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Déclaration d'incident
Sous-formulaire I: Renseignements généraux
1.Type de rapport.
Nouvelle déclaration d'incident
No de la demande: 2023-0601
2. Renseignements concernant le titulaire.
Numéro de référence du titulaire d'homologation: M-650694-01-1
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer CropScience Inc.
Adresse: Suite 200, 160 Quarry Park Boulevard SE
Ville: CALGARY
État: AB
Pays: Canada
Code postal /Zip: T2C 3G3
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.
Matière(s) active(s)ARLA No d'homologation 33713 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: TETRANILIPROLE 200SC TURF INSECTICIDE
- Matière active
- TETRANILIPROLE
ARLA No d'homologation 33711 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: VAYEGO 200SC INSECTICIDE
- Matière active
- TETRANILIPROLE
ARLA No d'homologation 34488 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: CL73507 200 SC INSECTICIDE
- Matière active
- TETRANILIPROLE
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 Determination of the residues of tetraniliprole and its metabolite tetraniliprole-N-methyl-quinazolinone in bee relevant matrices collected from succeeding crops following applications of tetraniliprole SC 200 G (200 g/L) via soil incorporation - Field phase conducted with maize, buckwheat, mustard and phacelia in Northern France
Date 11-FEB-19
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 a recent review of pollinator residue work for tetraniliprole, we believe that the study entitled, Determination of the residues of Tetraniliprole and its metabolite Tetraniliprole-N-methyl-quinazolinone in bee relevant matrices collected from succeeding crops following applications of Tetraniliprole SC 200 G (200 g/L) via soil incorporation. Field phase conducted with Maize, Buckwheat, Mustard and Phacelia in Northern France (2019, Bayer no. M-650694-01-1) may meet the criterion for reportability under Incident Reporting. In this study, tetraniliprole and metabolite residues were measured in buckwheat, with residues in pollen ranging from below the Level of Detection (LOD) to 2.5 ppb. The highest residue reported in pollen was 2 times higher than residues in buckwheat pollen that were previously reported to EPA and PMRA. In this study, residues in mustard were also measured, with residues in pollen ranging from 1.1 to 6.5 ppb. The highest value obtained in this study was 6.5 ppb where previously, levels were below the level of detection.
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?
À l'usage du titulaire seulement
7. Donner des renseignements additionnels ici
In a recent review of pollinator residue work for tetraniliprole, we believe that the study entitled, Determination of the residues of Tetraniliprole and its metabolite Tetraniliprole-N-methyl-quinazolinone in bee relevant matrices collected from succeeding crops following applications of Tetraniliprole SC 200 G (200 g/L) via soil incorporation. Field phase conducted with Maize, Buckwheat, Mustard and Phacelia in Northern France (2019, Bayer no. M-650694-01-1) may meet the criterion for reportability under Incident Reporting Regulation. In this study, tetraniliprole and metabolite residues were measured in buckwheat, with residues in pollen ranging from below the Level of Detection (LOD) to 2.5 ppb. The highest residue reported in pollen was 2 times higher than residues in buckwheat pollen that were previously reported to EPA and PMRA. In this study, residues in mustard were also measured, with residues in pollen ranging from 1.1 to 6.5 ppb. The highest value obtained in this study was 6.5 ppb where previously, levels were below the level of detection. However, these residues do not pose any risk to bees as compared to the colony feeding study. The NOEC from the colony feeding study (624 ppb) is 96 times higher than the resulting calculation for nectar exposure and 1400 times higher than the resulting calculation for pollen exposure when extrapolating to a nectar-equivalents study endpoint.There was an additional study conducted during the same timeframe using a similar methodology (Residues of BCS-CL73507 in Guttation Fluid, Nectar and Pollen of Flowering Rotational Crops in Western Germany, 2018, Bayer Report No. M-620354-01-1). This study does not meet the criteria for reporting under Incident Reporting Regulation, but we are providing it as supplemental information relevant to this submission.
