United States Prevention, Pesticides EPA 712-C-98-414
Environmental Protection and Toxic Substances March 1998
Agency (7101)
4»EPA Product Performance
Test Guidelines
OPPTS 810.3200
Livestock, Poultry, Fur-
and Wool-Bearing
Animal Treatments
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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), or call 202-512-0132 for disks
or paper copies. This guideline is also available electronically in ASCII
and PDF (portable document format) from EPA's World Wide Web site
(http://www.epa.gov/epahome/research.htm) under the heading "Research-
ers and Scientists/Test Methods and Guidelines/OPPTS Harmonized Test
Guidelines."
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OPPTS 810.3200 Livestock, poultry, fur- and wool-bearing animal
treatments.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) (7 U.S.C. 136, et seq.)
(2) Background. The source materials used in developing this har-
monized OPPTS test guideline are OPP guidelines 95-8 Livestock, poul-
try, fur and wool bearing animal treatments and 95-30 Acceptable methods
(Pesticide Assessment Guidelines, Subdivision G: Product Performance,
EPA report 540/9-82-026, October 1982).
(b) Overview. This guideline concerns efficacy testing of invertebrate
control pesticides used on cattle, horses, sheep, goats, swine, chicken, tur-
keys, other domestic fowls, and fur-bearing animals, such as mink and
rabbits, for control of the major arthropod pests that parasitize these ani-
mals, and are additionally considered to be public health pests. See OPPTS
810.7000 for a definition of public health invertebrates.
(c) General considerations—(1) Site selection. Pests of livestock,
poultry, fur- and wool-bearing animals include, but are not limited to, nose
bot, sheep ked, various biting flies (horn fly and stable fly), ticks, housefly,
face fly, and mosquitoes. Evaluating an insecticide that is to be applied
directly to such animals to control these pests should generally be based
on adequate tests on representative animals from herds or flocks in at least
5 widely-separated regions where the insecticide is to be marketed, unless
applicability so limits use of the pesticide in special representative regions.
Tests on dairy cattle may not be necessary if comparable to efficacy data
are reported from tests using beef cattle.
(2) Sample size. Sample size should be representative of the number
of animals in a particular treatment group, which can range from one to
a herd or flock of thousands.
(3) Number of trials. A minimum of 5 large-scale geographically-
separated trials are generally necessary, but the number of trials can vary
somewhat due to the accessibility of infestations, fluctuations in pest popu-
lation pressures, behavior, and other important considerations in the biol-
ogy of the target pest.
(4) Dosage selection. Dosage levels and concentrations should be
identified in the laboratory or small-scale tests before field testing. The
data should include support of the schedule of repeated applications as
indicated in the directions for use of the product.
(5) Application techniques and equipment—(i) Single oral dose.
For insecticides administered orally as drenches, boluses, or in capsules,
care should be taken that animals receive the entire dose. Record the for-
mulation, final concentration of active ingredient, total amount adminis-
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tered, and dosage in terms of mg of active ingredient per kg of body
weight of animal. The regulation of many internal applications comes
under the authority of the Food and Drug Administration, Bureau of Vet-
erinary Medicine. Some of these pesticides may fall into this category.
(ii) Feed treatment. Insecticides administered to animals as part of
a feeding regimen should be mixed into the entire feed ration or fed in
a small amount of feed which, when consumed, is followed by untreated
feed. Record the formulation, final percent content of active ingredient
(ppm in feed), or total mg of active ingredient per kg body weight of
animal, amount of feed or treatment consumed, and length of treatment
period.
(iii) Water treatment. Some insecticides may be administered to ani-
mals through drinking water. Animals may be treated individually or in
groups, which, when having consumed the treated water, are given un-
treated water. Regardless of the size of the group, the following should
be recorded: The formulation, final concentration of active ingredient in
terms of ppm in water or mg of active ingredient per kg of body weight
of animal, average consumption of water per animal, and duration of treat-
ment.
(iv) Mineral, salt, or protein supplement. Insecticides of this type
are generally formulated at low concentrations in mineral, salt, or protein
supplements and are offered free choice to animals. Because consumption
of salt, mineral, and protein supplement varies considerably from animal
to animal, it is important to determine whether or not all animals consumed
treated materials. Record the formulation, final concentration of active in-
gredient in terms of percentage or ppm of treated supplement, average
consumption per animal per day, dosage in terms of mg active ingredient
per kg body weight per day, and length of treatment period.
(v) Injections. For insecticides given to animals in the form of
intramuscular, intraperitoneal, or subcutaneous injections, record the for-
mulation, amount of material injected per animal, location of injection,
and dosage in terms of mg of active ingredient per kg of body weight.
