[Code of Federal Regulations]
[Title 40, Volume 23]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR158.740]

[Page 127-138]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents
 
                    Subpart D_Data Requirement Tables
 
Sec. 158.740  Microbial pesticides--Product analysis data requirements.

    (a) Microbial pesticides product analysis data requirements--(1) 
Table. Sections 158.50 and 158.100 through 158.102 describe how to use 
this table to determine the microbial pesticides--product analysis data 
requirements and the substance to be tested.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Product identity manufacturing  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............      151-20
 process.
                                      (i)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-21
Discussion of formation of           (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-22
 unintentional ingredients.

[[Page 128]]


Analysis of samples...........      (iii)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       MP and TGAI.....  EP* and TGAI....      151-23
Certification of limits.......  .........  [R]         R           [R]         R           [R]        R          R          R          R          MP..............  EP*.............      151-25
Analytical methods............  .........  R           R           R           R           R          R          R          R          R          MP..............  EP*.............      151-25
Physical and chemical           .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-26
 properties.
Submittal of samples..........       (iv)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       MP and TGAI, PAI  EP* TGAI and PAI      151-27
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product: EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
  satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical grade of the active ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
  requirements that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.
(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under scale production.
(ii) If the product is not already under full scale production and an experimental use permit is being sought, a discussion of unintentional ingredients shall be submitted to the extent this
  information is available.
(iii) Required to support registration of each manufacturing-use product and end use products produced by an integrated formulation system. Data on other end use products will be required on a
  case-by-case basis. For pesticide in the production stage, a rudimentary product analytical method and data will suffice to support an experimental use permit.
 AAA(iv) Routinely required for products produced by an integrated formulation system. Required on a case-by-case basis for other products or materials.

    (b) Microbial pesticides-residue data requirements--(1) Table. 
Sections 158.50 and 158.100 through 158.102 describe how to use this 
table to determine the microbial pesticides-residue data requirements 
and the substances to be tested.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Residue data..................        (i)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       ................  ................       153-4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: CR=Conditionally required data; EP=End-use product; MP=Manufacturing-use product; [ ]=Brackets (i.e., [CR]) indicate data requirements that apply when an experimental use permit is being
  sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (b)(1) of this section.
(i) Residue data requirements shall apply to microbial pesticides when Tier II or Tier III toxicology data are required, as specified for microbial pesticides in (c)(1) of this section.
(ii) [Reserved)

    (c) Microbial pesticides-toxicology data requirements--(1) Table. 
Sections 158.50 and 158.100 through 158.102 describe how to use this 
table to determine the microbial pesticides-toxicology data requirements 
and the substances to be tested.

[[Page 129]]



------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
    Acute oral................  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP*            152-30
                                                                                                                                                                     dilution and
                                                                                                                                                                     TGAI.
    Acute dermal..............  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP             152-31
                                                                                                                                                                     dilution and
                                                                                                                                                                     TGAI.
    Acute inhalation..........        (i)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* or EP             152-32
                                                                                                                                                                     Dilution* and
                                                                                                                                                                     TGAI.
    I.V., I.C., I.P. injection       (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        TGAI............  TGAI............      152-33
    Primary dermal............  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............      152-34
    Primary eye...............  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............      152-35
    Hypersensitivity study....      (iii)  R           R           R           R           R          R          R          R          R          MP..............  EP*.............      152-36
    Hypersensitivity incidents       (iv)  CR          CR          CR          CR          CR         CR         CR         CR         CR         ................  ................      152-37
    Immune response...........  .........  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............      152-38
    Tissue culture............        (v)  [R]         R           [R]         R           [R]        R          R          R          R          TGAI............  TGAI............      152-39
Tier II:
    Acute oral................       (vi)  CR          CR          CR          CR          CR         CR         CR         CR         CR         MP..............  EP*.............      152-40
    Acute inhalation..........      (vii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         MP..............  EP*.............      152-41
    Subchronic oral...........     (viii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-42
    Acute I.P., I.C...........       (ix)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-43
    Primary dermal............        (x)  CR          CR          CR          CR          CR         CR         CR         CR         CR         ................  EP*.............      152-44
    Primary eye...............       (xi)  CR          CR          CR          CR          CR         CR         CR         CR         CR         ................  EP*.............      152-45
    Immune response...........      (xii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-46
    Teratogenicity............     (xiii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-47
    Virulence enhancement.....      (xiv)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-48
    Mammalian mutagenicity....       (xv)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-49
Tier III:
    Chronic feeding...........      (xvi)  CR          ..........  CR          ..........  CR         .........  .........  .........  CR         TGAI............  TGAI............      152-50
    Oncogenicity..............     (xvii)  CR          ..........  CR          ..........  CR         .........  .........  .........  CR         TGAI............  TGAI............      151-51
    Mutagenicity..............    (xviii)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-52
    Teratogenicity............      (xix)  CR          CR          CR          CR          CR         CR         CR         CR         CR         TGAI............  TGAI............      152-53
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product; EP*=End use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must
  satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical Grade of the Active Ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data
  requirements that apply when an experimental use permit is being sought.
(2) Notes. The following notes are referenced in column two of the table contained in paragraph (c)(1) of this section.
(i) Required if 20 percent or more of the aerodynamic equivalent of the product (as registered or under conditions of use) is composed of particulates less than 10 microns in diameter.
(ii) Data required for products as follows:
(A) Intravenous (``IV'') infectivity study for bacterial, and viral agents;
(B) Intracerebral (``IC'') infectivity study for viral and protozoan agents; and

