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Addition Of A Claim For Goat Milk To The IDEXX Laboratories, Inc. New SNAP Beta-Lactam Test Kit

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HHS:PHS:FDA:CFSAN:OFS:DPDFS:DEB:MST

5100 Paint Branch Parkway
College Park, MD 20740-3835

M-I-13-7

October 31, 2013

TO:  All Regional Food and Drug Directors
Attn:  Regional Milk Specialists

FROM:  Dairy and Egg Branch (HFS-316)

SUBJECT:  Addition Of A Claim For Goat Milk To The IDEXX Laboratories, Inc. New SNAP Beta-Lactam Test Kit

The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) has evaluated data supporting the use of the NCIMS accepted IDEXX Laboratories, Inc. New SNAP Beta Lactam Test Kit for raw, commingled goat milk

The FDA evaluation of the data, presented by IDEXX Laboratories, Inc., indicates that the performance of the test meets the standards established to determine the acceptance of a test for use in testing milk from an additional species, specifically raw, commingled goat milk.  The extension of a claim for an additional species can only be conducted for a test kit that has already met the standards for use with raw, commingled cow‘s milk.  These data have been evaluated in accordance with the standards established for the acceptance of screening tests for monitoring raw, commingled milk in accordance with the provisions of Appendix N-Drug Residue Testing and Farm Surveillance of the Grade “A” Pasteurized Milk Ordinance

The NCIMS Executive Board accepted the use of this test for raw, commingled goat milk at their October 9-10, 2013 meeting.  Attached is the letter of acceptance from FDA's CVM.

Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. This memorandum should be widely distributed to representatives of the dairy industry, State Veterinarians, State Veterinary and Pharmacy Boards, Veterinarian Professional Organizations and other interested parties and will also be available on the FDA Web Site at http://www.fda.gov at a later date.

If you would like an electronic version of this document prior to it being available on the FDA Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.

/s/

CAPT Robert F. Hennes, RS, MPH

Attachment:   FDA CVM Memorandum of the Acceptance of the Test Kit
IDEXX New SNAP Test Kit Label Insert

HHS Logo
 

Memorandum

Date:      October 23, 2013

From:      Philip James Kijak, Ph.D.

Subject:  Addition of a Claim for Goat Milk to the IDEXX New SNAP Test Kit

To:           Robert F. Hennes, Milk Safety Team

 

The Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) has evaluated data supporting the use of the IDEXX New SNAP Beta-Lactam Test Kit for use in raw, commingled goat milk. 

The study was coordinated by the American Institute for Goat Research, Langston University, Langston, OK.  The testing was conducted at an independent laboratory.  The test kit manufacturer provided the test kits.  The protocol for the study was reviewed and approved by CVM.  The testing protocol was based on the CVM’s “PROTOCOL FOR EVALUATION OF MILK RESIDUE SCREENING TESTS FOR USE WITH OTHER SPECIES”.

The testing was conducted using milk collected at mid-lactation in four (4) groups, one (1) each for Ampicillin, Amoxicillin, Cephapirin and Penicillin, with sixty (60) control samples in each group.  An additional two (2) groups were tested for penicillin, one (1) at early lactation and one (1) at late lactation.  For all sets of sixty (60) control samples tested, no false positive responses were observed.  For the incurred samples, fifteen (15) animals were used, three (3) animals for each of the four (4) drugs and three (3) control animals. The milk from the dosed animals was positive initially and becoming negative in the expected manner as the drugs depleted. 

The results of the study were reviewed and accepted by the National Conference on Interstate Milk Shipment’s (NCIMS) Laboratory Committee and the FDA/NCIMS 2400 Form for the use of the IDEXX New SNAP Beta-Lactam Test Kit for raw, commingled goat milk was approved by the NCIMS Executive Board at their 10/9-10/2013 meeting.

Based on the data generated, it is recommended that the IDEXX New SNAP Test Kit for Amoxicillin, Ampicillin, Ceftiofur, Cephapirin and Penicillin G, is suitable for testing raw, commingled goat milk.

/s/

Philip James Kijak, Ph.D.
Director, Division of Residue Chemistry
CVM Office of Research

cc:  CFSAN MST/LPET

Attachment:  New SNAP Beta-Lactam Kit Label rev. 10/13

 Image of SNAP Beta-Lactam test kit instructions. These instructions show images of the test kit components, the heating unit, preparing the test sample, loading the test into the heating unit, and how to interpret test results.  There are also tables included to show the test’s sensitivity and selectivity.
Image of SNAP Beta-Lactam test kit instructions. These instructions show images of the test kit components, the heating unit, preparing the test sample, loading the test into the heating unit, and how to interpret test results.  There are also tables included to show the test’s sensitivity and selectivity.