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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-5753

2. Registrant Information.

Registrant Reference Number: 3705194

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.

01-SEP-23

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

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. 524-308

Product Name: ROUNDUP EXPORT HERBICIDE

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

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 / Rs - 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

  • General
    • Symptom - Cancer
    • Specify - Bladder cancer
  • Renal System
    • Symptom - Polyuria
    • Symptom - Frequent urination

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?

Unknown

6. b) For how long?

7. Exposure scenario

Occupational

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

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

Other

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.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>6 mos / > 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.)

9/1/2023 All of the following was spontaneously reported by the caller: He reported the product to be called Round Up, but did not have any further identifying info on it. Caller is reporting that he has bladder cancer that his doctor says is caused by the product. He first started using the original Round up in 1974 to spray for weed control regularly at work. He did lawn care for a living. He guesses he breathed the fumes but denies skin exposures. He got sick with the cancer in 2015. He had most of his bladder removed and had chemo and radiation treatments. He is not in very good health but has no cancer concerns at this time. He is under the care of a doctor. He complains that sometimes he has to go to the bathroom every 15 min. He is calling to inquire on possible compensation and check if the company will do anything.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Although the reporter could not provide product-specific identifying information, the registrant has chosen to report this using the selected product in this report. As the product was not identified, the product was selected according with due diligence, but may not be accurate due to lack of information provided. Company correlation assessment: 1 (Unlikely relationship). While a temporal relationship exists between the use of the product and onset of symptoms an exposure to the product is not known and it is unclear if and how he is being exposed to the product. The Pest Management Regulatory Agency (PMRA) concluded that Glyphosate is not likely to be carcinogenic to humans.