[Code of Federal Regulations]
[Title 40, Volume 20]
[Revised as of July 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR158.202]
[Page 98-129]
TITLE 40--PROTECTION OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
PART 158--DATA REQUIREMENTS FOR REGISTRATION--Table of Contents
Subpart D--Data Requirement Tables
Sec. 158.202 Purposes of the registration data requirements.
(a) General. The data requirements for registration are intended to
generate data and information necessary to address concerns pertaining
to the identity, composition, potential adverse effects and
environmental fate of each pesticide.
(b) [Reserved]
(c) Residue chemistry. (1) Residue Chemistry Data are used by the
Agency to estimate the exposure of the general population to pesticide
residues in food and for setting and enforcing tolerances for pesticide
residues in food or feed.
(2) Information on the chemical identity and composition of the
pesticide product, the amounts, frequency and time of pesticide
application, and results of test on the amount of residues remaining on
or in the treated food or feed, are needed to support a finding as to
the magnitude and identity of residues which result in food or animal
feed as a consequence of a proposed pesticide usage.
(3) Residue chemistry data are also needed to support the adequacy
of one or more methods for the enforcement of the tolerance, and to
support practicable methods for removing residues that exceed any
proposed tolerance.
(d) Environmental fate--(1) General. The data generated by
environmental fate studies are used to: assess the toxicity to man
through exposure of humans to pesticide residues remaining after
application, either upon reentering treated areas or from consuming
inadvertently-contaminated food; assess the presence of widely
distributed and persistent pesticides in the environment which may
result in loss of usable land, surface water, ground water, and wildlife
resources; and, assess the potential environmental exposure of other
nontarget organisms, such as fish and wildlife, to pesticides. Another
specific purpose of the environmental fate data requirements is to help
applicants and the Agency estimate expected environmental concentrations
of pesticides in specific habitats where threatened or endangered
species or other wildlife populations at risk are found.
(2) Degradation studies. The data from hydrolysis and photolysis
studies are used to determine the rate of pesticide degradation and to
identify pesticides that may adversely affect nontarget organisms.
(3) Metabolism studies. Data generated from aerobic and anaerobic
metabolism studies are used to determine the nature and availability of
pesticides to rotational crops and to aid in the evaluation of the
persistence of a pesticide.
(4) Mobility studies. These data requirements pertain to leaching,
adsorption/desorption, and volatility of pesticides. They provide
information on the mode of transport and eventual destination of the
pesticide in the environment. This information is used to assess
potential environmental hazards related to: contamination of human and
animal food; loss of usable land and water resources to man through
contamination of water (including ground water); and habitat loss of
wildlife resulting from pesticide residue movement or transport in the
environment.
(5) Dissipation studies. The data generated from dissipation studies
are used to assess potential environmental hazards (under actual field
use conditions) related to: reentry into treated areas; hazards from
residues in rotational crop and other food sources; and the loss of land
as well as surface and ground water resources.
(6) Accumulation studies. Accumulation studies indicate pesticide
residue levels in food supplies that originate from wild sources or from
rotational crops. Rotational crop studies are necessary to establish
realistic crop rotation restrictions and to determine if tolerances may
be needed for residues on rotational crops. Data from irrigated crop
studies are used to determine the amount of pesticide residues that
could be taken up by representative crops irrigated with water
containing pesticide residues. These studies allow the Agency to
establish label restrictions regarding application of pesticides on
sites where the residues can be taken up by irrigated crops. These data
also provide information that aids the Agency in establishing
[[Page 99]]
any corresponding tolerances that would be needed for residues on such
crops. Data from pesticides accumulation studies in fish are used to
establish label restrictions to prevent applications in certain sites so
that there will be minimal residues entering edible fish or shell fish.
These residue data are also used to determine if a tolerance or action
level is needed for residues in aquatic animals eaten by humans.
(e) Hazard to humans and domestic animals. Data required to assess
hazards to humans and domestic animals are derived from a variety of
acute, subchronic and chronic toxicity tests, and tests to assess
mutagenicity and pesticide metabolism.
(1) Acute studies. Determination of acute oral, dermal and
inhalation toxicity is usually the initial step in the assessment and
evaluation of the toxic characteristics of a pesticide. These data
provide information on health hazards likely to arise soon after, and as
a result of, short-term exposure. Data from acute studies serve as a
basis for classification and precautionary labeling. For example, acute
toxicity data are used to calculate farmworker reentry intervals and to
develop precautionary label statements pertaining to protective clothing
requirements for applicators. They also: provide information used in
establishing the appropriate dose levels in subchronic and other
studies; provide initial information on the mode of toxic action(s) of a
substance; and determine the need for child resistant packaging.
Information derived from primary eye and primary dermal irritation
studies serves to identify possible hazards from exposure of the eyes,
associated mucous membranes and skin.
(2) Subchronic studies. Subchronic tests provide information on
health hazards that may arise from repeated exposures over a limited
period of time. They provide information on target organs and
accumulation potential. The resulting data are also useful in selecting
dose levels for chronic studies and for establishing safety criteria for
human exposure. These tests are not capable of detecting those effects
that have a long latency period for expression (e.g., carcinogenicity).
(3) Chronic studies. Chronic toxicity (usually conducted by feeding
the test substance to the test species) studies are intended to
determine the effects of a substance in a mammalian species following
prolonged and repeated exposure. Under the conditions of this test,
effects which have a long latency period or are cumulative should be
detected. The purpose of long-term oncogenicity studies is to observe
test animals over most of their life span for the development of
neoplastic lesions during or after exposure to various doses of a test
substance by an appropriate route of administration.
(4) Teratogenicity and reproduction studies. The teratogenicity
study is designed to determine the potential of the test substance to
induce structural and/or other abnormalities to the fetus as the result
of exposure of the mother during pregnancy. Two-generation reproduction
testing is designed to provide information concerning the general
effects of a test substance on gonadal function, estrus cycles, mating
behavior, conception, parturition, lactation, weaning, and the growth
and development of the offspring. The study may also provide information
about the effects of the test substance on neonatal morbidity,
mortality, and preliminary data on teratogenesis and serve as a guide
for subsequent tests.
(5) Mutagenicity studies. For each test substance a battery of tests
are required to assess potential to affect the mammalian cell's genetic
components. The objectives underlying the selection of a battery of
tests for mutagenicity assessment are:
(i) To detect, with sensitive assay methods, the capacity of a
chemical to alter genetic material in cells.
(ii) To determine the relevance of these mutagenic changes to
mammals.
(iii) When mutagenic potential is demonstrated, to incorporate these
findings in the assessment of heritable effects, oncogenicity, and
possibly, other health effects.
(6) Metabolism studies. Data from studies on the absorption,
distribution, excretion, and metabolism of a pesticide aid in the
valuation of test results from other toxicity studies and in the
extrapolation of data from animals
[[Page 100]]
to man. The main purpose of metabolism studies is to produce data which
increase the Agency's understanding of the behavior of the chemical in
its consideration of the human exposure anticipated from intended uses
of the pesticide.
(f) Reentry Protection. Data required to assess hazard to farm
employees resulting from reentry into areas treated with pesticides are
derived from studies on toxicity, residue dissipation, and human
exposure. Monitoring data generated during exposure studies are used to
determine the quantity of pesticide to which people may be exposed after
application and to develop reentry intervals.
(g) Pesticide Spray Drift Evaluation. Data required to evaluate
pesticide spray drift are derived from studies of droplet size spectrum
and spray drift field evaluations. These data contribute to development
of the overall exposure estimate and 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 these
tests is to provide data which will be used to determine the need for
(and appropriate wording for) precautionary labeling to minimize the
potential adverse effect to nontarget organisms.
(h) Hazard to nontarget organisms--(1) General. The information
required to assess hazards to nontarget organisms are derived from tests
to determine pesticidal effects on birds, mammals, fish, terrestrial and
aquatic invertebrates, and plants. These tests include short-term acute,
subacute, reproduction, simulated field, and full field studies arranged
in a hierarchial or tier system which progresses from the basic
laboratory tests to the applied field tests. The results of each tier of
tests must be evaluated to determine the potential of the pesticide to
cause adverse effects, and to determine whether further testing is
required. A purpose common to all data requirements is to provide data
which determines the need for (and appropriate wording for)
precautionary label statements to minimize the potential adverse effects
to nontarget organisms.
(2) Short term studies. The short-term acute and subchronic
laboratory studies provide basic toxicity information which serves as a
starting point for the hazard assessment. These data are used: to
establish acute toxicity levels of the active ingredient to the test
organisms; to compare toxicity information with measured or estimated
pesticide residues in the environment in order to assess potential
impacts on fish, wildlife and other nontarget organisms; and to indicate
whether further laboratory and/or field studies are needed.
(3) Long term and field studies. Additional studies (i.e., avian,
fish, and invertebrate reproduction, lifecycle studies and plant field
studies) may be required when basic data and environmental conditions
suggest possible problems. Data from these studies are used to: estimate
the potential for chronic effects, taking into account the measured or
estimated residues in the environment; and to determine if additional
field or laboratory data are necessary to further evaluate hazards.
Simulated field and/or field data are used to examine acute and chronic
adverse effects on captive or monitored fish and wildlife populations
under natural or near-natural environments. Such studies are required
only when predictions as to possible adverse effects in less extensive
studies cannot be made, or when the potential for adverse effects is
high.
(i) Product performance. Requirements to develop data on product
performance provide a mechanism to ensure that pesticide products will
control the pests listed on the label and that unnecessary pesticide
exposure to the environment will not occur as a result of the use of
ineffective products. Specific performance standards are used to
validate the efficacy data in the public health areas, including
disinfectants used to control microorganisms infectious to man in any
area of the inanimate environment and those pesticides used to control
vertebrates (such as rodents, birds, bats and skunks) that may directly
or indirectly transmit diseases to humans.
[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993,
May 4, 1988]
[[Page 101]]
Sec. 158.240
Sec. 158.240 Residue chemistry data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
residue chemistry data requirements and the substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food corp Nonfood Food corp Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical identity............. (1) [R] [R] [R] [R] [R] [R] [R] [R] [R] TGAI............ TGAI............ 171-2
Directions for use............ (2) [R] [R] [R] [R] [R] [R] [R] [R] [R] ................ ................ 171-3
Nature of the residue:
Plants.................... (13), [R] .......... [R] .......... [R] ......... ......... [CR] [CR] PAIRA........... PAIRA........... 171-4
(14)
Livestock................. (3), [CR] .......... [CR] .......... [CR] ......... ......... [CR] [CR] PAIRA and plant PAIRA and plant 171-4
(13), metabloites. metabolites.
(14)
Residue analytical method..... (4), [R] .......... [R] .......... [R] ......... ......... [CR] [CR] TGAI and TGAI and 171-4
(13), metabolites. metabolites.
(14),
(15)
Magnitude of the residue:
Crop field trials......... (13), [R] .......... [R] .......... [R] ......... ......... [CR] [CR] TEP............. TEP............. 171-4
(14)
Processed food/feed....... (5), (14) [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] EP.............. EP.............. 171-4
Meat/milk/poultry/eggs.... (6), (14) [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] TGAI or plant TGAI or plant 171-4
metabolites. metabolites.
