residue in                                                                               metabolite
                                livestock
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1340                     Residue           CR                CR                R                 CR               Residue of       4, 9, 10
                                analytical                                                                               concern
                                method
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1360                     Multiresidue      CR                CR                R                 CR               Residue of       10, 11
                                method                                                                                concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Potable water     NR                CR                NR                NR               TGAI             1, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Fish              NR                CR                NR                NR               TGAI             1, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Irrigated crops   NR                CR                NR                NR               TGAI             1, 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                     Food handling     NR                NR                NR                CR               TGAI             1, 15
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1480                     Meat/milk/        CR                CR                CR                CR               TGAI or plant    1, 7, 8, 10
                                poultry/eggs                                                                             metabolites
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                     Crop field        CR                CR                CR                CR               TEP              1, 3, 4
                                trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                     Processed food/   CR                CR                CR                CR               TEP              1, 16
                                feed
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                     Anticipated       CR                CR                CR                CR               Residue of       1, 10, 17
                                residues                                                                                concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                     Proposed          CR                CR                CR                CR               --               1, 18
                                tolerances
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                     Reasonable        CR                CR                CR                CR               --               1, 10
                                grounds in
                                support of the
                                petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                     Submittal of      CR                CR                CR                CR               TGAI and         10, 19
                                analytical                                                                               residue of
                                reference                                                                                concern
                                standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for biochemical pesticides product chemistry and are in
the last column of the table contained in paragraph (d) of this
section.
    1. Residue chemistry data requirements apply to biochemical
pesticide products when Tier II or Tier III toxicology data are
required, as specified for biochemical agents in the biochemical
human health assessment data requirements, Sec. 158.2050.
    2. The same chemical identity data are required for biochemical
product chemistry data requirements, Sec. 158.2030, with an emphasis
on impurities.
    3. Required information includes crops to be treated, rate of
application, number and timing of applications, preharvest
intervals, and relevant restrictions.
    4. Required for residential outdoor uses on food crops if the
corresponding agricultural use is not approved or the residential
use is expected to produce higher residues based on the label
directions .
    5. Required unless it is an arthropod pheromone applied at a
rate less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied
directly to food, in order to determine metabolites and/or
degradates. Not required when only indirect contact with food would
occur (e.g., crack and crevice treatments).
    7. Required when a pesticide is to be applied directly to
livestock, to livestock premises, to livestock drinking water, or to
crops used for livestock feed.
    8. If results from the plant metabolism study show differing
metabolites in plants from those found in animals, an additional
livestock metabolism study involving dosing with the plant
metabolite(s) may also be required.
    9. A residue analytical method suitable for enforcement of
tolerances is required whenever a numeric tolerance (including
temporary and time-limited tolerances) is proposed.
    10. Required if indoor use could result in pesticide residues in
or on food or feed.
    11. Data are required to determine whether FDA/USDA multiresidue
methodology would detect and identify the pesticides and any
metabolites.

    12. Data are required whenever a pesticide may be applied
directly to water, unless it can be demonstrated that the treated
water would not be available for human or livestock consumption.
    13. Data on fish are required for all pesticides applied
directly to water inhabited, or which will be inhabited by fish that
may be caught or harvested for human consumption .
    14. Data 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.
    15. Data are required whenever a pesticide may be used in food/
feed handling establishments.
    16. Data on the nature and level of residue in processed food/
feed are required when detectible residues could potentially
concentrate on processing thus requiring the establishment of a
separate tolerance higher than that of the raw agricultural
commodity.
    17. Required when residues at the tolerance level may result in
risk of concern. These data may include washing, cooking,
processing, or degradation studies as well as market basket surveys
for a more precise residue determination.
    18. The proposed tolerance must reflect the maximum residue
likely to occur in crops, in meat, milk, poultry, or eggs.
    19. Required when a residue analytical method is required.

Sec.  158.2050  Biochemical pesticides human health assessment data
requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to
use this table to determine the biochemical human health assessment
data requirements for a particular biochemical pesticide product.
    (2) The data in this section are not required for straight chain
lepidopteran pheromones when applied up to a maximum use rate of 150
grams active ingredient/acre/year.
    (b) Use patterns. (1) Food use patterns, in general, include
products classified under the following general uses: terrestrial food
crop use; terrestrial feed crop use; aquatic food crop use; greenhouse
food crop use.
    (2) Nonfood use patterns include products classified under the
general use patterns of terrestrial nonfood crop use; aquatic nonfood
residential use; aquatic nonfood outdoor use; aquatic nonfood
industrial use; greenhouse nonfood crop use; forestry use; residential
outdoor use; residential indoor use; indoor food use; indoor nonfood
use; indoor medical use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; Residue of
concern=the active ingredient and its metabolites, degradates, and
impurities of toxicological concern; All=All of the above. Specific
conditions, qualifications, or exceptions to the designated test
procedures appear in paragraph (e) of this section, and apply to the
individual tests in the following table:
    (d) Table. The following table shows the data requirements for
biochemical pesticides human health assessment. The test notes are
shown in paragraph (e) of this section.

                                         Table--Biochemical Pesticides Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                           Test Substance
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test Notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   R                   TGAI and MP         TGAI and EP         1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         R                   R                   TGAI and MP         TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2600                          Dermal              R                   R                   TGAI and MP         TGAI and EP         2, 4
                                   sensitization
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    R                   R                   All                 All                 5
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    R                   CR                  TGAI                TGAI                6
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3250                          90-day dermal -     CR                  CR                  TGAI                TGAI                7
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3465                          90-day inhalation - CR                  CR                  TGAI                TGAI                8
                                    rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            R                   CR                  TGAI                TGAI                9
                                   developmental -
                                   rat preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------

870.5100                          Bacterial reverse   R                   CR                  TGAI                TGAI                10
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vitro mammalian  R                   CR                  TGAI                TGAI                10, 11
870.5375........................   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing (In vivo cytogenetics)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5385                          In vivo Mammalian   CR                  CR                  TGAI                TGAI                13
870.5895........................   Cytogenetics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            CR                  CR                  TGAI                TGAI                9
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Tests
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3550                          Immunotoxicity      CR                  CR                  TGAI                TGAI                12, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Applicator/User Exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1100                          Dermal outdoor      CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1200                          Dermal indoor       CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1300                          Inhalation outdoor  CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1400                          Inhalation indoor   CR                  CR                  TGAI                TGAI                15
                                   exposure
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1500                          Biological          CR                  CR                  TGAI                TGAI                15
                                   monitoring
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Chronic Testing/Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.3800                          Immune response     CR                  CR                  TGAI                TGAI                14
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3800                          Reproduction and    CR                  CR                  TGAI                TGAI                16
                                   fertility effects
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4100                          Chronic oral -      CR                  CR                  TGAI                TGAI                17
                                   rodent and
                                   nonrodent
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.4200                          Carcinogenicity -   CR                  CR                  TGAI                TGAI                18
                                   two species - rat
                                   and mouse
                                   preferred
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5380                          Mammalian           CR                  CR                  TGAI                TGAI                19
                                   spermatogonial
                                   chromosome
                                   aberration test
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Special Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.7200                          Companion animal    CR                  CR                  NR                  TGAI or EP          20
                                   safety
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for biochemical pesticides human health assessment as
referenced in the last column of the table in paragraph (d) of this
section.

