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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5127

2. Registrant Information.

Registrant Reference Number: 1820721

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.

Human

Domestic Animal

4. Date registrant was first informed of the incident.

12-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: IOWA

6. Date incident was first observed.

12-MAY-16

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. 264-1066

Product Name: Bayer Corvus Herbicide

  • Active Ingredient(s)
    • ISOXAFLUTOLE
      • Guarantee/concentration 19 %
    • THIENCARBAZONE-METHYL

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

Product Name: Nitrogen

  • Active Ingredient(s)

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: Field adjacent to caller's property

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 II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Female

Age: >12 <=19 yrs / >12 <=19 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Respiratory irritation
    • Symptom - Shortness of breath
    • Symptom - Pulmonary edema

4. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Unknown

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

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

Drift from the application site

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.

Unknown

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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.)

5/12/2016 Caller's neighbor applied products on the field next to caller's property on 5/7/2016. Caller has a chicken coop next to that field. The day after application, some of the chickens began showing signs of difficulty breathing. Ten chickens died the morning after application, and 2 more died that evening. Caller found 2 more dead chickens the following morning. Caller went to the veterinarian to discuss chickens symptoms, and caller was sent home with Albon to administer to the chickens' water. Caller has lost a total of 23 chickens. Caller also states that a few of their dogs were running in a pasture near the field while products were being applied. The dogs may have been lethargic this week. The 2 dogs vomited the evening after application, and a large amount of grass and dog food was found in the vomitus. Caller saw 1 dog having a seizure this morning, which lasted 5 minutes before the dog recovered. The dog is still at home and has not been examined by the veterinarian. Caller realized today that the animals' water had been outside during application, and changed the water today. Caller also reports that chores were done after the product was sprayed, but did not indicate if this occurred on the day of application or the day after. Caller's daughter has asthma, and has had respiratory irritation since the day of application. Daughter has been using a nebulizer, inhaler, and taking Prednisone. Daughter complained that it is difficult to breath today. 5/13/2016 Call back to the original caller. Caller took 10 dead chickens for necropsy today and approximately 20 more were put down. Caller's daughter is doing okay, but her lungs fill with fluid at night and caller has to give her a nebulizer treatment. The family cat was also found today after laying in the weeds for a couple of days. The cat is refusing food, and they intend to take cat to the veterinarian. The dog is no longer seizing. 5/17/2016 Call back to the original caller. The cat was brought to the veterinarian on 5/13/2016. The cat was at the clinic for 3 hours and was given subcutaneous fluids, Convenia injection, Cerenia subcutaneous, and sent home. The cat is much better, but not back to normal. The dogs were bathed at home and are back to normal. The dogs were not treated by a veterinarian. A pesticide reporter has been at the home today taking pictures, samples, and getting affidavits from the neighbor.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.50

7. Weight (provide a range if necessary )

53.00

lbs

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Seizure

12. How long did the symptoms last?

<=30 min / <=30 min

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

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

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

5/12/2016 Caller's neighbor applied products on the field next to caller's property on 5/7/2016. Caller has a chicken coop next to that field. The day after application, some of the chickens began showing signs of difficulty breathing. Ten chickens died the morning after application, and 2 more died that evening. Caller found 2 more dead chickens the following morning. Caller went to the veterinarian to discuss chickens symptoms, and caller was sent home with Albon to administer to the chickens' water. Caller has lost a total of 23 chickens. Caller also states that a few of their dogs were running in a pasture near the field while products were being applied. The dogs may have been lethargic this week. The 2 dogs vomited the evening after application, and a large amount of grass and dog food was found in the vomitus. Caller saw 1 dog having a seizure this morning, which lasted 5 minutes before the dog recovered. The dog is still at home and has not been examined by the veterinarian. Caller realized today that the animals' water had been outside during application, and changed the water today. Caller also reports that chores were done after the product was sprayed, but did not indicate if this occurred on the day of application or the day after. Caller's daughter has asthma, and has had respiratory irritation since the day of application. Daughter has been using a nebulizer, inhaler, and taking Prednisone. Daughter complained that it is difficult to breath today. 5/13/2016 Call back to the original caller. Caller took 10 dead chickens for necropsy today and approximately 20 more were put down. Caller's daughter is doing okay, but her lungs fill with fluid at night and caller has to give her a nebulizer treatment. The family cat was also found today after laying in the weeds for a couple of days. The cat is refusing food, and they intend to take cat to the veterinarian. The dog is no longer seizing. 5/17/2016 Call back to the original caller. The cat was brought to the veterinarian on 5/13/2016. The cat was at the clinic for 3 hours and was given subcutaneous fluids, Convenia injection, Cerenia subcutaneous, and sent home. The cat is much better, but not back to normal. The dogs were bathed at home and are back to normal. The dogs were not treated by a veterinarian. A pesticide reporter has been at the home today taking pictures, samples, and getting affidavits from the neighbor.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Bird / Oiseau

3. Breed

Chicken

4. Number of animals affected

23

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Respiratory irritation

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?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