Potable water............. (7) .......... .......... [R] [R] ......... ......... ......... ......... ......... EP.............. EP.............. 171-4
Fish...................... (8) .......... .......... [R] [R] ......... ......... ......... ......... ......... EP.............. EP.............. 171-4
Irrigated crops........... (9) .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 171-4
Food handling............. (10), .......... .......... .......... .......... ......... ......... ......... ......... [CR] EP.............. EP.............. 171-4
(14)
Reduction of residue.......... (11), [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] Residue of Residue of 171-5
(14) concern. concern.
Proposed tolerance............ (12), [R] .......... [R] .......... [R] ......... ......... ......... [CR] Residue of Residue of 171-6
(14) concern. concern.
Reasonable grounds in support (14) [R] .......... [R] .......... [R] ......... ......... ......... [CR] ................ ................ 171-7
of the petition.
Submittal of analytical (14) [R] .......... [R] .......... [R] ......... ......... ......... [CR] PAIRA........... PAIRA........... 171-13
reference standards.
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Key: R=Required data; CR=Conditionally required data; TGAI=Technical grade of the active ingredient; PAIRA=Pure active ingredient, radio labeled; EP=End-use product; TEP=Typical end-use
product; MP=Manufacturing-use product; [ ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) The same chemical identity data as required under subpart C of this part are required, with emphasis on impurities that could constitute a residue problem.
(2) Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
(3) Data on metabolism in livestock are required when residues occur on a livestock feed, or the pesticide is to be applied directly to livestock.
[[Page 102]]
(4) A residue method for enforcement of tolerances is needed whenever a numeric tolerance is proposed. Exemptions from the requirement of a tolerance will also usually require an analytical
method. Analytical methods used to enforce residue limits for emergency exemptions, temporary tolerances and permanent tolerances must be available for use by enforcement agencies and thus
may not be claimed as confidential business information.
(5) Data on the nature and level of residue in processed food/feed are required when detectable residues could concentrate on processing and thus require establishment of a food additive
tolerance.
(6) Livestock feeding studies are required whenever a pesticide occurs as a residue in a livestock feed. Use involving direct application to livestock, including poultry, will require animal
treatment residue studies.
(7) Data on residues in potable water are required whenever a pesticide is to be applied directly to water, unless it can be determined that the treated water would not be used (eventually)
for drinking purpose, by man or animals.
(8) Data on residue in fish are required whenever a pesticide is to be applied directly to water inhabited by fish.
(9) Data on residues in irrigated crops are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation
ditches.
(10) Data on residues in food/feed in food handling establishments are required whenever a pesticide is to be used in food/feed handling establishments. Disinfectants and sanitizers used in
food or feed handling establishment are exempt from this requirement if their residues are regulated by the Food and Drug Administration at 21 CFR 178.1010.
(11) Reduction of residue data are required when the assumption of tolerance level residues would result in predicted exposure at an unsafe level. Data on the level of residue in food as
consumed will be used to obtain a more precise estimate of potential dietary exposure. The Agency recommends that such data be generated to support all pesticides requiring a tolerance in
case new data are revealed which indicates the pesticide is more toxic than initially determined.
(12) The proposed tolerance must reflect the maximum residue likely to occur in crops and meat/milk/poultry eggs.
(13) Residue data for outdoor domestic uses are required if home gardens are to be treated and the home garden use pattern is different from the use pattern on which the tolerance was
established.
(14) Required to support registration of an indoor use pesticide if such a use could result in residues in food or feed.
(15) For all food uses, data on whether the FDA/USDA multiresidue methodology would detect and identify the pesticide are required.
[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993,
15999, May 4, 1988; 58 FR 34203, June 23, 1993]
Sec. 158.290
Sec. 158.290 Environmental fate data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
environmental fate data requirements and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Degradation studies-lab
Hydrolysis.................... ......... [R] [R] [R] [R] [R] [R] [R] [R] ......... TGAI or PAIRA... TGAI or PAIRA... 161-1
Photodegradation:
In water.................. ......... R R R R ......... ......... R ......... ......... TGAI or PAIRA... TGAI or PAIRA... 161-2
On soil................... (1) CR .......... .......... .......... ......... ......... CR ......... ......... TGAI or PAIRA... TGAI or PAIRA... 161-3
In air.................... (2) CR .......... .......... .......... ......... ......... ......... ......... ......... TGAI or PAIRA... TGAI or PAIRA... 161-4
Metabolism studies-lab
Aerobic soil.............. ......... [R] [R] .......... .......... R R [R] R ......... TGAI or PAIRA... TGAI or PAIRA... 162-1
Anaerobic aquatic......... ......... .......... .......... R R ......... ......... R ......... ......... TGAI or PAIRA... TGAI or PAIRA... 162-3
[[Page 103]]
Aerobic aquatic........... ......... .......... .......... [R] [R] ......... ......... ......... ......... ......... TGAI or PAIRA... TGAI or PAIRA... 162-4
Mobility studies
Leaching and adsorption/ ......... [R] [R] R R R R [R] R ......... TGAI or PAIRA... TGAI or PAIRA... 163-1
desorption.
Volatility:
(Lab)..................... (2) CR .......... .......... .......... CR CR ......... ......... ......... TEP............. TEP............. 163-2
(Field)................... (2) CR .......... .......... .......... CR CR ......... ......... ......... TEP............. TEP............. 163-3
Dissipation studies-field
Soil.......................... ......... R R .......... .......... ......... ......... ......... R ......... TEP............. TEP............. 164-1
Aquatic (sediment)............ ......... .......... .......... R R ......... ......... ......... ......... ......... TEP............. TEP............. 164-2
Forestry...................... ......... .......... .......... .......... .......... ......... ......... R ......... ......... TEP............. TEP............. 164-3
Combination and tank mixes.... (2) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 164-4
Soil, long-term............... (4) CR .......... CR .......... ......... ......... ......... ......... ......... TEP............. TEP............. 164-5
Accumulation studies
Rotational crops:
(Confined)................ (5) [CR] .......... [CR] .......... ......... ......... ......... ......... ......... PAIRA........... PAIRA........... 165-1
(Field)................... (6) CR .......... CR .......... ......... ......... ......... ......... ......... TEP............. TEP............. 165-2
Irrigated crops............... (7) .......... .......... [CR] CR ......... ......... ......... ......... ......... TEP............. TEP............. 165-3
In fish....................... (8) [CR] [CR] [CR] [CR] ......... ......... [CR] ......... ......... TGAI or PAIRA... TGAI or PAIRA... 165-4
In aquatic non-target (8), (9) .......... .......... .......... CR ......... ......... CR ......... ......... TEP............. TEP............. 165-5
organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required: CR=Conditionally required; [ ]=Brackets (ie. [R], [CR], indicate data requirements that apply when an experimental use permit is being sought; TGAI=Technical grade of the
active ingredient, PAIRA=``Pure'' active ingredient-radio labeled; TEP=typical end use product; EP =End use product.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Not required if use involves application to soils solely by injection of the product into the soil or by incorporation of the product into the soil upon application.
AAA(2) Required on case by case basis depending on product use pattern and other pertinent factors.
AAA(3) Not required if anaerobic aquatic metabolism study has been conducted.
AAA(4) Required if pesticide residues do not readily dissipate in soil.
AAA(5) Confined accumulation study is required when it is reasonably foreseeable that any food or feed crop may be subsequently planted on the site of pesticide application.
AAA(6) Field accumulation study is required if significant pesticide residue is likely to be present in soil at time of plant crop, as evidenced by residue data obtained from confined
accumulation study.
AAA(7) Required if it is reasonably foreseeable that water at treated site may be used for irrigation purposes.
AAA(8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic
organisms.
AAA(9) Required unless tolerance or action level for fish has been granted.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988]
Sec. 158.340
Sec. 158.340 Toxicology data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
toxicology data requirements and the substance to be tested.
[[Page 104]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Acute testing
Acute oral toxicity--rat...... (1) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 81-1
dilution* and
TGAI.
Acute dermal toxicity......... (1), (2) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 81-2
dilution* and
TGAI.
Acute inhalation toxicity--rat (16) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 81-3
Primary eye irritation--rabbit (2) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 81-4
Primary dermal irritation..... (1), (2) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 81-5
Dermal sensitization.......... (3) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 81-6
Acute delayed neurotoxicity-- (4) [R] [R] [R] [R] [R] [R] [R] [R] [R] TGAI............ TGAI............ 81-7
hen.
Subchronic testing
90-day feeding studies--rodent (17) [R] CR [R] CR [R] CR CR CR CR TGAI............ TGAI............ 82-1
and nonrodent.
21-day dermal................. (18) CR CR CR CR CR CR CR CR CR TGAI............ TGAI and EP*.... 82-2
90-day dermal................. (5), (19) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 82-3
90-day inhalation--rat (6) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 82-4
90-day neurotoxicity:
Hen......................... (7) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 82-5
Mammal...................... (8) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 82-5
Chronic testing
Chronic feeding--2 spp. rodent (9), [R] CR [R] CR [R] CR CR CR CR TGAI............ TGAI............ 83-1
and nonrodent. (13),
(20)
Oncogenicity study--2 Spp. rat (9), (21) R CR R CR R CR CR CR CR TGAI............ TGAI............ 83-2
and mouse preferred.
Teratogenicity--2 species..... (10), [R] CR [R] CR [R] CR CR CR CR TGAI............ TGAI............ 83-3
(15)
Reproduction, 2-generation.... (11), [R] CR [R] CR [R] CR CR CR CR TGAI............ TGAI............ 83-4
(14)
Mutagenicity testing
Gene mutation................. (22) [R] R [R] R [R] R R R R TGAI............ TGAI............ 84-2
Structural chromosomal (22) [R] R [R] R [R] R R R R TGAI............ TGAI............ 84-2
aberration.
Other genotoxic effects....... (22) [R] R [R] R [R] R R R R TGAI............ TGAI............ 84-4
[[Page 105]]
Special testing
General metabolism............ (23) R CR R CR R CR CR CR CR PAI or PAIRA.... PAI or PAIRA.... 85-1
Dermal penetration............ (24) CR CR CR CR CR CR CR CR CR Choice.......... Choice.......... 85-2
Domestic animal safety........ (12) CR CR CR CR ......... ......... CR CR ......... Choice.......... Choice.......... 86-1
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AAAKey: R=Required data; CR=Conditionally required; [ ]=Brackets (ie [R], [CR] indicate data requirements that apply when an experimental use permit is being sought; MP=manufacturing-use
product; EP*=End-Use Product; (asterisk identifies those data requirements that end-use applicants (i.e. ``formulators'') must satisfy, provided that their active ingredient(s) is (are)
purchased from a registered source); TGAI=Technical grade of the active ingredient; PAI=``Pure'' active ingredient; PAIRA=``Pure'' active ingredient, radio-labeled; Choice=choice of several
test substances, depending on studies required.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Not required if test material is a gas or highly volatile.
(2) Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as toxicity category I on the basis of potential eye and
dermal irritation effects.
(3) Required unless repeated dermal exposure does not occur under conditions of use.
(4) Not required unless test material, is an organophosphate, or a metabolite or degradation product thereof which causes acetyl cholinesterase depression or is structurally related to a
substance that causes delayed neurotoxicity.
(5) Required if use involves purposeful dermal application to, or prolonged exposure of, human skin.
(6) Required if use may result in repeated inhalation exposure at a concentration likely to be toxic. A test with duration of 21 days is required if pesticide is used on tobacco.
(7) Required if acute delayed neurotoxicity test showed neuropathy or neurotoxicity or if closely related structural to a compound which can induce these effects.
(8) Required if acute oral, dermal, or inhalation studies showed neuropathy or neurotoxicity.