[[Page 130]]


(C) Intraperitoneal (``IP'') infectivity study for fungal and protozoan agents.
(iii) Required if commonly recognized use practices will result in repeated human contact by inhalation or dermal routes.
(iv) Hypersensitivity incidents must be reported, if they occur.
(v) Data required for products whose active ingredient is a virus.
(vi) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus or protozoa) is observed in the test animals treated in the Tier I acute oral
  infectivity tests or the intraperitoneal or intracerebral injection test for protozoa.
(vii) Required if survival, replication, infectivity, toxicity, or persistence of the microbial agent (virus or protozoa) is observed in the test animals treated in the comparable Tier I acute
  inhalation tests.
(viii) Required if there is evidence of survival, replication, infectivity, or persistence of the protozoan agent in the Tier I oral infectivity test.
(ix) Required if in Tier I acute oral infectivity testing, Tier I dermal toxicity/infectivity testing, or Tier I intraperitoneal or intracerebral injection testing, the test microorganism
  (bacteria, fungi, or protozoa) survived for more than 2 weeks, caused toxic effects, or caused a severe illness response in an experimental animal as evidenced by irreversible gross
  pathology, severe weight loss, toxemia, or death.
(x) Required if infectivity or if marked edema or broad erythema was observed in the Tier I dermal irritation study.
(xi) Required if infectivity or if severe ocular lesions are observed in the Tier I primary eye irritation study.
(xii) Required if results of the Tier I immune response test indicate abnormalities.
(xiii) Required when Tier I tests on viral agents show replication of the virus in mammalian hosts and significant damage to mammalian cells.
(xiv) Required when Tier I infectivity tests on bacteria or fungi indicate prolonged survival (including presence of viable microbial agents in test animal excreta) and/or multiplication
  (infectivity) of the bacteria or fungal agent, respectively.
(xv) Required if any of the following criteria are met:
(A) Acute infectivity tests are positive in Tier I studies.
(B) Adverse effects are observed in immune response studies.
(C) Positive results are obtained in tissue culture tests with viral agents.
(xvi) Required when the potential for chronic adverse effects (e.g., replication or persistence of viral or subviral constituents, protozoans, fungi, or bacteria) are demonstrated by any of
  the Tier II tests (except primary dermal, primary ocular, and mammalian mutagenicity tests).
(xvii) Required when the potential for oncogenic effects is indicated (e.g., adverse cellular effects due to presence, replication, or persistence of viral or subviral constituents, or
  bacteria, fungi or protozoans; or mutagenic effects) by any of the Tier II tests except the primary dermal and primary ocular studies.
(xviii) Required when the potential for mutagenic effects is indicated (e.g., adverse cellular effects due to presence, replication, or persistence of viral or subviral constituents, bacteria,
  fungi or protozoa) by any of the Tier II tests except primary dermal or primary ocular studies.
(xix) Required when the potential for teratogenic effects is expected based on the presence of persistence of fungi, bacteria, viruses, or protozoa in mammalian species as a result of testing
  performed in Tier II, except primary dermal and primary ocular studies.

