Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-0740

2. Registrant Information.

Registrant Reference Number: 3184727

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.

31-JAN-22

5. Location of incident.

Country: UNITED STATES

Prov / State: ARKANSAS

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)

---

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

Product Name: Round-up non specific

• Active Ingredient(s)
  • GLYPHOSATE

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 264-829

Product Name: Ignite 280 SL Herbicide

• Active Ingredient(s)
  • GLUFOSINATE AMMONIUM
    • Unknown

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

9. Application Rate.

Unknown

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).

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

• Cardiovascular System
  • Symptom - Arrhythmia
  • Symptom - Hypertension

• Gastrointestinal System
  • Symptom - Weight loss

• General
  • Symptom - Death
  • Symptom - Cancer

• Blood
  • Symptom - Other
  • Specify - Septic Shock

• General
  • Symptom - Pain

• Renal System
  • Symptom - Renal failure

• Respiratory System
  • Symptom - Respiratory failure
  • Symptom - Pneumonia

• Cardiovascular System
  • Symptom - Other
  • Specify - Rapid ventricular response

4. How long did the symptoms last?

Persisted until death

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

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?

>1 yr / > 1 an

12. Time between exposure and onset of symptoms.

>6 mos / > 6 mois

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.)

1/31/2022 Caller's husband died on 12/4/2021. The cause of death on the death certificate was metastatic colon cancer, chronic respiratory failure, atrial fibrillation with rapid ventricular response, and septic shock. Her husband worked as a farm worker for 25 to 30 years. Caller believes he used Round-up because she also worked at the farm during harvest and saw the product there. He told her often that he had done spraying at work when they talked about his day. Caller found a container of Ignite 280 in their garage, but could not confirm if her husband ever used it or not. He saw his doctor in July 2021 for a regular check up. Prior to that appointment he was healthy other than Type 2 diabetes. He only took medication for diabetes. After that appointment he had several other doctor appointments and was prescribed more medications. He had new medication for high blood pressure, inhalers, pain medication, and several other medications that she does not know what for. He was diagnosed with colon cancer but he did not tell her at the time. In September or October 2021 she went with him to his doctor appointment because he was in so much pain and had been losing weight. She asked the doctor why he wasn't doing anything for his pain, and the doctor asked her husband if he had told her about his diagnosis. He said he had not, and the doctor told her he had bone and other cancers and the cancer was too advanced to treat. Her husband was hospitalized in late November 2021 due to his pain. While in the hospital he developed pneumonia and kidney failure. He remained in the hospital until he died on 12/4/2021. He quit smoking about one year prior to his death. She does not have information on tests or treatments he received for the cancer. She has not spoken with his doctor as to what might have cause the cancers.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

While no known exposure occurred to either product, the patient may have been exposed to an unspecified Round-Up product at work over the years and Ignite 280 SL was found in the patient's home. Neither product is expected to cause cancer when used as directed or with acute inadvertent exposures that may occur while using the product at work or at home. Other differential diagnoses, such as his history of smoking, have not been ruled out and should be considered. Further product information would be necessary for a more thorough assessment.