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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3826

2. Registrant Information.

Registrant Reference Number: 2979401

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: Suite 130, 160 Quarry Park Boulevard SE

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

12-JUN-21

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

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. 30102      PMRA Submission No.       EPA Registration No.

Product Name: Raxil Pro

  • Active Ingredient(s)
    • METALAXYL
      • Guarantee/concentration 6.2 g/L
    • PROTHIOCONAZOLE
      • Guarantee/concentration 15.4 g/L
    • TEBUCONAZOLE
      • Guarantee/concentration 3 g/L

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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: treated barley

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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Angus

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

1100.00

lbs

8. Route(s) of exposure

Unknown

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
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Recumbent
  • General
    • Symptom - Weakness
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

specify Presumed ingestion of product

17. Provide any additional details about the incident

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

On 12-Jun-2021 an animal owner reported that their beef cows may have ingested treated barley from a bin over the prior 2-3 days. The barley was sprayed with Raxil Pro on 05-Jun-2021. One of the cows (known as 130) developed lethargy and ataxia the morning of 11-Jun-2021. The owner gave the cow a dose of penicillin the evening of 11-Jun-2021 but the morning of 12-Jun-2021 the cow's condition worsened and was unable to stand or walk. Four other cows were anorexic the morning of 12-Jun-2021 but otherwise appeared normal. Given the progressive signs reported for cow 130, veterinary evaluation was recommended. On 16-Jun-2021 the owner reported that 130 died on 13-Jun-2021 after becoming progressively more weak and lethargic. The owner gave the cow a dose of meloxicam just prior to death. Veterinary evaluation did not occur. No further information was received in this case.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The fungicides in this product are present in low concentration and carry a wide margin of safety in mammals following acute ingestion. General GI upset may occur but severe signs including ataxia and death are not anticipated. The ingestion of product was not witnessed and no evaluation was performed by a veterinarian. The signs reported in this case are consistent with grain overload due to acute ingestion of a large amount of the barley and should be considered as a possible cause of death. No necropsy was performed so the cause of death in this case is ultimately unknown.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Mixed Breed

4. Number of animals affected

4

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Accidental ingestion/Ingestion accident.

specify Presumed ingestion of product

17. Provide any additional details about the incident

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

On 12-Jun-2021 an animal owner reported that their beef cows may have ingested treated barley from a bin over the prior 2-3 days. The barley was sprayed with Raxil Pro on 05-Jun-2021. One of the cows (known as 130) developed lethargy and ataxia the morning of 11-Jun-2021. The owner gave the cow a dose of penicillin the evening of 11-Jun-2021 but the morning of 12-Jun-2021 the cow's condition worsened and was unable to stand or walk. Four other cows were anorexic the morning of 12-Jun-2021 but otherwise appeared normal. Given the progressive signs reported for cow 130, veterinary evaluation was recommended. On 16-Jun-2021 the owner reported that 130 died on 13-Jun-2021 after becoming progressively more weak and lethargic. The owner gave the cow a dose of meloxicam just prior to death. Veterinary evaluation did not occur. No further information was received in this case.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The fungicides in this product are present in low concentration and carry a wide margin of safety in mammals following acute ingestion. General GI upset may occur. Anorexia is a fairly non-specific sign in cows with a large number of potential causes. Ingestion was not witnessed in this case and veterinary evaluation did not occur after signs began. Another more likely cause is grain overload due to acute ingestion of a large amount of the barley, but without further information the cause of signs in this case is ultimately unknown.