    1. Required unless the test material is a gas or highly volatile
(vapor pressure >10-4torr (mm/Hg)).
    2. Required unless the test material is corrosive to skin or has
pH <2 or >11.5.
    3. Required when the pesticide, under conditions of use, would
result in respirable material (e.g., gas, volatile substance or
aerosol/particulate), unless it is a straight chain lepidopteran
pheromone.
    4. Required if repeated contact with human skin is likely to
occur under conditions of use.
    5. Hypersensitivity incidents must be reported as adverse
effects data.
    6. Required for non-food uses that are likely to result in
repeated oral exposure to humans.
    7. Required to support uses involving purposeful application to
the human skin or which would result in comparable prolonged human
exposure to the product (e.g., insect repellents) and if any of the
following criteria are met:
    i. Data from a 90-day oral study are not required.
    ii. The active ingredient is known or expected to be metabolized
differently by the dermal route of exposure than by the oral route
and the metabolite is of toxicological concern.
    iii. The use pattern is such that the dermal route would be the
primary route of exposure.
    8. Required if there is a likelihood of significant levels of
repeated inhalation exposure to the pesticide as a gas, vapor, or
aerosol.
    9. Required if the use of the product under widespread and
commonly recognized practice may reasonably be expected to result in
significant exposure to female humans (e.g., occupational exposure
or repeated application of insect repellents directly to the skin).
Tier II data is required on a different test species from Tier I
data when

developmental effects are observed in the first study and
information on species-to-species extrapolation is needed.
    10. Required to support nonfood uses if either:
    i. The use is likely to result in significant human exposure; or
    ii. The active ingredient (or its metabolites) is structurally
related to a known mutagen or belongs to any chemical class of
compounds containing a known mutagen. Additional mutagenicity tests
that may have been performed plus a complete reference list must
also be submitted. Subsequent testing may be required based on the
available evidence.
    11. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene
locus, maximizing assay conditions for small colony expression or
detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung
fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl
transferase (hgprt) gene locus, accompanied by an appropriate in
vitro test for clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl
transferase (xprt) gene locus.
    12. Required if there are effects on hematology, clinical
chemistry, lymphoid organ weights, and histopathology are observed
in the 90-day studies.
    13. The micronucleus rodent bone marrow assay is preferred;
however, rodent bone marrow assays using metaphase analysis
(aberrations) are acceptable.
    14. Required if adverse effects are observed in the Tier II
immunotoxicity study. The protocol for evaluating adverse effects to
the immune response should be developed after evaluating the effects
noted in the immunotoxicity study.
    15. These data are required when the data used for the human
health assessment indicates that the biochemical may pose a
potential hazard to the applicator/user.
    16. Required if there is evidence of:
     i. Endocrinological effects from the subchronic toxicity
studies.
    ii. Developmental effects in the prenatal developmental toxicity
study(s), or
    iii. Genotoxicity to mammals based on results from the
mutagenicity tests.
The use of a combined study that utilizes the two-generation
reproduction study in rodents (guideline 870.3800) as a basic
protocol for the addition of other endpoints or functional
assessments in the immature animal is encouraged.
    17. Required if the potential for adverse chronic effects is
indicated based on any of the following:
    i. The subchronic effect level established in the following Tier
I studies: 90-day oral toxicity study, 90-day dermal toxicity study,
or 90-day inhalation toxicity study.
    ii. The pesticide use pattern (e.g., rate, frequency, and site
of application).
    iii. The frequency and level of repeated human exposure that is
expected.
    18. Required if the product meets either of the following
criteria:
    i. The active ingredient (or any of its metabolites, degradation
products, or impurities) produce(s) in Tier I subchronic studies a
morphologic effect (e.g., hyperplasia or metaplasia) in any organ
that potentially could lead to neoplastic change.
    ii. Adverse cellular effects suggesting carcinogenic potential
are observed in Tier II immunotoxicity and Tier III immune response
study or in Tier II mammalian mutagenicity assays.
    In addition, a 90-day range finding study in both rats and mice
is required to determine the dose levels if carcinogenicity studies
are required. If the mouse carcinogenicity study is not required,
the 90-day mouse subchronic study is likewise not required.
    19. Required if results from lower tiered mutation or
reproductive studies indicate there is potential for chromosomal
aberration to occur.
    20. May be required if the product's use will result in exposure
to domestic animals through, but not limited to, direct application
or consumption of treated feed.

Sec.  158.2060  Biochemical pesticides nontarget organisms and
environmental fate data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to
use this table to determine the terrestrial and aquatic nontarget
organisms and fate data requirements for a particular biochemical
pesticide product. Notes that apply to an individual test including
specific conditions, qualifications, or exceptions to the designated
test are listed in paragraph (e) of this section. In general, for all
outdoor end-use products including turf, the following studies are
required: one avian acute oral, one avian dietary, one acute freshwater
fish, one acute freshwater invertebrate study, plant toxicity testing,
and a honeybee acute contact study.
    (2) The data in this section are not required for arthropod
pheromones when applied at up to a maximum use rate of 150 grams active
ingredient/acre/year except when the product is expected to be
available to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products
classified under the general use patterns of terrestrial food crop,
terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The
greenhouse use pattern includes products classified under the general
use patterns of greenhouse food crop and greenhouse nonfood crop. The
indoor use pattern includes products classified under the general use
patterns of indoor food and nonfood use. The remaining terrestrial uses
include: forestry and residential outdoor use. Data are also required
for the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; Residue of
concern=the active ingredient and its metabolites, degradates, and
impurities of toxicological concern; All=All of the above. Specific
conditions, qualifications, or exceptions to the designated test
procedures appear in paragraph (e) of this section, and apply to the
individual tests in the following table:
    (d) Table. The following table shows the data requirements for
biochemical pesticides nontarget organisms and environmental fate. The
test notes are shown in paragraph (e) of this section.