    (d) Microbial pesticides non-target organism and environmental 
expression data requirements--(1) Table. Sections 158.50 and 158.100 
through 158.102 describe how to use this table to determine the 
microbial pesticides non-target organism and environmental expression 
data requirements and substances to be tested.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    General use patterns                                                    Test substance
                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines
     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference
                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.
                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor      use            MP                EP
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tier I:
    Avian oral................       (i),  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............      154-16
                                    (ii),
                                    (iii)
    Avian injection test......       (i),  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        CR         TGAI............  TGAI............      154-17
                                    (ii),
                                    (iii)
    Wild mammal testing.......       (iv)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-18
    Freshwater fish testing...        (i)  [R]         [R]         [R]         [R]         CR         CR         [R]        CR         CR         TGAI............  TGAI............      154-19
    Freshwater aquatic                (i)  [R]         [R]         [R]         [R]         CR         CR         [R]        CR         CR         TGAI............  TGAI............      154-20
     invertebrate testing.
    Estuarine and marine              (v)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............       154-2
     animal testing.

[[Page 131]]


    Nontarget plant studies...  .........  [R]         [R]         [R]         [R]         .........  .........  [R]        [R]        CR         TEP.............  TEP.............       154-2
    Nontarget insect testing..  .........  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        .........  TGAI............  TGAI............      154-23
    Honey bee testing.........  .........  [R]         [R]         [R]         [R]         CR         CR         [R]        [R]        .........  TGAI............  TGAI............      154-24
Tier II:
    Terrestrial environmental        (vi)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI or TEP.....  TGAI or TEP.....      155-18
     testing.
    Freshwater environmental        (vii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI or TEP.....  TGAI or TEP.....      155-19
     expression tests.
    Marine or estuarine           (xiii),  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI or TEP.....  TGAI or TEP.....      155-20
     environmental expression        (ix)
     tests.
Tier III:
    Terrestrial wildlife and          (x)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI or TEP.....  TGAI or TEP.....      154-25
     aquatic organism testing.
    Avian pathogenicity/             (xi)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-26
     reproduction test.
    Definitive aquatic animal       (xii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-27
     tests.
    Aquatic embryo larvae and      (xiii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-28
     life cycle studies.
    Aquatic ecosystem test....      (xiv)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TGAI............      154-29
    Special aquatic tests       .........  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................      154-30
     (reserved).
    Nontarget plant studies...       (xv)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TGAI............  TEP.............      154-31
Tier IV:                            (xvi)
    Simulated and actual field     (xiii)  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............      154-33
     tests (birds, mammals).
    Simulated and actual field    (xvii),  CR          CR          CR          CR          .........  .........  CR         CR         .........  TEP.............  TEP.............      154-34
     tests (aquatic organisms).   (xviii)
    Simulated and actual field  .........  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................      154-35
     tests (insect predators,
     parasites) (reserved).
    Simulated and actual field  .........  ..........  ..........  ..........  ..........  .........  .........  .........  .........  .........  ................  ................      154-36
     tests (insect
     pollinators) (reserved).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 AAAKey: R=Required; CR=Conditionally required; [ ]=Brackets (i.e., [R], [CR]) indicates data requirements that apply to products for which an experimental use permit is being sought;
  MP=Manufacturing-use Product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; EP=End-use product; PAI=``Pure'' active ingredient.
 AAA(2) Notes. The following notes are referenced in column two of the table contained in paragraph (d)(1) of this section.

[[Page 132]]


