Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1995

2. Registrant Information.

Registrant Reference Number: 2211670

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: 160 QUARRY PARK BLVD. SE Suite 200

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

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

Human

4. Date registrant was first informed of the incident.

03-APR-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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)

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PMRA Registration No. 28590      PMRA Submission No.       EPA Registration No.

Product Name: Forbid

• Active Ingredient(s)
  • SPIROMESIFEN

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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-Indoor / Agricole-intérieur

Préciser le type: Greenhouses

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

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

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

Yes

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

• Nervous and Muscular Systems
  • Symptom - Confusion
  • Symptom - Dizziness

• Skin
  • Symptom - Rash

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?

No

6. b) For how long?

Unknown

7. Exposure scenario

Occupational

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

Application

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

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

Long-sleeve shirt

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

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.)

4/3/2018 Caller reports that he used product to spray several greenhouses at his workplace over the last month. He indicates that he used the properly-diluted product on four separate occasions for approximately an hour each time, between 3/13/2018 and 3/29/2018. Sometimes he wore a mask while spraying the product, sometimes he did not. He wore a protective raincoat each time, and he didn't initially wear the hood up. Initially he used a pump sprayer, but later he used an electric sprayer to save time. The product did not leak onto his skin, and there was not a witnessed exposure to the product. He thinks he may have inhaled the product, but he does not report any respiratory symptoms. He does indicate that he was seen in the local hospital for a rash once the day after using the product, and was prescribed a topical steroid which cleared up the rash within a couple of days. The caller believes that the product may have dripped onto the back of his neck to cause the rash, but there was not a witnessed exposure. He indicates that he was seen by a physician today for dizziness and confusion, but was not admitted. The caller reports that they drew blood. He indicates that he was told to go home and keep himself well hydrated, and he admits that he may be dehydrated. He reports that he hasn't been eating well lately due to his concerns about his exposure. The caller indicates that a physician told him that he was poisoned by the product.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The active ingredient in this product works by inhibiting lipid biosynthesis (especially triglycerides and free fatty acids) and does not appear to have any direct effects on the nervous system. The noted effects of dizziness and confusion would not be expected to be associated with any direct contact with the product. Unexpected dermal eruptions such as rashes and other similar effects are always possible from direct contact from any substance for some people (including soaps, cosmetics and personal care products) in an often-unpredictable fashion; however, direct contact would need to have occurred (which cannot be verified in this case). Of note, this consumer is reported to have underlying atopy (allergy to bees) and thus may be at increased risk for other allergy-type events following exposure to an agent they react to and does not appear that any testing was completed to verify the etiology of the dermal eruption in this case. Inadvertent inhalation exposure would not have resulted in any systemic toxicity, rather, minimal, self-limiting upper respiratory effects such as throat irritation or cough might occur, though none of these such effects were reported either. In summary, it is more likely than not, that the reported effects are unrelated to the use of the product other than the temporal nature of the event(s) following the application.