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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2450

2. Registrant Information.

Registrant Reference Number: 182492

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

Address: Suite 100, 3131 114 Avenue SE

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2Z 3X2

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

Human

4. Date registrant was first informed of the incident.

02-MAR-09

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-MAR-09

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. 28952      PMRA Submission No.       EPA Registration No.

Product Name: Spirotetramat Technical

  • Active Ingredient(s)
    • SPIROTETRAMAT

7. b) Type of formulation.

Other (specify)

TC

Application Information

8. Product was applied?

No

9. Application Rate.

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

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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.

Data Subject

2. Demographic information of data subject

Sex: Unknown

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Rash
    • Symptom - Red skin

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?

Unknown

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)

Unknown

10. Route(s) of exposure.

Skin

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.)

On 2 March 2009, Bayer CropScience Region Americas Industrial Operations Group received information regarding possible spirotetramat dermal sensitization cases at the BCS production plant in (city), (country), where spirotetramat technical grade active ingredient is produced. Spirotetramat technical was shown to be positive for dermal sensitization in regulatory studies in the guinea pig and mouse. In 2004 during the development of spirotetramat, cases of type 4 skin sensitization were seen and proven by patch testing in two R+D personnel who frequently handled technical active ingredient. These findings were included in the registration dossier submitted in 2006 for joint review by AGES, PMRA and US EPA. No additional sensitization cases have been reported by any R+D or field personnel. In 2008 the (city) plant produced spirotetramat in a campaign ending in September. Late in 2008 several workers in the production plant complained about skin symptoms suggestive of a type 4 allergy. Eight possible cases of allergic reactions were identified. Symptoms in all cases involved reddening or rashes on the face and sometimes also on the wrists. Cyclohexanone and epoxy resin, two other known sensitizers, were also in the plant. Since workers involved in the production of spirotetramat could have been exposed to multiple sensitizers, testing is in place for a standard allergy test panel including the other substances as well as spirotetramat.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

One individual with a known tendency to develop allergies has undergone patch testing, and sensitization to spirotetramat was confirmed. BCS has encouraged the remaining workers to undergo the allergy test, but under local labor agreements in (country) having the test is strictly voluntary. Two workers have refused testing; five cases remain open. Any additional test results will be reported if workers voluntarily agree to undergo the allergy tests.