Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2023-7147

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3304776

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

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

20-JUN-22

5. Lieu de l'incident.

Pays: UNITED STATES

État: FLORIDA

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

Nom du produit: Roundup

• Matière active
  • GLYPHOSATE
    • Inconnu

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

Nom du produit: Nemacur Nematicide (non-company)

• Matière active
  • FENAMIPHOS

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

Nom du produit: Paraquat (non-company)

• Matière active
  • PARAQUAT
    • Inconnu

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7. b) Type de formulation.

Liquide

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: Agricultural-Outdoor/Agricole-extérieur

Specify Type: Orange groves

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?

Inconnu

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 - Difficulté de marcher
  • Symptôme - Douleur musculaire
  • Symptôme - Engourdissement

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?

Oui

6. b) Pendant combien de temps?

Inconnu

7. Scénario d'exposition

Professionnel

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

Application

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

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)

Inconnu

10. Voie(s) d'exposition.

Peau

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.)

6/20/2022 All of the following was spontaneously reported by the caller. The caller is reporting that he worked in orange groves for 30 years and he was the individual that sprayed the chemicals as his profession. He named using several chemicals and reported them to be RoundUp, Paraquat, and Nemacur Nematicide. He was unable to give any identifying numbers for these products. He then spoke of an incident that occurred when he was 35 years old or so. He was in an open-door tractor and described that the levels of the chemicals were changing. At one point he had a skin exposure with the chemical mixture and was covered in the liquid. He removed his clothes and rinsed his skin. He was taken to the emergency room by ambulance after the exposure. He also stated that he was in the hospital for 4 to 5 days after the exposure. The caller referenced that he now has to use a wheelchair and crutches at times since he has trouble walking. He states he suffers from numbness and muscle pain. He has taken pain medication in the past for it. He feels his exposure to the chemicals has caused his health issues. The caller stated that he is trying to reach the manufacturers of the products so he knows who to go after. The statement was clarified with him that he is looking to seek legal action to sue the companies of these chemicals. He states he does not have much and expressed wanting to leave something to his children. Due to the legal threat, no primary medical history was obtained other than the caller mentioning his age during the conversation.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

Company causality score: 1 (unlikely relationship). As the reporter did not identify a specific product alleged to have caused the exposure, Bayer has chosen to report this exposure using the product in this report using the information it had available, including reported use and market share. This selection may not be accurate due to the lack of information provided by the reporter. The consumer reported using the three products over a thirty-year period but did not specify any exposures to the products outside of the one dermal exposure that occurred approximately 27 years ago. While a temporal relationship exists between the reported dermal exposure and the onset of his symptoms it is unknown what and when symptoms developed over the course of time since the exposure. RoundUp branded products typically contain glyphosate as the main active ingredient and a one-time dermal exposure to glyphosate being sprayed from a tractor as described here is unlikely to result in hospitalization, and permanent trouble walking, numbness or muscle pain. Glyphosate is not well absorbed through the skin. Paraquat is also not well absorbed through the skin but can be absorbed through non-intact or damaged skin. It can also be corrosive at higher concentrations and given prolonged dermal contact time may cause caustic injury and facilitate itas on absorption through the damaged skin. It is unclear if this consumer had intact skin at the time of the dermal exposure or how long it stayed on his skin. Toxicity from paraquat typically results from ingestions and causes pulmonary, hepatic, renal and myocardial injuries. There is one report of painful weakness of extremities, confirmed by biopsy, in a 44-year-old female who survived an ingestion but continued to occupationally use paraquat for 1.5 more years. Nemacur Nematicide typically contains fenamiphos, an organophosphate compound. Organophosphates competitively inhibit pseudocholinesterase and acetylcholinesterase, preventing hydrolysis and inactivation of acetylcholine. The acetylcholine accumulates at nerve junctions, causing malfunction of sympathetic, parasympathetic, and peripheral nervous systems and some of the central nervous system. Fenamiphos can be absorbed through the skin following dermal contact, especially in large or prolonged exposures and cause acute toxicity. Additionally, delayed distal sensory-motor polyneuropathy has been reported following exposures to organophosphates and in some cases complete recovery does not occur. This can be characterized by burning/tingling followed by weakness beginning in the legs which spreads proximally and in severe cases can result in spasticity or flaccidity. While not a diagnosis specifically reported in this case the patient did report having trouble walking, numbness and muscle pain in which he needs a wheelchair or crutches to aid him. Further information regarding his exposure, hospitalization and course of current signs and symptoms would be necessary in order to complete a full evaluation and analysis. All other differential causes need to be considered and ruled out. Yang GY, Tominack RL, Chung HM: Hepatic and muscle sequelae in a paraquat poisoning survivor (Abstract). Vet Human Toxicol 1987c; 29:480.