----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 or TEP       1, 2, 5
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         R                   R                  R                  R                 CR               CR                CR                CR                TGAI or TEP       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                TEP                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
                                 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 pesticides 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.
    2. The preferred species for the avian oral study is either the
upland game or waterfowl. The preferred species for the avian
inhalation toxicity/pathogenicity study and the avian chronic
toxicity/pathogenicity study is the upland game. There is also the
option to test the passerine if there is a concern. The coldwater
fish is preferred for freshwater fish testing. However, two species
(coldwater and warmwater fish species are the preferred species)
must be tested for uses involving direct freshwater exposure.
Freshwater invertebrate testing is also required.
    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
by Sec.  158.2140 are inadequate or inappropriate for assessment of
hazards to wild mammals.
    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 one
or more 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 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 as post-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 observed 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.  158.2160  Microbial pesticides product 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.

Sec.  158.2170  Experimental use permit data requirements--microbial
pesticides.

    (a) For all microbial pesticides. (1) The following Sec.  158.2171
through Sec.  158.2174 identify the data requirements that are required
to support experimental use permits for microbial pesticides. The
variations in the test conditions are identified within the test notes.
    (2) For general information on the data requirement tables, see
Sec.  158.2110(a)(2)-(4).
    (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.  158.2171  Experimental use permit microbial pesticides product
analysis data requirements table.

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

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

  830.6320                           Corrosion               R                       MP                     EP                     5
                                      Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7000                           pH                      R                       TGAI                   TGAI                   --
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7100                           Viscosity               R                       MP                     EP                     6
--------------------------------------------------------------------------------------------------------------------------------------------------------
  830.7300                           Density/relative        R                       TGAI                   TGAI                   --
                                      density/bulk density
                                      (specific gravity)
--------------------------------------------------------------------------------------------------------------------------------------------------------

    (d) Test notes. The following test notes are applicable to the data
requirements for experimental use permit microbial pesticides 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.  158.2172  Experimental use permit microbial pesticides residue
data requirements table.

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

                            Table--EUP Microbial Pesticides Residue Data Requirements
----------------------------------------------------------------------------------------------------------------
                                                                            Test Substance
        Guideline Number           Data Requirement    All Use Patterns   Data to Support MP      Test Notes
                                                                                or EP
----------------------------------------------------------------------------------------------------------------
885.2100                          Chemical Identity   CR                  EP                  1
----------------------------------------------------------------------------------------------------------------
885.2200                          Nature of the       CR                  EP                  1
                                   Residue in plants
----------------------------------------------------------------------------------------------------------------
885.2250                          Nature of the       CR                  EP                  1
                                   Residue in
                                   animals
----------------------------------------------------------------------------------------------------------------
885.2300                          Analytical methods  CR                  TGAI                1
                                   - plants
----------------------------------------------------------------------------------------------------------------
885.2350                          Analytical methods- CR                  TGAI                1
                                   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 experimental use permit microbial pesticides residue
as referenced in the last column of the table contained in paragraph
(c) of this section.
    1. Required when the results of testing:
    i. Indicate the potential to cause adverse human health effects
or the product characterization indicates the microbial pesticide
has a significant potential to produce a mammalian toxin; and
    ii. The use pattern is such that residues may be present in or
on food or feed crops.

Sec.  158.2173  Experimental use permit microbial pesticides toxicology
data requirements table.

    (a) General. Sections 158.100 through 158.130 describe how to use
this table to determine the toxicology data requirements for a
particular microbial pesticide product. Notes that apply to

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

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

    (d) Test notes. The following test notes are applicable to the data
requirements for experimental use permit microbial pesticides
toxicology as referenced in the last column of the table contained in
paragraph (c) of this section:
    1. The acute oral toxicity/pathogenicity study is required to
support the TGAI. However, it can be combined with the unit dose
portion of the acute oral toxicity study, with an EP or MP test
material to fulfill the requirement for the TGAI and the MP or EP in
a single study, if the new protocol is designed to address the
endpoints of concern.
    2. Data not required for products whose active ingredient is a
virus. For test materials whose size or consistency may prevent use
of an intravenous injection, the intraperitoneal injection procedure
may be employed.
    3. Hypersensitivity incidents, including immediate type and
delayed type reactions of humans or domestic animals occur during
the testing or production of the TGAI, MP, or EP, or are otherwise
known to the applicant must be reported if they occur.
    4. Data must be submitted only for products whose active
ingredient is a virus.
    5. The 870 series studies for the MP and EP are intended to
provide data on the acute toxicity of the product. Waivers for any
or all of these studies may be granted when the applicant can
demonstrate that the combination of inert ingredients is not likely
to pose any significant human health risks. Where appropriate, the
limit dose approach to testing is recommended.
    6. Required when the product consists of, or under conditions of
use that would result in an inhalable material (e.g., gas, volatile
substances, or aerosol particulate).

Sec.  158.2174  Experimental use permit microbial pesticides nontarget
organisms and environmental fate data requirements table.

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

                                                                      Table--EUP Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Use Patterns
                                                  ---------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Aquatic                                                                Terrestrial
       Guideline Number          Data Requirement ---------------------------------------------------------------------------------------------------------------------------------------------------  Test Substance      Test Notes
                                                                                Residential       Greenhouse          Indoor
                                                       Food/Feed           Nonfood       Food/Feed/Nonfood      Forestry     ------------------------------------------------------    Industrial
                                                                                Outdoor        Food/Nonfood      Food/Nonfood
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4050                        Avian oral         NR                 R                  R                  R                 R                 NR                NR                NR                TGAI              1, 2
                                toxicity.........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4200                        Freshwater fish    NR                 R                  R                  R                 NR                NR                NR                NR                TGAI              1, 2, 3
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4240                        Freshwater         NR                 R                  R                  R                 NR                NR                NR                NR                TGAI              1, 2, 3
                                 invertebrate
                                 toxicity/
                                 pathogenicity
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4300                        Nontarget plant    NR                 NR                 NR                 R                 NR                NR                NR                NR                TEP               1, 4
                                testing..........
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4340                        Nontarget insect   R                  R                  R                  R                 NR                NR                NR                NR                TGAI              1, 5
                                 testing
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
885.4380                        Honey bee testing  R                  R                  R                  R                 NR                NR                NR                NR                TGAI              1
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    (e) Test notes. The following test notes are applicable to the data
requirements for microbial pesticides 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
upland game or waterfowl. The preferred species for the avian
inhalation toxicity/pathogenicity study and the avian chronic
toxicity/pathogenicity study is the upland game. There is also the
option to test a passerine species if there is a concern. The
coldwater fish is preferred for freshwater fish testing. However,
two species (coldwater and warmwater fish are the preferred species)
must be tested for uses involving direct freshwater exposure.
Freshwater invertebrates are preferred for invertebrate testing.
    3. Required when there will be significant exposure to aquatic
organisms (fish and invertebrates).
    4. Required if the microbial pesticide is taxonomically related
to a known plant pathogen.
    5. 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.

[FR Doc. E7-20828 Filed 10-25-07; 8:45 am]

BILLING CODE 6560-50-S