<pubnumber>712C98001</pubnumber>
<title>Product Performance Test Guidelines OPPTS 810.1000 Overview, Definitions, and General Considerations</title>
<pages>20</pages>
<pubyear>1998</pubyear>
<provider>NEPIS</provider>
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<abstract></abstract>
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United States Prevention, Pesticides EPA712-C-98-001
Environmental Protection and Toxic Substances March 1998
Agency (7101)
&EPA Product Performance
Test Guidelines
OPPTS 810.1000
Overview, Definitions,
and General
Considerations
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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 810.1000 Overview, definitions, and general considerations.
(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 90-1, 90-2, 90-3, 90-
30, and the performance standards in Series 91 through 96 (Pesticide As-
sessment Guidelines, Subdivision G: Product Performance, EPA report
540/9-82-026, November 1982).
(b) Overview—product performance—(1) General concepts, (i)
The term "product performance" refers to all aspects of a product's effec-
tiveness and usefulness. Any evaluation of product performance is con-
ducted in light of expressed and implied labeling claims or recommenda-
tions concerning pests, sites, methods of application, application equip-
ment, dosage rates, timing and number of applications, use situations, na-
ture and level of pest control, duration of pest control, compatibility with
other chemicals, benefits and/or adverse effects of product use, compatibil-
ity of common practices associated with the sites, active ingredient status
of chemicals in the formulation, and equipment.
(ii) Initial laboratory, greenhouse, or small plot field testing is con-
ducted to determine the effectiveness of a substance to control or kill spe-
cific pest organisms, or to produce desired effects on plants or plant parts,
and also to determine whether the substance has sufficient pesticide poten-
tial to warrant larger scale testing.
(iii) Effectiveness and usefulness of the proposed product is further
proven through advanced large-scale laboratory tests, field tests, in-use
tests, or simulated-use tests by procedures which closely approximate ac-
tual use and which employ typically-used application equipment.
(iv) All advanced tests must address those factors which would nor-
mally be encountered in the use patterns claimed for the product. These
factors would depend on the type of pest and site to be treated, and may
include: Specificity, degree, and duration of pest control; impact of climate
on chemical residuals and bait acceptance; nature and extent of spray cov-
erage; adverse environmental effects such as bioaccumulation (see OPPTS
Test Guidelines Series 835 and 840), and toxicity to beneficial nontarget
organisms (see OPPTS Test Guidelines Series 850, 870, and 885); increase
in population levels of other pests of the target site resulting from control
of predatory or competitive microorganisms, or interference with the per-
formance of other pesticides; or any other factors which would establish
the safe, effective use of the product.
(v) Except as provided in 40 CFR part 172, an experimental use per-
mit must be obtained to cover test trials involved in use of a pesticide
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that is not registered with the Agency and test trials involving a new use
of a previously registered pesticide.
(vi) The Agency may require additional information on benefits when
a product does not achieve the performance standards, when exorbitant
rates are used to achieve the performance standards, or when exceptionally
low levels of effectiveness are attained.
(2) Waiver policy. The Agency has waived all requirements to sub-
mit efficacy data unless the pesticide product bears a claim to control pests
that may pose a threat to human health. Data for termiticides are required
because the user cannot determine if they have performed their intended
function. However, each registrant must ensure through testing that his
products are efficacious when used in accordance with label directions and
commonly accepted pest control practices. The registrant must develop and
maintain the relevant data upon which the determination of efficacy is
based. The agency reserves the right to require, on a case-by-case basis
(e.g., conditional registrations or benefits data in cases of special reviews),
submission of efficacy data for any pesticide product, registered or pro-
posed for registration, when necessary.
(i) Public health uses include the following ones listed and product
performance data are, therefore, required to be submitted for these uses.
(A) Uses of antimicrobial agents intended to control pest microorga-
nisms (except bacteria, pathogenic fungi, or viruses living on or in man
or other animals) that pose a threat to human health including, but not
limited to, microorganisms infectious to man in any area of the inanimate
environment. (Also see OPPTS 810.2000, paragraph (b), for additional in-
formation on public health considerations.)
(B) Uses of fungicides intended for control of organisms that produce
mycotoxins.
(C) Public health uses of invertebrate control agents including, but
not limited to, agents intended to control the following: Mosquitoes, biting
flies, ticks, fleas, houseflies, cockroaches,fireants, hornets, wasps, poison-
ous spiders, scorpions, biting midges, centipedes, bedbugs, human lice, and
dust mites.
(D) Public health uses of vertebrate control agents including, but not
limited to, the; following: Aquatic amphibian and reptilian control agents,
terrestrial amphibian and reptilian control agents, avian toxicants, avian
repellants, avian frightening agents, bat toxicants and repellants,
commensal rodenticides, rodenticides in orchards, rodenticides on farms
and rangelands, rodent repellants on cables, rodent fumigants, rodent re-
productive inhibitors, mammalian predicides, and domestic dog and cat
repellants.
