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

     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

     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, 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

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

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

    (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

     (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

     (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.

                    Table 1.—Organization of the 810 Series
Pesticide type
Antimicrobials — Public health
Rest of Non-public Health Pesticides except
Public Health except antimicrobials
Applicable guideline series
General considerations sections
Specific sections
     (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

     (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).

     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-

     (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:

     (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
        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-

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

    (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

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.


     (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

     (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

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.


     (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-

     (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.


     (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:


     (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

     (C) Testing period.  Report dates during  which each test was con-

     (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.


     (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.


     (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
        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

     (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.


     (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

     (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.


     (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.


    (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.