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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2059

2. Registrant Information.

Registrant Reference Number: 3891161

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

Address: 160 Quarry Park Boulevard SE Suite 130

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.

16-APR-24

5. Location of incident.

Country: UNITED STATES

Prov / State: NEVADA

6. Date incident was first observed.

14-APR-24

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. 71995-33

Product Name: ROUNDUP WEED & GRASS KILLER READY-TO-USE PLUS

  • Active Ingredient(s)
    • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
      • Unknown
    • PELARGONIC ACID

7. b) Type of formulation.

Liquid

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?

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Cardiovascular System
    • Symptom - Palpitations
  • Respiratory System
    • Symptom - Coughing
    • Symptom - Other
    • Specify - Collapsed Lung
    • Symptom - Shortness of breath
    • Symptom - Pneumonia

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Yes

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

Drift from the application site

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

4/16/2024 All of the following was spontaneously reported by the consumer. Consumer reports shortness of breath, Slight pounding in his chest, and coughing after exposure to Roundup the Scotts Weed and Grass Killer Ready-To-Use Plus. Consumer disconnected while on hold with the Toxicologist. Called out to continue case. Two days ago, the consumer was spraying roundup outside and a light wind kicked up twice and he inhaled when the product blew back at him. He stated that he had some shortness of breath right after the exposure, he felt a pounding in his chest and he would cough occasionally. He stated that the shortness of breath and the chest pounding are resolved, but he is still coughing occasionally and wants to know if it is related to the product exposure. The consumer was speaking in full sentences and there were no audible breathing sounds. He stated he took an aspirin the day of the exposure and it helped him. As of today he can breathe in deeply but occasionally he is coughing when he does. 4/18/2024 Attempted call back and left message with reason for call, case number and call back number. 4/19/2024 Attempted call back and the caller answer but stated I cannot talk right now I am in the emergency room. 4/22/2024 Attempted callback and spoke with caller. He went into the emergency department on 19Apr24. He was diagnosed with a collapsed lung and pneumonia. He was admitted and is still in hospital. He has discussed the product with the doctors. When asked what they said, caller at first says he does not know, then says that is between him and them, and he does not want to share it. He declined to provide any further details.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Company correlation score: 2 (Unlikely relationship). The product contains glyphosate 2%, pelargonic acid 2% and additional formulating agents. The reporter described two possible inhalations of droplets during application from a light wind blowing the sprayed product back at him. While self-limiting coughing can occur upon inhalation of droplets, it is unlikely that two inhalations of the sprayed product would result in pneumonia and a collapsed lung. Consumer declined to provide differential diagnosis from providers or elaborate on course of symptoms. Further information regarding symptom evolvement that led him to seek medical evaluation in the emergency room, laboratory testing, and treatment is necessary for further assessment.