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National Milk Drug Residue Data Base Fiscal Year 2001 Annual Report

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FISCAL YEAR 2001 ANNUAL REPORT
October 1, 2000 - September 30, 2001
Submitted by:
GLH, Incorporated
2900 NE 46th Street
Lighthouse Point, FL 33064
954-783-9819

Contract Number: 223-01-4299
January 31, 2002


TABLE OF CONTENTS

  • INTRODUCTION
  • BACKGROUND
  • SUMMARY
  • SAMPLE RESULTS
    • TABLE 1 Sample Results
    • TABLE 2 Industry and Regulatory Samples
  • TESTS CONDUCTED
    • TABLE 3 Tests Conducted by Sample Sources
    • TABLE 3A Validated Tests Conducted
    • TABLE 3B Non-Validated Tests Conducted
    • TABLE 4 Tests Conducted by Industry and Regulatory Agencies
    • TABLE 4A Validated Tests Conducted by Industry and Regulatory Agencies
    • TABLE 4B Non-Validated Tests Conducted by Industry and Regulatory Agencies
    • TABLE 5 Number of Tests Conducted by Family/Drug
    • TABLE 5A Validated Number of Tests Conducted by Family/Drug
    • TABLE 5B Non-Validated Number of Tests Conducted by Family/Drug
    • TABLE 6 Number of Tests by Method by Family/Drug
    • TABLE 6A Comparison of Validated and Non-Validated Tests
    • TABLE 7-1 Grade A Bulk Milk Pick-Up Tanker Testing
    • TABLE 7-2 Grade A Pasteurized Fluid Milk and Milk Products Testing
    • TABLE 7-3 Grade A Producer Testing
    • TABLE 7-4 Grade A Other Testing (milk from milk plant silos, over-the-road tankers, etc.)
    • TABLE 7-5 Non-Grade A Bulk Milk Pick-Up Tanker Testing
    • TABLE 7-6 Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
    • TABLE 7-7 Non-Grade A Producer Testing
    • TABLE 7-8 Non-Grade A Other Testing (milk from milk plant silos, over-the-road tankers, etc.)
    • TABLE 8-1 Number of Tests by Method by Family/Drug for Grade A Bulk Milk Pick-Up Tanker Testing
    • TABLE 8-2 Number of Tests by Method by Family/Drug for Grade A Pasteurized Fluid Milk and Milk Products Testing
    • TABLE 8-3 Number of Tests by Method by Family/Drug for Grade A Producer Testing
    • TABLE 8-4 Number of Tests by Method by Family/Drug for Grade A Other Testing (milk from milk plant silos, over-the-road tankers, etc.)
    • TABLE 8-5 Number of Tests by Method by Family/Drug for Non-Grade A Bulk Milk Pick-Up Tanker Testing
    • TABLE 8-6 Number of Tests by Method by Family/Drug for Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
    • TABLE 8-7 Number of Tests by Method by Family/Drug for Non-Grade A Producer Testing
    • TABLE 8-8 Number of Tests by Method by Family/Drug for Non-Grade A Other Testing (milk from milk plant silos, over-the-road tankers, etc.)

NATIONAL MILK DRUG RESIDUE DATA BASE
FISCAL YEAR 2003 ANNUAL REPORT
October 1, 2000 - September 30, 2001

INTRODUCTION

The National Milk Drug Residue Data Base is a voluntary industry reporting program.  Mandatory reporting is required by State regulatory agencies under the National Conference on Interstate Milk Shipments (NCIMS).  Data are reported on the extent of the national testing activities, the analytical methods used, the kind and extent of the animal drug residues identified, and the amount of contaminated milk, including whether it was disposed of properly for non-human use.  The system includes all milk, Grade A and non-Grade A, commonly known as manufacturing grade.  Grade A milk represents approximately 90% of the milk supply and is regulated through NCIMS by State regulatory agencies.  Manufacturing grade milk is under the direction of the regulatory agencies in the States where it is produced and may be subject to the standards recommended by the United States Department of Agriculture (USDA).  Data reported to the National Milk Drug Residue Data Base are for educational and analytical purposes and are not intended or suitable for regulatory follow-up.

BACKGROUND

The National Conference on Interstate Milk Shipments (NCIMS) is a voluntary organization directed and controlled by member States to promote the availability of a high quality milk supply.  FDA and the NCIMS through their collaborative efforts have developed a cooperative, federal-state program (The Interstate Milk Shipper program) to ensure the sanitary quality of milk and milk products shipped interstate.  During the 1991 meeting of the NCIMS, the Conference authorized a national program to compile the results of residue testing by industry and regulatory agencies.

