[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR158.740]



[Page 118-129]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 158_DATA REQUIREMENTS FOR REGISTRATION--Table of Contents

 

                    Subpart D_Data Requirement Tables

 

Sec.  158.740  Microbial pesticides--Product analysis data requirements.



    (a) Microbial pesticides product analysis data requirements--(1) 

Table. Sections 158.50 and 158.100 through 158.102 describe how to use 

this table to determine the microbial pesticides--product analysis data 

requirements and the substance to be tested.



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

                                                                                    General use patterns                                                    Test substance

                                          ------------------------------------------------------------------------------------------------------------------------------------------- Guidelines

     Kind of data required      (2) Notes        Terrestrial               Aquatic              Greenhouse                                                                             reference

                                          ----------------------------------------------------------------------  Forestry   Domestic    Indoor    Data to support   Data to support      No.

                                            Food crop    Nonfood    Food crop    Nonfood   Food crop   Nonfood               outdoor                     MP                EP

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

Product identity manufacturing  .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP..............  EP*.............      151-20

 process.

                                      (i)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-21

Discussion of formation of           (ii)  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-22

 unintentional ingredients.

Analysis of samples...........      (iii)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       MP and TGAI.....  EP* and TGAI....      151-23

Certification of limits.......  .........  [R]         R           [R]         R           [R]        R          R          R          R          MP..............  EP*.............      151-25

Analytical methods............  .........  R           R           R           R           R          R          R          R          R          MP..............  EP*.............      151-25

Physical and chemical           .........  [R]         [R]         [R]         [R]         [R]        [R]        [R]        [R]        [R]        MP and TGAI.....  EP* and TGAI....      151-26

 properties.

Submittal of samples..........       (iv)  [CR]        [CR]        [CR]        [CR]        [CR]       [CR]       [CR]       [CR]       [CR]       MP and TGAI, PAI  EP* TGAI and PAI      151-27

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

Key: R=Required; CR=Conditionally required; MP=Manufacturing-use product: EP*=End-use product (asterisk identifies those data requirements that end-use applicants (i.e., ``formulators'') must

  satisfy, provided that their active ingredient(s) is (are) purchased from a registered source); TGAI=Technical grade of the active ingredient; [ ]=Brackets (i.e., [R], [CR]) indicate data

  requirements that apply when an experimental use permit is being sought.

(2) Notes. The following notes are referenced in column two of the table contained in paragraph (a)(1) of this section.

(i) If an experimental use permit is being sought, a schematic diagram and/or description of the manufacturing process will suffice if the pesticide is not already under scale production.



[[Page 119]]





(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.



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

                                                                                    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



[[Page 120]]





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

(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.



[[Page 121]]





(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.

    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.



[[Page 122]]





    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.

 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.



[[Page 123]]





 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 124]]



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

                                  Index



How to use this Index:

    1. Identify the Pesticide Use Site Group listed below (e.g., 

agricultural crops, forests, ornamental plants) that covers the specific 

use pattern of interest to you.

    2. Find your specific use pattern under the appropriate Pesticide 

Use Site Group.

    3. Identify the general use pattern that corresponds to your 

specific use pattern.

    4. Use the general use pattern in determining applicable data 

requirements on the Data Requirements tables presented in 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

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