CFR / Title 40 / Part 158 / Sec. 158.2150 Microbial pesticides nontarget organisms and environmental

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. Aquatic uses include: food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food and food), Indoor (food and nonfood), and Industrial.

(c) Key. R=Required; CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; All=All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:

(d) Table. The following table shows the data requirements for microbial pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.

Table--Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Use Patterns

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

Aquatic Terrestrial

Guideline Number Data Requirement --------------------------------------------------------------------------------------------------------------------------------------------------- Test Substance Test Notes

Residential Greenhouse Indoor

Food/Feed Nonfood Food/Feed/Nonfood Forestry ------------------------------------------------------ Industrial

Outdoor Food/Nonfood Food/Nonfood----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Tier I----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4050 Avian oral R R R R R CR CR CR TGAI 1, 2

toxicity----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4100 Avian inhalation CR CR CR CR CR CR CR CR TGAI 1, 2, 3

toxicity/

pathogenicity----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4150 Wild mammal CR CR CR CR CR NR NR CR TGAI 1, 4

toxicity/

invertebrate

toxicity/

fish testing

Estuarine and

marine

invertebrate

testing.----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4300 Nontarget plant CR CR CR R CR NR CR CR TEP 1, 7

testing..........----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4340 Nontarget insect R R R R R CR NR CR TGAI 1, 8

testing----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4380 Honey bee testing R R R R R CR NR CR TGAI 1----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Tier II----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.5200 Terrestrial CR CR CR CR CR NR NR CR TGAI or TEP 9

environmental

885.5300 Freshwater CR CR CR CR CR NR NR CR TGAI or TEP 10

environmental

estuarine

environmental

expression tests----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Tier III----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4600 Avian chronic CR CR CR CR CR NR NR CR TGAI 12, 13

pathogenicity

and reproduction

invertebrate

range testing----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4700 Fish life cycle CR CR CR CR CR NR NR CR TGAI 12, 14

studies----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------885.4750 Aquatic ecosystem CR CR CR CR CR NR NR CR TGAI 15

test----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Tier IV----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------850.2500 Field testing for CR CR CR CR CR NR NR CR TGAI or TEP 11, 16850.1950...................... terrestrial

wildlife and

Field testing

for aquatic

organisms----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------850.2500 Simulated or CR CR CR CR CR NR NR CR TEP 16, 17, 20

actual field

tests (birds,

mammals)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------850.1950 Simulated or CR CR CR CR CR NR NR CR TEP 16, 18, 19, 20

actual field

test (aquatic

organisms)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------850.2500 Simulated or CR CR CR CR CR NR NR CR TEP 16, 18, 19, 20

actual field

tests (insect

predators,

parasites)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------850.3040 Simulated or CR CR CR CR CR NR NR CR TEP 16, 18, 19, 20

actual field

tests (insect

pollinators)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------850.4300 Simulated or CR CR CR CR CR NR NR CR TEP 16, 18, 19, 20

actual field

tests (plants)----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

(e) Test notes. The following test notes are applicable to the data requirements for microbial pesticides nontarget organism and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.

1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors.

2. The preferred species for the avian oral study is either the upland game or waterfowl. The preferred species for the avian inhalation toxicity/pathogenicity study and the avian chronic toxicity/pathogenicity study is the upland game. There is also the option to test the passerine if there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish species are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrate testing is also required.

3. Data required when the nature of the microbial pesticide and/or its toxins indicates potential pathogenicity to birds.

4. Required on a case-by-case basis if results of tests required by Sec. 158.2140 are inadequate or inappropriate for assessment of hazards to wild mammals.

5. Required when there will be significant exposure to aquatic organisms (fish and invertebrates).

6. Required if the product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of expected use or mobility pattern.

7. Required if the microbial pesticide is taxonomically related to a known plant pathogen.

8. Data are not required unless an active microbial ingredient controls the target insect pest by a mechanism of infectivity; i.e., may create an epizootic condition in nontarget insects.

9. Required if toxic or pathogenic effects are observed in one or more of the following tests for microbial pesticides:

i. Avian acute oral or avian inhalation studies.

ii. Wild mammal studies.

iii. Nontarget plant studies (terrestrial).

iv. Honey bee studies.

v. Nontarget insect studies.

10. Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents:

i. Freshwater fish studies.

ii. Freshwater invertebrate studies.

iii. Nontarget plant studies (aquatic).

11. Required if product is applied on land or in fresh water or marine/estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pesticides:

i. Estuarine and marine animal toxicity and pathogenicity.

ii. Plant studies - estuarine or marine species.

12. An appropriate dose-response toxicity test is required when toxic effects on nontarget terrestrial wildlife or aquatic organisms (including plants) are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the microbial agent to the affected nontarget terrestrial wildlife or aquatic organisms. The protocols for these tests may have to be modified in accordance with results from the nontarget organism and environmental expression studies.

13. Required when one or more of the following are present:

i. Pathogenic effects are observed in Tier I avian studies.

ii. Tier II environmental expression testing indicate that long-term exposure of terrestrial animals is likely.

14. Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenicity or infectivity was observed in Tier I aquatic studies.

15. Required if, after an analysis of the microbial pesticide's ability to survive and multiply in the environment and what ecological habitat it would occupy, the intended use patterns, and the results of previous nontarget organisms and environmental expression tests, it is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments. Testing is to determine if applications of the microbial pest control would be expected to disrupt the balance of populations in the target ecosystem.

16. Tier IV studies may be conducted as a condition of registration as post-registration monitoring if the potential for unreasonable adverse effects appears to be minimal during that period of use due to implementation of mitigation measures.

17. Required when both of the following conditions occur:

i. Pathogenic effects observed at actual or expected field residue exposure levels are reported in Tier III; and

ii. The Agency determines that quarantine methods would not prevent the microbial pesticide from contaminating areas adjacent to the test area.

18. Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of available laboratory data, use patterns, and exposure rates.

19. Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and growth of natural populations are observed) are required if laboratory data indicate that adverse long-term, cumulative, or life-cycle effects may result from intended use.

20. Since test standards would be developed on a case-by-case basis, consultation with the Agency and development of a protocol is advised before performing these Tier IV studies.