HAZARD EVALUATION DIVISION
STANDARD EVALUATION PROCEDURE
DIRECTIONS FOR USE
Prepared By
Alfred Smith, Chemist
Standard Evaluation Procedures Project Manager
Orville E. Paynter, Ph.D., D.A.B.T.
Hazard Evaluation Division
Office of Pesticide Programs
Unites States Environmental Protection Agency
Office of Pesticide Programs
Washington, D.C., 20460
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Sequential detailed steps for the evaluation of use directions
for a chemical pesticide are covered under the following topics:
crops, pesticide application, animal treatments, fumigations,
aquatic uses, food handling establishments, agricultural premises,
and use restrictions. Detailed steps are given such that the
reviewer can adequately assess the clarity, conciseness, and
accuracy of the pesticide label.
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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
I. INTRODUCTION Page
A. Purpose of the Standard Evaluation
Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
B. Background Information ......................... 1
C. Objective of the Directions for Use ............ 1
II. THE DATA EVALUATION PROCESS ........................ 1
A. Prepare a Summary .............................. 1
B • Crops . . • . . . . . • • . . • . • • • • . • . • . . • . . • • • • . • • • . • . . . . 2
C. Pesticide Applications •........................ 2
D • Animals Treatments • . • • . . • • • . . • • . • . • . . . . . . • . . . . . 3
E. Fumigation • . • . • . . . . . . . . . • • . . . . • . • . . • . . • . . • • , , . • 3
F. Aquatic Uses • . • . . . • •.• . • . . • . . • . • . . • . • • • . . • • • • . • 3
G. Food Handling Establishments •...•....•......... 4
H. Agricultural Premises .......................... 5
I • Use Restrictions . . • . . . . . . . . . . . . . . . . . . • . • . • . . • • • 5
III • REVIEWER AIDS • . . . • . . . . • • . . • . . . • . • . . . . . • • . . • . • . . . . • • 6
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DIRECTIONS FOR USE
I. INTRODUCTION
A. Purpose of the añdardEvilüátiàñ Prócêduré
This Standard Evaluation Procedure (SEP) is provided as an
aid to the Residue Chemistry Branch (RCB) data reviewers in the
evaluation of use directions contained in petitions for tolerance
or exemption from tolerance, or its registration submission
concerning amended food uses.
B. aa) ãrauna tnfârmatión
The directions for use form a part of the requirements for
the registration, reregistration, or amended registration of
pesticides intended for use on agricultural commodities under
Sections 408 and 409 of the amended Federal Food, Drug, and
Cosmetic Act and the amended Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA amended). Further regulatory support is
provided in 40 CFR parts 158.125, 162 and 180.
C. ôbjéàtivèâf iiDiróâtióiaiFârUéi
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, efficacious and safe treatments with pesticides.
The use directions are essential to an adequate evaluation of
the residue data. As a result such directions must be clear,
practical and reflect those uses expected to be effective
against the target pest. These data are important in
assessing pesticide exposure and risk to the public.
II. THE DATA EVALUATION PROCESS
A. Piiparéa ununary
The reviewer is to carefully examine the use directions
and provide a summary which is clear, concise, and contains the
information necessary to demonstrate the intended use of the
pesticide chemical. The information includes the dosage, frequency
and timing of application, as well as the mode of delivery. The
use directions should show which formulation is to be used, a
preharvest interval if necessary, or other limitations as needed.
Each of the essential factors of the directions for use are discussed
below. The use directions are included in Section B of a petition.
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Generally the directions are contained in copies of the labeling
and sununarized in tabular form. A practical path for the review
and evaluation of the use directions is discussed below.
B. Cropà
All crops (field arid/or orchard) which are to be treated
with the pesticide formulation should be clearly identified. The
crops listed should be consistent with those for which tolerances
have been proposed or exemptions requested. If there are crops
listed under the use directions and no tolerance has been proposed
on these crops, then the petitioner should be informed that
tolerances should be proposed for these crops, or the crops should
be withdrawn from consideration. Another option involves a non—f oód
use . If a use is proposed and the petitioner believes that no
residues are likely to result in food or feed items, then a
tolerance proposal may not be needed. However, residue data must
be provided to support this claim. (See SEP entitled, Specialty
Applications: (I) Classification of Seed Treatments and Treatment
of Crops Grown for Seed Use Only as Non—Food or Food Uses for
additional information on what constitutes a non—food use).
Conversely, if there are crops for which a tolerance has
been proposed and there are no use directions for these crops,
then the petitioner should be informed that use directions should
be provided for these crops, or the tolerance proposals for these
crops should be withdrawn.
The crop groupings represent exceptionB to the foregoing
discussion (see Section 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. However, the use directions for all crops in the group
must be similar.
