Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-7143

2. Registrant Information.

Registrant Reference Number: 3174082

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.

18-JAN-22

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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: Round Up

• Active Ingredient(s)
  • GLYPHOSATE
    • Unknown

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7. b) Type of formulation.

Liquid

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: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Other
  • Specify - Diabetes
  • Symptom - Cancer
  • Specify - Mycosa Fungoides Lymphoma

• Skin
  • Symptom - Lesion

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

Non-occupational

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

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

Other

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.)

1/18/2022 All of the following was spontaneously reported by the caller. Caller does not have product with her but identified it as Round Up. Caller stated back in 2000 she was diagnosed with Mycosa Fungoides Lymphoma. Her doctors stated it was from Round up. Caller saw an add in a magazine that Round up causes this. She talked with someone here a year ago, and she stated someone was supposed to follow up with her and access her medical records, and no one did that. Caller stated she used the Round Up every 2 weeks and she would use about a gallon of it each time. She last used the Round Up 3 years ago. Caller stated the cancer is on her right side and she has sores. Caller stated she was also diagnosed with Diabetes after she used the Round Up. Caller would like someone to reach back out to her regarding this. 2/16/2022 Call back from consumer. Caller stated she is trying to reach someone regarding her getting cancer from the Round Up and she has not been successful. Caller stated she has left a lot of messages, and she has never gotten a call back.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Company causality score: 1 (unlikely relationship). As the reporter did not identify a specific product alleged to have caused the exposure, Bayer has chosen to report this exposure using the product in this report using the information it had available, including reported use and market share. This selection may not be accurate due to the lack of information provided by the reporter. While a loose temporal relationship exists between the use of the product and diagnosis an exposure to the product is not known and it is unclear if and how she was being exposed to the product. The Pest Management Regulatory Agency (PMRA) concluded that glyphosate is not likely to be carcinogenic to humans.