EPA 540/9-86-135
June 1986
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HAZARD EVALUATION DIVISION
STANDARD EVALUATION PROCEDURE
NON-TARGET PLANTS:
TERRESTRIAL FIELD TESTING - TIER 3
Prepared by
Robert W. Hoist, Ph.D.
Standard Evaluation Procedures Project Manager
Stephen L. Johnson
Hazard Evaluation Division
Office of Pesticide Programs
'i.S. E.-:vJr".-">cn*,!:\ Protect!on Agency
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.Vi'ijliiagton, DC 20469
United States Environmental Protection Agency
Office of Pesticide Programs
Washington, D.C. 20460
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TABLE OF CONTENTS
I. INTRODUCTION
A. Purpose of the Standard Evaluation
Procedure ..., 1
B. Background Information 1
C. Objective of the Terrestrial Field
Testing Tier 3 Test 1
II. INFORMATION TO BE SUPPLIED 1
III. DATA INTERPRETATION 2
IV. THE DATA EVALUATION PROCESS
A. Identify Data Gaps 2
B. Assess the Appropriateness and
Adequacy of the Data 3
C. Report Preparation , 3
D. Conclude if the Requested Action
i s Supportable 3
V. APPENDICES
Appendix 1: Information Requested of the
Registrant 4
Appendix 2: Specific Questions for the
Reviewer 7
Appendix 3: Sample Standard Format for
Preparation of Scientific
Reviews 10
REFERENCES 11
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NON-TARGET PLANTSi TERRESTRIAL FIELD TESTING - TIER 3
I. INTRODUCTION
A. Purpose of the Standard Evaluation Procedure
This Standard Evaluation Procedure is designed to aid Ecologi-
cal Effects Branch (EEB) data reviewers in their evaluations of
Tier 3 terrestrial field testing plant studies submitted by regis-
trants in the assessment of pesticide effects on non-target plants.
B. Background Information
Terrestrial field testing (Tier 3) studies are designed to pro-
vide phytotoxicity data on a pesticide. These phytotoxicity data
are needed to evaluate the level of pesticide exposure to non-target
terrestrial plants and to assess the impact of pesticides on endan-
gered and threatened plants as noted under the Endangered Species
Act. Where 'a phytotoxic effect is noted in one or more plants,
additional terrestrial field testing studies may be required. These
data are required by 40 CFR § 158.150 to support the registration
of any pesticide intended for outdoor use under the Federal Insecti-
cide, Fungicide and Rodenticide Act (FIFRA), as amended.
Pesticides with outdoor use patterns that do not readily releas^
the pesticide to the environment do not have to be evaluated using
this phytotoxicity test. These use patterns include tree injection,
subsurface soil applications, recapture systems, wick applications,
and swimming pool uses. If any of these use patterns do readily
expose non-target plants to the pesticide, as through vapors, the
pesticide phytotoxicity potential may need to be evaluated.
C. Objective of the Terrestrial Field Testing Tier 3 Test
The objective of the Tier 3 terrestrial field testing study is
to determine if a pesticide exerts a detrimental effect to plants
during critical stages in their development. The test is performed
on species from a cross-section of the non-target terrestrial plant
population. This is a multiple dose test designed to evaluate the
phytotoxic effects of the pesticide over a wide range of anticipated
pesticide quantities as may be found in the environment.
II. INFORMATION TO BE SUPPLIED
The registrant's report on terrestrial field testing studies
should include all information necessary to provide: 1) a complete
and accurate description of the laboratory/greenhouse treatments
and procedures, 2) sampling data and phytotoxicity rating, 3) data
on storage of the plant material until analysis, if so performed,
4) any chemical analysis of the plant material as to chemical con-
tent, if so performed, 5) reporting of the data, rating system and
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statistical analysis, and 6) quality control measures/precautions
taken to ensure the fidelity of the operations.
A quideline of specific information that should be included in
the registrant's report of terrestrial field testing studies is pro-
vided in Appendix 1 of this document; The lists of requested infor-
mation and reviewer aids are derived from the Pesticide Assessment
Guidelines, Subdivision Jt Hazard Evaluation of Non-Target Plants,
which is complemented by this Standard Evaluation Procedure.
III. EftTA INTERPRETATION
The acceptability of the study results will depend upon whether
the test requirements/standards are followed. If a deviation is
made, a determination must be made as to whether the deviation has
changed the quality of the results in such a manner that the results
cannot be extrapolated to the natural environment. There should be
little or no deviation from the liberalized standards prescribed
in this study.
