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--rabbi
                                   t
--------------------------------------------------------------------------------------------------------------------------------------------------------
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--rat  CR                  CR                  TGAI                TGAI                7
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.3465                          90-day inhalation-- CR                  CR                  TGAI                TGAI                8
                                   rat
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Developmental Toxicity
--------------------------------------------------------------------------------------------------------------------------------------------------------

870.3700                          Prenatal            [R]                 [CR]                TGAI                TGAI                9
                                   developmental--ra
                                   t 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
                                   cell gene
                                   mutation test
--------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
--------------------------------------------------------------------------------------------------------------------------------------------------------
  Mutagenicity Testing (In vivo cytogenetics)
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5385                          Mammalian bone      CR                  CR                  TGAI                TGAI                13
                                   marrow
                                   chromosomal
                                   aberration
--------------------------------------------------------------------------------------------------------------------------------------------------------
870.5395                          Mammalian           CR                  CR                  TGAI                TGAI                13
                                   erythrrocyte
                                   micronucleus
--------------------------------------------------------------------------------------------------------------------------------------------------------
  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
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1000                          Background for      CR                  CR                  TGAI                TGAI                15
                                   application
                                   exposure
                                   monitoring test
                                   guidelines
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
875.1700                          Product use         [R]                 [R]                  TGAI               TGAI                --
                                   information
--------------------------------------------------------------------------------------------------------------------------------------------------------
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--t  CR                  CR                  TGAI                TGAI                18
                                   wo 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                  Choice              Choice              20
                                   safety
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for biochemical 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 >104torr).
    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. It is required to support nonfood uses if either (i) the use
is likely to result in significant human exposure; or (ii) if 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 (1) mouse lymphoma L5178Y
cells, thymidine kinase (tk) gene locus, maximizing assay conditions
for small colony expression or detection; (2) 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 (3) 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. Required if results from the Tier I mutagenicity tests are
positive. Allowed choice of assays, initial considerations usually
given to rodent bone marrow, using either metaphase analysis
(aberrations) or micronucleus assay.
    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 any human health effects
assessment data indicate that the biochemical may pose a potential
hazard to the applicator/user. It is recommended that the Agency be
consulted prior to study initiation to determine what studies are
appropriate based on the nature of the adverse effects seen in the
human health assessment data and the available exposure data.
Studies performed to support registration of insect repellents may
require modifications to these guidelines.
    16. Required if there is evidence of: (a) endocrinological
effects from the subchronic toxicity studies, (b) developmental
effects in the prenatal developmental toxicity study(s), or (c)
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 feeding toxicity study, the 90-day dermal
toxicity study, or the 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.  158.960  Nontarget organismsand 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 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; [R]=Required for registrations and
experimental use permits; CR=Conditionally required; [CR]=Conditionally
required for registrations and experimental use permits; 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 nontarget organisms and environmental fate. The test notes
are shown in paragraph (e) of this section.

                                                         Table--Biochemical Nontarget Organisms and Environmental Fate Data Requirements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use Groups containing data requirements
                                                      ---------------------------------------------------------------------------------------------------------
         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..........      2,3,4,5
                                   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)                 Anerobic 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)                  Anerobic 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
                                   invertebratetestin
                                   g
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  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 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 10-5 atm
m3/mol).
    4. Preferred test species are bobwhite quail, mallard, or
redwing blackbird for avian acute oral toxicity studies; bobwhite
quail or mallard for avian dietary studies, rainbow trout for acute
freshwater fish studies; and Daphnia magna for acute freshwater
invertebrate 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.
    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
or >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.  158.970  Biochemicalpesticides 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.

Subpart M--Microbial Pesticides

Sec.  158.1000  Definition andApplicability.

    (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 microorganism 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,
bacteria; or
    (3) Is an autonomous replicating microscopic element, including,
but not limited to, viruses.
    (c) Applicability. (1) In addition to the definition above, the
definitions in Sec.  158.3 also apply to this subpart.
    (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 microorganism and/or its parent
microorganism(s), the proposed pesticide use pattern, and the manner
and extent to which theorganism has been genetically modified.
Additional requirements may be required on a case-by-case basis.
    (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.  158.1010  Microbial pesticidedata requirements.