Subsequently, FDA awarded a contract to develop a National Milk Drug Residue Data Base.  The data base is operated by an independent third party, under contract to the FDA.  The data base design was developed in consultation with a project advisory group with members from the FDA and a NCIMS committee representing dairy producers, dairy processors, USDA, State regulatory agencies, and academia.  The data base was designed to promote maximum participation by the dairy industry to report on a voluntary basis all of their testing without compromising any confidential data.  Information regarding individual firm's data is not submitted to the data base contractor.  The data base includes results of the National Drug Residue Milk Monitoring Program (NDRMMP), a national drug residue in milk sampling program administered by FDA with the full cooperation by the States.  Results from this program are reported to the data base by the States.

It is important to recognize that the samples and tests reported do not necessarily represent one hundred percent of the milk supply from every State.  However, as State and industry participation in the data base increased, reporting of the number of samples and tests similarly increased.  Continuing efforts are being made to ensure that there is uniform reporting among all the States and the industry and to ensure that the drugs and test methods reported are correct. 

SUMMARY

This report presents summary data on samples and tests conducted during the Fiscal Year 2001,  October 1, 2000 to September 30, 2001.  Fifty States and Puerto Rico submitted data for this report. However, California failed to submit data for the 4th quarter of the fiscal year, Idaho only submitted data on its industry bulk milk pick-up testing, and Georgia only submitted industry bulk  milk pick-up tanker testing data if the sample was positive.  Some of the data submitted by Minnesota on its producer sample testing was incomplete. Also, some producer sample testing data from Tennessee was not submitted in time to be included in this report.

The Pasteurized Milk Ordinance (PMO) requires that all bulk milk tankers be sampled and analyzed for animal drug residues before the milk is processed.  Any tanker found positive is rejected for human consumption.

During this period 4,203,616 samples were analyzed for animal drug residues.  Of these samples 3,401 were positive for a residue.  A total of 4,314,181 tests were reported on the samples for 14 different groups of families or individual drugs.  Forty-seven testing methods were used to analyze the samples for residues.  Details are presented in the tables in this report.

SAMPLE RESULTS

A SAMPLE  is defined as representing a load or lot of milk sampled and analyzed, e.g. a bulk milk pick-up tanker, producer, or over-the-road tanker, a silo, etc.

Table 1 shows the results of the samples tested by source.

Data are reported by four SOURCES OF SAMPLES:

  1. Bulk Milk Pick-Up Tanker - bulk raw  milk from a dairy farm.
  2. Pasteurized Fluid Milk and Milk Products  - after pasteurization; finished product in package form or bulk.  Includes milk products such as milk, cream, condensed milk and dry milk products, and condensed and dry whey products.
  3. Producer - raw milk obtained from a dairy farm.  Samples are reported by the permitting State, rather than by the analyzing State.
  4. Other - milk from silos, over-the-road tankers, etc.

A POSITIVE result, as used in this report, means that the sample was found to be positive for a drug residue by a test acceptable for taking regulatory action in a certified laboratory by a certified analyst or the milk was rejected on the basis of an initial test by the milk processors.

The DISPOSITION PER PMO column represents the amount of milk contained in the tank or lot found to be positive and disposed of in accordance with the PMO and/or applicable State regulations.  The PMO governs the rules which State agencies use to implement their milk program.

TABLE 1 - Sample Results
October 1, 2000 to September 30, 2001
Source of SampleTotal SamplesNumber PositivePercent PositiveDisposition per PMO (Pounds)
Bulk Milk Pick-Up Tanker3,280,0362,1910.067%79,913,000
Pasteurized Fluid Milk and Milk Products63,99620.003%79,000
Producer758,3801,1750.155%7,737,000
Other101,204330.033%1,769,000
Total4,203,6163,401*89,498,000

The asterisk (*) notes that a summary of the percent positive cannot be provided because there is not uniformity in terms of sampling in the four categories.  For example, the PMO sets forth specific sampling requirements for beta-lactam testing as follows:

  1. Bulk Milk Pick-Up Tanker Samples - samples are taken daily on every tanker;
  2. Pasteurized Fluid Milk and Milk Products - a minimum of four samples must be tested for each product at each plant every six months;
  3. Producer - each producer must be tested at least four times every six months; and
  4. Other - samples are conducted on a random basis.

Table 2 presents these results in greater detail and shows the number of samples conducted by industry and by regulatory agencies.  Industry samples are taken by processing facilities, receiving and transfer stations, and marketing groups or cooperatives.  Industry samples may be conducted to meet the industry requirements of Appendix N of the PMO which sets forth testing requirements for animal drug residues or for quality control purposes.  Regulatory samples are taken by State and local regulatory agencies.

