Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2023-1760

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3489606

Nom du titulaire (nom légal complet, aucune abbréviation): Bayer CropScience Inc.

Adresse: 160 Quarry Park Boulevard SE Suite 130

Ville: CALGARY

État: AB

Pays: Canada

Code postal /Zip: T2C 3G3

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

Incident chez l'humain

Incident chez un animal domestique

Environnement

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

09-JAN-23

5. Lieu de l'incident.

Pays: CANADA

État: ALBERTA

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

Inconnu

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)

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ARLA No d'homologation 29367      ARLA No de la demande d'homologation       EPA No d'homologation.

Nom du produit: TUNDRA HERBICIDE

• Matière active
  • BROMOXYNIL
  • FENOXAPROP-P-ETHYL (ISOMER)
  • PYRASULFOTOLE

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7. b) Type de formulation.

Renseignments sur l'application

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

Oui

9. Dose d'application.

Inconnu

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

Site: Res. - Out Home / Rés - à l'ext.maison

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

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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?

Oui

Sous-formulaire II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Personne affectée

2. Renseignement démographique sur la personne affectée

Sexe: Homme

Âge: >19 <=64 yrs / >19 <=64 ans

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

• Systèmes nerveux et musculaire
  • Symptôme - Douleur musculaire

4. Quelle a été la durée des symptômes?

Unknown / Inconnu

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Oui

6. a) Est-ce que la personne a été hospitalisée?

Non

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

Quelle était l'activité? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Dérive du pesticide à partir de la zone traitée

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

Aucun

10. Voie(s) d'exposition.

Inconnu

11.Durée de l'exposition?

Unknown / Inconnu

12.Temps écoulé entre l'exposition et l'apparition des symptômes.

>2 mos <=6 mos / > 2 mois < = 6 mois

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, etc.)

1/9/2023 An individual has reported that the Tundra Herbicide was sprayed in June of 2022 by a neighbor, a cloud of product lasted over 3 hours and had drifted over to their garden. The reporter then called the local municipality, was told his neighbor was using this product, and was told he could eat his vegetables as long as he waited 2 weeks before consuming them. Caller waited the 2 weeks and then harvested beets, carrots, potatoes, cucumbers, squash, lettuce, and other vegetables that he can't remember. Caller states the potatoes looked weird. Half of the potato looked normal on one side and rotten on the other side with a perfect line down the middle. Callers symptoms of muscle aches began in approximately September or October 2022. His wifes symptoms, also muscle aches, either began in July of that year, or October or November 2022. His symptoms worsen when eating the potatoes, or when out in the garden. On or around December 16th, 2022 caller consulted his health care provider regarding his symptoms and the potential exposure to this product. His doctor told him his symptoms were not from this product because if he had an ingestion of this product he would have been vomiting. He was advised to stop eating the potatoes, and his symptoms improved. He does not know whether his wife did anything to manage her symptoms, although their symptoms persist. His dog has also been shaking her head and ears since around the time the product was sprayed. She was evaluated by a veterinarian on January 5th, 2023 with no noted cause. She does swim often in a dugout during the warm months until October. The veterinarian performed an otic exam and ear swab, but no noted results. Caller reports he had his water tested on December 2nd, 2022 from a dugout in the garden that showed values of 2,4D = 5.21, MCPA = 5.26, and 2,4,5-T = 5.36. No further information is available.

À être déterminé par le titulaire

14. Classification selon la gravité.

Modérée

15. Donner des renseignements additionnels ici.

The symptoms started after the product was sprayed near the caller (unclear if an exposure occurred at the time) and a few months after chronically ingesting the produce. While a temporal relationship exists between product exposure and the onset of symptoms the amount of product is not expected to be in high enough concentrations to cause or otherwise influence the reported symptoms. The caller reports a drift from Tundra Herbicide came through his garden. Given the described exposure, minimal amounts would have been deposited on the produce and would not be expected to cause the reported symptoms. Additionally, the caller waited two weeks before harvesting, in which the product likely dried and was potentially washed off while watering the produce or by rain. The caller also likely washed the produce after harvest before eating. The amount of product left on the produce that would have been potentially ingested would be minimal, if any. All other differential diagnoses have not been ruled out and the product has not been re-challenged.

