Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-7147

2. Registrant Information.

Registrant Reference Number: 3304776

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.

20-JUN-22

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

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: Nemacur Nematicide (non-company)

• Active Ingredient(s)
  • FENAMIPHOS

---

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

Product Name: Paraquat (non-company)

• Active Ingredient(s)
  • PARAQUAT
    • 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: Orange groves

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

• Nervous and Muscular Systems
  • Symptom - Difficulty walking
  • Symptom - Muscle pain
  • Symptom - Numbness

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?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

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

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?

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.)

6/20/2022 All of the following was spontaneously reported by the caller. The caller is reporting that he worked in orange groves for 30 years and he was the individual that sprayed the chemicals as his profession. He named using several chemicals and reported them to be RoundUp, Paraquat, and Nemacur Nematicide. He was unable to give any identifying numbers for these products. He then spoke of an incident that occurred when he was 35 years old or so. He was in an open-door tractor and described that the levels of the chemicals were changing. At one point he had a skin exposure with the chemical mixture and was covered in the liquid. He removed his clothes and rinsed his skin. He was taken to the emergency room by ambulance after the exposure. He also stated that he was in the hospital for 4 to 5 days after the exposure. The caller referenced that he now has to use a wheelchair and crutches at times since he has trouble walking. He states he suffers from numbness and muscle pain. He has taken pain medication in the past for it. He feels his exposure to the chemicals has caused his health issues. The caller stated that he is trying to reach the manufacturers of the products so he knows who to go after. The statement was clarified with him that he is looking to seek legal action to sue the companies of these chemicals. He states he does not have much and expressed wanting to leave something to his children. Due to the legal threat, no primary medical history was obtained other than the caller mentioning his age during the conversation.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Company causality score: 1 (unlikely relationship). 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. The consumer reported using the three products over a thirty-year period but did not specify any exposures to the products outside of the one dermal exposure that occurred approximately 27 years ago. While a temporal relationship exists between the reported dermal exposure and the onset of his symptoms it is unknown what and when symptoms developed over the course of time since the exposure. RoundUp branded products typically contain glyphosate as the main active ingredient and a one-time dermal exposure to glyphosate being sprayed from a tractor as described here is unlikely to result in hospitalization, and permanent trouble walking, numbness or muscle pain. Glyphosate is not well absorbed through the skin. Paraquat is also not well absorbed through the skin but can be absorbed through non-intact or damaged skin. It can also be corrosive at higher concentrations and given prolonged dermal contact time may cause caustic injury and facilitate itas on absorption through the damaged skin. It is unclear if this consumer had intact skin at the time of the dermal exposure or how long it stayed on his skin. Toxicity from paraquat typically results from ingestions and causes pulmonary, hepatic, renal and myocardial injuries. There is one report of painful weakness of extremities, confirmed by biopsy, in a 44-year-old female who survived an ingestion but continued to occupationally use paraquat for 1.5 more years. Nemacur Nematicide typically contains fenamiphos, an organophosphate compound. Organophosphates competitively inhibit pseudocholinesterase and acetylcholinesterase, preventing hydrolysis and inactivation of acetylcholine. The acetylcholine accumulates at nerve junctions, causing malfunction of sympathetic, parasympathetic, and peripheral nervous systems and some of the central nervous system. Fenamiphos can be absorbed through the skin following dermal contact, especially in large or prolonged exposures and cause acute toxicity. Additionally, delayed distal sensory-motor polyneuropathy has been reported following exposures to organophosphates and in some cases complete recovery does not occur. This can be characterized by burning/tingling followed by weakness beginning in the legs which spreads proximally and in severe cases can result in spasticity or flaccidity. While not a diagnosis specifically reported in this case the patient did report having trouble walking, numbness and muscle pain in which he needs a wheelchair or crutches to aid him. Further information regarding his exposure, hospitalization and course of current signs and symptoms would be necessary in order to complete a full evaluation and analysis. All other differential causes need to be considered and ruled out. Yang GY, Tominack RL, Chung HM: Hepatic and muscle sequelae in a paraquat poisoning survivor (Abstract). Vet Human Toxicol 1987c; 29:480.