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U.S. Department of Health and Human Services

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M-I-03-7: Charm SL6™ 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)
AmoxicillinAmpicillinCeftiofurCephapirinCloxacillinPenicillin G
Tolerance or
Safe Level
10 ppb10 ppb50 ppb220 ppb10 ppb5 ppb
1     7
200  023
3     93
473 040100
5     100
65717  83 
89777 4097 
101001000 100 
12   53  
16   100  
20   100  
20  27100  
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)