Sous-formulaire II : Incident chez l'humain (Obligation d'utiliser un formulaire séparé pour chaque personne affectée)

1. Source de la déclaration.

Personne affectée

2. Renseignement démographique sur la personne affectée

Sexe: Femme

Âge: >19 <=64 yrs / >19 <=64 ans

3. Énumérez tous les symptômes, au moyen des choix suivants.

Système

• Systèmes nerveux et musculaire
  • Symptôme - Douleur musculaire

4. Quelle a été la durée des symptômes?

Unknown / Inconnu

5. La personne affectée a-t-elle reçu des soins médicaux? Donner les détails à la question 13.

Non

6. a) Est-ce que la personne a été hospitalisée?

Non

6. b) Pendant combien de temps?

7. Scénario d'exposition

Non professionnel

8. Comment l'exposition s'est-elle produite? (cocher tout ce qui s'applique)

Quelle était l'activité? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Dérive du pesticide à partir de la zone traitée

9.Si l'exposition s'est produite lors du traitement ou au moment du retour dans la zone traitée, de l'équipement de protection individuelle était-il porté? (cocher tout ce qui s'applique)

Aucun

10. Voie(s) d'exposition.

Inconnu

11.Durée de l'exposition?

Unknown / Inconnu

12.Temps écoulé entre l'exposition et l'apparition des symptômes.

Unknown / Inconnu

13.Donner tout détail additionnel au sujet de l'incident (p.ex. description des symptômes tels que la fréquence et la gravité, type de soins médicaux, résultats des tests médicaux, quantité de pesticide à laquelle la personne a été exposée, etc.)

1/9/2023 An individual has reported that the Tundra Herbicide was sprayed in June of 2022 by a neighbor, a cloud of product lasted over 3 hours and had drifted over to their garden. The reporter then called the local municipality, was told his neighbor was using this product, and was told he could eat his vegetables as long as he waited 2 weeks before consuming them. Caller waited the 2 weeks and then harvested beets, carrots, potatoes, cucumbers, squash, lettuce, and other vegetables that he can't remember. Caller states the potatoes looked weird. Half of the potato looked normal on one side and rotten on the other side with a perfect line down the middle. Callers symptoms of muscle aches began in approximately September or October 2022. His wifes symptoms, also muscle aches, either began in July of that year, or October or November 2022. His symptoms worsen when eating the potatoes, or when out in the garden. On or around December 16th, 2022 caller consulted his health care provider regarding his symptoms and the potential exposure to this product. His doctor told him his symptoms were not from this product because if he had an ingestion of this product he would have been vomiting. He was advised to stop eating the potatoes, and his symptoms improved. He does not know whether his wife did anything to manage her symptoms, although their symptoms persist. His dog has also been shaking her head and ears since around the time the product was sprayed. She was evaluated by a veterinarian on January 5th, 2023 with no noted cause. She does swim often in a dugout during the warm months until October. The veterinarian performed an otic exam and ear swab, but no noted results. Caller reports he had his water tested on December 2nd, 2022 from a dugout in the garden that showed values of 2,4D = 5.21, MCPA = 5.26, and 2,4,5-T = 5.36. No further information is available.

À être déterminé par le titulaire

14. Classification selon la gravité.

Modérée

15. Donner des renseignements additionnels ici.

The symptoms started after the product was sprayed near the caller (unclear if an exposure occurred at the time) and a few months after chronically ingesting the produce. While a temporal relationship exists between product exposure and the onset of symptoms the amount of product is not expected to be in high enough concentrations to cause or otherwise influence the reported symptoms. The caller reports a drift from Tundra Herbicide came through his garden. Given the described exposure, minimal amounts would have been deposited on the produce and would not be expected to cause the reported symptoms. Additionally, the caller waited two weeks before harvesting, in which the product likely dried and was potentially washed off while watering the produce or by rain. The caller also likely washed the produce after harvest before eating. The amount of product left on the produce that would have been potentially ingested would be minimal, if any. All other differential diagnoses have not been ruled out and the product has not been re-challenged.