 AAA(i) Tests for pesticides intended solely for indoor application will be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.
 AAA(ii) Preferable test species are: bobwhite quail or mallard for avian acute oral and avian dietary studies; rainbow trout for freshwater fish studies.
 AAA(iii) Data from either the avian acute oral or the avian injection study are required to support an experimental use permit.
 AAA(iv) Required on a case-by-case basis if results of tests required by paragraph (c)(1) of this section are inadequate or inappropriate for assessment of hazards to wild animals.
 AAA(v) Required when product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of
  expected use or mobility pattern.
 AAA(vi) Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
 AAA(A) Avian single dose oral toxicity and pathogenicity tests.
 AAA(B) Avian injection pathogenicity tests.
 AAA(C) Wild mammals toxicity and pathogenicity test.
 AAA(D) Plant studies--terrestrial.
 AAA(E) Honey bee toxicity/pathogenicity test.
 AAA(F) Testing for toxicity/pathogenicity to insect predators and parasites.
 AAA(vii) Required when toxic or pathogenic effects are observed in any of the following Tier I test for microbial pest control agents:
 AAA(A) Freshwater fish toxicity and pathogenicity testing.
 AAA(B) Freshwater aquatic invertebrate toxicity and pathogenicity test.
 AAA(C) Plant studies--aquatic.
 AAA(viii) Required if product is applied on land or in fresh water and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:
 AAA(A) Estuarine and marine animal toxicity and pathogenicity test.
 AAA(B) Plant studies--estuarine or marine.
 AAA(ix) Required if product is applied in marine or estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests:
 AAA(A) Avian single dose oral toxicity and pathogenicity test.
 AAA(B) Avian injection pathogenicity test.
 AAA(C) Estuarine and marine animal toxicity and pathogenicity test.
 AAA(x) Required when toxic effects on nontarget terrestrial wildlife or aquatic organisms are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the
  mocrobial agent to the affected nontarget terrestrial wildlife or aquatic organisms.
 AAA(xi) Required when:
 AAA(A) Pathogenic effects are observed in Tier I avian tests at a level equal to the adjusted host equivalent amount.
 AAA(B) Chronic, carcinogenic, or teratogenic effects are reported in tests required by paragraph (c)(1) of this section for evaluating hazard to humans and domestic animals.
 AAA(C) Tier II Environmental expression testing indicates that exposure of terrestrial animals to the microbial agent is likely.
 AAA(xii) Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenicity or infectivity was observed in Tier I
  tests.
 AAA(xiii) Required when both of the following conditions are met:
 AAA(A) Pathogenic effects at actual or expected field residue exposure levels are reported in Tier III.
 AAA(B) The agency determines that quarantine methods will prevent the microbial pest control agent from contaminating areas adjacent to the test area.
 AAA(xiv) Required if, after an analysis of the microbial agent's properties, the individual use patterns, and the results of previous nontarget organism and environmental expression tests, it
  is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments, including those of the water column and bottom sediments. When
  a microbial pest control agent is used in or is expected to transport to water from the intended use site, major considerations for requiring these infectivity tests include, but are not
  limited to:
 AAA(A) Infectivity or pathogenicity demonstrated in previous testing.
 AAA(B) Viability of the microorganism in natural waters as demonstrated in Tier II tests.
 AAA(xv) Required if the product is transported from the site of application by air, soil, or water or transmission by other animals. The extent of movement will be determined by the
  environmental expression tests in Tier II.
 AAA(xvi) The Agency expects that Tier IV requirements would be imposed retrospectively--after product registration as post registration monitoring, since it is unlikely a registrant would
  pursue registration of a microbial agent posing potential hazards such that testing beyond Tier III is required.
 AAA(xvii) Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of
  available laboratory data, use patterns, and exposure rates.
 AAA(xviii) Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and
  growth of natural populations are observed) are required if laboratory data indicate adverse long-term, cumulative, or life-cycle effects may result from intended use.


[49 FR 42881, Oct. 24, 1984. Redesignated at 53 FR 15993, May 4, 1988, 
and amended at 58 FR 34203, June 23, 1993]

[[Page 133]]

Appendix A to Part 158--Data Requirements for Registration: Use Pattern 
                                  Index

How to use this Index:
    1. Identify the Pesticide Use Site Group listed below (e.g., 
agricultural crops, forests, ornamental plants) that covers the specific 
use pattern of interest to you.
    2. Find your specific use pattern under the appropriate Pesticide 
Use Site Group.
    3. Identify the general use pattern that corresponds to your 
specific use pattern.
    4. Use the general use pattern in determining applicable data 
requirements on the Data Requirements tables presented in Sec. Sec. 
158.120 through 153.170.
Pesticide use site group
    1. Agricultural Crops.
    2. Ornamental Plants and Forest Trees.
    3. General Soil Treatment and Composting.
    4. Processed or Manufactured Products, and food or feed containers 
or dispensers.
    5. Pets and Domestic Animals.
    6. Agricultural Premises and Equipment.
    7. Household.
    8. Wood or Wood Structure Protection Treatments.
    9. Aquatic sites.
    10. Noncrop, wide area, and general indoor/outdoor treatments.
    11. Antifouling treatments.
    12. Commercial and Industrial Uses.
    13. Domestic and Human Use.
    14. Miscellaneous Indoor Uses.

