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National Milk Drug Residue Data Base Fiscal Year 2002 Annual Report

<< Back to Milk Guidance Documents & Regulatory Information

 

FISCAL YEAR 2002 ANNUAL REPORT
October 1, 2001 - September 30, 2002
Submitted by:
GLH, Incorporated
2900 NE 46th Street
Lighthouse Point, FL 33064
954-783-9819

Contract Number: 223-02-4299
February 14, 2003


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 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 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 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 silos, over-the-road tankers, etc.)

NATIONAL MILK DRUG RESIDUE DATA BASE
FISCAL YEAR 2003 ANNUAL REPORT
October 1, 2001 - September 30, 2002

 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 that was removed from the human food supply. 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 the 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 Grade A 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.

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 2002, October 1, 2001 to September 30, 2002. Fifty States and Puerto Rico submitted data for this report. However, Idaho only submitted data on its industry bulk milk pick-up testing. Minnesota has submitted less than ten percent of its producer testing and its Pasteurized Fluid Milk testing reporting was incomplete.

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 4,526,414 samples were analyzed for animal drug residues. Of these samples 3,500 were positive for a residue. A total of 4,613,839 tests were reported on the samples for 11 different groups of families or individual drugs. Thirty-two 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 the bulk tank/silo on 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 processor.

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, 2001 to September 30, 2002
Source of SampleTotal SamplesNumber PositivePercent PositiveDisposition per PMO (Pounds)
Bulk Milk Pick-Up Tanker3,623,7022,2120.061%80,043,000
Pasteurized Fluid Milk and Milk Products56,59630.005%5,000
Producer752,2181,2610.168%4,657,000
Other93,898240.026%998,000
Total4,526,4143,500*85,703,000

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 lactams 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 from 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 and reporting 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, 2001 to September 30, 2002
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 ABulk Milk Pick-Up Tanker3,266,0291,92525,151423,291,1801,9670.060%72,178,000
Pasteurized Fluid Milk and Milk Products5,522050,153355,67530.05%5,000
Producer516,557857184,356263700,9131,1200.160%4,547,000
Other75,00496,1441181,148200.025%818,000
NON-GRADE ABulk Milk Pick-Up Tanker1332,2422452800332,5222450.074%7,865,000
Pasteurized Fluid Milk and Milk Products240897092100.000%0,000
Producer47,5581403,747151,3051410.275%110,000
Other12,0254725012,75040.031%180,000
TOTALS4,254,9613,180271,4533204,526,4143,500*85,703,0002

1It 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.
2Note that this represents 0.0520% 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, 2001 to September 30, 2002. 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, 2001 to September 30, 2002
Source of SampleTotal TestsNumber of Tests PositivePercent Positive
Bulk Milk Pick-Up Tanker3,701,9672,4500.066
Pasteurized Fluid Milk and Milk Products56,865100.018
Producer757,9161,3060.172
Other97,091380.039
Total4,613,8393,804*

* = See Table 1 for explanation

TABLE 3A -- Validated Tests Conducted
October 1, 2001 to September 30, 2002
Source of SampleTotal TestsNumber of Tests PositivePercent Positive
Bulk Milk Pick-Up Tanker3,677,5332,4470.067
Pasteurized Fluid Milk and Milk Products55,70670.013
Producer757,9001,3060.172
Other95,237380.040
Total4,586,3763,798*

* = See Table 1 for explanation.

TABLE 3B -- Non-Validated Tests Conducted
October 1, 2001 to September 30, 2002
Source of SampleTotal TestsNumber of Tests PositivePercent Positive
Bulk Milk Pick-Up Tanker24,43430.012
Pasteurized Fluid Milk and Milk Products1,15930.259
Producer1600.000
Other1,85400.000
Total27,4636*

* = 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, 2001 to September 30, 2002
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 Tanker3,343,0322,12025,670433,368,7022,1630.064%
Pasteurized Fluid Milk and Milk Products5,707050,2371055,944100.018%
Producer521,615919184,945275706,5601,1940.169%
Other77,24296,7962584,038340.040%
NON-GRADE ABulk Milk Pick-Up Tanker1332,9852872800333,2652870.086%
Pasteurized Fluid Milk and Milk Products240897092100.000%
Producer47,5951113,761151,3561120.218%
Other12,1554898013,05340.031%
TOTALS4,340,3553,450273,4843544,613,8393,804*

