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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0835

2. Registrant Information.

Registrant Reference Number: 2667816

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.

09-MAY-20

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-MAY-20

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. 32524      PMRA Submission No.       EPA Registration No.

Product Name: TEMPRID SC INSECTICIDE

  • Active Ingredient(s)
    • BETA-CYFLUTHRIN
      • Guarantee/concentration 10.5 %
    • IMIDACLOPRID
      • Guarantee/concentration 21 %

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: Res. - In Home / Rés. - à l'int. maison

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?

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

  • Respiratory System
    • Symptom - Difficulty Breathing
    • Symptom - Respiratory pain
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Irritated throat

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?

7. Exposure scenario

Non-occupational

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

Contact with treated area

Amount of time between application and contact 12

Hour(s) / Heure(s)

What was the activity? The individual returned to his apartment which had been treated with the product.

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

None

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 h

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.)

5/9/2020 Caller lives in an apartment that was sprayed with the product by a company on 5/8/2020. He was out of the apartment during application and did not return for 12 hours. He returned after 12 hours and went to bed. He woke up this morning with difficulty breathing, throat irritation, and soreness in his lungs. He has also vomited twice today. He had a fan running and windows open overnight, but says the smell is very strong in the apartment. he has now left the apartment. Caller also mentioned that in February 2020 he had aches/pains, leg cramps, and a cough. He was concerned that he had corona virus, so he isolated for 2 weeks. He has been taking what sounds like Quinine to help with the leg cramps. 5/14/2020 Attempted call back to the original caller. A message was left requesting follow up information. Caller returned the previous message. Caller reports that his symptoms resolve with fresh air, but would return when he sat on a couch in the apartment again. He saw his doctor on 5/11/2020. They ruled out covid19, and advised caller to avoid product treated areas. He still smells the product in his apartment, and has had to cover his couch with a plastic sheet. Sitting on the couch does not bother him since he covered the couch with plastic.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

There is a temporal relationship between the product exposure and onset of symptoms. While the product has a wide margin of safety people can be sensitized or have allergic reactions to anything in their environment including the product. All other differential diagnoses have not been ruled out and allergy testing would be necessary to determine if he is allergic to the product. His symptoms do abate when he removes himself from the environment and reappears when he sits in areas where the product was applied.