                                                   Table--Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use Patterns
                                                      ---------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement       Terrestrial            Aquatic             Greenhouse                                  Indoor          Test Substance     Test Notes
                                                      ---------------------------------------------------------------      Forestry,      ---------------------
                                                        Food/Feed/Nonfood       Food/Nonfood         Food/Nonfood     Residential Outdoor      Food/Nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                          Avian acute oral     R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   1, 2, 3, 4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

850.2200                          Avian dietary        R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   1, 2, 3, 4
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                          Fish acute           R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........   2, 3, 4, 5
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010                          Aquatic              R..................  R..................  CR.................  R..................  CR.................  TGAI, EP..........      2, 3, 5
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4100                          Terrestrial Plant    R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........            5
                                   Toxicity, Seedling
                                   emergence
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4150                          Terrestrial Plant    R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........            5
                                   Toxicity,
                                   Vegetative vigor
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Insect Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
880.4350                          Nontarget Insect     R..................  R..................  R..................  R..................  NR.................  TGAI..............           14
                                   Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Environmental Fate Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-1 (835.1230)                  Sediment and soil    CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   adsorption/
                                   desorption for
                                   parent and
                                   degradates
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-1 (835.1240)                  Soil column          CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
163-2 (835.1410)                  Laboratory           CR.................  NR.................  CR.................  CR.................  NR.................  TEP...............            7
                                   volatilization
                                   from soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-1 (835.2120)                  Hydrolysis           CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-1 (835.4100)                  Aerobic soil         CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-2 (835.2240)                  Photodegradation in  CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   water
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
161-3 (835.2410)                  Photodegradation on  CR.................  NR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   soil
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-2 (835.4200)                  Anaerobic soil       CR.................  NR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-4 (835.4300)                  Aerobic aquatic      CR.................  CR.................  CR.................  CR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
162-3 (835.4400)                  Anaerobic aquatic    CR.................  CR.................  NR.................  NR.................  NR.................  TGAI..............            6
                                   metabolism
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
880.4425                          Dispenser - water    CR.................  NR.................  CR.................  CR.................  NR.................  EP................            8
                                   leaching
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plant
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                          Seedling emergence   R..................  R..................  NR.................  R..................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4250                          Vegetative vigor     R..................  R..................  NR.................  R..................  NR.................  TGAI..............            9
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Fauna Chronic, Life Cycle, and Field Studies
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1300                          Freshwater fish/     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1400........................   invertebrate
850.1500........................   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

850.1025                          Marine/Estuarine     CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           10
850.1035........................   fish/invertebrate
850.1045........................   animal testing
850.1055........................
850.1350........................
850.1400........................
850.1500........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                          Aquatic field fish/  CR.................  CR.................  NR.................  CR.................  NR.................  EP................           10
                                   invertebrate
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Terrestrial Wildlife
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2300                          Avian Reproduction   CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2400                          Wild mammal acute    CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           11
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                          Terrestrial field    CR.................  CR.................  NR.................  CR.................  NR.................  EP................           11
                                   testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Beneficial Insects
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                          Field testing for    CR.................  CR.................  NR.................  CR.................  NR.................  TEP...............           12
                                   Pollinators
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Nontarget Plants
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4225                          Nontarget plant      CR.................  CR.................  NR.................  CR.................  NR.................  TGAI..............           13
850.4250........................
850.4300........................
850.4450........................
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for biochemical pesticides nontarget organisms and
environmental fate as referenced in the last column of the table
contained in paragraph (d) of this section.
    1. Required for the EP when any end-use formulation may contain
other ingredients that may be toxic to nontarget organisms or to
support arthropod pheromones that would be available to avian
wildlife, (e.g., a granular product).
    2. Tests for pesticides intended solely for indoor application
would be required on a case-by-case basis, depending on use pattern,
physical/chemical properties, production volume, and other pertinent
factors.
    3. Not required for any use groups if the pesticide is highly
volatile (estimated volatility >5 X 10-5atm
m3/mol).
    4. Preferred test species are Upland game, waterfowl, or
passerine for avian acute oral toxicity studies; Upland game and
waterfowl for avian dietary studies; and coldwater fish species for
acute freshwater fish studies.
    5. Required for the EP when the end-use formulation may contain
other ingredients that may be toxic to nontarget organisms.
    6. Required on a case-by-case basis when results from Tier I
studies indicate adverse effects.
    7. Required when results of any one or more of the nontarget
organism studies in Tier I indicate potential adverse effects on
nontarget organisms and the pesticide is to be applied on land. In
view of methdological difficulties with the study of
photodegradation in air, prior consultation with the Agency
regarding the protocol is recommended before the test is performed.
    8. Required when results of any one or more of the nontarget
organism studies in Tier I indicate potential adverse effects on
nontarget organisms and the pesticide is to be applied in a passive
dispenser.
    9. Required to support registration of known phytotoxicants,
i.e. herbicides, desiccants, defoliants, and plant growth
regulators.
    10. Required if environmental fate characteristics indicate that
the estimated environmental concentration of the pesticide in the
aquatic environment is >0.01 of any EC50 or
LC50 determined in the aquatic nontarget organism
testing.
    11. Required if either of the following criteria are met:
    i. Environmental fate characteristics indicate that the
estimated concentration of the pesticide in the terrestrial
environment is > 0.20 the avian dietary LC50 or equal to
> 0.20 the avian oral single dose LD50 (converted to
ppm).
    ii. 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 or mammalian
feed.
    12. Required when results of Tier I nontarget organism studies
indicate potential adverse effects on nontarget insects and results
of Tier II tests indicate exposure of nontarget insects. Additional
insect species may have to be tested if necessary to address issues
raised by use patterns and potential exposure of important nontarget
insect species, (e.g., threatened or endangered species).
    13. Required if the product is expected to be transported from
the site of application by air, soil, or water. The extent of
movement would be determined by the results of the Tier II
environmental fate studies.
    14. Required depending on pesticide mode of action, method and
timing of application, and results of any available efficacy data.
Typically the honeybee acute toxicity guideline (guideline 850.3020)
satisfies this requirement, however, additional nontarget insect
species may have to be tested if necessary to address issues raised
by use patterns and potential exposure of important nontarget insect
species, (e.g., endangered species.)

Sec.  158.2070  Biochemical pesticides product performance data
requirements.

    Product performance data must be developed for all biochemical

pesticides. However, the Agency typically does not require applicants
to submit such efficacy data unless the pesticide product bears a claim
to control public health pests, such as pest microorganisms infectious
to man in any area of the inanimate environment or a claim to control
vertebrates (including but not limited to: rodents, birds, bats,
canids, and skunks) or invertebrates (including but not limited to:
mosquitoes and ticks) 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.

Sec.  158.2080   Experimental use permit data requirements--biochemical
pesticides.

    (a) Sections 158.2081 through 158.2084 describe the experimental
use permit (EUP) data requirements for biochemical pesticides.
Variations in the test conditions are identified within the test notes.
Definitions that apply to all biochemical data requirements can be
found in Sec.  158.2000.
    (b) For general information on the data requirement tables, see
Sec.  158.2010(b)-(f).

