United States Prevention, Pesticides EPA712-C-96-171
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Residue Chemistry
Test Guidelines
OPPTS 860.1200
Directions for Use
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INTRODUCTION
This guideline is one of a series of test guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental Protection Agency for use in the testing of
pesticides and toxic substances, and the development of test data that must
be submitted to the Agency for review under Federal regulations.
The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has developed this guideline through a process of harmonization that
blended the testing guidance and requirements that existed in the Office
of Pollution Prevention and Toxics (OPPT) and appeared in Title 40,
Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical Information Service (NTIS) and the guidelines pub-
lished by the Organization for Economic Cooperation and Development
(OECD).
The purpose of harmonizing these guidelines into a single set of
OPPTS guidelines is to minimize variations among the testing procedures
that must be performed to meet the data requirements of the U. S. Environ-
mental Protection Agency under the Toxic Substances Control Act (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).
Final Guideline Release: This guideline is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin Board. By modem dial 202-512-1387, telnet and ftp:
fedbbs.access.gpo.gov (IP 162.140.64.19), internet: http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies.
This guideline is also available electronically in ASCII and PDF (portable
document format) from the EPA Public Access Gopher (gopher.epa.gov)
under the heading "Environmental Test Methods and Guidelines."
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OPPTS 860.1200 Directions for use.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of both the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.) and the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301, et seq.}.
(2) Background. The source material used in developing this har-
monized OPPTS guideline is OPP 171-3 Directions for Use (Pesticide As-
sessment Guidelines, Subdivision O: Residue Chemistry, EPA Report 5407
9-82-023, October 1982). The earlier OPP guideline is superseded by this
OPPTS guideline. This OPPTS guideline should be used in conjunction
with OPPTS guideline 860.1000, Background, which provides general in-
formation and overall guidance for the 860 series on Residue Chemistry.
(b) Purpose. Directions for use are utilized by the Agency to deter-
mine the routes of exposure to pesticides and to determine what types
of data are necessary to calculate risk to humans and the environment.
In the area of residue chemistry, the directions for use help to determine
whether a particular application of a pesticide is a food use or a nonfood
use. In general, a food use requires substantial amounts of residue data
to establish a tolerance, while a nonfood use needs minimal or no such
data. For food uses, the directions for use allow an assessment of whether
the residue data reflect the maximum residues likely to occur in foods
and animal feeds.
(c) General. (1) The directions for use are ordinarily contained in
specimen labeling submitted concurrently for registration under FIFRA.
Labeling means the actual label affixed to the container together with cir-
culars or leaflets that may accompany it.
(2) It is important that the proposed use be described concisely to
facilitate correlation of the proposed use patterns with the method of appli-
cation used to obtain residue data. The directions should be stated in a
manner which is readily understood by the user of the product. Where
several products or multiple uses are involved in a petition, it is suggested
that Section B of the petition should contain a summary table of all the
uses relating to the proposed tolerances. This table should show the crop,
dosage range, schedule of applications, formulations to be used, preharvest
interval and all other use-relevant use limitations.
(3) All crops (field and/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 ex-
emptions requested.
(4) The crop groupings represent exceptions to the foregoing discus-
sion (see 40 CFR 180.41). A tolerance may be proposed for a collection
of related crops (crop group) without use directions for each individual
crop in the group if the use is the same for each crop in the group. Rep-
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resentative 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 should be similar before a crop group tolerance is established
and the specific crops are registered under FIFRA.
(5) The formulation to be used should be expressed quantitatively
in terms of its active and inert ingredients. Inert ingredients are defined
as all ingredients which are not active ingredients (40 CFR 162.3 (t)) and
which may serve various functions.
(6) Paragraphs (d)(l) through (d)(8) of this guideline contain addi-
tional points which should be observed in specifying the directions for
use in adequate detail.
(d) Application directions—(1) Field and orchard crops. Applica-
tion of each formulation should be expressed in terms of pounds active
ingredient per acre but may also be givent in kilograms of active ingredient
per hectare. For band or row treatments, it should be clearly stated whether
the pounds per acre rate refers to the area treated or the entire field. In
the case of full coverage sprays, as for orchards, the dosage should also
be expressed as pounds active ingredient per 100 gallons of spray solution
to runoff, because of the large variation in the number of pounds per acre
needed for small trees versus large trees. The quantity of pesticide applied
per acre for concentrate orchard sprays should also be related to tree size,
usually by specifying the same or less active ingredient as that which
would be applied using a full coverage spray. In order to lessen the possi-
bility of excess treatment, some options include information on the label
which indicates that smaller trees should be treated with smaller volumes
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 commercial production. Additionally, methods of ad-
justing for tree size as reflected in agricultural practices should be pro-
vided. For special modes of application (aircraft, ultra low volume (ULV),
mist sprays), the directions for use should include both the spray con-
centration and the spray volume per acre. The names and quantities of
any stickers, spreaders, or other adjuvants used in the spray solution should
be given. The maximum number of applications allowed, the minimum
interval between application and harvest (preharvest interval (PHI)), and
the minimum interval between treatments should be indicated.
