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Sécurité des produits de consommation

Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2010-2575

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2

Nom du titulaire (nom légal complet, aucune abbréviation): Valent BioSciences Corporation

Adresse: 870 Technology Way

Ville: Libertyville

État: IL

Pays: USA

Code postal /Zip: 60048

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.

06-MAY-10

5. Lieu de l'incident.

Pays: CANADA

État: BRITISH COLUMBIA

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

02-MAY-10

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 24977      ARLA No de la demande d'homologation       EPA No d'homologation. 73049-427

Nom du produit: Foray 48B

  • Matière active
    • BACILLUS THURINGIENSIS BERLINER SSP KURSTAKI STRAIN HD-1

7. b) Type de formulation.

Renseignments sur l'application

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

Oui

9. Dose d'application.

4

Unités: L/ha

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

Site: Forest - Woods / Forêt et boisés

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

Alleged Incident History: On April 30, the first morning of the treatment, lines 34-51 were sprayed and on subsequent days (May 5), lines 25-33, 52-59, (May 6) lines 2-24, 60-65, and (May 7) lines 66-81 were flown. The residence in question was flown over on May 6. Flight logs from these applications are included herein. Subsequent applications, as noted below, were also conducted. On Wednesday May 5, (name), of BC Ministry of Forests and Range, received a telephone call from a resident of the treatment area (Bird Road, near lines 12-15) who indicated that her (age) son spitting up blood on May 2 and had required medical attention from his respirologist. She indicated that he is immuno-compromised and suffers from a very rare condition (Addison's Disease); he is one of about 10 cases in Canada. She thought that perhaps her son may have been exposed to the Btk treatment on April 30 and was seeking some answers to his current medical situation. She had been in contact with the local Health Authority, who in turn contacted Health Canada - PMRA. After the conversation with the Bird Road resident, (name) spoke with (name) of Health Canada - PMRA re appropriate measures, if any, to take, (name) contacted Valent BioSciences Corporation (VBC) on Thursday May 6 for further information and inquired about the possibility of obtaining a Foray Btk strain sample to compare to swab samples reportedly collected by Vancouver Coastal Health. Although the local Vancouver Public Health was reportedly in communication with the BC Centre for Disease Control, there have been no communications between any of the local health authorities and BCMFR and/or Valent BioSciences. In the course of subsequent investigations by MFR, it became apparent that the young man's residence was not treated on April 30, and in fact, the aircraft was no closer than 800 metres to their young man's residence that day and weather records taken in the treatment area and from YVR indicate that wind speed and direction precluded any drift.

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.

Autre

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

  • Système respiratoire
    • Symptôme -

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)

Inconnu

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)

10. Voie(s) d'exposition.

Respiratoire

11.Durée de l'exposition?

Unknown / Inconnu

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

>24 hrs <=3 days / >24 h <=3 jours

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.)

Backround: Due to the presence of European Gypsy Moth egg masses and the threat of a possible Quarantine, the BC Ministry of Forests & Range (BCMFR) decided to conduct a local European Gypsy Moth eradication program centered in northwest Richmond BC, immediately east of the Vancouver International Airport (YVR), and south of the Fraser River. Three aerial applications of Foray 4B (each @ 50 CLU/4.0/ha) were planned with spray timing determined by a degree-day based biological development model, BioSim. This application program was well planned and involved staff from several federal and provincial government agencies as well as input from Transport Canada, the City of Richmond, and the local department of public health (Vancouver Coastal Health-Richmond). BCMFR has extensive experience in mounting these campaigns, having been involved in periodic gypsy moth eradication program since 1992. These programs are well executed, based on sound scientific criteria, and great efforts are invested in public outreach to ensure that all residents in the affected area have been advised and are aware of the program. (1-800 Moth line, ListServe, MFR web-site, print advertising, media advisories, and an Open House in the treatment area are all part of the communication strategy.) BioSim indicated that the first application should be conducted on Friday April 30, and a small twin-engine aircraft, crewed by an experienced licensed application team started the applications. The aircraft is equipped with a Digital Global Positioning System (Satloc), which is specialized navigation equipment that is installed in most application aircraft working in North America. The DGPS provides accurate aircraft guidance across the spray block, monitors pesticide output, and indicates spray line intervals (approximately 80 lines) and treatment boundaries. Dedicated program staff include a communications manager (name) working at MFR headquarters in Victoria, an operations manager (name) located in the treatment area monitoring weather and spray deposition, and an airbase manager (name) overseeing pesticide handling and loading of the aircraft at the nearby Boundary Bay Airport. Bird Road Resident, pg 2. Due to the small size of the aircraft, and application time restrictions due to potential airspace conflicts with Vancouver airport and early morning vehicular traffic, several mornings are required to complete the program in entirely. All applications are conducted between sunrise and 7:30am.

À être déterminé par le titulaire

14. Classification selon la gravité.

Modérée

15. Donner des renseignements additionnels ici.