Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2104

2. Registrant Information.

Registrant Reference Number: 2223499

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

Address: 160 QUARRY PARK BLVD. SE Suite 200

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.

26-APR-18

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

26-SEP-17

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.       PMRA Submission No.       EPA Registration No. 72155-80

Product Name: Home Pest plus Germ Killer Indoor & Outdoor Killer RTU (1 Gal)

• Active Ingredient(s)
  • 2-PHENYLPHENOL (PRESENT AS SODIUM SALT)
    • Guarantee/concentration .3 %
  • BETA-CYFLUTHRIN
    • Guarantee/concentration .05 %

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7. b) Type of formulation.

Other (specify)

Ready To Use Water based 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).

The product is sold as a ready to used formulation. According to the caller the product was further diluted into water. Further dilution is not recommended for this product. The concentration of the active ingredient in the water based formulation is low enough that Personal Protective Equipment such as gloves and respirators are not mandated on the label.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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

• Cardiovascular System
  • Symptom - Cardiac arrest

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Shortness of breath

4. How long did the symptoms last?

Persisted until death

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

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

Unknown

7. Exposure scenario

Unknown

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

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 h

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.)

4/26/2018 Caller's spouse applied the product at their home on 10/5/2017. He mixed the product with water (unknown dilution) and was spraying it outdoors for an unknown period of time. During application he was wearing shorts and gloves, but no mask or goggles. Following application, he came indoors and showered. He subsequently developed shortness of breath and collapsed in the living room. Emergency medical services were contacted, and paramedics arrived and attempted resuscitation. Attempts to resuscitate were unsuccessful. An autopsy was not conducted to determine the cause of death. The death certificate reportedly lists possible pesticide poisoning or heart attack. Caller also notes that the product had a rancid odor that was notable on the spouse's clothing.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

It is difficult to correlate product use with the outcome in this case. Based on the product and its components as formulated, it has a wide margin of safety associated with it and intended for routine consumer-level use. Incidental contact (splash / spill) or ingestion or inhalation of small quantities in the processes of mixing, loading or applying would not result in any significantly ill effects. This consumer had several significant confounding factors involved which were more likely involved in his death including a history of heart disease (diagnosed high blood pressure requiring multiple anti-hypertensive medications) and an unspecified form of diabetes which placed him at greater risk of sudden death independent of any postulated exposure to any chemical. An autopsy (not performed) would have identified a true cause of death through an examination of the organs, notable vasculature and appropriate toxicological testing to identify other factors.