Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-1760

2. Registrant Information.

Registrant Reference Number: 3489606

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

Domestic Animal

Environment

4. Date registrant was first informed of the incident.

09-JAN-23

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

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)

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PMRA Registration No. 29367      PMRA Submission No.       EPA Registration No.

Product Name: TUNDRA HERBICIDE

• Active Ingredient(s)
  • BROMOXYNIL
  • FENOXAPROP-P-ETHYL (ISOMER)
  • PYRASULFOTOLE

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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: Res. - Out Home / Rés - à 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?

Yes

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 - Muscle pain

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?

No

6. b) For how long?

7. Exposure scenario

Non-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

Drift from the application site

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.

>2 mos <=6 mos / > 2 mois < = 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.)

1/9/2023 An individual has reported that the Tundra Herbicide was sprayed in June of 2022 by a neighbor, a cloud of product lasted over 3 hours and had drifted over to their garden. The reporter then called the local municipality, was told his neighbor was using this product, and was told he could eat his vegetables as long as he waited 2 weeks before consuming them. Caller waited the 2 weeks and then harvested beets, carrots, potatoes, cucumbers, squash, lettuce, and other vegetables that he can't remember. Caller states the potatoes looked weird. Half of the potato looked normal on one side and rotten on the other side with a perfect line down the middle. Callers symptoms of muscle aches began in approximately September or October 2022. His wifes symptoms, also muscle aches, either began in July of that year, or October or November 2022. His symptoms worsen when eating the potatoes, or when out in the garden. On or around December 16th, 2022 caller consulted his health care provider regarding his symptoms and the potential exposure to this product. His doctor told him his symptoms were not from this product because if he had an ingestion of this product he would have been vomiting. He was advised to stop eating the potatoes, and his symptoms improved. He does not know whether his wife did anything to manage her symptoms, although their symptoms persist. His dog has also been shaking her head and ears since around the time the product was sprayed. She was evaluated by a veterinarian on January 5th, 2023 with no noted cause. She does swim often in a dugout during the warm months until October. The veterinarian performed an otic exam and ear swab, but no noted results. Caller reports he had his water tested on December 2nd, 2022 from a dugout in the garden that showed values of 2,4D = 5.21, MCPA = 5.26, and 2,4,5-T = 5.36. No further information is available.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The symptoms started after the product was sprayed near the caller (unclear if an exposure occurred at the time) and a few months after chronically ingesting the produce. While a temporal relationship exists between product exposure and the onset of symptoms the amount of product is not expected to be in high enough concentrations to cause or otherwise influence the reported symptoms. The caller reports a drift from Tundra Herbicide came through his garden. Given the described exposure, minimal amounts would have been deposited on the produce and would not be expected to cause the reported symptoms. Additionally, the caller waited two weeks before harvesting, in which the product likely dried and was potentially washed off while watering the produce or by rain. The caller also likely washed the produce after harvest before eating. The amount of product left on the produce that would have been potentially ingested would be minimal, if any. All other differential diagnoses have not been ruled out and the product has not been re-challenged.

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: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Muscle pain

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-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

Drift from the application site

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.)

1/9/2023 An individual has reported that the Tundra Herbicide was sprayed in June of 2022 by a neighbor, a cloud of product lasted over 3 hours and had drifted over to their garden. The reporter then called the local municipality, was told his neighbor was using this product, and was told he could eat his vegetables as long as he waited 2 weeks before consuming them. Caller waited the 2 weeks and then harvested beets, carrots, potatoes, cucumbers, squash, lettuce, and other vegetables that he can't remember. Caller states the potatoes looked weird. Half of the potato looked normal on one side and rotten on the other side with a perfect line down the middle. Callers symptoms of muscle aches began in approximately September or October 2022. His wifes symptoms, also muscle aches, either began in July of that year, or October or November 2022. His symptoms worsen when eating the potatoes, or when out in the garden. On or around December 16th, 2022 caller consulted his health care provider regarding his symptoms and the potential exposure to this product. His doctor told him his symptoms were not from this product because if he had an ingestion of this product he would have been vomiting. He was advised to stop eating the potatoes, and his symptoms improved. He does not know whether his wife did anything to manage her symptoms, although their symptoms persist. His dog has also been shaking her head and ears since around the time the product was sprayed. She was evaluated by a veterinarian on January 5th, 2023 with no noted cause. She does swim often in a dugout during the warm months until October. The veterinarian performed an otic exam and ear swab, but no noted results. Caller reports he had his water tested on December 2nd, 2022 from a dugout in the garden that showed values of 2,4D = 5.21, MCPA = 5.26, and 2,4,5-T = 5.36. No further information is available.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

