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Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2007-6713

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 20051041/F2-BFEU and 20061138/F2-BFEU

Nom du titulaire (nom légal complet, aucune abbréviation): Syngenta Crop Protection

Adresse: 140 Research Lane, Research Park

Ville: Guelph

État: ON

Pays: Canada

Code postal /Zip: N1G 4Z3

3.Choisir le (les) sous-formulaire(s) correspondant à l'incident.

Étude scientifique

4. Date à laquelle le titulaire d'homologation a été informé pour la première fois de l'incident.

5. Lieu de l'incident.

6. Date de la première observation de l'incident.

Description du produit

7. a) Donner le nom de la matière active et, si disponibles, le numéro d'homologation et le nom du produit (incluant tous les mélanges). Si le produit n'est pas homologué, donner le numéro de la demande d'homologation.

ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation.

Nom du produit: A9807C

• Matière active
  • FLUDIOXONIL
  • METALAXYL-M (MEFENOXAM)
  • THIAMETHOXAM

7. b) Type de formulation.

Renseignments sur l'application

8. Est-ce que le produit a été appliqué?

Inconnu

9. Dose d'application.

10. Site d'application (choisir tout ce qui s'applique).

11. Donner tout renseignement additionnel concernant l'application (comment le produit a été appliqué, la quantité utilisée, la superficie de la zone traitée, etc.)

À être déterminé par le titulaire

12. Selon vous, le produit a-t-il été utilisé en conformité avec le mode d'emploi de L'étiquette?

Inconnu

Sous-formulaire VII : Étude scientifique

1. Renseignements concernant l'étude

Titre A field study with A10590C treated maize seed and with A9807C treated winter oilseed rape seed, investigating the effects of honey bees over three years in NORTHERN FRANCE.

Date 03-AUG-07

2. Si une traduction est requise, a-t-on besoin d'un délai?

Non

3. Type d'incident indiqué dans l'étude:

Nouveau danger pour la santé ou pour l'environnement

4. Décrire l'incident indiqué dans l'étude (p. ex. l'étude indique un risque accru de lymphome non hodgkinien des suites d'une exposition au produit)

In accordance with the Incident Reporting provisions of PCPA 2002 reporting requirements, Syngenta Crop Protection, Inc. is informing the PMRA of preliminary results from the second year of two three-year field studies in progress in FRANCE. The studies are being conducted to investigate potential effects on honey bees from maize and oilseed rape seed treated with a thiamethoxam formulation. Syngenta AG, Basel, Switzerland is conducting a suite of five honey bee field trials (2 in oilseed rape, 3 in maize) over three years in FRANCE. Each year the test organisms (6 colonies per site) are exposed to crops grown from seed treated with a thiamethoxam formulation. These trails are being conducted with a thiamethoxam formulation that is not registered in CANADA. No differences in the parameters studies on the bees were observed during the first year at any of the five trial sites. In the second year, three out of six colonies in one of the two treated oilseed rape trial sites had only done (male) brood present after over-wintering. No differences in the parameters studies were seen at the other oilseed rape trial site or in the control colonies of either oilseed rape trial. In one of the three maize trial sites, four out of six colonies in the treated maize plot failed to successfully raise a new queen following colony splitting. No differences in the parameters studied were seed in the other two maize trials or in the control colonies of all three maize trials. The results seen in these trials are equivocal and the available data do not necessarily indicate a treatment effect. In both no differences in the parameters studies were observed in first year of study, and only one trial site in each study showed differences in the second year. Further, previously submitted data do not indicate the potential for a treatment related effect. The suite of trials is continuing into a third year as planned and the results of this study will be submitted when available.

5. a) L'étude a-t-elle été abandonnée avant son d'achèvement?

Non

5. b) Provide the reason for discontinuation

6. Si l'étude est en cours, quelle est la date d'achèvement prévue?

Inconnu

À l'usage du titulaire seulement

7. Donner des renseignements additionnels ici

Thiamethoxam is registered in Canada for seed treatment uses although this specific seed treatment formulation is neither registered nor is it planned to be registered in Canada in the future. [The study 'Two field trials to determine the effects of HELIX seed treatement on honeybees foraging on canola flowers' is attached to this IR as support/rationale. This study was done in Alberta, Canada to determine the effects of HELIX seed treatment on honeybees foraging on canola flowers. The study was done following typical bee management practices in Canada. The bees were not affected by foraging on canola flowers grown from seed treated with HELIX liquid seed treatment. All exposed hives thrived and grew during this study. There were no observable on bee foraging activity, no evidence of repellency, loss of co-ordination or disorientation. There was no apparent effect on brood pattern or egg laying. The bees from all hives in the exposed groups were observed actively foraging in the HELIX-treated canola. Bee mortality was low and not related to the treatment. ]