PB84-189216
PESTICIDE ASSESSMENT GUIDELINES SUBDIVISION R
PESTICIDE SPRAY DRIFT EVALUATION
U. S. Environmental Protection Agency
Washington, DC
Apr 84
U.S. DEPARTMENT OF GOMMERCE
National Technical Information Service
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PB84-189216
EPA-540/9-84-00 2
April 1, 1984
PESTICIDE ASSESSMENT GUIDELINES
SUBDIVISION R
PESTICIDE SPRAY DRIFT EVALUATION
by
Robert W. Hoist, Ph.D.
and
Thomas C. Ellwanger, Ph.D.
Office of Pesticide Programs
U.S. Environmental Protection Agency
Office of Pesticides and Toxic Substances
Washington, DC 20460
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50372-lOt
REPORT DOCUMENTATION »• Report no. 2.
PAGE
3. Recipient's Accession No.
PB8L-189216
4. Title end Subtitle
Pesiticide Assessment Guideline, Subdivision R
Pesticide Spray Drift Evaluation
5. Report Date
«.
7. Authorts)
Robert W. Hoist and Thomas C. Ellwanger
8. Performing Organization Reot. No
9. Performing Organization Nam* and Address
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D-C. 20460
10. Proiect/Task/Worit Unit No
11. Contract(C> or Granl(G) No
(O
(G)
12* Sponsoring Organization Name and Address
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
13. Type of Report & Period Covered
Guideline
14.
15. Supplementary Notes
16. Abstract (Limit- 200 words)
Subdivison R, a Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) guideline, prescribes spray drift evaluation protocols that the
U.S. Environmental Protection Agency recommends to support the registration
of formulated end-use products. This subdivision establishes procedures
for testing and data submission concerning the evaluation of pesticide
spray drift. The studies outlined by this subdivision will not be
required for every product but only for selected chemicals based on
their toxicity and use pattern. A summary of the rulemaking spray drift
evaluation test requirements can be found in 40 CFR 158. The results of
the spray drift studies together with the toxicity evaluation of the
chemical to humans and nontarget animals and plants are used to assess
the potential hazard of pesticides to these nontarget organisms.
Subdivision R constitutes an additional volume to the original
guideline series sublished by the National Technical Information Service.
17. Document Analysis a. Descriptors
b. ldentffiers/Open*£nded Ttrmi
c. COSAT1 Fleld/Grouo
IS. Availability Statemen;
19. Security Class (This Report)
21. No. of Pages
20. Security Class (This Page)
22. Price
(Sm ANSl-239 18) Sm instructions on Reverse OPTIONAL FORM 272 (4—77)
(Formerly NTlS-35)
I Department of Commerce
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Foreword
Subdivision R describes study protocols and reporting
requirements which may be used to perform pesticide aerial spray
drift testing to support registration of pesticides under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Public comment on subdivision R was accepted in a series of
public meetings in October 1982 and February 1983 and papers
presented at those times. Data requirements established by
40 CFR Part 158 are discussed in subdivision R so that it can
be read as a complete package and so that the protocols can
be explained in their proper context.
//
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Subdivision R - Pesticide Aerial Drift Evaluation
Table of Contents
DISCUSSION
I. Introduction 1
II. Organization 2
III. Major Issues 3
Guidelines
Series 200: GENERAL
§ 200-1 Overview. 7
§ 200-2 Definitions. 9
§ 200-3 Standards for testing. 10
§ 200-4 Reporting and evaluation of data. 11
Series 201: DROPLET SIZE SPECTRUM TESTING
§ 201-1 Droplet size spectrum testing. 14
Series 202: DRIFT FIELD EVALUATION
i 202-1 Drift field evaluation. 16
I k •
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SUBDIVISION R ~ PESTICIDE AERIAL DRIFT EVALUATION
DISCUSSION
I. Introduction
The performance requirements and testing and reporting proce-
dures of pesticide chemical, environmental, and toxicity properties
to support the registration of each pesticide under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) are provided
in two document series. The first is Volume 40 Part 158 of the
Code of Federal Regulations (CFR) which specifies the kind of data
and information that must be submitted. Section 158.142 specifies
the performance requirements for pesticide aerial drift evaluation.
The Agency intends to promulgate 40 CFR Part 158 as a final rule
during 1984.
The second series of documents [Guideline Subdivisions, such as
the present one, published by the National Technical Information
Service (NTIS)] provide the test criteria and reporting procedures
for the various studies. This subdivision, entitled Subdivision R -
Pesticide Aerial Drift Evaluation, provides detailed information
relating to the pesticide aerial drift data requirements listed in
40 CFR part 158, § 158.142. Subdivision R describes the conditions
under which the aerial drift data requirements are applicable, the
standards and protocols for acceptable testing, stated with as much
specificity as the current scientific disciplines allow, and
reporting procedures. Also provided in this subdivision are
circumstances under which an applicant should consult with the
Agency before initiating a study.
