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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0895

2. Registrant Information.

Registrant Reference Number: 1050457

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.

01-OCT-12

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 432-763

Product Name: Suspend SC

  • Active Ingredient(s)
    • DELTAMETHRIN
      • Guarantee/concentration 4.75 %

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

Product Name: Gentrol IGR (non-company product)

  • Active Ingredient(s)

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

Product Name: Nyguard IGR B & G (non-company product)

  • Active Ingredient(s)

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

Product Name: Glue Boards (non-company product)

  • Active Ingredient(s)

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

Product Name: BP-100 (non-company product)

  • Active Ingredient(s)

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: 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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Reproductive System
    • Symptom - Premature birth

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?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

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

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.)

A professional pest control operator contacted Bayer CropScience on October 1, 2012 to report that he was informed of incident on Sept 7, 2012 from a customer who had a premature birth of a child an an unspecified time after March 19, the last day the customer's home was treated by a pesticide. Reports that initial treatment of the woman's apartment was done on 14FEB2012 at which time Suspend SC was used in typical crack / crevasse application manner. The woman was not home at the time of the application and it is not clear how long after application was done that reentry was made. They were called back to the residence for re-treatment on 25FEB2012 whereby BP 100 and Nyguard were applied also in typical crack / crevasse application manner. Also noted that woman was not home at the time of application and it is believed that they had learned of the woman's pregnancy status between the 14FEB and 25FEB 2012 treatments. A 3rd re-treatment was done 19MARCH2012 with BP-100 and Gentrol and again the woman was not home at the time of treatment. He does not have further details of the woman (name, demographics, etc), prenatal medical status, etc. No other details of the reported "pre-mature birth" are similarly not known.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.