Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1041

2. Registrant Information.

Registrant Reference Number: 1050551

Registrant Name (Full Legal Name no abbreviations): McLaughlin Gormley King Company

Address: 8810 Tenth Ave North

City: Minneapolis

Prov / State: MN

Country: USA

Postal Code: 55427-4319

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

Human

4. Date registrant was first informed of the incident.

01-OCT-12

5. Location of incident.

Country: UNITED STATES

Prov / State: KANSAS

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. 1021-1603

Product Name: NyGuard IGR

• Active Ingredient(s)
  • PYRIPROXYFEN
    • Guarantee/concentration 10 %

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Bayer CropScience Suspend SC

• Active Ingredient(s)
  • DELTAMETHRIN
    • 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: Res. - In Home / Rés. - à l'int. maison

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

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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.

Other

2. Demographic information of data subject

Sex: Unknown

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Reproductive System
  • Symptom - Premature birth

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?

No

6. b) For how long?

7. Exposure scenario

Non-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)

None

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.)

10/1/2012 Caller is a professional pest control operator. They had applied NyGuard IGR as well as a Bayer CropScience product called Suspend SC as a crack and crevice application within a customer's home on 2/25/2012. The customer was not in the home during the application. Customer did not return to the home until 3 hours after the application. An unspecified period of time after the application, the customer birthed a premature baby. The caller did not have specific information on how premature the baby was or what the state of the babies health was. The date of birth is not known. The customer is now alleging that the premature birth occurred as a result of the pesticide application.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. Any relationship between the use of these pesticides in a person's home and the occurrence of a premature birth is inconceivable and lacks biological plausibility as these active ingredients are not known teratogens at the concentrations used with applications. Secondly, the product use history lacks any description of a known or defined point of direct exposure to these pesticide products. Even had casual or incidental contact with a surface exposed to these pesticides occurred, such a serious complication would be unexpected. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the active ingredients used in this product such a causal relationship appears to be scientifically implausible.