The results of the phytotoxicity test of the chemical with
respect to the quantity applied to the foliage are important. The
concentration of the chemical in the carrier is important in that
stronger concentrations than normally used can lead to burning and
necrosis. Subtoxic concentrations, on the other hand, may also
cause unwanted rapid growth.
Plants can recover from certain types of injury that will have
little or no effect on the esthetic or economic value of the plant(s
tested or to which an evaluation is made. Therefore, it is importan
that a minimum of two weeks of observations be made after applicatio
of the pesticide; three to four weeks are preferable.
A decision point to perform additional Tier 3 terrestrial tests
is a 25% detrimental effect, i.e., a 25% change in plant growth or
injury as compared to untreated controls. This level is considered
to be that point at which the plants will not recover to their full
esthetic value, economic value or reproductive potential as in the
case of the maintenance of the endangered or threatened species.
IV. THE DATA EVALUATION PROCESS
Upon careful examination of the information/data supplied by
trie registrant in his submission to the Agency, the reviewer shall
evaluate the data as follows.
A. Identify Data Gaps
Using Appendix 1 of this document as a guide, the reviewer
should look for data gaps - omissions in the information supplied
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by the registrant in his report. These should be duly noted in the
reviewer's report, and a judgment made as to which are considered
significant enough to adversely affect the review process. Those
so identified should be communicated back to the registrant by the
Product Manager for corrective action.
B. Assess the Appropriateness and Adeguacy of the Data
The data reviewer then considers the appropriateness, i.e., the
intended use pattern, and adeguacy of the data/information that has
been supplied. Appendix 1 of this document is a useful guide to the
various parameters that need to be considered. Appendix 2 provides
specific guestions that should be answered by the reviewer during
the study evaluation process. Statistical treatments of the data
should be independently verified and the guality control precautions
noted.
As an adjunct to these, the reviewer should draw upon the tech-
nical guidance in the reviewer aids materials that are available.
{See also the recommended references in Subdivision J - Hazard Eval-
uation; N on- Target Pi ants . ) A listing of additional source materials
is located in the References section of this document.
In addition to the data gaps noted above, any perceived defi-
ciencies in the data/information supplied should also be identified.
A statement as to these deficiencies should be made in the reviewer'
report and corrective action to resolve them should be provided.
This information can be relayed to the registrant by the Product
Manager for appropriate action.
C. Report Preparation
The Agency reviewer prepares a standard review report following
the standard format for preparation of scientific reviews as provide):!
in Appendix 3 of this document. All important information provided
fcy the registrant including the methodology and results should be
summarized in order that future evaluations can be made. The resultjs
ir.ay be expressed in the form of tables where specific values are
related. Figures (graphs) may be provided but are not to be the sol
source of the values needed for future evaluations.
D. Conclude if the Requested Action is Supportable
Lastly, the reviewer considers the results of the terrestrial
field testing studies and makes a judgment as to whether they sup-
port the requested registration action of the data submitter. If
the data are not supportive, possible alternative action(s) that
iray be taken by the registrant, such as label modification, are
suggested. If deficiencies/omissions exist in the submitted data,
the reviewer may have to defer judgment until such time as appro-
priate corrective action has been rendered by the registrant.
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APPENDIX 1
INFORMATION REQUESTED OF THE REGISTRANT
The registrant's report on terrestrial field testing studies
include all information necessary to provide: 1) a complete
d accurate description of the field treatments and procedures,
sampling data and phytotoxicity rating, 3) data on storage of the
ant material, if so performed, 4) any chemical analysis of the
jant material as to chemical content, if so performed, 5) reporting
the data, rating system and statistical analysis, and 6) Quality
ntrol measures/precautions taken to ensure the fidelity of the
erations.
Specifically, each laboratory/greenhouse/small field plot ter-
r ^trial field testing report should include the following informati<
1 General •
0 Cooperator or researcher (name and address), test location
( Bounty and state; country, if outside of the U.S.A.), and date of
s fudy;
0 Name (and signature), title, organization, address, and
i ;lephone number of the person(s) responsible for planning/super-
\ .sing/monitoring and, for field plot studies, applying the pesticid
0 Trial identification number;
0 Quality assurance indicating: control measures/precautions
jllowed to ensure the fidelity of the phytotoxicity determinations;
icord-keeping procedures and availability of logbooks; skill of
ie laboratory personnel; status of the field and supporting labora-
>ry equipment; degree of adherence to good laboratory practices;
id degree of adherence to good agricultural practices in maintainin
^althly plants; and
0 Other information the registrant considers appropriate and
i slevant to provide a complete and thorough description of the test
I -ocedures and results.