    (a) For all microbial pesticides. (1) The following Sec.  Sec.
158.1010 through 158.1050 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) indicating all of
the above. 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 the manufacturing product
(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.  158.1020  Product analysisdata 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 (d) of this section, and the test notes appear in
paragraph (e) of this section.
    (b) Key. R=Required; [R]=Required for registrations andexperimental
use permits; CR=Conditionally required; [CR]=Conditionally required for
registrations and experimental use permits; 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 product analysis. The test notes are shown in paragraph (d)
of this section.

                                                   Table--Microbial Product Analysis Data Requirements
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  All Use patterns                   Test substances to support
         Guideline Number           Data Requirement --------------------------------------------------------------------------------      Test notes
                                                            Food Use          Nonfood Use              MP                  EP
--------------------------------------------------------------------------------------------------------------------------------------------------------
Product Chemistry and Composition
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1100                         Product Identity   [R]                 [R]                  MP                 EP                  --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1200                         Manufacturing      [R]                 [R]                 TGAI and MP         TGAI and EP          1,2
                                   process
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Deposition of a    [R]                 [R]                 TGAI                TGAI                --
                                   sample in a
                                   nationally
                                   recognized
                                   culture
                                   collection
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1300                         Discussion of      [R]                 [R]                 TGAI and MP         TGAI and EP          2
                                   formation of
                                   unintentional
                                   ingredients
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis and Certified Limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1400                         Analysis of        [R]                 [R]                 TGAI and MP         TGAI and EP          2,3
                                   samples
--------------------------------------------------------------------------------------------------------------------------------------------------------
  885.1500                         Certification of   [R]                 R                   MP                  EP                  --
                                   limits
--------------------------------------------------------------------------------------------------------------------------------------------------------
Physical and Chemical Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6302                         Color              [R]                 [R]                 TGAI                TGAI                --
--------------------------------------------------------------------------------------------------------------------------------------------------------

  830.6303                         Physical state     [R]                 [R]                 TGAI                TGAI                --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6304                         Odor               [R]                 [R]                 TGAI                TGAI                --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6313                         Stability to       [R]                 [R]                 TGAI                TGAI                --
                                   normal and
                                   elevated
                                   temperatures,
                                   metals and metal
                                   ions
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6317                         Storage stability  [R]                 [R]                 TGAI and MP         TGAI and EP         --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6319                         Miscibility        [R]                 [R]                 MP                  EP                  4
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.6320                         Corrosion          [R]                 [R]                 MP                  EP                  5
                                   Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7000                         pH                 [R]                 [R]                 TGAI                TGAI                --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7100                         Viscosity          [R]                 [R]                 MP                  EP                  6
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7300                         Density/relative   [R]                 [R]                 TGAI                TGAI                --
                                   density/bulk
                                   density (specific
                                   gravity)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the
data requirements for microbial product analysis as referenced in
the last column of the table contained in paragraph (c) of this
section.
    1. If an experimental use permit is being sought, and if the
pesticide is not already under full-scale production, a schematic
diagram and/or description of the manufacturing process suffices.
    2. If an experimental use permit is being sought, and if the
product is not already under full-scale production, a discussion of
unintentional ingredients is required to be submitted to the extent
this information is available.
    3. 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
pesticides in the production stage, a preliminary product analytical
method and data would suffice to support an experimental use permit.
For full registration, generally an analysis of samples is a
compilation of batches, over a period of time, depending on the
frequency of manufacturing.
    4. Only required for emulsifiable liquid forms of microbial
pesticides.
    5. Required when microbial pesticides are packaged in metal,
plastic, or paper containers.
    6. Only required for liquid forms of microbial pesticides.

Sec.  158.1030  Residue datarequirements 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 (d) of this section, and the procedures appear in paragraph (e) of
this section.
    (b) Key. R=Required; [R]=Required for registrations and
experimental use permits; CR=Conditionally required; [CR]=Conditionally
required for registrations and experimental use permits; 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 residue. The test notes are shown in paragraph (d) of this
section.

                                   Table--Microbial Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                             Test Substance
        Guideline Number            Data Requirement    All Use Patterns  Data to support MP       Test notes
                                                                                or EP
----------------------------------------------------------------------------------------------------------------
885.2000                           Background for      [CR]                EP                  1
                                   Residue analysis
                                   of microbial pest
                                   control agents
----------------------------------------------------------------------------------------------------------------
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 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; andii. The
use pattern is such that residues may be present in or on food or
feed crops.