(9)(i) Studies designed to simultaneously meet the requirements of both the chronic feeding and oncogenicity studies (i.e., a combined study) can be conducted.
(ii) Minimum acceptable test durations for chronic feeding and oncogenicity studies are as follows:
(A) Chronic rodent feeding study (food use pesticides)--24 months.
(B) Chronic rodent feeding study (non-food pesticides)--12 months is usually sufficient.
(C) Chronic nonrodent (i.e., dog) feeding study--12 months.
(D) Mouse oncogenicity study--18 months.
(E) Rat oncogenicity study--24 months.
(10) Required to support products intended for food uses and to supoort products intended for non-food uses if significant exposure of human females of child bearing age may reasonably be
expected.
(11) Required to support products intended for food uses and to support products intended for non-food uses if use of the product is likely to result in human exposure over a portion of the
human lifespan which is significant in terms of the frequency of exposure, magnitude of exposure, or the duration of exposure (for example; pesticides used in treated fabrics for wearing
apparel, diapers, or bedding; insect repellents applied directly to human skin; swimming pool additives; constant-release indoor pesticides which are used in aerosol form).
(12) Required on a case by case basis.
(13) In most cases, where theoretical maximum residue contribution (TMRC) exceeds 50 percent of the maximum permitted intake (MPI), a one year (or longer) interim report on a chronic feed
study is required to support a temporary tolerance.
(14) In most cases, where theoretical maxium residue contribution (TMRC) exceeds 50 percent of the maxium permitted intake (MPI), a first generation (or longer) interim report on a
multigeneration reproduction study is required to support a temporary tolerance.
(15) A teratology study in one species is required to support a temporary tolerance.
(16) Required if the product consists of, or under conditions of use will result in, an inhalable material (e.g., gas volatile substances, or aerosol/particulate).
(17) Required if intended use(s) of the pesticide product is expected to result in human exposure to the product, under the following conditions:
(i) Human exposure is via the oral route.
(ii) Expected human exposure is over a limited portion of the human lifespan, yet is significant in terms of the frequency of exposure, magnitude of exposure, or the duration of exposure (for
example, products requiring a temporary tolerance to support an experimental use permit or emergency exemption).
(18) Required if intended use(s) of the pesticide product is expected to result in human exposure to the product, under the following conditions:
(i) Human exposure is via skin contact.
(ii) Expected human skin contact is not purposeful, and such exposure is of limited frequence and duration (for example, such exposure could result from use of certain disinfectant, liquid
fumigant or agricultural or home/garden pesticide products, and other circumstances where the Agency determines that more than acute dermal exposure is involved).
(iii) Data from a subchronic 90-day dermal toxicity study are not required.
(19) Required if pesticidal use will involve purposeful application to the human skin or will result in comparable human exposure to the product, (e.g., swimming pool algaecides, pesticides
for impregnating clothing), and if either of the following criteria are met:
(i) Data from a subchronic oral study are not required.
(ii) The active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient
is the toxic moiety.
(20) Required if either of the following criteria are met:
(i) Use of the pesticide product is likely to result in repeated human exposure to the product, over a significant portion of the human life-span (for example, products intended for use in and
around residences, swimming pools, and enclosed working spaces or their immediate vicinity).
[[Page 106]]
(ii) The use requires a tolerance for the pesticide or an exemption from the requirement to obtain a tolerance, or requires issuance of a food additive regulation.
(21) Required if any of the following criteria are met:
(i) The active ingredient(s) or any of its (their) metabolites, degradation products, or impurities:
(A) Is structually related to a recognized carcinogen.
(B) Is a substance that cause mutagenic effect as demonstrated by in vitro or in vivo testing.
(C) Produces in subchronic studies a morphologic effect (e.g., hyperplasia, metaplasia) in any organ that may lead to neoplastic change.
(ii) The use requires a tolerance for the pesticide or exemption from the requirement to obtain a tolerance, or requires the issuance of a food additive regulation.
(iii) Use of the pesticide product is likely to result in human exposure over a portion of the human lifespan which is significant in terms of either the time the exposure occurs or the
duration of exposure (for example; pesticides used in treated fabrics for wearing apparel, diapers, or bedding; insect repellents applied directly to human skin; swimming pool additives;
constant-release indoor pesticides which are used in aerosol form).
(22)(i) The required battery of mutagenicity tests must include tests appropriate to address the following three categories in accordance with the objectives set forth in Sec. 158.202:
(A) Gene mutations.
(B) Structural chromosomal aberrations.
(C) Other genotoxic effects as appropriate for the test substance, e.g., numerical chromosome abberations, direct DNA damage and repair, mammalian cells transformation, target organ/cell
analysis.
(ii) Currently recognized tests for each of these categories are listed with the National Technical Information Service (NTIS). Applicants shall explain their reasons for selecting specific
tests from the battery of currently recognized tests. Because of the rapid improvements in this field, applicants are encouraged to discuss with the Agency: test selection, protocol design
and results of preliminary testing.
(iii) Not required if the pesticide use pattern precludes human exposure (e.g., nonvolatile pesticides packaged and used in enclosed bait boxes).
(23) Required if chronic feeding or oncogenicity studies are required.
(24) Dermal absorption studies required for compounds having a serious toxic effect as identified by oral or inhalation studies, for which a significant route of human exposure is dermal and
for which the assumption of 100 percent absorption does not produce an adequate margin of safety. Registrants should work closely with the Agency in developing an acceptable protocol and
performing dermal absorption studies.
[49 FR 42881, Oct. 24, 1984. Redesignated and amended at 53 FR 15993,
15999, May 4, 1988; 58 FR 34203, June 23, 1993]
Sec. 158.390
Sec. 158.390 Reentry protection data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the reentry protection data requirements and the
substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
-------------------------------------------------------------------------------------------------------------------------------------------- Guideline
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
----------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Foliar dissipation............ (1) CR CR CR CR .......... ......... CR ......... ......... TEP............. TEP............. 132-1
Soil dissipation.............. (1), (4) CR CR CR CR .......... ......... CR ......... ......... TEP............. TEP............. 132-1
Dermal exposure............... (1), (2), CR CR CR CR .......... ......... CR ......... ......... TEP............. TEP............. 133-3
(3)
Inhalation exposure........... (1), (2), CR CR CR CR .......... ......... CR ......... ......... TEP............. TEP............. 133-4
(3)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TEP=Typical end-use product.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Data are required if the following conditions are met:
(i)(A) The acute dermal toxicity of the technical grade of active ingredient is less than 200 mg/kg (body weight); or
(B) The acute inhalation toxicity of the technical grade of active ingredient is less than 200 mg/m \3\ (for a one-hour exposure); or
(C) The acute oral toxicity of the technical grade of active ingredient is less than 50 mg/kg (body weight); or
(D) Neurotoxic, teratogenic, or oncogenic effects or other adverse effects as evidenced by subchronic, chronic, and reproduction studies would be expected from entry of persons into treated
sites; or
(E) The Agency receives other scientifically validated toxicological or epidemiological evidence that a pesticide or residue of a pesticide could cause adverse effects on persons entering
treated sites. In the last situation, reentry intervals and supporting data may be required on a case-by-case basis.
(ii) And if: end-use product is to be registered for:
(A) Application to growing crops, such as to or around horticultural and agronomic crops that are field- or orchard-grown.
[[Page 107]]
(B) Application to outdoor tree nursery and forestry operations.
(C) Application to turf crops and commercial applications to turf.
(D) Application to parks and arboretums; or (E) application to aquatic crops.
(iii) And if: human exposure to residues of the pesticide can be reasonably foreseen. This applies primarily to pesticides that will be used on crops where human tasks will involve substantial
exposure to residues of the pesticide.
(2) Data required if appropriate surrogate data are not available.
(3) Data required if the applicant chooses to use the allowable exposure level method for proposal of a reentry interval.
(4) Soil dissipation data required if agricultural practice involves human tasks that would cause substantial exposure to residues sorbed to soil.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.440
Sec. 158.440 Spray drift data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the aerial spray drift data requirements and the
substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Droplet size spectrum......... (1) CR CR CR CR ......... ......... CR ......... ......... TEP............. TEP............. 201-1
Drift field evaluation........ (1) CR CR CR CR ......... ......... CR ......... ......... TEP............. TEP............. 202-1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TEP=Typical end use product.
(b) Notes.--The following are referenced in column two of the table contained in paragraph (a) of this section.
(1) This study is required when aerial applications (rotary and fixed winged) and mist blower or other methods of ground application are proposed and it is estimated that the detrimental
effect level of those nontarget organisms expected to be present would be exceeded. The nontarget organisms include humans, domestic animals, fish and wildlife, and nontarget plants. This
requirement may be satisfied by submittal of published or unpublished information regarding spray drift patterns that would be expected to be similar to the proposed product.
(2) [Reserved]
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.490
Sec. 158.490 Wildlife and aquatic organisms data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
wildlife and aquatic organisms data requirements and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food Crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Avian and mammalian testing
Avian oral LD50 (preferably (1) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 71-1
mallard or bobwhite).
[[Page 108]]
Avian dietary LC50 (preferably (1) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 71-2
mallard and bobwhite).
Wild mammal toxicity.......... (2) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 71-3
Avian reproduction (preferably (3) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 71-4
mallard and bobwhite).
Simulated and actual field (2) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 71-5
testing--mammals and birds.
Aquatic organism testing
Freshwater fish LC50 (1), (7) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 72-1
(preferably rainbow and
bluegill).
Acute LC50 freshwater (1), (7) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 72-2
invertebrates (preferably
Daphnia).
Acute LC50 estuarine and (4), (7) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-3
marine organisms.
Fish early life stage and (5) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-4
aquatic invertebrate life-
cycle.
Fish--life-cycle.............. (6) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 72-5
Aquatic organism accumulation. (8) CR CR CR CR ......... ......... CR CR ......... TGAI, PAI, or TGAI, PAI, or 72-6
degradation degradation
product. product.
Simulated or actual field (2) CR CR CR CR ......... ......... CR CR ......... TEP TEP 72-7
testing--aquatic organisms.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditonally required; [ ]=Brackets (ie. [R], [CR]) indicate data requirements that apply when an experimental use permit is being sought; TGAI=Techical grade of the active
ingredient; TEP=Typical end-use product; PAI=``Pure'' active ingredient.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1)(i) Data are required as follows to support manufacturing use products and those end-use products for indoor use for which there is no registered manufacturing use product:
(A) Solid formulation indoor use products require avian oral LD50 (bobwhite), avian dietary LC50 (bobwhite), freshwater fish LC50 (rainbow trout) and acute LC50 freshwater invertebrate
(Daphnia).
(B) Liquid formulation indoors use products require all tests listed under (b)(1)(i) of this section except the avian oral LD50.
(ii) Data are not required to support:
(A) Indoor end-use products consisting of a gas/highly volatile liquid or a highly reactive solid.
(B) Indoor end-use products for which there is a manufacturing use product registration.
(2) Tests required on a case-by-case basis depending on the results of lower tier studies such as acute and subacute testing, intended use pattern, and pertinent environmental fate
characteristics.
(3) Data required if one or more of the following criteria are met:
[[Page 109]]
(i) Birds may be subjected to repeated or continued exposure to the pesticide or any of its major metabolite degradation products, especially preceding or during the breeding season.
(ii) The pesticide or any of its major metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in avian feed.
