HHS:PHS:FDA:CFSAN:OC:DCP:MSB
 
5100 Paint Branch Parkway
        College Park, MD 20740-3835
 
      M-I-03-7
 
          	          May 30, 2003
 
 
TO:  		All Regional Food and Drug Directors
      Attn:  Regional Milk Specialists
 
FROM:  	Milk Safety Branch (HFS-626)
 
SUBJECT:  	Charm SL6TM Beta-lactam Test
 
 
The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM)
has evaluated data supporting the use of the Charm SL6TM Beta-lactam test for
raw, commingled bovine milk.
 
The FDA evaluation of the data, presented by Charm Sciences, 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, cloxacillin 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: Charm SL6TM Beta-lactam Test for Amoxicillin, Ampicillin, Ceftiofur,
Ceph-apirin, Cloxacillin and Penicillin G-Operator's Manual Validated for Raw,
Commingled Bovine Milk
 
 
 
								/ss/
 
      CAPT Robert F. Hennes, RS, MPH
      Chief, Milk Safety Branch
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      									Memorandum	
 
Date	March 17, 2003
									
From	Philip James Kijak, Ph.D.
 
Subject	Charm Sciences, Inc. Charm SL6 Beta-Lactam Test
 
To	Robert F. Hennes, Milk Safety Team												
Charm Sciences, Inc. has provided data supporting the use of the Charm SL6
Beta-Lactam Test for amoxicillin, ampicillin, ceftiofur, cephapirin,
cloxacillin, 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	7.1
		Ampicillin	9.6
		Ceftiofur	37.5
		Cephapirin	18.7
		Cloxacillin	8.3
		Penicillin G	4.2
 
Drug Concentration Response (Displayed as Percent Positive)
Concentration
ppb (part     Amoxicillin    Ampicillin     Ceftiofur     Cephapirin     Cloxacillin    Penicillin G
per billion)
 
Tolerance or
Safe Level    10 ppb         10 ppb         50 ppb2        20 ppb         10 ppb         5 ppb
1                                                                                        7
2             0              0                                            0              23
3                                                                                        93
4             7              3                             0              40             100
5                                                                                        100
6             57             17                                           83
8             97             77                            40             97
10            100            100            0                             100
12                                                         53
16                                                         100
20                                          27             100
30                                          73
40                                          93
50                                          100
 
2 Parent Drug
 
 
RECOMMENDATION
 
Our evaluation of the data presented by Charm Sciences, 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.  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-03-7	1	May 30, 2003
 
1
 
 
 
 
M-I-03-7	4	May 30, 2003
 

Attachment: Charm SL6TM Beta-lactam Test for Amoxicillin, Ampicillin, Ceftiofur, Ceph-apirin, Cloxacillin and Penicillin G-Operator's Manual Validated for Raw, Commingled Bovine Milk (available in PDF)