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(ii) For those products for which the Administrator will ordinarily
waive the requirement for submittal of efficacy test data as indicated in
paragraph (b)(2)(ii)(A) of this guideline, the Agency reserves the right and
authority to require, on a case-by-case basis, submission of such efficacy
data or other test data for any specific product, registered or proposed
for registration, whenever the Agency deems that such data are necessary
to make proper evaluations for a decision as to acceptability for registra-
tion or continued registration.
(A) Conditions under which the Agency may request efficacy data
for any product, registered or proposed for registration, include but are
not limited to the following:
(7) A lack of efficacy has been reported for it.
(2) The Agency needs such data to evaluate benefits of the pesticide
(or of alternative pesticides) when substantial risks have been identified.
(3) The Agency has reason to suspect that the product may not be
efficacious.
(B) Thus, the guidelines in this series shall be used by registration
applicants as efficacy testing standards in conjunction with label claims
and efficacy data reporting requirements.
(3) How to use OPPTS Test Guidelines Series 810. (i) Table 1 ad-
dresses the organization of the 810 Series. For pesticides which are not
antimicrobials, the reader should use paragraph (d) of this guideline, Gen-
eral Considerations for Pesticides Other Than Anti-microbials. OPPTS
810.3000 and 810.4000 contain performance standards and test methods
for public health uses of invertebrate and vertebrate control agents, respec-
tively. The actual test procedures will vary according to the characteristics
of the chemical, the type of formulation, the target pest, the use patterns,
the methods and timing of application, and many other factors.
Antimicrobial pesticides are covered in OPPTS 810.2000 which contain
both general and specific requirements for these pesticides.
(ii) Identification of explicit methods in these guidelines for all uses
is not practical, because an acceptable test for one product or use may
not be valid to support another product intended for the same use, or for
the same product intended for even a slightly different use. Examples of
acceptable methods are provided in specially designated paragraphs of the
guidelines, but the applicant or his testing agent must be responsible for
the validity of any particular test or tests employed.
(iii) For termiticides and public health pesticides for invertebrate and
vertebrate control, the registrant should use additional guidance provided
at OPPTS 810.5000 and 810.6000. Table 1 summarizes the organization
of the OPPTS Test Guidelines Series 810.
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Table 1.—Organization of the 810 Series
Pesticide type
Antimicrobials — Public health
Rest of Non-public Health Pesticides except
termiticides
Termiticides
Public Health except antimicrobials
Applicable guideline series
General considerations sections
No
Yes
Yes
Yes
Specific sections
810.2000
None
810.3000
810.3000,
810.4000
(4) Relation of OPPTS Test Guidelines Series 810 to 40 CFR part
158 and to other series of the guidelines. Relation to 40 CFR part 158,
subparts A and B. The registration applicant is referred to 40 CFR Part
158—Data Requirements for Registration for general provisions and poli-
cies pertaining to registration data requirements including policy on flexi-
bility in relation to deviation from test standards and acceptable protocols,
when tests are required (40 CFR 158.32), and requirements for additional
data.
(5) Relation of OPPTS Test Guidelines Series 810 to OPPTS Test
Guidelines Series 850. The registration applicant is referred to OPPTS
Test Guidelines Series 850, Group D: Nontarget Plants, for data guidance
on pesticides that contact plants through direct application or through
movement of pesticides in the environment, and submission of data on
adverse phytotoxic effects to nontarget plants both within the target area
and outside the target area.
(c) Definitions. The following definitions apply to this guideline.
Effective dosage range or EDR refers to the range of dosage levels
beginning with the lowest dosage capable of achieving the level of control
specified by the applicable performance standard for the least taxing condi-
tions under which it will be used (e.g., pest levels, soil types, water condi-
tions, geographical and climatological conditions, etc.), and ending at the
lowest dosage required to achieve the specified level of control under the
most taxing conditions under which it will be used.
Effectiveness refers to a product's ability to control the specific target
pest or produce the specified plant or animal response when the product
is applied in accordance with the label directions, precautions, and limita-
tions of use. The term effectiveness, as used in this guideline, is synony-
mous with the term efficacy.
Full coverage, as used in common agricultural practice, refers to a
volume of spray applied to plants to the point of runoff or drip.
Large scale plot refers to any plot large enough to permit the use
of typical commercial application and harvest equipment (when such
equipment is needed for pesticide application).
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Low volume or LV, as used in common agricultural practice, refers
to a total volume of spray applied broadcast as more than 0.5 gal but
less than 5.0 gal/acre (more than 1.89 L but less than 18.93 L/ha) or less
than a full coverage spray.
Minimum effective dosage or MED refers to the lowest dose level
at which the test substance achieves the level of control specified by the
applicable performance standard.
