on animals should be included
in the Use Directions. Some of the factors include the frequency
and maximum number of treatments, amount of time that the animal
is to be held in the dip tank, the delivery rate of sprays, and
the amount of solution to be applied per animal for spot or
other specialized treatments.
For the application of pesticides by automatic devices, for
example, photoelectric or actuated sprays, or backrubbers, the
Use Directions should include discussions on the recharging and
placement of devices so that the degree of exposure of the
animals may be estimated. *
4. Aquatic Uses
Aquatic uses entail the application of a pesticide to flowing
water, impounded water, irrigation ditchbanks, dry beds of water
conveyance systems, and other aquatic sites.
The mode of application varies and depends on the intended effect
of the pesticide. Herbicides for deep-growing submerged weeds
may require deposition of slow-release granules on the bottom
near the root zone. For this type of treatment, the dosage
would be expressed in terms of pounds active ingredient per
surface acre. The use of a water-soluble herbicide Which acts
by direct absorption into the target plant is dependent upon
maintaining a certain concentration in the water, and the dosage
should be expressed in terms of parts per million in water. The
use directions should relate the dosage per surface area to
average pond depth.
Specialized equipment may be required for some aquatic herbicide
applications. As a result, a detailed description of the equipment
and principles involved in the treatment should be included. For
example, metered pumping of invert emulsions to the bottom of lakes
through weighted hoses may be used. A proposed use of time-released
capsules will require information on how the encapsulated material
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is placed and the mechanisn of the release.
Often sane limitations on the minimum distance from a potable
water or irrigation intake pipe are needed. Such limitations
are needed whenever unacceptable levels of a pesticide chemical
occur in water at the intake pipe.
In order to avoid losses of desirable species through oxygen
depletion, it is sometimes necessary to treat at intervals only
portions of ponds with heavy weed infestations. The label
should state what proportions of a pond should be treated per
application and the required interval between treatments. If
treatments are intended only for pond margins, as opposed to
overall broadcast treatment, then it should be so indicated.
Ditchbank treatments are usually made by boon sprayers from
trucks. For adequate coverage there is an unavoidable overlap
with some direct addition to the water as well as runoff
contamination. The label should clearly indicate how such
treatments are to be made with minimum contribution of herbicide
to the water. A prohibition may be required against cross-ditch
spraying.
5. food-Handling Establishments
The potential exists for the contamination of foods due to
pesticide treatment of areas where food is prepared or processed.
Therefore, the applicator must have clear Use Directions in
order to minimize the contamination of foods.
The Directions for Use should include:
a. The type of establishment that may be treated;
b. The dilution instructions for preparing the working solutions;
c. The spray concentration;
d. The type of application equipment;
e. The mode of application (e.g., directed spray to crevices,
baseboards, space spray, etc.);
f. Dosage limitations including cubic and square foot limitations;
g. Frequency of treatment; and
h. Time of treatment (e.g., after-hours in restaurants).
Other information which should be provided, where necessary, are
as follows:
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a. Sanitation procedures;
b. Removal of food;
c. Covering of dishes and utensils; and
d. Cleanup procedures before food preparation, processing, or
serving resumes.
6. Agricultural Premises
Agricultural premise uses include distribution of granular
insecticides to feed lots; fogging of dairy barns; installation of
impregnated strips in animal barns; and applications of sugarbase
bait sprays to walls, stanchions, and other surfaces of barns.
The Use Directions should be sufficiently detailed to permit an
evaluation of the potential for residues on milking equipment,
exposure to feeds, and drinking and feed troughs, or in meat,
milk, and eggs of livestock housed on treated premises.
The Use Directions should state What areas are to be treated, the
frequency of treatment, whether animals must be removed at time of
treatment, and any other pertinent information.
Dosage for fogging treatments should be expressed in terms of nutrber
of installations per unit volume; sprays in terms of concentration
of active ingredient in the solution applied; and feed lot applications
in terms of weight of active ingredient per unit area.
D. Use Restrictions
Restrictions placed on the use of the pesticide should be clearly
written and practical. The following is a stannary of the use restrictions
ccrmonly on labels, and the information needed to adequately support
such restrictions.
1. The maximum number of applications permitted during a growing
season should be indicated. Also, the timing of the applications
should be noted as well as the intervals permitted between treatments.
2. The interval between the last application and harvest should be
indicated. This interval is oomonly referred to as the preharvest
interval (PHI), and expressed in days. For animal treatments, the
interval between the last treatment and slaughter is commonly
referred to as the preslaughter interval (PSI) and is usually
expressed in days.
3. For crops, the timing of the application may be tied to a stage of
crop growth. For example, with cotton the statement "not after
first bolls open" is used.
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Again, information an the minimum interval from the treatment
stage to harvest is needed.
4. Impractical or unrealistic use restrictions should be avoided.
Restrictions on the food or feed use of plant parts are practical
only when (1) the item remains under the direct control of the
grower; (2) the item is not of significant econonic importance
as a feed item; and, (3) the US customary practice is not to use
the item as a feed. For example, a restriction on the feed use
of soybean straw is practical because the plant refuse remains
under the control of the grower, the item is not of significant
economic importance as a feed item and the percentage of US
soybean acreage fed as forage is very low. Also, a restriction
in the form of a PHI would be practical for pasture grass.
Conversely, restrictions on the feed use of corn forage or
fodder would be impractical since these are major livestock feed
items. While corn forage and fodder are under the control of
the grower, the high economic value of the feed items and the
overwhelming practice of growers to feed these items make the
restriction impractical.
5. The use restrictions should be as specific as possible. For
example, a restriction such as "Do not use after lay-by" is
indefinite because the "lay-by time" may vary considerably for a
given crop. Indefinite terms such as "Do not use on animals
being finished for slaughter" are not acceptable. Instead, a
specific withdrawal period should be requested by the petitioner.
6. Where use in food-handling establishments is proposed, specific
Use Directions to minimize human exposure through residue transfer
are needed. Explicit warnings such as "Cover food utensils" and
"Do not apply to food contact surfaces" are most useful. However,
a general statement such as "Avoid contamination of food" is
less useful and therefore of limited effectiveness.
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