(iii) The pesticide or any of its major metalolites or degradation products is stored or accumulated in plant animal tissues, as indicated by its octanol/water partition coefficient,
accumulation studies, metabolic release and retention studies, or as indicated by structural similarity to known bioaccumulative chemicals.
(iv) Any other information, such as that derived from mammalian reproduction studies that indicates the reproduction in terrestrial vertebrates may be adversely affected by the anticipated use
of the pesticide product.
Note: Prior to conducting this test to support the registration of an avicide, the applicant should consult the Agency.
(4) Data required if the product is intended for direct application to the estuarine or marine environment, or the product is expected to enter this environment in significant concentrations
because of its expected use or mobility pattern.
(5) Data from fish early life-stage tests or life-cycle tests with aquatic invertebrates (on whichever species is most sensitive to the pesticide as determined from the results of the acute
toxicity tests) are required if the product is applied directly to water or expected to be transported to water from the intended use site, and when any one or more of the following
conditions apply:
(i) If the pesticide is intended for use such that its presence in water is likely to be continuous or recurrent regardless of toxicity.
(ii) If any LC 50 or EC 50 value determined in acute toxicity testing is less than 1 mg/l; or
(iii) If the estimated environmental concentration in water is equal to or greater than 0.01 of any EC 50 or LC 50 determined in acute toxicity testing.
(iv) If the actual or estimated environmental concentration in water resulting from use is less than 0.01 of any EC50 or LC50 determined in acute toxicity testing and any of the following
conditions exist:
(A) Studies of other organisms indicate the reproductive physiology of fish and/or invertebrates may be affected.
(B) Physiochemical properties indicate cumulative effects.
(C) The pesticide is persistent in water (e.g., half-life in water greater than 4 days).
(6) Data are required if end-use product is intended to be applied directly to water or expected to transport to water from the intended use site, and when any of the following conditions
apply:
(i) if the estimated environmental concentration is equal to or greater than one-tenth of the no-effect level in the fish early life-stage or invertebrate life-cycle test.
(ii) If studies of other organisms indicate the reproductive physiology of fish may be affected. NOTE: The applicant should consult the Agency prior to these tests to support the registration
of a pesticide.
(7) Data from testing with the applicant's end-use product or a typical end-use product is required to support the registration of each end-use product which meets any one of the following
conditions:
(i) The end-use pesticide will be introduced directly not an aquatic environment when used as directed.
(ii) The LC50 or EC50 of the technical grade of active ingredient is equal to or less than the maximum expected environmental concentration (MEEC) or the estimated environmental concentration
(EEC) in the aquatic environment when the end-use pesticide is used as directed.
(iii) An ingredient in the end-use formulation other than the active ingredient is expected to enhance the toxicity of the active ingredient or to cause toxicity to aquatic organisms.
(8) Required if significant concentrations of the active ingredient and/or its principal degradation products are likely to occur in aquatic environments and may accumulate in aquatic
organisms.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.540
Sec. 158.540 Plant protection data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
plant protection data requirements and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Target area phytotoxicity..... (1) .......... .......... .......... .......... ......... ......... ......... ......... ......... EP.............. EP.............. 121-1
Nontarget area phytotoxicity..
Tier I:
Seed germination/seedling (2) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 122-1
emergence.
Vegetative vigor.......... (2) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 122-1
[[Page 110]]
Aquatic plant growth...... (2) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 122-2
Tier II:
Seed germination/seedling (3) .......... CR .......... CR ......... ......... CR ......... ......... TGAI............ TGAI............ 123-1
emergence.
Vegetative vigor.......... (3) .......... CR .......... CR ......... ......... CR ......... ......... TGAI............ TGAI............ 123-1
Aquatic plant growth...... (4) .......... CR .......... CR ......... ......... CR ......... ......... TGAI............ TGAI............ 123-2
Tier III:
Terrestrial field......... (3) .......... CR .......... CR ......... ......... CR ......... ......... TEP............. TEP............. 124-1
Aquatic field............. (4) .......... CR .......... CR ......... ......... CR ......... ......... TEP............. TEP............. 124-2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; TGAI=Technical grade of the active ingredient; EP=End-use product; TEP=Typical end-use product.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Data are required for Special Review and certain public health situations.
(2) Data are required for pesticides to be used in forests and natural grasslands. For herbicide used in forest site preparation; the acquatic plant growth tests will be required. Data are
required to support products to be used in other locations when any of the following conditions are met:
(i) Phytotoxicity problems concerning the product arise and open literature data are not available to address the problems.
(ii) The product may pose hazards to endangered or threatened species.
(iii) Special Review has been initiated on the product.
(3) Required if a 25 percent or greater detrimental effect was found in 1 or more plant species in the corresponding test of the previous tier.
(4) Required if a 50 percent or greater detrimental effect was found on any plant species in the corresponding test of the previous tier.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.590
Sec. 158.590 Nontarget insect data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
nontarget insect data requirements and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use pattern Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Nontarget insect testing--
pollinators
Honey bee acute contact LD50.. (1) [CR] [CR] [CR] [CR] ......... ......... [CR] [CR] ......... TGAI............ TGAI............ 141-1
Honey bee--toxicity of (1), (2) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 141-2
residues on foliage.
Honey bee subacute feeding (3) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 141-4
study.
Field testing for pollinators. (4) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 141-5
[[Page 111]]
Nontarget insect testing--
aquatic insects
Acute toxicity to aquatic (5) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 142-1
insects.
Aquatic insect life-cycle (5) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 142-1
study.
Simulated or actual field (5) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 142-3
testing for aquatic insects.
Nontarget insect testing-- (5) .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 143-1
predators and parasites. thru
143-3
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required; [ ]=Brackets (ie, [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; TGAI=Technical grade of the
active ingredient; TEP=Typical end-use product.
(b) Notes.--The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) Required only if proposed use will result in honey bee exposure.
(2) Required only when formulation contains one or more active ingredients having an acute LD50 of less than 1 microgram/bee.
(3) This requirement is reserved pending development of test methodology.
(4) May be required under the following conditions:
(i) Data from the honey bee subacute feeding study indicate adverse effects on colonies, especially effects other than acute mortality (reproductive, behavioral, etc.).
(ii) Data from residual toxicity studies indicate extended residual toxicity.
(iii) Data derived from studies with organisms other than bees indicate properties of the pesticide beyond acute toxicity, such as the ability to cause reproductive or chronic effects.
(5) This requirement is reserved pending further evaluation to determine what and when data should be required, and to develop appropriate test methods.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
Sec. 158.640
Sec. 158.640 Product performance data requirements.
(a) Table. Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the
product performance data requirements and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (b) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Efficacy of antimicrobial
agents
Products for use on hard (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-2
surfaces.
Products requiring (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-3
confirmatory data.
Products for use on fabrics (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-4
and textiles.
Air sanitizers................ (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-5
Products for control of (1) .......... .......... .......... .......... ......... ......... ......... ......... CR ................ EP*............. 91-7
microbial pests associated
with human and animal wastes.
[[Page 112]]
Products for treating water (1) .......... .......... [CR] .......... ......... ......... ......... ......... CR ................ EP*............. 91-8
systems.
Efficacy of fungicides and
nematicides
Products for control of (1) [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... ................ EP*............. 93-16
organisms producing
mycotoxins.
Efficacy of Vertebrate Control
Agents
Avian toxicants............... (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... (R)...... ................ EP*............. 96-5
Avian repellents.............. (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... ......... ................ EP*............. 96-6
Avian frightening agents...... (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... ......... ................ EP*............. 96-7
Bat toxicants and repellents.. (1) .......... .......... .......... .......... ......... ......... ......... ......... (R)...... ................ EP*............. 96-9
Commensal rodenticides........ (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... (R)...... TEP............. EP*............. 96-10
Rodenticides on farm and (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... ......... ................ EP*............. 96-12
rangelands.
Rodent fumigants.............. (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... (R)...... ................ EP*............. 96-13
Rodent reproductive inhibitors (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... (R)...... ................ EP*............. 96-16
Mammalian predacides.......... (1) (R)....... (R)....... .......... .......... ......... ......... ......... (R)...... ......... ................ EP*............. 96-17
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; [ ]=Brackets (i.e., [R], [CR]) indicate data requirements that apply to products for which an experimental use permit is being sought; EP=End-use
product* (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must satisfy, provided that their active ingredient(s) is (are) purchased from a
registered source); MP=Manufacturing use product; TEP=Typical end-use product.
(b) Notes: The following notes are referenced in column two of the table contained in paragraph (a) of this section.
(1) The Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control pest microorganisms that pose a threat to human health and whose
presence cannot readily be observed by the user including, but not limited to, microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates
(such as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are
efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of
efficacy data for any pesticide product registered or proposed for registration.
(2) [Reserved]
[49 FR 42881, Oct. 24, 1984, as amended at 50 FR 46766, Nov. 13, 1985.
Redesignated at 53 FR 15993, May 4, 1988, and amended at 58 FR 34203,
June 23, 1993]
Sec. 158.690
Sec. 158.690 Biochemical pesticides data requirements.
(a) Biochemical pesticide product analysis data requirements--(1) Table. Sections 158.50 and 158.100
through 158.102 describe how to use this table to determine the biochemical pesticides--product analysis data
requirements and the substance to be tested.
[[Page 113]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product identity ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 151-10
Manufacturing process......... (i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-11
Discussion of formation of (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-12
unintentional ingredients.
Analysis of samples........... (iii) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI..... EP* and TGAI.... 151-13
Certification of limits....... ......... [R] R [R] R [R] R R R R MP.............. EP*............. 151-15
Analytical methods............ ......... R R R R R R R R R MP.............. EP*............. 151-16
Physical and chemical ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-17
properties.
Submittal of samples.......... (iv) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI, PAI EP*, TGAI and 151-18
PAI.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required CR=Conditionally required; MP=Manufacturing-use product; EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
satisfy, provided that their active ingredient(s) (are) purchased from a registered source); TGAI=Technical grade of the active ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
requirements that apply when an experimental use permit is being sought.
(2) Notes.The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.
(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under full scale production.
(ii) If the product is not already under full scale production and an experimental use permit is being sought, a discussion of unintentional ingredients shall be submitted to the extent this
information is available.
(iii) Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end use products will be required on a
case-by-case basis. For pesticides in the production stage, a rudimentary product analytical method and data will suffice to support an experimental use permit.
(iv) Routinely required for products produced by an integrated formulation system. Required on a case-by-case basis for other products or materials.
(b) Biochemical pesticides residue data requirements. (1) Table. Sections 158.50 and 158.100 though 158.102
describe how to use this table to determine the biochemical pesticides--residue data requirements and the
substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Chemical identity............. (i), [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] TGAI............ TGAI............ 153-3
(ii),
(xiv)
Directions for use............ (i), [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] ................ ................ 153-3
(iii),
(xiv)
Nature of the residue:
Plants.................... (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... PAIRA........... PAIRA........... 153-3
(xiv)
Livestock................. (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... PAIRA and plant PAIRA and plant 153-3
(iv), metabo- lites. metabo- lites.
(xiv)
[[Page 114]]
Residue analytical method..... (i), (v), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... TGAI and metabo- TGAI and metabo- 153-3
(xiv) lites. lites.
Magnitude of the residue:
Crop field trials......... (i), [CR] .......... [CR] .......... [CR] ......... ......... [CR] ......... TEP............. TEP............. 153-3
(xiv)
Processed food/feed....... (i), (vi) [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... EP.............. EP.............. 153-3
Meat/mild/poultry/eggs.... (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... [CR] TGAI or plant TGAI or plant 153-3
(vii) metabo- lites. metabo- lites.
