f/EPA
United States
Environmental Protection
Agency
Office of Pesticide Programs
Washington, DC 20460
EPA 540/9-86-130
June 1986
Hazard Evaluation Division
Standard Evaluation Procedure
Non-Target Plants: Target Area Testing
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EPA 540/9-86-130
June 1986
HAZARD EVALUATION DIVISION
STANDARD EVALUATION PROCEDURE
NON-TARGET PLANTS:
TARGET AREA TESTING
Prepared by
Robert W. Hoist, Ph.D.
Standard Evaluation Procedures Project Manager
Stephen L. Johnson
Hazard Evaluation Division
Office of Pesticide Programs
United States Environmental Protection Agency
Office of Pesticide Programs
Washington, D.C. 20460
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TABLE OF CONTENTS
Page
I. INTRODUCTION
A. Purpose of the Standard Evaluation
Procedure 1
B. Background Information ......... 1
C. Objective of the Target Area Test ... . 2
II. INFORMATIONTOBE SUPPLIED . ........ 2
III. DATA INTERPRETATION 2
IV. THE DATA EVALUATION PROCESS
A. Identify Data Gaps . . . •. . . . 3
B. Assess the Appropriateness and Adequacy
of the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
C . Re p0 r t P rep a r a t 10 n . . . . . . . . . . . . . . . . . . . 4
D. Conclude it the Requested Action is
Supportable . . . . . . . . 4
V. APPENDICES
Appendix 1: Information Requested of the
Reyistrant . . . . . . . . . . . . . . . 5
Appendix 2: Specific Questions for the
Reviewer • . . . . . . . . . . . . , . . . . . . . . . . . . 8
Appendix 3: Sample Standard Format for
Preparation of Scientific
Reviews . • 4I • . • • . • . . . . . . . •1 • • • • • . . 14
RE 1 1h,RENCES 1S•••••• •• .... . ... • .. • .. • •• , •,•.••.. . .. •. lb
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NON-TARGET PLANTS: TARGET AREA TESTING
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
greenhouse/field plot target area testing studies submitted by
registrants in the assessment of pesticide effects on desirable
plants within the target area.
B. Background Information
Target area testing studies are designed to provide phytotoxi—
city information on a pesticide. These phytotoxicity data are needed
to evaluate the effect of the level of pesticide exposure to target
area terrestrial and aquatic plants that are not intended to be con-
trolled, and to assess the impact of pesticides on endangered and
threatened plants as noted under the Endangered Species Act. Where
a phytotoxic effect is noted in one or more plant species, further
target area phytotoxicity studies may be required (after consultation
with the Agency). These studies are required by 40 CFR § 158.150
to support the registration of any pesticide intended for outdoor
use under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA), as amended.
The target area phytotoxicity studies are unique because the
pesticide is being applied directly to the plant. In addition to
the direct application, several factors can affect the degree of
possible phytotoxic response. Cultural practices can vary with
production areas and frequently from grower to grower within an
area. These include irrigation practices, mowing, and field culti-
vation practices. Method of application can dictate the route of
exposure of the pesticide to the plant, i.e., whether it is by the
roots or shoots and leaves. Spray versus furrow chemigation can
also dictate the degree of exposure and resultant phytotoxicity.
Pesticides with outdoor use patterns that do not readily
release the pesticide to the environment will have to be evaluated
using this phytotoxicity test. These use patterns include subsurface
soil applications, recapture systems, wick applications and swimming
pool uses. Those uses that include long—term or total vegetation
control, e.g., clean yard chemicals, desiccants and defoliants, need
not be evaluated.
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C. Objective of the Target Area Test
The objective of the target area test is to determine if a
pesticide exerts any detrimental effects to plants during the
exposed growth period of their development. The test is performed
on those desirable target area or pest host plant species as listed
on the label which will be in the target area. Being a multiple
dose test, it is 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. INfDRMATION TO BE SUPPLIED
The registrant’s report on target area testing studies should
include all information necessary to provide: 1) a complete and
accurate description of the greenhouse/field plot 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 p1ant material as to chemical con-
tent, if so performed, 5) reporting of the data, rating system and
statistical analysis, and 6) quality control measures/precautions
taken to ensure the fidelity of the operations.
