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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-3036

2. Registrant Information.

Registrant Reference Number: 3602988

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-MAY-23

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

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 Ready Weed Killer

  • 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: Unknown / Inconnu

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

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Confusion
    • Symptom - Difficulty concentrating
    • Specify - Hard to concentrate
  • Skin
    • Symptom - Irritated skin
    • Symptom - Discolouration
    • Specify - Skin discoloration
  • General
    • Symptom - Cancer
    • Specify - Lymphoma
    • Symptom - Pain
    • Symptom - Fatigue

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

Unknown

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

Application

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.)

5/16/2023 Caller refers to product 真真真Round UP Ready Weed Killer真真真 and did not provide a registration number. Caller states he was diagnosed with lymphoma in 1997. Caller states he had a painful black ring develop around his stomach, he was very tired, easily confused, found it hard to concentrate, and was partially paralyzed from a previous spinal cord injury. He stated visiting his doctor regarding his symptoms and was diagnosed with cancer. He said he believes it is related to an exposure to this product in the 80s while using it on his grandfather's farm to spray weeds. He stated that he currently has a diagnosis of stage 4 lymphoma of the spine and is being treated for lymphoma with hemp seed oil. Caller states his grandfather used this product as well on his farm for many years and died from cancer. He states his grandfather died from stomach cancer in 1992 and was treated with chemo for 2 years before passing.He also states grandmother passed away in the 2000s of low white blood cell count and that she did receive medical treatments, but caller did not have specifics. Caller states his grandparents died prematurely in their 80s and 90s, he cannot recall the exact ages. He states his father could provide more information regarding his grandparents. Caller states he has been reading online that others have had large pay outs of up to 10 billion from lawsuits and he would like to request reimbursement and compensation to pay for his treatments. He also stated seeing another product featured on the news where lawsuits came up and that he was exposed to that too but was unable to say what the product was.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Glyphosate has a wide margin of safety in humans and is not known to be a cause of cancers in humans. Glyphosate has been recognized by the PMRA as not presenting a carcinogenic risk to humans.

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 - Death
    • Symptom - Cancer
    • Specify - Stomach cancer

4. How long did the symptoms last?

Persisted until death

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

Unknown

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

Application

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.

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.)

5/16/2023 Caller refers to product 真真真Round UP Ready Weed Killer真真真 and did not provide a registration number. Caller states he was diagnosed with lymphoma in 1997. Caller states he had a painful black ring develop around his stomach, he was very tired, easily confused, found it hard to concentrate, and was partially paralyzed from a previous spinal cord injury. He stated visiting his doctor regarding his symptoms and was diagnosed with cancer. He said he believes it is related to an exposure to this product in the 80s while using it on his grandfather's farm to spray weeds. He stated that he currently has a diagnosis of stage 4 lymphoma of the spine and is being treated for lymphoma with hemp seed oil. Caller states his grandfather used this product as well on his farm for many years and died from cancer. He states his grandfather died from stomach cancer in 1992 and was treated with chemo for 2 years before passing.He also states grandmother passed away in the 2000s of low white blood cell count and that she did receive medical treatments, but caller did not have specifics. Caller states his grandparents died prematurely in their 80s and 90s, he cannot recall the exact ages. He states his father could provide more information regarding his grandparents. Caller states he has been reading online that others have had large pay outs of up to 10 billion from lawsuits and he would like to request reimbursement and compensation to pay for his treatments. He also stated seeing another product featured on the news where lawsuits came up and that he was exposed to that too but was unable to say what the product was.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

Glyphosate has a wide margin of safety in humans and is not known to be a cause of cancers in humans. Glyphosate has been recognized by the PMRA as not presenting a carcinogenic risk to humans.

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: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Blood
    • Symptom - Leukopenia
  • General
    • Symptom - Death

4. How long did the symptoms last?

Persisted until death

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

Unknown

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

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.

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.)

5/16/2023 Caller refers to product 真真真Round UP Ready Weed Killer真真真 and did not provide a registration number. Caller states he was diagnosed with lymphoma in 1997. Caller states he had a painful black ring develop around his stomach, he was very tired, easily confused, found it hard to concentrate, and was partially paralyzed from a previous spinal cord injury. He stated visiting his doctor regarding his symptoms and was diagnosed with cancer. He said he believes it is related to an exposure to this product in the 80s while using it on his grandfather's farm to spray weeds. He stated that he currently has a diagnosis of stage 4 lymphoma of the spine and is being treated for lymphoma with hemp seed oil. Caller states his grandfather used this product as well on his farm for many years and died from cancer. He states his grandfather died from stomach cancer in 1992 and was treated with chemo for 2 years before passing.He also states grandmother passed away in the 2000s of low white blood cell count and that she did receive medical treatments, but caller did not have specifics. Caller states his grandparents died prematurely in their 80s and 90s, he cannot recall the exact ages. He states his father could provide more information regarding his grandparents. Caller states he has been reading online that others have had large pay outs of up to 10 billion from lawsuits and he would like to request reimbursement and compensation to pay for his treatments. He also stated seeing another product featured on the news where lawsuits came up and that he was exposed to that too but was unable to say what the product was.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

Glyphosate has a wide margin of safety in humans and is not known to cause low white blood cell count.