The pesticide spray drift protocols and, reporting procedures
are provided to the registrants and general public for information
purposes. Results of the phytotoxicity studies :found in this Sub-
division will be reported to the Agency on a limited basis.
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The aerial drift data submitted along with data on toxicity
for humans, fish and wildlife, or plants are used to assess the
potential hazard of pesticides to these organisms.
A purpose common to all tests is to provide data which will be
used to determine the need for (and support the wording for) pre-
cautionary labeling or other statements to minimize the potential
adverse effects to nontarget organisms. Generally, the registrant
will provide adequate precautionary labeling with respect to non-
target organisms, that is, humans, domestic animals, fish and
wildlife, and plants. However, there may be situations where the
Agency will have to develop additional precautionary labeling.
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II. ORGANIZATION
Subdivision R addresses the data requirements for the submis-
sion of pesticide aerial or spray drift data. It is organized
into three section series. The first series, § 200, provides
general information concerning the guidelines and relationships to
other subdivisions. It also addresses submission of other data
which can be substituted for the test data of droplet spectra and
field evaluation of spray drift. The second series, § 201, specifies
the data requirements with respect to droplet spectrum determination
for the various types of nozzles and associated equipment. The
third section series, § 202, provides guidance and reporting require-
ments for conduct of field studies using spray equipment.
Each individual test section contains an opening paragraph
indicating under what circumstances and for what products the data
are required. These test sections also contain specific standards
and reporting requirements. In addition to these specific test
standards and test requirements, the general test standards and
reporting requirements apply to the conduct of the required studies.
The requirement to produce data from these studies depends on
the results of toxicity studies in the other subdivisions on hazard
evaluation of pesticides to nontarget organisms (Subdivisions E,
F, J, and L). Due to the complexity of the criteria to progress
from those effect studies to this exposure study, specific criteria
cannot be readily determined and provided with this subdivision.
The decision to require and perform spray drift studies will be
made onn a case-by-case basis by registrant and Agency scientists.
A general basis for performing these studies would be if the pesti-
cide is toxic to nontarget organisms and the application methodology
includes situations where the product may be carried off-target
by air currents.
The data generated by the spray drift studies described in
these guidelines are used by the Agency, along with other d^ta, to
assess the potential risk posed by use of a pesticide product, as
part of making the determination as to whether EPA should register
the product. This subdivision establishes standards and require-
ments for testing and data submissions concerning the exposure to
pesticides by nontarget organisms. This exposure can be through
both dermal (or foliar) and inhalation means.
No set of results from these tests will automatically preclude
the registration of a pesticide product. In certain cases, limit-
ations, precautions and/or restrictions would be imposed upon the
use of the pesticide because of its ability to drift, thereby
increasing its exposure potential.
The data requirements for this subdivision are a portion of the
information required for an overall environmental risk assessment.
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The combination of the information submitted in response to the
requirements of this subdivision, with information derived from
other studies performed concerning the environmental fate of the
pesticide, and the effect of the pesticide on humans and domestic
animals, fish, wildlife, and Invertebrate animals, and nontarget
plants will lead to an all-encompassing risk assessment.
III. MAJOR ISSUES
The Agency received comments from 7 persons or groups regarding
the spray drift tests as found in the proposed Subpart J 1980
guidelines. The Agency also received other comments in response to
public presentations made at the American Society for Testing and
Materials (ASTM) symposiums on pesticide application methodology in
October 1980, Philadelphia PA, and October 1982, Fort Mitchell KY,
and at the Weed Science Society of America meeting in February 1983,
St. Louis MO. In many cases the commenters provided information
on the applicability and the scientific merit of the various tests.
In response to these public comments, the Agency has modified or
clarified all sections and many paragraphs of these guidelines.
Only the more significant and controversial issues submitted by the
public are addressed in this discussion. Many recommendations were
adopted by the Agency which do not warrant discussion here.
A. General
Drift of pesticide sprays is known to affect not only nontarget
plants but also nontarget animals and humans. Because of this
broad spectrum of potential adverse effects from spray drift, the
Agency removed the data requirements for this testing from the
proposed Subpart J guidelines. These data requirements were of
such nature as to warrent a new subdivision for the assessment of
spray drift. This subdivision is an attempt to consolidate and
standardize the test protocols and reporting procedures. They are
not general restrictive regulations to be imposed where only local
conditions warrent specific regulations.
With its removal from proposed Subpart J, the conduct of the
spray drift tests will be based on the effects of the particular
pesticides on humans and domestic animals, fish and wildlife,
nontarget plants, and beneficial insects. These effects will be
determined from data submitted in accordance with the requirements
of Subdivisions F, E, J, and L, respectively. Accordingly the
Plant Activity tests which were part of the proposed section series
(proposed § 163.126-2) have been deleted. Specific end point
criteria to progress from the various nontarget organism effects
tests to this series of tests on spray drift will not be addressed
due to the complex nature of such criteria. A general rule, though,
would be that, where there is a suspected adverse effect to nontarget
organisms through aerial transport of the pesticide spray, the
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drift studies would be required.
