Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-6785

2. Registrant Information.

Registrant Reference Number: 3648631

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

Address: 160 Quarry Park Boulevard SE Suite 130

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

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

Human

4. Date registrant was first informed of the incident.

02-JUL-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-JUL-23

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)

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PMRA Registration No. 31896      PMRA Submission No.       EPA Registration No.

Product Name: XTENDIMAX WITH VAPORGRIP TECHNOLOGY

• Active Ingredient(s)
  • DICAMBA (PRESENT AS ACID, AMINE SALT, ESTER, OR SODIUM SALT)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Roundup

• Active Ingredient(s)
  • GLYPHOSATE

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Unknown / Inconnu

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

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

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

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Decreased vision

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Dizziness
  • Symptom - Headache

• Eye
  • Symptom - Double vision

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Soft tissue tumor of pituitary gland

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 h

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

7/2/2023 Caller reports that his son used this product on Friday 06/30/23 and may have gotten it on his hands. He reports his son is not with him at time of call, and he cannot describe how the exposure happened or how the product was used. He reports his son was vomiting yesterday (07/01/23) and feels dizzy, he has a headache, and something is off with his vision. 7/3/2023 Attempted call back. No answer. Left message with reason for call, and case and callback numbers. 7/3/2023 Call back to Caller. He reports his son did not go to the emergency room yesterday. He reports he is feeling better today but he still has double vision. He reports he is getting ready to go to the emergency room right now. Caller agrees to another call back. 7/5/2023 Call back placed. Caller reports the patient was evaluated at the emergency room where a computed tomography scan was done and he was diagnosed with a soft tissue tumor of his pituitary gland. Caller reports it had nothing to do the product and he will be seeing a neurosurgeon to have surgery to remove the tumor. 7/5/2023 Addendum: On call back, the caller also reported that his son was using RoundUp the same day he was using the XTENDIMAX. The product was not available for the caller to provide the EPA or more specific product information.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Company correlation assessment: 1 (Unlikely relationship). Based on the described exposure, possible minor dermal exposure two days prior to onset of symptoms, there is no expected physiologic explanation for the product to cause or other influence the development of a soft tissue tumor on his pituitary gland. Additionally, the reporter stated the tumor was not caused by the product.