"One" of the Agraquest Products that the injured/ill Assistant Researcher was exposed to was QST 713 Bacillus Subtilis Technical. This was the Seven Hundred Thirteenth microorganisms that Agraquest "screened". This bacterium was also discovered in a peach orchard by Agraquest scientist, Sherry Heins.
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 (Janet L. Anderson, Ph.D, Director - Biopesticides and Pollutions Prevention Division) as the EPA themselves found fault.... Storage Stability, Manufacturing Process - toxicity/pathogenicity to; Freshwater Fish, Freshwater aquatic invertebrate, paleomonetes vulgaris (shrimp) and HONEY BEES.
Alarming reasons were questions to cause of death in Freshwater Aquatic Invertebrate, question of Bacillus Subtilis infection in shrimp, questions of death to "HONEY BEES" and Agraquest DID NOT meet guideline requirements in their submission (studies) on the toxicity and pathogenicity to "FRESH WATER FISH".
[See the four (4) page EPA form here→ June 20, 2000 "Conditional Time-Limited" Registration for QST 713 Technical]
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 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 28, 1999 and June 19, 1999 by Agraquest to the EPA were one of the products, [QST Technical wettable powder] which the injured/ill Assistant Researcher was instructed to transferred, from LARGE drums, to 24 pound bags for shipment. He was told "it was safe" and "it wouldn't hurt a fly". He didn't wear a respirator.