One commenter stated that the Agency is attempting to conduct
basic research through regulatory test requirements. The Agency
feels that there has been sufficient basic research to set up
meaningful data requirements on spray drift. On the matter of
requiring too much data or data that would be meaningless, the
Agency feels that the data available do not adequately address
specific information or inherent problems that are associated with
the various pesticide categories. Some categories are wettable
powders, emulsifiable concentrates, flowable liquids, and oil
bases. It should also be noted that when sufficient and meaningful
data become available, the Agency foresees a reduction in the
requirement of this data.
B. State Regulation
Several commenters expressed a concern that through requiring
data on spray drift, the Agency will in effect regulate pesticide
application equipment. The Agency is not attempting to regulate
pesticide application equipment with respect to spray drift. The
data produced by these testing requirements are used in an overall
hazard assessment for each pesticide. Spray drift data are specif-
ically used in the exposure analysis of, not only plants, but
increasingly more so of wildlife and humans. This assessment may
then be used for general cautions and restrictions or may be passed
to the States for specific regulations or control at the local
level as proposed by the State Federal Issues Research and Evaluation
Group (SFIREG).
C. Test Substance
The formulated end-use product to be registered was proposed
as the substance to be tested. Several commenters stated that this
would lead to excessive and, therefore, expensive testing. ,
Originally, the proposal to test each product was based on the fact
that each product is unique in its physical properties, ie., surface
tension, density, visco-elasticity, etc. All of these properties
affect the droplet spectrum, however, this effect is minimal when
compared to the effect of the selection, operation, and adjustment
of the application equipment and the environmental factors through
which the droplets must pass to their targets. It was noted that
pesticides within categories of pesticides, ie., wettable powders,
emulsifiable concentrates, flowable liquids, and oil bases, do
tend to have similar physical characteristics. The categories are
sufficiently discernable to allow testing of the product in question
or a similar product within that category (see above) and use
pattern, ie., herbicide, fungicide, insecticide, etc. If the Agency
determineds that the physical properties of the pesticide in question
and the respective category differ significantly, the specific
formulated end-use product will be tested.
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D. Droplet Spectrum Studies
In answer to comments received that requiring the droplet
spectrum studies is excessive, the spectrum studies are performed
to determine the influence of a number of equipment and formulation
parameters. The major parameters, such as formulation, type of
nozzle, and orientation to the wind shear, must be tested, both
individually and collectively, in order to correctly evaluate
droplet spectrum. Droplet distributions are essential information
in the use of models to more accurately predict drift.
E. Field Protocols
Commenters have noted that single applications (passes) to one
swath as implied by the protocols of § 202-l(b)(5)(i) would be
hardly a realistic use pattern. The protocol has been changed in
order to obtain a better understanding of the deposition. Multiple
passes, usually three or more, of a single swath are preferred in
order to obtain more statistically consistant data of the deposit
or drift. Full field applications, that is, successive swaths
upwind, can also be evaluated with data taken from instruments
placed immediately downwind of the field.
Several commenters stated that use of an open field or runway
area is more desirable because the pesticide would cause less harm
if any to the target area crop. The Agenc7 requires the use of
fields where crops or other plants exist rather than the use of
open fields with bare soil or over airport runways. The plants act
as dampening devices and have a strong effect on the extent of the
swath displacement and other airborne movement of the pesticide.
If non-crop fields with plants of similar height and density are
available, their use is recommended.
Commenters from several interested groups noted that the
studies Included the testing of various ground equipment. This was
also stated to be excessive testing. It was pointed out th£t boom,
hydraulic, ground sprayers used by farmers, and other applicators
are used very close to the crop or ground ie., one to two feet, and
there is virtually no wind sheer across the nozzle. Upon reviewing
these facts, the Agency agrees that this type of testing is not
necessary for registration and has deleted the requirement to test
hydraulic boom, ground spray equipment.. Voluntary testing of
ground rigs is still encouraged in order that the applicators
become familiar with any possible drift from their equipment.
Applications through overhead sprinklers or irrigation equipment
where the liquid is sprayed up into the air still pose a problem
similar to mist blowers. Therefore, overhead sprinkler or irrigation
equipment applications must still be tested.
Rights-of-way applications using "cannon" nozzles can also
lead to problems of off-target exposure. However, this is generally
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an applicator rather than a pesticide, equipment, or weather
problem. Accordingly, data reports on this type of equipment are
not required.
F. Collection Devices
Several commenters noted that some of the collection devices
were excessive in number or that their placement was inordinant.
The number of collection devices for the field evaluations as stated
in the proposed guidelines was quite flexible. What is required is
sufficient data to "present a definitive uninterrupted picture of
deposits across the treated swath as well as outside the target
area" [§ 202-l(b)(4)].
