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Drug Residue Test Methods For Confirmation Of Presumptive Positive Results And Initial Producer Trace Back


Return to M-I-96-10 Table of Content


HHS:PHS:FDA:CFSAN:OFS:DPDFS:DEB:MST

5100 Paint Branch Parkway
College Park, MD 20740-3835
 

M-I-96-10 (Revision #8)
 

March 22, 2012

 

TO:

All Regional Food and Drug Directors
Attn:  Regional Milk Specialists

FROM:

Dairy and Egg Branch (HFS-316)

SUBJECT:

Drug Residue Test Methods For Confirmation Of Presumptive Positive Results And Initial Producer Trace Back

 
This coded memorandum replaces and rescinds the previous revision of this coded memorandum (M-I-96-10 (Revision #7), Issued January 4, 2010).  Revision #7 will be identified in the next Index of Memoranda of Information (M-I) as “INACTIVE”.

This revision is based on the phasing out and addition of several Tests as reflected in M-a-85 (Revision #14), Issued March 22, 2012.  It modifies the Tables to reflect the acceptance of the following Tests:

  • Neogen Corporation BetaStar® Plus Beta Lactam Test;
  • Charm Sciences, Inc. Charm® 3 SL3 Beta Lactam Test; and
  • Charm Sciences, Inc. Charm® FLUSLBL Flunixin and Beta Lactam Test.

The following Tests have been removed as they are no longer available:

  • Neogen Corporation BetaStar® US Beta Lactam Test; and
  • Charm® SL3 Beta Lactam Test.

The following Tables have been developed by FDA’s Center for Veterinary Medicine (CVM) to demonstrate those screening Tests that have been accepted under the requirements of Appendix N of the Grade “A” Pasteurized Milk Ordinance (PMO) to determine whether presumptive positive milk tank truck results are screening positive (load confirmation).  These Tables may also be used to determine an appropriate initial producer trace back test to identify the positive producer(s) who contributed the milk containing drug(s) on a positive milk tank truck load.  These Tables do not include any additional requirements for testing and are a reference for which Tests are appropriate to test samples from a producer(s), which has contributed milk containing drug(s) to a positive milk tank truck.

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 should be widely distributed to representatives of the dairy industry, State Veterinarians, State Veterinary and Pharmacy Boards, Veterinarian Professional Organizations and other interested parties and will also be available on the FDA Web Site at

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/

/S/

Thomas Graham, PhD, Team Leader
Laboratory Proficiency & Evaluation Team 
Dairy and Egg Branch

Robert F. Hennes, RS, MPH
CAPT U.S. Public Health Service
 

 

PRESUMPTIVE POSITIVE TESTSCREENING TEST POSITIVE (CONFIRMATION TEST) OPTIONS

BetaStar® Plus Beta Lactam Test

BetaStar® Plus Beta Lactam Test
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® II Tablet Beta Lactam Test (Competitive Assay)
+ Charm® II Test for Cloxacillin in Milk (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
+ Charm® II Test for Cloxacillin in Milk (Competitive Assay)
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test

Charm® B. stearothermophilus Tablet Disk Assay

Not a Beta lactam Specific Test.  Refer to Footnote1.

BetaStar® Plus Beta Lactam Test
Charm® B. stearothermophilus Tablet Disk Assay
Charm® II Tablet Beta Lactam Test (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® SL Beta Lactam Test
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test
Charm® FLUSLBL Flunixin and Beta Lactam Test
Delvotest P 5 Pack (Reader and Visual)
Delvotest P/Delvotest P Mini
Delvotest SP/Delvotest SP Mini
New Snap® Beta Lactam Test

Charm® II Tablet Beta Lactam Test (Competitive Assay)

BetaStar® Plus Beta Lactam Test
Charm® II Tablet Beta Lactam Test (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® SL Beta Lactam Test
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test
Charm® FLUSLBL Flunixin and Beta Lactam Test
New Snap® Beta Lactam Test

Charm® II Tablet Beta Lactam Test
(Sequential Assay)

BetaStar® Plus Beta Lactam Test
Charm® II Tablet Beta Lactam Test (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® SL Beta Lactam Test
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test
Charm® FLUSLBL Flunixin and Beta Lactam Test
New Snap® Beta Lactam Test

Charm® II Tablet Beta Lactam Test (Quantitative Assay)

