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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0057

2. Registrant Information.

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

3. Select the appropriate subform(s) for the incident.

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No. 30509      PMRA Submission No.       EPA Registration No.

Product Name: Luna Privilege

  • Active Ingredient(s)
    • FLUOPYRAM

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform VII: Scientific Study

1. Study Reference

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

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

Increased health or environmental risk

4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)

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).

5. a) Was the study discontinued before completion?

No

5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

For Registrant use only

7. Provide supplemental information here

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.