(vi) Whole-body sprays. For insecticides applied to animals as
whole-body sprays, care should be taken that animals are treated thor-
oughly and that enough pressure is used to penetrate hair coat and assure
wetting of the skin. A variation of the whole-body spray is the use of
spray-dip machine to apply spray to animals. With either method, record
the formulation, final concentration of active ingredient, equipment used
and application techniques, and average volume of spray applied per ani-
mal.
(vii) Dip. For insecticides used to charge dipping vats, animals should
be immersed thoroughly in the dip fluids. Record the formulation, final
concentration of active ingredient, volume of liquid in the vat, age of
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charge at time of dipping, number of animals dipped, and data on recharg-
ing (if necessary). Chemical analyses of active ingredient in vat fluids be-
fore and after dipping are necessary to determine the actual amount of
active ingredient in the vat fluid.
(viii) Pour-on treatment. Insecticides applied to animals by the pour-
on technique, ready-to-use formulations, or emulsifiable concentrates di-
luted with water or oil, are poured down the backline of animals in ounce
(milliliter) rates. In an extension of this technique, ready-to-use formula-
tions are applied to a spot on the backline at milliliter rates. Record formu-
lation, diluent, final concentration of active ingredient, amount applied per
animal, area treated, and dosage based on mg active ingredient per kg
body weight of animal.
(ix) Dust treatment (livestock). Insecticides are applied as dusts by
power duster or by hand or contained in dust bags and placed in the pas-
ture for free-choice use or placed in openings to feed, mineral, and/or
water sources so that animals are forced to use them on a daily basis.
With cattle grub control, it is important that dust bags be located so that
animals are forced to treat themselves on a daily basis to insure that suffi-
cient insecticide is applied for cattle control. In tests with dust bags for
control of ectoparasites, such daily treatment is not essential. Record for-
mulation, final concentration of active ingredient, average amount of dust
per animal, location of dust bags, and length of treatment period.
(x) Back spray. In tests to control cattle grubs, the animal's backs
are sprayed thoroughly with the contact insecticide. Care is taken to force
insecticide into the warble openings in the animal's backs. Record formu-
lation, final concentration of active ingredient, equipment used, application
techniques, and average volume of spray applied per back.
(xi) Floor or litter treatment. Insecticides are applied as mists or
fogs, dust, or granules directly to floor areas, litter, or nest areas. Record
formulation, final concentration of active ingredient, equipment used,
amount of insecticide per square meter of surface treated, and total surface
area treated.
(xii) Dust box treatment (poultry). Insecticides formulated as dusts
or granules are placed into dust box containers and fowl allowed to treat
themselves. Record formulation, diluent, final concentration of active in-
gredient, amount of material per dust box, length of treatment period, num-
ber of birds, and average amount of material used per bird during treatment
period.
(xiii) Vapor treatment. Strands, cords, or other devices impregnated
with insecticides are attached underneath or around cages containing in-
fested birds. Insecticides volatilize from the impregnated surfaces and kill
ectoparasites on birds. Record the formulation, impregnated material, final
concentration of active ingredient, length or weight of impregnated mate-
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rial per bird or per cage containing a specific number of birds, and length
of treatment period. Low volume or ultra low volume application must
be evaluated if these methods are to be specified on the label.
(6) Record of toxicity and other adverse effects. Adjusted average
daily gains (ADG) on the test and control groups should be recorded and
reported. The pesticide product's possible toxic effects on the animal must
be evaluated. For example, small amounts of certain solvents cause toler-
able minor itching and burning for short periods after application. Higher
concentrations may cause death if not diluted before application. The rec-
ommended method of treatment for pour-on and other ready-to-use prod-
ucts containing oils should be tested to ensure that the recommended meth-
od of treatment will not result in excessive dosages of oil which may evoke
adverse reactions in treated animals. The final use dilution of emulsifiable
concentrations should be tested to ensure that it does not contain dangerous
amounts of oil. Insecticides which are tested for use on livestock, poultry,
of fur- or wool-bearing animals should not injure the animal even when
application is repeated over a long period of time; the margin of safety
to the treated animal is a vital consideration in determining usefulness.
Neither should the insecticides appear illegally in or on meat, meat by-
products, milk, or eggs. If the treated animal is less than 3 months of
age (excluding poultry), the effects of stress caused by a particular oper-
ation such as castration, dehorning, or other similar procedures, should
be evaluated in conjunction with toxicity data. This is especially important
for feed-through insecticides. For other requirements on toxicity, refer to
OPPTS guideline series 870, Health Effects Test Guidelines.
(7) Evaluation and reporting procedures. The evaluation proce-
dures used should be specified in the presentation of the data. Reports
should include formulations, final concentrations of active ingredient in
terms of ppm in water or percent active ingredient in dusts, dosage in
terms of mg of active ingredient per kg of body weight of animal, length
of treatment period, equipment used, and other similar factors. The average
daily gain in weight should be reported for any tests of 7 to 14 days dura-
tion.
