Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4535

2. Registrant Information.

Registrant Reference Number: AEINBX_04

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.

03-AUG-23

5. Location of incident.

Country: UNITED STATES

Prov / State: COLORADO

6. Date incident was first observed.

Unknown

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Roundup (Unspecified)

• Active Ingredient(s)
  • GLYPHOSATE
    • Unknown

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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: Res. - Out Home / Rés - à l'ext.maison

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

Please see detailed case information.

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

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Cancer

4. How long did the symptoms last?

>6 mos / > 6 mois

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

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

Caller contacted Bayer Corporation (United States) and stated the following: They are making contact regarding Round-up settlements, and looking for settlement for thyroid cancer. They began using Round-up on his lawn about 4 to 5 years ago and was diagnosed with thyroid cancer nearly 2 years ago. He had surgery to remove 1/2 of his thyroid and will have to take medications for the rest of life. He knows the allegations of the settlements deal with non-Hodgkin's lymphoma, but he states seeing studies that show links round-up use to increase in thyroid cancer.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Glyphosate has a wide margin of safety in humans and is not known to be a cause of cancers in humans. Glyphosate has been recognized by the PMRA as not presenting a carcinogenic risk to humans.