(2) Animal treatments. Animal treatments present special dosage
control problems. The concentration of pesticide in the working solution
is the primary consideration in dips and wetting sprays. The directions
for dips should include some instructions for recharging and maintaining
a constant solution strength in the dip tank, and for the disposal of spent
dip solutions. Any factors which may affect the deposition of residues
should be covered in the directions for use, e.g. the maximum number
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of retreatments, time of the animal in the dip tank, nozzle type, pressure
or delivery rate of sprays, and the amount of solution to be applied per
animal for pour-on or other specialized treatments. When application of
pesticides by automatic devices (i.e. photoelectric or treadle actuated
sprays) or backrubbers is proposed, the directions for use should take into
consideration such factors as how often they should be recharged and
where they are to be placed so that the degree of exposure of the animals
may be gauged.
(3) Fumigants. (i) Fumigation generally involves the chemical treat-
ment of crops which have been harvested and are being stored or are al-
ready in storage. Dosages may be expressed in terms of weight of fumigant
per volume of storage space (pounds of active ingredient per 100 ft3) or,
where appropriate, weight of fumigant per unit weight of commodity treat-
ed (pounds of active ingredient per 1,000 Ib grain).
(ii) Parameters such as time of exposure, temperature, pressure, geom-
etry and airtightness of containers, and aeration procedures (including time
of aeration) should be specified.
(4) Aquatic uses, (i) Aquatic uses include the application of a pes-
ticide to flowing water, impounded water, irrigation ditch banks, dry beds
of water conveyance systems, or other aquatic sites.
(ii) The types of application will vary widely, depending on the mode
of action 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 of active ingredient per surface area, much like an agricul-
tural field use. The use of a water-soluble herbicide which acts by direct
absorption into the target plant is dependent on maintaining a certain con-
centration in the water and the dosage should be expressed in terms of
parts per million in water. In the latter case, the directions for use should
relate the dosage per surface acre to average pond depth.
(iii) Aquatic herbicide applications may require some very specialized
equipment. 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. A pro-
posed use of timed-release capsules requires information on how the en-
capsulated material is placed and on the mechanism of the release.
(iv) It is frequently necessary to include limitations on the minimum
distance from a potable water or irrigation intake pipe. This limitation is
necessary whenever unacceptable pesticide levels occur in water at the
intake pipe.
(v) It is sometimes necessary to treat at intervals only portions of
impounded water with heavy weed infestations to avoid loss of desirable
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species through oxygen depletion. The label should state what proportions
of an impoundment should be treated per application and the required in-
terval between treatments. If treatments are intended only for impound-
ment margins, as opposed to overall broadcast treatment, it should be so
indicated.
(vi) Ditchbank treatments are usually made from trucks by boom
sprayers. For adequate coverage, there is an unavoidable overlap with
some direct addition to the water as well as runoff contamination. The
label should clearly direct how such treatments are to be made with mini-
mum contribution of herbicide to the water. A prohibition against cross-
ditch spraying may be required.
(5) Foreign uses, (i) Tolerances may be proposed to cover residues
resulting on food treated in foreign countries so that such foods may be
imported into this country. The pesticide products used in the treatment
may be of foreign manufacture, or may be manufactured in the United
States and exported to the country where the application is made. Use
of a pesticide in a foreign country is not registered under FIFRA. There-
fore, section 408 l(d) of the FFDCA, which provides only that registrants
under the FIFRA may petition for tolerances, is not applicable. The pro-
ponent of a tolerance on imported foods should therefore petition under
section 408(e) of the FFDCA.
(ii) For domestic pesticide uses, a determination is made by the Agen-
cy that the tolerance is adequate to cover residues likely to result from
uses as directed on registered labels. In the case of foreign uses, it is re-
quired that the petitioner provide all necessary information on the amount,
frequency, and time of application.
(6) Food handling establishments, (i) The potential exists for the
contamination of foods due to pesticide treatment of areas where food is
prepared or processed. Therefore, the applicant should have clear use di-
rections in order to minimize the contamination of foods. A food additive
regulation set under section 409 of the FFDCA specifying the conditions
of use in food handling establishments is a requirement for registration
of such a use under FIFRA.
(ii) Although directions for use will ordinarily be contained on the
product label, the usage directions for those products intended for use sole-
ly by professional pest control operators may be presented as a technical
bulletin. The potential for food contamination from treatments in areas
where food is prepared or processed rests largely upon the care exercised
by the applicator in following the directions and observing specified re-
strictions. For this reason, the instructions should be explicit. The direc-
tions for use should include (for example) the type of establishments that
may be treated, the dilution instructions for preparing the working solution,
the spray concentration, the type of equipment by which it is to be applied,
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the mode of application (directed spray to crevices, baseboards, space
spray, etc.), dosage limitations including cubic and square foot limitations,
frequency of treatment, time of treatment (after-hours in restaurants), and
other pertinent information, such as sanitation procedures, removal or cov-
ering of food, covering of dishes and utensils, and cleanup procedures be-
fore food preparation, processing, or serving resumes.