The placement of the air samplers and recorders of temperature
and wind on 10 in towers can lead to some difficulties in obtaining
and maintaining the towers and equipment. The minimum tower that
will be required will be 3 m (10 feet). Temperature differences
for the Barad stability determination will be measured at crop
height and 2 meters above that. Wind direction and velocity should
be measured at a 1 to 2 meter height above the canopy. For tall
crops, taller towers may be needed to obtain temperature gradients
at and 2 m above the top of the crop canopy.
The use of air samplers as noted by a commenter was not germane
to Subdivision J plant tests. Air samplers were added because the
Agency desired airborne particle exposure data not so much for
plants but for humans and other animals. It should be noted that
in order to gather maximum data on the extent of airborne material,
ideally 3 to 4 samplers should be placed on each tower at each
station. This is not a requirement but is highly desirable. Air
samplers at 3 locations downwind are imperative, though.
G. Exposure Assessment
An exposure assessment is being requested as part of the report
provided to the Agency [§ 202—1(d)]. The purpose of this report
is for the registrant to make an evaluation as to the extent of
possible exposure with respect to the quantity of pesticide to
which nontarget organisms including humans may be exposed. The
spray drift exposure assessment is a portion of an overall exposure
assessment which may include assessments with respect to pesticides
in ground and surface waters.
An overall risk assessment is also desirable in which the
registrant compares the pesticide exposure with toxicity of the
pesticide. From this, the degree of risk with respect to that use
pattern may be determined.
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SUBDIVISION R - PESTICIDE AERIAL DRIFT EVALUATION
GUIDELINES
Series 200: GENERAL
§ 200-1 Overview.
(a) General. (1) Scope. This subdivision deals with the
data submittal to support the registration of all outdoor use
pesticides that are to be applied by aerial application methods
(fixed- or rotary-wing), by air carrier (mist blowers), or by
overhead sprinkler irrigation devices. This submission provides
guidance to test and report the extent of exposure that occurs to
nontarget organisms, ie., humans, fish and wildlife, and plants,
by aerially transported pesticides. Though the extent of pesticide
drift from other ground application equipment are not specifically
required, there may be Instances where the estimated environmental
exposure would indicate a need for field testing with this equipment.
(2) Organization. (1) This subdivision contains two areas
of data requirements:
(A) Droplet size spectrum studies (§ 201-1); and
(B) Field evaluation of pesticide drift (§ 202-1).
(ii) These data must be derived from tests and reported in a
manner which complies with the general test standards contained in
§ 120-3 and the general reporting requirements contained in §
120-4 as well as the specific standards and reporting requirements
of each section listed in paragraphs (a)(2)(i) and (ii) of t»his
section.
(b) Requirements. (1) "When required" and "test substance"
requirements~ The registration applicant should be careful to
distinguish between the "when required" and the "test substance"
paragraph requirements of each section of this subdivision:
(I) The "when required" paragraphs pertain to the circumstances
under which data shall be required, and specify the categories of
products for which data must be generated to support registration
applications. The test data are ordinarily required to support the
registration of each end-use product with the prescribed use
pattern and each manufacturing-use product used to make such an
end-use product.
(II) The "test substance" paragraphs refer to kinds of
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testing required to produce acceptable data, and state the kind of
pesticide material that must be used in each test. The test sub-
stance for studies in this subdivision will be a typical end-use
formulated product. Generally, this test substance is prepared by
the basic manufacturer of a pesticide chemical.
(2) Testing to meet requirements. Since studies found in
this subdivision would ordinarily be conducted by the basic manu-
facturer, pesticide formulators would not often be expected to
conduct such tests themselves to develop data to support their
individual products. (See 40 CFR §158.50 concerning the formu-
lator's exemption). They may do so if they wish, but they may
also merely rely on the data already developed by the basic pesti-
cide manufacturer.
(c) Data requirements. The drift hazard of a pesticide
applied either by aircraft or ground equipment shall be determined
in two stages. The initial stage involves the determination of
possible detrimental effects to nontarget organisms that may be
produced through dermal (or foliar) exposure to the pesticide. See
Subdivisions E, F, J, and L to determine if a potential exists.
The second stage (see §§ 201-1 and 202-1) is a combined study of
both determination of droplet size spectrums and field evaluation.
The droplet size spectrum study would indicate which of the conven-
tionally used nozzle types, orifice sizes and cores, operating
conditions, adjuvants, formulations, and discharge orientations
would produce the greatest probable drift potential- (for example,
greatest volume of droplets less than 100 microns in diameter).
The field studies involve commercial equipment to determine the
extent of spray drift (concentration vs. distance) from swath and
airborne displacement under "worst case" equipment and environ-
mental (e.g., inversion) conditions. Determination of the spray
droplet size spectrum may be performed by two alternative methods.
It may be performed either using wind tunnels or during the field
study evaluation using commercial equipment.
