• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Food

  • Print
  • Share
  • E-mail

National Milk Drug Residue Data Base Fiscal Year 2003 Annual Report

<< Back to Milk Guidance Documents & Regulatory Information
  

FISCAL YEAR 2003 ANNUAL REPORT
October 1, 2002 - September 30, 2003
Submitted by:
GLH, Incorporated
2900 NE 46th Street
Lighthouse Point, FL 33064
954-783-9819

Contract Number: 223-03-4299
February 15, 2004


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, 2002 - September 30, 2003

 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. The Food and Drug Administration (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.

To enhance these efforts and at the request of the FDA, audits of data providers were conducted during this contract period. Staff performed audits in Missouri, California and Pennsylvania. The results of these audits prompted the contractor to revise and redistribute the instructions and reporting form used by the data providers. In addition, a Question and Answer sheet was developed and included with the revised instructions that addressed the most frequently asked and/or misunderstood aspects of data collection and submission.

 SUMMARY

This report presents summary data on samples and tests conducted during the Fiscal Year 2003, October 1, 2002 to September 30, 2003. Fifty States and Puerto Rico submitted data for this report.

The Pasteurized Milk Ordinance (PMO), the rules which State agencies use to implement their milk program, 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 4,382,974 samples were analyzed for animal drug residues. Of these samples 2,945 were positive for a residue. A total of 4,456,141 tests were reported on the samples for 11 different groups of families or individual drugs. Thirty-four 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 milk plant 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.

 TABLE 1 -- Sample Results
October 1, 2002 to September 30, 2003
Source of SampleTotal
Samples
Number
Positive
Percent
Positive
Disposition per
PMO (Pounds)
Bulk MilkPick-Up Tanker3,571,8341,8990.053%70,106,000
Pasteurized Fluid Milk
and Milk Products
54,93280.015%64,000
Producer665,6271,0090.152%4,881,000
Other90,581290.032%1,319,000
Totals4,382,9742,945*76,370,000


 

The asterisk (*) notes that a summary of the percent positive cannot be provided because there is no 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 receipt of every tanker;
  2. Pasteurized Fluid Milk and Milk Products -- a minimum of four samples must be tested for each finished 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, 2002 to September 30, 2003
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 Tanker3,243,0921,65822,402423,265,4941,7000.052%64,167,000
Pasteurized Fluid Milk and Milk Products4,933149,494754,42780.015%64,000
Producer471,970714148,047204620,0179180.148%4,780,000
Other72,215156,8481279,023270.034%1,248,000
NON-GRADE ABulk Milk Pick-Up Tanker 1305,0401981,3001306,3401990.065%5,939,000
Pasteurized Fluid Milk and Milk Products1590346050500.000%0.000
Producer42,851912,759045,610910.200%101,000
Other10,6592859011,51820.017%71,000
TOTALS4,150,9192,679232,0552664,382,9742,945*76,370,0002

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 0.0449% of the Totals milk supply of the annual production of 170 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 conducted (4,456,141) is greater than the number of samples (4,382,974). 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, 2002 to September 30, 2003. 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 PMO 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, 2002 to September 30, 2003
Source of SampleTotal TestsNumber of Tests PositivePercent Positive
Bulk MilkPick-Up Tanker3,639,5832,1670.060
Pasteurized Fluid Milk and Milk Products55,20880.014
Producer670,1111,0410.155
Other91,239300.033
Totals4,456,1413,246*

* = See Table 1 for explanation

 TABLE 3A-- Validated Tests Conducted 
October 1, 2002 to September 30, 2003
Source of SampleTotal TestsNumber of Tests PositivePercent Positive
Bulk Milk Pick-Up Tanker3,597,7722,1490.060
Pasteurized Fluid Milk
and Milk Products
54,28680.015
Producer668,2011,0390.155
Other90,948300.033
Totals4,411,2073,226*

