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National Milk Drug Residue Data Base Fiscal Year 2001 Annual Report

<< Back to Milk Guidance Documents & Regulatory Information

 

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 Samp##_CURSORPOSITION_##le Total Samples Number Positive Percent Positive Disposition per PMO (Pounds)
Bulk Milk Pick-Up Tanker 3,280,036 2,191 0.067% 79,913,000
Pasteurized Fluid Milk and Milk Products 63,996 2 0.003% 79,000
Producer 758,380 1,175 0.155% 7,737,000
Other 101,204 33 0.033% 1,769,000
Total 4,203,616 3,401 * 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 Sample Number of Industry Samples Number of Positive Industry Samples Number of Regulatory Samples Number of Positive Regulatory Samples Total Samples Total Positive Samples Total Percent Positive Disposition Per PMO (Pounds)
Grade A
Bulk Milk Pick-Up Tanker 2,913,675 1,801 25,244 50 2,938,919 1,851 0.063% 69,109,000
Pasteurized Fluid Milk and Milk Products 7,958 2 55,128 0 63,086 2 0.003% 79,000
Producer 550,132 855 153,568 248 703,700 1,057 0.150% 7,729,000
Other 79,206 18 6,720 8 85,926 26 0.030% 1,584,000
Non-Grade A Bulk Milk Pick-Up Tanker1 339,346 336 1,771 4 341,117 340 0.100% 10,804,000
Pasteurized Fluid Milk and Milk Products 228 0 682 0 910 0 0.000% 0,000
Producer 52,440 117 2,240 1 54,680 118 0.216% 8,000
Other 14,302 6 976 1 15,278 7 0.046% 185,000
TOTALS 3,957,287 3,135 246,329 266 4,203,616 3,401 * 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 Sample Total Tests Number of Tests Positive Percent Positive
Bulk Milk Pick-Up Tanker 3,381,313 2,538 0.075
Pasteurized Fluid Milk and Milk Products 64,829 4 0.006
Producer 762,046 1,269 0.167
Other 105,993 38 0.036
Total 4,314,181 3,849 *

* = See Table 1 for explanation.

TABLE 3A - Validated Tests Conducted
 October 1, 2000 to September 30, 2001
Source of Sample Total Tests Number of Tests Positive Percent Positive
Bulk Milk Pick-Up Tanker 3,338,828 2,519 0.075
Pasteurized Fluid Milk and Milk Products 64,350 4 0.006
Producer 761,345 1,266 0.166
Other 103,347 38 0.037
Total 4,267,870 3,827 *

* = See Table 1 for explanation.

TABLE 3B - Non-Validated Tests Conducted
 October 1, 2000 to September 30, 2001
Source of Sample Total Tests Number of Tests Positive Percent Positive
Bulk Milk Pick-Up Tanker 42,485 19 0.045
Pasteurized Fluid Milk and Milk Products 479 0 0.000
Producer 701 3 0.428
Other 2,646 0 0.000
Total 46,311 22 *

* = 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 Sample Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Total Percent Positive
Grade A Bulk Milk Pick-Up Tanker 3,015,261 2,140 22,985 50 3,038,246 2,190 0.072%
Pasteurized Fluid Milk and Milk Products 8,107 2 555,812 2 63,919 4 0.006%
Producer 553,558 916 153,587 219 707,145 1,135 0.161%
Other 82,679 20 7,803 8 90,482 28 0.031%
Non-Grade A Bulk Milk Pick-Up Tanker1 341,243 344 1,824 4 343,067 348 0.101%
Pasteurized Fluid Milk and Milk Products 228 0 682 0 910 0 0.000%
Producer 52,662 133 2,239 1 54,901 134 0.244%
Other 14,282 9 1,229 1 15,511 10 0.064%
TOTALS 4,068,020 3,564 246,161 285 4,314,181 3,849 *

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 Sample Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Total Percent Positive
Grade A Bulk Milk Pick-Up Tanker 2,979,633 2,127 19,086 50 2,998,719 2,177 0.073%
Pasteurized Fluid Milk and Milk Products 7,966 2 55,474 2 63,440 4 0.006%
Producer 552,862 915 153,582 263 706,444 1,132 0.160%
Other 80,905 20 7,799 8 88,704 28 0.032%
Non-Grade A Bulk Milk Pick-Up Tanker1 338,307 339 1,802 3 340,109 342 0.101%
Pasteurized Fluid Milk and Milk Products 228 0 682 0 910 0 0.000%
Producer 52,662 133 2,239 1 54,901 134 0.244%
Other 13,414 9 1,229 1 14,643 10 0.068%
TOTALS 4,025,943 3,545 241,893 282 4,267,870 3,827 *

