HHS:PHS:FDA:CFSAN:OC:DCP:MSB
 
5100 Paint Branch Parkway
        College Park, MD 20740-3835
 
      M-I-03-8
 
          	          May 30, 2003
 
 
TO:  		All Regional Food and Drug Directors
      Attn:  Regional Milk Specialists
 
FROM:  	Milk Safety Branch (HFS-626)
 
SUBJECT:  	IDEXX Laboratories Inc. New Snap Beta-lactam Test
 
 
The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM)
has evaluated data supporting the use of the IDEXX Laboratories Inc. New Snap
Beta-lactam Test for raw, commingled bovine 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 raw, commingled bovine milk.   The
acceptance of the test for raw, commingled bovine milk represents a claim for
amoxicillin, ampicillin, cerftiofur, cephapirin, and penicillin G.  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" of the Grade "A" Pasteurized Milk Ordinance.
 
The NCIMS Executive Board at the 2003 NCIMS Conference in Seattle, WA accepted
the use of this test when used as labeled.  Following 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 will also be available on the FDA Web site at
http://www.cfsan.fda.gov at a later date and should be widely distributed to
State Veterinarians, State Veterinary and Pharmacy Boards, Veterinarian
Professional Organizations, representatives of the dairy industry and other
interested parties.
 
 
 
 
Attachment: (DRAFT) New SNAP Beta-lactam Test Kit (penicillin G, amoxicillin,
ampicillin, ceftiofur, and cephapirin) Validated for raw, commingled bovine milk
 
 
 
 
 
								/ss/
 
      CAPT Robert F. Hennes, RS, MPH
      Chief, Milk Safety Branch
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
										Memorandum	
Date	April 9, 2003
										
From	Philip James Kijak, Ph.D.
			
Subject	IDEXX Laboratories Inc. New SNAP Beta-Lactam Test
 
To	Robert F. Hennes, Milk Safety Team												
IDEXX Laboratories, Inc. has provided data supporting the use of the IDEXX
Laboratories, Inc. New SNAP Beta-Lactam Test for amoxicillin, ampicillin,
ceftiofur, cephapirin, and penicillin G in bovine milk.  These data have been
evaluated in accordance with the standards established for the acceptance of
screening tests for raw, commingled bovine milk to monitor milk in accordance to
the provisions of appendix N of the Pasteurized Milk Ordnance. (PMO)
 
The 90/95 percent detection levels and drug concentration responses for the six
beta-lactam drugs are as follows:
 
90/95 Percent Detection Levels (ppb)
 
		Amoxicillin	7.3
		Ampicillin	5.8
		Ceftiofur	5.4
		Cephapirin	11.7
		Penicillin G	3.0
 
Drug Concentration Response (Displayed as Percent Positive)
Concentration
ppb (part per 	Amoxicillin	Ampicillin	Ceftiofur	Cephapirin	Penicillin G
billion)	
Tolerance or
Safe Level	10 ppb		10 ppb		50 ppb2		20 ppb		5 ppb
1										7
2		0		0				0		37
3										93
4		20		37				0		100
5										100
6		70		100			
8		100		100				0	
10		100		100		87		
12								100	
20						100		100	
30						100		
40						100		
50						100	
	
2Parent Drug
 
It is important to note that this is a new test and as such does not have an
approval for visual reading.  IDEXX Laboratories, Inc. has agreed cease
production of the current SNAP beta-lactam test, which can be read visually once
the new test is released.  Upon phase out of the current SNAP Beta-Lactam Test,
no IDEXX Laboratories, Inc. products will be approved for visual reading.
 
As a new test, the printout from the reader used with the test must meet the
current requirements printing results.  Currently, only the IDEXX SNAPshot
reader meets these requirements and can be used as a reader with the New SNAP
Beta-Lactam Test.  The use of the older SNAP Image Reader as currently
configured will not be allowed.  IDEXX Laboratories, Inc. has the option of
providing a software update for the SNAP Image Reader to bring the printout into
compliance with current labeling requirements.  Otherwise, the use of the New
SNAP Beta-Lactam Test will be limited to being read with only the SNAPshot
Reader.
 
RECOMMENDATION
 
Our evaluation of the data presented by IDEXX Laboratories, Inc. indicates that
the performance of this test meets the standards established for acceptance of
screening tests for monitoring raw commingled milk in accordance with the
provisions of Appendix N of the PMO when used with the IDEXX Laboratories, Inc.
SNAPshot reader.  We recommend that the appropriate announcement be issued to
the milk industry advising of the Agency's concurrence with the use of the test
as labeled.  We also recommend that revised M-a-85 and M-I-96-10 be issued
concurrently with this announcement.
 
 
							/ss/
 
						Philip James Kijak, Ph.D.
						Analytical Methods Team Leader
						Division of Residue Chemistry
						CVM Office of Research
 
 
Linda D. Youngman, Ph.D., Acting Director, CVM Office of Research:
 
Concur ____x___ Do not Concur _______
 
Attachment
 
cc:
LJ Maturin HFH-450
 
Page 2 - Robert F. Hennes - Milk Safety Team
 
 
M-I-03-8	3	May 30, 2003
 
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M-I-03-8	4	May 30, 2003
 

Attachment: (DRAFT) New SNAP Beta-lactam Test Kit (penicillin G, amoxicillin, ampicillin, ceftiofur, and cephapirin) Validated for raw, commingled bovine milk (available in PDF)