------------------------------------------------------------------------
 Specific use patterns--listed according to    Corresponding general use
               use site group                           pattern
------------------------------------------------------------------------
            1. Agricultural crops
Small fruits                                  Terrestrial food crop
  Caneberries (e.g., raspberry, dewberry)
  Bushberries (e.g., blueberry, currant)
  Vine fruits (e.g., grape, kiwi fruit)
  Strawberry
  Cranberry
  Pome fruits (e.g., apple, quince)
  Stone fruits (e.g., peach, cherry)
  Nut crops--tree & shrub (e.g., pecan,
   filbert)
  Other temperate fruits (e.g., persimmon,
   pawpaw)
Tropical and subtropical fruits
  Citrus
  Banana and plantain
  Palm fruits and nuts (e.g., date, coconut)
  Pineapple
  Other fruits and nuts
Beverage crops
  Woody--cocoa, coffee, tea
  Herbaceous--chicory, mint
Flavoring and spice crops
  Woody--leaf/stem, root, seed and pod
  Herbac.--leaf/stem, root, seed and pod
Vegetables--leaf/stem, root, seed and pod,
 fruiting vegetables, cucurbits
  Commercial annual (e.g., tomato, bean)
  Commercial perennial (e.g., asparagus,
   rhubarb)
Greenhouse (commercial)                       Greenhouse food crop
  Mushrooms
  Nursery/seed crop/medical crop/tobacco      Greenhouse non-food crop
Fiber crops                                   Terrestrial food crop
  Cotton
  Others--(e.g., flax)
Forage crops
  Typical grasses--annual (e.g., sudan
   grass)
  Typical grasses--perennial (e.g.,
   bromegrass)
  Corn and sorghum
  Small grains for forage (e.g., rye)
  Perennial legumes (e.g., white clover)
Annual legumes (e.g., crotalaria, soybean)
Crop harvest residue (peanut vines, beet
 tops, etc.)
Grain and edible seed crops
  Corn
  Rice                                        Aquatic food crop
  Wheat, barley, rye, oats                    Terrestrial food crop
  Sorghum
  Alfalfa
  Other grains
  Other nongrains (e.g., squash, pumpkin)
  Buckwheat
  Sesame
  Peanut
  Sunflower
Seed sprout crops
  Mung bean, red clover, soybean, alfalfa,
   etc.
  Nonlegume crops (e.g., wheat, radish,
   black mustard)
Crops grown exclusively for seed for
 planting
Sugar crops
Stored raw agricultural commodities           Indoor
  Honey (principal nectar-producing crops)
  Sugar beet
  Sugarcane
  Sugar maple
  Sorghum (for sugar)
Crops for smoking and chewing                 Terrestrial nonfood crop
    --field
    --shade
    --storage
    --greenhouses
  Sapodilla (for chewing gum)                 Terrestrial food crop
Oil crops
  Annual herbaceous crops
  Perennial herbaceous crops
  Tropical/subtropical woody crops
Drug and medicinal crops                      Terrestrial nonfood crop
  Annual herbaceous crops
  Perennial herbaceous crops
  Temperate woody crops
  Tropical/subtropical wood crops

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    2. Ornamental plants and forest trees
Ornamental plants                             Terrestrial nonfood crop
  Annual garden plants
  Temperate perennial nonfood garden herbs
  Commercial greenhouse crops                 Greenhouse nonfood crop
  Houseplants                                 Indoor
  Home and retail greenhouse and
   conservatory plants
  Public display plantings                    Terrestrial nonfood crop
  Bulb, corm, and tuber ornamentals
  Subtropical/tropical garden evergreen
   plants (dry--e.g., agave)
  Subtropical/tropical garden evergreen
   plants (moist--e.g., ferns)
  Groundcovers
  Aquatic plants (e.g., waterlilies)          Aquatic nonfood use
Ornamental trees, shrubs, and vines (woody)   Terrestrial nonfood crop
  Deciduous temperate broadleaf
  Evergreen temperate broadleaf
  Deciduous temperate conifer
  Evergreen temperate conifer
  Tropical/subtropical broadleaf
  Tropical/subtropical conifer
  Tropical/subtropical miscellaneous (e.g.,
   cycad, tree fern, bamboo)
Lawn and turf grasses--ornamental             Terrestrial nonfood crop
                                               or domestic outdoor
  Cool season Winter grasses (bent,
   bluegrass, fescue, etc.)
  Summer grasses (zoysia, bermudagrass,
   etc.)
  Ornamental bunch grasses (pampasgrass,
   blue fescue)
Forest trees--nonornamental--trees forests,   Forestry
 plantings
  Deciduous temperate (broadleaf)
  Evergreen temperate (broadleaf)
  Deciduous and evergreen conifers
  Tropical/subtropical broadleaf
  Tropical/subtropical conifer
Forest tree nurseries--Temperate broadleaf
 trees
  Temperate conifer trees
Forest trees: dead trees/logs/stumps in the
 forest or in plantings
  3. General soil treatment and composting
General soil treatments                       Terrestrial nonfood crop
  Soil application with no mention of crops
   to be grown (potting soil, top soil).
  Manure
  Composts
  Cull piles
  Mulches
 4. Processed or manufactured products, and
    food or feed containers or dispensers
Processed vegetables, fruits, and nuts        Indoor
  Fruits
  Leafy vegetables
  Root vegetables
  Fruited vegetables
  Nuts
  Peanuts
  Seeds (sesame, sunflower)
Dried processed
  Fruits
  Vegetables
  Tobacco
  Beverages (tea, coffee)
  Herbs and spices
Animal Feeds
  Cattle (beef)
  Cattle (dairy)
  Goat (nondairy)
  Goat (dairy)
  Horse, mule, donkey
  Poultry (chicken, turkey, etc.)
  Sheep (meat)
  Sheep (wool)
  Swine
  Dog
  Cat
  Other pets (including birds)
  Fur-bearing stock
  Other meat-producing stock (e.g., rabbit)
  Fish food (commercial)
  Fish food (pet)
  Birdseed
Processed grain products for human
 consumption
  Corn
  Soybean
  Wheat
  Other grains (rice, barley, etc.)
  Cereal foods
  Flour
  Baked goods
  Farinaceous products
  Processed animal products for human
   consumption
  Cheese
  Egg yolks
  Meats, including fish and poultry
  Milk
Processed plant products for human
 consumption
  Chocolate
  Candy
  Sugar
  Yeast
  Citrus pulp
  Chewing gum
  Cigarettes, etc.
  Herbs and spices
  Pickles
  Glazed fruits
  Jellies
  Seed oils
  Fruit syrups (e.g., cola)
  Fruit juices
  Fermentation beverages (wine, beer,
   whiskey, vinegar)
  Processed or manufactured nonfood plant
   and animal products
  Textiles, fabrics, fibers
  Fur and hair products
  Leather products
Food and feed containers, dispensers, and
 processing equipment
  Airtight storages--large (empty/full)
  Airtight storages--small (empty/full)
  Fumigation chambers
  Bins
  Elevators