TABLE 2 - Industry and Regulatory Samples October 1, 2000 to September 30, 2001
Source of SampleNumber of Industry SamplesNumber of Positive Industry SamplesNumber of Regulatory SamplesNumber of Positive Regulatory SamplesTotal SamplesTotal Positive SamplesTotal Percent PositiveDisposition Per PMO (Pounds)
Grade A
Bulk Milk Pick-Up Tanker2,913,6751,80125,244502,938,9191,8510.063%69,109,000
Pasteurized Fluid Milk and Milk Products7,958255,128063,08620.003%79,000
Producer550,132855153,568248703,7001,0570.150%7,729,000
Other79,206186,720885,926260.030%1,584,000
Non-Grade ABulk Milk Pick-Up Tanker1339,3463361,7714341,1173400.100%10,804,000
Pasteurized Fluid Milk and Milk Products2280682091000.000%0,000
Producer52,4401172,240154,6801180.216%8,000
Other14,3026976115,27870.046%185,000
TOTALS3,957,2873,135246,3292664,203,6163,401*89,498,0002

1 It is a common practice in some States, including two large milk production States, that bulk milk pick-up tankers pickup milk from Grade A and non-Grade A milk producers on the same truck.  Then, these loads are delivered to non-Grade A processing facilities.  Because of this commingling of the two grades of milk, all data related to these loads are reported under non-Grade A.

2 Note that this represents 0.0524% of the total milk supply of the annual production of 165 billion pounds.

* = See Table 1 for explanation

TESTS CONDUCTED

An objective of the National Milk Drug Residue Data Base is to record every test run on each sample analyzed.  Since some samples are analyzed for more than one drug residue, the number of tests run is greater than the number of samples.  To avoid duplicate reporting of samples, the number of samples analyzed is reported separately from the number of tests run in the data base.

Table 3 presents summary results of the number of tests which were conducted during October 1, 2000 to September 30, 2001.  The term, validated test, as used in this report, is a test used for the screening of raw milk for drug residue which has been evaluated in accordance with Appendix N of the Pasteurized Milk Ordinance and found acceptable by FDA in accordance with the standards established for the evaluation of tests.  In addition, FDA validated drug residue detection procedures for screening and quantitation of drug residues in milk may be used. Table 3A presents summary results using validated tests and Table 3B presents summary results using non-validated tests.

TABLE 3 - Tests Conducted
 October 1, 2000 to September 30, 2001
Source of SampleTotal TestsNumber of Tests PositivePercent Positive
Bulk Milk Pick-Up Tanker3,381,3132,5380.075
Pasteurized Fluid Milk and Milk Products64,82940.006
Producer762,0461,2690.167
Other105,993380.036
Total4,314,1813,849*

* = See Table 1 for explanation.

TABLE 3A - Validated Tests Conducted
 October 1, 2000 to September 30, 2001
Source of SampleTotal TestsNumber of Tests PositivePercent Positive
Bulk Milk Pick-Up Tanker3,338,8282,5190.075
Pasteurized Fluid Milk and Milk Products64,35040.006
Producer761,3451,2660.166
Other103,347380.037
Total4,267,8703,827*

* = See Table 1 for explanation.

TABLE 3B - Non-Validated Tests Conducted
 October 1, 2000 to September 30, 2001
Source of SampleTotal TestsNumber of Tests PositivePercent Positive
Bulk Milk Pick-Up Tanker42,485190.045
Pasteurized Fluid Milk and Milk Products47900.000
Producer70130.428
Other2,64600.000
Total46,31122*

* = See Table 1 for explanation.

Table 4 presents additional details in terms of the tests conducted by industry and by regulatory agencies.  Tables 4A and 4B present these data by validated and non-validated tests.

TABLE 4 -  Tests Conducted by Industry and Regulatory Agencies
October 1, 2000 to September 30, 2001
Source of SampleNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsTotal Percent Positive
Grade ABulk Milk Pick-Up Tanker3,015,2612,14022,985503,038,2462,1900.072%
Pasteurized Fluid Milk and Milk Products8,1072555,812263,91940.006%
Producer553,558916153,587219707,1451,1350.161%
Other82,679207,803890,482280.031%
Non-Grade ABulk Milk Pick-Up Tanker1341,2433441,8244343,0673480.101%
Pasteurized Fluid Milk and Milk Products2280682091000.000%
Producer52,6621332,239154,9011340.244%
Other14,28291,229115,511100.064%
TOTALS4,068,0203,564246,1612854,314,1813,849*

1 It is a common practice in some States, including two large milk production States, that bulk milk pick-up tankers pickup milk from Grade A and non-Grade A milk producers on the same truck.  Then, these loads are delivered to non-Grade A processing facilities.  Because of this commingling of the two grades of milk, all data related to these loads are reported under non-Grade A.

* = See Table 1 for explanation; Table 2 shows data on the disposition of milk in compliance with the PMO.