Sec.  158.1040  Toxicology datarequirements 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 (e) of this section.
    (b) Use patterns. (1) This category includes products classified
under the following general uses: terrestrial food and nonfood crop
use; terrestrial feed crop use; aquatic food and nonfood crop use;
greenhouse food and nonfood crop use; forestry; residential outdoor and
indoor; and indoor food 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.
    (c) Key. R=Required; [R]=Required for registrations andexperimental
use permits; CR=Conditionally required; [CR]=Conditionally required for
registrations and experimental use permits; 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 toxicology. The test notes are shown in paragraph (e) of this
section.

                                  Table--Microbial 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             5,7
                                   toxicity
----------------------------------------------------------------------------------------------------------------
870.2400                           Acute eye          [R]                  MP , EP             5
                                   irritation
----------------------------------------------------------------------------------------------------------------
870.2500                           Primary dermal     [CR]                 MP , EP             5,6
                                   irritation
----------------------------------------------------------------------------------------------------------------

Tier II
----------------------------------------------------------------------------------------------------------------
885.3550                           Acute toxicology    CR                  TGAI                8
----------------------------------------------------------------------------------------------------------------
885.3600                           Subchronic          CR                  TGAI                9
                                   toxicity/
                                   pathogenicity
----------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------
885.3650                           Reproductive        CR                  TGAI                10,14
                                   fertility effects
----------------------------------------------------------------------------------------------------------------
870.4200                           Carcinogenicity     CR                  TGAI                11,14
----------------------------------------------------------------------------------------------------------------
870.7800                           Immunotoxicity      CR                  TGAI                12,14
----------------------------------------------------------------------------------------------------------------
885.3000                           Infectivity/        CR                  TGAI                13,14
                                   pathogenicity
                                   analysis
----------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for microbial toxicology as referenced in the last column
of the table contained in paragraph (d) 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 i.v. injection, the i.p. injection procedure may be employed.
    3. Hypersensitivity incidents for registered products 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. Data are required only if dermal irritation is found after
dosing in acute dermal toxicity study.
    7. 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).
    8. 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 routes where toxicity was observed in Tier I studies.
The toxic component of the TGAI is to be tested.
    9. 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.
    10. Data are required when any 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.
    11. 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.
    12. Data may be required for products known to contain or
suspected to contain viruses that can interact in an adverse manner
with components of mammalian immune system.
    13. 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.
    14. 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.  158.1050  Nontarget organismsand 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; [R]=Required for registrations and
experimental use permits; CR=Conditionally required; [CR]=Conditionally
required for registrations and experimental use permits; 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 nontarget organisms and environmental fate. The test notes
are shown in paragraph (e) of this section.

                                                                              Table--Microbial Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                 Terrestrial
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Non-Food
        Guideline Number         Data Requirement                    --------------------                                                                                Test Substance      Test notes
                                                       Food, Feed             Out          Food, Feed, Non-      Forestry        Residential        Greenhouse       Indoor Food,       Industrial
                                                                       door,Residential,        food                               outdoor       Food, Non-Food       Non-Food
                                                                          Industrial
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                         Avian oral        R                   [R]                 [R]               [R]               [R]               CR               CR                CR                TGAI              1,2
                                toxicity.........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4100                        Avian inhalation    CR                CR                  CR                CR                CR                CR                CR                CR                TGAI              1,2,3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4150                        Wild mammal         CR                CR                  CR                CR                CR                NR                NR                CR                TGAI              1,4
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4200                        Freshwater fish     R                  [R]                 [R]               [R]               CR               CR                CR                CR                TGAI              1, 2,5
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         R                   [R]                 [R]               [R]               CR               CR                CR                CR                TGAI              1, 2,5
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4280                        Estuarine/Marine    CR                CR                  CR                CR                CR                NR                NR                CR                TGAI              1,6
                                 fish testing
                                Estuarine and
                                 marine
                                 invertebrate
                                 testing.
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant     CR                CR                  CR                [R]                CR               NR                CR                CR                TE                 1,7
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   [R]                 [R]                 [R]               [R]               R                 CR               NR                CR                TGAI              1,8
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  [R]                [[R]                 [R]               [R]               R                 CR               NR                CR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier II
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5200                        Terrestrial         CR                CR                  CR                CR                CR                NR                NR                CR                TGAI or TEP        9
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5300                        Freshwater          CR                CR                  CR                CR                CR                NR                NR                CR                TGAI or TEP        10
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.5400                        Marine or           CR                CR                  CR                CR                CR                NR                NR                CR                TGAI or TEP        11,12
                                 estuarine
                                 environmental
                                 expression tests
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier III
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4600                        Avian chronic      CR                  CR                 CR                CR                CR                NR                NR                CR                TGAI              12, 13
                                 pathogenicity
                                 and reproduction
                                 test
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4650                        Aquatic             CR                CR                  CR                CR                CR                NR                NR                CR                TGAI              12, 14
                                 invertebrate
                                 range testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4700                        Fish life cycle     CR                CR                  CR                CR                CR                NR                NR                CR                TGAI              12, 14/ROW>
                                 studies
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4750                        Aquatic ecosystem  CR                  CR                 CR                CR                CR                NR                NR                CR                TGAI              15
                                 test                                                                                ................
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier IV
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