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Labrador Retriever

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

6. Âge (fournir un ordre de grandeur si nécessaire)

4

7. Poids (fournir un ordre de grandeur si nécessaire)

100.00

lbs

8. Voie(s) d'exposition:

Inconnu

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• Systèmes nerveux et musculaire
  • Symptôme - Agitation de la tête
  • Symptôme - Agitation
  • Specify - Ear shaking

12. Quelle a été la durée des symptômes?

Unknown / Inconnu

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Oui

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Non

14. b) Combien de temps l'animal était-il hospitalisé?

15. Issue de l'incident

Unknown/Inconnu

16. De quelle manière l'animal a-t-il été exposé?

Other / Autre

préciser It is unknown how the animal was exposed as the product is suspected to have been sprayed on a neighbor's land by the neighbor.

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

1/9/2023 An individual has reported that the Tundra Herbicide was sprayed in June of 2022 by a neighbor, a cloud of product lasted over 3 hours and had drifted over to their garden. The reporter then called the local municipality, was told his neighbor was using this product, and was told he could eat his vegetables as long as he waited 2 weeks before consuming them. Caller waited the 2 weeks and then harvested beets, carrots, potatoes, cucumbers, squash, lettuce, and other vegetables that he can't remember. Caller states the potatoes looked weird. Half of the potato looked normal on one side and rotten on the other side with a perfect line down the middle. Callers symptoms of muscle aches began in approximately September or October 2022. His wifes symptoms, also muscle aches, either began in July of that year, or October or November 2022. His symptoms worsen when eating the potatoes, or when out in the garden. On or around December 16th, 2022 caller consulted his health care provider regarding his symptoms and the potential exposure to this product. His doctor told him his symptoms were not from this product because if he had an ingestion of this product he would have been vomiting. He was advised to stop eating the potatoes, and his symptoms improved. He does not know whether his wife did anything to manage her symptoms, although their symptoms persist. His dog has also been shaking her head and ears since around the time the product was sprayed. She was evaluated by a veterinarian on January 5th, 2023 with no noted cause. She does swim often in a dugout during the warm months until October. The veterinarian performed an otic exam and ear swab, but no noted results. Caller reports he had his water tested on December 2nd, 2022 from a dugout in the garden that showed values of 2,4D = 5.21, MCPA = 5.26, and 2,4,5-T = 5.36. No further information is available.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mineure

19. Donner des renseignements additionnels ici

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.

Sous-formulaire IV : Environnement (y compris les plantes, les insectes et la faune)

1. Type d'organisme touché

Herbaceous Plants / Plante herbacée

2. Nom(s) commun(s)

Potato

3.Nom(s) scientifique(s)

Solanum tuberosum

4. Nombre d'organismes touchés

1

5. Description du lieu où l'incident a été observé:

Eau douce

Terrestre

Résidentiel

Eau salée

6. Cocher tous les symptômes qui s'appliquent à:

Malformation

Lésions visibles à l'oeil nu (p. ex. chlorose [jaunissement], nécrose, décoloration)

7.Décrire les symptômes et issue (mort, rétablissement, etc.).

Half of the potato looked normal on one side and rotten on the other side with a perfect line down the middle. It is unknown how far from the application site the potato was growing. The nature of exposure to the plant is similarly unknown.

8. a) Est-ce que l'incident a été causé par (coucher tout ce qui s'applique) :

Autre

The product was applied by the neighbor to the neighbor's property, after which a cloud of product remained suspended for 3 hours.

8. b) i)Combien de fois le produit a-t-il été appliqué cette année?

8. b) ii)Date de la dernière application

9. Est-ce qu'il a plu

9. a) Pendant l'application?

Non

9. b) Jusqu'à 3 jours après l'application?

Non

10. a)Y avait-il une zone tampon?

Non

10. b) De quel genre?

10. c) Quelle étaite la taille de la zone tampon?

11.Est-ce que des échantillons ont été recueillis dans l'environnement et analysés?

Non

À être déterminé par le titulaire

12.Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Modérée

13.Donner des renseignements additionnels ici

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.