5100 Paint Branch Parkway
College Park, MD 20740-3835
October 9, 2012
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Dairy and Egg Branch (HFS-316)
SUBJECT: Addition of a Claim for Camel 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 camel 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 camel 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 on July 30, 2012 accepted the use of this test when used as labeled. 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.
CAPT Robert F. Hennes, RS, MPH
Attachments: FDA CVM Memorandum of the acceptance of the test kit
IDEXX New SNAP Test Kit Label Insert
Date: September 28, 2012
From: Philip James Kijak, Ph.D.
Subject: Addition of a Claim for Camel 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 camel milk.
The study was coordinated by the American Camel Coalition and Camel Milk USA who also provided the control and incurred camel milk samples. 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 done in four (4) groups, one (1) for each drug, with sixty (60) control samples in each group. For all sets of sixty (60) control samples tested, no false positive responses were observed. For the incurred samples, one (1) animal was dosed with penicillin and one (1) animal was dosed with Cephapirin. The milk from both animals was positive initially and becoming negative in the expected manner as the drugs depleted. No problems were observed. The test kit gave acceptable results with the incurred camel milk.
The results of the study were reviewed and accepted by the National Conference on Interstate Milk Shipment’s (NCIMS) Laboratory Committee and the 2400 Series Form for the use of the IDEXX New SNAP Beta-Lactam Test Kit for raw, commingled camel milk was approved by the NCIMS Executive Board.
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 camel milk
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. 9/12