Potable water............. (i), .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
(viii)
Fish...................... (i), (ix) .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
Irrigated crops........... (i), (x) .......... .......... [CR] [CR] ......... ......... ......... ......... ......... EP.............. EP.............. 153-3
Food handling............. (i), (xi) .......... .......... .......... .......... ......... ......... ......... ......... [CR] EP.............. EP.............. 153-3
Reduction of residue.......... (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... Residue of Residue of 153-3
(xii) concern. concern.
Proposed tolerance............ (i), [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... Residue of Residue of 153-3
(xiii) concern. concern.
Reasonable grounds in support ......... [CR] .......... [CR] .......... [CR] ......... ......... ......... ......... ................ ................ 153-3
of the petition.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required data; TGAI=Technical grade of the active ingredient; PAIRA=Pure active ingredient, radio labeled; TEP=typical end-use product, MP=Manufacturing-use product; [
]=Brackets (i.e., [CR]) indicate data requirements that apply when an experimental use permit is being sought.
(2) Notes.--The following notes are referenced in column two of the table contained in paragraph (b)(1) of this section.
(i) Residue chemistry data requirements shall apply to biochemical pesticide products when any one or more of the following conditions apply:
(A) Tier II or III toxicology data are required, as specified for biochemical agents in (c)(1) of this section.
(B) The application rate of the product exceeds 0.7 ounces (20 grams) active ingredient per acre per application.
(C) The application rate of the product exceeds a level determined to be comparable to 0.7 ounces active ingredient per application but the application rate is not expressable in terms of
ounces per acre per application.
(ii) The same chemical identity data as required in (a)(1) of this section are required, with emphasis on impurities that could constitute a residue problem.
(iii) Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
(iv) Data on metabolism in livestock are required when residues occur on a livestock feed, or the pesticide is to be applied directly to livestock.
(v) A residue method suitable for enforcement of tolerances is needed whenever a numeric tolerance is proposed Exemptions from the requirement of a tolerance will also usually require an
analytical method.
(vi) Data on the nature and level of residue in processed food/feed are required when detectable residues could concentrate on processing and thus require establishment of a food additive
tolerance.
(vii) Livestock feeding studies are required whenever a pesticide occurs as a residue in an livestock feed. Direct application to livestock uses will require animal treatment residue studies.
(viii) Data on residues in potable water are required whenever a pesticide is to be applied directly to water, unless it can be determined that the treated water would not be used (eventually)
for drinking purpose, by man or animals.
(ix) Data on residues in fish are required whenever a pesticide is to be applied directly to water.
(x) Data on residues in irrigated crops are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation
ditches.
(xi) Data or residues in food/feed in food handling establishments are required whenever a pesticide is to be used in food/feed handling establishments.
(xii) Reduction of residue data are required when the assumption of tolerance level residues results in an unsafe level of exposure. Data on the level of residue in food as consumed will be
used to obtain a more precise estimate of potential dietary exposure.
(xiii) The proposed tolerance must reflect the maximum residue likely to occur in crops and meat/milk/poultry/eggs.
(xiv) Residue data for outdoor domestic uses are required if home gardens are to be treated and the home garden use pattern is different from the use pattern on which the tolerances were
established.
[[Page 115]]
(c) Biochemical pesticides toxicology data requirements--(1) Table. Sections 158.50 and 158.100 through
158.102 describe how to use this table to determine the biochemical pesticides--toxicology data requirements
and the substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
Acute oral toxicity....... (i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-10
dilution* and
TGAI.
Acute dermal toxicity..... (i), (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-11
dilution* and
TGAI.
Acute inhalation.......... (xiv) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 152-12
Primary eye irritation.... (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP.............. 152-13
Primary dermal irritation. (i), (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP.............. 152-14
Hypersensitivity study.... (iii) CR CR CR CR CR CR CR CR CR MP.............. EP.............. 152-15
Hypersensitivity incidents (iv) CR CR CR CR CR CR CR CR CR ................ ................ 152-16
Studies to detect (v) [R] [CR] [R] [CR] [R] [CR] [CR] [CR] [CR] TGAI............ TGAI............ 152-17
genotoxicity.
Immune response........... ......... [R] R [R] R [R] R R R R TGAI............ TGAI............ 152-18
90-day feeding (1 spp.)... (vi) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-20
90-day dermal (1 spp.).... (vii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-21
90-day inhalation (1 spp.) (viii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-22
Teratogenicity (1 spp.)... (ix) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-23
Tier II:
Mammalian mutagenicity (x) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-19
tests.
Immune response........... (xi) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-24
Tier III:
Chronic exposure.......... (xii) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 152-26
Oncogenicity.............. (xiii) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 152-29
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally Required; MP=Manufacturing-use product; EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e. ``formulators'') must
satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical Grade of the Active Ingredient; [ ]=Brackets (i.e., [R], [CR]] indicate data
requirement that apply when an experimental use permit is being sought.
(2) Notes.--The following notes are referenced in column two of the table contained in paragraph (c)(1) of this section.
(i) Not required if test material is a gas or is highly volatile.
[[Page 116]]
(ii) Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified toxicity category I on the basis of potential eye and
dermal irritation effects.
(iii) Required if repeated contact with human skin results under condition of use.
(iv) Incidents must be reported, if they occur.
(v) Required to support non-food uses if use is likely to result in significant human exposure; or the active ingredient or its metabolites is (are) structurally related to a known mutagen, or
belongs(s) to any chemical class of compounds containing known mutagens.
(vi) Required if the use requires a tolerance or an exemption from the requirement for a tolerance, or its use requires a food additive regulation; or the use of the product is otherwise
likely to result in repeated human exposure by the oral route.
(vii) Required if pesticidal use will involve purposeful application to the human skin or will result in comparable prolonged human exposure to the product, (e.g., swimming pool algaecides,
pesticides for impregnating clothing), and if either of the following criteria are met:
(A) Data from a subchronic oral study are not required.
(B) The active ingredient of the product is known or expected to be metabolized differently by the dermal route of exposure than by the oral route, and a metabolite of the active ingredient is
the toxic moiety.
(viii) Required if pesticidal use may result in repeated inhalation exposure at a concentration which is likely to be toxic.
(ix) Required if any of the following criteria are met:
(A) Use of the product under widespread and recognized practice may reasonably be expected to result in significant exposure to female humans.
(B) Its use requires a tolerance or an exemption from the requirement for a tolerance, or its use requires issuance of a food additive regulation.
(x) Required if results from any one of the Tier I mutagenicity tests were positive.
(xi) Required if adverse effects are observed in the Tier I immune response studies.
(xii) Required if the potential for adverse chronic effects are indicated based on:
(A) The subchronic effect levels established in the Tier I subchronic oral toxicity studies, the Tier I subchronic dermal toxicity studies or the Tier I subchronic inhalation toxicity studies.
(B) The pesticide use pattern (e.g., rate, frequency, and site of application).
(C) The frequency and level of repeated human exposure that is expected.
(xiii) Required if the product meets either of the following criteria:
(A) The active ingredient(s) or any of its (their) metabolites, degradation products, or impurities produce(s) in Tier I subchronic studies a morphologic effect (e.g., hyperplasia, metaplasia)
in any organ that potentially could lead to neoplastic change.
(B) If adverse cellular effects suggesting oncogenic potential are observed in Tier I or Tier II immune response studies or in Tier II mammalian mutagenicity assays.
(xiv) Required if the product consists of, or under conditions of use results in, an inhalable material (e.g., gas, volatile substance, or aerosol/particulate).
(d) Nontarget organism, fate and expression data requirements--(1) Table. Sections 158.50 and 158.100
through 158.102 describe how to use this table to determine the biochemical pesticides non-target organism,
fate and expression data requirements and substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
Avian acute oral.......... (i), (ii) [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-6
Avian dietary............. (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-7
(ii),
(vi)
Freshwater fish LC50...... (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-8
(ii), (v)
Freshwater invertebrate (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-9
LC50. (ii),
(vii)
Nontarget plant studies... (iii) .......... R .......... R ......... ......... R ......... ......... TGAI............ TGAI............ 154-10
Nontarget insect testing.. (iv), (v) CR CR CR CR CR CR CR CR ......... TGAI............ TGAI............ 154-11
Tier II:
Volatility................ (viii) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 155-4
[[Page 117]]
Dispenser-water leaching.. (ix) CR CR CR CR ......... ......... CR CR ......... EP.............. EP.............. 155-5
Adsorption-desorption..... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-6
Octanol/Water Partition... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-7
U.V. absorption........... (xi) CR CR CR CR ......... ......... CR CR ......... PAI............. PAI............. 155-8
Hydrolysis................ (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-9
Aerobic soil metabolism... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-10
Aerobic aquatic metabolism (x) CR CR CR CR ......... CR CR ......... TGAI............ TGAI............ 155-11
Soil photolysis........... (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-12
Aquatic photolysis........ (x) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 155-13
Tier III:
Terrestrial wildlife (xii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 15-12
testing.
Aquatic animal testing.... (xiii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-13
Nontarget plant studies... (xiv) .......... .......... .......... .......... ......... ......... ......... ......... ......... TGAI............ TGAI............ 154-14
Nontarget insect testing.. (xv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-15
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally reguired; [ ]=Brackets (i.e., [R], [CR]) indicates data requirements that apply to products for which an experimental use permit is being sought;
MP=Manufacturing-use product; TEP=Typical end-Use product; TGAI=Technical grade of the active ingredient; EP=End-use product, PAI=``Pure'' active ingredient.
(2) Notes.--The following notes are referenced in column two of the table contained in paragraph (d)(1) of this section.
(i) Tests for pesticides intended solely for indoor application will be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
(ii) Preferable test species are: bobwhite quail or mallard for avian acute oral and avian dietary studies: rainbow trout for freshwater fish studies; and Daphnia for freshwater invertebrate
studies on biochemicals.
(iii) Data are required for pesticides to be used in forests and natural grasslands. For herbicides used in forest site preparation; the aquatic plant growth tests will be required. Data are
required when to support products to be used in other locations when any of the following conditions are met.
(A) Phytotoxicity problems arise and open literature data are not available.
(B) The product may pose hazards to endangered or threatened species.
(C) A rebuttable presumption against registration Special Review has been initiated on the product.
(iv) Required depending on pesticide mode of action and results of any available product performance data.
(v) Biochemicals introduced directly into an aquatic environment when used as directed shall be tested as specified in Sec. 158.145.
(vi) Not required if pesticide is highly volatile (estimated volatility greater than 5x10-5 atm. m3/mol).
(vii) If the pesticide will be introduced directly into an aquatic environment when used as directed, then it must be tested as indicated in Sec. 158.145.
(viii) Required when results of any one or more of the Tier I tests indicate potential adverse effects on nontarget organisms and the biochemical agent is to be applied on land.
(ix) Required when results of any one or more of the Tier I tests indicate potential adverse effects on nontarget organisms and the biochemical agent is to be applied on land in a passive
dispenser.
(x) Required on a case-by-case basis when results of Tier I tests indicate environmental fate data are needed.
(xi) Required when results of Tier I tests indicate potential adverse effects on beneficial insects and the intended route of exposure of the pesticide is through vapor phase contact.
(xii) Required if either of the following criteria are met:
(A) Environmental fate characteristics indicate that the estimated concentration of the biochemical pesticide in the terrestrial environment is equal to or greater than \1/5\ the avian dietary
LC50 or the avian single dose oral LD50 (converted to ppm).