(8) Untreated controls and comparative treatments. When it is im-
practical to maintain untreated control animals, the effectiveness of the
test product may be measured by comparative treatments with products
of well-known efficacy used as reference standards. To evaluate the effect
of treatments, records should be kept on the comparative changes in meat,
milk, or egg production or some similar measurement; and insect counts
following each treatment. The numbers of animals in the control or com-
parative treatment groups must be equal to the numbers of animals in a
treatment group in small scale tests; in large-scale tests, only a small por-
tion of the animals need to be treated or given a standard treatment. Con-
trol groups should contain animals of the same general size, age, condition,
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and origin as those in the treatment groups and have similar infestations
of parasites or be exposed to similar populations of arthropod parasites.
(d) Suggested performance standards. Unless otherwise specified,
these standards are presented on the basis of pest population counts from
treated compared to untreated animals. All percentages of control refer
to the performance of the test product (as determined by insect counts,
yield of meat and milk, and any other measures correlated to insect popu-
lation pressures) against the vulnerable stage(s) of the target pest, when
evaluated according to a recognized treatment program under actual field
conditions.
(1) Cattle (beef and dairy)—(i) Horn fly. The percentages of control
for the horn fly are based upon pre- and post-treatment counts coupled
with a comparison to separate untreated control groups. Such percentages
are derived from actual counts of the number of adult flies per side per
animal, and may additionally be correlated with average daily weight or
milk production.
(A) Feed treatment, drinking-water treatment, and mineral salt
or protein supplements. A minimum of 90% control of emerging adults
along with a 70% reduction of adults on the cattle as measured by side
or whole-body counts.
(B) Whole-body sprays, dips, pour-ons. A minimum of 90% reduc-
tion in infestation.
(C) Dusts. A minimum of 95% reduction in infestation.
(D) Backrubbers. A minimum of 90% reduction in infestation, under
continued use for one month.
(E) Low volume (LV), ultralow volume (ULV) and waxed-bar ap-
plications. A minimum of 90% reduction in infestation under continued
use.
(ii) Other biting flies: (Stable fly, deer flies, and horse flies). The
percentages of control given for these pests are based upon the feeding
rates of flies before treatment compared to the feeding rates of flies on
the same cattle after treatment as correlated to the feeding rates on un-
treated animals taken at the same time. Such feeding rates should be ex-
pressed as populations of each separate pest species observed consistently
at a particular time of day associated with fly activity.
(A) Whole-body sprays, dips, pour-on, and dusts. A minimum of
90% reduction in infestation one day after application and 75% reduction
in infestation one week after application.
(B) Backrubber, LV and ULV applications. A minimum of 90%
reduction in infestation under continued use.
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(iii) Face fly: Whole-body sprays, dips, pour-ons, dusts, back-
rubbers, LV and ULV applications, smears, baits, ointments, and face
wipes. Reduction in infestation should range from 20-60% for 2-3 days
from a single application, based upon a comparison of the numbers of
flies per animal pre- and post-treatment correlated with populations of the
pest occurring on adjacent untreated herds observed at the same time.
(iv) Ticks. The percentage of control listed as suggested performance
standards for ticks are based upon pre- and post-treatment counts on the
same animals or as the average number counted on untreated controls dur-
ing the same post-treatment intervals. If pre- and post-treatment counts
are utilized as a basis for computing the percentage, then untreated control
counts should still be reported to permit correlation with natural tick popu-
lation dynamics for the site/pest complex.
(A) Whole-body sprays, dips, pour-ons, and dusts. A minimum of
90% reduction in infestation one day after application and 75% reduction
in infestation for one week after application.
(B) Backrubber, LV and ULV applications. A minimum of 90%
reduction in infestation under continued use.
(2) Horses—(i) Ticks. A minimum of 90% reduction in infestation
for one week and 75% reduction in infestation for one month, based upon
pre- and post-treatment counts in comparison with untreated controls.
(ii) Flies: Dips, whole-body sprays, fine-mist sprays, toxicants and/
or repellents in aerosols, sponge-ons, wipe-ons, smears, baits, and
treated halters. The percentage given as a suggested performance stand-
ard for fly control are based upon a reduction in infestation numbers for
a minimum period of 3 hours or that period of protection to be claimed
on the label, whichever is shorter. A minimum of 90% reduction in infesta-
tion under continued use.
(3) Chickens, turkeys, and other domestic fowl—(i) Manure-in-
habiting fly larvae—(A) Feed treatment. A minimum of 90% reduction
in infestation under continued use, based upon both adult fly reductions
determined either by manure emergence or manure bioassay testing, com-
paring both treated and control groups.
(B) Fly larvicides to manure. A minimum of 90% reductions in in-
festation for period of 2 weeks after treatment, based on the criteria pre-
sented in paragraph (d)(3)(i)(A) of this guideline.
(ii) [Reserved]
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