Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2572

2. Registrant Information.

Registrant Reference Number: PROSAR Case #: 1-26554002

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.

19-JUN-11

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

17-JUN-11

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)

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

Product Name: Unknown paraquat product

• Active Ingredient(s)
  • PARAQUAT

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7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

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

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

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: Male

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

3. List all symptoms, using the selections below.

System

• Renal System
  • Symptom - Renal failure
  • Specify - renal insufficiency

• Respiratory System
  • Symptom - Other
  • Specify - pulmonary fibrosis

• Blood
  • Symptom - Acidosis
  • Symptom - Cytopenia
  • Specify - pancytopenia

• General
  • Symptom - Death

4. How long did the symptoms last?

Persisted until death

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

5

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

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

Poisoning from ingestion of the pesticide

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.

Oral

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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.)

1-26554002- The reporter, a physician, indicated a patient in his care was exposed to an herbicide containing the active ingredient paraquat. The physician stated that a (age) year old male was landscaping his own home at 4:30 pm two days prior to the initial contact with the registrant. It was reported he mistook a water bottle for a container carrying a paraquat product and took 'a swallow'. The product ingested was described as 37% by volume, the caller was unable to provide the precise name of the product or identify any applicable PCP number or EPA registration number. The caller did not clarify why the product was in the patient¿s residence. The caller indicated the patient may have ingested as much as 30 mL of the product, but the exact volume ingested was unknown. The patient was able to spit out some of the product on scene and had induced emesis on scene. He had presented to hospital 6 pm the same day he was exposed. The patient was given multiple doses of activated charcoal upon presentation. The patient was, at the time of initial contact with the registrant, being treated in the intensive care unit where dialysis was being performed. The reporter indicated he was made aware of the exposure the day following presentation and he was providing support for the treating physicians as a Resident in Medical Biochemistry. The day following his initial contact with the registrant the reporter indicated the patient was still admitted to the ICU and multiple treatment teams were involved in his care. The reporter indicated at that time lung transplantation was being discussed. The reporter at that point posed questions regarding qualitative bedside testing, sputum testing, and sample submission. The reporter was advised of submission protocols and put in direct phone contact with a medical toxicologist to discuss the nuances of sample collection both qualitative and quantitative and how it might potentially guide therapy/response to therapy. During the discussion with the toxicologist the reporter revealed the patient was experiencing renal insufficiency and showing signs of pulmonary fibrosis. The caller indicated the patient¿s treatment at the time of the call included N-acetylcysteine, NaK, Dexamethasone, Solumedrol, immunotherapy, and Cyclophosphamide. On follow up, one day later the reporter indicated the patient was 'not doing the greatest'. He stated at that point the patient was intubated and they were struggling with his lactate levels. It was indicated his acidosis was under control, his liver function was stable and made the comment that they were 'on top of' his renal function. It was indicated the patient was developing pancytopenia attributed to the cyclophosphamide and there was evidence he was developing 'lung injury'. On additional follow up five days after the exposure the reporter stated he had last evaluated the patient 10:30 that morning and the patient appeared to be passing away. The reporter stated the patient¿s family had suspended care for him at that point. The final follow up was obtained six days following the reported exposure. The reporter stated the patient had died the day prior. He provided no further information.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

This product is only available to licensed applicators in Canada. Information provided indicates patient was a home owner. It is unknown how he obtained the material. Based on the information provided (37% by volume), the product is not registered in Canada.