Performance data refers to any data pertaining to pesticide effective-
ness and usefulness.
Serial application refers to the label recommended use of a pesticide
on a site before or after application of another pesticide to that site, such
that the presence of one of the pesticides may affect the effectiveness and
usefulness of the other.
Ultra low volume or ULV, as used in common agricultural practice,
refers to a total volume of 0.5 gal or less per acre (1.89 L or less per
hectare) broadcast.
(d) General considerations for pesticides other than
antimicrobials—(1) Scope of considerations, (i) The registration appli-
cant is reminded that certain efficacy data submittal requirements are
waived as described generally in paragraphs (b) and (d)(3)(i) of this guide-
line. Therefore, while the other paragraphs in this guideline provide guid-
ance concerning the methodology of efficacy testing and the content of
test reports, they do not independently establish any data submittal require-
ments.
(ii) The standards contained in this paragraph apply generally to all
studies in this guideline (except for antimicrobial agents (OPPTS 810.2000
(b) and (c)), unless another paragraph of this guideline contains a specific
standard on the same subject. In such a case, the specific standards in
the other paragraphs shall apply to the conduct of that particular study.
(2) Test standards—(i) Personnel. All testing and evaluation should
be done under the direction of personnel who have the education, training,
and/or experience to perform the testing and evaluation in accordance with
sound scientific experimental procedures. The Agency may require re-
sumes of personnel who have performed, supervised, reviewed, or evalu-
ated the testing.
(ii) Test substance. (A) The test substance shall generally be the for-
mulated product.
(B) In addition to or in lieu of data otherwise mentioned by this
guideline, the Agency may require, after consultation with the applicant,
data derived from testing to be conducted with:
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(7) An analytically pure grade of an active ingredient with or without
radioactive tagging.
(2) The technical grade of an active ingredient.
(3) The representative technical grade of an active ingredient.
(4) The inert ingredient of a pesticide formulation.
(5) A contaminant or impurity of an active or inert ingredient.
(6) A plant or animal metabolite or degradation product of an active
or inert ingredient.
(7) The end-use pesticide product.
(8) The end-use pesticide product plus any recommended vehicles and
adjuvants.
Any additional substance which could act as a synergist to the
product for which registration is sought.
(10) Any combination of substances mentioned in paragraph
(d)(2)(ii)(B) of this guideline.
(iii) Dosage rates. (A) The test substance should be tested at various
dosage levels including the dosage rates associated with the proposed use.
Dosage rates should be tested as requested by each paragraph when appli-
cable. Special attention should be paid to treatment rates on food crops
in relation to the tolerance or proposed tolerance. For public health pes-
ticides and termiticides, additional guidance on selection of test dosage
rates may be found in the specific discipline paragraphs of this guideline.
(B) The test program (sum total of preliminary and final stage tests)
should establish clearly the EDR or the MED as appropriate for the uses
involved. The development of an EDR, rather than a single MED, is en-
couraged, whenever feasible and practical, because the EDR permits at
least some of the users the opportunity to use rates other than the maxi-
mum rate needed to cover all use situations.
(iv) Serial applications. The label use directions may specifically di-
rect serial applications of different products, such as when tank mixing
is impractical. These directions should be supported by tests designed to
compare the effectiveness and usefulness of application of each product
alone with applications of the products applied serially. Special emphasis
should be directed toward determining whether or not a minimum time
interval between applications of the respective chemicals is warranted.
(v) Package mixtures. These products contain more than one active
ingredient. Data are needed to establish the efficacy of each active ingredi-
ent in a package mixture. However, since it is the efficacy of the formu-
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lated product/use-pattern combination that is to be established, testing as
part of an experimental use permit program is usually conducted with the
package mixture only. In many instances one or more of the separate ac-
tive components will have been previously registered as a single-compo-
nent product. In such cases, these data may be included as part of the
data base for the package mixture when suitable comparability data have
been developed to demonstrate that each active ingredient is effective and
safe to use on the target site regardless of whether it is used alone or
in the package mixture. (Note: Package mixtures which result in a signifi-
cant amount of inappropriate or unnecessary usage (dosages, certain active
ingredients, inappropriate timing, and unnecessarily high number of appli-
cations) of one or more of the active ingredients are not acceptable.)
(vi) Tank mixes. Product labeling which implies or recommends mix-
ing products in the spray tank before application should have acceptable
supporting data as described below.
(A) Directions for tank mixing of products should be supported by
performance data on each component (of the proposed mixture) tested sep-
arately as well as data on the mixture used at the dosage rate(s) specified
for each pest indicated. The combined minimum and combined maximum
dosage rates of each product in the tank mixture should be tested. Guid-
ance pertaining to tank mixtures for environmental fate data appear in
OPPTS 835.6400.
