Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-0373

2. Registrant Information.

Registrant Reference Number: 3508177

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.

03-AUG-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 32405      PMRA Submission No.       EPA Registration No.

Product Name: MIRAGE STRESSGARD

• Active Ingredient(s)
  • TEBUCONAZOLE

---

PMRA Registration No. 32206      PMRA Submission No.       EPA Registration No.

Product Name: EXTERIS STRESSGARD

• Active Ingredient(s)
  • FLUOPYRAM
  • TRIFLOXYSTROBIN (CGA 279202)

---

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: Pub. Area - Outdoor/Zone publique - ext

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?

Yes

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Rash

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?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

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

Contact with treated area

What was the activity? Walking on treated fairways and greens.

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.

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.)

08/03/2022 A consumer reached out by email reporting that at least two golf club members developed a severe rash on their lower legs following application of Stressgard to their fairways and greens. He thought they had narrowed down the cause to Mirage Stressguard which was applied in Spring 2022, after which both members had a reaction, but then just recently an Exteris Stressguard application seems to have caused the same issue. 8/4/2022 In follow up information received by email from the consumer he further clarified that they both developed a rash in Spring 2022 after application of Mirage to the golf course greens. He additionally clarified that this has been occurring for at least a few years, and only recently he has been trying to investigate and determine a cause. It is the same two members developing symtpoms. Most recently prior to the initial email, they had sprayed Exteris at a rate of 100mL on fairways on a Tuesday and 200mL to greens that same Thursday during the mornings. One of the members played both days a couple hours after the product was sprayed, and developed a rash to her legs an unknown period of time after playing on Thursday.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

While a temporal relationship may exist since reported symptoms presented after a potential product exposure it is unclear if the patient came into contact with the products and how the contact occurred. The products could potentially cause slight irritation or allergic reaction in sensitive individuals if a person came into direct contact with the wet product but it is unclear if that occurred. The symptoms did presumably resolve after product exposure. It is unknown what decontamination efforts were employed and how soon after the rash resolved. It is unclear if a true re-challenge occurred in which the exposure was removed and symptoms completely resolved and when they were exposed again, to the same product, symptoms reappeared. In this case we are unsure if they were previously exposed to the same products in the past when the rashes occurred. Further information is necessary for a complete evaluation.

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Rash

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?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

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

Contact with treated area

What was the activity? Walking on treated fairways and greens.

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.

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.)

08/03/2022 A consumer reached out by email reporting that at least two golf club members developed a severe rash on their lower legs following application of Stressgard to their fairways and greens. He thought they had narrowed down the cause to Mirage Stressguard which was applied in Spring 2022, after which both members had a reaction, but then just recently an Exteris Stressguard application seems to have caused the same issue. 8/4/2022 In follow up information received by email from the consumer he further clarified that they both developed a rash in Spring 2022 after application of Mirage to the golf course greens. He additionally clarified that this has been occurring for at least a few years, and only recently he has been trying to investigate and determine a cause. It is the same two members developing symtpoms. Most recently prior to the initial email, they had sprayed Exteris at a rate of 100mL on fairways on a Tuesday and 200mL to greens that same Thursday during the mornings. One of the members played both days a couple hours after the product was sprayed, and developed a rash to her legs an unknown period of time after playing on Thursday.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

While a temporal relationship may exist since reported symptoms presented after a potential product exposure it is unclear if the patient came into contact with the products and how the contact occurred. The products could potentially cause slight irritation or allergic reaction in sensitive individuals if a person came into direct contact with the wet product but it is unclear if that occurred. The symptoms did presumably resolve after product exposure. It is unknown what decontamination efforts were employed and how soon after the rash resolved. It is unclear if a true re-challenge occurred in which the exposure was removed and symptoms completely resolved and when they were exposed again, to the same product, symptoms reappeared. In this case we are unsure if they were previously exposed to the same products in the past when the rashes occurred. Further information is necessary for a complete evaluation.