 * = See Table 1 for explanation

 TABLE 3B -- Non-Validated Tests Conducted 
October 1, 2002 to September 30, 2003
Sourceof SampleTotalTestsNumber of TestsPositivePercentPositive
Bulk MilkPick-Up Tanker41,811180.043
Pasteurized Fluid Milk and Milk Products92200.000
Producer1,91020.105
Other29100.000
Totals44,93420*

 * = 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, 2002 to September 30, 2003
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 Tanker3,309,8121,92322,575423,332,3871,9650.059%
Pasteurized Fluid Milk and Milk Products5,178149,525754,70380.015%
Producer474,638734149,735214624,3409480.152%
Other72,382157,2311379,653280.035%
NON-GRADE ABulk Milk Pick-Up Tanker 1305,8802011,3161307,1962020.066%
Pasteurized Fluid Milk and Milk Products1590346050500.000%
Producer42,979932,759045,738930.203%
Other10,6622924011,58620.017%
TOTALS4,221,6902,969234,4512774,456,1413,246*

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, 2002 to September 30, 2003
Sourceof SampleNumber of Industry TestsNumber of Positive Industry TestsNumber of Regulatory TestsNumber ofPositive Regulatory TestsTotal TestsTotal Positive TestsTotal Percent Positive
GRADE ABulk Milk Pick-Up Tanker3,274,1781,90517,329423,291,5071,9470.059%
Pasteurized Fluid Milk and Milk Products4,883148,898753,78180.015%
Producer472,728732149,735214622,4639460.152%
Other72,095157,2671379,362280.035%
NON-GRADE ABulk Milk Pick-Up Tanker 1304,9492011,3161306,2652020.066%
Pasteurized Fluid Milk and Milk Products1590346050500.000%
Producer42,979932,759045,738930.203%
Other10,6622924011,58620.017%
TOTALS4,182,6332,949228,5742774,411,2073,226*

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, 2002 to September 30, 2003
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 Tanker35,634185,246040,880180.044%
Pasteurized Fluid Milk and Milk Products2950627092200.000%
Producer1,9102001,91020.105%
Other28704029100.000%
NON-GRADE ABulk Milk Pick-Up Tanker 193100093100.000%
Pasteurized Fluid Milk and Milk Products0000000.000%
Producer0000000.000%
Other0000000.000%
TOTALS39,057205,877044,93420*

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, 2002 to September 30, 2003
Family/DrugTotal TestsTotalPositive
AMINOGLYCOSIDES1,2901
Neomycin1,8582
AMPHENICOLS2010
BETA lactams4,354,0873,207
Cloxacillin3173
MACROLIDES640
SULFONAMIDES66,12423
Sulfadimethoxine4,4783
Sulfamethazine17,4663
TETRACYCLINES10,1384
Tetracycline1180
TOTALS4,456,1413,246

 

 TABLE 5A -- Number of Validated Tests Conducted by Family/Drug
October 1, 2002 to September 30, 2003
Family/DrugTotal TestsTotalPositive
AMPHENICOLS2010
BETA lactams4,353,5943,205
Cloxacillin3173
SULFONAMIDES52,54716
TETRACYCLINES4,4302
TETRACYCLINE1180
TOTALS4,411,2073,226

 

 TABLE 5B -- Number of Non-Validated Tests Conducted by Family/Drug
October 1, 2002 to September 30, 2003
Family/DrugTotal TestsTotalPositive
AMINOGLYCOSIDES1,2901
Neomycin1,8582
BETA lactams4932
MACROLIDES640
SULFONAMIDES13,5777
Sulfadimethoxine4,4783
Sulfamethazine17,4663
TETRACYCLINES5,7082
TOTALS44,93420

 