Sec.  158.2081  Experimental use permit biochemical pesticides product
chemistry data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to
use this table to determine the product chemistry data requirements for
a particular biochemical pesticide product. Notes that apply to an
individual test and include specific conditions, qualifications, or
exceptions to the designated test are listed in paragraph (e) of the
section.
    (2) Depending on the results of the required product chemistry
studies, appropriate use restrictions, labeling requirements, or
special packaging requirements may be imposed.
    (b) Use patterns. Product chemistry data are required for all
pesticide products and are not use specific.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; Residue of
concern=the active ingredient and its metabolites, degradates, and
impurities of toxicological concern; All=All of the above. Specific
conditions, qualifications, or exceptions to the designated test
procedures appear in paragraph (e) of this section, and apply to the
individual tests in the following table:
    (d) Table. The following table shows the data requirements for
experimental use permit biochemical pesticides product chemistry. The
test notes are shown in paragraph (e) of this section .

                                          Table--EUP Biochemical Pesticides Product Chemistry Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Test Substance
          Guideline Number              Data Requirement        All Use Patterns    ----------------------------------------------       Test Notes
                                                                                MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Identity and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1100                             Product identity and    R                       TGAI, MP               TGAI, EP               1, 2
                                      composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1200                             Description of          R                       TGAI, MP               TGAI, EP               2, 3
                                      starting materials,
                                      production and
                                      formulation process
--------------------------------------------------------------------------------------------------------------------------------------------------------
880.1400                             Discussion of           R                       TGAI and MP            TGAI and EP            4
                                      formation of
                                      impurities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1700                             Preliminary analysis    CR                      TGAI and MP            TGAI and EP            5, 8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1750                             Certified limits        R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.1800                             Enforcement analytical  R                       MP                     EP                     7
                                      method
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6302                             Color                   R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6303                             Physical state          R                       TGAI and MP            TGAI and EP            8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6304                             Odor                    R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6313                             Stability to normal     R                       TGAI                   TGAI                   8, 17
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6315                             Flammability            CR                      MP                     EP                     9
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6317                             Storage stability       R                       MP                     EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6319                             Miscibility             CR                      MP                     EP                     10
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.6320                             Corrosion               R                       MP                     EP                     --
                                      characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------

830.7000                             pH                      CR                      TGAI and MP            TGAI and EP            8, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7050                             UV/Visible light        R                       TGAI                   TGAI                   --
                                      absorption
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7100                             Viscosity               CR                      MP                     EP                     12
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7200                             Melting point/melting   CR                      TGAI                   TGAI                   8, 13
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7220                             Boiling point/boiling   CR                      TGAI                   TGAI                   8, 14
                                      range
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7300                             Density/relative        R                       TGAI and MP            TGAI and EP            8, 18
                                      density/bulk density
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7520                             Particle size, fiber    CR                      TGAI                   TGAI                   8, 15
                                      length, and diameter
                                      distribution
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7550                             Partition coefficient   CR                      TGAI                   TGAI                   16
830.7560...........................   (n-Octanol /Water)
830.7570...........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7840                             Water solubility        R                       TGAI                   TGAI                   8
--------------------------------------------------------------------------------------------------------------------------------------------------------
830.7950                             Vapor pressure          R                       TGAI                   TGAI                   8, 19
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for experimental use permit biochemical pesticides product
chemistry and are referenced in the last column of the table in
paragraph (d) of this section.
    1. Data must be provided in accordance with Sec.  158.320.
    2. If the MP and EP are produced by an integrated formulation
system (non-registered source), these data are also required on
TGAI.
    3. Data must be provided in accordance with Sec.  158.325, Sec.
158.330, and Sec.  158.335.
    4. Data must be provided in accordance with Sec.  158.340.
    5. Data must be provided in accordance with Sec.  158.345. Also,
required to support the registration of each manufacturing-use
product (including registered TGAIs) and end-use products produced
by an integrated formulation system. Data on other end-use products
would be required on a case-by-case basis. For pesticides in the
production stage, a preliminary product analytical method and data
would suffice to support an experimental use permit.
    6. Data must be provided in accordance with Sec.  158.350.
    7. Data must be provided in accordance with Sec.  158.355.
    8. If the TGAI cannot be isolated, data are required on the
practical equivalent of the TGAI. EP testing may also be
appropriate.
    9. Required if the product contains combustible liquids.
    10. Required if the product is an emulsifiable liquid and is to
be diluted with petroleum solvents.
    11. Required if the test substance is soluble or dispersible in
water.
    12. Required if the product is a liquid.
    13. Required when the technical chemical is a solid at room
temperature.
    14. Required when the technical chemical is a liquid at room
temperature.
    15. Required for water insoluble test substances
(>10-6g/l) and fibrous test substances with diameter
>=0.1 [mu]m.
    16. Required for organic chemicals unless they dissociate in
water or are partially or completely soluble in water.
    17. Data on the stability to metals and metal ions is required
only if the active ingredient is expected to come in contact with
either material during storage.
    18. True density or specific density are required for all test
substances. Data on bulk density is required for MPs or EPs that are
solid at room temperature.
    19. Not required for salts.

Sec.  158.2082  Experimental use permit biochemical pesticides residue
data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the biochemical pesticides residue data
requirements for a particular pesticide product and the substance that
needs to be tested. These data requirements apply to all biochemical
pesticides, i.e. naturally occurring insect repellents and attractants,
semiochemicals (e.g., insect pheromones), natural and plant growth
regulators. Notes that apply to an individual test and include specific
conditions, qualifications, or exceptions to the designated test are
listed in paragraph (e) of this section.
    (b) Use patterns. (1) Data are required or conditionally required
for all pesticides used in or on food and for residential outdoor uses
where food crops are grown. Food use patterns include products
classified under the general use patterns of terrestrial food crop use,
terrestrial feed crop use, aquatic food crop use, greenhouse food crop
use, and indoor food use. Data are also conditionally required for
aquatic nonfood use if there is direct application to water that could
subsequently result in exposure to food.
    (2) Data are conditionally required for nonfood uses if pesticide
residues may occur in food or feed as a result of the use. Data
requirements for these nonfood uses would be determined on a case-by-
case basis. For example, most products used in or near kitchens require
residue data for risk assessment purposes even though tolerances may
not be necessary in all cases.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing end-use product; EP=End-use product; TEP=Typical end-
use product; TGAI=Technical grade of the active ingredient; Residue of
concern=the active ingredient and its metabolites, degradates,and
impurities of toxicological concern. All=All of the above. Specific
conditions, qualifications, or exceptions to the designated test
procedures appear in paragraph (e) of this section, and apply to the
individual tests in the following table:
    (d) Data table. The following table shows the data requirements for
biochemical pesticides residue. The test notes are shown in paragraph
(e) of this section.