(d) Substitution of data. (1) The requirement to submit test
data established by §§ 201-1 TDroplet size spectrum) and 202-1
(Field evaluation) may be satlsifled by the submittal of published
or unpublished information regarding spray drift patterns that
would be expected to be similar to those for the formulated product
when used according to commonly recognized practices. Such submitted
information must be accompanied by a statement of reasons why the
registration applicant considers that the characteristics of his
product are identical or similar to those of the designated
formulation described in the published information;
(2) A registrant may feel that his product has superior or
different characteristics regarding spray drift patterns with
respect to resultant toxicity other than that which published or
unpublished cest data would demonstrate. If the applicant chooses
not to use available information as provided by paragraph (c)(1)
of this section, he may use this subdivision as guidance for
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studies he may wish to conduct to support his product.
(e) Relation to other subdivision requirements. (1) The data
requirements of other subdivisions are imposed such that duplicative
testing is avoided to meet the requirements of 40 CFR Part 158.
Where data are submitted to fulfill the requirements of one sub-
division, cross references to that data should be made by the
registrant if the data are also required elsewhere.
(2) The registration applicant is referred to Subdivision H
"Labeling for Pesticides and Devices" for requirements on pesticide
labeling. One of the important objectives of the testing programs
required in Subdivision R is to develop sufficient data to support
appropriate and adequate precautionary statements and instructions
for use with respect to spray drift. Applicants should read the
appropriate paragraphs of § 100-9 and section series 104 of
Subdivision H dealing with spray drift.
§ 200-2 Definitions.
Terms used in this subdivision shall have the meanings set
forth in FIFRA at § 162.3 of the FIFRA sec. 3 regulations, and
at §60-2 of Subdivision D. In addition, for the purposes of
this subdivision:
(a) The term "drift" as defined in 40 CFR 162.3(n) means
movement of a pesticide through air during or immediately after
appllcaton or use to a site other than the Intended site of
application or use. Drift includes two major components:
(1) Swath displacement downwind: that which is deposited in
or adjacent to the intended target area.
(2) Extended airborne displacement: that which is carried and
deposited beyond and not necessarily adjacent to the target area.
(b) The term "nontarget organism" means any plant, animal, or
human species not considered to be pests. These species are not
intended to be controlled, injured, killed, or detrimentally affected
in any way by a pesticide.
(c) The term "target area" means the area intentionally
treated with a pesticide when label use directions are followed.
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§ 200-3 Basic test standards.
(a) Scope. This section contains test standards that apply
to all studies in this subdivision. If a specific test of this
subdivision (R) contains a standard on the same subject, that
specific test standard shall take precedence in the performance of
that particular study.
(b) General. The experimental design, execution of the
experiments, classification of the organism, sampling, measurement,
and data analysis in support of an application for registration
must be accomplished by use of sound scientific techniques recog-
nized by the scientific community. The uniformity of procedures,
materials, and reporting must be maintained throughout the toxicity
evaluation process. Refinements of the procedures to increase
their accuracy and effectiveness of the evaluation are encouraged.
When such refinements include major modifications of any test
procedure or standard, the Agency should be consulted before imple-
mentation. All references supplied with respect to protocols or
other test standards are provided as recommendations.
(c) Personnel. (1) All testing and evaluation must 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.
(2) To help assure consistency in the development of data,
one person should be responsible for each particular phase of study.
(d) Test substance. (1) Spray drift evaluation tests to
support the registration of a pesticide shall employ the formulated
product(s), as specified in the following series- of sections in
this subdivision: 201, and 202.
%
(2) The composition of the test substance shall be reported,
including the name and quantity of adjuvants and surfactants, in
order to account for 100 percent of the test sample in accordance
with § 61-1 of Subdivision D. The typical end-use product (formulated
product) shall be within the limits, if any, certified in accordance
with § 62-2.
(3) Field tests may use samples from several lots due to the
volume and geographical requirements. The samples should be stored
under conditions that maintain their purity and stability. In the
case of formulated products, storage should be under conditions
as found in commonly-recognized storage practices.
(e) Nontarget organism test species. Bioassays may be used to
evaluate the extent of pesticide exposure as found in section series
202. For these tests:
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(1) Healthy organisms must be used.
(2) Either domesticated, cultured (cultivated), or wild
indigenous organisms may be used; endangered or threatened species
as determined by the Endangered Species Act of 1973 (Public Law 93-
205) shall not be used.
(3) Test organisms that are obtained from natural systems and
which are to be used for testing should be maintained under conditions
similar to their natural or normal cultural environment.
(f) Nontarget organism safety. While performing field tests,
all necessary,measures shall be taken to ensure that nontarget
plants and animals, especially endangered or threatened species,
are not adversely affected either by direct hazard or by impact
on food supply or food chain.
(g) Controls~ Where bioassays are used, bioassay control
groups are used to assure that effects observed are associated or
attributed to the test substance exposure. The appropriate control
group should be similar in every respect to the test group except
for exposure to the test substance. Within a given study, all test
organisms including the controls should be from the same source.
To prevent bias, a system of random assignment of the test organisms
to test and control groups is required.
