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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-3972
2. Registrant Information.
Registrant Reference Number: 20150625
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: Suite 200, 160 Quarry Park Blvd 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.
Active(s)PMRA Registration No. PMRA Submission No. EPA Registration No. 264-856
Product Name: Iodosulfuron 10 WDG
- Active Ingredient(s)
- IODOSULFURON-METHYL-SODIUM
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 Algal growth inhibition - Pseudokirchneriella subcapitata AEF115008 Water dispersible granule; 10 %.
Date 27-MAR-00
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)
BCS is submitting new information to PMRA related to Iodosulfuron-methyl-sodium (IMS). This information is not necessarily a new adverse effect of the subject chemical, but is rather new information submitted for the Agencys own review and evaluation because the data meet the Agencys administrative reporting criteria. The relevance of these formulation studies to the aquatic risk assessment has a high degree of uncertainty, as IMS has no labeled aquatic use patterns. It is important to note that formulation-based studies do not accurately represent aquatic exposure and toxicity compared to aquatic estimated environmental concentrations that include runoff. Formulations do not runoff as intact components, and comparison of percent active ingredient endpoints derived from the formulation studies may overestimate risk in these cases. The overly conservative approach of comparing endpoints based on percent active ingredient derived from formulations to estimated environmental concentrations calculated on runoff can however offer some insights when considering potential relative risk.
5. a) Was the study discontinued before completion?
No
