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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-1213

2. Registrant Information.

Registrant Reference Number: M-782653-01-1

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: Suite 200, 160 Quarry Park Boulevard SE

City: CALGARY

Prov / State: AB

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. 19204      PMRA Submission No.       EPA Registration No.

Product Name: Phenmedipham TC

• Active Ingredient(s)
  • PHENMEDIPHAM

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 Raphidocelis subcapitata growth inhibition test with Phenmedipham TC

Date 14-DEC-21

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)

The average growth rate 72 hour ErC50, LOErC, and NOErC, based on geometric mean measured values, were determined as: ErC50=16.8 ug a.s./L, LOErC=2.25 ug a.s./L, and NOErC=0.563 ug a.s./L. The average yield 72 hour EyC50, LOEyC, and NOEyC, based on geometric mean measured values, were determined as: EyC50=5.19 ug a.s./L, LOEyC=2.25 ug a.s./L, and NOEyC=0.563 ug a.s./L. The area under the growth curve for 72 hour EbC50, LOEbC, and NOEbC, based on geometric mean measured values, were determined as: EbC50=5.61 ug a.s./L, LOEbC=2.25 ug a.s./L, and NOEbC=0.563 ug a.s./L. This appears to be lower than the current acute green algae LC50 value that is considered in the risk assessment, thus would meet the criteria for adverse effects reporting [Bruns, E.; (2011) Pseudokirchneriella subcapitata Growth Inhibition Test with Phenmedipham.; MRID 49682517]

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

Phenmedipham is moderately toxic to freshwater organisms on an acute exposure basis. Therefore, it is unlikely the new green algal data would change the current aquatic risk assessment.