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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0058

2. Registrant Information.

Registrant Reference Number: M-688441-01-1

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.

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 Vegetative Vigour 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 vegetative vigour studies performed in accordance with OECD 227 and US EPA OCSPP 850.4150 guidelines evaluated the impacts of exposure to 0.45 lb ai/A Fluopyram SC 400 and Fluopyram SC 500, respectively, on six dicotyledonous and four monocotyledonous species: 25% threshold on plants, terrestrial 1. M-688441-01-1 (Fluopyram SC400 formulation): The study reports a statistically significant deviation from the control that is greater than 25% for oilseed rape. This observation triggered a Tier II study, which concluded no effects greater than 25% or statistically significant deviations from the control for exposures up to 0.45 lb ai/A (see M-755295-01-1, box 7). 2. M-688439-01-1 (Fluopyram SC500 formulation): The study reports a statistically significant deviation from the control that is greater than 25% for ryegrass, onion, and oat. These observations triggered a Tier II study which concluded no statistically significant deviations from the control for exposures at 0.45 lb ai/A (see M-696933-02-1, 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): The submitted Tier I studies triggered the following Tier II studies which confirmed no deviations from the control for the ten species tested at exposures of 0.45 lb ai/A (500g ai/ha). 1. Ripperger, D. 2020; M-755295-01-1 (Fluopyram 400SC): This tier II vegetative vigour study was performed in accordance with OECD 227 and US EPA OCSPP 850.4150 guidelines and in response to the observed 25% deviation from control shoot dry weight in the Tier I study for oilseed rape (Ripperger, D. 2020; M-688441-01-1). In addition to oilseed rape this tier II study tested onion which had a statistically significant deviation from the control shoot dry weight of 23.5% in the tier I study. This tier II study reported no deviations from the control greater than 25% or statistically significant deviations from the control observations at application rates of 0.45 lb ai/A. 2. Ripperger, D. 2020; M-696933-02-1 (Fluopyram 500SC): This tier II vegetative vigour study was performed in accordance with OECD 227 and US EPA OCSPP 850.4150 guidelines and in response to the observed 25% deviation from control in the Tier I study for ryegrass, onion, and oat (Ripperger, D. 2020; M-688439-01-1). This tier II study reported no deviations from the control greater than 25% or statistically significant deviations from the control observations at application rates of 0.45 lb ai/A. Fluopyram 400SC: This formulation is not registered by the PMRA.