850.2500                        Field testing for   CR                CR                  CR                CR                CR                NR                NR                CR                TGAI or TEP        11, 16
850.1950......................   terrestrial
                                 wildlife and
                                 Field testing
                                 for aquatic
                                 organisms
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 17, 20
                                 actual field
                                 tests (birds,
                                 mammals)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.1950                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 test (aquatic
                                 organisms)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.2500                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 18,19, 20
                                 actual field
                                 tests (insect
                                 predators,
                                 parasites)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.3040                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 18,19, 20
                                 actual field
                                 tests (insect
                                 pollinators)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
850.4300                        Simulated or       CR                  CR                 CR                CR                CR                NR                NR                CR                TEP               16, 18, 19, 20
                                 actual field
                                 tests (plants)
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for microbial nontarget organism and environmental fate as
referenced in the last column of the table contained in paragraph (d)
of this section.
    1. Tests for pesticides intended solely for indoor application
would be required on a case-by-case basis, depending on use pattern,
production volume, and other pertinent factors. Tests to support
EUP's are based on the application timing and acreage.
    2. The preferred species for the avian oral study is either the
bobwhite quail or mallard duck. The preferred species for the avian
inhalation toxicity/pathogenicity study and the avian chronic
toxicity/pathogenicity study is the bobwhite quail. There is also
the option to test the redwing black bird if there is a concern for
passerine species. The rainbow trout is preferred for freshwater
fish testing. However, two species (rainbow trout and bluegill
sunfish are the preferred species) must be tested for uses involving
direct freshwater exposure. Daphnia magna is the preferred species
for freshwater invertebrate testing.
    3. Data required when the nature of the microbial pesticide and/
or its toxins indicates potential pathogenicity to birds.
    4. Required on a case-by-case basis if results of tests required
bySec.  158.1040 are inadequate or inappropriate for assessment of
hazards to wild animals.
    5. Required when there will be significant exposure to aquatic
organisms (fish and invertebrates).
    6. Required if the product is intended for direct application
into the estuarine or marine environment or expected to enter this
environment in significant concentrations because of expected use or
mobility pattern.
    7. Required if the microbial pesticide is taxonomically related
to a known plant pathogen.
    8. Data are not required unless an active microbial ingredient
controls the target insect pest by a mechanism of infectivity; i.e.
may create an epizootic condition in nontarget insects.
    9. Required if toxic or pathogenic effects are observed in any
of the following tests for microbial pesticides:
    (i) Avian acute oral or avian inhalation studies.
    (ii) Wild mammal studies.
    (iii) Nontarget plant studies (terrestrial).
    (iv) Honey bee studies.
    (v) Nontarget insect studies.
    10. Required when toxic or pathogenic effects are observed in
any of the following Tier I tests for microbial pest control agents:
    (i) Freshwater fish studies.
    (ii) Freshwater aquatic invertebrate studies.
    (iii) Nontarget plant studies (aquatic).
    11. Required if product is applied on land or in fresh water or
marine/estuarine environments and toxic or pathogenic effects are
observed in any of the following Tier I tests for microbial
pesticides:
    (i) Estuarine and marine animal toxicity and pathogenicity.
    (ii) Plant studies--estuarine or marine species.
    12. An appropriate dose-response toxicity test is required when
toxic effects on nontarget terrestrial wildlife or aquatic organisms
(including plants) are reported in one or more Tier I tests and
results of Tier II tests indicate exposure of the microbial agent to
the affected nontarget terrestrial wildlife or aquatic organisms.
The protocols for these tests may have to be modified in accordance
with results from the nontarget organism and environmental
expression studies.
    13. Required when one or more of the following are present:
    (i) Pathogenic effects are observed in Tier I avian studies.
    (ii) Tier II environmental expression testing indicate that
long-term exposure of terrestrial animals is likely.
    14. Required when product is intended for use in water or
expected to be transported to water from the intended use site, and
when pathogenicity or infectivity was observed in Tier I aquatic
studies.
    15. Required if, after an analysis of the microbial pesticide's
ability to survive and multiply in the environment and what
ecological habitat it would occupy, the intended use patterns, and
the results of previous nontarget organisms and environmental
expression tests, it is determined that use of the microbial agent
may result in adverse effects on the nontarget organisms in aquatic
environments. Testing is to determine if applications of the
microbial pest control would be expected to disrupt the balance of
populations in the target ecosystem.
    16. Tier IV studies may be conducted as a condition of
registration aspost-registration monitoring if the potential for
unreasonable