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 4A -- Validated Tests Conducted by Industry and Regulatory Agencies
October 1, 2001 to September 30, 2002
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 Tanker3,327,6822,11717,323433,345,0052,1600.065%
Pasteurized Fluid Milk and Milk Products5,533049,252754,78570.013%
Producer521,599919184,945275706,5441,1940.169%
Other75,65796,7962582,453340.041%
NON-GRADE ABulk Milk Pick-Up Tanker1332,2482872800332,5282870.086%
Pasteurized Fluid Milk and Milk Products240897092100.000%
Producer47,5951113,761151,3561120.218%
Other11,8864898012,78440.031%
TOTALS4,322,2243,447264,1523514,586,3763,798*

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, 2001 to September 30, 2002
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 Tanker15,35038,347023,69730.013%
Pasteurized Fluid Milk and Milk Products174098531,15930.259%
Producer160001600.000%
Other1,5850001,58500.000%
NON-GRADE ABulk Milk Pick-Up Tanker173700073700.000%
Pasteurized Fluid Milk and Milk Products0000000.000%
Producer0000000.000%
Other26900026900.000%
TOTALS18,13139,332327,4636*

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, 2001 - September 30, 2002
Family/DrugTotal TestsTotal Positive
AMINOGLYCOSIDES8160
Neomycin230
AMPHENICOLS3670
BETA lactams4,506,0893,766
Cloxacillin1,6281
MACROLIDES4330
NOVOBIOCIN3670
SULFONAMIDES84,01432
Sulfadimethoxine1330
Sulfamethazine2670
TETRACYCLINES19,7025
TOTALS4,613,8393,804



 

TABLE 5A -- Number of Validated Tests Conducted by Family/Drug
October 1, 2001 to September 30, 2002
Family/DrugTotal TestsTotal Positive
AMPHENICOLS3670
BETA lactams4,506,0043,766
Cloxacillin1,6281
SULFONAMIDES69,95231
TETRACYCLINES8,4250
TOTALS4,586,3763,798



 

TABLE 5B -- Number of Non-Validated Tests Conducted by Family/Drug
October 1, 2001 to September 30, 2002
Family/DrugTotal TestsTotal Positive
AMINOGLYCOSIDES9020
Neomycin230
BETA lactams2141
MACROLIDES4820
NOVOBIOCIN4040
SULFONAMIDES14,4762
Sulfadimethoxine1330
Sulfamethazine3,5230
TETRACYCLINES12,4625
TOTALS32,6198

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 testing methods with the largest use were Charm SL - Beta lactams used over 2 million times and Snap (Reader) used over 663 thousand times. Use of the Delvotest P 5 Pack - Beta lactams followed closely, used for over 640 thousand tests. The Charm II Tablet Competitive - Beta lactams method was used for 392 thousand tests. 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, 2001 - September 30, 2002
Tests By Method by Family/DrugNumber of TestsNumber PositivePercent Positive
AMINOGLYCOSIDESCharm II Tablet Competitive-N **81600.000%
NEOMYCINID Block - Neomycin **2300.000%
AMPHENICOLSCharm II Tablet Competitive36700.000%
BETA lactamsCharm BSDA Tablet - Beta lactams84,8331070.126%
Charm Farm - Beta lactams **8500.000%
Charm I/Cowside II Tablet - Beta lactams13,311160.120%
Charm II Tablet Competitive392,9742680.068%
Charm II Tablet Quantitative32,2561250.388%
Charm II Tablet Sequential250,1202270.091%
Charm SL Beta lactams2,018,3401,0410.052%
Delvo-X-PRESS - Beta lactams18,004170.094%
Delvotest P 5 Pack - Beta lactams640,6321,0540.165%
Delvotest P/Delvotest P Mini75,540560.074%
Delvotest SP/Delvotest SP Mini2,21200.000%
Lak Tek - Beta lactams2,63530.114%
Parallux Beta lactams Assay99,845320.032%
Penzyme III Test - Beta lactams26,198170.065%
Penzyme Milk Test - Beta lactams6,11610.016%
Snap (Reader) - Beta lactams663,8206140.092%
Snap (Visual) - Beta lactams179,1681880.105%
CLOXACILLINCharm II Test for Cloxacillin in Milk1,62810.061%
MACROLIDESCharm II Tablet Sequential - Macrolides **43300.000%
NOVOBIOCINCharm II Tablet Competitive - Novobiocin **36700.000%
SULFONAMIDESAgri-Screen for Sulfonamides ***2,13300.000%
Charm II Tablet Competitive69,952310.044%
Charm II Tablet Sequential **4,73510.021%
Parallux Sulfa Trio (Reader)**7,19400.000%
SULFADIMETHOXINEID Block - Sulfadimethoxine **13300.000%
SULFAMETHAZINECharm SL - Sulfamethazine **26700.000%
TETRACYCLINESCharm II Tablet Competitive8,42500.000%
Charm SL - Tetracyclines **1,19700.000%
Snap - Tetracyclines **10,08050.050%
TOTALS4,613,8393,804*