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  Storage areas--(empty/full)
  Processing or handling equipment and
   machinery (other than food processing)
  5. Pets and domestic animals--animals and
           their man-made premises
Dairy cattle--lactating                       Indoor
Dairy cattle--nonlactating
Dairy cattle--heifers, calves
Goats--lactating
Goats--nonlactating
Goats--young (kids)
Fur- and wool-bearing animals
  Goats
  Sheep
  Mink
  Chinchilla
  Rabbit
  Fox
  Nutria
Meat animals (mammals)
  Cattle (and calves)
  Goats (and kids)
  Horses
  Rabbits
  Sheep (and lambs)
  Swine
  Bison
  Reindeer
Poultry (meat, eggs)
  Chickens
  Turkeys
  Ducks, geese
  Guineas, pheasants, quail, etc.
Honey production
  Bees
  Beehives
  Honeycombs
Fish and shellfish production                 Aquatic food use
  Hatchery buildings
  Culture ponds, containers
Animals for labor, display, riding, racing,   Indoor
 lab use, etc.
  Dogs
  Horses, donkeys, mules
  Guinea pigs
  Mice
  Rats
  Gerbils
  Hamsters
  Monkeys
  Cats
  Chickens, birds
  Wild rodents
  Alfalfa leafcutting bee (pollinator)
  Alkaline bee (pollinator)
  Zoo ruminants
  Zoo ungulates
  Zoo canines
  Zoo felines
  Zoo primates
  Zoo reptiles
  Zoo amphibians
  Zoo birds
  Zoo--others
  Aquarium fish
Animals for pets, including their cages,
 bedding, nests, etc.
  Dogs
  Cats
  Birds
  Rodents
  Lagomorphs
  Fish
  Amphibians
  Reptiles
  Primates
  Other vertebrates
   6. Agricultural premises and equipment
Egg handling facilities and equipment         Indoor
  Egg washers
  Egg rooms
  Hatching egg treatments
  Hatching egg rooms
  Hatching egg equipment
  Egg packing plants and hatcheries
Milk handling facilities and equipment
  Milk storage rooms
  Milking stalls and parlors
  Milking machines, milk tanks, etc.
  Teat cups, liners, etc.
  Milk processing equipment
                7. Household
Non-food area and sites                       Indoor
  Closets, storage areas
  Basements, cellars
  Bedrooms
  Attics
  Recreation rooms
  Living rooms
  Baseboards, window sills, etc.
  Plumbing fixtures
  Sickrooms
Food-handling and food storage areas
  Kitchens
  Dining rooms
  Pantry and food storage shelving
Household contents and space
  Air
  Beds
  Rugs
  Book cases
  Furs, fabrics, blankets
  Play pens
  Sickroom utensils
  Filters for air vents, air conditioners,
   furnaces, etc.
Outdoor areas (Noncommercial homeowner use)   Domestic outdoor or
                                               terrestrial food crop
  Home garden, orchards
  Porches                                     Domestic outdoor
  Patios
  Foundations
  Steps
  Eaves
  Yards, lawn, turf
  Domestic ornamental plantings
    8. Wood or Wood Structure Protection
                 Treatments
Buildings (for termite, powderdust beetle     Domestic outdoor or indoor
 controls, etc.)
Unseasoned forest products
Seasoned forest products
Finished wood products
Wood pressure treatments
Plant-growing wood structures and containers
Wood containers for nonfood, nonfeed uses
              9. Aquatic sites
Food processing water systems                 Aquatic food crop
Poultry and livestock drinking water
Pulp and papermill systems                    Aquatic noncrop
Swimming pool water
Industrial disposal systems

