New incident report
Incident Report Number: 2022-0057
Registrant Reference Number: M-688445-01-1
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: Suite 200, 160 Quarry Park Blvd S.E.
City: Calgary
Prov / State: Alberta
Country: Canada
Postal Code: T2C 3G3
Scientific Study
PMRA Registration No. 30509 PMRA Submission No. EPA Registration No.
Product Name: Luna Privilege
Unknown
Unknown
Title Fluopyram SC 400 g/L:Effects on the Seedling Emergence and Seedling Growth of Ten Non-Target Terrestrial Plant Species under Greenhouse Conditions (Tier 1)
Date 03-JUL-20
No
Increased health or environmental risk
Two tier I seedling emergence and seedling growth test were performed in compliance with OECD guideline 208 and US EPA OCSPP 850.4100: 25% threshold on plants, terrestrial 1. M-688445-01-1 (Fluopyram SC400 formulation): Six dicotyledonous and 4 monocotyledonous species were tested at a rate of 0.45 lb ai/A. Statistically significant deviations from the control were reported for two species and a non-statistically significant deviation of 25% relative to controls was reported for a single species. Additional submitted studies provide definitive ER25 endpoints and NOERs for these species (see M-468973-01-1, box 7). 2. M-688440-01-1 (Fluopyram SC500 formulation): Six dicotyledonous and 4 monocotyledonous species were tested at a rate of 0.45 lb ai/A. Statistically significant deviations from the control 25% were reported for some monocot and dicot species. These deviations were not observed in previously submitted studies (MRIDs 47372349 and 48934301; PMRA # 1599591) or the triggered additional testing following a Tier II dose response study design (see M-696931-01-1, box 7).
No
Supplemental studies submitted to complete the NTTP database (DACO 9.8.6): 1. Ripperger, D. 2020; M-696931-01-1 (Fluopyram 500SC): The study was triggered based on statistically significant deviations from the control greater than 25% reported in a Tier I seedling emergence and seedling growth test with the Fluopyram SC500 formulation (Ripperger, D. 2020; M-688440-01-1). This study reports ER25 values 0.45 lb ai/A for all monocot and dicot species tested. The NOER is 0.45 lb ai/A for all species tested with the exception of sugarbeet for which the study reports a NOER of 0.056 lb ai/A. This Tier II study confirms the ER25s for species tested in this study are greater than the maximum registered broad acre application rate (0.45 lb ai/A). 2. Koehler, P. 2013; M-468973-01-1 (Fluopyram 400SC): Six dicotyledonous and 4 monocotyledonous species were tested at a rate of 0.223 lb ai/A and no statistically significant deviations, or deviations 25%, relative to the control were reported. This study is being submitted to provide a definitive endpoint following reported d statistically significant deviations from the controls in recently performed Tier I seedling emergence and seedling growth tests performed at a higher rate of 0.45 lb ai/A (Ripperger, D. 2020; M-688445-01-1 and Ripperger, D. 2020; M-688440-01-1). The Fluopyram SC400 formulation is not registered by the PMRA.