adverse effects appears to be minimal during that period of use due
to implementation of mitigation measures.
    17. Required when both of the following conditions occur:
    (i) Pathogenic effects at actual or expected field residue
exposure levels are reported in Tier III; and
    (ii) The Agency determines that quarantine methods would not
prevent the microbial pesticide from contaminating areas adjacent to
the test area.
    18. Short term simulated or actual field studies are required
when it is determined that the product is likely to cause adverse
short-term or acute effects, based on consideration of available
laboratory data, use patterns, and exposure rates.
    19. Data from a long-term simulated field test (e.g., where
reproduction and growth of confined populations are observed) and/or
an actual field test (e.g., where reproduction and growth of natural
populations are observed) are required if laboratory data indicate
that adverse long-term, cumulative, or life-cycle effects may result
from intended use.
    20. Since test standards would be developed on a case-by-case
basis, consultation with the Agency and development of a protocol is
advised before performing these Tier IV studies.

Sec.  158.1060  Microbial pesticidesproduct performance data
requirements.

    Product performance data must be developed for all microbial
pesticides. However, the Agency has waived all requirements to submit
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.

PART 172--[AMENDED]

    5. The authority citation continues to read as follows:

    Authority:  7 U.S.C. 136c, 136w. Section 172.4 is also issued
under 31 U.S.C. 9701.

    6. In Sec.  172.43 revise the definition for ``microbial
pesticide'' to read as follows:

Sec.  172.43  Definitions.

* * * * *
     Microbial pesticide means a microorganism 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,
bacteria; or
    (3) Is an autonomous replicating microscopic element, including,
but not limited to, viruses.
* * * * *

[FR Doc. 06-2185 Filed 3-7-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Page 59703]
[FR Doc No: 2021-23486]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2883-000]

Aquenergy Systems, LLC; Notice of Authorization for Continued
Project Operation

    On May 30, 2018, Aquenergy Systems, LLC, licensee for the Fries
Hydroelectric Project No.2883, filed an Application for a New Major
License pursuant to the Federal Power Act (FPA) and the Commission's
regulations thereunder. The Fries Hydroelectric Project is located on
the New River in the Town of Fries, Grayson County, Virginia.
    The license for Project No. 2883 was issued for a period ending May
31, 2020. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires
the Commission, at the expiration of a license term, to issue from
year-to-year an annual license to the then licensee(s) under the terms
and conditions of the prior license until a new license is issued, or
the project is otherwise disposed of as provided in section 15 or any
other applicable section of the FPA. If the project's prior license
waived the applicability of section 15 of the FPA, then, based on
section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and
as set forth at 18 CFR 16.21(a), if the licensee of such project has
filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 2883 is issued to
Aquenergy Systems, LLC for a period effective June 1, 2020 through May
31, 2021 or until the issuance of a new license for the project or
other disposition under the FPA, whichever comes first. If issuance of
a new license (or other disposition) does not take place on or before
May 31, 2021, notice is hereby given that, pursuant to 18 CFR 16.18(c),
an annual license under section 15(a)(1) of the FPA is renewed
automatically without further order or notice by the Commission, unless
the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that Aquenergy Systems, LLC is authorized to continue
operation of the Fries Hydroelectric Project, until such time as the
Commission acts on its application for a new major license.

    Dated: October 19, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-23486 Filed 10-27-21; 8:45 am]
BILLING CODE 6717-01-P