United States Prevention, Pesticides EPA 712-C-98-413
Environmental Protection and Toxic Substances March 1998
Agency (7101)
4»EPA Product Performance
Test Guidelines
OPPTS 810.3500
Premises 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 810.3500 Premises 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 95-11 Premises treat-
ments and 95-30 Acceptable methods (Pesticide Assessment Guidelines,
Subdivision G: Product Performance, EPA report 540/9-82-026, October
1982).
(b) Overview. This guideline is concerned with the efficacy data
guidance for invertebrate control pesticides used against pests of premises.
Commercial and industrial pesticide formulations used for premises treat-
ments include, but are not limited to, liquid or pressurized products for
spray treatments and pastes, powders, and granules for baits.
(c) Definitions. The following definitions are of special importance
in understanding this guideline:
The term crack and crevice treatment means the application of small
amounts of insecticide into cracks and crevices in which insects hide or
through which they may enter the building. Such openings commonly
occur at expansion joints, between different elements of construction, and
between equipment and floors. These openings may lead to voids such
as hollow walls, equipment legs and bases, conduits, motor housing, junc-
tion or switch boxes.
The term food handling establishment refers to any place, other than
a private residence, in which food is held, processed, prepared, and/or
served. Food areas include those used for receiving, serving, storing (dry,
cold, frozen, raw), packaging (canning, bottling, wrapping, boxing) and
preparing (cleaning, slicing, cooking, grinding) food; for edible waste stor-
age; and for enclosed processing systems (mills, dairies, edible oil extrac-
tors, and evaporators).
The term general treatment is application to broad expanses of sur-
faces such as walls, floors, and ceilings or as an outside treatment.
The term non-food areas refers to premise areas such as garbage
rooms, lavatories, floor drains (to sewers), entries and vestibules, offices,
locker rooms, machine rooms, boiler rooms, garages, mop closets, and
storage (after packaging).
The term premises refers to the spaces within structures, their walls
(both inside and outside), and the immediate adjacent surrounding grounds.
Such structures include households (e.g., houses, apartments); commercial,
industrial and institutional buildings; agricultural structures (e.g., barns);
and food-handling establishments.
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The term spot treatment is application to limited areas on which in-
sects are likely to occur, but which will not be in contact with food or
utensils and will not ordinarily be contacted by workers. These areas may
occur on floors, walls, and bases or undersides of equipment. For this pur-
pose, a "spot" will not exceed 2 square feet. Spot treatments must be
limited to 20% of the lower wall and floor surfaces. The 2 square foot
"spots" cannot be contiguous.
(d) General considerations. The testing of a pesticide product for
use in households should follow the same procedures as are appropriate
for its commercial use.
(1) Site selection. The uniqueness of each application site or struc-
ture, and the fact that identical sites or structures will usually not be avail-
able, should be recognized.
(2) Number of trials. Under controlled conditions in the laboratory,
at least 5 trials are usually necessary. A minimum of 5 large-scale field
trials are generally needed, but the number of trials can vary somewhat
due to the accessibility of infestations, fluctuations in pest population pres-
sures, behavior, and other important considerations in the biology of the
target pest.
(3) Test species. Test invertebrates should be representative of flying
and/or crawling species against which the test product is to be used. A
pest population may be difficult to estimate or to sample, and it will often
be necessary to limit testing to the laboratory, or to develop a system of
estimating the extent of an infestation in the field. The pests to be con-
trolled often cannot be distinguished as separate entities and will frequently
need to be grouped according to control methods, geographical locations,
infested premises, life stage or form, type of damage and other factors.
Therefore, testing may need to be directed at the most important pest or
pests, life stage or pest complex, or at the species most resistant to a par-
ticular pesticide.
(4) Exposure period. The duration of exposure to the test product
is important in order to achieve maximum control, and data must be re-
ported in terms of time length, such as 12-, 24-, or 48-hour exposure peri-
ods.
(5) Temperature and humidity. The temperature and humidity at
the time the product is tested should be recorded, since these factors are
important relative to the activity of the pest population, and the degrada-
tion of the active ingredient(s).
(6) Residual considerations. The amount of pesticide residue depos-
ited on treated surfaces is critical to the effectiveness of many treatments
against crawling pests. The amount of residue deposited should be deter-
mined under actual or simulated use conditions, and the method(s) of de-
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termination must be submitted with the test data. The types of surfaces
to which residual pesticides are applied must be reported since surface
type has a pronounced effect on the amount of active residue available
to pests. In general, the following absorptive and non-absorptive surfaces
should be tested for crawling pests: vinyl tile or linoleum, stainless steel,
painted and unpainted wood and ceramic tile.