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 more than 2.3 million times followed by Delvotest P 5 Pack - Beta lactams used more than 624 thousand times, Snap (Reader) used more than 451 thousand times and Charm II Tablet Competitive - Beta lactams used for 334 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, 2002 to September 30, 2003
Tests Used by Family/DrugNumber of TestsNumber PositivePercent Positive
AMINOGLYCOSIDESCharm II Tablet Competitive-N**6500.000%
Charm II Tablet Sequential1,22510.082%
NEOMYCINID Block - Neomycin**1,85820.108%
AMPHENICOLSCharm II Tablet Competitive20100.000%
BETA lactamsCharm BSDA Tablet - Beta lactams76,538880.115%
Charm I/Cowside II Tablet - Beta lactams6,14340.065%
Charm II Liquid - Beta lactams26010.385%
Charm II Tablet Competitive334,5321730.052%
Charm II Tablet Quantitative26,5091090.411%
Charm II Tablet Sequential187,0481520.081%
Charm Rapid Inhibition Test49320.406%
Charm SL Beta lactams2,,321,651,2110.052%
Delvo-X-PRESS - Beta-Lactams4,06420.049%
Delvotest P 5 Pack - Beta lactams624,4678800.141%
Delvotest P/Delvotest P Mini48,148210.044%
Delvotest SP/Delvotest SP Mini1,31600.000%
Parallux Beta lactams Assay102,864420.041%
Penzyme III Test - Beta lactams13,271110.083%
Penzyme Milk Test - Beta lactams6,37830.047%
Snap (Reader) - Beta lactams451,1793880.086%
Snap (Visual) - Beta lactams149,2271200.080%
CLOXACILLINCharm II Tablet Quantitative24200.000%
Charm II Test for Cloxacillin in Milk7534.000%
MACROLIDESCharm II Tablet Sequential - Macrolides**6400.000%
SULFONAMIDESAgri-Screen for Sulfonamides***4,12550.121%
Charm II Tablet Competitive52,547160.030%
Charm II Tablet Sequential**3,44320.058%
Parallux Sulfa Trio (Reader)**6,00900.000%
SULFADIMETHOXINEID Block - Sulfadimethoxine**4,47830.067%
SULFAMETHAZINECharm SL - Sulfamethazine**17,46630.017%
TETRACYCLINESCharm II Tablet Competitive4,43020.045%
Charm SL - Tetracyclines**2,07500.000%
Snap - Tetracyclines3,63320.055%
TETRACYCLINEHPLC Tetracyclines - Tetracycline11800.000%
TOTALS4,456,1413,246*

* = 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, 2002 to September 30, 2003
Tests By Method by Family/DrugNumber of TestsNumber PositivePercent Positive
VALIDATED FOR
SULFONAMIDES
Charm II Tablet Competitive52,547160.030%
NON-VALIDATED
FOR SULFONAMIDES
Agri-Screen for Sulfonamides ***4,12550.121%
Charm II Tablet Sequential **3,44320.058%
Parallux Sulfa Trio (Reader)**6,00900.000%
VALIDATED FOR
TETRACYCLINES
Charm II Tablet Competitive4,43020.045%
HPLC Tetracyclines - Tetracycline11800.000%
NON-VALIDATED
FOR TETRACYCLINES
Charm SL -Tetracyclines **2,07500.000%
Snap - Tetracyclines **3,63320.055%

** 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 Totals for the family, e.g, Beta lactams, Sulfonamides, etc.

 

 TABLE 7-1 -- Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2002 to September 30, 2003
Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
AMINOGLYCOSIDES1,2901001,2901
BETA lactams3,221,7041,89017,299413,239,0031,931
Cloxacillin3173003173
MACROLIDES64000640
SULFONAMIDES55,512205,274160,78621
Sulfadimethoxine4,4783004,4783
Sulfamethazine16,89530016,8953
TETRACYCLINES9,5523209,5543
TOTALS3,309,8121,92322,575423,332,3871,965

 

 TABLE 7-2 -- Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2002 to September 30, 2003
Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
TotalTestsTotal Positive
Tests
BETA lactams4,744148,780753,5248
SULFONAMIDES139049806370
Sulfamethazine2950002950
TETRACYCLINES0015001500
Tetracycline00970970
TOTALS5,178149,525754,7038



 