* = 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, 2001 to September 30, 2002
Tests By Method by Family/DrugNumber of TestsNumber PositivePercent Positive
VALIDATED FOR SULFONAMIDESCharm II Tablet Competitive69,952310.044%
NON-VALIDATED FOR SULFONAMIDESAgri-Screen for Sulfonamides ***2,13300.000%
Charm II Tablet Sequential **5,14920.039%
Parrallux Sulfa Trio (Reader)**7,19400.000%
VALIDATED FOR TETRACYCLINESCharm II Tablet Competitive8,42500.000%
NON-VALIDATED FOR TETRACYCLINESCharm SL -Tetracyclines **1,69400.000%
Snap - Tetracyclines **10,83850.049%

* = 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.

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., Cloxacillin, 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, 2001 to September 30, 2002
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
AMINOGLYCOSIDES88000880
Neomycin23000230
BETA lactams3,252,2992,08617,020433,269,3192,129
Cloxacillin1,4681001,4681
MACROLIDES66000660
SULFONAMIDES72,974316,637079,61131
Sulfamethazine1480001480
TETRACYCLINES15,96622,013017,9792
TOTALS3,343,0322,12025,670433,368,7022,163



 

TABLE 7-2 -- Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2001 to September 30, 2002
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA lactams5,391049,252754,6437
SULFONAMIDES142072308650
Sulfadimethoxine10003301330
Sulfamethazine74000740
TETRACYCLINES0022932293
TOTALS5,707050,2371055,94410



 

TABLE 7-3 -- Grade A Producer Testing
October 1, 2001 to September 30, 2002
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA lactams519,280918184,817275704,0971,193
Cloxacillin1600001600
SULFONAMIDES2,159112802,2871
TETRACYCLINES16000160
TOTALS521,615919184,945275706,5601,194



 

TABLE 7-4 -- Grade A Other Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2001 to September 30, 2002
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
AMINOGLYCOSIDES7280007280
AMPHENICOLS3670003670
BETA lactams74,49996,2742580,77334
MACROLIDES3670003670
NOVOBIOCIN3670003670
SULFONAMIDES438028507230
Sulfamethazine45000450
TETRACYCLINES431023706680
TOTALS77,24296,7962584,03834



 

TABLE 7-5 -- Non-Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2001 to September 30, 2002
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA lactams331,8562872800332,136287
SULFONAMIDES5280005280
TETRACYCLINES6010006010
TOTALS332,9852872800333,265287



 

TABLE 7-6 -- Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2001 to September 30, 2002
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA lactams24089709210
TOTALS24089709210



 

TABLE 7-7 -- Non-Grade A Producer Testing
October 1, 2001 to September 30, 2002
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA lactams47,5951113,761151,356112
TOTALS47,5951113,761151,356112



 

TABLE 7-8 -- Non-Grade A Other Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2001 to September 30, 2002
Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive Tests
BETA lactams11,9464898012,8444
TETRACYCLINES2090002090
TOTALS12,1554898013,0534

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 by Family/Drug Grade A Bulk Milk Pickup Tanker October 1, 2001 - September 30, 2002
Tests By Method 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-N **880008800.000%
NEOMYCINID Block - Neomycin **230002300.000%
BETA lactamsCharm BSDA Tablet - Beta lactams1,336085602,19200.000%
Charm Farm - Beta lactams **250002500.000%
Charm I/Cowside II Tablet - Beta lactams10,9441572011,016150.136%
Charm II Tablet Competitive374,1852501,2349375,4192590.069%
Charm II Tablet Quantitative25,918109138026,0561090.418%
Charm II Tablet Sequential218,3761878403219,2161900.087%
Charm SL Beta lactams1,756,0688351,01701,757,0858350.048%
Delvo-X-PRESS - Beta lactams14,63917172014,811170.115%
Delvotest P 5 Pack - Beta lactams3,194193,914227,108410.577%
Delvotest P/Delvotest P Mini5,13414,41609,55010.010%
Delvotest SP/Delvotest SP Mini1,8480001,84800.000%
Lak Tek -Beta lactams2,5423002,54230.118%
Parallux Beta lactams Assay99,010326099,016320.032%
Penzyme III Test - Beta lactams11,37120011,37120.018%
Penzyme Milk Test - Beta lactams4,8481404,85210.021%
Snap (Reader) - Beta lactams581,2394624,2179585,4564710.080%
Snap (Visual) - Beta lactams141,6221531340141,7561530.108%
CLOXACILLINCharm II Test for Cloxacillin in Milk1,4681001,46810.068%
MACROLIDESCharm II Tablet Sequential - Macrolides **660006600.000%
SULFONAMIDESAgri-Screen for Sulfonamides ***2,1190002,11900.000%
Charm II Tablet Competitive66,25630166066,422300.045%
Charm II Tablet Sequential **4,5991004,59910.022%
Parallux Sulfa-Trio (Reader)**006,47106,47100.000%
SULFAMETHAZINECharm SL - Sulfamethazine **14800014800.000%
TETRACYCLINESCharm II Tablet Competitive7,684013707,82100.000%
Charm SL - Tetracyclines **1,1970001,19700.000%
Snap - Tetracyclines **7,08521,87608,96120.022%
TOTALS3,343,0322,12025,670433,368,7022,1630.064%