(7) Application techniques and equipment. The application tech-
nique should reflect the claims proposed on the label, whether crack and
crevice, spot, general, space spray, contact spray or total release. Insecti-
cides to be evaluated in or around dairy barns, horse barns, stables, poultry
houses and yards, and other agricultural structures may be applied as
sprays, dusts, and baits to stanchions, walls, floors, manure, bedding, and
other areas where the target insects may rest or breed.
(e) Test methods and suggested performance standards. These
suggested standards are determined on the basis of results obtained from
laboratory and simulated or actual field tests in which the efficacy of the
test product is compared with that of official test pesticides such as the
official test pressurized spray (OTPS), from the Chemical Specialties Man-
ufacturers Association (CSMA), untreated controls, or a registered stand-
ard. The performance standards are the same for household, commercial
and industrial, agricultural, structural and food handling establishment
treatments.
(1) Non-residual aerosols and space sprays—(i) Flying insects. The
product should demonstrate efficacy equal to, greater than, or within 5
percentage points of the OTPS when tested according to the CSMA Aero-
sol and Pressurized Spray Insecticide Test Method for flying insects or
the ANSI-ASTM E653-78 Standard Method for Testing Effectiveness of
Aerosol and Pressurized Space Spray Insecticides Against Flying Insects.
(ii) Crawling insects—(A) Contact spray. The product should be
tested against the proposed target pest and demonstrate performance equal
to, greater than, or within 10 percentage points of the OTPS when tested
according to the CSMA Cockroach Aerosol Method or the ANSI-ASTM
E654-78 Standard Method for Testing the Effectiveness of Aerosol and
Pressurized Spray Insecticides Against Cockroaches.
(B) Space spray. There are no official test methods for space sprays.
However, the following general considerations apply to pesticides applied
as space sprays for crawling insects, as most of these insects are not ex-
posed at the time of application.
(7) The room size and dosage must be consistent with label claims
and directions.
(2) Replication is necessary to provide reliability.
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(3) Controls should be utilized for comparison.
(4) As some products may knockdown but not kill a high percentage
of insects, mortality must be recorded at 1 and 24 hrs. post-treatment.
(5) Usually German cockroaches are used in testing. When dosage
rates are very small, a larger species, such as American or Oriental cock-
roaches, may also be necessary. Resistant strains should be utilized if the
pesticide has a history of resistance problems. Last instar nymphs and
adults are recommended for all species.
(6) A product registered for the use pattern should be used as a posi-
tive control.
(7) The containers or enclosures for holding the roaches should be
representative of those areas which commonly shelter roaches (underneath
refrigerators, stoves, sinks, cabinets and in certain wall voids).
(8) The number of specimens should be sufficient to provide accurate
statistical evaluation of the results. Perhaps the greatest problems have
arisen with respect to paragraph (e)(l)(ii)(B)(7) of this guideline. Note that
open containers or those with unobstructed holes in the top area are not
representative of covered or enclosed situations.
(2) Residual sprays—(i) General. Efficacy data for residual sprays
should indicate the appropriate dosage and the utility of the formulation
when used as directed. Usually, laboratory testing is performed to establish
the effective dosage range, determine if the formulation is repellent to the
point of adversely affecting performance of the product, and to evaluate
the effects of the various substrates upon which deposition is to occur.
Field studies are then necessary to confirm the performance of the
compound under actual use conditions.
(ii) Sprays—(A) Crawling insects—(7) Laboratory testing. Labora-
tory testing should evaluate the proper dosage range utilizing treated panels
representative of field substrates. Usually these include such items as
painted and unpainted wood, glass, formica, chipboard or particle board,
stainless steel, concrete, and vinyl tile. Such treated panels should be aged
under conditions similar to field situations and challenged with the target
insect at regular intervals to determine the duration of efficacy. Addition-
ally, choice box testing or some other method of evaluation must be per-
formed to determine if a high degree of repellence is likely to affect field
performance. All laboratory testing should utilize both untreated and posi-
tive controls to determine the relative vigor of the laboratory populations.
(2) Field testing. Field testing for crawling insects involves utilizing
sites and methods of application essentially the same as those to appear
on the proposed label. Evaluation is based upon pre- and post-application
counts of living insects. For example, cockroaches are normally counted
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by flashlight, trapping, or flushing agents. Untreated areas or sites should
be used as controls if possible, and a positive control should also be used
in the testing.