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

5/12/2016 Caller's neighbor applied products on the field next to caller's property on 5/7/2016. Caller has a chicken coop next to that field. The day after application, some of the chickens began showing signs of difficulty breathing. Ten chickens died the morning after application, and 2 more died that evening. Caller found 2 more dead chickens the following morning. Caller went to the veterinarian to discuss chickens symptoms, and caller was sent home with Albon to administer to the chickens' water. Caller has lost a total of 23 chickens. Caller also states that a few of their dogs were running in a pasture near the field while products were being applied. The dogs may have been lethargic this week. The 2 dogs vomited the evening after application, and a large amount of grass and dog food was found in the vomitus. Caller saw 1 dog having a seizure this morning, which lasted 5 minutes before the dog recovered. The dog is still at home and has not been examined by the veterinarian. Caller realized today that the animals' water had been outside during application, and changed the water today. Caller also reports that chores were done after the product was sprayed, but did not indicate if this occurred on the day of application or the day after. Caller's daughter has asthma, and has had respiratory irritation since the day of application. Daughter has been using a nebulizer, inhaler, and taking Prednisone. Daughter complained that it is difficult to breath today. 5/13/2016 Call back to the original caller. Caller took 10 dead chickens for necropsy today and approximately 20 more were put down. Caller's daughter is doing okay, but her lungs fill with fluid at night and caller has to give her a nebulizer treatment. The family cat was also found today after laying in the weeds for a couple of days. The cat is refusing food, and they intend to take cat to the veterinarian. The dog is no longer seizing. 5/17/2016 Call back to the original caller. The cat was brought to the veterinarian on 5/13/2016. The cat was at the clinic for 3 hours and was given subcutaneous fluids, Convenia injection, Cerenia subcutaneous, and sent home. The cat is much better, but not back to normal. The dogs were bathed at home and are back to normal. The dogs were not treated by a veterinarian. A pesticide reporter has been at the home today taking pictures, samples, and getting affidavits from the neighbor.


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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

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

Unknown

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

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

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

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

5/12/2016 Caller's neighbor applied products on the field next to caller's property on 5/7/2016. Caller has a chicken coop next to that field. The day after application, some of the chickens began showing signs of difficulty breathing. Ten chickens died the morning after application, and 2 more died that evening. Caller found 2 more dead chickens the following morning. Caller went to the veterinarian to discuss chickens symptoms, and caller was sent home with Albon to administer to the chickens' water. Caller has lost a total of 23 chickens. Caller also states that a few of their dogs were running in a pasture near the field while products were being applied. The dogs may have been lethargic this week. The 2 dogs vomited the evening after application, and a large amount of grass and dog food was found in the vomitus. Caller saw 1 dog having a seizure this morning, which lasted 5 minutes before the dog recovered. The dog is still at home and has not been examined by the veterinarian. Caller realized today that the animals' water had been outside during application, and changed the water today. Caller also reports that chores were done after the product was sprayed, but did not indicate if this occurred on the day of application or the day after. Caller's daughter has asthma, and has had respiratory irritation since the day of application. Daughter has been using a nebulizer, inhaler, and taking Prednisone. Daughter complained that it is difficult to breath today. 5/13/2016 Call back to the original caller. Caller took 10 dead chickens for necropsy today and approximately 20 more were put down. Caller's daughter is doing okay, but her lungs fill with fluid at night and caller has to give her a nebulizer treatment. The family cat was also found today after laying in the weeds for a couple of days. The cat is refusing food, and they intend to take cat to the veterinarian. The dog is no longer seizing. 5/17/2016 Call back to the original caller. The cat was brought to the veterinarian on 5/13/2016. The cat was at the clinic for 3 hours and was given subcutaneous fluids, Convenia injection, Cerenia subcutaneous, and sent home. The cat is much better, but not back to normal. The dogs were bathed at home and are back to normal. The dogs were not treated by a veterinarian. A pesticide reporter has been at the home today taking pictures, samples, and getting affidavits from the neighbor.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

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?

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.

Yes

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?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

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

5/12/2016 Caller's neighbor applied products on the field next to caller's property on 5/7/2016. Caller has a chicken coop next to that field. The day after application, some of the chickens began showing signs of difficulty breathing. Ten chickens died the morning after application, and 2 more died that evening. Caller found 2 more dead chickens the following morning. Caller went to the veterinarian to discuss chickens symptoms, and caller was sent home with Albon to administer to the chickens' water. Caller has lost a total of 23 chickens. Caller also states that a few of their dogs were running in a pasture near the field while products were being applied. The dogs may have been lethargic this week. The 2 dogs vomited the evening after application, and a large amount of grass and dog food was found in the vomitus. Caller saw 1 dog having a seizure this morning, which lasted 5 minutes before the dog recovered. The dog is still at home and has not been examined by the veterinarian. Caller realized today that the animals' water had been outside during application, and changed the water today. Caller also reports that chores were done after the product was sprayed, but did not indicate if this occurred on the day of application or the day after. Caller's daughter has asthma, and has had respiratory irritation since the day of application. Daughter has been using a nebulizer, inhaler, and taking Prednisone. Daughter complained that it is difficult to breath today. 5/13/2016 Call back to the original caller. Caller took 10 dead chickens for necropsy today and approximately 20 more were put down. Caller's daughter is doing okay, but her lungs fill with fluid at night and caller has to give her a nebulizer treatment. The family cat was also found today after laying in the weeds for a couple of days. The cat is refusing food, and they intend to take cat to the veterinarian. The dog is no longer seizing. 5/17/2016 Call back to the original caller. The cat was brought to the veterinarian on 5/13/2016. The cat was at the clinic for 3 hours and was given subcutaneous fluids, Convenia injection, Cerenia subcutaneous, and sent home. The cat is much better, but not back to normal. The dogs were bathed at home and are back to normal. The dogs were not treated by a veterinarian. A pesticide reporter has been at the home today taking pictures, samples, and getting affidavits from the neighbor.


To be determined by Registrant

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

Minor

19. Provide supplemental information here