** 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, 2001 - September 30, 2002
Tests By Method 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 lactams1,85403,73005,58400.000%
Charm II Tablet Competitive52083013500.000%
Charm II Tablet Quantitative590076066600.000%
Charm II Tablet Sequential001,30401,30400.000%
Charm SL Beta lactams1,786070102,48700.000%
Delvo-X-PRESS - Beta lactams004204200.000%
Delvotest P 5 Pack - Beta lactams871037,394538,26550.013%
Delvotest P/Delvotest P Mini005,60905,60900.000%
Delvotest SP/Delvotest SP Mini390003900.000%
Snap (Reader) - Beta lactams1710312148310.207%
Snap (Visual) - Beta lactams280112913.448%
SULFONAMIDESCharm II Tablet Competitive14200014200.000%
Parallux Sulfa-Trio (Reader) **00723072300.000%
SULFADIMETHOXINEID Block - Sulfadimethoxine **100033013300.000%
SULFAMETHAZINECharm SL - Sulfamethazine740007400.000%
TETRACYCLINESSnap - Tetracyclines **00229322931.310%
TOTALS5,707050,2371055,944100.018%

** Non-Validated Test Method

Table 8-3 -- Number of Tests By Method by Family/Drug Grade A Producer Sample
October 1, 2001 - September 30, 2002
Tests By Method 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 lactams39,5176229,7572869,274900.130%
Charm I/Cowside II Tablet - Beta lactams49400049400.000%
Charm II Tablet Competitive9,329727919,60880.083%
Charm II Tablet Quantitative4,46216004,462160.359%
Charm II Tablet Sequential2,05592,58724,642110.237%
Charm SL Beta lactams6,811575,9441812,755750.588%
Delvo-X-PRESS - Beta lactams3,1500003,15000.000%
Delvotest P 5 Pack - Beta lactams416,671719117,950189534,6219080.170%
Delvotest P/Delvotest P Mini28,413727,841856,254150.027%
Delvotest SP/Delvotest SP Mini720007200.000%
Lak Tek - Beta lactams930009300.000%
Penzyme III Test - Beta lactams42500042500.000%
Penzyme Milk Test - Beta lactams31900031900.000%
Snap (Reader) - Beta lactams4,87741352295,229701.339%
Snap (Visual) - Beta lactams2,592010702,69900.000%
CLOXACILLINCharm II Test for Cloxacillin in Milk16000016000.000%
SULFONAMIDESCharm II Tablet Competitive2,159112802,28710.044%
TETRACYCLINESSnap - Tetracyclines **160001600.000%
TOTALS521,615919184,945275706,5601,1940.169%

