Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5623

2. Registrant Information.

Registrant Reference Number: 3698255

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

Domestic Animal

4. Date registrant was first informed of the incident.

24-AUG-23

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

27-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. 34095      PMRA Submission No.       EPA Registration No. 264-1207

Product Name: Delaro Complete

• Active Ingredient(s)
  • FLUOPYRAM
  • PROTHIOCONAZOLE
    • Unknown
  • TRIFLOXYSTROBIN (CGA 279202)
    • 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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Field

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

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Metallic taste in the mouth

• Gastrointestinal System
  • Symptom - Retching

• General
  • Symptom - Diaphoresis
  • Symptom - Weakness

• Nervous and Muscular Systems
  • Symptom - Headache
  • Symptom - Other
  • Specify - Feeling total body paralysis

• General
  • Symptom - Lightheadedness

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Seizure-like activity
  • Symptom - Other
  • Specify - Stroke-like symptoms

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?

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)

Contact with treated area

What was the activity? Walked through his barn and the treated field, and touched his livestock which were sprayed.

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.

Skin

Oral

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

8/24/2023 Consumer calling to report stroke like symptoms, seizure like activity, metallic taste, sweating, headaches, weakness, severe light headedness, dry heaving, and feeling total body paralysis after possible exposure to Delaro complete. Caller reports that on 7/27, there was a plane that passed over his barn and fields about three times spraying this product (however it was intended to have been sprayed on the fields of the neighboring farm). Consumer stated he was not directly sprayed, however he did go out to the barn shortly after this and he said he could smell the product and sort of taste the product when he went out into the field. He stated the barn is relatively open and that he thinks some of the spray did get into the barn, and was also sprayed directly onto some of his livestock. Consumer stated that he went out into the field and handled his livestock shortly after the exposure, so a dermal exposure could be possible. Consumer stated that a couple of days after the possible exposure, around 7/30, he developed severe headaches, weakness, and a metallic taste in his mouth. He state that he tried ibuprofen and acetaminophen to treat headaches but this didn't help. He stated the metallic taste is still ongoing and is intermittent. He stated that on 8/12 was in the barn cleaning and started profusely sweating. He stated he went to get some water and became severely lightheaded, was dry heaving, and he said he barely made it to the house where he then sat on the porch swing. He reports developing a severe headache after 15 minutes of sitting, at which point ems was called. He stated he had total body paralysis and seizure like activity before emergency medical services arrived. He reports it was not overly hot that day, he thinks it was in the low 80s and he was in and out of the barn working prior to the event. Consumer stated he was admitted to the hospital 8/12, was discharged late on 8/14.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Incident narrative, continued: Consumer stated he was diagnosed with stroke like symptoms and seizure like activity but no definitive cause was identified by the doctors. He said during his hospitalization he had an intravenous catheter placed, but could not recall what treatments were given to him. He did state that he had an electroencephalogram that was abnormal and that he was discharged with a seizure medication to take as needed but he has not needed to take any. He reports he has an appointment with his family doctor today and is scheduled to have a 48-hour electroencephalogram next month. He said he did tell the doctors near the end of his hospitalization that he had been exposed to something on July 27th but he didn't have the specific information on what the product was. He said the doctors did not mention anything about this exposure being the cause of his symptoms. Caller also reports one of his herd of cattle died post exposure, and the rest had unspecified symptoms. 8/24/2023 Left message with consumer to callback to follow up with cattle symptoms and details of exposure. 8/25/2023 Attempted callback to follow up with cattle symptoms and details of exposure. Left voice message for with reason for calling, asked caller to contact us at provided number and reference case number to provide information. Company correlation assessment: 1 (Unlikely relationship). No known direct exposure occurred to the product. If he was exposed dermally to the product while working with the livestock it was not a noticeable amount. Symptoms did not occur until three days after application of the product. The symptoms reported are not expected given the ingredients in the product, the described exposure and the onset of symptoms three days later. All other differential diagnoses have not been ruled out and symptoms have not improved upon removal from the product.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Spray drift / Dérive de pulvérisation

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

8/24/2023 Consumer calling to report stroke like symptoms, seizure like activity, metallic taste, sweating, headaches, weakness, severe lightheadedness, dry heaving, and feeling total body paralysis after possible exposure to Delaro complete. Caller reports that on 7/27 there was a plane that passed over his barn and fields about three times spraying this product (however it was intended to have been sprayed on the fields of the neighboring farm). Consumer stated he was not directly sprayed, however he did go out to the barn shortly after this and he said he could smell the product and sort of taste the product when he went out into the field. He stated the barn is relatively open and that he thinks some of the spray did get into the barn, and was also sprayed directly onto some of his livestock. Consumer stated that he went out into the field and handled his livestock shortly after the exposure, so a dermal exposure could be possible. Consumer stated that a couple of days after the possible exposure, around 7/30, he developed severe headaches, weakness, and a metallic taste in his mouth. He state that he tried ibuprofen and acetaminophen to treat headaches but this didn't help. He stated the metallic taste is still ongoing and is intermittent. He stated that on 8/12 was in the barn cleaning and started profusely sweating. He stated he went to get some water and became severely lightheaded, was dry heaving, and he said he barely made it to the house where he then sat on the porch swing. He reports developing a severe headache after 15 minutes of sitting, at which point ems was called. He stated he had total body paralysis and seizure like activity before emergency medical services arrived. He reports it was not overly hot that day, he thinks it was in the low 80s and he was in and out of the barn working prior to the event. Consumer stated he was admitted to the hospital 8/12, was discharged late on 8/14.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Incident narrative, continued: Caller also reported one of his herd of cattle died post exposure, and the rest had unspecified symptoms. 8/24/2023 Left message with consumer to callback to follow up with cattle symptoms and details of exposure. 8/25/2023 Attempted callback to follow up with cattle symptoms and details of exposure. Left voice message for with reason for calling, asked caller to contact us at provided number and reference case number to provide information. Company correlation assessment: 0 (Unlikely relationship). Very limited information was provided in this case regarding the deaths of some of the cows on this farm. It was not specified how long after exposure the cows died or if any clinical signs were observed prior to death. However, the three fungicidal active ingredients in the product are all considered to have a low order of toxicity in mammals. Significant clinical signs are not expected following acute exposure.