Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4823

2. Registrant Information.

Registrant Reference Number: 2035915

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

Address: 160 QUARRY PARK BLVD. SE Suite 200

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.

09-MAY-17

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

09-APR-17

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. 432-763

Product Name: Suspend SC

• Active Ingredient(s)
  • DELTAMETHRIN
    • Guarantee/concentration 4.75 %

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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: Res. - Out Home / Rés - à l'ext.maison

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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

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?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Muscle weakness
  • Symptom - Seizure

• Renal System
  • Symptom - Other
  • Specify - Grey Spots on Kidneys Discovered on Necropsy
  • Symptom - Urinary incontinence

12. How long did the symptoms last?

Persisted until death

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

Yes

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?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

5/9/2017 Caller is company representative who was notified of an animal death from a pest control company that had recently applied product to an apartment complex in April 2017. There was also mention of a dog owned by a neighbor that became ill as well. According to the pest control company, their records indicate that the product was diluted at 0.5 ounce to 1 gallon of water. 5/12/2017 Conference call with pest control operator and the cat owner. According to the pest control company, the product was diluted according to directions. The same product was applied at the apartment complex outdoors in cracks and crevices. Foliage and plant matter was not sprayed. Applications of approximately 1 gallon of the diluted product have been applied several times to the apartment complex. Applications at the same concentrations occurred in November 2016, January 2017, and February 2017. There were no reported adverse events following these applications. An application was also made most recently on April 19, 2017. Following the application on April 19, 2017, three of the six pets in the apartment complex developed symptoms. It is unclear the exact time frame from application to symptoms onset, but this was at least 2 days after product application. According to the cat owner, all of the animals involved experienced loss of muscle control and vomiting. Cat owner noted a seizure like event in his cat and inappropriate urination. One of the two dogs owned by a neighbor also had blood in vomit. Cat owner gave an activated charcoal tablet at home and bathed the cat with baby shampoo. The cat was seen by the emergency veterinarian where several unspecified lab tests were performed in addition to x-ray and ultrasound. Nothing unusual or out of normal limits was seen with these tests. The cat reportedly recovered within 2 to 3 days. The cause of the cats reported symptoms was not known. Upon returning home, the cat was let out on the patio again and seen laying down. The previously reported symptoms recurred, and was the cat was taken back to the veterinarian for further care, though did not survive. It is not known what tests or treatments the cat received with this second visit. A necropsy was performed by the veterinarian, and grey spots were found on the kidneys. It is not clear as to the significance of these pathological findings, and the owner did not know what the reported cause of death was following the necropsy. The owner did report though that veterinarian attributed the urination to this kidney abnormality that was subsequently found. Cat owner also has a second cat that never developed any symptoms. Two dogs owned by neighbors of the cat owner were reportedly seen by a veterinarian, and following unknown treatments fully recovered in a day or two.

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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

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Unknown

4. Number of animals affected

2

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 - Bloody vomit

• Nervous and Muscular Systems
  • Symptom - Muscle weakness

12. How long did the symptoms last?

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

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

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

5/9/2017 Caller is company representative who was notified of an animal death from a pest control company that had recently applied product to an apartment complex in April 2017. There was also mention of a dog owned by a neighbor that became ill as well. According to the pest control company, their records indicate that the product was diluted at 0.5 ounce to 1 gallon of water. 5/12/2017 Conference call with pest control operator and the cat owner. According to the pest control company, the product was diluted according to directions. The same product was applied at the apartment complex outdoors in cracks and crevices. Foliage and plant matter was not sprayed. Applications of approximately 1 gallon of the diluted product have been applied several times to the apartment complex. Applications at the same concentrations occurred in November 2016, January 2017, and February 2017. There were no reported adverse events following these applications. An application was also made most recently on April 19, 2017. Following the application on April 19, 2017, three of the six pets in the apartment complex developed symptoms. It is unclear the exact time frame from application to symptoms onset, but this was at least 2 days after product application. According to the cat owner, all of the animals involved experienced loss of muscle control and vomiting. Cat owner noted a seizure like event in his cat and inappropriate urination. One of the two dogs owned by a neighbor also had blood in vomit. Cat owner gave an activated charcoal tablet at home and bathed the cat with baby shampoo. The cat was seen by the emergency veterinarian where several unspecified lab tests were performed in addition to x-ray and ultrasound. Nothing unusual or out of normal limits was seen with these tests. The cat reportedly recovered within 2 to 3 days. The cause of the cats reported symptoms was not known. Upon returning home, the cat was let out on the patio again and seen laying down. The previously reported symptoms recurred, and was the cat was taken back to the veterinarian for further care, though did not survive. It is not known what tests or treatments the cat received with this second visit. A necropsy was performed by the veterinarian, and grey spots were found on the kidneys. It is not clear as to the significance of these pathological findings, and the owner did not know what the reported cause of death was following the necropsy. The owner did report though that veterinarian attributed the urination to this kidney abnormality that was subsequently found. Cat owner also has a second cat that never developed any symptoms. Two dogs owned by neighbors of the cat owner were reportedly seen by a veterinarian, and following unknown treatments fully recovered in a day or two.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here