Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6403

2. Registrant Information.

Registrant Reference Number: PROSAR case: 1-40522975

Registrant Name (Full Legal Name no abbreviations): Valent Biosciences Corporation

Address: 870 Technology Way

City: Libertyville

Prov / State: Illinois

Country: USA

Postal Code: 60048

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

Human

Domestic Animal

4. Date registrant was first informed of the incident.

16-APR-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

15-APR-15

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. 24977      PMRA Submission No.       EPA Registration No.

Product Name: Foray 48B

• Active Ingredient(s)
  • BACILLUS THURINGIENSIS BERLINER SSP KURSTAKI STRAIN HD-1

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

Units: L/ha

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

Site: Agricultural-Outdoor/Agricole-extérieur

Préciser le type: Unknown

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Helicopter

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: Female

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

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing
  • Symptom - Irritated throat
  • Symptom - Sore throat

4. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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)

Drift from the application site

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Respiratory

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 that her city has been doing several aerial applications of the product for gypsy moths. The 1st session started 4/15 and the 2nd session started 4/18. Each spraying session lasted 4 days. She, the caller, her husband, and their tenant all developed dry coughs the next day after the 1st spraying (4/16). None of them smoke. Her husband has slight allergies to cats but no asthma. She does not have allergies or asthma. She does not know whether or not her tenant has allergies or asthma. Her husband's cough lasted 3 days. She does not know the duration of the tenant's cough. Her cough lasted 3 days but she has had a sore throat since 4/16. She saw an MD about the sore throat about 1 week ago. The MD thought it was a virus, but can her an Rx for abxs just in case. The caller filled the Rx but has not yet started the abxs.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Her tenant's dog had 2 asthma attacks over 4/18-4/19/15. She does not know if the dog needed to be seen by a DVM. She does not know if the dog has a hx of asthma. Caller states her dog developed pancreatitis on 4/20. The dog almost died but recovered with treatment. She states that the last spraying ended on 5/2/15. She and her husband were working the yard last night and both developed a dry cough again. Caller states she has been taking with neighbors, with city and provincial officials, with Health Canada, and with researchers in New Zealand about the AI in the product. Q1: Her research has shown her that the product produced reduced pancreatic enzymes in lab mice. Could the product have caused her dog's pancreatitis?A1: No, pancreatitis is most commonly the rest of an ingestion of a fatty meal. Pre-diabetics and diabetic animals are also more likely to develop pancreatitis. Pancreatitis could not develop from skin contact with or inhalation of the product. The mice studies were likely those of ingestion of large amounts of the product over a period of time.Q2: Caller states that according to the head pathologist at her local university, there is no way to test bodily fluids for the AI. Yet in looking at studies, she sees the authors mention people and animals getting tested. Caller wants herself and her husband along with her dog tested for the AI.A2: The AI is a biological pesticide. Unfortunately I have no information on how one would test for it. It is practically non-toxic, thou it can cause irritation by all routes. It would not be absorbed into the skin to get into bodily fluids. Perhaps the studies were testing for presence of product in the air.- Rec. you discuss your desire for testing with your local/provincial public health agencyQ3: Can she get her throat swabbed and that swab tested for the AI?A3: I am not aware of any such test. Rec. continuing to work with your MD. Caller states she lives in a city of 250,000 people and she feels like she is in a war zone with the helicopters flying overhead. She feels like her civil liberties have been violated. When the product was used in New Zealand, studies were done before and after, the government moved sensitive people away from their homes for the spraying, and took care of expenses if a reaction happened.

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing

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

Non-occupational

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

Drift from the application site

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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.)

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

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

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Unknown

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing

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

Non-occupational

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

Drift from the application site

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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.)

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Respiratory

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Respiratory System
  • Symptom - Asthma

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Other / Autre

specify Unknown

17. Provide any additional details about the incident

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

Caller states that her city has been doing several aerial applications of the product for gypsy moths. The 1st session started 4/15 and the 2nd session started 4/18. Each spraying session lasted 4 days. She, the caller, her husband, and their tenant all developed dry coughs the next day after the 1st spraying (4/16). None of them smoke. Her husband has slight allergies to cats but no asthma. She does not have allergies or asthma. She does not know whether or not her tenant has allergies or asthma. Her husband's cough lasted 3 days. She does not know the duration of the tenant's cough. Her cough lasted 3 days but she has had a sore throat since 4/16. She saw an MD about the sore throat about 1 week ago. The MD thought it was a virus, but can her an Rx for abxs just in case. The caller filled the Rx but has not yet started the abxs.

---

To be determined by Registrant

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

Minor

19. Provide supplemental information here

Her tenant's dog had 2 asthma attacks over 4/18-4/19/15. She does not know if the dog needed to be seen by a DVM. She does not know if the dog has a hx of asthma. Caller states her dog developed pancreatitis on 4/20. The dog almost died but recovered with treatment. She states that the last spraying ended on 5/2/15. She and her husband were working the yard last night and both developed a dry cough again. Caller states she has been taking with neighbors, with city and provincial officials, with Health Canada, and with researchers in New Zealand about the AI in the product. Q1: Her research has shown her that the product produced reduced pancreatic enzymes in lab mice. Could the product have caused her dog's pancreatitis?A1: No, pancreatitis is most commonly the rest of an ingestion of a fatty meal. Pre-diabetics and diabetic animals are also more likely to develop pancreatitis. Pancreatitis could not develop from skin contact with or inhalation of the product. The mice studies were likely those of ingestion of large amounts of the product over a period of time.Q2: Caller states that according to the head pathologist at her local university, there is no way to test bodily fluids for the AI. Yet in looking at studies, she sees the authors mention people and animals getting tested. Caller wants herself and her husband along with her dog tested for the AI.A2: The AI is a biological pesticide. Unfortunately I have no information on how one would test for it. It is practically non-toxic, thou it can cause irritation by all routes. It would not be absorbed into the skin to get into bodily fluids. Perhaps the studies were testing for presence of product in the air.- Rec. you discuss your desire for testing with your local/provincial public health agencyQ3: Can she get her throat swabbed and that swab tested for the AI?A3: I am not aware of any such test. Rec. continuing to work with your MD. Caller states she lives in a city of 250,000 people and she feels like she is in a war zone with the helicopters flying overhead. She feels like her civil liberties have been violated. When the product was used in New Zealand, studies were done before and after, the government moved sensitive people away from their homes for the spraying, and took care of expenses if a reaction happened.