Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4183

2. Registrant Information.

Registrant Reference Number: NZB US 1

Registrant Name (Full Legal Name no abbreviations): Novozymes BioAg Limited

Address: 3935 Thatcher Avenue

City: Saskatoon

Prov / State: Saskatchewan

Country: Canada

Postal Code: S7R1A3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

21-NOV-12

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

19-NOV-12

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. 29146      PMRA Submission No.       EPA Registration No.

Product Name: Metarhizium anisopliae strain F52

• Active Ingredient(s)
  • METARHIZIUM ANISOPLIAE (STRAIN F52)

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7. b) Type of formulation.

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

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: Female

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

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Itchy eye

• Ear
  • Symptom - Ear irritation

• Respiratory System
  • Symptom - Sore throat

4. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Occupational

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

Other

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.

Respiratory

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.)

Worked was exposed to Metarhizium anisopliae in the research lab but was not wearing the appropriate protective equipment. The symptoms were relatively minor and no medical intervention was necessary.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Laboratory protocols have been updated to ensure that all lab personnel are wearing the appropriate PPE's before working with this active ingredient. Concentration of active is 10000000000 cfu/gram. Type of formulation TGAI