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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-3395

2. Registrant Information.

Registrant Reference Number: SC1006899

Registrant Name (Full Legal Name no abbreviations): Dow AgroSciences Canada Inc.

Address: 450-1st Street SW, Suite 2100

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2P 5H1

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

Human

Domestic Animal

4. Date registrant was first informed of the incident.

13-JUL-12

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

13-JUL-12

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. 28551      PMRA Submission No.       EPA Registration No.

Product Name: Restore A Herbicide

  • Active Ingredient(s)
    • AMINOPYRALID

PMRA Registration No. 28552      PMRA Submission No.       EPA Registration No.

Product Name: Restore B Herbicide

  • Active Ingredient(s)
    • 2,4-D (PRESENT AS AMINE SALTS : DIMETHYLAMINE SALT, DIETHANOLAMINE SALT, OR OTHER AMINE SALTS)

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?

Unknown

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

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Malaise
  • Nervous and Muscular Systems
    • Symptom - Headache

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.

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Occupational

8. How did exposure occur? (Select all that apply)

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.

Skin

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 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.)

The caller stated that County employees came out to their property the morning of Friday, July 13, 2012 to spray diluted Restore Herbicide for weed control primarily for tall buttercup (a noxious weed in AB, which can be toxic to livestock). The County was enforcing the Provincial Weed Control Act. The caller alleged that the County staff were not doing targeted spraying but general over-spray over wide swatches of the property. The caller, her husband and daughter were all outside at the time trying to get them to stop spraying. Apparently, their daughter had been exposed to some of the airborne spray during the application. About 4-5 hours later, the daughter developed a headache, vomiting and general malaise. She was taken to a local ER where she was prescribed an antihistamine. She apparently gradually recovered over the following 3 days. The caller and her husband reported developing general malaise during the 3-days following this incident although the caller was unable to describe how they were exposed to the herbicide other than their reentry to areas they feel were exposed to the herbicide spray. Also, 5 quarter horses were reported to have developed labored breathing since the incident occurred. These horses were within a barn during the herbicide application so it is unclear how the horses would have been exposed to the airborne spray. These horses have received a veterinary evaluation and where prescribed an unspecified medication. The owner does not know what the veterinarian thought was the cause for this illness. The caller denies that it could be related to tall buttercup ingestion because they know how dangerous tall buttercup can be to their horses so they try to keep the horses away from these areas.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. The signs and symptoms reported in the human subjects are not consistent with the toxicological profile of these herbicides even had dermal exposure occurred. The only well defined exposure occurred with the daughter, however, her symptoms were delayed in onset and did not involve the development of dermatological symptoms such as rash.

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

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Malaise

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.

Unknown

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Occupational

8. How did exposure occur? (Select all that apply)

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?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

The caller stated that County employees came out to their property the morning of Friday, July 13, 2012 to spray diluted Restore Herbicide for weed control primarily for tall buttercup (a noxious weed in AB, which can be toxic to livestock). The County was enforcing the Provincial Weed Control Act. The caller alleged that the County staff were not doing targeted spraying but general over-spray over wide swatches of the property. The caller, her husband and daughter were all outside at the time trying to get them to stop spraying. Apparently, their daughter had been exposed to some of the airborne spray during the application. About 4-5 hours later, the daughter developed a headache, vomiting and general malaise. She was taken to a local ER where she was prescribed an antihistamine. She apparently gradually recovered over the following 3 days. The caller and her husband reported developing general malaise during the 3-days following this incident although the caller was unable to describe how they were exposed to the herbicide other than their reentry to areas they feel were exposed to the herbicide spray. Also, 5 quarter horses were reported to have developed labored breathing since the incident occurred. These horses were within a barn during the herbicide application so it is unclear how the horses would have been exposed to the airborne spray. These horses have received a veterinary evaluation and where prescribed an unspecified medication. The owner does not know what the veterinarian thought was the cause for this illness. The caller denies that it could be related to tall buttercup ingestion because they know how dangerous tall buttercup can be to their horses so they try to keep the horses away from these areas.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. The signs and symptoms reported in the human subjects are not consistent with the toxicological profile of these herbicides even had dermal exposure occurred. The only well defined exposure occurred with the daughter, however, her symptoms were delayed in onset and did not involve the development of dermatological symptoms such as rash.

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: Male

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

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Malaise

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.

Unknown

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Occupational

8. How did exposure occur? (Select all that apply)

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?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

The caller stated that County employees came out to their property the morning of Friday, July 13, 2012 to spray diluted Restore Herbicide for weed control primarily for tall buttercup (a noxious weed in AB, which can be toxic to livestock). The County was enforcing the Provincial Weed Control Act. The caller alleged that the County staff were not doing targeted spraying but general over-spray over wide swatches of the property. The caller, her husband and daughter were all outside at the time trying to get them to stop spraying. Apparently, their daughter had been exposed to some of the airborne spray during the application. About 4-5 hours later, the daughter developed a headache, vomiting and general malaise. She was taken to a local ER where she was prescribed an antihistamine. She apparently gradually recovered over the following 3 days. The caller and her husband reported developing general malaise during the 3-days following this incident although the caller was unable to describe how they were exposed to the herbicide other than their reentry to areas they feel were exposed to the herbicide spray. Also, 5 quarter horses were reported to have developed labored breathing since the incident occurred. These horses were within a barn during the herbicide application so it is unclear how the horses would have been exposed to the airborne spray. These horses have received a veterinary evaluation and where prescribed an unspecified medication. The owner does not know what the veterinarian thought was the cause for this illness. The caller denies that it could be related to tall buttercup ingestion because they know how dangerous tall buttercup can be to their horses so they try to keep the horses away from these areas.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. The signs and symptoms reported in the human subjects are not consistent with the toxicological profile of these herbicides even had dermal exposure occurred. The only well defined exposure occurred with the daughter, however, her symptoms were delayed in onset and did not involve the development of dermatological symptoms such as rash.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Horse / Cheval

3. Breed

Quarter Horses

4. Number of animals affected

5

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

Respiratory

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Respiratory System
    • Symptom - Laboured breathing

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?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Other / Autre

17. Provide any additional details about the incident

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

The caller stated that County employees came out to their property the morning of Friday, July 13, 2012 to spray diluted Restore Herbicide for weed control primarily for tall buttercup (a noxious weed in AB, which can be toxic to livestock). The County was enforcing the Provincial Weed Control Act. The caller alleged that the County staff were not doing targeted spraying but general over-spray over wide swatches of the property. The caller, her husband and daughter were all outside at the time trying to get them to stop spraying. Apparently, their daughter had been exposed to some of the airborne spray during the application. About 4-5 hours later, the daughter developed a headache, vomiting and general malaise. She was taken to a local ER where she was prescribed an antihistamine. She apparently gradually recovered over the following 3 days. The caller and her husband reported developing general malaise during the 3-days following this incident although the caller was unable to describe how they were exposed to the herbicide other than their reentry to areas they feel were exposed to the herbicide spray. Also, 5 quarter horses were reported to have developed labored breathing since the incident occurred. These horses were within a barn during the herbicide application so it is unclear how the horses would have been exposed to the airborne spray. These horses have received a veterinary evaluation and where prescribed an unspecified medication. The owner does not know what the veterinarian thought was the cause for this illness. The caller denies that it could be related to tall buttercup ingestion because they know how dangerous tall buttercup can be to their horses so they try to keep the horses away from these areas.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. Given that the horses were not outside of the barn during the application, there is no apparent exposure via the respiratory route which would potentially explain the development of respiratory symptoms.