(h) Equipment. All equipment used in conducting the test,
including equipment used to prepare and administer the test sub-
stance, and equipment to maintain and record environmental condi-
tions, should be of such design and capacity that tests involving
this equipment can be conducted In a reliable and scientific manner.
Equipment should be inspected, cleaned, and maintained regularly,
and be properly calibrated.
§ 200-4 Reporting and evaluation of data.
(a) Overview. This section establishes general reporting and
evaluation requirements which apply to studies in the subdivision.
Each test report submitted under this subdivision should satisfy the
reporting requirements of this section, unless a specific section
elsewhere in this subdivision directs otherwise.
(b) Submission. Data required by this subdivision should be
submitted in a single report to the extent possible. Any data
that have been furnished in response to the requirements of another
subdivision and that are also required by this subdivision either
shall be referenced to specific pages in other volumes or shall be
duplicated and submitted in the volumes containing spray drift
data.
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(c) Content. The test report should include a complete and
accurate description of test procedures and evaluation of the test
results. It should also contain a summary of the data, an analysis
of the data, sufficient data for the Agency to verify calculated
statistical values, and a statement of conclusions to be drawn from
the analysis. The summary should contain sufficient detail to permit
the reader to understand the conclusions of the author. In addition
to the specific information required by § 201-1, through § 202-1
of this subdivision, the test report should include the following
information:
(1) Language. The English language shall be used in all test
reports. English tranlations must be provided with foreigh language
reports.
(2) General information. Each report should contain:
(i) Dates on which study began and ended;
(ii) Name and address of laboratory or institution performing
the test;
(iii) Location where the test was performed;
(iv) Names of principal investigators and the name, address,
and phone number of the employer;
(v) Certification by the applicant that the report is a
complete and unaltered copy of the report provided by the testing
facility.
(3) Test method. Each report should contain a statement
regarding the test method used, including a full description of the
experimental design and procedures.
(4) Test substance. The report shall identify the test
substance, and shall include chemical name and percentage of active
ingredient, and qualitative and quantitative description of the
formulation composition.
(5) Control data. Due to the wide diversity of pesticide
properties, use patterns, and organisms exposed in the field
environment, specific reporting requirements for control values (as
to source, sampling regime, and total number of sample data
submitted) will depend upon the complexity and variability of the
environment in which the test is to be conducted.
(6) Test equipment. The report should include a description
of the test equipment used, and photographs or detailed descriptions
of nonstandard equipment.
(7) Units of measurement. Reporting units should be in the
metric system, but the English system may be used, in addition.
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In no instance should the systems be mixed (e.g., kilograms/acre).
(8) Calculations and tabular and graphic information. Each
report should contain the principal mathematical equations used in
generating and analyzing data, as well as representative calcula-
tions using these equations. Tables and graphs may be used to
illustrate the data.
(9) Location. Geographic location of the test site, including
relation to the target sites, should be reported. This portion
should contain a description of the aquatic or terrestrial site to
which the pesticide is applied.
(10) Data evaluation. Evaluation of data submitted to fulfill
the requirements of this subdivision should take into account and be
used by the Agency in the assessment of the following environmental
hazards:
(i) The direct consequences to humans resulting from exposure
to pesticide residues remaining in the target areas after applica-
tion, as a result of ingestion of contaminated rotational crops,
edible fish and shellfish, contamination of drinking water, and
other similar sources, and by inhalation of the airborne pesticide
mists;
(11) The indirect consequences to humans from the presence
of widely distributed and persistent pesticide spray drift In
the environment, possibly resulting in loss of usable land, water,
and wildlife resources; and
(ill) The potential environmental exposure of domestic,
cultivated, or wild nontarget organisms to pesticide spray drift
that may either be taken up and accumulated in the food web or
result in loss of habitat.
(d) References~ Copies of references of literature used in
modifying the test protocol, performing the test, making and
interpreting observations, and compiling and evaluating the'results
should be submitted. Copies of unpublished literature should also
be included. Copies of the recommended literature referenced In
these guidelines are not required.
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Series 201: DROPLET SIZE SPECTRUM STUDIES
§ 201-1 Droplet size spectrum studies.
(a) When required. (1) Data on the droplet size spectrum are
required by 40 CFR Part 158 on a case-by-case basis to support the
registration of each formulated end-use product expected to be
applied by aerial, air carrier mist blower, and by overhead sprinkler
irrigation application equipment. The data are required when the
detrimental effect level of those nontarget organisms anticipated
to be present is exceeded. [See Subdivision E, F, J, and L to
determine if the pesticide detrimentally affects fish and wildlife,
humans, nontarget plants, and beneficial insects, respectively.]
[See § 120-l(c).]
(2) In lieu of the wind tunnel study required by this section,
droplet size distribution may be determined under field conditions
during the spray drift evaluation test as provided in § 202-1.
