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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-0792

2. Registrant Information.

Registrant Reference Number: 1424082

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

Address: 295 Henderson Drive

City: Regina

Prov / State: SK

Country: Canada

Postal Code: S4N 6C2

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

Human

4. Date registrant was first informed of the incident.

15-JUL-14

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

10-JUL-14

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. 29367      PMRA Submission No.       EPA Registration No.

Product Name: TUNDRA HERBICIDE (CANADA)

  • Active Ingredient(s)
    • BROMOXYNIL
    • FENOXAPROP-P-ETHYL (ISOMER)
    • PYRASULFOTOLE

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: Farm

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.

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

  • Gastrointestinal System
    • Symptom - Diarrhea

4. How long did the symptoms last?

Unknown / Inconnu

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

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

Other

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.

Respiratory

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

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

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.)

7/15/2014 Product was sprayed on caller's farm over 3 days 7/11/2014 through 7/13/2014. Caller and his father have been working on the farm. They have not had any direct exposure to the product, but can smell the odor. Caller's father developed diarrhea during the day yesterday, and caller developed diarrhea last night. 7/16/2014 Caller has been unable to go to the doctor. He took an Imodium about 1 hour ago. 7/17/2014 Attempted call back to the original caller. A message was left requesting follow up information. Caller is returning previous message. Caller has not been able to go to the doctor. Father's symptoms have resolved as of yesterday. 7/21/2014 Caller was seen by a doctor on 7/18/2014, and blood work was normal. He was asymptomatic for 2 days, and then diarrhea developed again. They could still smell the odor of the product yesterday.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Diarrhea

4. How long did the symptoms last?

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

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

7. Exposure scenario

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

Other

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.

Respiratory

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

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

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.)

7/15/2014 Product was sprayed on caller's farm over 3 days 7/11/2014 through 7/13/2014. Caller and his father have been working on the farm. They have not had any direct exposure to the product, but can smell the odor. Caller's father developed diarrhea during the day yesterday, and caller developed diarrhea last night. 7/16/2014 Caller has been unable to go to the doctor. He took an Imodium about 1 hour ago. 7/17/2014 Attempted call back to the original caller. A message was left requesting follow up information. Caller is returning previous message. Caller has not been able to go to the doctor. Father's symptoms have resolved as of yesterday. 7/21/2014 Caller was seen by a doctor on 7/18/2014, and blood work was normal. He was asymptomatic for 2 days, and then diarrhea developed again. They could still smell the odor of the product yesterday.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.