(7) Agricultural premises. Agricultural premise uses will vary wide-
ly and might include distribution of granular insecticides to feed lots, fog-
ging of dairy barns, installation of impregnated strips or cords in animal
barns, or applications of sugar-based bait sprays to walls, stanchions, and
other surfaces of barns. The directions for use should be sufficiently de-
tailed to permit an evaluation of the potential for residues on milking
equipment, exposed feeds, drinking and feed troughs, or in meat, milk,
poultry, and eggs of animals quartered on treated premises. The directions
should state what areas are to be treated, frequency of treatment, whether
animals should be removed at time of treatment, and any other pertinent
information. Dosage for fogging treatments should be expressed in terms
of pounds per unit volume of the structure treated; impregnated strips and
similar devices in terms of number 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.
(8) Miscellaneous applications. The general criteria for use direc-
tions do not apply to certain specialized processes, such as 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.
Under these circumstances, the user of the pesticide product is a trained
operator experienced in the use of relatively complex mechanical equip-
ment, and directions for use on the retail packages are usually not nec-
essary. However, a complete description of the process including quality
control measures and directions for disposal of spent dip solutions or run-
off should be made a part of Section B of a petition.
(e) Restrictions. (1) Clearly written and practical use restrictions are
necessary so that the Agency may gauge the residues likely to result. The
following are limitations which should be specified when pertinent to the
use:
(i) The maximum number of applications permitted during a growing
season together with the timing and the interval between treatments must
be given.
(ii) The interval between last application and harvest (or slaughter)
should be specified. For plants, this interval is commonly referred to as
the PHI. This may be expressed in terms of days before harvest or may
be tied to a stage of crop maturity such as not after first bolls open.
If the directions for use are related to some identifiable growth stage, such
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as first bolls open or pegging time, the petitioner should indicate the
minimum time from this stage to harvest. For animal treatments, the inter-
val between the last treatment and slaughter is commonly referred to as
the preslaughter interval (PSI) and is usually expressed in days.
(iii) Impractical or unrealistic use restrictions should be avoided. Re-
strictions against the food or feed uses of plant parts other than the primary
raw agricultural commodity are practical only if the item remains under
the control of the grower and is not of major economic importance. For
example, a restriction against feeding soybean forage is practical because
it remains under control of the grower and is of little economic importance.
A restriction against feeding dried citrus pulp from a treated grove is not
practical or acceptable, since the pulp from a treated fruit would not retain
its identity in processing. As another example, a restriction against feeding
corn forage or stover (fodder) is impractical because of the major eco-
nomic importance of corn forage and stover. Restrictions of more than
3 days in the time interval between application to animals and slaughter
are normally considered impractical because animals may be sent to
slaughter over an extended period of time, and once sold are no longer
under control of the user of the pesticide. The table titled Raw Agricultural
and Processed Commodities and Livestock Feeds Derived from Field
Crops in OPPTS 860.1000 may be consulted for an indication of whether
a feed item is subject to a feeding restriction on pesticide labels
(2) A restriction calling for discarding of milk during a prolonged
interval after the treatment of lactating dairy cattle would be considered
unrealistic, since it would impose an economic hardship on the user and
would tend to be ignored.
(f) Specificity of use restrictions, (i) A restriction such as Do not
use after lay-by is indefinite in that lay-by time for a given crop may
vary considerably due to differences in cultural practices and geographical
area. Indefinite terms such as Do not use on animals being finished for
slaughter should be avoided and a specific withdrawal period should be
stated. Similarly, withdrawal times after an animal treatment should be
practical. Restrictions should also be as inclusive as possible. For example,
the warning Do not use on dairy animals is preferable to Do not use
on dairy cows, if, for example, the intention is to exclude dairy goats.
(ii) In the case of uses in food handling establishments, specific direc-
tions to minimize residue transfer are especially important. A general cau-
tion such as Avoid contamination of food is by itself of limited effective-
ness and should be supplemented by explicit warnings such as Cover food
utensils, Do not apply when exposed food is present, Apply after plant
operations are shut down, or Wash food contact surfaces before plant
resumes operation.
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(g) References. Additional source material used in the preparation
of this guideline is listed below (items marked with an asterisk are super-
seded by this guideline).
*(1) Environmental Protection Agency, Pesticide Assessment Guide-
lines, Subdivision O: Residue Chemistry, Series 171-3; Addendum No.
6 on Data Reporting, Directions for Use, EPA Report 540/09-88-049.
(2) [Reserved]
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