(b) Test standards. In addition to those test standards set
forth in § 200-3, the following standards apply:
(1) Test substance. A formulated end-use product of the same
formulation category as the end-use product to be registered, ie.,
wettable powders, emulsifable concentrates, etc., and use, ie.,
herbicide, insecticide, etc., will be tested.
(2) Equipment. The label-recommended or commonly-used nozzles
and associated parts, nozzle pressures, and nozzle discharge
orientation that would produce droplets that would be most conducive
to spray drift should be tested.
(3) Meteorological conditions, (i) For wind tunnel studies,
the following conditions should be tested:
(A) The product should be tested at various temperature levels
from 10 to 35°C.
(B) The air flow (velocity) in the wind tunnel may be adjusted
to relate to the type of equipment used [e.g., 130 to 225 kmph (80
to 140 mph) for fixed-winged aircraft and air carriers, 65 to 110
kmph (40 to 70 mph) for helicopter (rotary-winged aircraft), and 5
to 40 kmph (3 to 25 mph) for ground applications (including
sprinkler irrigation) other than air carriers (mist blowers)].
(ii) For field determination studies, the meteorological
conditions should be those most conducive to spray drift (rel-
atively high temperature, low relative humidity, and inversion).
Field studies with the elevated temperatures are conducted to
determine the effect of a higher evaporation rate on the droplets.
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15
(4) Collection devices. The collection devices should be
either laser particle measuring systems, collection cards (flat
horizontal or vertical surfaces), air samplers, or other devices
by which droplet size distribution can be determined.
(c) Reporting. In addition to those reporting requirements
set forth in § 202-1, the following data are required:
(1) The nozzle type, orifice size, and core identification;
(2) The nozzle pressure and flow rate;
(3) The nozzle discharge orientation to the airstream;
(4) Air velocity past the nozzle;
(5) Descriptions of techniques and size determination devices
(6) Particle size distribution vs. cumulative percent volume
and particle size distribution vs. droplet number (frequency) (an
attempt should be made to determine the droplet size distribution
where droplet formation is finalized);
(7) Product formulation, diluent and extent of dilution,
mixtures, adjuvants, and their physical properties (surface tension
viscosity, density, vapor pressure, etc); and
(8) Air temperature and relative humidity (not required for
wind tunnel studies where droplets near the nozzles are measured).
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16
Series 202: DRIFT FIELD EVALUATION
§ 202-1 Drift field evalutlon.
(a) When required. (1) Data on the extent of potential
drift of a pesticide are required by 40 CFR Part 158 on a case-
by-case basis to support the registration of each formulated end-
use product expected to be applied by aerial, air carrier mist
blower, and by overhead irrigation sprinkler application equipment.
The data are required when the detrimental effect level of those
nontarget orgainisms anticipated to be present is exceeded. [See
Subdivision E, F, J, and L to determine if the pesticide detrimen-
tally affects fish and wildlife, humans, nontarget plants, and
beneficial insects, respectively.] [See § 120-l(c).]
(2) Experimental use permits will usually be required for
conduct of these field evaluations where field applications are
made of an unregistered product.
(b) Test standards. In addition to the test standards set
forth in § 200-3, the following test standards apply:
(1) Test substance, (i) A formulated end-use product of the
same formulation category as the end-use product to be registered,
ie., wettable powders, emulsifable concentrates, etc., and use,
ie., herbicide, Insecticide, etc., will be tested. Use of dyes or
other indicators with the pesticide are acceptable only If these
materials do not interfere with chemical analysis or bioresponse,
do not alter chemical or physical properties of the diluted spray,
do deposit In direct proportion to concentrations of active
ingredients, and do remain stable until analysis.
(ii) Tank mixes and package mixes. Drift .data requirements
for each package mix, and for each tank mix allowed in labeling are
identical to those requirements for any single pesticide applied
alone; that is, the droplet spectrum, and swath displacement should
be evaluated. Alternatively, the swath displacement data for the
mixture may not be required if the mixture activity spectrum,
droplet size spectrum, and physical data are sufficiently similar
to such data characterizing the mixture's most phytotoxic single
component for which acceptable swath displacement data have been
submitted.
(2) Dosage levels. Maximum label-recommended pesticide
dosages should be evaluated in all spray drift field evaluations.
(3) Study location. The site should be typical in geography,
topography, season, and meteorology of those sites within in-
tended use patterns. The use of two or more topographically and
meteorologically diverse sites is recommended in order to ascertain
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17
the effects of these variables oil spray drift. The evaluation
should preferably be performed in a field(s) having foliage or crop
cover conditions similar to actual use conditions. Open fields
(not runways) may be acceptable only for evaluation of pesticides
to be applied directly to soil or just emerging plants. If it is
felt that barren fields should be used to test a product where
vegetation would exist according to the label recommendations, the
justification should be submitted to indicate the reason for this
test modification.