A guideline of specific information that should be included in
the registrant’s report of target area testing studies is provided
in Appendix 1 of this document. The lists of required information
and reviewer aids are derived from the Pesticide Assessment Guide-
lines, Subdivision 3: Hazard Evaluation of Non—Target Plants , which
is complemented by this Standard Evaluation Procedure.
III. DATA 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 tests of the chemical with
respect to the quantity applied to the plant as a whole, whether to
the foliage, fruit or soil, 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 con-
centrations, on the other hand, may cause unwanted rapid growth.
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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 on which an evaluation is made. Therefore, it is important
that a minimum of two weeks of observations be made after the last
application of the pesticide, preferably three to four weeks, to
note any detrimental effects.
There is no decision point for this test as to whether addi-
tional target area/non—target plant studies must be performed.
IV. THE DATA EVALUATION PROCESS
Upon careful examination of the information/data supplied by
the 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 tor data gaps — omissions in the information supplied
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 Adequacy of the Data
The data reviewer then considers the appropriateness, i.e. , the
intended use pattern, and adequacy 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 questions that should be answered by the reviewer during
the Study evaluation process. Statistical treatments of the data
should be independently verified and the quality 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: Non—Target Plants. ) 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 defici-
encies in the data/information supplied should also be identified.
A statement as to these deficiencies should be made in the reviewer’s
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.
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C. Report Preparation
The Agency reviewer prepares a standard review report following
the standard format for preparation of scientific reviews as provided
in Appendix 3 of this document. All important information provided
by the registrant including the methodology and results is to be
summarized in order that future evaluations can be made. The
results may be expressed in the form of tables where specific values
are related. Figures (graphs) may be provided but are not to be the
sole source of the values needed for future evaluations.
D. Conclude it 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. It
the data are not supportive, possible alternative action(s) that
may be taken by the registrant, such as label modifications, are
suggested. It deficiencies/omissions exist in the submitted data,
the reviewer may have to defer judgment until such time as appropri-
ate corrective action has been rendered by the registrant.
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APPENDIX 1
INFORMATION REQUESTED OF THE REGISTRANT
The registrant’s report on target area testing studies should
include all information necessary to provide: 1) a complete and
accurate description of the greenhouse/field plot treatments and
procedures, 2) sampling data and phytotoxicity rating, 3) data on
storage of the, plant material, if so performed, 4) any chemical
analysis of the plant material as to chemical content, if so per-
formed, 5) reporting of the data, rating system and statistical
analysis, and 6) quality control measures/precautions taken to en-
sure the fidelity of the operations.
Specifically, each greenhouse/field plot target area testing
report should include the following information.
I. General
o Cooperator or researcher (name and address), test location
(county and state; country, if outside of the U.S.A.), and date of
study;
o Name (and signature), title, organization, address, and tele-
phone number of the person(s) responsible for planning/supervising/
monitoring and, for field plot studies, applying the pesticide;
o Trial identification number;
o Quality assurance indicating: control measures/precautions
followed to ensure the fidelity of the phytotoxicity determinations;
record—keeping procedures and availability of logbooks; skill of
the laboratory personnel; equipment status of the laboratory and/or
greenhouse; degree of adherence to good laboratory practices; and
degree of adherence to good agricultural practices in maintaining
healthly plants; and
o Other information the registrant considers appropriate and
relevant to provide a complete and thorough description of the test
procedures and results.
II. Test Substance (Pesticide)
O Identification of the test pesticide active ingredient (ai)
including chemical name, common name (ANSI, BSI, ISO, WSSA), and
Company developmental/experimental name;
o Active ingredient percentage in the end—use product or repre-
sentative end—use product. The representative end—use product shall
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be of the same active ingredient and formulation category, but it
may be of a different concentration, i.e. , 2% wettable powder vs.
4% wettable powder;
o Additional solvents or adjuvants used to dissolve and apply
the pesticide if the pesticide is intended for use at aquatic sites
and it is insoluble in or immiscible with water;
o Dose rate(s) in terms of active ingredient per area of land,
water, or leaf (if leaf—area—index is provided);
o Dose rate(s) in terms of minimum, maximum (or greatest allow-
able concentration) and two times the maximum label application level
rate and with an estimated non—discernible effect (or no—effect)
level;
o Method of application including equipment type, nozzles, pres-
sure, etc.; and
o Number of applications.
III. Plant Species
o Identification of the desirable target area or pest host plant
species with family identification. Scientific and common names
shall be provided;
O Identification of the number of replicates and the number of
plants per replicate per dose; and
O Identification of the date of planting, date(s) of pesticide
application, and date(s) of phytotoxicity rating or harvest.
