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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3825

2. Registrant Information.

Registrant Reference Number: 2977045

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

Address: Suite 130, 160 Quarry Park Boulevard SE

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-JUN-21

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Round-Up Weed and Grass Killer Non-Selective Herbicide

  • Active Ingredient(s)
    • GLYPHOSATE

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. - Out Home / Rés - à l'ext.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?

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Numbness

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

7. Exposure scenario

Non-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

Pesticide Spill

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

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

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

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.)

6/9/2021 Caller was a poor historian. He states approximately 2 years ago that he experienced an incident where the product was hooked up to a hose sprayer on his farm, and during application it accidentally blew off due to increased water pressure causing the skin of his upper left leg to be exposed to the diluted product. He rinsed the exposed skin 30 minutes later and did not note any symptoms initially. However, 1 year later he has noticed that the exposed area is numb to the touch. He then mentioned that he has worked with this product for several years and also had direct exposure on the skin of his hands on multiple occasions during use and never experienced symptoms. He was evaluated by a provider on an unspecified date in regards to the exposure, and was told that as long as the skin was rinsed he should be fine. No further treatments were used or recommended for the exposure. 6/14/2021 Attempted call back to the original caller. A message was left requesting follow up.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The onset of symptoms was a year after product exposure and all other differential diagnoses have not been ruled out. Symptoms did not abate after removal and decontamination and he has been exposed to the product on his skin many times and has not had similar symptoms. The symptoms are unlikely to be related to the product exposure.