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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1345

2. Registrant Information.

Registrant Reference Number: 12110101

Registrant Name (Full Legal Name no abbreviations): Nufarm Agriculture Inc.

Address: 5507 1st Street SE

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2H 1H9

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

Human

4. Date registrant was first informed of the incident.

01-NOV-12

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 228 366

Product Name: Razor Pro Herbicide

  • Active Ingredient(s)
    • GLYPHOSATE (PRESENT AS ISOPROPYLAMINE SALT OR ETHANOLAMINE SALT)
      • Guarantee/concentration 41 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Unknown

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.

Medical Professional

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Chest congestion
    • Symptom - Coughing
  • Skin
    • Symptom - Jaundice
  • Liver
    • Symptom - Hepatic failure
  • Cardiovascular System
    • Symptom - Cardiac arrest
  • General
    • Symptom - Death

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?

Yes

6. b) For how long?

5

Hour(s) / Heure(s)

7. Exposure scenario

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.

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 1 2012 10 34 28 AM WT from Chemtrec (number) Chemtrec case # (number) Chemtrec employee indicates he has a doctor on the line that is from (name) County medical examiner s office in (city). The doctor is investigating a human death that took place in (month). The doctor is transferred. Razor Pro Herbicide No label or EPA reg is available; the doctor has the MSDS History: The doctor describes a (age) YO male landscaper who began to feel punky around Labor day. Symptoms were primarily respiratory such as a cough. Over the next week he felt progressively more ill and decided to stay home from work. On the 13th (09/13/12) he is sitting home watching television and went into cardiac arrest. He was transported to the hospital and resuscitated. He died 5 6 hours later. The autopsy was done and there are some changes associated with poor perfusion following the cardiac arrest (hypoxic encephalopathy). The notable change found on autopsy was liver failure or necrosis that appears fulminant. The family had mentioned the patient had switched the herbicide protocols he used at work to include the product. The caller indicates he is doing due diligence for the family. He had spoken to his staff toxicologist and they could find no information that indicated this may be seen with this AI. Chemtrec (C) Exposure would have been dermal or respiratory I assume, there was no report of ingestion? Attending Doctor (AD) correct C The skin is a pretty effective barrier to absorption here and the respiratory route is not one where generalized harm is typically seen. We would primarily expect an irritant effect here. Even following ingestion the AI is fairly well tolerated. There is report in our literature that liver effects can be seen, but that is not qualified. I am unsure what this is referring to. AD I see that. C Since you are asking for information beyond my scope I can offer a consult with our medical toxicologist if you would like The caller accepted 11 1 2012 10 54 48 AM PROSAR call out Responding doctor (RD) Prosar Case # (number) Conveyed history and conferenced with AD RD Do we have an idea when the time frame of the switch over to the glyphosate herbicide took place AD No, when they had heard he was in a nursery they had focused on the OP angle. RD It s not a OP, did they do a cholinesterase assay AD They did not, I did it was 40% normal but it was after cardiac arrest and resuscitation RD Was it RBC or serum AD I think it was whole blood. Enzymes do a lot of funny things after cardiac arrest and resuscitation. RD Well yes we can have hemolysis. AD He basically had a cough and nasal secretions, became progressively more and more fatigued and this fits with a guy going into liver failure. He is jaundiced. He hits the door with pretty impressive liver necrosis that is mostly centralobular. Expanding out but there is broad geographic areas of necrosis. He did not take medications such as acetaminophen. RD There has been described microvascular steatosis in the hepatocytes, centralobular. In fact there was just publication about this sept 2012 American Journal of Forensic Medicine Vol 33 244 247 in association with a glyphosate ingestion . AD I have no reason to suspect this type of exposure. The route is either cutaneous or inhalation and he was away from it (work) for a week. RD The AI is absorbed less than 2 % dermally Inhalation it is not very volatile, you do not want it to be volatile as a herbicide Most of it is irritation signs mucosal , eyes burning nasal burning AD He has a cough initially which he attributes to allergies RD Any lung injury AD Shock lung stuff RD Liver is not typically a target organ for glyphosate per say. Plus the mechanism you describe is unusual by the routes you describe. If he was drinking it this may be different. Especially outdoors. AD I m not ringing the bell on causation, more coincidental. About 10 15 %

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.

acute fulminate liver things we see are left etiology unknown RD Ask the family about supplements he may be taking AD He is not a medicine guy according to his family RD Consider ergogenic drugs, anabolic steroids. Look for steatosis. The kidneys were fine? AD Acute injury is present from the period of poor perfusion RD The mechanism and route are not consistent of the expectation of glyphosate AD Fair enough Call closed, case # and call back # provided