IV. Site of the Test
o Site description of the target area testing study such as
whether it was performed in a greenhouse, field plot, forest, or
aquatic site;
o Location of the test site, geographically;
o Climatological data during the test (records of applicable
conditions for the type of site, i.e. , temperature, thermoperiod
rainfall or water regime, photoperiod, light intensity and quality,
relative humidity, wind speed, etc.);
O Field lay—out (for field plots), e.g., size and number of
control and experimental plots; number of plants per p1ot/unj
area;
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o Pot (greenhouse only) or row density of terrestrial plants
(or their seeds);
o The intended use pattern(s) as noted on the label for which
the test(s) is (are) being performed;
o Cultural practices such as cultivation and irrigation; and
o Substrate characteristics (terrestrial uses, including forests:
name/designation of soil type and its physical and chemical properties
including p1-I and percent organic matter, soil moisture content;
aquatic uses: water body type, water chemistry including pH, hardness,
CEC, suspended sediments, benthic conditions).
V. Results
o Target area plant responses, including detrimental etfects on
crops, commodities (produce), or any other desirable plant species,
such as stand, vigor, planting depths, lodging, phytotoxicity
(including a description of the rating system), and yields, to
ascertain toxic effects of the pesticide upon the plants;
o Statistical analysis of the results; and
o Other evaluations for the individual use pattern(s) and appli—
cation methodology, and cultural practices as indicated in Section
121—1 (c) of Subdivision J .
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APPENDIX 2
SPECIFIC QUESTIOP4S FOR THE REVIEWER
The following questions are provided to aid the reviewer in
performing the standard evaluation procedure in a scientific manner
and in acquiring the necessary information to complete the standard
format for preparation of scientific reviews.
I. General
o 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?
o Were the name (and signature), title, organization, address,
and telephone number of the person(s) responsible for planning/super-
vising/monitoring and, for greenhouse and/or small field plot studies,
applying the pesticide provided?
o Was the trial identification number provided?
o Were quality assurance control measures/precautions indicated?
II. Test Chemical
o Was the test chemical used the end—use product or a repre—
sentative end—use product of a similar formulation, i.e., wettable
powder, liquid, emulsifiable concentrate, etc.?
o Was the active ingredient percentage of the chemical given?
o Were the doses given in quantity per unit area (of plant or
land or water surface)?
o Were the doses the minimum, maximum (or greatest allowable
concentration), and two times the maximum label application level or
rate?
o was an estimated non—discernible effect (or no—effect) level
tested?
o If an adjuvant was allowed or recommended on the label, was
it also tested at the maximum rate in conjunction with the intended
pesticide product?
o where tank mixtures are recommended, were such tank mixtures
required and tested?
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o Where serial applications of pesticides are recommended on
the label, were such applications made and evaluated?
III. Test Species
o Were the test species the desirable target area or pest host
plant species as listed on the label?
o Where various cultivars could be used, such as in the case of
most agronomic and horticultural plants, were cultivar or varietal
names and sources provided, where available?
o Were the scientific names provided?
o Were the cultivars or varieties representative of those that
would most likely be used?
o Were the plants in the stage(s) of growth development during
which the pesticide would be applied as according to the label?
o Were the plants healthy and not in a state of stress?
o Were endangered or threatened plant species not used?
IV. Test Procedures
o Was the test site specified, i.e. , greenhouse or small field
plot?
o Were the environmental conditions that prevailed during the
test (temperature, thermoperiod, light regime — intensity and quality,
rainfall or watering regime, relative humidity, wind speed, etc.)
provided as appropriate for the site?
o Were the environmental conditions that prevailed during the
test those that would normally prevail during the application of
the pesticide as labeled?
o Was the test duration at least two weeks in length or until
either severe detrimental effects or sustained recovery had occurred?
o Were observations taken at least weekly?
o Was the method of pesticide application as indicated on the
label, i.e., aerial, irrigation, directed sprays (hydraulic ground—
rig), mist blowers, subsurface, and aquatic systems other than
irrigation, evaluated and the type of application equipment use
reported? Specific detail as to descriptions of equipment design,
adjustment, and operation should be provided involving aerial appli-
cations and applications using conventional farm equipment (such as
tillage or planting equipment), irrigation systems, mechanical
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incorporation, directed sprays, mist blower (air blast, air carrier),
subsurface placement, or band rather than broadcast distribution?
o Were sufficient untreated controls or checks provided?
o Did the untreated controls receive the same treatment, i.e.,
fertilization, pesticide treatments and cultivation, with the excep-
tion of the pesticide in question, as did the treated plants?
