Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2023-7146

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 3588885

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.

01-MAY-23

5. Lieu de l'incident.

Pays: UNITED STATES

État: NORTH CAROLINA

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)

---

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

Nom du produit: Round Up

• Matière active
  • GLYPHOSATE
    • Inconnu

---

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: 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?

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: Femme

Âge: >19 <=64 yrs / >19 <=64 ans

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

Système

• Système cardiovasculaire
  • Symptôme - Arythmie cardiaque

• General
  • Symptôme - Autre
  • Specify - Chronic inflammatory response
  • Symptôme - Autre
  • Specify - Hashimoto's

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.

Inconnu

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

Autre

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.)

5/1/2023 All of the following was spontaneously reported by the caller. Caller states that she and her son developed auto-immune disorders from being exposed to an unidentified Round-Up product. She reports she developed Graves disease at age 28 in about 2008. She is unaware of any product exposure prior to her developing Graves. She also had a metabolic problem causing her to have low vitamin D levels prior to any known exposures. She was able to keep her Graves under control with supplements, herbs and diet for 20 years. She reports that she never used the Round-Up herself. Her neighbor's gardener used the product next to her house for several years before 2016. 2016 was her first FaceBook post about him using the product near her home and organic garden. She had eaten only organic food for 20 years. She states that she has developed Hashimoto's, Chronic Inflammatory Response and a non-specific Arrhythmia since her exposure to the product. Product exposure ended last year in 2022 when the gardener was fired. She reports she was exposed to the product during her pregnancy which caused her son to develop auto-immune problems as well. In 2018 or 2019 her son was diagnosed with Type1 Diabetes, Autoimmune Encephalitis, and Hashimoto's. He was hospitalized and nearly died from the Encephalitis. His condition is currently stable. She and her son see an Integrated medical doctor who prescribes all of their supplements. She states that the product was detected in blood tests for her son in 2019. She was tested and the product was found in her blood as well. She insisted that Round-up was detected in her blood not glyphosate. All of her supplements have been prescribed with by an integrative medical doctor. Caller was a poor historian. She continued to insist the product can cause auto-immune problems. She did not provide specific tests or detailed treatment information.

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. While a loose temporal relationship exists between the use of the product near her home and the onset of reported symptoms/diagnoses at an unknown time later, an exposure to the product is not confirmed and it is unclear if and how the consumer or her son could have been exposed to the product. Glyphosate use as directed is not expected to result in Hashimotoas disease, chronic inflammatory response, arrhythmias, diabetes, or autoimmune encephalitis. The consumer reported her blood and her sonas blood tested positive for RoundUp and denies testing for glyphosate specifically. At the time of this report, I am unaware of a blood testing method to decipher glyphosate brand. All other differential diagnoses have not been ruled out. Further information is necessary regarding exposure, medical testing, and course to provide a full evaluation and analysis.

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: >12 <=19 yrs / >12 <=19 ans

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

Système

• General
  • Symptôme - Autre
  • Specify - Autoimmune encephalitis
  • Symptôme - Autre
  • Specify - Hashimoto's
  • Symptôme - Autre
  • Specify - Type 1 diabetes

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

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

Autre

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.)

5/1/2023 All of the following was spontaneously reported by the caller. Caller states that she and her son developed auto-immune disorders from being exposed to an unidentified Round-Up product. She reports she developed Graves disease at age 28 in about 2008. She is unaware of any product exposure prior to her developing Graves. She also had a metabolic problem causing her to have low vitamin D levels prior to any known exposures. She was able to keep her Graves under control with supplements, herbs and diet for 20 years. She reports that she never used the Round-Up herself. Her neighbor's gardener used the product next to her house for several years before 2016. 2016 was her first FaceBook post about him using the product near her home and organic garden. She had eaten only organic food for 20 years. She states that she has developed Hashimoto's, Chronic Inflammatory Response and a non-specific Arrhythmia since her exposure to the product. Product exposure ended last year in 2022 when the gardener was fired. She reports she was exposed to the product during her pregnancy which caused her son to develop auto-immune problems as well. In 2018 or 2019 her son was diagnosed with Type1 Diabetes, Autoimmune Encephalitis, and Hashimoto's. He was hospitalized and nearly died from the Encephalitis. His condition is currently stable. She and her son see an Integrated medical doctor who prescribes all of their supplements. She states that the product was detected in blood tests for her son in 2019. She was tested and the product was found in her blood as well. She insisted that Round-up was detected in her blood not glyphosate. All of her supplements have been prescribed with by an integrative medical doctor. Caller was a poor historian. She continued to insist the product can cause auto-immune problems. She did not provide specific tests or detailed treatment information.

À être déterminé par le titulaire

14. Classification selon la gravité.

Majeure

15. Donner des renseignements additionnels ici.

Company causation 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. While a loose temporal relationship exists between the use of the product near her home and the onset of reported symptoms/diagnoses at an unknown time later, an exposure to the product is not confirmed and it is unclear if and how the consumer or her son could have been exposed to the product. Glyphosate use as directed is not expected to result in Hashimotoas disease, chronic inflammatory response, arrhythmias, diabetes, or autoimmune encephalitis. The consumer reported her blood and her sonas blood tested positive for RoundUp and denies testing for glyphosate specifically. At the time of this report, I am unaware of a blood testing method to decipher glyphosate brand. All other differential diagnoses have not been ruled out. Further information is necessary regarding exposure, medical testing, and course to provide a full evaluation and analysis.