BetaStar® Plus Beta Lactam Test
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® II Tablet Beta Lactam Test (Competitive Assay)
+ Charm® II Test for Cloxacillin in Milk (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
+ Charm® II Test for Cloxacillin in Milk (Competitive Assay)
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test

Charm® SL Beta Lactam Test

BetaStar® Plus Beta Lactam Test
Charm® II Tablet Beta Lactam Test (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® SL Beta Lactam Test
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test
Charm® FLUSLBL Flunixin and Beta Lactam Test
New Snap® Beta Lactam Test

Charm® SL6 Beta Lactam Test

BetaStar® Plus Beta Lactam Test
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® II Tablet Beta Lactam Test (Competitive Assay)
+ Charm® II Test for Cloxacillin in Milk (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
+ Charm® II Test for Cloxacillin in Milk (Competitive Assay)
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test

Charm® 3 SL3 Beta Lactam Test

BetaStar® Plus Beta Lactam Test
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® II Tablet Beta Lactam Test (Competitive Assay)
+ Charm® II Test for Cloxacillin in Milk (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
+ Charm® II Test for Cloxacillin in Milk (Competitive Assay)
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test

Charm® FLUSLBL Flunixin and Beta Lactam Test

Charm® FLUSLBL Flunixin and Beta Lactam Test

Charm® II Chloramphenicol Test

Charm® II Chloramphenicol Test

Charm® II Sulfa Drug Test (Competitive Assay)

Charm® II Sulfa Drug Test (Competitive Assay)

Charm® II Tetracycline Drug Test (Competitive Assay)

Charm® II Tetracycline Drug Test (Competitive Assay)

Delvotest P 5 Pack
(Reader and Visual)

Not a Beta lactam Specific Test.  Refer to Footnote1.

BetaStar® Plus Beta Lactam Test
Charm® B. stearothermophilus Tablet Disk Assay
Charm® II Tablet Beta Lactam Test (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® SL Beta Lactam Test
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test
Charm® FLUSLBL Flunixin and Beta Lactam Test
Delvotest P 5 Pack (Reader and Visual)
Delvotest P/Delvotest P Mini
Delvotest SP/Delvotest SP Mini
New Snap® Beta Lactam Test

Delvotest P/Delvotest P Mini

Not a Beta lactam Specific Test.  Refer to Footnote1.

BetaStar® Plus Beta Lactam Test
Charm® B. stearothermophilus Tablet Disk Assay
Charm® II Tablet Beta Lactam Test (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® SL Beta Lactam Test
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test
Charm® FLUSLBL Flunixin and Beta Lactam Test
Delvotest P 5 Pack (Reader and Visual)
Delvotest P/Delvotest P Mini
Delvotest SP/Delvotest SP Mini
New Snap® Beta Lactam Test

Delvotest SP/Delvotest SP Mini

Not a Beta lactam Specific Test.  Refer to Footnote1.

BetaStar® Plus Beta Lactam  Test
Charm® B. stearothermophilus Tablet Disk Assay
Charm® II Tablet Beta Lactam Test (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® SL Beta Lactam Test
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test
Charm® FLUSLBL Flunixin and Beta Lactam Test
Delvotest P 5 Pack (Reader and Visual)
Delvotest P/Delvotest P Mini
Delvotest SP/Delvotest SP Mini
New Snap® Beta Lactam Test

New Snap® Beta Lactam Test

BetaStar® Plus Beta Lactam Test
Charm® II Tablet Beta Lactam Test (Competitive Assay)
Charm® II Tablet Beta Lactam Test (Sequential Assay)
Charm® II Tablet Beta Lactam Test (Quantitative Assay)
Charm® SL Beta Lactam Test
Charm® SL6 Beta Lactam Test
Charm® 3 SL3 Beta Lactam Test
Charm® FLUSLBL Flunixin and Beta Lactam Test
New Snap® Beta Lactam Test

1These Tests are not specific for Beta lactams.  While they are not validated to NCIMS standards for any drugs other than Beta lactams, a non-Beta lactam drug residue can cause a positive test.  A negative or not found (NF) test result using one of the Beta lactam specific Tests to follow-up or confirm a positive result with this test kit will require re-testing the sample using the Charm® B. stearothermophilus Tablet Disk Assay, Delvotest P 5 Pack, Delvotest P/Delvotest P Mini or Delvotest SP/Delvotest SP Mini. Any of the listed confirmation test options, other than the four (4) identified in the Tables, are Beta lactam specific Tests.