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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-5626

2. Registrant Information.

Registrant Reference Number: SC1482358

Registrant Name (Full Legal Name no abbreviations): Dow AgroSciences Canada Inc.

Address: 450-1st Street SW, Suite 2100

City: Calgary

Prov / State: AB

Country: Canada

Postal Code: T2P 5H1

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

Human

4. Date registrant was first informed of the incident.

14-OCT-14

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

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. 62719-2

Product Name: DMA-6 Weed Killer

  • Active Ingredient(s)
    • 2,4-D (PRESENT AS AMINE SALTS : DIMETHYLAMINE SALT, DIETHANOLAMINE SALT, OR OTHER AMINE SALTS)
      • Unknown

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

Caller, who does not have a significant amount of detail about her brother-in-law's use or exposure to the product, states that her brother-in-law has been using the product for 'a long time' during his farm work, she would guess 2-3yrs, but admits it could be completely inaccurate. She is unable to say how often he would apply the product, other than 'a lot', once using it 'all day'. She is also unable to say how he came into contact with the product.

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Other
    • Specify - Respiratory arrest
  • Skin
    • Symptom - Rash
    • Symptom - Edema
  • General
    • Symptom -
    • Specify - anaphylactic reaction
    • Symptom - Other
    • Specify - swollen lymph nodes
    • Symptom - Swelling

4. How long did the symptoms last?

>6 mos / > 6 mois

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Occupational

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

Application

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.

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.)

Approx. 2yrs ago the farmer began to develop swelling in his hands and feet as well as a rash (unknown location on his body). His MD suspected the blood pressure medication he was on, so he switched medications. Symptoms then recurred and became worse. Approx. 20 days prior to the call he began to have swelling (unknown location on his body) and difficulty breathing. He was taken to 3 different hospitals 5 times in total, diagnosed with anaphylactic shock and given 'emergency injections' (suspected to be epinephrine). Approx. 9 days prior to the call he was hospitalized because his body was swelling and 3 days prior to the call he stopped breathing, was placed on a respirator, and moved to ICU, where he remains. Caller states he has had many tests for cancer, has had biopsies performed of his bone marrow and they are planning to take biopsies of his lymph nodes (also now swollen) and skin. He had an echocardiogram 1day prior to the call (10/13/14) and caller states MDs have also been 'checking his heart and his kidneys'. She is unable to say what other specific tests have been performed and unable to say what medications he has been given or prescribed, aside from prednisone and 'allergy medications'. She states MDs are not able to determine the cause of his symptoms.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The AI in product has a well established safety profile following routine and longer term use. It is not clear that any exposure to the product has even occurred and is difficult to establish any correlation of the current (or past) medical issues this gentleman has apparently experienced with this product or any of its components. The product use history is extremely vague and lacks any description of a known or defined point of direct exposure to this product. The course of events in this case are highly speculative. Even had casual or incidental contact with this product occurred, the serious illness reported lacks plausibility. Other etiological causes should be considered.