Print | Need Larger Text?

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0867

2. Registrant Information.

Registrant Reference Number: 112911

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.

Scientific Study

4. Date registrant was first informed of the incident.

5. Location of incident.

6. Date incident was first observed.

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.

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 264-746

Product Name: Baythroid

• Active Ingredient(s)
  • CYFLUTHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

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 VII: Scientific Study

1. Study Reference

Title Assessment of Pubertal Development and Thyroid Function in Juvenile/Peripubertal Male and Female Rats

Date 27-JUN-11

2. a) Is an extension needed to translate the document?

No

3. Type of incident identified in the study

Increased health or environmental risk

4. Describe the incident identified in the study (e.g. study demonstrates an increased risk to non-Hodgkin's Lymphoma after exposure to pesticide X)

Pursuant to the Agencys interpretation of requirements imposed on registrants by way of Section 6(a)(2) of FIFRA, Bayer CropScience LP (BCS), is conservatively submitting studies whose effects are potentially deemed reportable adverse effects associated with Cyfluthrin as per guidance offered by the EPA in 75 FR 70566-70567, and in correspondence as per their letter dated July 15, 2011. With the submission of the studies to PMRA, and concurrently a list of studies to OPPs 6(a)(2) Document Processing Office, BCS believes it has completed its reporting obligations in response to its understanding of PMRAs interpretation of Incident Reporting Regulation and EPAs interpretation of FIFRA 6(a)(2) requirements for EDSP screening assays and 40 C.F.R. 159.158(a) and 40 C.F.R. 159.195(a). This notice does not necessarily reflect a new adverse effect of the subject chemical, but may meet the criteria identified in 40 CFR 159.165(a) and 40 CFR 159.158(a).The Tier 1 EDSP test battery is intended for screening purposes only and should not be used for endocrine classification or risk assessment. Results of the Tier 1 screening battery, along with other scientifically relevant information, are to be used in a weight-of- evidence determination of a substances potential to interact with the androgen, estrogen, or thyroid systems. The fact that a substance may interact with a hormone system does not mean that when the substance is used, it will cause adverse effects in humans or ecological systems.

5. a) Was the study discontinued before completion?

No

5. b) Provide the reason for discontinuation

6. If the study is ongoing, what is the expected completion date?

For Registrant use only

7. Provide supplemental information here