The symptoms started after the product was sprayed near the caller (unclear if an exposure occurred at the time) and a few months after chronically ingesting the produce. While a temporal relationship exists between product exposure and the onset of symptoms the amount of product is not expected to be in high enough concentrations to cause or otherwise influence the reported symptoms. The caller reports a drift from Tundra Herbicide came through his garden. Given the described exposure, minimal amounts would have been deposited on the produce and would not be expected to cause the reported symptoms. Additionally, the caller waited two weeks before harvesting, in which the product likely dried and was potentially washed off while watering the produce or by rain. The caller also likely washed the produce after harvest before eating. The amount of product left on the produce that would have been potentially ingested would be minimal, if any. All other differential diagnoses have not been ruled out and the product has not been re-challenged.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

100.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Head shaking
  • Symptom - Shaking
  • Specify - Ear shaking

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

16. How was the animal exposed?

Other / Autre

specify It is unknown how the animal was exposed as the product is suspected to have been sprayed on a neighbor's land by the neighbor.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1/9/2023 An individual has reported that the Tundra Herbicide was sprayed in June of 2022 by a neighbor, a cloud of product lasted over 3 hours and had drifted over to their garden. The reporter then called the local municipality, was told his neighbor was using this product, and was told he could eat his vegetables as long as he waited 2 weeks before consuming them. Caller waited the 2 weeks and then harvested beets, carrots, potatoes, cucumbers, squash, lettuce, and other vegetables that he can't remember. Caller states the potatoes looked weird. Half of the potato looked normal on one side and rotten on the other side with a perfect line down the middle. Callers symptoms of muscle aches began in approximately September or October 2022. His wifes symptoms, also muscle aches, either began in July of that year, or October or November 2022. His symptoms worsen when eating the potatoes, or when out in the garden. On or around December 16th, 2022 caller consulted his health care provider regarding his symptoms and the potential exposure to this product. His doctor told him his symptoms were not from this product because if he had an ingestion of this product he would have been vomiting. He was advised to stop eating the potatoes, and his symptoms improved. He does not know whether his wife did anything to manage her symptoms, although their symptoms persist. His dog has also been shaking her head and ears since around the time the product was sprayed. She was evaluated by a veterinarian on January 5th, 2023 with no noted cause. She does swim often in a dugout during the warm months until October. The veterinarian performed an otic exam and ear swab, but no noted results. Caller reports he had his water tested on December 2nd, 2022 from a dugout in the garden that showed values of 2,4D = 5.21, MCPA = 5.26, and 2,4,5-T = 5.36. No further information is available.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Minor

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.

Subform IV: Environment (includes plants insects and wildlife)

1. Type of organism affected

Herbaceous Plants / Plante herbacée

2. Common name(s)

Potato

3. Scientific name(s)

Solanum tuberosum

4. Number of organisms affected

1

5. Description of site where incident was observed

Fresh water

Terrestrial

Residential

Salt Water

6. Check all symptoms that apply

Deformities

Visible injury ( eg. chlorosis, necrosis, bleaching)

7. Describe symptoms and outcome (died, recovered, etc.).

Half of the potato looked normal on one side and rotten on the other side with a perfect line down the middle. It is unknown how far from the application site the potato was growing. The nature of exposure to the plant is similarly unknown.

8. a) Was the incident a result of (select all that apply)

Other

The product was applied by the neighbor to the neighbor's property, after which a cloud of product remained suspended for 3 hours.

8. b) i) How many times has the product been applied this year?

8. b) ii) What was the date of the last application?

9. Did it rain

9. a) During application?

No

9. b) Up to 3 days after application?

No

10. a) Was there a buffer zone?

No

10. b) What type?

10. c) What was the size of the buffer zone?

11. a) Were environmental samples collected and analysed?

No

To be determined by Registrant

12. Severity classification (if there is more than one possible classification, select the most severe)

Moderate

13. Please provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.