TABLE 4A - Validated Tests Conducted by Industry and Regulatory Agencies
October 1, 2000 to September 30, 2001
Source of SampleNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsTotal Percent Positive
Grade ABulk Milk Pick-Up Tanker2,979,6332,12719,086502,998,7192,1770.073%
Pasteurized Fluid Milk and Milk Products7,966255,474263,44040.006%
Producer552,862915153,582263706,4441,1320.160%
Other80,905207,799888,704280.032%
Non-Grade ABulk Milk Pick-Up Tanker1338,3073391,8023340,1093420.101%
Pasteurized Fluid Milk and Milk Products2280682091000.000%
Producer52,6621332,239154,9011340.244%
Other13,41491,229114,643100.068%
TOTALS4,025,9433,545241,8932824,267,8703,827*

1 It is a common practice in some States, including two large milk production States, that bulk milk pick-up tankers pickup milk from Grade A and non-Grade A milk producers on the same truck.  Then, these loads are delivered to non-Grade A processing facilities.  Because of this commingling of the two grades of milk, all data related to these loads are reported under non-Grade A.

* = See Table 1 for explanation.

TABLE 4B - Non-Validated Tests Conducted by Industry and Regulatory Agencies
October 1, 2000 to September 30, 2001
Source of SampleNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsTotal Percent Positive
Grade ABulk Milk Pick-Up Tanker35,628133,899039,527130.033%
Pasteurized Fluid Milk and Milk Products1410338047900.000%
Producer69615270130.428%
Other1,7740401,77800.000%
Non-Grade ABulk Milk Pick-Up Tanker12,93652212,95860.203%
Pasteurized Fluid Milk and Milk Products0000000.000%
Producer0000000.000%
Other86800086800.000%
TOTALS42,043194,268346,31122*

1 It is a common practice in some States, including two large milk production States, that bulk milk pick-up tankers pickup milk from Grade A and non-Grade A milk producers on the same truck.  Then, these loads are delivered to non-Grade A processing facilities.  Because of this commingling of the two grades of milk, all data related to these loads are reported under non-Grade A.

* = See Table 1 for explanation.

Table 5 shows the number of tests conducted by family and by individual drug. Tables 5A and 5B present these data by validated and non-validated tests.

TABLE 5 - Number of  Tests Conducted by Family/Drug
October 1, 2000 to September 30, 2001
Family/DrugTotal TestsTotal Positive
AMINOGLYCOSIDES2,1432
BETA-LACTAMS4,156,9033,806
Ceftiofur1,9190
Cloxacillin3,5951
CHLORAMPHENICOL4140
ENROFLOXACIN6462
MACROLIDES1,1710
NEOMYCIN90
NOVOBIOCIN4340
SULFONAMIDES93,29614
Sulfadimethoxine1410
Sulfamethazine3,5200
TETRACYCLINES49,98524
Chlortetracycline50
TOTALS4,314,1813,849
TABLE 5A - Number of Validated Tests Conducted by Family/Drug
October 1, 2000 to September 30, 2001
Family/DrugTotal TestsTotal  Positive
BETA-LACTAMS4,155,7013,806
Ceftiofur1,9190
Cloxacillin3,5951
CHLORAMPHENICOL4140
SULFONAMIDES83,97411
TETRACYCLINES22,2289
Chlortetracycline50
TOTALS4,267,8703,827
TABLE 5B - Number of Non-Validated Tests Conducted by Family/Drug
October 1, 2000 to September 30, 2001
Family/DrugTotal TestsTotal  Positive
AMINOGLYCOSIDES2,1432
BETA-LACTAMS1,1680
ENROFLOXACIN6462
MACROLIDES1,1710
NEOMYCIN90
NOVOBIOCIN4340
SULFONAMIDES9,3223
Sulfadimethoxine1410
Sulfamethazine3,5200
TETRACYLINES27,75715
TOTALS46,31122

Table 6 presents details on the tests used.  The data in this table are comparable to Table 5, but the data are arranged by tests within each family/drug.  Therefore, the totals are the same in both tables.  The tests with the largest use were Charm SL - Beta-Lactam and Snap (Reader) - Beta-Lactams used to test over 1.15 million  and 737 thousand samples respectively.  Charm II Tablet Competitive - Beta-Lactams  was used to test over 426 thousand samples.  Delvotest P 5 Pack - Beta-Lactams was used to test over 423 thousand samples.  Table 6A shows a comparison of tests conducted  using Validated and Non-Validated test methods for Sulfonamides and Tetracyclines.