(B) Flying insects—(7) Lab tests. Laboratory tests for residual appli-
cations to control flying insects are usually done in screen cages with one
side replaced by the treated panel. Such testing should evaluate the appro-
priate dosage range (usually mg active ingredient per square foot), and
the degree of repellency exhibited by the formulation.
(2) Field testing. Field tests should utilize the proposed sites of appli-
cation. Counts may be made by visual observation, fly speck cards, black
light traps, or other suitable methods.
(3) Baits—(i) General. The important factors relating to testing bait
products are to:
(A) Establish the proper dosage and intrinsic attractancy of the formu-
lation in "free-choice" laboratory tests.
(B) Evaluate the utility of the product under actual-use conditions.
(ii) Laboratory testing. The most important factor involved in lab
testing is to provide a free-choice alternative food source to the test insects.
This may be laboratory dog chow for insects like cockroaches, or sugar
based material for houseflies. The formulation should demonstrate accept-
able toxicity in competition with the alternative food source.
(A) Cockroach bait test-method—(7) Introduction. This is a sug-
gested test procedure for cockroach baits to be used to control cockroaches
in homes, warehouses, food establishments, etc. The following outline is
a suggested series of laboratory and field tests. The important factors are
to establish the proper dosage and intrinsic attractancy of the formulation
in "free-choice" laboratory tests and to evaluate the utility of the product
under actual-use conditions.
(2) Test protocol—(/) Choice box laboratory test—(a) Enclosures
(4) constructed out of plywood. Dimensions approximately 2' x 4' x 4".
Tops are either made of plexiglass or the sides are greased or teflon coated
to prevent escape. Each enclosure is divided into two halves by a line
drawn or painted down the center giving two 2' x 2' areas. In each side
are placed a cardboard hide (12" x 12" x 12" ht. is suggested) and water.
In three of the enclosures, one side is treated with the proposed dosage
of bait (gm. per unit area) and on the other side an equal amount of Purina
Dog Chow (R) is placed. Some of the bait and dog chow may be placed
in the hides. In the remaining box only Purina Dog Chow is used as a
control. Each box receives 50 last instar nymph or adult German cock-
roaches, Blatella germanica, placed either along the center line or 25 in
each side. Boxes are kept in areas providing a normal day/night
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photoperiod or a minimum of 8 hours darkness each day. Roaches are
counted at 1, 3, 5, 7, 10, 14 and 21 days and the percent mortality can
be derived from Abbott's formula. A table of results and the counts for
the individual boxes should be submitted. Consumption may indicate that
additional bait is necessary to give acceptable mortality. If all the bait
is consumed, then additional bait or dog chow may be added as necessary.
Such additions must be recorded and reported. Testing may need to be
repeated in situations where definitive results are not obtained.
(b) Ovicidal and chemosterilant action-trials may be designed to indi-
cate either a chemosterilant effect or toxicity to the eggs carried by the
female. For chemosterilants, the laboratory choice box test should be con-
tinued for as many days as necessary to collect significant numbers of
oothecae. Upon deposition, these should be collected from the boxes, and
kept in separate containers. Percent eclosion should be recorded for treated
boxes and compared to the controls. To enhance deposition, a high number
of non-gravid adult females should be used at the beginning of the test.
No gravid females should be used at the initiation of a test for
chemosterilant effects. For oothecal toxicity, only oothecae-bearing fe-
males should be used. The oothecae are again collected and percent eclo-
sion compared to the control group.
(if) Field trials—An experimental use permit may be required.
Once the appropriate dosage has been discovered in the laboratory testing,
the product must be field tested to be registered. Field testing usually in-
volves apartment houses, but food establishments or other areas with heavy
infestations may also be used. The most popular methods of infestation
assessment are via flashlight inspection or trapping. After the pretreatment
counts are made, and application has been completed, additional comments
are usually initiated on a weekly basis. Along with cockroach numbers,
the degree of sanitation and any other pertinent details should be reported.
Comparison treatments (i.e., a registered standard bait material) should be
used as a point of reference.
(3) Modifications. Most testing laboratories make modifications in
protocol specifications as facilities dictate. For this reason we suggest that
protocols be prepared and submitted for EPA review prior to the initiation
of testing. Such protocols should be submitted to the product manager for
the proposed product.
(iii) Field testing. Testing under actual use conditions should dem-
onstrate utility of the product when used in situations where a continuous
source of pest insects is available. The product should demonstrate both
mortality and a reduction in the overall population over time. Measurement
techniques are essentially the same as for residual sprays.
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