(B) The components of a pesticide tank mixture should be physically
and chemically compatible. Evaluations of physical compatibility should
be conducted using maximum rates of each component in minimum rec-
ommended volumes of diluent per acre or hectare, demonstrating effects
of order-of-component-addition to the tank, and evaluating effects of water
hardness, pH, and temperature on separation, suspendability, and
sprayability. Where compatibility is questionable from static tests, actual
testing should be done which should employ constant agitation of the mix-
ture as in most commercial field sprayers. (Note: Tank mixes which result
in a significant amount of inappropriate or unnecessary usage (dosages,
certain active ingredients, inappropriate timing, and unnecessarily high
number of applications) of one or more of the active ingredients are not
acceptable.)
(vii) Adjuvants. Products with labeling which allows or recommends
the additions of separately packaged adjuvants to the spray tank should
be supported with data indicating their benefits (if claimed) and any det-
rimental effects (such as increased crop phytotoxicity) which may result
from their addition to the herbicide, plant regulator, desiccant, or defoliant.
The only adjuvants actually permitted for use with a pesticide will be those
adjuvant brand names or defined adjuvant classes specifically named on
the pesticide label. The adjuvant rate or range of rates should be indicated
on the pesticide label, and should be supported with data on efficacy and
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any detrimental effects. If a range of adjuvant rates is recommended, the
maximum and minimum rates within that range should be evaluated in
conjunction with the intended pesticide product.
(viii) Geographic distribution of tests. Pesticide products marketed
on a nationwide basis may be used under a wide variety of conditions.
The pesticide should be tested in each major geographic area where the
pest is known to exist and be of importance, or where the crop is grown
in significant acreage. When a pest control program is intended for only
one locality where the pest is known to exist in significant amounts, test
data from that locality are usually sufficient. For public health pesticides
and termiticides, further instructions regarding testing in various geo-
graphic areas are located in the individual paragraph series on efficacy.
(ix) Test design and statistical procedures—(A) General test de-
sign. Sound statistical designs and procedures are necessary to assure that
valid and appropriate statistical analyses of the data can be performed and
that any observed statistically significant differences are attributable to the
respective pesticide treatments, and that such pesticide treatments provide
the expected pest organism response. Direct comparison of group means
of treated sites and untreated control sites is usually sufficient for evaluat-
ing treatment effects. The test results, however, for termiticides and public
health pesticides should show more than just statistically significant dif-
ferences between treated and control sites: The differences should gen-
erally be of a magnitude which meets or exceeds the performance stand-
ards described in each of the subsequent paragraphs of this guideline. (See
paragraph (d)(3) of this guideline for more information on performance
standards.) For useful references on test design and statistical procedures,
see paragraphs (e)(l) through (e)(7) of this guideline.
(B) Multiple site and pest target combinations. When more than
one pest or site is involved in pesticide applications, separate tests are
usually necessary to evaluate product performance against each kind of
pest or each kind of plant under each set of variables or use conditions.
For vertebrate control agents, however, it is preferred that efficacy be eval-
uated on one pest species at a time. If more than one method of application
is to be employed (such as, for example, air and ground sprays, drenches
and injections, or impregnation and surface coating), experiments should
be designed to obtain the required data for each method, on or in the
same experimental sites, and if separate evaluations can be made, their
respective levels of control can be assessed during the test.
(C) Replicates. Generally, the number of replicates necessary to dem-
onstrate treatment differences will depend upon several factors, such as
variability of test organisms and materials (crops, pests, application equip-
ment, soil conditions), magnitude of treatment effects, and the desired sta-
tistical confidence level.
8
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(D) Sampling procedures. Sampling procedures should assure that
all of the characteristics of the test population to be measured are rep-
resented in the samples. The size and number of samples necessary for
reliable estimates will vary mainly with the level and uniformity of the
organism or the effect to be measured as well as the size and precision
of available equipment. For example, entire replicates may need to be har-
vested to make accurate yield estimates or to measure plant growth re-
sponses when low pest populations are present, while representative por-
tions of each plot will probably be sufficient for measuring high density
pest populations.
(E) Considerations for crop test designs. In designing the test, all
variables, both uncontrollable (such as soil texture and microclimate) and
controllable (such as irrigation, cultivation, pruning, fertilization, cultivar,
and test product application) should be considered. Care should be taken
to duplicate carefully all controllable variables (other than test product ap-
plication) on all treated and untreated plots.
(7) Plot sizes. Plots should be large enough to reflect actual use con-
ditions and to allow representative application techniques, which may in-
clude commercial application equipment. Small plots, such as a single 10-
ft (3.3 m) row of vegetable and forage crops, and single-branch or single-
tree plots of fruits, are ordinarily insufficient to support valid conclusions
about product performance. Factors such as the crop grown, equipment
used, expected incidence of the pest, need for residue samples, yield data,
and quality studies should be considered in selecting the size of field plots.