(B) The pesticide or any of its metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in the avian feed.
(xiii) Required if environmental fate characteristics indicate that the estimated environmental concentration of the biochemical agent in the aquatic environment is equal to or greater than
0.01 of any EC50 or LC50 determined in testing required by Tier I aquatic tests.
(xiv) Required if the product is expected to be transported from the site of application by air, soil, or water. The extent of movement will be determined by the Tier II environmental fate
tests.
(xv) Required when results of Tier I tests indicate potential adverse effects on nontarget insects and results of Tier II tests indicate exposure of nontarget insects.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
[[Page 118]]
Sec. 158.740
Sec. 158.740 Microbial pesticides--Product analysis data requirements.
(a) Microbial pesticides product analysis data requirements--(1) Table. Sections 158.50 and 158.100
through 158.102 describe how to use this table to determine the microbial pesticides--product analysis data
requirements and the substance to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product identity manufacturing ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 151-20
process.
(i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-21
Discussion of formation of (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-22
unintentional ingredients.
Analysis of samples........... (iii) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI..... EP* and TGAI.... 151-23
Certification of limits....... ......... [R] R [R] R [R] R R R R MP.............. EP*............. 151-25
Analytical methods............ ......... R R R R R R R R R MP.............. EP*............. 151-25
Physical and chemical ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* and TGAI.... 151-26
properties.
Submittal of samples.......... (iv) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] MP and TGAI, PAI EP* TGAI and PAI 151-27
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product: EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical grade of the active ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
requirements that apply when an experimental use permit is being sought.
(2) Notes.--The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.
(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under scale production.
(ii) If the product is not already under full scale production and an experimental use permit is being sought, a discussion of unintentional ingredients shall be submitted to the extent this
information is available.
(iii) Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end use products will be required on a
case-by-case basis. For pesticide in the production stage, a rudimentary product analytical method and data will suffice to support an experimental use permit.
AAA(iv) Routinely required for products produced by an integrated formulation system. Required on a case-by-case basis for other products or materials.
(b) Microbial pesticides-residue data requirements--(1) Table. Sections 158.50 and 158.100 through 158.102
describe how to use this table to determine the microbial pesticides-residue data requirements and the
substances to be tested.
[[Page 119]]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Residue data.................. (i) [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] [CR] ................ ................ 153-4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required data; EP=End-use product; MP=Manufacturing-use product; [ ]=Brackets (i.e., [CR]) indicate data requirements that apply when an experimental use permit is being
sought.
(2) Notes.--The following notes are referenced in column two of the table contained in paragraph (b)(1) of this section.
(i) Residue data requirements shall apply to microbial pesticides when Tier II or Tier III toxicology data are required, as specified for microbial pesticides in (c)(1) of this section.
(ii) [Reserved)
(c) Microbial pesticides-toxicology data requirements--(1) Table. Sections 158.50 and 158.100 through
158.102 describe how to use this table to determine the microbial pesticides-toxicology data requirements and
the substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
Acute oral................ ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP* 152-30
dilution and
TGAI.
Acute dermal.............. ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-31
dilution and
TGAI.
Acute inhalation.......... (i) [R] [R] [R] [R] [R] [R] [R] [R] [R] MP and TGAI..... EP* or EP 152-32
Dilution* and
TGAI.
I.V., I.C., I.P. injection (ii) [R] [R] [R] [R] [R] [R] [R] [R] [R] TGAI............ TGAI............ 152-33
Primary dermal............ ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 152-34
Primary eye............... ......... [R] [R] [R] [R] [R] [R] [R] [R] [R] MP.............. EP*............. 152-35
Hypersensitivity study.... (iii) R R R R R R R R R MP.............. EP*............. 152-36
Hypersensitivity incidents (iv) CR CR CR CR CR CR CR CR CR ................ ................ 152-37
Immune response........... ......... [R] R [R] R [R] R R R R TGAI............ TGAI............ 152-38
Tissue culture............ (v) [R] R [R] R [R] R R R R TGAI............ TGAI............ 152-39
Tier II:
Acute oral................ (vi) CR CR CR CR CR CR CR CR CR MP.............. EP*............. 152-40
Acute inhalation.......... (vii) CR CR CR CR CR CR CR CR CR MP.............. EP*............. 152-41
Subchronic oral........... (viii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-42
Acute I.P., I.C........... (ix) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-43
Primary dermal............ (x) CR CR CR CR CR CR CR CR CR ................ EP*............. 152-44
Primary eye............... (xi) CR CR CR CR CR CR CR CR CR ................ EP*............. 152-45
[[Page 120]]
Immune response........... (xii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-46
Teratogenicity............ (xiii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-47
Virulence enhancement..... (xiv) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-48
Mammalian mutagenicity.... (xv) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-49
Tier III:
Chronic feeding........... (xvi) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 152-50
Oncogenicity.............. (xvii) CR .......... CR .......... CR ......... ......... ......... CR TGAI............ TGAI............ 151-51
Mutagenicity.............. (xviii) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-52
Teratogenicity............ (xix) CR CR CR CR CR CR CR CR CR TGAI............ TGAI............ 152-53
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product; EP*=End use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical Grade of the Active Ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
requirements that apply when an experimental use permit is being sought.
(2) Notes.--The following notes are referenced in column two of the table contained in paragraph (c)(1) of this section.
(i) Required if 20 percent or more of the aerodynamic equivalent of the product (as registered or under conditions of use) is composed of particulates less than 10 microns in diameter.
(ii) Data required for products as follows:
(A) Intravenous (``IV'') infectivity study for bacterial, and viral agents;
(B) Intracerebral (``IC'') infectivity study for viral and protozoan agents; and
(C) Intraperitoneal (``IP'') infectivity study for fungal and protozoan agents.
(iii) Required if commonly recognized use practices will result in repeated human contact by inhalation or dermal routes.
(iv) Hypersensitivity incidents must be reported, if they occur.
(v) Data required for products whose active ingredient is a virus.
(vi) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus or protozoa) is observed in the test animals treated in the Tier I acute oral
infectivity tests or the intraperitoneal or intracerebral injection test for protozoa.
(vii) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus or protozoa) is observed in the test animals treated in the comparable Tier I acute
inhalation tests.
(viii) Required if there is evidence of survival, replication, infectivity, or persistence of the protozoan agent in the Tier I oral infectivity test.
(ix) Required if in Tier I acute oral infectivity testing, Tier I dermal toxicity/infectivity testing, or Tier I intraperitoneal or intracerebral injection testing, the test microorganism
(bacteria, fungi, or protozoa) survived for more than 2 weeks, caused toxic effects, or caused a severe illness response in an experimental animal as evidenced by irreversible gross
pathology, severe weight loss, toxemia, or death.
(x) Required if infectivity or if marked edema or broad erythema was observed in the Tier I dermal irritation study.
(xi) Required if infectivity or if severe ocular lesions are observed in the Tier I primary eye irritation study.
(xii) Required if results of the Tier I immune response test indicate abnormalities.
(xiii) Required when Tier I tests on viral agents show replication of the virus in mammalian hosts and significant damage to mammalian cells.
(xiv) Required when Tier I infectivity tests on bacteria or fungi indicate prolonged survival (including presence of viable microbial agents in test animal excreta) and/or multiplication
(infectivity) of the bacteria or fungal agent, respectively.
(xv) Required if any of the following criteria are met:
(A) Acute infectivity tests are positive in Tier I studies.
(B) Adverse effects are observed in immune response studies.
(C) Positive results are obtained in tissue culture tests with viral agents.
(xvi) Required when the potential for chronic adverse effects (e.g., replication or persistence of viral or subviral constituents, protozoans, fungi, or bacteria) are demonstrated by any of
the Tier II tests (except primary dermal, primary ocular, and mammalian mutagenicity tests).
(xvii) Required when the potential for oncogenic effects is indicated (e.g., adverse cellular effects due to presence, replication, or persistence of viral or subviral constituents, or
bacteria, fungi or protozoans; or mutagenic effects) by any of the Tier II tests except the primary dermal and primary ocular studies.
(xviii) Required when the potential for mutagenic effects is indicated (e.g., adverse cellular effects due to presence, replication, or persistence of viral or subviral constituents, bacteria,
fungi or protozoa) by any of the Tier II tests except primary dermal or primary ocular studies.
(xix) Required when the potential for teratogenic effects is expected based on the presence of persistence of fungi, bacteria, viruses, or protozoa in mammalian species as a result of testing
performed in Tier II, except primary dermal and primary ocular studies.
[[Page 121]]
(d) Microbial pesticides non-target organism and environmental expression data requirements--(1) Table.
Sections 158.50 and 158.100 through 158.102 describe how to use this table to determine the microbial
pesticides non-target organism and environmental expression data requirements and substances to be tested.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General use patterns Test substance
------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
Kind of data required (2) Notes Terrestrial Aquatic Greenhouse reference
---------------------------------------------------------------------- Forestry Domestic Indoor Data to support Data to support No.
Food crop Nonfood Food crop Nonfood Food crop Nonfood outdoor use MP EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
Avian oral................ (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-16
(ii),
(iii)
Avian injection test...... (i), [R] [R] [R] [R] CR CR [R] [R] CR TGAI............ TGAI............ 154-17
(ii),
(iii)
Wild mammal testing....... (iv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-18
Freshwater fish testing... (i) [R] [R] [R] [R] CR CR [R] CR CR TGAI............ TGAI............ 154-19
Freshwater aquatic (i) [R] [R] [R] [R] CR CR [R] CR CR TGAI............ TGAI............ 154-20
invertebrate testing.
Estuarine and marine (v) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-2
animal testing.
Nontarget plant studies... ......... [R] [R] [R] [R] ......... ......... [R] [R] CR TEP............. TEP............. 154-2
Nontarget insect testing.. ......... [R] [R] [R] [R] CR CR [R] [R] ......... TGAI............ TGAI............ 154-23
Honey bee testing......... ......... [R] [R] [R] [R] CR CR [R] [R] ......... TGAI............ TGAI............ 154-24
Tier II:
Terrestrial environmental (vi) CR CR CR CR ......... ......... CR CR ......... TGAI or TEP..... TGAI or TEP..... 155-18
testing.
Freshwater environmental (vii) CR CR CR CR ......... ......... CR CR ......... TGAI or TEP..... TGAI or TEP..... 155-19
expression tests.
Marine or estuarine (xiii), CR CR CR CR ......... ......... CR CR ......... TGAI or TEP..... TGAI or TEP..... 155-20
environmental expression (ix)
tests.
Tier III:
Terrestrial wildlife and (x) CR CR CR CR ......... ......... CR CR ......... TGAI or TEP..... TGAI or TEP..... 154-25
aquatic organism testing.
Avian pathogenicity/ (xi) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-26
reproduction test.
Definitive aquatic animal (xii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-27
tests.
Aquatic embryo larvae and (xiii) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-28
life cycle studies.
Aquatic ecosystem test.... (xiv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TGAI............ 154-29
[[Page 122]]
Special aquatic tests ......... .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 154-30
(reserved).
Nontarget plant studies... (xv) CR CR CR CR ......... ......... CR CR ......... TGAI............ TEP............. 154-31
Tier IV: (xvi)
Simulated and actual field (xiii) CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 154-33
tests (birds, mammals).
