Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4961

2. Registrant Information.

Registrant Reference Number: 2018-CA-02772

Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)

Address: 6750 Transcanada Highway

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

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

Residues in Food

4. Date registrant was first informed of the incident.

20-AUG-18

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

27-JUN-18

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. 27829      PMRA Submission No.       EPA Registration No. 773-74

Product Name: Saber Pour On

• Active Ingredient(s)
  • LAMBDA-CYHALOTHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Animal / Usage sur un animal domestique

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

Narrative: Suspected residues in milk reported by the herd vet on 20 Aug 2018. The herd vet reported that a dairy producer used Saber Pour On on approximately 20 of their lactating dairy cows, and resulted in the dumping of the milk. Residues were found in the milk. The testing method used is not known. There was no health event to the cattle. A follow-up is expected.Follow-up 06 Sept 2018: Additional information was received from the herd vet. On 26 June 2018, 4 lactating dairy cows was applied the Saber Pour On. The cows were sampled individually on 26 and 27 June 2018 at milking. A sample was also taken from the bulk tank in the truck on the 27 June 2018 to check for residues of Lambda-Cyhalothrin. The sample from the tank was considered positive at 11 ng/gm (limit is 10 ng/gm), and the contents of the truck were discarded. On 28 June 2018 a sample from 1 of the lactating dairy cows was 20 ng/gm and the other 3 were below 10 ng/gm (negative). As of 01 July 2018 all the dairy cows were negative for Lambda-Cyhalothrin. Nothing further is expected.Follow-up 24 Sept 2018, additional information was received, the complete report was received. Clarification on result samples taken from the individual cows on 28 June 2018. Cow #1 was negative(10ng/gm) in the AM and PM, Cow#2 was negative in the AM but positive at in the PM at 17 ng/gm, Cow#3 was negative in the AM and positive in the PM 18 ng/gm, Cow#4 was positive both in the AM and PM 20 and 42 ng/gm respectively. A second sample from a bulk tank had been taken and was negative. No other additions have been made. Nothing further is expected.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform V: Residues in Food

1. Pesticide(s) and degradate(s) analysed for

Lambda-Cyhalothrin

2. Concentration of pesticide/degradate in food

42

Other Units ng/gm

3. Corresponding limit of detection

10

Other Units ng/gm

4. Sample Type

Raw Agricultural commodity

5. Method of analysis (include if a confirmatory method was used in addition to the screening method)

unknown

Sample Information

6. What is the reason the sample was collected (e.g. complaint, inspection, process monitoring)?

process monitoring

7. What organization collected the sample?

Other

8. From what point in the distribution channel was the sample taken?

Farm

9. How large was the food commodity from which the sample was taken?

4 cows and bulk tank

10. How many samples were taken?

14

11. How large was the sample size?

Unknown

12. What action was taken based on the violative residue?

Shipment destroyed

For Registrant use only

14. Provide supplemental information here

Individual samples from 4 cows( 3 times), and 2 from Bulk tank