The plots should be located within a field so as to be representative of
conditions throughout the field. Areas of fields such as borders and atypi-
cal wet or dry locations must generally be avoided, unless these are the
optimum areas for pest damage. For public health pesticides and
termiticides, more specific guidance as to adequate test plot sizes is pro-
vided in the guidelines on specific pesticide types.
(2) Crops or sites treated. A representative number of the major
cultivars of crops should be represented in the tests. Cultivars should be
more extensively utilized as a test variable to demonstrate adverse re-
sponses in tests.
(3) Climatic factors. The testing schedule should be designed to per-
mit evaluation of the effectiveness of pesticides applied under different
environmental conditions such as low versus moderate and high precipita-
tion, cool and cloudy versus normally hot and sunny conditions, and low
versus high humidity and dew formation, as appropriate to the product
use.
(4) Edaphic (soil) and other substrate factors. The effectiveness
of a pesticide product can often be influenced by the type of substrate
to which it is applied. Therefore, testing procedures should be designed
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to evaluate product performance on those surfaces or substrates intended
for treatment. A number of variables relating to soil, such as soil tempera-
ture, texture, fertility, pH, organic matter content, moisture content, tillage
practices, irrigation, and crop rotation schedules, measurably influence per-
formance of soil-applied pesticides. Accordingly, field tests should be de-
signed, as appropriate, to assess the potential effects of the pertinent vari-
ables. Data to determine safety to crops planted in the treated area the
same season and in following seasons should be submitted. (See OPPTS
850.1950, 850.2500, 850.4025 (Ecological Effects Test Guidelines).
(5) Spray volume. The volume of spray is another important variable
affecting the performance of pesticides because it directly relates to the
distribution and coverage obtained on the target site. When appropriate,
testing procedures must be designed to determine the acceptable range of
spray volume to be used with the intended application equipment. Special
emphasis should be placed on obtaining data on the minimum and maxi-
mum spray volumes when a specific amount of product is intended for
use in a range of spray gallonages.
(6) Timing of applications. Test reports should specify the time at
which treatment was begun, duration of exposure (if applicable), and inter-
vals between succeeding applications. For example, data on crop treat-
ments should include the following information (when applicable) in rela-
tion to timing of applications:
(/) Dates of treatments and harvest.
(//) Treatment time in relation to number of days before or after plant-
ing, plant emergence, or harvest.
(///) The stage of growth of the crop when treatment was made.
(/v) The stage of growth or expected appearance of the pest at treat-
ment time.
(v) Duration of exposure to pesticide treatment.
(v/) Treatment-to-observation intervals.
(7) Seasons. For pesticides used outdoors where variations in climato-
logical conditions alter efficacy, the seasons during which the tests were
conducted shall be reported.
(3) Suggested performance standards, (i) When efficacy data sub-
missions are not waived, performance standards will represent the levels
of a product performance that are exhibited by pesticides on specific site/
pest combinations and considered acceptable for registration purposes.
These standards, however, are not always absolute or inflexible. Labeling
statements are based on the performance standards and utilize tests in
OPPTS Test Guidelines Series 810.
10
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(ii) Suggested performance standards are usually expressed as per-
centages of pest control, or percentages of other intended responses, cal-
culated from measurements made on treated plots compared with those
made on untreated control plots. Reliance only on untreated control plots,
however, is not always sufficient or appropriate, particularly when testing
on very large areas against mobile pests, when testing dog repellents, or
when conducting tests in mobile substrates, e.g., herbicides applied to
moving bodies of water. In such cases, a product may be tested against
some other base, such as against another formulation or chemical of known
efficacy, or by comparison to pest levels or damage measured before and
after the test. For most pest control patterns, efficacy data should be ob-
tained under a full range of pest severity conditions, with particular empha-
sis on the maximum pest severity likely to be encountered by users.
(4) Adverse effects. To the extent possible, efficacy tests should be
designed to evaluate possible adverse effects resulting from use of the pes-
ticide. The following are examples of adverse effects which should be con-
sidered:
(i) Phytotoxicity. Details of data submitted on phytotoxicity are pro-
vided in OPPTS Test Guidelines Series 850, Group D (Ecological Ef-
fects—Nontarget Plants), but the following explanation may serve as an
introduction for those persons developing product performance data. A
good test design providing for dosages higher than necessary for pest con-
trol on plants will allow an estimate of the adequacy of the margin of
safety between effective pesticide levels and those which may injure the
plants intended to be protected. Phytotoxicity is usually measured in terms
of chlorosis, malformed plant parts, leaf burning, plant wilting, stunting
(reduced height), reduced stand, and death. For certain uses, some injury
can be tolerated (depending upon the reversibility of effects, or on eco-
nomic or aesthetic factors), but all injuries should be evaluated and re-
ported. Accordingly, the lack of observable phytotoxic effects should also
be reported.