Simulated and actual field (xvii), CR CR CR CR ......... ......... CR CR ......... TEP............. TEP............. 154-34
tests (aquatic organisms). (xviii)
Simulated and actual field ......... .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 154-35
tests (insect predators,
parasites) (reserved).
Simulated and actual field ......... .......... .......... .......... .......... ......... ......... ......... ......... ......... ................ ................ 154-36
tests (insect
pollinators) (reserved).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
AAAKey: R=Required; CR=Conditionally required; [ ]=Brackets (i.e., [R], [CR]) indicates data requirements that apply to products for which an experimental use permit is being sought;
MP=Manufacturing-use Product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; EP=End-use product; PAI=``Pure'' active ingredient.
AAA(2) Notes.--The following notes are referenced in column two of the table contained in paragraph (d)(1) of this section.
AAA(i) Tests for pesticides intended solely for indoor application will be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
AAA(ii) Preferable test species are: bobwhite quail or mallard for avian acute oral and avian dietary studies; rainbow trout for freshwater fish studies.
AAA(iii) Data from either the avian acute oral or the avian injection study are required to support an experimental use permit.
AAA(iv) Required on a case-by-case basis if results of tests required by paragraph (c)(1) of this section are inadequate or inappropriate for assessment of hazards to wild animals.
AAA(v) Required when product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of
expected use or mobility pattern.
AAA(vi) Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
AAA(A) Avian single dose oral toxicity and pathogenicity tests.
AAA(B) Avian injection pathogenicity tests.
AAA(C) Wild mammals toxicity and pathogenicity test.
AAA(D) Plant studies--terrestrial.
AAA(E) Honey bee toxicity/pathogenicity test.
AAA(F) Testing for toxicity/pathogenicity to insect predators and parasites.
AAA(vii) Required when toxic or pathogenic effects are observed in any of the following Tier I test for microbial pest control agents:
AAA(A) Freshwater fish toxicity and pathogenicity testing.
AAA(B) Freshwater aquatic invertebrate toxicity and pathogenicity test.
AAA(C) Plant studies--aquatic.
AAA(viii) Required if product is applied on land or in fresh water and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
AAA(A) Estuarine and marine animal toxicity and pathogenicity test.
AAA(B) Plant studies--estuarine or marine.
AAA(ix) Required if product is applied in marine or estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests:
AAA(A) Avian single dose oral toxicity and pathogenicity test.
AAA(B) Avian injection pathogenicity test.
AAA(C) Estuarine and marine animal toxicity and pathogenicity test.
[[Page 123]]
AAA(x) Required when toxic effects on nontarget terrestrial wildlife or aquatic organisms are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the
mocrobial agent to the affected nontarget terrestrial wildlife or aquatic organisms.
AAA(xi) Required when:
AAA(A) Pathogenic effects are observed in Tier I avian tests at a level equal to the adjusted host equivalent amount.
AAA(B) Chronic, carcinogenic, or teratogenic effects are reported in tests required by paragraph (c)(1) of this section for evaluating hazard to humans and domestic animals.
AAA(C) Tier II Environmental expression testing indicates that exposure of terrestrial animals to the microbial agent is likely.
AAA(xii) Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenicity or infectivity was observed in Tier I
tests.
AAA(xiii) Required when both of the following conditions are met:
AAA(A) Pathogenic effects at actual or expected field residue exposure levels are reported in Tier III.
AAA(B) The agency determines that quarantine methods will prevent the microbial pest control agent from contaminating areas adjacent to the test area.
AAA(xiv) Required if, after an analysis of the microbial agent's properties, the individual use patterns, and the results of previous nontarget organism and environmental expression tests, it
is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments, including those of the water column and bottom sediments. When
a microbial pest control agent is used in or is expected to transport to water from the intended use site, major considerations for requiring these infectivity tests include, but are not
limited to:
AAA(A) Infectivity or pathogenicity demonstrated in previous testing.
AAA(B) Viability of the microorganism in natural waters as demonstrated in Tier II tests.
AAA(xv) Required if the product is transported from the site of application by air, soil, or water or transmission by other animals. The extent of movement will be determined by the
environmental expression tests in Tier II.
AAA(xvi) The Agency expects that Tier IV requirements would be imposed retrospectively--after product registration as post registration monitoring, since it is unlikely a registrant would
pursue registration of a microbial agent posing potential hazards such that testing beyond Tier III is required.
AAA(xvii) Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of
available laboratory data, use patterns, and exposure rates.
AAA(xviii) Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and
growth of natural populations are observed) are required if laboratory data indicate adverse long-term, cumulative, or life-cycle effects may result from intended use.
[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988,
and amended at 58 FR 34203, June 23, 1993]
[[Page 124]]
Appendix A to Part 158--Data Requirements for Registration: Use Pattern
Index
How to use this Index:
1. Identify the Pesticide Use Site Group listed below (e.g.,
agricultural crops, forests, ornamental plants) that covers the specific
use pattern of interest to you.
2. Find your specific use pattern under the appropriate Pesticide
Use Site Group.
3. Identify the general use pattern that corresponds to your
specific use pattern.
4. Use the general use pattern in determining applicable data
requirements on the Data Requirements tables presented in Secs. 158.120
through 153.170.
Pesticide use site group
1. Agricultural Crops.
2. Ornamental Plants and Forest Trees.
3. General Soil Treatment and Composting.
4. Processed or Manufactured Products, and food or feed containers
or dispensers.
5. Pets and Domestic Animals.
6. Agricultural Premises and Equipment.
7. Household.
8. Wood or Wood Structure Protection Treatments.
9. Aquatic sites.
10. Noncrop, wide area, and general indoor/outdoor treatments.
11. Antifouling treatments.
12. Commercial and Industrial Uses.
13. Domestic and Human Use.
14. Miscellaneous Indoor Uses.
------------------------------------------------------------------------
Specific use patterns--listed according to Corresponding general use
use site group pattern
------------------------------------------------------------------------
1. Agricultural crops
Small fruits Terrestrial food crop
Caneberries (e.g., raspberry, dewberry)
Bushberries (e.g., blueberry, currant)
Vine fruits (e.g., grape, kiwi fruit)
Strawberry
Cranberry
Pome fruits (e.g., apple, quince)
Stone fruits (e.g., peach, cherry)
Nut crops--tree & shrub (e.g., pecan,
filbert)
Other temperate fruits (e.g., persimmon,
pawpaw)
Tropical and subtropical fruits
Citrus
Banana and plantain
Palm fruits and nuts (e.g., date, coconut)
Pineapple
Other fruits and nuts
Beverage crops
Woody--cocoa, coffee, tea
Herbaceous--chicory, mint
Flavoring and spice crops
Woody--leaf/stem, root, seed and pod
Herbac.--leaf/stem, root, seed and pod
Vegetables--leaf/stem, root, seed and pod,
fruiting vegetables, cucurbits
Commercial annual (e.g., tomato, bean)
Commercial perennial (e.g., asparagus,
rhubarb)
Greenhouse (commercial) Greenhouse food crop
Mushrooms
Nursery/seed crop/medical crop/tobacco Greenhouse non-food crop
Fiber crops Terrestrial food crop
Cotton
Others--(e.g., flax)
Forage crops
Typical grasses--annual (e.g., sudan
grass)
Typical grasses--perennial (e.g.,
bromegrass)
Corn and sorghum
Small grains for forage (e.g., rye)
Perennial legumes (e.g., white clover)
Annual legumes (e.g., crotalaria, soybean)
Crop harvest residue (peanut vines, beet
tops, etc.)
Grain and edible seed crops
Corn
Rice Aquatic food crop
Wheat, barley, rye, oats Terrestrial food crop
Sorghum
Alfalfa
Other grains
Other nongrains (e.g., squash, pumpkin)
Buckwheat
Sesame
Peanut
Sunflower
Seed sprout crops
Mung bean, red clover, soybean, alfalfa,
etc.
Nonlegume crops (e.g., wheat, radish,
black mustard)
Crops grown exclusively for seed for
planting
Sugar crops
Stored raw agricultural commodities Indoor
Honey (principal nectar-producing crops)
Sugar beet
Sugarcane
Sugar maple
Sorghum (for sugar)
Crops for smoking and chewing Terrestrial nonfood crop
--field
--shade
--storage
--greenhouses
Sapodilla (for chewing gum) Terrestrial food crop
Oil crops
Annual herbaceous crops
Perennial herbaceous crops
Tropical/subtropical woody crops
Drug and medicinal crops Terrestrial nonfood crop
Annual herbaceous crops
Perennial herbaceous crops
Temperate woody crops
Tropical/subtropical wood crops
[[Page 125]]
2. Ornamental plants and forest trees
Ornamental plants Terrestrial nonfood crop
Annual garden plants
Temperate perennial nonfood garden herbs
Commercial greenhouse crops Greenhouse nonfood crop
Houseplants Indoor
Home and retail greenhouse and
conservatory plants
Public display plantings Terrestrial nonfood crop
Bulb, corm, and tuber ornamentals
Subtropical/tropical garden evergreen
plants (dry--e.g., agave)
Subtropical/tropical garden evergreen
plants (moist--e.g., ferns)
Groundcovers
Aquatic plants (e.g., waterlilies) Aquatic nonfood use
Ornamental trees, shrubs, and vines (woody) Terrestrial nonfood crop
Deciduous temperate broadleaf
Evergreen temperate broadleaf
Deciduous temperate conifer
Evergreen temperate conifer
Tropical/subtropical broadleaf
Tropical/subtropical conifer
Tropical/subtropical miscellaneous (e.g.,
cycad, tree fern, bamboo)
Lawn and turf grasses--ornamental Terrestrial nonfood crop
or domestic outdoor
Cool season Winter grasses (bent,
bluegrass, fescue, etc.)
Summer grasses (zoysia, bermudagrass,
etc.)
Ornamental bunch grasses (pampasgrass,
blue fescue)
Forest trees--nonornamental--trees forests, Forestry
plantings
Deciduous temperate (broadleaf)
Evergreen temperate (broadleaf)
Deciduous and evergreen conifers
Tropical/subtropical broadleaf
Tropical/subtropical conifer
Forest tree nurseries--Temperate broadleaf
trees
Temperate conifer trees
Forest trees: dead trees/logs/stumps in the
forest or in plantings
3. General soil treatment and composting
General soil treatments Terrestrial nonfood crop
Soil application with no mention of crops
to be grown (potting soil, top soil).
Manure
Composts
Cull piles
Mulches
4. Processed or manufactured products, and
food or feed containers or dispensers
Processed vegetables, fruits, and nuts Indoor
Fruits
Leafy vegetables
Root vegetables
Fruited vegetables
Nuts
Peanuts
Seeds (sesame, sunflower)
Dried processed
Fruits
Vegetables
Tobacco
Beverages (tea, coffee)
Herbs and spices
Animal Feeds
Cattle (beef)
Cattle (dairy)
Goat (nondairy)
Goat (dairy)
Horse, mule, donkey
Poultry (chicken, turkey, etc.)
Sheep (meat)
Sheep (wool)
Swine
Dog
Cat
Other pets (including birds)
Fur-bearing stock
Other meat-producing stock (e.g., rabbit)
Fish food (commercial)
Fish food (pet)
Birdseed
Processed grain products for human
consumption
Corn
Soybean
Wheat
Other grains (rice, barley, etc.)
Cereal foods
Flour
Baked goods
Farinaceous products
Processed animal products for human
consumption
Cheese
Egg yolks
Meats, including fish and poultry
Milk
Processed plant products for human
consumption
Chocolate
Candy
Sugar
Yeast
Citrus pulp
Chewing gum
Cigarettes, etc.