 TABLE 7-3-- Grade A Producer Testing
October 1, 2002 to September 30, 2003
Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
NEOMYCIN1,8582001,8582
BETA lactams470,186730149,640214619,826944
SULFONAMIDES2,54229302,6352
Sulfamethazine51000510
TETRACYCLINES100010
Tetracycline002020
TOTALS474,638734149,735214624,373948



 

 TABLE 7-4 -- Grade A Other Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2002 to September 30, 2003
Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
AMPHENICOLS2010002010
BETA lactams71,283156,8421378,12528
SULFONAMIDES334033406680
Sulfamethazine2250002250
TETRACYCLINES33908904280
Tetracycline006060
TOTALS72,382157,2711379,65328




 

 TABLE 7-5 -- Non-Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2002 to September 30, 2003
Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
BETA lactams304,4782001,3161305,794201
SULFONAMIDES1,3970001,3970
TETRACYCLINES510051
TOTALS305,8802011,3161307,196202

 

 TABLE 7-6 -- Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2002 to September 30, 2003
Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
BETA lactams159034605050
TOTALS159034605050

 

 TABLE 7-7 -- Non-Grade A Producer Testing
October 1, 2002 to September 30, 2003
Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
BETA lactams42,966932,759045,72593
TETRACYCLINE13000130
TOTALS42,979932,759045,73893

 

 TABLE 7-8 -- Non-Grade A Other Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2002 to September 30, 2003
Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
BETA lactams10,6622923011,5852
SULFONAMIDES001010
TOTALS10,6622924011,5862

 

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/DrugGrade A Bulk Milk Pickup Tanker
October 1, 2002 to September 30, 2003
Tests by Method by Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
Percent Positive
AMINOGLYCOSIDESCharm II Tablet Competitive-N **650006500.000%
Charm II Tablet Sequential1,2251001,22510.082%
BETA lactamsCharm BSDA Tablet - Beta lactams19,369110019,369110.057%
Charm I/Cowside II Tablet - Beta lactams4,936342415,36040.075%
Charm II Liquid - Beta lactams111001119.091%
Charm II Tablet Competitive324,3311651665324,4971700.052%
Charm II Tablet Quantitative23,99410924024,0181090.454%
Charm II Tablet Sequential168,6651261,7471170,4121270.075%
Charm Rapid Inhibition Test49320049320.406%
Charm SL Beta lactams2,039,2251,0251,50322,040,7281,0270.050%
Delvo-X-PRESS - Beta-lactams1,5492001,54920.129%
Delvotest P 5 Pack - Beta lactams7,336114,2651711,601280.241%
Delvotest P/Delvotest P Mini5,05103,82408,87500.000%
Delvotest SP/Delvotest SP Mini90800090800.000%
Parallux Beta lactams Assay102,078391322102,210410.040%
Penzyme III Test - Beta lactams10,00660010,00660.060%
Penzyme Milk Test - Beta lactams5,24022815,26830.057%
Snap (Reader) - Beta lactams394,8692991,1416396,0103050.077%
Snap (Visual) - Beta lactams113,643894,0456117,688950.081%
CLOXACILLINCharm II Tablet Quantitative24200024200.000%
Charm II Test for Cloxacillin in Milk753007534.000%
MACROLIDESCharm II Tablet Sequential - Macrolides **640006400.000%
SULFONAMIDESAgri-Screen for Sulfonamides ***3,1945003,19450.157%
Charm II Tablet Competitive48,5871330148,617140.029%
Charm II Tablet Sequential **3,4432003,44320.058%
Parallux Sulfa Trio (Reader) **28805,24405,53200.000%
SULFADIMETHOXINEID Block - Sulfadimethoxine4,4783004,47830.067%
SULFAMETHAZINECharm SL - Sulfamethazine **16,89530016,89530.018%
TETRACYCLINESCharm II Tablet Competitive4,0631004,06310.025%
Charm SL - Tetracyclines **2,0750002,07500.000%
Snap - Tetracyclines **3,4142203,41620.059%
TOTALS3,309,8121,92322,575423,332,3871,9650.059%

