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EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION

COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN 

THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: Microbial Pesticides

Branch, Ms. Sheryl Reilly, 703-308-8059.

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In 

cases where the outline element does not apply, please insert “NA-Remove” and 

maintain the outline. Please do not change the margins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert 

company name],” with the information specific to your action.

SUBMISSION: Email the completed template to: hollis.linda@epa.gov.

TEMPLATE:

Bayer CropScience LP

[Insert petition number]

EPA has received a pesticide petition ([insert petition number]) from Bayer 

CropScience LP, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709 

requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act 

(FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180

(Options (pick one)

1. by establishing a tolerance for residues of NA-Remove

2. to establish an exemption from the requirement of a tolerance for

3. to establish an amendment/expansion of an existing tolerance exemption for the

NA-Remove

(Options (pick one)

1. microbial pesticide Streptomyces microflavus, strain AQ 6121

2. biochemical pesticide [insert name of active ingredient] NA-Remove

3. plant-pesticide [insert name of active ingredient] in or on [insert commodity].

NA-Remove
2

Pursuant to section 408(d)(2)(A)(i) of FFDCA, as amended, Bayer CropScience LP has 

submitted the following summary of information, data, and arguments in support of their 

pesticide petition. This summary was prepared by Bayer CropScience LP and EPA has 

not fully evaluated the merits of the pesticide petition. The summary may have been 

edited by EPA if the terminology used was unclear, the summary contained extraneous 

material, or the summary unintentionally made the reader conclude that the findings 

reflected EPA’s position and not the position of the petitioner.

I. Bayer CropScience LP Petition Summary

[Insert petition number]

A. Product Name and Proposed Use Practices

AQ 6121 Technical is the technical grade of the active ingredient/manufacturing use 

product. The end-use product, AQ 6121 75WP is intended for use as a broad spectrum 

miticide for the control of i phytophagous mite pests. AQ 6121 75WP is intended 

primarily for use on a variety of agricultural crops. The end-use product is a 75% a.i. 

wettable powder formulation that is mixed with water and applied as a foliar spray with 

spray equipment commonly used for making ground or aerial applications and 

sprinkler/irrigation systems commonly used for chemigation. It may be used in 

alternating spray programs or in tank mixes with other registered crop protection 

products, up to and including the day of harvest.

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. Streptomyces microflavus, 

strain AQ 6121, including spent fermentation media, is the active ingredient in the 

proposed formulated end-use product AQ 6121 75WP. Streptomyces microflavus 

is a mesophilic, saprophytic bacterium belonging to the genus Streptomyces,

found commonly in soil and decaying vegetation.

2. Magnitude of residues at the time of harvest and method used to determine the 

residue. No significant residues of Streptomyces microflavus, strain AQ 6121are 

expected to occur at the time of harvest. The active ingredient consists of a 

naturally occurring microorganism that has little or no viability in the formulated 

product, the residues of which have been tested in their entirety (both TGAI and 

end product) to establish the absence of toxic or pathogenic effects in mammals at 

levels far in excess of any potential residue at the time of harvest.

3. A statement of why an analytical method of detecting and measuring the levels 

of the pesticide residue are not needed. Bayer CropScience LP is submitting a
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petition requesting that EPA establish an exemption from the requirement of a 

tolerance for the AQ 6121 strain of Streptomyces microflavus, therefore, an 

analytical method for residues is not applicable. It is expected that, when used as 

proposed, AQ 6121 would not result in residues that are of toxicological concern.

C. Mammalian Toxicological Profile

As the results show below, and the submission application clearly indicate, Streptomyces 

microflavus strain AQ 6121, including the natural chemistry responsible for its miticidal 

activity, is not pathogenic, is not cytotoxic, and is not mutagenic. Additionally, the 

standard battery of acute toxicity tests indicate that AQ 6121 Technical and AQ 6121

75WP elicit no significant toxicity concerns in any of the tests conducted. The results of 

the studies indicate there are no significant human health risks.

Studies to evaluate the safety to mammals have been conducted with the AQ 6121

Technical and AQ 6121 75WP, and are summarized as follows:

Guideline Test

Subject

AQ 6121 Technical AQ 6121 75WP

Acute Oral Toxicity

(OCSPP 870.1100)

Rat LD50 > 2,000 mg/kg in

studies with AQ 6121

Technical

LD50 >5,000 mg/kg

in studies with AQ

6121 75WP

Acute Dermal

Toxicity (OCSPP

870.1200)

Rat LD50 limit test result

for AQ 6121 Technical 

was > 5,050 mg/kg.

LD50 limit test result

for AQ 6121 75WP

end product was >

5,050 mg/kg.

Acute Inhalation

Toxicity (OCSPP

870.1300)

Rat LC50 for AQ 6121

Technical was > 5.26 

mg/L

LC50 for AQ 6121

75WP end-use 

product was > 5.26 

mg/L

Primary Eye

Irritation (OCSPP

870.2400)

Rabbit AQ 6121 Technical was 

classified as mildly 

irritating

AQ 6121 75WP 

exhibited no adverse 

positive effects in any 

of the test animals

Primary Dermal

Irritation (OCSPP

870.2500)

Rabbit AQ 6121 Technical nonirritating under the 

conditions of the test.

AQ 6121 75WP nonirritating under the 

conditions of the test.

Dermal

Sensitization

(OCSPP 870.2600)

Mice N/A Non-sensitizer

Acute Injection (IP) 

Toxicity and

Pathogenicity

(OCSPP 885.3200)

Rat Non-toxic to rats when 

administered by IP

injection at a single dose 

of 1.0 x 109 CFU

(colony forming

N/A
4

units)/rat.