V. Reporting
o Were the detrimental eftects reported for the following use
patterns as indicated?
— Use in field crops . Were the effects of pesticides on
desirable target area plants evaluated and reported? Were the
extent and duration of the effect expressed in terms of stand and
vigor, recovery, yields and degree of phytotoxicity?
— Use on pastures and rangelands . Were the effects of
pesticides on desirable target area plants evaluated and reported?
Were the severity and duration of adverse effects on desirable plant
species expressed in terms of stand and vigor reductions, recovery,
and changes in yields? Were data submitted addressing reseeding
intervals which minimize adverse effects on reseeded plants, and
animal grazing recommendations which allow recovery of desired plant
species? If the applied pesticide kills all vegetation in the treated
area for an extended period of time resulting in bare spots, did the
registrant record the duration of this effect, estimated soil loss
by erosion and any changes in vegetation cover (desirable or unde-
sirable)?
— Use on and around fruit and nut trees . Where applica-
tions of pesticides were made on and/or around fruit and nut trees,
were evaluations and reports made of the detrimental effects on
foliage, and changes in growth compared to preapplication measure-
ments and simultaneous controls? Were reports made of pesticide
applications to bearing fruit and nut tree areas with reporting
of detrimental effects on yields and commodity (produce) quality
for the year of and the year after application? Were supporting
data provided addressing, for all trees, the age of the trees, the
transplant-to—application interval, and the maximum allowable ex-
tent of contact between the pesticide (with particular reference to
herbicide spray drift) and trees? For ground sprays, unless the
pesticide is broadcast over the entire orchard floor, were the method
of the application (band, spot, shielded, or directed spray applica-
tion) and the size of the treated ground area around the tree trunk
indicated? Were assessments of root sucker treatments made, where
applicable? For foliar sprays, did the data include the volume of
finished spray applied per unit of land area, concentration of pro-
duct in the spray solution, and the extent of foliage coverage (such
as volume of finished spray per tree or application to the point of
runoff)?
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— Use on lawns and turf . Did the evaluation of effects
of pesticides on representative species or cultivars of desirable
lawn and turf plants include such factors as color, density, percent
cover, growth rate, rooting, and tillering? If use on bentgrass is
intended, was this highly susceptible species evaluated? Did the
data address use on newly—seeded lawns by demonstrating safety to
representative species and cultivars of desirable lawn plants to be
named on the label as kinds on which the product is safe to use,
with seeding—to—application intervals (if appropriate)? Did the
data also address use of an appropriate application—to—reseeding
interval for each of these desirable lawn plants that may be reseeded?
Where interactions between herbicide application and lawn cultural
practices can occur such as with raking, mowing, mowing height,
watering, and fertilizing, were they evaluated for possible adverse
effects on desirable lawn species? In situations where fertilizer
and a pesticide are applied serially and both types of products may
contact the emerged crop foliage (such as in turf or lawns), was the
interval between application of the pesticide and the fertilizer
reported, as well as any resultant phytotoxic effect, stunting, or
discoloration, and recovery time for the injured desirable species?
— Use around ornamentals . Was an evaluation of the sensi-
tivity of representative cultivars of the desirable ornamental
species included? Was the method of application identified as to
directed spray and/or topical applications? Were the growth stage
of the ornamentals and the transplant—to—application interval (when
applicable) indicated in the test report? Was information submitted
on specialized nursery cultural practices employed in tests, such
as use of artificial soils, mulches, containerized stock, and other
pesticides?
— Use in forest management . Were the effects of the
pesticide on desirable plant species commonly present in forest
management, in addition to the desirable forest trees, indicated in
the report with any detrimental or adverse effects that the pesticide
may cause? Was special attention given to pesticidal effects on
noncompetitive ground cover species that aid in the land management
practices such as erosion control? Were appropriate testing and
assessment techniques adapted to the size of the plot to determine
the effect of pesticides on all plants?