                                               Table--EUP Biochemical Pesticides Residue Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Use Patterns
                                                -----------------------------------------------------------------------
       Guideline Number        Data Requirement     Terrestrial         Aquatic                                          Test Substance     Test Notes
                                                ------------------------------------  Greenhouse Food    Indoor Food
                                                     Food/Feed           Food
--------------------------------------------------------------------------------------------------------------------------------------------------------
Supporting Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1100                     Chemical          CR                CR                CR                CR               TGAI             1, 2, 4
                                identity
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1200                     Directions for    CR                CR                CR                CR               --               1, 3, 4
                                use
--------------------------------------------------------------------------------------------------------------------------------------------------------
Nature of Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI             1, 4, 5, 6
                                residue in
                                plants
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1300                     Nature of the     CR                CR                CR                CR               TGAI or plant    1, 7, 8, 9, 13
                                residue in                                                                               metabolite
                                livestock
--------------------------------------------------------------------------------------------------------------------------------------------------------
Magnitude of the Residue
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Potable water     NR                CR                NR                NR               TGAI             1, 11
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Fish              NR                CR                NR                NR               TGAI             1, 12
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1400                     Irrigated crops   NR                CR                NR                NR               TGAI             1, 13
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1460                     Food handling     NR                NR                NR                CR               TGAI             1, 14
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1480                     Meat/milk/        CR                CR                CR                CR               TGAI or plant    1, 7, 8, 9
                                poultry/eggs                                                                             metabolites
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1500                     Crop field        CR                CR                CR                CR               TEP              1, 3, 4
                                trials
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1520                     Processed food/   CR                CR                CR                CR               TEP              1, 15
                                feed
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1540                     Anticipated       CR                CR                CR                CR               Residue of       1, 9, 16
                                residues                                                                                concern
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1550                     Proposed          CR                CR                CR                CR               --               1, 17
                                tolerances
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1560                     Reasonable        CR                CR                CR                CR               --               1, 9
                                grounds in
                                support of the
                                petition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  860.1650                     Submittal of      CR                CR                CR                CR               TGAI and         9, 18
                                analytical                                                                               residue of
                                reference                                                                                concern
                                standards
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for biochemical pesticides product chemistry and are
referenced referenced in the last column of the table contained in
paragraph (d) of this section.
    1. Residue chemistry data requirements apply to biochemical
pesticide products when Tier II or Tier III toxicology data are
required, as specified for biochemical agents in the biochemical
human health assessment data requirements, Sec. 158.2050.
    2. The same chemical identity data are required for biochemical
product chemistry data requirements,Sec. 158.2030 with an emphasis
on impurities.
    3. Required information includes crops to be treated, rate of
application, number and timing of applications, preharvest
intervals, and relevant restrictions.
    4. Required for residential outdoor uses on food crops if the
corresponding agricultural use is not approved or the residential
use is expected to produce higher residues based on the label
directions.
    5. Required unless it is an arthropod pheromone applied at a
rate less than or equal to 150 grams active ingredient per acre.
    6. Required for indoor uses where the pesticide is applied
directly to food, in order to determine metabolites and/or
degradates. Not required when only indirect contact with food would
occur (e.g., crack and crevice treatments).
    7. Required when a pesticide is to be applied directly to
livestock, to livestock premises, to livestock drinking water, or to
crops used for livestock feed. If results from the plant metabolism
study show differing metabolites in plants form those found in
animals, an additional livestock metabolism study involving dosing
with the plant metabolite(s) may also be required.
    8. Livestock feeding studies are required whenever a pesticide
residue is present in livestock feed or when direct application to
livestock uses occurs.
    9. Required if indoor use could result in pesticide residues in
or on food or feed.
    10. Data are required to determine whether FDA/USDA multiresidue
methodology would detect and identify the pesticides and any
metabolites.
    11. Data are required whenever a pesticide may be applied
directly to water, unless it can be demonstrated that the treated
water would not be available for human or livestock consumption.
    12. Data on fish are required for all pesticides applied
directly to water inhabited, or which will be inhabited, by fish
that may be caught or harvested for human consumption.
    13. Data 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.
    14. Data are required whenever a pesticide may be used in food/
feed handling establishments.
    15. Data on the nature and level of residue in processed food/
feed are required when detectible residues could potentially
concentrate on processing thus requiring the

establishment of a separate tolerance higher than that of the raw
agricultural commodity.
    16 Anticipated residue data are required when the assumption of
tolerance level residues would result in predicted exposure at an
unsafe level of exposure. Data, using single serving samples of a
raw agricultural commodity, on the level or residue in food as
consumed would be used to obtain a more precise estimate of
potential dietary exposure. These data may also include washing,
cooking, processing or degradation studies as well as market basket
surveys for a more precise residue determination.
    17. The proposed tolerance must reflect the maximum residue
likely to occur in crops, in meat, milk, poultry, or eggs.
    18. Required when a residue analytical method is required.

Sec.  158.2083  Experimental use permit biochemical pesticides human
health assessment data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to
use this table to determine the human health assessment data
requirements for a particular biochemical pesticide product.
    (2) The data in this section are not required for straight chain
lepidopteran pheromones when applied up to a maximum use rate of 150
grams active ingredient/acre/year.
    (b) Use patterns. (1) Food use patterns, in general, include
products classified under the following general uses: terrestrial food
crop use; terrestrial feed crop use; aquatic food crop use; greenhouse
food crop use.
    (2) Nonfood use patterns include products classified under the
general use patterns of terrestrial nonfood crop use; aquatic nonfood
residential use; aquatic nonfood outdoor use; aquatic nonfood
industrial use; greenhouse nonfood crop use; forestry use; residential
outdoor use; residential indoor use; indoor food use; indoor nonfood
use; indoor medical use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; Residue of
concern=the active ingredient and its metabolites, degradates, and
impurities of toxicological concern; All=All of the above. Specific
conditions, qualifications, or exceptions to the designated test
procedures appear in paragraph (e) of this section, and apply to the
individual tests in the following table:
    (d) Table. The following table shows the data requirements for
experimental use permit biochemical pesticides human health assessment.
The test notes are shown in paragraph (e) of this section.