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 Sample Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Total Percent Positive
Grade A Bulk Milk Pick-Up Tanker 35,628 13 3,899 0 39,527 13 0.033%
Pasteurized Fluid Milk and Milk Products 141 0 338 0 479 0 0.000%
Producer 696 1 5 2 701 3 0.428%
Other 1,774 0 4 0 1,778 0 0.000%
Non-Grade A Bulk Milk Pick-Up Tanker1 2,936 5 22 1 2,958 6 0.203%
Pasteurized Fluid Milk and Milk Products 0 0 0 0 0 0 0.000%
Producer 0 0 0 0 0 0 0.000%
Other 868 0 0 0 868 0 0.000%
TOTALS 42,043 19 4,268 3 46,311 22 *

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/Drug Total Tests Total Positive
AMINOGLYCOSIDES 2,143 2
BETA-LACTAMS 4,156,903 3,806
Ceftiofur 1,919 0
Cloxacillin 3,595 1
CHLORAMPHENICOL 414 0
ENROFLOXACIN 646 2
MACROLIDES 1,171 0
NEOMYCIN 9 0
NOVOBIOCIN 434 0
SULFONAMIDES 93,296 14
Sulfadimethoxine 141 0
Sulfamethazine 3,520 0
TETRACYCLINES 49,985 24
Chlortetracycline 5 0
TOTALS 4,314,181 3,849

 

TABLE 5A - Number of Validated Tests Conducted by Family/Drug
October 1, 2000 to September 30, 2001
Family/Drug Total Tests Total  Positive
BETA-LACTAMS 4,155,701 3,806
Ceftiofur 1,919 0
Cloxacillin 3,595 1
CHLORAMPHENICOL 414 0
SULFONAMIDES 83,974 11
TETRACYCLINES 22,228 9
Chlortetracycline 5 0
TOTALS 4,267,870 3,827

 

TABLE 5B - Number of Non-Validated Tests Conducted by Family/Drug
October 1, 2000 to September 30, 2001
Family/Drug Total Tests Total  Positive
AMINOGLYCOSIDES 2,143 2
BETA-LACTAMS 1,168 0
ENROFLOXACIN 646 2
MACROLIDES 1,171 0
NEOMYCIN 9 0
NOVOBIOCIN 434 0
SULFONAMIDES 9,322 3
Sulfadimethoxine 141 0
Sulfamethazine 3,520 0
TETRACYLINES 27,757 15
TOTALS 46,311 22

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/Drug Number of Tests Number Positive Percent Positive
AMINOGLYCOSIDES Charm II Tablet Competitive ** 2,143 2 0.093%
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 325,684 729 0.224%
Charm Farm -Beta-Lactams ** 559 0 0.000%
Charm I/Cowside II Tablet -Beta-Lactams 46,102 39 0.085%
Charm II Tablet Competitive 426,913 300 0.070%
Charm II Tablet Quantitative 32,412 131 0.404%
Charm II Tablet Sequential 326,681 274 0.084%
Charm II Tablet Transit -Beta-Lactams 2,820 0 0%
Charm Rapid Inhibition Test ** 609 0 0%
Charm SL Beta-Lactams 1,151,023 550 0.048%
Delvo-X-PRESS -Beta-Lactams 22,744 24 0.106%
Delvotest P 5 Pack -Beta-Lactams 423,787 397 0.094%
Delvotest P/Delvotest P Mini 58,032 10 0.017%
Delvotest SP/Delvotest SP Mini 3,916 1 0.026%
Lak Tek -Beta-Lactams 226,440 121 0.053%
Parallux-Beta Lactam Assay 924 3 0.325%
Penzyme III Test -Beta-Lactams 63,260 13 0.021%
Penzyme Milk Test -Beta-Lactams 19,124 5 0.026%
Snap (Reader) -Beta-Lactams 737,820 902 0.122%
Snap (Visual) -Beta-Lactams 288,053 320 0.111%
CEFTIOFUR Lak Tek -Ceftiofur 1,919 0 0%
CLOXACILLIN Charm I/Cowside II Tablet -Cloxacillin 203 0 0%
Charm II Test for Cloxacillin in Milk 3,392 1 0.029%
CHLORAMPHENICOL Charm II Tablet Competitive 414 0 0%
ENROFLOXACIN Charm SL-Floroquinlone ** 646 2 0.310%
MACROLIDES Charm II Tablet Sequential -Macrolides ** 1,171 0 0%
NEOMYCIN ID Block -Neomycin ** 9 0 0%
NOVOBIOCIN Charm II Tablet Competitive -Novobiocin ** 434 0 0%
SULFONAMIDES Agri-Screen for Sulfonamides *** 917 1 0.109%
Charm II Tablet Competitive 83,974 11 0.013%
Charm II Tablet Sequential ** 5,922 2 0.034%
Cite Sulfa Trio *** 2,483 0 0%
SULFADIMETHOXINE ID Block -Sulfadimethoxine ** 141 0 0%
SULFAMETHAZINE Charm SL -Sulfamethazine ** 417 0 0%
Lak Tek -Sulfamethazine *** 3,103 0 0%
TETRACYCLINES Charm II Tablet Competitive 22,228 9 0.040%
Charm SL -Tetracyclines ** 754 0 0%
Lak Tek -Tetracyclines *** 3,103 0 0%
Snap -Tetracyclines ** 23,900 15 0.063%
CHLORTETRACYCLINE Isocratic LC Tetracyclines 5 0 0%
TOTALS 4,314,181 3,849 *