C. PeitiâideAppliâàtioñ
The application of dusts, sprays, and granular formulations
are to be expressed in terms of pounds active ingredient per
acre. (Occasionally, data from foreign countries are expressed
in terms of kilograms per hectare. These units are easily expressed
in pounds per acre through the use of readily available conversion
factors.) 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. For full coverage sprays, for example orchards,
the dosage should be expressed as pounds active ingredient per
100 gallous spray solution of runoff. The dosage is expressed
in this manner because of the variation in the quantity of active
ingredient applied as a result of the variation in the size of
the trees. In the case of concentrate orchard sprays, the amount
or 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 as the amount which would be applied
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using a full coverage spray.
In order to lessen the possibility of excess treatment,
some options include information on the labeling which indicate
that smaller trees should be treated with less volume of solution
and thus less active ingredient per acre. Alternatively, date
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 commercial production.
D. Animal Tréatmiñté
The uses on animals occur in the form of tags, dusts, dips,
pour—ons, 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 olution 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 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 treadle actuated sprays, or back—
rubbers, 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.
E. Fumigation
Dosages may be expressed in terms of weight of fumigant
per volume of storage space (pounds active ingredient per 100
cubic feet) or weight of fumigant per unit weight of commodity
treated (pounds active ingredient per 1000 pounds grain) or weight
of fumigant per unit areas and depth of preplant field treatment.
Other factors should also be noted. Such factors are time of
exposure; temperature; pressure; geometry and airtightness of
containers; and aeration procedures (including time of aeration).
F. AauaticUge .
Aquatic uses entail the application of a pesticide to
flowing water, impounded water, irrigation ditch banks, 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 submersed
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
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(4)
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 acre 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 timed release capsules will require information on how the
encapsulated material is placed and the mechaniBms of the release.
Often some limitations on the minimum distance from a
potable water or irrigation intake pipe are included. 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 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.
Ditch bank treatments are usually made by boom 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 water. A prohibition may be required against cross—ditch
spraying.
G. Food iñdliñ êtib1iá) zné tê
The potential exists for the contaminati3n of foods due to
pesticide treatments 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 directio for use should include the type of
establishment that may be treated; the dilution instructions for
preparing the working solutions; the spray concentration; the
type of application equipment; the mode of application (e.g.,
directed spray to crevices, baseboards, space spray, etc.);
dosage limitations including cubic and square foot limitations;
frequency of treatment; time of treatment (e.g., after—hours in
restaurants). Other information which should be provided, where
necessary, are as follows: sanitation procedures; removal of
food; covering dishes and utensils; and cleanup procedures before
food preparation, processing, or serving resumes.
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‘bI’
(5)
H. Agricültôril Premises
Agricultural premise uses include distribution of granular
insecticides to feed lots; fogging of dairy barns; installation of
impregnated strips or cords in animal barns; and applications of
sugar—based 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, 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 number of
fogging devices 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.
I. Ulé Rêstrictiônê
In addition to the directions for use of the pesticide,
there are often restrictions placed on the use of the pesticide.
Such restrictions should be clearly written and practical. The
following is a summary of the use restrictions commonly noted and
the information needed to adequately support such restrictions.
• 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 treatment.
• The interval between the last application
and harvested should be indicated. This
interval is commonly referred to as the
pre—harvest interval, or PHI, and expressed
in days. For animal treatments, the in-
terval between the last treatment and
slaughter is commonly referred to as the
pr’s—slaughter interval, or PSI, and usually
expressed in days.
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 boils open is used. Again,
information on the minimum interval from the
treatment stage to harvest is needed.
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 economic
importance as a feed item; and, (3) the U.S. customary practice
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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 U.S. soybean acreage fed 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 a-re 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.
• The u e restrictions should be as specific
as possible. For example, a restriction
such as UDO not, use after lay—by’ is inde-
finite because the ‘lay—by time’ may vary
considerably for a given crop. Indefinite
terms such is ‘Do not use on animals being
finished for slaughter’ should not be accepted.
Instead, a specific withdrawal period should
be requested of the petitioner.
• Where use in food handling establishments is
proposed, specific use directions to minimize
residue transfer are needed. Explicit warnings
such as ‘Cover food utensils’ is most useful.
However, a general statement such as ‘Avoid
contamination of food is less useful and
therefore of limited effectiveness.
III. REVIEWER AIDS
Cultural practices files for agricultural crops are
available in the Residue Chemistry Branch file area. These files
are invaluable in providing information on agricultural crops,
their byproducts, and market information on the distribution of
the crops into economic channels. These files should be consulted
when questions arise concerning agricultural crops and other
p sticide uses.
Other sources of up—to—date information on cultural prac-
tices for plants and animals include:
• USDA Publication, ‘Information Contacts.’
• USDA Telephone Directory, Science S
Education Staff, pp. 106—109, Spring 1984
(update annually).
• USDA Handbook Number 305, ‘1984—85
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Directory of Professional Workers in State
Agricultural Experiment Stations and other
cooperating State Institutions (updated
annually).
Miscellaneous reference books are available throughout the
branch on many CiO S.
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