(ii) Effects on quality of commodities and inanimate objects. Test
programs should be designed to evaluate adverse pesticide effects on treat-
ed commodities and surfaces, such as discolored and weakened fabrics,
deteriorated food quality, decrease in wool quality, milk production, and
unsightly residues on plant foliage. Taste panel tests, color determinations,
blemish counts, livestock palatability trials, or other similar measures,
should be considered for incorporation into the test program, depending
upon the end use of the commodity.
(iii) Yields and other effects. Such determinations will aid in ad-
vanced planning in the test design. Pesticide treatments may decrease
yield, reduce crop quality, or so alter the normal ripening or maturing
process that economic problems arise in harvesting. Data should address
the absence or the extent to which such effects occur.
11
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(iv) Effects on wildlife and aquatic organisms. Refer to OPPTS
Test Guidelines Series 850, Groups A and B (Ecological Effects—Aquatic
Fauna and Terrestrial Wildlife), for test requirements to evaluate adverse
effects on wildlife and aquatic organisms. Observations and evaluation of
efficacy test results should include relevant information about possible in-
crease in harmful nontarget organisms as a result of the pesticide use and
application, as well as possible increase in beneficial organisms to intoler-
able levels, and possible adverse effects of presence of pesticides.
(5) Test descriptions and data reporting—(i) Extent of report.
Systematic and complete descriptions of the tests employed and accurate
reporting of data derived from laboratory tests and field tests to support
label claims for performance of a product or mixture may be essential
for proper Agency review and evaluation. Both English and metric units
should be given for all rates and measurements for laboratory tests; English
units alone are sufficient for field data, but both measurements may be
supplied. Application rates expressed as parts per million (ppm) must indi-
cate the basis (weight/weight (w/w) or weight/volume (w/v)).
(ii) Assembly of report. Considerations for assembling the reported
efficacy data to expedite Agency review of the detailed report include:
(A) An index of the test reports. The index should be arranged pri-
marily according to the general types of performance data and secondarily
by the site/pest combinations on the label. Additional guidelines based on
methods of application, soil textures, geographic areas, or other pertinent
variables are encouraged wherever it is feasible and will facilitate an eval-
uation of the data. It is recommended that numbered tabs be used to iden-
tify the individual test reports.
(B) Tabular summaries of the data. It is recommended that each
horizontal line (or series of several lines) be equivalent to a test, and that
columns reflect the major test variables being reported, such as those de-
tails listed in paragraph (d)(5)(iii) of this guideline. These summaries
should be organized primarily according to site/pest combinations and sec-
ondarily according to pertinent variables, such as methods of application,
soil textures, or test locations. The purpose of summary tables is to present
a condensed and simplified overview of the scope of the test program
and the level of product performance obtained. In order to achieve maxi-
mum utilization of space in tables, the use of abbreviations, acronyms,
or defined codes as well as the grouping of several types of information
within columns is encouraged.
(C) Summarized conclusions related to label claims. Data analyses
and evaluations should be included.
(iii) Details of report. All details of the tests should be reported,
giving particular emphasis to variables that relate to the label directions,
limitations, and precautions. Such details may include:
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(A) Personnel data. Names, positions, and addresses of persons who
conducted and supervised the tests should be reported. Names of all per-
sons who recorded or generated data for the tests should be made part
of the record (not submitted but held as records) along with the dates
when the items of data were recorded.
(B) Test substance. (7) Identification should be made of the test sub-
stance, including chemical name, molecular structure, and qualitative and
quantitative description of its chemical composition as required by OPPTS
Test Guidelines Series 830.
(2) Manufacturer and lot sample numbers of the test substance should
be reported.
(3) Type of formulation and content (percent and, for liquids, pounds
per gallon or kilograms per liter) of active ingredients should be reported.
When a product is diluted before or during application, the report should
specify the quantities and identification of each diluent.
(4) For many pesticide products, data on similar formulations may
be used to supplement data on the specific formulation when the com-
parability of the formulations has been demonstrated. This procedure is
not acceptable, however, for vertebrate control agents because very slight
differences in formulation may cause marked differences in efficacy due,
principally, to the highly developed sensory perception of many vertebrate
pests.
(C) Testing period. Report dates during which each test was con-
ducted.
(D) Method of application. The methods and types of pesticide
placement, such as surface, subsurface (as in soils), or incorporated, shall
be reported. Descriptions of surface placements should indicate the method
of application, such as wiping, soaking, mopping, dusting, painting, spray-
ing, trail-building, broadcast seeding, or scoop placement.
(7) If the surface is to be sprayed, details on spray volume, such
as ULV, LV, concentrate, or conventional full coverage spray, should be
given in terms of volume per unit area.
(2) For subsurface methods, descriptions should indicate whether
done by furrow placement, side-dressing, injection, or burrowbuilding.