TABLE 6 - Number of  Tests by Method by Family/Drug
October 1, 2000 to September 30, 2001
 Tests Used by Family/DrugNumber of TestsNumber PositivePercent Positive
AMINOGLYCOSIDESCharm II Tablet Competitive **2,14320.093%
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams325,6847290.224%
Charm Farm -Beta-Lactams **55900.000%
Charm I/Cowside II Tablet -Beta-Lactams46,102390.085%
Charm II Tablet Competitive426,9133000.070%
Charm II Tablet Quantitative32,4121310.404%
Charm II Tablet Sequential326,6812740.084%
Charm II Tablet Transit -Beta-Lactams2,82000%
Charm Rapid Inhibition Test **60900%
Charm SL Beta-Lactams1,151,0235500.048%
Delvo-X-PRESS -Beta-Lactams22,744240.106%
Delvotest P 5 Pack -Beta-Lactams423,7873970.094%
Delvotest P/Delvotest P Mini58,032100.017%
Delvotest SP/Delvotest SP Mini3,91610.026%
Lak Tek -Beta-Lactams226,4401210.053%
Parallux-Beta Lactam Assay92430.325%
Penzyme III Test -Beta-Lactams63,260130.021%
Penzyme Milk Test -Beta-Lactams19,12450.026%
Snap (Reader) -Beta-Lactams737,8209020.122%
Snap (Visual) -Beta-Lactams288,0533200.111%
CEFTIOFURLak Tek -Ceftiofur1,91900%
CLOXACILLINCharm I/Cowside II Tablet -Cloxacillin20300%
Charm II Test for Cloxacillin in Milk3,39210.029%
CHLORAMPHENICOLCharm II Tablet Competitive41400%
ENROFLOXACINCharm SL-Floroquinlone **64620.310%
MACROLIDESCharm II Tablet Sequential -Macrolides **1,17100%
NEOMYCINID Block -Neomycin **900%
NOVOBIOCINCharm II Tablet Competitive -Novobiocin **43400%
SULFONAMIDESAgri-Screen for Sulfonamides ***91710.109%
Charm II Tablet Competitive83,974110.013%
Charm II Tablet Sequential **5,92220.034%
Cite Sulfa Trio ***2,48300%
SULFADIMETHOXINEID Block -Sulfadimethoxine **14100%
SULFAMETHAZINECharm SL -Sulfamethazine **41700%
Lak Tek -Sulfamethazine ***3,10300%
TETRACYCLINESCharm II Tablet Competitive22,22890.040%
Charm SL -Tetracyclines **75400%
Lak Tek -Tetracyclines ***3,10300%
Snap -Tetracyclines **23,900150.063%
CHLORTETRACYCLINEIsocratic LC Tetracyclines500%
TOTALS4,314,1813,849*

* = See Table 1 for explanation.

** Non-Validated Test Method

*** FDA evaluated these tests and they do not perform as labeled - see M-I-99-4.

TABLE 6A - Comparison of Validated and Non-Validated Tests for Sulfonamides and Tetracyclines
October 1, 2000 to September 30, 2001
Tests By Method by Family/DrugNumber of TestsNumber PositivePercent Positive
VALIDATED FOR SULFONAMIDESCharm II Tablet Competitive83,974110.013%
NON-VALIDATED FOR SULFONAMIDESAgri-Screen for Sulfonamides ***91710.109%
Charm II Tablet Sequential **5,92220.34%
Cite Sulfa Trio ***2,48300.0%
VALIDATED FOR TETRACYCLINESCharm II Tablet Competitive22,22890.040%
NON-VALIDATED FOR TETRACYCLINESCharm SL - Tetracyclines **75400.0%
Lak Tek - Tetracyclines ***3,10300.0%
Snap - Tetracyclines **23,900150.063%

** Non-Validated Test Method

*** FDA evaluated these tests and they do not perform as labeled - see M-I-99-4.

Tables 7-1 to 7-8 present additional details of the testing conducted.  These tables show the testing by family and by individual drugs and present results in terms of Grade A and Non-Grade A testing.  Data on individual drugs listed in these tables, e.g., Ceftiofur, Sulfamethazine, etc., are not included in the total for the family, e.g, Beta-Lactams, Sulfonamides, etc.

