Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-3825

2. Registrant Information.

Registrant Reference Number: 3659108

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.

13-JUL-23

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

13-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.       PMRA Submission No.       EPA Registration No. 71995-29

Product Name: ROUNDUP CONCENTRATE PLUS WEED & GRASS KILLER

• Active Ingredient(s)
  • DIQUAT
    • Unknown
  • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

9. Application Rate.

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).

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Cardiovascular System
  • Symptom - Cardiac arrest

• Gastrointestinal System
  • Symptom - Irritated throat
  • Symptom - Nausea
  • Symptom - Vomiting

• General
  • Symptom - Death

• Renal System
  • Symptom - Renal failure

• Gastrointestinal System
  • Symptom - Stomach pain
  • Specify - Stomach irritation

• Nervous and Muscular Systems
  • Symptom - Coma
  • Specify - Medically induced coma

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?

2

Day(s) / Jour(s)

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

Poisoning from ingestion of the pesticide

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

None

10. Route(s) of exposure.

Oral

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 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.)

7/13/2023 Caller is reporting that his neighbor is experiencing vomiting, throat and stomach irritation after ingesting the product. He states his neighbor is having some mental issues this morning and drank approximately 6-7 ounces of the product about 45 minutes ago. Caller states that Emergency Medical Services (EMS) is on the way to the scene for the patient. He states he would like any info we can provide on what to do. Caller disconnected while on hold. Callback to caller. Caller passed phone to Paramedic, who stated he is holding a 35.2 fluid ounce bottle of the product and it feels like approximately 4 ounces plus or minus is missing from the bottle. No additional symptoms other than what is already listed. 7/14/2023 Attempted callback: Left detailed message requesting a callback. Case and callback. numbers also provided. 7/14/2023 Callback from primary caller. The caller reports the patient was admitted to the hospital and is currently on life support in a medically induced coma. Caller stated the patient's heart stopped last night and he was revived but now his kidneys are failing. Caller stated patient was attempting to take his own life and Doctors are unsure if he will survive. 7/18/2023 Attempted callback and spoke with original caller, the patient's neighbor. He states the patient passed away two days after the ingestion. This was the only thing he ingested. He does not know the patient's medical history. Caller states he is away on vacation with his family, and does not have current info. He provided the patient's wife's name and phone number, and stated that we should call her directly.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

The estimated amount of product, reported to have been intentionally ingested, was approximately 4-7 fl. oz. (120-210mL). The product contains 18% ispropylamine salt of glyphosate, 0.73% diquat and a surfactant resulting in a potential ingestion of 37.8 grams and 1.53 grams respectively. The reported signs and symptoms are in line with reports of intentional ingestions of glyphosate containing products and diquat. After ingestions of less than 1 gram of diquat, oral and pharyngeal irritation, nausea and repeated vomiting have been reported. Severe toxicity may develop with ingestions of more than 1 gram resulting in renal impairment, toxicity to all organ systems and death within 24-48 hours. Ingestions of glyphosate/surfactant containing products can cause irritation to the gastric mucosa, nausea, vomiting, and abdominal pain. More serious toxicity can occur in large or deliberate ingestions, most often 200mL, including, pulmonary edema, respiratory failure, ventricular dysrhythmias, and coma. Severe toxicity resulting in death has been related to hypovolemic shock followed by respiratory failure. Additionally, a temporal relationship exists between the time of the reported ingestion and onset of symptoms. It was reported that no other substances were have known to be ingested and while not confirmed with the treating healthcare team all other obvious causes appear to have been ruled out.