Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2007-5671

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-15077661

Registrant Name (Full Legal Name no abbreviations): Syngenta Crop Protection Canada, Inc.

Address: 140 Research Lane, Research Park

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G4Z3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

06-JUL-07

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

19-JUN-07

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

---

PMRA Registration No. 16370      PMRA Submission No.       EPA Registration No.

Product Name: Princep Nine-T Herbicide (Water Dispersible Granule)

• Active Ingredient(s)
  • SIMAZINE PLUS RELATED ACTIVE TRIAZINES

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Gramoxone

• Active Ingredient(s)
  • PARAQUAT

---

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Apple Orchard

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Hand Spraying for duration of 6 hours, windy conditions

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Fever

• Skin
  • Symptom - Rash

• Respiratory System
  • Symptom - Pulmonary edema
  • Symptom - Pneumonia
  • Specify - pneumonitis
  • Symptom - Respiratory irritation
  • Symptom - Shortness of breath

• Nervous and Muscular Systems
  • Symptom - Shaking

• Respiratory System
  • Symptom -
  • Specify - Nodes found on Lung CT Scan
  • Symptom - Tachypnea

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

12

Day(s) / Jour(s)

7. Exposure scenario

Occupational

8. How did exposure occur? (Select all that apply)

Application

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

12. Time between exposure and onset of symptoms.

>3 days <=1 wk / >3 jours <=1 sem

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Caller received voice mail about possible exposure. Calling to see if we can assist her. Assessment: - Yes we do. - Caller will gather information about incident - appears a woman working in an orchard. Was exposed to 2 chemicals. - Will call back with further information. Calling back with further details. She works at Poison Control Center and is reporting from a somewhat limited case synopsis. RWK PC Case # (NUMBER) History: 17.5 days ago (6/19/07) (age) female patient inhaled some of listed products in the course of work in an apple orchard. Details of exposure are otherwise not known by reporter (products' concentrations, duration of use, onset of symptoms relative to exposure were unanswerable questions at this time). She presented to HCF on 6/23/07 with some apparent respiratory distress, and pulse oximetry indicated 80 % O2 Sat on room air. Pt was started on O2 with resultant improvement in O2 sat values, and was admitted to HCF where CXR and pulmonary CT scans revealed conditions of pneumonitis, pulmonary edema, and also demonstrated pleural effusions, and pulmonary nodes. Pulmonary embolus was ruled out. On or about 6/27/07, patient developed a fever which was treated with antibiotic therapy. Duration of treatments not stipulated. Pt also developed a rash for which antihistamines and bronchodilators were prescribed and utilized. Pt was discharged on 7/3/07 with an order to return in 2 weeks for pulmonary assessment. ASSESS: Would be helpful to establish better product information. Also, would be helpful to have RFT's performed, if not already done. REC: Provided case & tele # if questions arise. Follow-Up Received Caller states that exposed individual works at a local orchard, and was hand spraying for 6 hours. Caller reports that exposed individual inhaled Gramoxone product for up to 6 hours due to windy conditions, and lack of respiratory protection. Exposed individual did not experience any dermal exposure or ingestion. Exposure occurred on 6-17-07 or 6-18-07. Exposed individual developed signs / symptoms post exposure, and was transported to emergency room via ambulance: Low oxygen saturation - 80% on room air, Oxygen saturation - 90% on oxygen (3 liters) ,Rash on arms and legs - responsive to diphenhydramine, Shortness-of-breath, Fever, Rigors, Fluid on lungs, Tachypnea Patient was not acutely toxic, but was diagnosed with pneumonitis and pulmonary edema. Admitted to hospital for 1 week (from 06/23/07 to discharge on 7/3/07). Received antibiotics, antihistamines, bronchodilators, oxygen, lasix, and intravenous fluids. Result of lung CT showed nodes, which will be further investigated on an outpatient basis. Caller states that patient¿¿¿s chest still did not feel "100%" upon discharge. Patient is scheduled for follow-up chest CT and pulmonary function tests.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The Princep Nine T label recommends avoiding inhalation of dusts, vapours or spray mist. The Gramaxone label contains very strict recommendations regarding the maximum allowable concentration of Gramoxone in water, specific articles of personal protective clothing depending on the type of spray application equipment, restrictions on the type of spray application equipment that can be used (to ensure the particles of a respirable size are not produced). Paraquat is not generally inhaled into the lungs. Paraquat is non-volatile and formulations containing paraquat are not applied through spray equipment, which would generate a significant proportion of respirable spray droplets. Paraquat is applied with conventional hydraulic spray equipment. The inhalable fraction that is taken into the noise and the mouth during breathing is also too large to reach the alveolar region of the lung. This fraction, could, however, be swallowed and is therefore, a source of secondary oral ingestion. Mist blowers, which product large numbers of very fine droplets, are not recommended for spraying paraquat. The patient did not experience any kidney effect, exposure to paraquat is characterized by kidney effects that precede the lung effects.