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Industrial ponds
Human drinking water                          Aquatic food crop
Cooling water towers                          Aquatic noncrop
Agricultural irrigation water, and ditches    Aquatic food crop
Agricultural drainage water and ditches
Sewage systems and drainfields                Aquatic noncrop
Dishwashing water                             Indoor
Domestic and commercial nonpotable water      Aquatic noncrop
Lakes, ponds, impounded water
Streams, rivers, canals
Swamps, marshes, wetlands
Air conditioner water
  Humidifier water
Air washer water systems
Secondary oil recovery injection water
Heat exchange water system
Polluted water
Bait boards (floating--for vertebrate
 control)
Catch basins, puddles, tree holes
Estuaries, tidal marshes
Commercial and sport fish-bearing waters      Aquatic food crop
 10. Noncrop, wide area, and general indoor/
             outdoor treatments
Uncultivated agricultural areas (nonfood      Terrestrial noncrop
 producing)
  Farmyards
  Fuel storage areas
  Fence rows
  Rights-of-way
  Fallow land                                 Terrestrial food crop
  Soil bank land                              Terrestrial noncrop
  Barrier strips
Uncultivated nonagricultural areas (outdoor)
  Airports
Recreation areas, fairgrounds, race tracks,
 tennis courts, etc.
  Campgrounds
  Recreation area structures
  Highway rights-of-way
  Railroad rights-of-way
  Utility rights-of-way
  Sewage disposal areas
Industrial sites (lumberyards, tank farms,
 etc.)
Paved areas
  Private roads and walks
  Fencerows and hedgerows (nonagricultural)
Directed Pest Control to Pests' Nests, etc.,  Terrestrial noncrop or
 and for Traps                                 indoor
  Diseased beehives
  Nuisance bee nests
  Ant mounds, hills, dens
  Termite mounds
  Insect traps (chemical lures)
  Repellents and irritants to pests (when
   not covered by other sites)
Wide area and general indoor/outdoor
 treatments
  Rural areas (unspecified)
  Urban areas (unspecified)
  Public buildings and structures
  Animal burrow entrances, dens, tunnels
  Animal nests
  Animal trails
  Mammal feeding areas
  Nonagricultural areas for public health
   treatments
  Bird roosting, nesting areas
  Bird feeding areas
         11. Antifouling Treatments
Sites for marine exposures                    Aquatic noncrop
  Boat bottoms and other submersed
   structures
    Steel
    Fiberglass
    Aluminum
    Wood
    Plastic
    Other substances and materials
  Crab pots and lobster pots
Sites for fresh water exposures
Cooling tower influent conduits
     12. Commercial and Industrial Uses
Transportation Facilities                     Indoor
  Bus
  Truck and Trailer
  Containerized units
  Railroad cars
  Aircraft
  Ships/barges
  Auto, taxis
  Recreational vehicles
  Shipping containers
Food and feed processing plants
  Bakeries
  Bottlers
  Canneries
  Dairies, creameries, milk processing
   plants
  Feed mills, feed stores
  Fresh fruit packing and processing
  Meat processing
  Poultry processing
  Wineries, wine cellars
  Flour mills, machinery, warehouses, bins,
   elevators
  Egg processing
  Candy and confectionary plants
  Sugar processing, cane mills, etc.
  Cider mills
  Dry food products plants
  Tobacco processing
  Air treatment for processing and
   transportation of foods
  Beverage processing
  Nut processing
  Cereal processing
  Seafood processing
  Vegetable oil processing
  Spice mills
  Vinegar processing
  Farinaceous processing (noodles, etc.)
  Mushroom processing
  Dried fruit processing
  Pickle processing
  Ice plants
  Chocolate processing
  Fruit juice processing
Eating establishments (all)
  Food handling areas
  Food serving areas
  Eating establishment nonfood areas
  Air treatment for eating establishments
  Food storage equipment (coolers,
   refrigerators, etc.)