TABLE 7-1 --Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2000 to September 30, 2001
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
AMINOGLYCOSIDES1,32723901,3662
BETA-LACTAMS2,878,9472,10917,020502,895,9672,159
Ceftiofur74026603400
Cloxacillin3,5861703,5931
CHLORAMPHENICOL008080
ENROFLOXACIN410221406242
MACROLIDES68501306980
NOVOBIOCIN32000320
SULFONAMIDES83,102103,106086,20810
Sulfamethazine3,5200003,5200
TETRACYLINES43,578162,308045,88616
Chlortetracycline004040
TOTALS3,015,2612,14022,985503,038,2462,190
TABLE 7-2 - Grade A Pasteurized Fluid Milk and Milk Products  Testing October 1, 2000 to September 30, 2001
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA-LACTAM7,822254,285262,1074
Ceftiofur001,18201,1820
SULFONAMIDES144020003440
Sulfadimethoxine1410001410
TETRACYLCINES0014401440
Chlortetracycline001010
TOTALS8,107255,812263,9194
TABLE 7-3 --Grade A Producer Testing
October 1, 2000 to September 30, 2001
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA-LACTAMS549,810914153,457216703,2671,130
Cloxacillin200020
SULFONAMIDES3,735211903,8542
TETRACYLINES110113223
TOTALS553,558916153,587219707,1451,135
TABLE 7-4 - Grade A Other  Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
AMINOGLYCOSIDES7700007700
BETA-LACTAMS79,260206,952886,21228
Ceftiofur0027002700
CHLORAMPHENICOL4020004020
ENROFLOXACIN8040120
MACROLIDES4730004730
NOVOBIOCIN4020004020
SULFONAMIDES885037501,2600
TETRACYCLINES479020206810
TOTALS82,679207,803890,48228
TABLE 7-5 --Non-Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2000 to September 30, 2001
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
AMINOGLYCOSIDES007070
BETA-LACTAMS336,7213381,7593338,480341
Ceftiofur00280280
CHLORAMPHENICOL004040
ENROFLOXACIN00100100
SULFONAMIDES1,5811511,5862
TETRACYCLINES2,94151102,9525
TOTALS341,2433441,8244343,067348
TABLE 7-6--Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2000 to September 30, 2001
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA-LACTAMS228068209100
TOTALS228068209100
TABLE 7-7 - Non-Grade A Producer Testing
October 1, 2000 to September 30, 2001
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA-LACTAMS52,6211332,239154,860134
SULFONAMIDES41000410
TOTALS52,6621332,239154,901134
TABLE 7-8 --Non-Grade A Other  Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA-LACTAMS13,97091,130115,10010
Ceftiofur00990990
NEOMYCIN900090
SULFONAMIDES300030
TETRACYCLINES3000003000
TOTALS14,28291,229115,51110

Tables 8-1 to 8-8 present details on the number of tests conducted by industry and by regulatory agencies.  The data are arranged by test within each family/drug and present results in terms of sample type and Grade A and non-Grade A testing.

 Table 8-1 Number of Tests By Method Family/Drug
Grade A Bulk Milk Pick-Up Tanker
October 1, 2000 to September 30, 2001
Tests Used by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
AMINOGLYCOSIDESCharm II Tablet Competitive **1,32723901,36620.146%
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams1,48301,25742,74040.146%
Charm I/Cowside II Tablet -Beta-Lactams38,56418121338,685210.054%
Charm II Tablet Competitive401,0282772,49515403,5232920.072%
Charm II Tablet Quantitative28,279125190028,4691250.439%
Charm II Tablet Sequential286,0542368891286,9432370.083%
Charm II Tablet Transit -Beta-Lactams39400039400%
Charm Rapid Inhibition Test **60900060900%
Charm SL Beta-Lactams992,1674171,1001993,2674180.042%
Delvo-X-PRESS -Beta-Lactams17,82019248018,068190.105%
Delvotest P 5 Pack -Beta-Lactams932104,09085,022180.358%
Delvotest P/Delvotest P Mini3,22504,27407,49900%
Delvotest SP/Delvotest SP Mini3,6701003,67010.027%
Lak Tek -Beta-Lactams195,317903110195,628900.046%
Parallux-Beta Lactam Assay91320091320.219%
Penzyme III Test -Beta-Lactams36,56790036,56790.025%
Penzyme Milk Test -Beta-Lactams11,413446011,45940.035%
Snap (Reader) -Beta-Lactams626,27166540018626,6716830.109%
Snap (Visual) -Beta-Lactams234,2412361,5990235,8402360.100%
CEFTIOFURLak Tek -Ceftiofur740266034000%
CLOXACILLINCharm I/Cowside II Tablet -Cloxacillin20300020300%
Charm II Test for Cloxacillin in Milk3,3831703,39010.029%
CHLORAMPHENICOLCharm II Tablet Competitive0080800%
ENROFLOXACINCharm SL-Floroquinlone **4102214062420.321%
MACROLIDESCharm II Tablet Sequential -Macrolides **685013069800%
NOVOBIOCINCharm II Tablet Competitive -Novobiocin **320003200%
SULFONAMIDESAgri-Screen for Sulfonamides ***23200023200%
Charm II Tablet Competitive77,0239791077,81490.012%
Charm II Tablet Sequential ***5,84717005,91710.017%
Cite Sulfa Trio ***002,24502,24500.00%
SULFAMETHAZINECharm SL - Sulfamethazine **41700041700%
Lak Tek -Sulfamethazine ***3,1030003,10300%
TETRACYCLINESCharm II Tablet Competitive20,6128990021,60280.037%
Charm SL -Tetracyclines **75400075400%
Lak Tek -Tetracyclines ***3,1030003,10300%
Snap -Tetracyclines **19,10981,318020,42780.039%
CHLORTETRACYCLINEIsocratic LC Tetracyclines0040400%
TOTALS3,015,2612,14022,985503,038,2462,1900.072%

