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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-2286

2. Registrant Information.

Registrant Reference Number: 052908-01 MCPPp TF

Registrant Name (Full Legal Name no abbreviations): MCPP-p Task Force (members: A.H. Marks and Company Ltd.; Nufarm b.v.)

Address: 44 Tamarack Circle

City: Toronto

Prov / State: Ontario

Country: CANADA

Postal Code: M9P 3T9

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. 27635      PMRA Submission No.       EPA Registration No.

Product Name: Mecoprop-p

• Active Ingredient(s)
  • MECOPROP P-ISOMER (PRESENT AS ACID)

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 Notification of Possible 6(a)(2) Data (Related to Separately Submitted Study: Mecoprop-p Dietary Two Year Carcinogenicity Study in the Rat)

Date 27-MAY-08

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)

The 1200 ppm inclusion rate was established as an MTD in both male and female rats with bodyweight gain reduced compared to controls. Liver changes consistent with peroxisome proliferation were seen in both sexes. At 600 ppm, bodyweight gain was reduced in female rats with minor hepatic changes in both sexes. The incidence of subcutaneous (benign) lipoma in male rats was 0, 0, 1 and 4 in the groups fed diets containing 0, 100, 600 or 1200 ppm mecoprop-p, respectively. At the high dose, the incidence is statistically significant compared to the contemporary control, but not when compared to the (limited) historical control data. There was no histological change in the skin or subcutaneous tissue, or other tissues in which fat is stored, to suggest an effect of compound on these tissues. A recent paper (Tannehill-Gregg, et al 2007) describes an association between lipoma incidence in the male rat and peroxisome proliferation. Thus, although the recorded incidence is probably a spontaneous event, an association with peroxisome proliferation cannot be ruled out. A copy of this paper is enclosed for reference.

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

Actual study submitted separately.