                                       Table--EUP Biochemical Pesticides Human Health Assessment Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Use Patterns                           Test Substance
        Guideline Number           Data Requirement  --------------------------------------------------------------------------------     Test Notes
                                                             Food               Nonfood               MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Acute Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1100                          Acute oral          R                   R                   TGAI and MP         TGAI and EP         1
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1200                          Acute dermal        R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.1300                          Acute inhalation    R                   R                   TGAI and MP         TGAI and EP         3
                                   toxicity - rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2400                          Primary eye         R                   R                   TGAI and MP         TGAI and EP         2
                                   irritation -
                                   rabbit
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.2500                          Primary dermal      R                   R                   TGAI and MP         TGAI and EP         1, 2
                                   irritation
--------------------------------------------------------------------------------------------------------------------------------------------------------
none                              Hypersensitivity    R                   R                   All                 All                 4
                                   incidents
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Subchronic Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3100                          90-day oral (one    R                   NR                  TGAI                TGAI                --
                                   species)
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            R                   CR                  TGAI                TGAI                5
                                   developmental -
                                   rat preferably
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5100                          Bacterial reverse   R                   CR                  TGAI                TGAI                6
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5300                          In vivo mammalian   R                   CR                  TGAI                TGAI                6, 7
                                   cell assay
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3700                          Prenatal            CR                  CR                  TGAI                TGAI                5
                                   developmental
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for experimental use permit biochemical pesticides human
health assessment as referenced in the last column of the table in
paragraph (d) of this section.
    1. Required unless the test material is a gas or highly volatile
(vapor pressure > 10-4torr (mm/Hg)).
    2. Required unless the test material is corrosive to skin or has
pH <2 or >11.5.
    3. Required when the pesticide, under conditions of use, would
result in respirable material (e.g., gas, volatile substance or
aerosol/particulate), unless it is a straight chain lepidopteran
pheromone.
    4. Hypersensitivity incidents must be reported as adverse
effects data.
    5. Required if the use of the product under widespread and
commonly recognized practice may reasonably be expected to result in
significant exposure to female humans (e.g., occupational exposure
or repeated application of insect repellents directly to the skin).
Tier II data is required on a different test species from Tier I
data when developmental effects are observed in the first study and
information on species-to-species extrapolation is needed.
    6. Required to support nonfood uses if either:
    i. The use is likely to result in significant human exposure; or
    ii. The active ingredient (or its metabolites) is structurally
related to a known mutagen or belongs to any chemical class of
compounds containing a known mutagen.

     Additional mutagenicity tests that may have been performed plus
a complete reference list must also be submitted. Subsequent testing
may be required based on the available evidence.
    7. Choice of assay using either:
    i. Mouse lymphoma L5178Y cells, thymidine kinase (tk) gene
locus, maximizing assay conditions for small colony expression or
detection;
    ii. Chinese hamster ovary (CHO) or Chinese hamster lung
fibroblast (V79) cells, hypoxanthine-guanine phosphoribosyl
transferase (hgprt) gene locus, accompanied by an appropriate in
vivo test for clastogenicity; or
    iii. CHO cells strains AS52, xanthine-guanine phosphoribosyl
transferase (xprt) gene locus.

Sec.  158.2084  Experimental use permit biochemical pesticides
nontarget organisms and environmental fate data requirements table.

    (a) General. (1) Sections 158.100 through 158.130 describe how to
use this table to determine the terrestrial and aquatic nontarget
organisms and fate data requirements for a particular biochemical
pesticide product. Notes that apply to an individual test including
specific conditions, qualifications, or exceptions to the designated
test are listed in paragraph (e) of this section. In general, for all
outdoor end-use products including turf, the following studies are
required: one avian acute oral, one avian dietary, one acute freshwater
fish, and one acute freshwater invertebrate study.
    (2) The data in this section are not required for arthropod
pheromones when applied at up to a maximum use rate of 150 grams active
ingredient/acre/year except when the product is expected to be
available to avian species (i.e., granular formulation).
    (b) Use patterns. The terrestrial use pattern includes products
classified under the general use patterns of terrestrial food crop,
terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The
greenhouse use pattern includes products classified under the general
use patterns of greenhouse food crop and greenhouse nonfood crop. The
indoor use pattern includes products classified under the general use
patterns of indoor food and nonfood use. The remaining terrestrial uses
include forestry and residential outdoor use. Data are also required
for the general use patterns of aquatic food and nonfood crop use.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; Residue of
concern=the active ingredient and its metabolites, degradates, and
impurities of toxicological concern; All=All of the above. Specific
conditions, qualifications, or exceptions to the designated test
procedures appear in paragraph (e) of this section, and apply to the
individual tests in the following table:
    (d) Table. The following table shows the data requirements for
experimental use permit biochemical pesticides nontarget organisms and
environmental fate. The test notes are shown in paragraph (e) of this
section.

                                                 Table--EUP Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use Patterns
                                                      ---------------------------------------------------------------------------------------------------------
        Guideline Number            Data Requirement       Terrestrial            Aquatic             Greenhouse                                  Indoor          Test Substance     Test Notes
                                                      ---------------------------------------------------------------      Forestry,      ---------------------
                                                        Food/Feed/Nonfood       Food/Nonfood         Food/Nonfood     Residential Outdoor      Food/Nonfood
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Avian Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2100                          Avian acute oral     R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      1, 2, 3
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2200                          Avian dietary        R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      1, 2, 3
                                   toxicity
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  Aquatic Organism Testing
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1075                          Fish acute           R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........      2, 3, 4
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1010                          Aquatic              R..................  R..................  NR.................  R..................  NR.................  TGAI, EP..........         2, 4
                                   invertebrate acute
                                   toxicity,
                                   freshwater
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for experimental use permit biochemical pesticides
nontarget organisms and environmental fate as referenced in the last
column of the table contained in paragraph (d) of this section.
    1. Required for the EP when any end-use formulation may contain
other ingredients that may be toxic to nontarget organisms or to
support arthropod pheromones that would be available to avian
wildlife, (e.g., a granular product).
    2. Not required for any use groups if the pesticide is highly
volatile (estimated volatility >5 X 10-5atm
m3/mol).
    3. Preferred test species are: upland game, waterfowl, or
passerine for avian acute oral toxicity studies; upland game or
waterfowl for avian dietary studies; and coldwater fish for acute
freshwater fish studies.
    4. Required for the EP when the end-use formulation may contain
other ingredients that may be toxic to nontarget organisms.

Subpart V--Microbial Pesticides

Sec.  158.2100  Microbial pesticides definition and applicability.

    (a) This subpart applies to all living or dead microbial pesticides
as described in paragraphs (b) and (c) of this section.
    (b) Definition. Microbial pesticide is a microbial agent intended
for preventing, destroying, repelling, or mitigating any pest, or
intended for use as a plant regulator, defoliant, or desiccant, that:
    (1) Is a eucaryotic microorganism including, but not limited to,
protozoa, algae, and fungi;
    (2) Is a procaryotic microorganism, including, but not limited to,
Eubacteria and Archaebacteria; or
    (3) Is a parasitically replicating microscopic element, including,
but not limited to, viruses.
    (c) Applicability. (1) This part applies to microbial pesticides as
specified in paragraphs (c)(2), (3) and (4) of this section.
    (2) Each new isolate of a microbial pesticide is treated as a new
strain and must be registered independently of any similar registered
microbial pesticide strain and supported by data required in this
subpart.
    (3) Genetically modified microbial pesticides may be subject to
additional data or information requirements on a case-by-case basis
depending on the particular microbial agent and/or its parental
strains, the proposed pesticide use pattern, and the manner and extent
to which the organism has been genetically modified.
    (4) Pest control organisms such as insect predators, nematodes, and
macroscopic parasites are exempt from the requirements of FIFRA as
authorized by section 25(b) of FIFRA and specified in Sec.  152.20 (a)
of this chapter.

Sec.  158.2110  Microbial pesticides data requirements.