** 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/DrugGrade A Pasteurized Fluid Milk and Milk Products
October 1, 2002 to September 30, 2003
Tests by Method by Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
Percent Positive
BETA lactamsCharm BSDA Tablet - Beta lactams1,24802,41503,66300.000%
Charm II Tablet Competitive00305030500.000%
Charm II Tablet Quantitative780027080700.000%
Charm II Tablet Sequential24201,18001,42200.000%
Charm SL Beta lactams1,33411,05912,39320.084%
Delvotest P 5 Pack - Beta lactams955039,515240,47020.005%
Delvotest P/Delvotest P Mini004,20544,20540.095%
Snap (Reader) - Beta lactams185048023300.000%
Snap (Visual) - Beta lactams002602600.000%
SULFONAMIDESCharm II Tablet Competitive139021016000.000%
Parallux Sulfa Trio (Reader)00477047700.000%
SULFAMETHAZINECharm SL - Sulfamethazine29500029500.000%
TETRACYCLINESSnap - Tetracyclines00150015000.000%
TETRACYCLINEHPLC Tetracyclines - Tetracycline009709700.000%
TOTALS5,178149,525754,70380.015%

 

 Table 8-3 -- Number of Tests by Method by Family/DrugGrade A Producer Sample
October 1, 2002 to September 30, 2003
Tests by Method by Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
Percent Positive
NEOMYCINID Block - Neomycin1,8582001,85820.108%
BETA lactamsCharm BSDA Tablet - Beta lactams31,3093217,3333448,642660.136%
Charm I/Cowside II Tablet - Beta lactams47900047900.000%
Charm II Liquid - Beta lactams24900024900.000%
Charm II Tablet Competitive4,286219504,48120.045%
Charm II Tablet Quantitative70600070600.000%
Charm II Tablet Sequential26162,59222,85380.280%
Charm SL Beta lactams5,905487,301213,206500.379%
Delvo-X-PRESS - Beta-lactams2,4990002,49900.000%
Delvotest P 5 Pack - Beta lactams404,468623104,878146509,3467690.151%
Delvotest P/Delvotest P Mini14,104317,1231331,227160.051%
Delvotest SP/Delvotest SP Mini930009300.000%
Parallux Beta lactams Assay001111100.000%
Penzyme III Test - Beta lactams30400030400.000%
Penzyme Milk Test - Beta lactams24800024800.000%
Snap (Reader) - Beta lactams3,3911689133,480290.833%
Snap (Visual) - Beta lactams1,884012832,01230.149%
SULFONAMIDESCharm II Tablet Competitive2,54229302,63520.076%
SULFAMETHAZINECharm SL - Sulfamethazine **510005100.000%
TETRACYCLINESSnap - Tetracyclines **1000100.000%
TETRACYCLINEHPLC Tetracyclines - Tetracycline0020200.000%
TOTALS474,638734149,735214624,3739480.152%

** Non-Validated Test Method

 

 Table 8-4 -- Number of Tests by Method by Family/DrugGrade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2002 to September 30, 2003
Tests by Method by Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
Percent Positive
AMPHENICOLSCharm II Tablet Competitive20100020100.000%
BETA lactamsCharm BSDA Tablet - Beta lactams1,758026702,02500.000%
Charm II Tablet Competitive4,088138904,47710.022%
Charm II Tablet Quantitative97800097800.000%
Charm II Tablet Sequential9,95024461210,396140.135%
Charm SL Beta lactams33,3255472033,79750.015%
Delvo-X-PRESS - Beta-Lactams160001600.000%
Delvotest P 5 Pack - Beta lactams11,51703,945115,46210.006%
Delvotest P/Delvotest P Mini1,09501,15402,24900.000%
Delvotest SP/Delvotest SP Mini31500031500.000%
Parallux Beta lactams Assay007207200.000%
Penzyme III Test - Beta lactams87400087400.000%
Penzyme Milk Test - Beta lactams0030300.000%
Snap (Reader) - Beta lactams4,24215804,30010.023%
Snap (Visual) - Beta lactams3,12563603,16160.190%
SULFONAMIDESCharm II Tablet Competitive3340334066800.000%
SULFAMETHAZINECharm SL - Sulfamethazine22500022500.000%
TETRACYCLINESCharm II Tablet Competitive277085036200.000%
Snap - Tetracyclines **620406600.000%
TETRACYCLINEHPLC Tetracyclines - Tetracycline0060600.000%
TOTALS72,382157,2711379,653280.035%