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  Eating and serving utensils (spoons, etc.)
Food marketing, storage, and distribution
  Food dispensing and vending equipment
  Food stores, markets, stands
  Meat and fish markets
  Food catering facilities
  Food marketing, storage, and distribution
   equipment and utensils
Hospitals and related institutions and
 facilities
  Critical premises (e.g., burn wards, etc.)
  Hospital patient premises (wards,
   emergency rooms, etc.)
  Noncritical premises (labs, lounges,
   lobbies, storage)
  Critical items (hypodermic needles, dental
   instruments, catheters, etc.)
  Noncritical items (bedpans, carpets,
   furniture, etc.)
  Air treatment (also to ambulances)
Janitorial equipment
Barber and beauty shop instruments and
 equipment
Morgues, mortuaries, and funeral homes
  Premises (embalming rooms, etc.)
  Equipment (tables, etc.)
  Instruments
  Burial vaults, mausoleums
  Air treatment
Commercial, institutional, and industrial
Maintenance, Buildings, and Structures
  Locker rooms, equipment
  Gyms, bowling alleys, and equipment
  Telephones and booths
  Shower rooms, mats, and equipment
  Cotton mill premises and equipment
  Auditoriums and stadiums
  Factories
  Rendering plants
  Loading areas, ramps
  School buildings and equipment
  Office buildings
  Laundries
Fuels from Crops (alcohol, methane)
  Fossil fuels (e.g., oils, jet fuel)
  Seed oils
  Paper
Pesticide materials preservation and
 protection
  Rodenticide baits (protection against
   insects)
  Dried plant parts (pyrethrum, red squill,
   rotenone, sabadilla)
  Paints
Preservatives and protectants
  Grains
  Hay, silage
  Adhesives
  Coatings (asphalt and lacquer)
  Fuels
  Leather and leather products
  Leather processing liquors
  Metalworking cutting fluids
  Oil recovery drilling muds and packer
   fluids
  Paints (latex)
  Paper and paper products
  Plastic products
  Resin emulsions
  Rubber (natural) products
  Specialty products (polishes, cleansers,
   dyes, etc.)
  Textiles, textile fibers, and cordage
  Wet-end additives, etc. (pulp sizing,
   alum, casein, printing pastes)
  Disposable diapers
  Wool, hair, mohair, furs, felt, feathers,
   etc.
  Electrical supplies, cables, and equipment
         13. Domestic and Human Use
Human Body and Hair                           Indoor
Fiber product protection (Moth,
    mildew-proofing)
  Clothing
  Upholstery
  Ornamental fabrics (draperies, tapestries)
  Ropes
  Sail cloth
Human articles and materials
  Bedding, blankets, mattresses
  (Treatments to) hair, body, clothing
   (while being worn)
  Clothing
  Face gear (goggles, face masks, etc.)
  Headgear (safety helmets, headphones,
   etc.)
  Wigs
  Contact lenses
  Dentures, toothbrushes, mouthpieces to
   musical instruments, etc.
  Brick, asbestos, etc.
  Wood surfaces
  Leather surfaces
  Fabric surfaces
  Paper/paperboard surfaces
Specialty uses
  Museum collectors (preserved animal and
   plant specimens)
  Military uses--not specified
  Quarantine uses--not specified
  DHHS/FDA uses--not specified
  Filters (air conditioning, air, and
   furnace)
  Biological specimens
  Underground cables
  Cuspidors, spittoons
  Vomitus
  Human wastes
  Air sanitizers
  Diapers
  Laundry equipment (carts, chutes, tables,
   etc.)
  Dust control--products and equipment
   (mops, etc.)
  Dry cleaning
  Carpets
  Upholstery
Bathrooms, toilets bowls, and related sites
  Bathroom premises
  Toilet bowls and urinals
  Toilet tanks
  Portable toilets, chemical toilets

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  Vehicular holding tanks
  Bathroom air treatment
  Diaper pails
Refuse and soild waste
  Refuse and solid waste containers
  Refuse and solid waste transportation and
   handling equipment
  Garbage dumps
  Household trash compactors
  Garbage disposal units, food disposals
  Incinerators
        14. Miscellaneous Indoor Uses
Surface Treatments                            Indoor
  Hard nonporous surfaces (painted, tile,
   plastic, metal, glass, etc.)
  Hard porous surfaces (cement, plaster)
  Camping equipment and gear
  Grooming instruments (brushes, clippers,
   razors, etc.)
Laundry, cleaning, and dry cleaning
------------------------------------------------------------------------