** Non-Validated Test Method

*** FDA evaluated these tests and they do not perform as labeled - see M-I-99-4.

Table 8-2 - Number of  Tests by Method by Family/Drug Grade A Pasteurized Fluid Milk and Milk Products
October 1, 2000 to September 30, 2001
Tests Used by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams97907,67728,65620.023%
Charm I/Cowside II Tablet -Beta-Lactams440004400%
Charm II Tablet Competitive00738073800%
Charm II Tablet Quantitative60300060300%
Charm II Tablet Sequential2,32801,54303,87100%
Charm SL Beta-Lactams1,643114601,78910.056%
Delvo-X-PRESS -Beta-Lactams00870087000%
Delvotest P 5 Pack -Beta-Lactams525036,710037,23500%
Delvotest P/Delvotest P Mini004,78704,78700%
Lak Tek -Beta-Lactams001,18201,18200%
Penzyme Milk Test -Beta-Lactams110156016700%
Snap (Reader) -Beta-Lactams1,517140501,92210.052%
Snap (Visual) -Beta-Lactams172071024300%
CEFTIOFURLak Tek -Ceftiofur001,18201,18200%
SULFONAMIDESCharm II Tablet Competitive14406015000%
Cite Sulfa Trio ***00194019400%
SULFADIMETHOXINEID Block -Sulfadimethoxine **14100014100%
SULFAMETHAZINE        
TETRACYCLINESSnap -Tetracyclines **00144014400%
CHLORTETRACYCLINEIsocratic LC Tetracyclines0010100%
TOTALS8,107255,812263,91940.006%

** Non-Validated Test Method

*** FDA evaluated these tests and they do not perform as labeled - see M-I-99-4.

Table 8-3 - Number of  Tests Used by Family/Drug Grade A Producer
October 1, 2000 to September 30, 2001
Tests Used by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams220,21557351,76065271,9756380.231%
Charm I/Cowside II Tablet -Beta-Lactams602024011842111.306%
Charm II Tablet Competitive9,75132419,77540.031%
Charm II Tablet Quantitative2,3746002,37460.253%
Charm II Tablet Sequential2,537134,98897,525190.252%
Charm SL Beta-Lactams5,802384965,851440.752%
Delvo-X-PRESS -Beta-Lactams3,2210003,22100%
Delvotest P 5 Pack -Beta-Lactams263,09222089,437145352,5293590.102%
Delvotest P/Delvotest P Mini33,413106,546039,959100.025%
Delvotest SP/Delvotest SP Mini11800011800%
Lak Tek -Beta-Lactams1,0862001,08620.184%
Parallux-Beta Lactam Assay111001119.091%
Penzyme III Test -Beta-Lactams94610094610.106%
Penzyme Milk Test -Beta-Lactams509027053600%
Snap (Reader) -Beta-Lactams3,29838291103,589481.337%
Snap (Visual) -Beta-Lactams2,83599502,93090.307%
CLOXACILLINCharm II Test for Cloxacillin in Milk2000200%
SULFONAMIDESAgri-Screen for Sulfonamides ***68510068510.146%
Charm II Tablet Competitive3,050111903,16910.032%
TETRACYCLINESCharm II Tablet Competitive00616116.667%
Snap -Tetracyclines **1105216212.500%
TOTALS553,558916153,587219707,1451,1350.160%

** Non-Validated Test Method

*** FDA evaluated these tests and they do not perform as labeled - see M-I-99-4.

Table 8-4 - Number of  Tests by Method by Family/Drug Grade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001
Tests Used by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
AMINOGLYCOSIDESCharm II Tablet Competitive **77000077000%
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams450096101,41100%
Charm I/Cowside II Tablet -Beta-Lactams4,3566004,35660.138%
Charm II Tablet Competitive6,946160207,54810.013%
Charm II Tablet Quantitative796092088800%
Charm II Tablet Sequential16,1484484416,63280.048%
Charm SL Beta-Lactams25,2784150125,42850.020%
Delvo-X-PRESS -Beta-Lactams00113011300%
Delvotest P 5 Pack -Beta-Lactams12,15203,367015,51900%
Delvotest P/Delvotest P Mini3,553079604,34900%
Delvotest SP/Delvotest SP Mini12800012800%
Lak Tek -Beta-Lactams1020280038200%
Penzyme III Test -Beta-Lactams14010014010.714%
Penzyme Milk Test -Beta-Lactams0080800%
Snap (Reader) -Beta-Lactams4,31614904,36510.023%
Snap (Visual) -Beta-Lactams4,89535034,94560.121%
CEFTIOFURLak Tek -Ceftiofur00270027000%
CHLORAMPHENICOLCharm II Tablet Competitive40200040200%
ENROFLOXACINCharm SL-Floroquinlone **80401200%
MACROLIDESCharm II Tablet Sequential -Macrolides **47300047300%
NOVOBIOCINCharm II Tablet Competitive -Novobiocin **40200040200%
SULFONAMIDESCharm II Tablet Competitive841037501,21600%
Cite Sulfa Trio ***440004400%
TETRACYCLINESCharm II Tablet Competitive4020202060400%
Snap -Tetracyclines **770007700%
TOTALS82,679207,803890,482280.031%