(4) Collection surface placement, (i) Collection surfaces
for fallout sampling should be located:
(A) Within the target area, at least one swath width upwind,
and at known distances outside the target area downwind to a minimum
of 1000 feet for aerial and air carrier applications and 500 feet
for other ground applications (including sprinkler irrigation
systems);
(B) In a straight line approximately parallel to a stable
wind direction and as close as possible to the perpendicular of
and centered to the direction of travel for the application equip-
ment ; and
(C) At the soil surface or, if vegetation is present, at a
level which corresponds to the height of the surrounding canopy.
(ii) Air samplers, such as a high volume type (20-50 ft^/min),
should be placed at a 2- to 3-meter height at at least three down
wind collection stations [for example, at 200, 600, and 1000 feet
(60, 80, and 300 meters) downwind] to sample airborne particles of
the chemical. The filters on the air samplers should be changed
frequently in order to minimize stripping of pesticide from the
filter.
(iii) While lateral distances between collection stations are
left to the discretion of the applicant, it is Important that a
sufficient number of collection stations be established to present
a definitive uninterrupted picture of deposits across the treated
swath as well as outside the target area. Location of collection
stations is particularly critical in areas where deposition rates
are expected to change rapidly over a small lateral distance.
(5) Protocols. (i) Spray drift evaluation data from one or
more applications to a single swath line are acceptable. Multiple
applications (passes) to a single swath are preferred. Full field
applications can be made. When bloassays are used in the swath
displacement test, multiple passes over the same swath may be made
only if the bioassay organisms are no closer than one swath width
downwind. The length of the treated swath should be such that the
spray cloud, if extended, would pass over the most distant downwind
collection devices, taking into account the probability that wind
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18
direction may not coincide perfectly with the line of collection
points. Normally the spray line should equal the sampling line
length, that is, the spraying line should be 1000 feet in length
if the downwind sampling line is 1000 feet.
(ii) At least one study should be conducted using equipment,
equipment adjustment and operation, procedures, and conditions most
conducive to drift as would be allowed in labeling, and as determined
in part from droplet spectrum tests. As an example, evaluate the
spray drift using the following parameters that would be permitted
in normal application practices: maximum recommended nozzle height
(from the ground), nozzle pressure, crosswind velocity, temperature
gradient at the canopy and 2 meters above it, ground speed of the
equipment, pesticide dosage, and airstream shear force (nozzle
discharge orientation to air stream); minimum recommended nozzle
orifice diameter, spray volume, and relative humidity; and using
cores or any other devices to increase droplet dispersion or produce
sheets, fans, or cones.
(c) Reporting. In addition to data reporting information
required by § 200-4, the following information should be submitted:
(1) A diagram of the plot indicating north, swath width, and
orientation, and location and spacing of the collection stations;
(2) Temperature at two levels, wind velocity and direction,
variations In velocity and direction during the application, relative
humidity, atmospheric pressure, and air stability. The latter is
expressed as Barad's stability ratio:
T3 meters - Tj meters
(ave. wind vel.)2
Temperature should be determined just above the canopy (T^) and at
least 2 meters above that (T3) for all applications. A standard
vertical separation should be 2 meters. Wind velocity should be
determined at at least 1 to 2 meters above the canopy height;
(3) Dosage of active ingredients or acid equivalent per
hectare (or acre). The concentration of the final diluted spray
mixture (in the spray tank) should be sampled, chemically analyzed,
and reported;
(4) Physical property data, including droplet size, viscosity,
density, vapor pressure, visco-elasticity, and surface tension;
(5) Spray volume (liters per hectare or gallons per acre) and
carrier(s). The maximum and minimum carrier volumes recommended on
the label should be reported;
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19
(6) Adjuvant identification and dilution used;
(7) The ground speed of application equipment, the number of
swaths sprayed during exposure of collecting surfaces, and swath
width;
(8) A description of the spray equipment, including nozzle
type, orifice size or core, nozzle pressure, nozzle spacing and
arrangement, and nozzle discharge orientation. Nozzle discharge
orientation should be designated in degrees related to the direction
of travel of the spray equipment. Zero degrees indicates a hori-
zontal nozzle discharge pointing rearward (opposite to the equip-
ment direction of travel), 90° indicates a vertical nozzle discharge
pointing downward, and 180° indicates a horizontal nozzle discharge
pointing forward (with the equipment direction of travel);
(9) The estimated minimum and maximum nozzle-to-target height.
(10) The quantity of active ingredient(s) or acid equivalent
collected or detected at each sampling point in terms of kilograms
per hectare (pounds per acre); and
(11) Where droplet size distribution is determined during the
field evaluation, refer to § 201-l(c) for the reporting requirements.
(d) Exposure assessment. Employing the field evaluation data
provided in paragraph (c) of this section, the registrant should
make an exposure assessment with respect to the quantity of pesti-
cide to which nontarget organisms including humans may be exposed.
Comparison of the toxicity data from studies conducted for plants,
animals, or humans to the exposure that may occur may be made as
a part of an overall risk assessment for nontarget organisms and
humans. The assessment should apply primarily to the nontarget
areas adjacent to the intended application sites.
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