When describing injection methods, such information as spacing, number,
and arrangement of chisels with respect to the row and depth of injection
should be given.
(3) Descriptions of incorporated methods of application should indi-
cate whether done by mixing, drenching, or impregnating. Details on the
methods and equipment used and depth of incorporation may be requested
for agricultural applications to soils.
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(4) Information detailing the type of application, such as row (furrow
placement, band, or side-dressing) or broadcast, bait boxes, swath place-
ment, pressure-treated, or soaked, should accompany the test report data.
Pesticides applied as row or band treatments should specify the band width
and the amount of material used per unit of linear row distance, and the
amount of material per acre (or hectare) and the row spacing. When per
acre (hectare) figures are included in test reports for row or band treat-
ments, the report should specify whether these figures represent the "ac-
tual" amounts of pesticides applied or the "broadcast equivalent" rates.
(E) Equipment. (7) The types of equipment used should be reported.
This may include such items as mistblowers, cyclone seeders, hydraulic
ground sprayers, artificial perches, dusters, burrow builders, soil injectors
or incorporators, aircraft systems (specify whether fixed wing or heli-
copter), metering devices, smoke generators, rodent guns, impregnators,
and aerosol dispensers.
(2) For mistblower applications, information on spray volume, air ve-
locity, swath width, distance from nozzles to the target, and angle of air
flow from the vertical should be given.
(3) For pesticide application through irrigation systems, the informa-
tion includes: The types of systems used, such as sprinkler (stationary or
mobile), furrow, drip, or flood; the quantity of water applied; description
of the pesticide metering devices; pesticide concentrations in water sam-
ples collected at various points throughout the system; and any spatial ar-
rangement of crops (if applicable).
(4) When pesticides are to be mechanically incorporated into soil,
information should be reported on the equipment used, speed and depth
of operation, number of passes over the treated area, and intervals between
repeated incorporations (if applicable). Sufficient information on mechani-
cal incorporations into soils or other growth media used at sites other than
fields may be needed.
(F) Dosage rate. (7) The dosage rate expressed as active ingredient
and formulated product should be reported. Dosages should be reported
in terms similar to the following: Amounts per unit of surface area, per
unit volume of solvent or diluent, per unit volume or weight of commodity,
per unit volume of space, per unit area and depth (acre-foot or hectare-
meter), per linear distance of crop row, per animal, per unit weight of
animals, and the length of time of spraying and the distance from the target
surface (as for certain pressurized products).
(2) When other pesticides are applied in the test area, the rates of
application for each product, the identification of pesticides used, and the
timing of application should be reported.
Spray volumes should be included in the data reports.
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(G) Description of application site. (7) The site of application should
be reported.
(2) The following information should be taken into consideration in
describing the sites. Contact pesticides are applied to the pests themselves
or to plant parts for which plant regulator, desiccant, or defoliant activity
is intended. Residual pesticides are applied to substrates or surfaces which
will in turn be contacted by pests. The specific site of application required
for effective use of residual pesticides may be related to feeding or behav-
ioral habits of insects and animals, characteristics of plants, mode-of-action
of the pesticide, or the location of infection sites of plant pathogenic fungi
and bacteria. For example, dogs establish urinary scent posts, and certain
repellents should be applied to these areas to be effective; or, as another
example, since mites feed principally on the undersides of plant leaves,
nonsystemic miticides should be applied to both surfaces to control those
feeding and those crawling around. The site of application may also be
directly related to the mode-of-action of the pesticide. A systemic insecti-
cide may, for example, be applied to foliage or the root system so it can
be transported to various parts of the plant where it will kill or repel feed-
ing insects. A plant regulator may be sprayed on the foliage and cause
the desired response at parts of the plant that were not directly sprayed.
A herbicide may be applied to the soil, be absorbed by the roots, and
be translocated through the stem to the foliage where it exerts its pesticidal
action.
Texture of soil and its organic matter content should be reported
if applicable to the pesticide usage. In situations where pesticides are in-
tended to act through soil or in burrows, conditions such as tilth, compac-
tion, drainage, moisture, mineral content, temperature, and pH should be
reported.
(4) Dimensions of test plots or sites and number of replicates should
be reported. The type of experimental design used such as detailed descrip-
tion and diagram of the experimental test area should be reported.
(5) Number and length of crop rows, row spacing, and plant spacing
within rows, if applicable, should be reported.
(6) If crops or crop sites are treated, a statement regarding cultivar
name and other distinguishing characteristics (e.g., level of pest suscepti-
bility) should be reported.
(7) When buildings are treated with pesticides, the number of rooms,
their dimensions, and their spatial arrangements should be reported.
(H) Geographic areas. Geographic areas (state, county, and town)
where the tests were conducted, and the rationales for selection of these
sites, should be reported.
