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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1835

2. Registrant Information.

Registrant Reference Number: PROSAR Case#: 1-25496880

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.

03-MAR-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 27428      PMRA Submission No.       EPA Registration No.

Product Name: Demand CS Insecticide

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN

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

Product Name: Tempo

  • Active Ingredient(s)
    • CYFLUTHRIN

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

Product Name: Prelude

  • Active Ingredient(s)
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Unknown

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.

Data Subject

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

  • Ear
    • Symptom - Tinnitus
  • Nervous and Muscular Systems
    • Symptom - Headache
    • Symptom - Dizziness
    • Symptom - Fasciculations
    • Symptom - Muscle weakness
  • General
    • Symptom - Fatigue
  • Nervous and Muscular Systems
    • Symptom - Muscle pain
  • Eye
    • Symptom - Blurred vision
    • Symptom - Difficulty focussing
    • Specify - delayed focusing of eyes
  • Ear
    • Symptom - Other
    • Specify - ear infection

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

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.

Skin

Respiratory

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.)

1-25496880- The reporter calls to indicate possible exposure to an insecticidal product containing the active ingredient lambda-cyhalothrin. The caller also indicated he has historically worked with vaguely identified products which contained the active ingredients cyfluthrin and permethrin. The caller indicated he has worked as a pest control operator for some time (nonspecific duration). He indicates during the past two seasons he has worked with the three products but has not used personal protective equipment. He indicates possible dermal and inhalation exposure, but does not indicate a discreet incident exposure. He reports within the past three months he has developed tinnitus hearing sensitivity, headache and dizziness. He reports within the past two months twitching in his lower legs and ach weakness in his thighs. Intermittently within the past three months the caller report his vision has got out of balance which he clarifies as blurriness or delayed focusing of his eyes. He has gotten corrective lenses which he has reported has helped. The reporter indicates he has been to his general practitioner which has diagnosed an ear infection and placed him on two separate courses of antibiotics. His symptoms have not resolved. The reporter indicates he has been to two specialists (nonspecific) who have reported his hearing and ears are normal. He reports he has had two MRIs which were not diagnostic. His general practitioner has released him from work for the past month, but he states the symptoms have not improved. The reporter has indicated he is currently being referred to a toxicologist and an otolaryngologist. These appointments are pending. The caller was advised of the typical symptoms seen following dermal and inhalation exposure these active ingredients. It was recommended he continue to work with his physician to determine the cause of his current symptoms. The symptoms described are inconsistent with the toxicity profile of the listed active ingredients. Update was obtained from the caller two weeks following his initial contact with the registrant. He reports he has been to a neurologist. His primary care physician had suggested he may have carpal tunnel syndrome. The neurologist stated he did not have carpal tunnel syndrome and reached no diagnosis. The caller stated he was told there was nothing that could be done for him by this doctor. He has been to two otolaryngologists since his initial contact for the symptom of tinnitus. The first detected minor hearing loss and no structural abnormalities. He was referred to a second otolaryngologist for studies of his inner ear which, he reported, showed no abnormalities. He reports he was given one prescription (unspecified) by his family doctor for the tinnitus which did not alleviate that symptom. Current symptoms, when asked, included: ringing in ears, sick feeling in head and twitching in legs when at rest. He reports he has been on work release for one and one half month. When asked about follow up appointments or plans for his care he could provide no plan. He indicated his family doctor had wanted him to see a toxicologist at one point but he had no current appointment. He reports his family doctor indicated his chief rule outs included chemical exposure (nonspecific) and viral. The caller was advised the symptoms and time line indicated were inconsistent with the toxicity profile of the product. He was urged to continue to follow with his health care provider to determine the etiology of his current illness and most appropriate therapy. No further information is available.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

This Incident Report is being filed based on PMRAs current interpretation of the Incident Reporting Regulations. There is no direct evidence of exposure; the subject cannot describe a discrete exposure event. The symptoms described are not consistent with exposure to any of the active ingredients involved. Follow-up with the patient indicates he is suffering from a series of signs and symptoms that are inconsistent with exposure to a pyrethroid insecticide.