Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-7148

2. Registrant Information.

Registrant Reference Number: 3785366

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-DEC-23

5. Location of incident.

Country: UNITED STATES

Prov / State: TENNESSEE

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: Roundup

• Active Ingredient(s)
  • GLYPHOSATE
    • Unknown

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Paraquat

• Active Ingredient(s)
  • PARAQUAT
    • Unknown

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Classic

• Active Ingredient(s)
  • CHLORIMURON-ETHYL
    • 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: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Family farm, No crop specified

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.

Other

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Other
  • Specify - Pulmonary fibrosis

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

Occupational

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.)

12/1/2023 Direct call from consumer. The following has been spontaneously reported by the caller. Caller was only able to verify product by name. Roundup Paraquat Classic. Caller is son reporting his father has been diagnosed with Pulmonary fibrosis and has been admitted to the hospital. Caller states x-ray, computed tomography, magnetic resonance imaging, ultrasound, and blood work have been done. Caller is not sure of the exact results but states his father has been diagnosed with Pulmonary fibrosis. Caller is inquiring if this product could have potentially lead to his fatheras diagnosis. Caller reports his father has been using this product on the family farm for 40 plus years. Caller states the product was diluted with water but he's not sure of the dilution rate. Caller reports the dilution amounts may have changed over the years. Caller was in the hospital and the reception was very poor. No additional details regarding symptoms and treatment was collected due to poor reception. Caller disconnected while on hold. Attempted callback one: Call rang a couple of times then went to dead air. Attempted callback two: Voicemail has not been set up. Unable to leave a voicemail message. Unable to provide case number to caller before he disconnected. 12/4/2023 Callback: Caller has not been had a chance to locate more specific product information. He is unable to take his case and callback numbers at this time. He would like another callback tomorrow so he can write down the numbers.12/5/2023 Attempted callback: No voicemail box available. Unable to leave a message.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Company causality assessment: 1 (unlikely relationship). The product was reported as aRoundup Paraquat Classic,a and could not be identified by EPA number or otherwise, and no further information was able to be obtained. It is likely the caller is referring to three separate products, RoundUp (BayerCrop Science), Classic Herbicide (Corteva) and another unknown product with the active ingredient paraquat. Little information was provided regarding product(s) use, dilution, or exposure. It is unclear if and how the consumer would have been exposed. RoundUp branded products typically contain glyphosate as the active ingredient and small inadvertent exposures during directed use are unlikely to result pulmonary fibrosis. Classic Herbicide contains the active ingredient chlorimuron-ethyl and although small inadvertent exposures after dilution with water as directed on the label is unlikely to result in pulmonary fibrosis it is of note that the product contains quartz. Inhalation of quartz in repeated dose toxicity studies in rats have reported chronic lung conditions and fibrosis. It is well documented that paraquat can cause pulmonary fibrosis and lung injury. Type I and types II pneumocytes selectively accumulate paraquat and causes redox cycling and production of toxic reactive oxygen species. This leads to cellular damage and pulmonary fibrosis. Most of the cases resulting in severe toxicity occur after ingestion. Paraquat is not well absorbed through intact skin and is typically only life threatening after exposure to non-intact skin or in prolonged exposures. Inhalational of sprayed paraquat can cause lung irritation but rarely results in systemic absorption. Given the lack of a known reported exposure and limited information all other differential diagnosis need to be considered and further information would be necessary to complete a full analysis.As the reporter did not identify a specific product alleged to have caused the exposure, Bayer has chosen to report this exposure using the product in this report using the information it had available, including reported use and market share. This selection may not be accurate due to the lack of information provided by the reporter.Sukumar CA, Shanbhag V, Shastry AB. Paraquat: The Poison Potion. Indian J Crit Care Med. 2019 Dec;23(Suppl 4):S263-S266. doi: 10.5005/jp-journals-10071-23306. PMID: 32021001; PMCID: PMC6996657.