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The 4/1999 and 6/1999 submission to the Environmental Protection Agency (EPA) by Agraquest of "new active ingredient" (QST713 - bacillus subtilis) only received a "CONDITIONAL TIME-LIMITED REGISTRATION from the EPA on 6/20/2000


Agraquest's submission to the EPA in 1999 of "new active ingredient" (QST713 - bacillus subtilis) AND in support of their pesticide petition

Agraquest's  4/26/1999 submission,"EPA has received a pesticide petition 8F5032 from AgraQuest, Inc., 1105 Kennedy Place, Davis, California 95616, proposing 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 to establish an exemption from the requirement of a tolerance for the microbial pesticide Bacillus subtilis QST 713 strain in or on all raw agricultural commodities (RAC).

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, AgraQuest, Inc. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by AgraQuest, Inc. 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 theposition of the petitioner."

Agraquest's 6/16/1999 submission, "2. File Symbol: 69592-L. Applicant: Agraquest Inc., 1105 KennedyPlace, Davis, CA 95616. Product Name: QST 713 Technical. Microbial Fungicide. Active ingredient: QST 713 strain of dried Bacillus subtilis at 5%. Proposed classification/Use: None. For use in manufacturing or formulating end-use products to control various fungal plant pathogens and terrestrial use.

**Agraquest only received a "CONDITIONAL TIME-LIMITED REGISTRATION [view 4 page form→HERE ] from the EPA on 6/20/2000 (Janet L. Anderson, Ph.D, Director - Biopesticides and Pollutions Preventon Division) as the EPA themselves found fault....

Listed on the above June 20, 2000 "Conditional Time-Limited" Registration for QST 713 Technical:

•The submitted manufacturing processed did not have sufficient quality control fermentation batches.

Data required

Data for the 12 month storage stability of the end-use product has not been submitted.

•Additional data described in the December 12, 1999 review and March 8 2000 letter are required to upgrade submitted process, MRID# 44519-04 to acceptable.  This includes:

•1) A formal submission that clearly describes new quality control steps taken to assure the consistent CFU/g values and limit microbial impurities in the Technical Powder.

•2) A 5 batch analysis of Technical Powder produced from cell cultures with latest QC.

•3)   Raw data for the above mentioned 5 batch analyses.

Ecological Effects Data Required

A 21 day Freshwater Aquatic Invertebrate Study must be performed.  Attenuated and filter sterilized controls should be used in the test. Test lab should attempt to determine cause of death and whether pathogenicity involved.

•[Shrimp] Required due to report of disease in terrestrial amphipod crustacean associated with B. subtilis infection. Protocol must be submitted before initiating study.

•QST Technical was shown to cause mortality to parasitic Hymenoptera.  MRID 44619-14 is graded supplemental. Potential pathogenicity was not investigated.

•[HONEY BEE] All test concentrations showed treatment related mortality. MRID 4456519-17 is supplemental due to the short test duration and the lack of a determination as to whether mortality was due to toxicity only or whether pathogenicity contributed.

PLEASE NOTE:  The submissions of April , 1999 and  June , 1999 by Agraquest to the EPA were one of the products, [QST Technical wettable powder] that “Research Technician / Assistant Researcher” had transferred from LARGE drums into 24 pound bags for shipment.  He was told "it was safe" and didn't wear a respirator.

Last Updated on Monday, 28 October 2013 01:13  

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