Document ID: EPA-HQ-OPP-2013-0253-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-07-19T04:00Z

i

 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

                               

 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

        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 non-
 irritating under the conditions of the test.
 AQ 6121 75WP non-
 irritating 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

 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

             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

 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