II. Test Substance (Pesticide)
0 Identification of the test pesticide active ingredient (ai)
including chemical name, common name (ANSI, BSI, ISO, WSSA), and
Company developmental/experimental name;
0 Active ingredient percentage in the end-use product or repre
sentative end-use product from the same major formulation category
for that general use pattern;
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0 Dose rate(s) in terms of active ingredient per area of land
or of leaf (if leaf-area-index is provided);
e Dose rate{s) in terms of less than the maximum label rate
with dosages in a geometrical progression of no more than two-fold
and with subtoxic (< EC$Q level) and non-toxic (no-observable-effect
level) concentrations;
0 Method of application including equipment type (nozzles,
orifices, pressures); and
0 Number and timing of applications.
III. Plant Species
0 Identification of the plant species used. They shall be
representatives of the following plant groups:
Dicotyledonae (dicots) 3 Families
Monocotyledonae (monocots) 3 Families
Vascular Cryptogamae (ferns and allies) 2 Families
Bryophyta (mosses) or Hepatophyta (liverworts)
(Wetland use patterns only) 1 Family
Gymnospermae (conifers) 1 Representative
" Identification of the cultivar(s) of the plant species used,
where possible;
0 Identification of the number of replicates and the number
of plants per replicate per dose; and
0 Identification of the date of planting, date of pesticide
application, and date of phytotoxicity rating or harvest.
IV. Site of the Test
0 Site description of the terrestrial field testing study such
as a grassland, forested area, fallow field, tilled field, etc.;
0 Location of the test site(s) that represent the general
regional areas of potential usage as noted below:
Northeastern temperate deciduous
Southeastern temperate deciduous
Northern grassland (cool prairie)
Southern grassland (warm prairie)
Northwestern (and Alaskan) conifer forest and high desert
Southwestern chaparral Mediterranean and low desert
Hawaiian and Caribbean semi-tropical and tropical regions
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0 Climatological data during the test (records of applicable
conditions for the type of site, i.e., temperature, thermoperiod,
rainfall or watering regime, light regime - intensity and quality,
relative humidity, wind speed);
0 Field lay-out (for field plots), e.g., size and number of
control and experimental plots; number of plants per plot/unit
area;
0 Population density of seeds or plants;
0 Cultural practices such as cultivation and irrigation; and
0 Substrate characteristics of the site(s) (name/designation
of soil type and its physical and chemical properties, including pH
and percent organic matter, presence and depth of fragipan or
shallow bedrock, etc.).
[ V. Results
0 Phytotoxicity rating (including a description of the rating
system) for each plant or group of plants (population) in the test;
0 Weight, height or other growth parameters that may have been
measured to ascertain toxic effects of the pesticide upon the
plants; and
0 Statistical analysis of the results including environmental
or effective concentration (EC) values.
VI. Evaluation
0 Determination as to whether additional phytotoxicity testing
will be necessary to characterize the phytotoxic nature of the
c.iemical.
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.»•» •
APPENDIX 2
SPECIFIC QUESTIONS FOR THE REVIEWER
The following questions are provided to aid the reviewer in
performing the standard evaluation procedure in a scientific manner
c.nd in acquiring the necessary information to complete a standard
format for preparation of scientific reviews.
I . General
0 Were the name of the cooperator or researcher (name and
address), test location (county and state; country, if outside of
the U.S.A.), and date of study provided?
0 Were the name (and signature), title, organization, address,
and telephone number of the person(s) responsible for planning/super
vising/monitoring and, for field plot studies, applying the pesticid
provided?
0 Was the trial identification number provided?
0 Were quality assurance control measures/precautions indicate
II . Test Chemical
° Was the test chemical used the end-use product or a repre-
tentative end-use product from the same major formulation category
for that general use pattern?
0 Was the active ingredient percentage of the chemical given?
0 Were the doses given in quantity per unit area (of plant or
land surface) or tank concentrations?
0 Was the maximum dose less than the maximum label rate?
9 Were the additional dosages of a geometric progression of
no more than two-fold, e.g., 0.1, 0.2, 0.4, 0.8, 1.6 kg/ha?
0 Were a subtoxic (< ECsg) and a non- toxic concentration
evaluated?
III. Test Species
0 Were representatives from the following groups included in
the studies?
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Dicotyledonae (dicots) 3 Families
Monocotyledonae (monocots) 3 Families
Vascular Cryptogamae (ferns and allies) 2 Families
Bryophyta (mosses) or Hepatophyta (liverworts)
(Wetland use patterns only) 1 Family
Gymnospermae (conifers) - 1 Representative
Where seed germination/seedling emergence studies have been performe
seeds of plants with low or variable germination potential should
have been avoided. Some seeds of Questionable species and varieties
should have been pretested for viability.