Herbs and spices
Pickles
Glazed fruits
Jellies
Seed oils
Fruit syrups (e.g., cola)
Fruit juices
Fermentation beverages (wine, beer,
whiskey, vinegar)
Processed or manufactured nonfood plant
and animal products
Textiles, fabrics, fibers
Fur and hair products
Leather products
Food and feed containers, dispensers, and
processing equipment
Airtight storages--large (empty/full)
Airtight storages--small (empty/full)
Fumigation chambers
Bins
Elevators
Storage areas--(empty/full)
[[Page 126]]
Processing or handling equipment and
machinery (other than food processing)
5. Pets and domestic animals--animals and
their man-made premises
Dairy cattle--lactating Indoor
Dairy cattle--nonlactating
Dairy cattle--heifers, calves
Goats--lactating
Goats--nonlactating
Goats--young (kids)
Fur- and wool-bearing animals
Goats
Sheep
Mink
Chinchilla
Rabbit
Fox
Nutria
Meat animals (mammals)
Cattle (and calves)
Goats (and kids)
Horses
Rabbits
Sheep (and lambs)
Swine
Bison
Reindeer
Poultry (meat, eggs)
Chickens
Turkeys
Ducks, geese
Guineas, pheasants, quail, etc.
Honey production
Bees
Beehives
Honeycombs
Fish and shellfish production Aquatic food use
Hatchery buildings
Culture ponds, containers
Animals for labor, display, riding, racing, Indoor
lab use, etc.
Dogs
Horses, donkeys, mules
Guinea pigs
Mice
Rats
Gerbils
Hamsters
Monkeys
Cats
Chickens, birds
Wild rodents
Alfalfa leafcutting bee (pollinator)
Alkaline bee (pollinator)
Zoo ruminants
Zoo ungulates
Zoo canines
Zoo felines
Zoo primates
Zoo reptiles
Zoo amphibians
Zoo birds
Zoo--others
Aquarium fish
Animals for pets, including their cages,
bedding, nests, etc.
Dogs
Cats
Birds
Rodents
Lagomorphs
Fish
Amphibians
Reptiles
Primates
Other vertebrates
6. Agricultural premises and equipment
Egg handling facilities and equipment Indoor
Egg washers
Egg rooms
Hatching egg treatments
Hatching egg rooms
Hatching egg equipment
Egg packing plants and hatcheries
Milk handling facilities and equipment
Milk storage rooms
Milking stalls and parlors
Milking machines, milk tanks, etc.
Teat cups, liners, etc.
Milk processing equipment
7. Household
Non-food area and sites Indoor
Closets, storage areas
Basements, cellars
Bedrooms
Attics
Recreation rooms
Living rooms
Baseboards, window sills, etc.
Plumbing fixtures
Sickrooms
Food-handling and food storage areas
Kitchens
Dining rooms
Pantry and food storage shelving
Household contents and space
Air
Beds
Rugs
Book cases
Furs, fabrics, blankets
Play pens
Sickroom utensils
Filters for air vents, air conditioners,
furnaces, etc.
Outdoor areas (Noncommercial homeowner use) Domestic outdoor or
terrestrial food crop
Home garden, orchards
Porches Domestic outdoor
Patios
Foundations
Steps
Eaves
Yards, lawn, turf
Domestic ornamental plantings
8. Wood or Wood Structure Protection
Treatments
Buildings (for termite, powderdust beetle Domestic outdoor or indoor
controls, etc.)
Unseasoned forest products
Seasoned forest products
Finished wood products
Wood pressure treatments
Plant-growing wood structures and containers
Wood containers for nonfood, nonfeed uses
9. Aquatic sites
Food processing water systems Aquatic food crop
Poultry and livestock drinking water
Pulp and papermill systems Aquatic noncrop
Swimming pool water
Industrial disposal systems
Industrial ponds
[[Page 127]]
Human drinking water Aquatic food crop
Cooling water towers Aquatic noncrop
Agricultural irrigation water, and ditches Aquatic food crop
Agricultural drainage water and ditches
Sewage systems and drainfields Aquatic noncrop
Dishwashing water Indoor
Domestic and commercial nonpotable water Aquatic noncrop
Lakes, ponds, impounded water
Streams, rivers, canals
Swamps, marshes, wetlands
Air conditioner water
Humidifier water
Air washer water systems
Secondary oil recovery injection water
Heat exchange water system
Polluted water
Bait boards (floating--for vertebrate
control)
Catch basins, puddles, tree holes
Estuaries, tidal marshes
Commercial and sport fish-bearing waters Aquatic food crop
10. Noncrop, wide area, and general indoor/
outdoor treatments
Uncultivated agricultural areas (nonfood Terrestrial noncrop
producing)
Farmyards
Fuel storage areas
Fence rows
Rights-of-way
Fallow land Terrestrial food crop
Soil bank land Terrestrial noncrop
Barrier strips
Uncultivated nonagricultural areas (outdoor)
Airports
Recreation areas, fairgrounds, race tracks,
tennis courts, etc.
Campgrounds
Recreation area structures
Highway rights-of-way
Railroad rights-of-way
Utility rights-of-way
Sewage disposal areas
Industrial sites (lumberyards, tank farms,
etc.)
Paved areas
Private roads and walks
Fencerows and hedgerows (nonagricultural)
Directed Pest Control to Pests' Nests, etc., Terrestrial noncrop or
and for Traps indoor
Diseased beehives
Nuisance bee nests
Ant mounds, hills, dens
Termite mounds
Insect traps (chemical lures)
Repellents and irritants to pests (when
not covered by other sites)
Wide area and general indoor/outdoor
treatments
Rural areas (unspecified)
Urban areas (unspecified)
Public buildings and structures
Animal burrow entrances, dens, tunnels
Animal nests
Animal trails
Mammal feeding areas
Nonagricultural areas for public health
treatments
Bird roosting, nesting areas
Bird feeding areas
11. Antifouling Treatments
Sites for marine exposures Aquatic noncrop
Boat bottoms and other submersed
structures
Steel
Fiberglass
Aluminum
Wood
Plastic
Other substances and materials
Crab pots and lobster pots
Sites for fresh water exposures
Cooling tower influent conduits
12. Commercial and Industrial Uses
Transportation Facilities Indoor
Bus
Truck and Trailer
Containerized units
Railroad cars
Aircraft
Ships/barges
Auto, taxis
Recreational vehicles
Shipping containers
Food and feed processing plants
Bakeries
Bottlers
Canneries
Dairies, creameries, milk processing
plants
Feed mills, feed stores
Fresh fruit packing and processing
Meat processing
Poultry processing
Wineries, wine cellars
Flour mills, machinery, warehouses, bins,
elevators
Egg processing
Candy and confectionary plants
Sugar processing, cane mills, etc.
Cider mills
Dry food products plants
Tobacco processing
Air treatment for processing and
transportation of foods
Beverage processing
Nut processing
Cereal processing
Seafood processing
Vegetable oil processing
Spice mills
Vinegar processing
Farinaceous processing (noodles, etc.)
Mushroom processing
Dried fruit processing
Pickle processing
Ice plants
Chocolate processing
Fruit juice processing
Eating establishments (all)
Food handling areas
Food serving areas
Eating establishment nonfood areas
Air treatment for eating establishments
Food storage equipment (coolers,
refrigerators, etc.)
Eating and serving utensils (spoons, etc.)
Food marketing, storage, and distribution
[[Page 128]]
Food dispensing and vending equipment
Food stores, markets, stands
Meat and fish markets
Food catering facilities
Food marketing, storage, and distribution
equipment and utensils
Hospitals and related institutions and
facilities
Critical premises (e.g., burn wards, etc.)
Hospital patient premises (wards,
emergency rooms, etc.)
Noncritical premises (labs, lounges,
lobbies, storage)
Critical items (hypodermic needles, dental
instruments, catheters, etc.)
Noncritical items (bedpans, carpets,
furniture, etc.)
Air treatment (also to ambulances)
Janitorial equipment
Barber and beauty shop instruments and
equipment
Morgues, mortuaries, and funeral homes
Premises (embalming rooms, etc.)
Equipment (tables, etc.)
Instruments
Burial vaults, mausoleums
Air treatment
Commercial, institutional, and industrial
Maintenance, Buildings, and Structures
Locker rooms, equipment
Gyms, bowling alleys, and equipment
Telephones and booths
Shower rooms, mats, and equipment
Cotton mill premises and equipment
Auditoriums and stadiums
Factories
Rendering plants
Loading areas, ramps
School buildings and equipment
Office buildings
Laundries
Fuels from Crops (alcohol, methane)
Fossil fuels (e.g., oils, jet fuel)
Seed oils
Paper
Pesticide materials preservation and
protection
Rodenticide baits (protection against
insects)
Dried plant parts (pyrethrum, red squill,
rotenone, sabadilla)
Paints
Preservatives and protectants
Grains
Hay, silage
Adhesives
Coatings (asphalt and lacquer)
Fuels
Leather and leather products
Leather processing liquors
Metalworking cutting fluids
Oil recovery drilling muds and packer
fluids
Paints (latex)
Paper and paper products
Plastic products
Resin emulsions
Rubber (natural) products
Specialty products (polishes, cleansers,
dyes, etc.)
Textiles, textile fibers, and cordage
Wet-end additives, etc. (pulp sizing,
alum, casein, printing pastes)
Disposable diapers
Wool, hair, mohair, furs, felt, feathers,
etc.
Electrical supplies, cables, and equipment
13. Domestic and Human Use
Human Body and Hair Indoor
Fiber product protection (Moth,
mildew-proofing)
Clothing
Upholstery
Ornamental fabrics (draperies, tapestries)
Ropes
Sail cloth
Human articles and materials
Bedding, blankets, mattresses
(Treatments to) hair, body, clothing
(while being worn)
Clothing
Face gear (goggles, face masks, etc.)
Headgear (safety helmets, headphones,
etc.)
Wigs
Contact lenses
Dentures, toothbrushes, mouthpieces to
musical instruments, etc.
Brick, asbestos, etc.
Wood surfaces
Leather surfaces
Fabric surfaces
Paper/paperboard surfaces
Specialty uses
Museum collectors (preserved animal and
plant specimens)
Military uses--not specified
Quarantine uses--not specified
DHHS/FDA uses--not specified
Filters (air conditioning, air, and
furnace)
Biological specimens
Underground cables
Cuspidors, spittoons
Vomitus
Human wastes
Air sanitizers
Diapers
Laundry equipment (carts, chutes, tables,
etc.)
Dust control--products and equipment
(mops, etc.)
Dry cleaning
Carpets
Upholstery
Bathrooms, toilets bowls, and related sites
Bathroom premises
Toilet bowls and urinals
Toilet tanks
Portable toilets, chemical toilets
Vehicular holding tanks
Bathroom air treatment
Diaper pails
Refuse and soild waste
Refuse and solid waste containers
Refuse and solid waste transportation and
handling equipment
Garbage dumps
Household trash compactors
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Garbage disposal units, food disposals
Incinerators
14. Miscellaneous Indoor Uses
Surface Treatments Indoor
Hard nonporous surfaces (painted, tile,
plastic, metal, glass, etc.)
Hard porous surfaces (cement, plaster)
Camping equipment and gear
Grooming instruments (brushes, clippers,
razors, etc.)
Laundry, cleaning, and dry cleaning
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