** Non-Validated Test Method

*** FDA evaluated these tests and they do not perform as labeled - see M-I-99-4.

Table 8-5 - Number of Tests By Method by Family/Drug Non-Grade A Bulk Milk Pick-Up Tanker
October 1, 2000 to September 30, 2001
Tests Used by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
AMINOGLYCOSIDESCharm II Tablet Competitive **0070700%
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams2,6330002,63300%
Charm I/Cowside II Tablet -Beta-Lactams1,9211001,92110.052%
Charm II Tablet Competitive5,0444605,05040.079%
Charm II Tablet Quantitative0010100%
Charm II Tablet Sequential11,6181015011,633100.086%
Charm II Tablet Transit -Beta-Lactams2,4260002,42600%
Charm SL Beta-Lactams116,81571140116,829710.061%
Delvo-X-PRESS -Beta-Lactams47250047251.059%
Delvotest P 5 Pack -Beta-Lactams209048025700%
Delvotest P/Delvotest P Mini45200045200%
Lak Tek -Beta-Lactams27,70929305028,014290.104%
Penzyme III Test -Beta-Lactams22,32520022,32520.009%
Penzyme Milk Test -Beta-Lactams6,1691006,16910.016%
Snap (Reader) -Beta-Lactams99,1641531,2702100,4341550.154%
Snap (Visual) -Beta-Lactams39,76462100139,864630.158%
CEFTIOFURLak Tek -Ceftiofur002802800%
CHLORAMPHENICOLCharm II Tablet Competitive0040400%
ENROFLOXACINCharm SL-Floroquinlone **001001000%
SULFONAMIDESCharm II Tablet Competitive1,5811001,58110.063%
Charm II Tablet Sequential **00515120%
TETRACYCLINESCharm II Tablet Competitive501101600%
Snap -Tetracyclines **2,9365002,93650.170%
TOTALS341,2433441,8244343,0673480.101%

** Non-Validated Test Method

Table 8-6 - Number of  Tests by Method Family/Drug Non-Grade A Pasteurized Fluid Milk and Milk Products
October 1, 2000 to September 30, 2001
Tests Used by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams2503606100%
Charm II Tablet Competitive008108100%
Delvotest P 5 Pack -Beta-Lactams00517051700%
Delvotest P/Delvotest P Mini104804900%
Penzyme III Test -Beta-Lactams320003200%
Snap (Reader) -Beta-Lactams8000800%
Snap (Visual) -Beta-Lactams16200016200%
TOTALS2280682091000.0%
Table 8-7 - Number of  Tests by Method by Family/Drug Non-Grade A Producer
October 1, 2000 to September 30, 2001
Tests Used by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams37,74895389038,137950.249%
Charm II Tablet Competitive19800019800%
Charm SL Beta-Lactams592349064130.468%
Delvotest P 5 Pack -Beta-Lactams10,462191,521111,983200.167%
Delvotest P/Delvotest P Mini5890280086900%
Lak Tek -Beta-Lactams400004000%
Penzyme III Test -Beta-Lactams24800024800%
Penzyme Milk Test -Beta-Lactams70600070600%
Snap (Reader) -Beta-Lactams3861400386143.627%
Snap (Visual) -Beta-Lactams1,6522001,65220.121%
SULFONAMIDESCharm II Tablet Competitive410004100%
TOTALS52,6621332,239154,9011340.244%
Table 8-8 - Number of  Tests by Method by Family/Drug Non-Grade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001
Tests Used by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
BETA-LACTAMSCharm BSDA Tablet -Beta-Lactams1205907100%
Charm Farm -Beta-Lactams **55900055900%
Charm I/Cowside II Tablet -Beta-Lactams25400025400%
Charm II Tablet Quantitative007707700%
Charm II Tablet Sequential007707700%
Charm SL Beta-Lactams7,2156307,21860.083%
Delvotest P 5 Pack -Beta-Lactams00725072500%
Delvotest P/Delvotest P Mini006806800%
Lak Tek -Beta-Lactams9099010800%
Penzyme III Test -Beta-Lactams3,0020003,00200%
Penzyme Milk Test -Beta-Lactams790007900%
Snap (Reader) -Beta-Lactams44500044500%
Snap (Visual) -Beta-Lactams2,39532212,41740.165%
CEFTIOFURLak Tek -Ceftiofur009909900%
NEOMYCINID Block -Neomycin **9000900%
SULFONAMIDESCharm II Tablet Competitive3000300%
TETRACYCLINESSnap -Tetracyclines **30000030000%
TOTALS14,28291,229115,511100.062%

** Non-Validated Test Method

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