** Non-Validated Test Method

Table 8-4 -- Number of Tests By Method by Family/Drug Grade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2001 - September 30, 2002
Tests By Method 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-N **72800072800.000%
AMPHENICOLSCharm II Tablet Competitive **36700036700.000%
BETA lactamsCharm BSDA Tablet - Beta lactams1,072052101,59300.000%
Charm I/Cowside II Tablet - Beta lactams96110096110.104%
Charm II Tablet Competitive6,425043006,85500.000%
Charm II Tablet Quantitative902087098900.000%
Charm II Tablet Sequential9,6831485810,16890.089%
Charm SL Beta lactams30,0024127030,12940.013%
Delvo-X-PRESS - Beta lactams0010100.000%
Delvotest P 5 Pack - Beta lactams11,89403,5631415,457140.091%
Delvotest P/Delvotest P Mini1,379096102,34000.000%
Delvotest SP/Delvotest SP Mini14700014700.000%
Parallux Beta lactams Assay0040400.000%
Penzyme III Test - Beta lactams51000051000.000%
Penzyme Milk Test - Beta lactams850008500.000%
Snap (Reader) - Beta lactams6,89406206,95600.000%
Snap (Visual) - Beta lactams4,54533334,57860.131%
MACROLIDESCharm II Tablet Sequential - Macrolides **36700036700.000%
NOVOBIOCINCharm II Tablet Competitive - Novobiocin **36700036700.000%
SULFONAMIDESAgri-Screen for Sulfonamides **140001400.000%
Charm II Tablet Competitive4240285070900.000%
SULFAMETHAZINECharm SL - Sulfamethazine **450004500.000%
TETRACYCLINESCharm II Tablet Competitive3670237060400.000%
Snap - Tetracyclines **640006400.000%
TOTALS77,24296,7962584,038340.040%

** Non-Validated Test Method

Table 8-5 -- Number of Tests By Method by Family/Drug Non-Grade A Bulk Milk Pickup Tanker
October 1, 2001 - September 30, 2002
Tests By Method by Family/DrugNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber of Positive Regulatory TestsTotal TestsTotal Positive TestsPercent Positive
BETA lactamsCharm I/Cowside II Tablet - Beta lactams75900075900.000%
Charm II Tablet Competitive893162095510.105%
Charm II Tablet Sequential14,684176014,690170.116%
Charm SL Beta lactams205,682117720205,7541170.057%
Delvotest P 5 Pack - Beta lactams2,711213102,84220.070%
Delvotest P/Delvotest P Mini5634000563407.105%
Delvotest SP/Delvotest SP Mini360003600.000%
Parallux Beta lactams Assay81800081800.000%
Penzyme III Test - Beta lactams13,892150013,892150.108%
Penzyme Milk Test - Beta lactams86000086000.000%
Snap (Reader) - Beta lactams64,758709064,767700.108%
Snap (Visual) - Beta lactams26,200250026,200250.095%
SULFONAMIDESCharm II Tablet Competitive39200039200.000%
Charm II Tablet Sequential **13600013600.000%
TETRACYCLINESSnap - Tetracyclines **60100060100.000%
TOTALS332,9852872800333,2652870.086%

** Non-Validated Test Method

Table 8-6 -- Number of Tests By Method by Family/Drug Non-Grade A Pasteurized Fluid Milk and Milk Products
October 1, 2001 - September 30, 2002
Tests By Method 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 lactams240002400.000%
Charm II Tablet Sequential0010100.000%
Charm SL Beta lactams0070700.000%
Delvotest P 5 Pack - Beta lactams00751075100.000%
Delvotest P/Delvotest P Mini00137013700.000%
Snap (Reader) - Beta lactams0010100.000%
TOTALS240897092100.000%



 

Table 8-7 -- Number of Tests By Method by Family/Drug Non-Grade A Producer Sample
October 1, 2001 - September 30, 2002
Tests By Method 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 lactams5,2881778906,077170.280%
Charm II Tablet Sequential001301300.000%
Charm SL Beta lactams1,087719611,28380.624%
Delvotest P 5 Pack - Beta lactams38,771842,282041,053840.205%
Delvotest P/Delvotest P Mini4330481091400.000%
Snap (Reader) - Beta lactams59020059020.339%
Snap (Visual) - Beta lactams1,4261001,42610.070%
TOTALS47,5951113,761151,3561120.220%



 

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, 2001 - September 30, 2002
Tests By Method 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 lactams890008900.000%
Charm Farm - Beta lactams **600006000.000%
Charm I/Cowside II Tablet - Beta-lactams810008100.000%
Charm II Tablet Competitive0020200.000%
Charm II Tablet Quantitative008308300.000%
Charm II Tablet Sequential308308600.000%
Charm SL Beta lactams8,82521508,84020.023%
Delvotest P 5 Pack - Beta lactams00535053500.000%
Delvotest P/Delvotest P Mini00173017300.000%
Delvotest SP/Delvotest SP Mini700007000.000%
Parallux Beta lactams Assay0070700.000%
Snap (Reader) - Beta lactams33800033800.000%
Snap (Visual) - Beta lactams2,4802002,48020.081%
TETRACYCLINESSnap - Tetracyclines **20900020900.000%
TOTALS12,1554898013,05340.003%

** Non-Validated Test Method