Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-1466

2. Registrant Information.

Registrant Reference Number: 1351575

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.

20-MAR-14

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

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.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Pub. Area - Indoor/Zone publique - int

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: Male

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

3. List all symptoms, using the selections below.

System

• Blood
  • Symptom - Anemia

• General
  • Symptom - Fatigue

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Other
  • Specify - Hypoplastic Bone Marrow

• Liver
  • Symptom - Elevated liver enzymes
  • Symptom - Hyperbilirubinemia

• General
  • Symptom - Jaundice

• Blood
  • Symptom - Other
  • Specify - Pancytopenia

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?

2

Week(s) / Semaine(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)

None

10. Route(s) of exposure.

Unknown

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.)

3/20/2014 Caller is a toxicologist for a poison control center. A local hospital called and reported they have a (age) year old child with aplastic anemia. They have done a pretty extensive work-up and cannot find a good cause for the aplastic anemia. The child was staying in a local shelter that had been previously treated with this product on 3/1/2014. Child had been staying in the shelter for many months prior. Child was out of the shelter for about 1 hr after treatment was made. Product was applied to cracks and crevices. Patient contact with treated surfaces is speculative. Within 2 to 3 days of the application child became ill with fatigue, vomiting, and apparent jaundice. Child was seen by his primary care doctor at that time. Unspecified lab work done that day in the clinic but he was subsequently admitted to the hospital the following day where he is at present. At the time of admission his aspartate aminotransferase was over 3000, and alanine aminotransferase and total bilirubin were elevated as well. There was also evidence of anemia and pancytopenia. A liver biopsy and bone marrow biopsy have been done, and found to have hypoplastic bone marrow. He has been seen by other specialists as well, and bacterial and vial cultures have all returned negative. Following admission his liver function appears to be improving though there has been no cause determined for the aplastic anemia that he has developed. Caller states she does not think the deltamethrin in the product would cause these signs.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.