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M-I-11-3: Neogen Corporation BetaStar® Plus Beta-Lactam Assay And BetaStar® US Beta-Lactam Test

<< Back to Index of Memoranda of Information (M-I) Main page
 

June 3, 2011

TO: All Regional Food and Drug Directors 
Attn: Regional Milk Specialists

FROM: Dairy and Egg Branch (HFS-316)

SUBJECT: Neogen Corporation BetaStar® Plus Beta-Lactam Assay And BetaStar® US Beta-Lactam Test

The Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) has evaluated data supporting the use of the Neogen Corporation BetaStar® Plus Beta-Lactam assay for raw, commingled bovine milk. Neogen has indicated that the BetaStar® Plus Beta-Lactam Assay Test will replace the current BetaStar® US Beta-Lactam Test.

The FDA evaluation of the data, presented by the Neogen Corporation 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, ceftiofur, cephapirin, cloxacillin and penicillin G. The data has 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.

In an e-mail dated April 6, 2011, Marlena G. Bordson, NCIMS Executive Secretary, indicated that the Executive Board voted to accept the use of this Test when used as labeled along with the withdrawal of the BetaStar® US Beta-Lactam Test. Following is the letter of acceptance from FDA's CVM.   

Neogen Corporation has indicated that the BetaStar® US Beta-Lactam Test will no longer be sold. The last lot of the BetaStar® US Beta Lactam Test will expire October 31, 2011. Users of the current Test may continue to use the product until the Test kit expiration date.

An electronic version of this memorandum is available for distribution to Regional Milk Specialists, State Milk Regulatory Agencies, State Laboratory Evaluation Officers and State Milk Sanitation Rating Officers in your region. The electronic version should be widely distributed to State Veterinarians, State Veterinary and Pharmacy Boards, Veterinarian Professional Organizations, representatives of the dairy industry and other interested parties and also will 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.

/s/

Robert F. Hennes, RS, MPH
CAPT, U.S. Public Health Service
Dairy and Egg Branch

Attachment:  FDA CVM Memorandum of the Acceptance of the Neogen Corporation

BetaStar® Plus Beta-Lactam Assay Test Kit

BetaStar® Plus Beta-Lactam Assay Label Insert


Date: May 31, 2011

FROM: Philip J. Kijak, Director Division of Residue Chemistry

SUBJECT: Neogen Corporation BetaStar US Beta-Lactam Test

TO: Robert F. Hennes, CFSAN, Dairy and Egg Branch/Milk Safety Team

The Neogen Corporation has provided data supporting the use of the BetaStar® Plus beta-lactam assay for amoxicillin, ampicillin, ceftiofur, cephapirin, cloxacillin, and penicillin G in raw commingled cow milk. The data has 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-Drug Residue Testing and Farm Surveillance of the Grade “A” Pasteurized Milk Ordinance (PMO).

The 90/95 percent detection levels and drug concentration responses for the six (6) Beta-lactam drugs are as follows:

90/95 Percent Detection Levels (ppb)

Amoxicillin

5.5

Ampicillin

5.2

Ceftiofur

80

Cephapirin

19.0

Cloxacillin

8.2

Penicillin G

4.7

Drug Concentration Response (Displayed as Percent Positive)

Concentration ppb (part per billion)

Amoxicillin

Ampicillin

Ceftiofur ′

Cephapirin

Cloxacillin

Penicillin G

1

 

 

 

 

 

0%

2

0%

0%

 

 

0%

0%

3

 

 

 

 

 

0%

4

0%

0%

 

0%

0%

0%

5

27%

10%

 

 

 

100%

6

100%

100%

 

 

0%

 

8

100%

100%

 

0%

83%

 

10

100%

100%

 

 

100%

 

12

 

 

 

0%

 

 

15

 

 

 

63%

 

 

20

 

 

0%

100%

 

 

40

 

 

0%

 

 

 

60

 

 

20%

 

 

 

80

 

 

90%

 

 

 

100

 

 

100%

 

 

 


RECOMMENDATION

Our evaluation of the data presented by the Neogen Corporation indicates that the performance of this test meets the standards established for the acceptance of screening tests for monitoring raw, commingled bovine milk in accordance with the provisions of Appendix N of the PMO when used with the Neogen Corporation AccuScan III Reader with software V3.551 or higher and printer. We recommend that the appropriate announcement be issued to the State Regulatory Agencies and the milk industry advising of the Agency’s concurrence with the use of this test as labeled. We also recommend that the next revision of M-a-85 and M-I-96-10 reflect the acceptance of this test.

/s/

Philip James Kijak, Ph.D
Director
Division of Residue Chemistry
CVM Office of Research

Attachment

cc:
TE Graham HFS-450

 BetaStar® Plus beta-lactam assay for Amoxicillin, Ampicillin, Ceftiofur¹, Cephapirin, Cloxacillin and Penicillin G in raw commingled cow milk

BetaStar® Plus beta-lactam assay for Amoxicillin, Ampicillin, Ceftiofur¹, Cephapirin, Cloxacillin and Penicillin G in raw commingled cow milk