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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2512

2. Registrant Information.

Registrant Reference Number: 32607276

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: Suite 200, 160 Quarry Park Blvd S.E.

City: Calgary

Prov / State: Alberta

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.

11-JUN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

16-MAY-20

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. 524-445

Product Name: Roundup Herbicide

  • Active Ingredient(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 34704-573

Product Name: Bromax

  • Active Ingredient(s)
    • BROMACIL (PRESENT IN FREE FORM, AS DIMETHYLAMINE SALT, OR AS LITHIUM SALT)

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

Product Name: R-11

  • Active Ingredient(s)

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).

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Difficulty Breathing
  • General
    • Symptom - Weakness
    • Symptom - Swelling
  • Gastrointestinal System
    • Symptom - Tongue swelling

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)

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.)

Caller states he was exposed to Roundup (unknown product), R-11, and Bromax that were sprayed outside his home (he did not spray them himself). He was near the area where it was being sprayed yesterday and his lips began swelling, he was feeling kind of weak, no respiratory symptoms at that time. He took a Benadryl. Today, after being outside again, his lips became swollen, he felt like he had difficulty breathing, and felt like his tongue was swelling. He took Benadryl again, but it hasn't resolved the problem. MRPC discussed the product toxicity. The symptoms are not an expected response to the product but are consistent with a possible allergic reaction to any number of things. Referred to ED for medical evaluation and treatment. The man says he will call the hospital and talk to them about it.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.