0 If any plant group is not likely to be exposed to the pesti-
cide under normal conditions of use, testing of such groups is not
required. Was justification for elimination of a test species or
group included in the test report?
0 Where various cultivars could be used/ such as in the case
of most agronomic and horticultural plants, were cultivar or varieta
names provided? Were the plant and seed sources identified?
0 Were there at least three replicates with five plants per
replicate for each dose?
0 Were the plants healthy and not in a state of stress?
0 Were the plants in a staqe of development under which the
pesticide would be normally applied?
0 If surrogate plant species were used to represent those of
the natural habitat, were such relationships identified?
0 Were endangered or threatened plant species not used?
IV. Test Procedures
0 Were the locations of the test site(s) within the following
general geographical regions in which the pesticide is to be used
provided?
Northeastern temperate deciduous
Southeastern temperate deciduous
Northern grassland (cool prairie)
Southern grassland (warm prairie)
Northwestern (and Alaskan) conifer forest and high desert
Southwestern chaparral Mediterranean and low desert
Hawaiian and Caribbean semi-tropical and tropical regions
0 Was the test site specified, i.e., small field plot or large
field plot?
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0 Were the environmental conditions that prevailed during the
test (temperature, thermoperiod, light regime - intensity and qualit
rainfall or watering regime, relative humidity, wind) provided as
appropriate for the site?
0 Were the environmental conditions that prevailed during
the test those most favorable and most typical to the growth of the
plants used? Were the conditions referenced?
0 Was the test duration two weeks to four weeks in length?
0 If multiple applications are directed on the label, were the
made and did the observations extend at least two weeks past the
last application?
0 Was the test substance applied over a period of time or
season according to the proposed label instructions?
0 Was the method of pesticide application including the type
of application equipment given?
V. Reporting
0 Were the detrimental effects reported as severity of phyto-
toxicity (rating or percentage)?
0 If a rating system was used, was an explanation provided?
0 Were observations to note plant growth and response to the
pesticide taken at least twice weekly?
0 Were abnormal changes in growth, development, and/or morpho-
logy reported as compared to the controls?
0 Though not required, were direct measurements of height,
weight, or other growth parameters provided?
VI. Evaluation
0 Were the results tabulated to indicate a percentage effect
level for each species as compared to the untreated control plants?
0 Were 25 and 50 percent detrimental effect levels determined
for those plant species of Tier 2 that showed a phytotoxic effect
to the chemical?
0 Was a determination made as to whether additional terres-
trial field phytotoxicity tests were necessary to evaluate the
effects of the pesticide on non-target plants?
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APPENDIX 3
SAMPLE STANDARD FORMAT FOR PREPARATION OF SCIENTIFIC REVIEWS
The following format shall be used in documenting the review
of the Subdivision J - Hazard Evaluation; Non-Target Plants - Tier
3 - Terrestrial Field Testing Study.
Chemical: (Common Name)
Formulation: (Percent Active Ingredient)
Study/Action: {Purpose of the Submission)
Study Identification:
. (Subdivision J Test Title)
(Reference or Registrant Data Information with
Study Number)
(EPA Accession Number)
Reviewer: (Name and Address of Reviewer; Date of Review)
Approvals (Quality Control Reviewer)
Conclusions: (Summary and Conclusion of Tests)
Acceptability and Recommendations:
(Decide as to (1) the scientific validity of the
study and (2) compliance to the Subdivision J -
Terrestial Field Testing guidelines)
Background:
Discussion:
(Introductory Information and Directions for Use)
1. Study Identification
2. Materials and Methods
3. Reported Results
4. Reported Conclusions
5. Reviewer's Interpretation of Results and Conclusion
Oil
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REFERENCES
Little, T. M., and F, J. Hills. 1978. Agricultural Experimentatio
Design and Analysis. New York: John Wiley and Sons.
"ruelove, B., ed. 1977. Research Methodsin Weed Science. Southe
Weed Science Society. Auburn, AL: Auburn Printing Inc.
Other scientific articles of seed germination may be found in
the following journals:
Agronomy Journal
Environmental Science and Technology
Journal of Environmental Quality
Soil Science and Plant Nutrition
Weed Science
U.S. Environmental Protection Agency
Liv T-fii"-'. PTD™; ?'0'i PM-211-A
^01 I' Ftroet. S.W.
Washington, DC 20460
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