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(I) Climatic factors. Critical environmental conditions at application
time, such as precipitation, temperature, sunlight, humidity, and wind ve-
locity, should be reported. Abnormal climatic conditions may occur within
a given area which cannot be considered in the test design but these may
markedly affect results. Such conditions and effects observed should be
reported in the discussion or conclusions.
(J) Pest populations and crop stage. Target pest population levels
at the beginning of treatment, at periodic intervals after treatment, and
at the end of the test period should be reported when applicable. The
growth stages of the pests and host plants should be reported. Crop growth
stage should be referenced to the number of days before or after planting,
emergence, or specific development stage or to its height. Whenever pos-
sible, the general level of the pest problem being tested should be charac-
terized (light, moderate, severe, or similar phraseology).
(K) Cultural practices. When applicable, information is needed on
cultural practices that may affect pesticide application to crops because
of their impact on product performance. Where applicable, the report must
include information on seedbed preparation, seed planting depth, cultiva-
tion practices, and supplemental irrigation. Additional details on irrigation
practices as an experimental variable are discussed in paragraph
(d)(5)(iii)(E)(3) of this guideline.
(L) Observation times. The interval between treatments and observa-
tions for pest control should be reported. Observations for efficacy and
adverse effects should be made at intervals which indicate minimum re-
sponse times and duration of effects. Dates observed and percent control
of specific pests or plant responses to growth regulators, desiccants, or
defoliants compared to untreated controls and to commercial pesticides (if
used as standards) should be reported.
(M) Unusual events. Pertinent comments regarding effects test condi-
tions on performance should be reported, particularly when they adversely
affect the level of product performance or would invalidate the test data
obtained.
(N) Mode of pesticide entry, movement, and action. A description
of the mode of action and movement of the pesticide (e.g., translocation,
tenacity, redistribution through rain) should be included in the test report
or referenced when known. For a pesticide used to control vertebrate ani-
mals, the report should note how the pesticide enters the pest organism,
such as by body contact, inhalation, oral ingestion, or by any combination
of these routes.
(O) Statistical procedures. A description of the statistical procedures
used in the test design and analysis should be reported.
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(iv) Performance evaluations. (A) A special section of the test report
should be devoted to product performance evaluations. The following are
examples of systems that may be used to evaluate the submitted data:
(7) A rating scale (or percent) showing performance related to effi-
cacy and commercial acceptability as a rating score. Descriptive criteria
for each numerical value if a rating scale should be presented.
(2) Dose-response data for all site/pest combinations for which reg-
istration is proposed.
Clearly defined statements of benefits, such as increased yields,
unblemished fruits, reduction in nuisance pest levels, reduced disease inci-
dence, fewer rat bites, to be derived from the pesticide use. The applicant
should indicate what he considers to be a commercially acceptable level
of pest control.
(B) Refer to OPPTS Test Guidelines Series 850, Groups D and E
(Ecological Effects — Nontarget Plants and Toxicity to Microorganisms),
for reporting phytotoxicity. Report other adverse effects such as spotting
of paint, weakening of cloth or fibers, presence or odors of dead pest orga-
nisms, secondary poisoning, increase of nontarget species to intolerable
levels, and similar adverse or undesirable results.
(6) Supporting statements. An applicant may submit written state-
ments of opinion regarding the efficacy and limitations of a particular
product, when expressed by individuals reasonably expert in observation
and having experience with repeated use of such products. Evidence of
the expert's experience should accompany such statements. Testimonials
or letters of recommendations from individuals with less than the qualifica-
tions described in this paragraph are not acceptable as support for effec-
tiveness claims.
(e) References. The following references may be consulted for infor-
mation on statistical design and analysis.
(1) Dowdy, Shirley and Stanley Wearden. 1991. Statistics for Re-
search. 2nd ed. John Wiley & Sons; NY, NY.
(2) Draper, N.R. and H. Smith. 1981. Applied Regression Analysis.
2nd ed. John Wiley & Sons; NY, NY.
(3) Frank, Harry and Steven C. Althoen. 1994. Statistics: Concepts
and Applications. Cambridge Universityi Press; NY, NY.
(4) Gomez, Kwanchai A. and Arturo A. Gomez. 1984. Statistical Pro-
cedures for Agricultural Research. 2nd ed. John Wiley & Sons; NY, NY.
(5) Hamburg, Morris and Peg Young. 1984. Statistical Analysis for
Decision Making. 6th ed. Harcourt Brace; NY, NY.
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(6) Mason, Robert L., Richard F. Gunst, James L. Hess. 1989. Statis-
tical Design and Analysis of Experiments. John Wiley & Sons; NY, NY.
(7) Steel, Robert G.D. and James H. Torrie. 1980. Principles and Pro-
cedures of Statistics. 2nd ed. McGraw-Hill; NY, NY.
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