** Non-Validated Test Method

 

 Table 8-5 -- Number of Tests by Method by Family/DrugNon-Grade A Bulk Milk Pickup Tanker
October 1, 2002 to September 30, 2003
Tests by Method by Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
Percent Positive
BETA lactamsCharm I/Cowside II Tablet - Beta lactams30400030400.000%
Charm II Tablet Competitive74400074400.000%
Charm II Tablet Sequential1,9443301,94730.154%
Charm SL Beta lactams221,9451209801222,9251210.054%
Delvotest P 5 Pack - Beta lactams7,4518307,45480.107%
Delvotest P/Delvotest P Mini545123056810.176%
Parallux Beta lactams Assay51600051600.000%
Penzyme III Test - Beta lactams2,0875002,08750.240%
Penzyme Milk Test - Beta lactams85900085900.000%
Snap (Reader) - Beta lactams44,04048273044,313480.108%
Snap (Visual) - Beta lactams24,0431534024,077150.062%
SULFONAMIDESAgri-Screen for Sulfonamides*93100093100.000%
Charm II Tablet Competitive46600046600.000%
TETRACYCLINESCharm II Tablet Competitive51005120.000%
TOTALS305,8802011,3161307,1962020.066%

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

 

 Table 8-6 -- Number of Tests by Method by Family/DrugNon-Grade A Pasteurized Fluid Milk and Milk Products
October 1, 2002 to September 30, 2003
Tests by Method by Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
Percent Positive
BETA lactamsCharm BSDA Tablet - Beta lactams200002000.000%
Charm SL Beta lactams0050500.000%
Delvotest P 5 Pack - Beta lactams1390241038000.000%
Delvotest P/Delvotest P Mini00100010000.000%
TOTALS1590346050500.000%

 

 Table 8-7-- Number of Tests by Method by Family/DrugNon-Grade A Producer Sample
October 1, 2002 to September 30, 2003
Tests by Method by Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotalPositive TestsPercent Positive
BETA lactamsCharm BSDA Tablet - Beta lactams2,3661144302,809110.392%
Charm II Tablet Competitive0060600.000%
Charm SL Beta lactams707648101,18860.505%
Delvotest P 5 Pack - Beta lactams37,696721,316039,012720.185%
Delvotest P/Delvotest P Mini2910485077600.000%
Snap (Reader) - Beta lactams1,7634001,76340.227%
Snap (Visual) - Beta lactams143028017100.000%
TETRACYCLINEHPLC Tetracyclines - Tetracycline130001300.000%
TOTALS42,979932,759045,738930.204%

 

 Table 8-8 -- Number of Tests by Method by Family/DrugNon-Grade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2002 to September 30, 2003
Tests by Method by Family/DrugNumber of
Industry Tests
Number of Positive
Industry Tests
Number of
Regulatory Tests
Number of Positive
Regulatory Tests
Total TestsTotal Positive
Tests
Percent Positive
BETA lactamsCharm BSDA Tablet - Beta lactams100001000.000%
Charm II Tablet Competitive002202200.000%
Charm II Tablet Sequential170101800.000%
Charm SL Beta lactams7,294011407,40800.000%
Delvotest P 5 Pack - Beta lactams1800562074200.000%
Delvotest P/Delvotest P Mini00148014800.000%
Parallux Beta lactams Assay006506500.000%
Snap (Reader) - Beta lactams1,0801001,08010.093%
Snap (Visual) - Beta lactams2,08111102,09210.048%
SULFONAMIDESCharm II Tablet Competitive0010100.000%
TOTALS10,6622924011,58620.001%