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M-I-03-7: Charm SL6TM Beta-lactam Test

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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

/s/

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
per billion)
Amoxicillin Ampicillin Ceftiofur Cephapirin Cloxacillin Penicillin G
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       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. 

/s/

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


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 Charm SL6™ Beta-lactam Test)

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