Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4993

2. Registrant Information.

Registrant Reference Number: 3619178

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-JUN-23

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-JUN-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. 28198      PMRA Submission No.       EPA Registration No.

Product Name: ROUNDUP TRANSORB HC LIQUID HERBICIDE

• Active Ingredient(s)
  • GLYPHOSATE (PRESENT AS POTASSIUM SALT)

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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.

Data Subject

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Conjunctivitis

• General
  • Symptom - Edema

• Eye
  • Symptom - Red eye
  • Symptom - Swollen eye

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?

No

6. b) For how long?

7. Exposure scenario

Unknown

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

Application

Other

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

Goggles

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 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.)

6/2/2023 Caller asked if an ocular exposure to the product could cause an eye infection. Caller reports that on 01-Jun-23 at 3:00 pm EDT he was spraying the product outside (dilution rate unknown). The caller reports he was wearing goggles while using the product and did not recall any direct exposure to it. He reports that later that day he went for a swim and afterward, around 9:00 pm EDT his left eye became red and swollen. He reports he flushed the eye with eye wash solution for a few seconds. He reports his symptoms remained ongoing by the next morning. 6/5/2023 Attempted callback, and spoke with the caller. He reports his eye is sort of better. He reports that he does not think it was the product, and again denies an eye exposure. He reports he did not go to the emergency room, but he saw his daughter who is a doctor. He reports he was diagnosed with pink eye, cause unknown, and was given eye drops.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The delayed symptoms reported are not expected from a possible minor unknown product exposure. Minor irritation can occur with direct eye contact but irritation appearing hours later would not be expected. Caller did not report a known eye exposure to the product and was diagnosed with pink eye.