Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3819

2. Registrant Information.

Registrant Reference Number: 2264237

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

4. Date registrant was first informed of the incident.

03-JUL-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEVADA

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)

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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. - In Home / Rés. - à l'int. 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 II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Unknown

Age: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Seizure

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

10

Day(s) / Jour(s)

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

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

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.)

7/3/2018 Product was applied in the home by a pest control operator on 5/25/2018. Product was applied to the baseboards in the home, and caller and family were present in the home during application. They were told they did not need to leave, and that product would dry within 15 minutes. No ventilation was performed during or after application. Caller does not recall any of the children having contact with the treated areas. One of caller's children developed seizures at an unknown time after application. She was taken to the hospital and admitted for 10 days. She is now taking Keppra and Phenobarbital. She is still having seizures. A second of caller's children developed diarrhea four days after the application. The diarrhea persisted, and child was taken to urgent care on 6/29/2018. Caller also mentioned this child also had a rash on the body that developed after the application and then resolved quickly. 7/5/2018 Attempted call back to the original caller. A message was left requesting follow up information.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

This is a reported case of the use of a pyrethroid-class of insecticide in a residential structure. Following application, a x-month-old child, with an unknown medical history, developed repeated seizures requiring in-patient hospitalization for ten days and anti-epileptic medications. There is no clear exposure to the product following application reported during the interview. The mother did not wish to discuss the child's experience or timeline of events further; the onset of the seizure activity following application of the product is not known. There is no scientific evidence to support a contention that use of the product, as formulated, in a home, would result in the neurological effects reported in this case. Accidental skin exposure may result in minimal and self-limiting skin reactions such as a brief numbness / tingling / paresthesia reaction or in some rare instances, skin rashes of an allergic type nature among some sensitive consumers. Ingestion of the product in its finished / ready to apply concentration would not result in neurological effects such as those described, rather self-liming stomach or digestive tract distress (nausea, vomiting) may occur. It is important to note that topically applied medications involving this class of insecticide are used widely on young children to treat head lice at concentrations far greater than this product in its finished form.

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

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Unknown

Age: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Diarrhea

• Skin
  • Symptom - Rash

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

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.)

7/3/2018 Product was applied in the home by a pest control operator on 5/25/2018. Product was applied to the baseboards in the home, and caller and family were present in the home during application. They were told they did not need to leave, and that product would dry within 15 minutes. No ventilation was performed during or after application. Caller does not recall any of the children having contact with the treated areas. One of caller's children developed seizures at an unknown time after application. She was taken to the hospital and admitted for 10 days. She is now taking Keppra and Phenobarbital. She is still having seizures. A second of caller's children developed diarrhea four days after the application. The diarrhea persisted, and child was taken to urgent care on 6/29/2018. Caller also mentioned this child also had a rash on the body that developed after the application and then resolved quickly. 7/5/2018 Attempted call back to the original caller. A message was left requesting follow up information.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

This is a reported case of the use of a pyrethroid-class of insecticide in a residential structure. Following application, a x-month-old child, with an unknown medical history, developed repeated seizures requiring in-patient hospitalization for ten days and anti-epileptic medications. There is no clear exposure to the product following application reported during the interview. The mother did not wish to discuss the child's experience or timeline of events further; the onset of the seizure activity following application of the product is not known. There is no scientific evidence to support a contention that use of the product, as formulated, in a home, would result in the neurological effects reported in this case. Accidental skin exposure may result in minimal and self-limiting skin reactions such as a brief numbness / tingling / paresthesia reaction or in some rare instances, skin rashes of an allergic type nature among some sensitive consumers. Ingestion of the product in i