    (a) For all microbial pesticides. (1) The following Sec.  158.2120
through Sec.  158.2150 identify the data requirements that are required
to support registration of microbial pesticides. The variations in the
test conditions are identified within the test notes.
    (2) Each data table includes ``use patterns'' under which the
individual data are required, with variations including all use
patterns, food and nonfood uses for terrestrial and aquatic
applications, greenhouse, indoor, forestry, and residential outdoor
applications under certain circumstances.
    (3) The categories for each data requirement are ``R,'' which
stands for required, and ``CR'' which stands for conditionally
required. If a bracket appears around the ``R'' or ``CR,'' the data are
required for both the registration and experimental use permit
requests. Generally, ``R'' indicates that the data are more likely
required than for those data requirements with ``CR.'' However, in each
case, the regulatory text preceding the data table and the test notes
following the data table must be used to determine whether the data
requirement must be satisfied.
    (4) Each table identifies the test substance that is required to be
tested to satisfy the data requirement. Test substances may include:
technical grade active ingredient (TGAI), manufacturing-use product
(MP), end-use product (EP), typical end-use product (TEP), residue of
concern, and pure active ingredient (PAI) or all of the above (All).
Commas between the test substances (i.e., TGAI, EP) indicate that data
may be required on the TGAI or EP or both depending on the conditions
set forth in the test note. Data requirements which list two test
substances (i.e., TGAI and EP) indicate that both are required to be
tested. Data requirements that list only MP as the test substance apply
to products containing solely the technical grade of the active
ingredient and manufacturing-use products to which other ingredients
have been intentionally added. Data requirements listing the EP as the
test substance apply to any EP with an ingredient in the end-use
formulation other than the active ingredient that is expected to
enhance the toxicity of the product.
    (b) Additional data requirements for genetically modified microbial
pesticides. Additional requirements for genetically modified microbial
pesticides may include but are not limited to: genetic engineering
techniques used; the identity of the inserted or deleted gene segment
(base sequence data or enzyme restriction map of the gene); information
on the control region of the gene in question; a description of the
``new'' traits or characteristics that are intended to be expressed;
tests to evaluate genetic stability and exchange; and selected Tier II
environmental expression and toxicology tests.

Sec.  158.2120  Microbial pesticides product analysis data requirements
table.

    (a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the product analysis data requirements and the
substance to be tested for a particular microbial pesticide. Specific
conditions, qualifications, or exceptions to the designated test are
identified in paragraph (d) of this section, and the test notes appear
in paragraph (e) of this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; All=All of the
above. Specific conditions, qualifications, or exceptions to the
designated test procedures appear in paragraph (e) of this section, and
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for
microbial pesticides product analysis. The test notes are shown in
paragraph (d) of this section.

                                             Table--Microbial Pesticides Product Analysis Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Test Substance
          Guideline Number               Data Requirement        All Use Patterns   ----------------------------------------------       Test Notes
                                                                                MP                     EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1100                            Product Identity       R                        MP                    EP                     --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1200                            Manufacturing process  R                       TGAI and MP            TGAI and EP            --
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                      Deposition of a        R                       TGAI                   TGAI                   --
                                      sample in a
                                      nationally recognized
                                      culture collection
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1300                            Discussion of          R                       TGAI and MP            TGAI and EP            --
                                      formation of
                                      unintentional
                                      ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1400                            Analysis of samples    R                       TGAI and MP            TGAI and EP            1
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1500                            Certification of       R                       MP                     EP                     --
                                      limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6302                            Color                  R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6303                            Physical state         R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6304                            Odor                   R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6313                            Stability to normal    R                       TGAI                   TGAI                   --
                                      and elevated
                                      temperatures, metals
                                      and metal ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6317                            Storage stability      R                       TGAI and MP            TGAI and EP            --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6319                            Miscibility            R                       MP                     EP                     2
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6320                            Corrosion              R                       MP                     EP                     3
                                      Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7000                            pH                     R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7100                            Viscosity              R                       MP                     EP                     4
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7300                            Density/relative       R                       TGAI                   TGAI                   --
                                      density/bulk density
                                      (specific gravity)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data
requirements for microbial pesticides product analysis as referenced in
the last column of the table contained in paragraph (c) of this
section.
    1. Required to support registration of each manufacturing-use
product and end-use product. This analysis must be conducted at the
point in the production process after which there would be no
potential for microbial contamination or microbial regrowth. For
full registration, generally an analysis of samples is a compilation
of batches, over a period of time, depending on the frequency of
manufacturing.
    2. Only required for emulsifiable liquid forms of microbial
pesticides.
    3. Required when microbial pesticides are packaged in metal,
plastic, or paper containers.
    4. Only required for liquid forms of microbial pesticides.

Sec.  158.2130  Microbial pesticides residue data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the residue chemistry data requirements and the
substance to be tested for a particular microbial pesticide. Specific
conditions, qualifications, or exceptions to the designated test appear
in paragraph (d) of this section, and the procedures appear in
paragraph (e) of this section.
    (b) Key. R=required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; All=All of the
above. Specific conditions, qualifications, or exceptions to the
designated test procedures appear in paragraph (d) of this section, and
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for
microbial pesticides residue. The test notes are shown in paragraph (d)
of this section.

                              Table--Microbial Pesticides Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test Substance
        Guideline Number            Data Requirement    All Use Patterns  Data to Support MP       Test Notes
                                                                                or EP
----------------------------------------------------------------------------------------------------------------
885.2100                           Chemical Identity   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                           Nature of the       CR                  EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                           Nature of the       CR                  EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2300                           Analytical          CR                  TGAI                1
                                   methods - plants
----------------------------------------------------------------------------------------------------------------
885.2350                           Analytical          CR                  TGAI                1
                                   methods - animals
----------------------------------------------------------------------------------------------------------------
885.2400                           Storage Stability   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2500                           Magnitude of        CR                  EP                  1
                                   residue in plants
----------------------------------------------------------------------------------------------------------------
885.2550                           Magnitude of        CR                  EP                  1
                                   residues in meat,
                                   milk, poultry,
                                   eggs
----------------------------------------------------------------------------------------------------------------
885.2600                           Magnitude of        CR                  EP                  1
                                   residues in
                                   potable water,
                                   fish, and
                                   irrigated crops
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test note is applicable to the data
requirements for microbial pesticides residue as referenced in the last
column of the table contained in paragraph (c) of this section.
    1. Required when the results of testing:
    i. Indicate the potential to cause adverse human health effects
or the product characterization indicates the microbial pesticide
has a significant potential to produce a mammalian toxin; and
    ii. The use pattern is such that residues may be present in or
on food or feed crops.

Sec.  158.2140  Microbial pesticides toxicology data requirements
table.

    (a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the toxicology data requirements for a
particular pesticide product. Notes that apply to an individual test
and include specific conditions, qualifications, or exceptions to the
designated test are listed in paragraph (d) of this section.
    (b) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; All=All of the
above. Specific conditions, qualifications, or exceptions to the
designated test procedures appear in paragraph (d) of this section, and
apply to the individual tests in the following table:
    (c) Table. The following table shows the data requirements for
microbial pesticides toxicology. The test notes are shown in paragraph
(d) of this section.