— Aquatic applications . When a pesticide is applied to
a natural aquatic system or flood or furrow irrigation system, was
the following application information included, where applicable
(Note: overhead and/or sprinkler irrigation system applications shall
follow the specific use patterns given above):
(1) Target site where the pesticide was applied (for
example, to weed foliage, to surface of water, to bottom of water
body, into water, to ditchbank, to shoreline, or to forests);
(2) Description of any water level changes used in
conjunction with the pesticide application, such as drawdown operation
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or drainage of conveyance system, including the extent of water
level change, the time of the change in relation to the pesticide
application, and the duration of the change in water level; and
(3) The date of the application in relation to the
stage of growth of the target and non—target organisms.
° Were the detrimental effects on crops, commodities (produce),
or any other desirable plant species or commodities within the
target area evaluated and reported? Were these effects compared to
the untreated control or check plots? Were the following characteris-
tics addressed as appropriate?
— Stand . Were crop stand counts, reported as percen-
tage of untreated control crop stands, submitted to support pesticides
applied prior to crop emergence?
— Vigor . Were crop vigor (or stunt) ratings or measure-
ments (plant height, weight, diameter, or length) in treated areas
compared to plants in the check plots in which commercially acceptable
levels of pest control are maintained?
— Planting depths . Was a range of planting depths within
the range recommended for the crop included in preliminary studies
with preplant and preemergence (to crop) applications? Were any
effects of varying planting depths on the incidence of crop injury
that might be encountered under commercial use conditions reported?
— Lodging . Were the effects of pesticides on lodging of
target area crops such as soybean, wheat, corn, sorghum, rice or
sugarcane indicated? Were the observed percentage of treated plants
affected and the severity or approximate degr.ee of angle of lodging
in treated plots compared to that in weed—free check plots?
— Phytotoxicity . Were evaluations of visible symptoms of
pesticide injury (such as discoloration, malformations, desiccation,
defoliation, or death) to crop plants at least visually assessed
and reported? Were these symptoms or signs compared to results in
check plants untreated with the pesticide in question? If a phyto—
toxicity rating system was used, was it provided?
— Development . Were effects of pesticides on plant
development (such as delayed emergence, prolonged vegetative growth,
delayed or decreased flowering or fruit set, or delayed maturation)
reported? If such effects were outgrown by or before the usual
harvest date, was such recovery reported?
— Yields . Were effects of pesticides on yields reported?
yield data cancóñ!irm that there ate no lasting detrimental effects
on the desirable target area pants due to the pesticide application,
Yield data may also be used to evaluate benefits derived from the
application.
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° Where subsequent planting practices are indicated on the
label, were the effects of pesticides on desirable plants subsequently
planted in the area within six months of application evaluated and
reported? Subsequent planting may include emergency replanting of
crops or trees within the target area where crop failure may have
occurred and where the planting of rotational crops (including
cover crops) takes place after the harvesting of the crop present
during the pesticide application.
VI. Evaluation
° Were the results tabulated to indicate a percentage effect
level for each species as compared to the untreated control plants,
where appropriate?
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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 —
Target Area Testing Study .
Chemical:
Formulation:
Study/Act ion:
Study Identif
Reviewer:
Approval:
Conclusions:
Acceptability
Background:
Discussion:
(Common Name)
(Percent Active Ingredient)
(Purpose of the Submission)
icat ion:
( Subdivision J Test Title)
(Reference or Registrant Data Information with
Study Number)
(EPA Accession Number)
(Name and Address of Reviewer; Date of Review)
(Quality Control Reviewer)
(Summary and Conclusion of Tests)
and Recommendations:
(Decide as to (1) the scientific validity of the
study and (2) compliance to the Subdivision j —
Target Area Testing guidelines)
(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
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REFERENCES
Little, T. M., and F. J. Hills. 1978. Agricultural Experimentation —
Design and Analysis . New York: John Wiley and Sons.
Phillips, E. A. 1959. Methods of Vegetation Study . New York: Holt,
Rhinehart, and Winston, Inc.
Truelove, 3., ed. 1977. Research Methods in Weed Science . Southern
Weed Science Society. Auburn, AL: Auburn Printing Inc.
Other scientific articles of target area testing may be found
in the following journals:
Agronomy Journal
Aquatic Botany
Environmental Science and Technology
Hydrobiolog ia
Journal of Environmental Quality
Microbios Letters
Soil Science and Plant Nutrition
Water Research
Weed Science
U I o, irr* , j, - *1-,u •
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