Acute Injection (IV) 

Toxicity and 

Pathogenicity 

(OCSPP 885.3200)

Rat Non-toxic to rats when 

injected intravenously at 

a dose of 3.2 x 1010

CFU/mL or 3.2 x 109

CFU/rat and is not 

pathogenic in the 

Sprague-Dawley albino 

rat.

N/A

The results of toxicity testing with AQ 6121 Technical and AQ 6121 75WP support the 

conclusion that the proposed use of the active ingredient Streptomyces microflavus, strain

6121 poses no foreseeable risks to human health. Correspondingly, the Tier 1 

environmental and ecotoxicology tests performed as part of the registration application 

support the contention that the use of this active ingredient poses no foreseeable risks to 

the environment. Due to a lack of residues of toxicological concern neither dietary nor 

non-dietary exposures would be expected to pose any quantifiable risk.

D. Aggregate Exposure

1. Dietary exposure.

i. Food. Dietary exposure from use of Streptomyces microflavus, strain AQ 6121, 

as proposed, is not expected to pose any toxicological concerns. AQ 6121 

is intended for application to agricultural crops to suppress or control 

certain important phytophagous mite pests.

Acute toxicity studies show that Streptomyces microflavus, strain AQ

6121 is not toxic to mammals and support the conclusion that the proposed 

use of AQ 6121 in end-use products poses no foreseeable risks to human 

health or the environment. Dietary exposures would not be expected to 

pose any quantifiable risk due to a lack of residues of toxicological 

concern.

ii. Drinking water. Similarly, exposure to humans from residues of Streptomyces 

microflavus, strain AQ 6121 in consumed drinking water would be 

unlikely. The proposed use pattern will minimize potential exposure to 

surface water, and exposure to drinking water (well or ground water) is 

unlikely to occur. AQ 6121is intended for application to agricultural crops 

and the end-use product is not applied directly to water.

The lack of residues of toxicological concern on treated crops and the 

results of toxicity testing with AQ 6121 Technical and AQ 6121 75WP 

support the conclusion that the proposed use of Streptomyces microflavus, 

strain AQ 6121 poses no foreseeable risks to human health or the
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environment. Drinking water exposures would not be expected to pose any

quantifiable risk due to a lack of residues of toxicological concern. 

Furthermore, although Streptomyces microflavus is a naturally occurring 

microorganism known to exist in terrestrial habitats (soil), it is not likely

to thrive in aquatic environments.

2. Non-dietary exposure. The potential for non-dietary exposure to the general 

population, including infants and children, is unlikely as the proposed use sites are 

agricultural settings. Streptomyces microflavus, strain AQ 6121 is intended for 

application to agricultural crops to control important phytophagous mite pests.

The lack of toxicologically significant residues on treated crops, the results of 

toxicity testing with AQ 6121 Technical and AQ 6121 75WP support the 

conclusion that the proposed use of AQ 6121 poses no foreseeable risks to human 

health or the environment. Non-dietary exposures would not be expected to pose 

any quantifiable risk due to a lack of residues of toxicological concern.

Additionally, Personal Protective Equipment (PPE) mitigates the potential for 

exposure to applicators and handlers of the proposed products, when used in 

agricultural settings.

E. Cumulative Effects

When used as proposed, it is not expected that Streptomyces microflavus, strain AQ 6121

would result in residues that are of toxicological concern. AQ 6121 is intended for 

application to agricultural crops to suppress or control certain important phytophagous 

mite pests.

Based on the results from mammalian toxicity tests with AQ 6121Technical and AQ

6121 75WP there is no indication of mammalian toxicity of Streptomyces microflavus 

strain AQ 6121 and no information to indicate that toxic effects would be cumulative. 

Our current understanding is that Streptomyces microflavus strain AQ 6121 does not

share a common mechanism of toxicity with any other registered substance. Therefore for the 

purposes of this tolerance exemption petition, Bayer CropScience LP requests the 

assumption that Streptomyces microflavus strain AQ 6121 does not have a common 

mechanism of toxicity with other substances and therefore no cumulative effects 

associated with Streptomyces microflavus strain AQ 6121 would be expected.

F. Safety Determination

1. U.S. population. When used as proposed, Streptomyces microflavus, strain AQ

6121 would not result in residues that are of toxicological concern. AQ 6121 is intended 

for application to agricultural crops to control important phytophagous mite pests. The
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lack of toxicologically significant residues on treated crops and the results of toxicity

testing on AQ 6121 Technical and AQ 6121 75WP support the conclusion that the 

proposed use of AQ 6121poses no foreseeable risks to human health or the environment. 

There is a reasonable certainty of no harm to the general US population from exposure to 

this active ingredient.

2. Infants and children. As mentioned above, it is not expected that, when used as 

proposed, Streptomyces microflavus, strain AQ 6121 would result in residues that are of 

toxicological concern. There is a reasonable certainty of no harm for infants and children 

from exposure to AQ 6121from the proposed uses

G. Effects on the Immune and Endocrine Systems

Streptomyces microflavus strain AQ 6121 is a naturally occurring, non-pathogenic 

organism. To date there is no evidence to suggest that Streptomyces microflavus strain 

AQ 6121 will compromise the immune or endocrine systems, or that it functions in a 

manner similar to any known hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

There is no US EPA Tolerance for Streptomyces microflavus strain AQ 6121.

I. International Tolerances

There is no Codex Alimentarius Commission Maximum Residue Level (MRL) for

Streptomyces microflavus strain AQ 6121.

January 25, 2013