                            Table--Microbial Pesticides Toxicology Data Requirements
----------------------------------------------------------------------------------------------------------------
        Guideline Number           Data Requirement    All Use Patterns     Test Substance        Test Notes
----------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------
885.3050                           Acute oral         R                    TGAI                1
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3150                           Acute pulmonary    R                    TGAI               --
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
885.3200                           Acute injection    R                    TGAI                2
                                   toxicity/
                                   pathogenicity/
                                   (intravenous)
                                   Acute injection
                                   toxicity/
                                   pathogenicity/
                                   (intraperitoneal).
----------------------------------------------------------------------------------------------------------------
885.3400                           Hypersensitivity   R                    All                 3
                                   incidents
----------------------------------------------------------------------------------------------------------------
885.3500                           Cell culture       R                    TGAI                4
----------------------------------------------------------------------------------------------------------------
870.1100                           Acute oral         R                    MP , EP             1, 5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1200                           Acute dermal       R                    MP , EP             5
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.1300                           Acute inhalation   R                    MP , EP             5, 6
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.2400                           Acute eye          R                    MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
870.2500                           Primary dermal     R                    MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------
885.3550                           Acute toxicology    CR                  TGAI                7
----------------------------------------------------------------------------------------------------------------
885.3600                           Subchronic          CR                  TGAI                8
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------

Tier III
----------------------------------------------------------------------------------------------------------------
885.3650                           Reproductive        CR                  TGAI                9, 13
                                   fertility effects
----------------------------------------------------------------------------------------------------------------
870.4200                           Carcinogenicity     CR                  TGAI                10, 13
----------------------------------------------------------------------------------------------------------------
870.7800                           Immunotoxicity      CR                  TGAI                11, 13
----------------------------------------------------------------------------------------------------------------
885.3000                           Infectivity/        CR                  TGAI                12, 13
                                   pathogenicity
                                   analysis
----------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data
requirements for microbial pesticides toxicology as referenced in the
last column of the table contained in paragraph (c) of this section:
    1. The acute oral toxicity/pathogenicity study is required to
support the TGAI. However, it can be combined with the unit dose
portion of the acute oral toxicity study, with an EP or MP test
material to fulfill the requirement for the TGAI and the MP or EP in
a single study, if the new protocol is designed to address the
endpoints of concern.
    2. Data not required for products whose active ingredient is a
virus. For test materials whose size or consistency may prevent use
of an intravenous injection, the intraperitoneal injection procedure
may be employed.
    3. Hypersensitivity incidents, including immediate type and
delayed-type reactions of humans or domestic animals, occur during
the testing or production of the TGAI, MP, or EP, or are otherwise
known to the applicant must be reported if they occur.
    4. Data must be submitted only for products whose active
ingredient is a virus.
    5. The 870 series studies for the MP and EP are intended to
provide data on the acute toxicity of the product. Waivers for any
or all of these studies may be granted when the applicant can
demonstrate that the combination of inert ingredients is not likely
to pose any significant human health risks. Where appropriate, the
limit dose approach to testing is recommended.
    6. Required when the product consists of, or under conditions of
use would result in, an inhalable material (e.g., gas, volatile
substances, or aerosol particulate).
    7. Data required when significant toxicity, in the absence of
pathogenicity and significant infectivity, is observed in acute
oral, injection, or pulmonary studies (Tier I). Route(s) of exposure
correspond to route(s) where toxicity was observed in Tier I
studies. The toxic component of the TGAI is to be tested.
    8. Data required when significant infectivity and/or unusual
persistence is observed in the absence of pathogenicity or toxicity
in Tier I studies. Routes of exposure (oral and/or pulmonary)
correspond to routes in Tier I studies where adverse effects were
noted. Data may also be required to evaluate adverse effects due to
microbial contaminants or to toxic byproducts.
    9. Data are required when one or more of the following criteria
are met:
    i. Significant infectivity of the microbial pest control agent
(MPCA) was observed in test animals in the Tier II subchronic study
and in which no significant signs of toxicity or pathogenicity were
observed.
    ii. The microbial pesticide is a virus which can persist or
replicate in mammalian cell culture lines.
    iii. The microbial pesticide is not amenable to thorough
taxonomic classification, and is related to organisms known to be
parasitic for mammalian cells.
    iv. The microbial pesticide preparation is not well purified,
and may contain contaminants which are parasitic for mammals.
    10. Data may be required for products known to contain or
suspected to contain carcinogenic viruses or for microbial
components that are identified as having significant toxicity in
Tier II testing.
    11. Data may be required for products known to contain or
suspected to contain viruses that can interact in an adverse manner
with components of the mammalian immune system.
    12. An analysis of human infectivity/pathogenicity potential
using scientific literature, genomic analysis, and/or actual
specific cell culture/animal data may be required for products known
to contain or suspected of containing intracellular parasites of
mammalian cells for products that exhibit pathogenic characteristics
in Tier I and/or Tier II, for products which are closely related to
known human pathogens based on the product analysis data, or for
known human pathogens that have been ``disarmed'' or rendered non-
pathogenic for humans.
    13. Test standards may have to be modified depending on the
characteristics of the microorganism. Requirements may vary for
these studies depending on the active ingredient being tested.
Consultation with the Agency is advised before performing these Tier
III studies.

Sec.  158.2150  Microbial pesticides nontarget organisms and
environmental fate data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the terrestrial and aquatic nontarget organisms
data requirements for a particular microbial pesticide product. Notes
that apply to an individual test including specific conditions,
qualifications, or exceptions to the designated test are listed in
paragraph (e) of this section.
    (b) Use patterns. Aquatic uses include: food and feed, nonfood uses
(e.g., outdoor, residential, and industrial). Terrestrial uses include:
Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food
and food), Indoor (food and nonfood), and Industrial.
    (c) Key. R=Required; CR=Conditionally required; NR=Not required;
MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use
product; TGAI=Technical grade of the active ingredient; All=All of the
above. Specific conditions, qualifications, or exceptions to the
designated test procedures appear in paragraph (e) of this section, and
apply to the individual tests in the following table:
    (d) Table. The following table shows the data requirements for
microbial pesticides nontarget organisms and environmental fate. The
test notes are shown in paragraph (e) of this section.

                                                                        Table--Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use Patterns
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                 Terrestrial
        Guideline Number         Data Requirement ---------------------------------------------------------------------------------------------------------------------------------------------------   Test Substance      Test Notes
                                                                                Residential        Greenhouse          Indoor
                                                        Food/Feed           Nonfood          Food/Feed/          Forestry    ------------------------------------------------------     Industrial
                                                                                Nonfood                              Outdoor         Food/Nonfood     Food/Nonfood