* = 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/Drug Number of Tests Number Positive Percent Positive
VALIDATED FOR SULFONAMIDES Charm II Tablet Competitive 83,974 11 0.013%
NON-VALIDATED FOR SULFONAMIDES Agri-Screen for Sulfonamides *** 917 1 0.109%
Charm II Tablet Sequential ** 5,922 2 0.34%
Cite Sulfa Trio *** 2,483 0 0.0%
VALIDATED FOR TETRACYCLINES Charm II Tablet Competitive 22,228 9 0.040%
NON-VALIDATED FOR TETRACYCLINES Charm SL - Tetracyclines ** 754 0 0.0%
Lak Tek - Tetracyclines *** 3,103 0 0.0%
Snap - Tetracyclines ** 23,900 15 0.063%

** 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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests
AMINOGLYCOSIDES 1,327 2 39 0 1,366 2
BETA-LACTAMS 2,878,947 2,109 17,020 50 2,895,967 2,159
Ceftiofur 74 0 266 0 340 0
Cloxacillin 3,586 1 7 0 3,593 1
CHLORAMPHENICOL 0 0 8 0 8 0
ENROFLOXACIN 410 2 214 0 624 2
MACROLIDES 685 0 13 0 698 0
NOVOBIOCIN 32 0 0 0 32 0
SULFONAMIDES 83,102 10 3,106 0 86,208 10
Sulfamethazine 3,520 0 0 0 3,520 0
TETRACYLINES 43,578 16 2,308 0 45,886 16
Chlortetracycline 0 0 4 0 4 0
TOTALS 3,015,261 2,140 22,985 50 3,038,246 2,190

 

TABLE 7-2 - Grade A Pasteurized Fluid Milk and Milk Products  Testing October 1, 2000 to September 30, 2001
Family/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests
BETA-LACTAM 7,822 2 54,285 2 62,107 4
Ceftiofur 0 0 1,182 0 1,182 0
SULFONAMIDES 144 0 200 0 344 0
Sulfadimethoxine 141 0 0 0 141 0
TETRACYLCINES 0 0 144 0 144 0
Chlortetracycline 0 0 1 0 1 0
TOTALS 8,107 2 55,812 2 63,919 4

 

TABLE 7-3 --Grade A Producer Testing
October 1, 2000 to September 30, 2001
Family/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests
BETA-LACTAMS 549,810 914 153,457 216 703,267 1,130
Cloxacillin 2 0 0 0 2 0
SULFONAMIDES 3,735 2 119 0 3,854 2
TETRACYLINES 11 0 11 3 22 3
TOTALS 553,558 916 153,587 219 707,145 1,135

 

TABLE 7-4 - Grade A Other  Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001
Family/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests
AMINOGLYCOSIDES 770 0 0 0 770 0
BETA-LACTAMS 79,260 20 6,952 8 86,212 28
Ceftiofur 0 0 270 0 270 0
CHLORAMPHENICOL 402 0 0 0 402 0
ENROFLOXACIN 8 0 4 0 12 0
MACROLIDES 473 0 0 0 473 0
NOVOBIOCIN 402 0 0 0 402 0
SULFONAMIDES 885 0 375 0 1,260 0
TETRACYCLINES 479 0 202 0 681 0
TOTALS 82,679 20 7,803 8 90,482 28

 

TABLE 7-5 --Non-Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2000 to September 30, 2001
Family/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests
AMINOGLYCOSIDES 0 0 7 0 7 0
BETA-LACTAMS 336,721 338 1,759 3 338,480 341
Ceftiofur 0 0 28 0 28 0
CHLORAMPHENICOL 0 0 4 0 4 0
ENROFLOXACIN 0 0 10 0 10 0
SULFONAMIDES 1,581 1 5 1 1,586 2
TETRACYCLINES 2,941 5 11 0 2,952 5
TOTALS 341,243 344 1,824 4 343,067 348

 

TABLE 7-6--Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2000 to September 30, 2001
Family/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests
BETA-LACTAMS 228 0 682 0 910 0
TOTALS 228 0 682 0 910 0

 

TABLE 7-7 - Non-Grade A Producer Testing
October 1, 2000 to September 30, 2001
Family/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests
BETA-LACTAMS 52,621 133 2,239 1 54,860 134
SULFONAMIDES 41 0 0 0 41 0
TOTALS 52,662 133 2,239 1 54,901 134

 

TABLE 7-8 --Non-Grade A Other  Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001
Family/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests
BETA-LACTAMS 13,970 9 1,130 1 15,100 10
Ceftiofur 0 0 99 0 99 0
NEOMYCIN 9 0 0 0 9 0
SULFONAMIDES 3 0 0 0 3 0
TETRACYCLINES 300 0 0 0 300 0
TOTALS 14,282 9 1,229 1 15,511 10

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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Percent Positive
AMINOGLYCOSIDES Charm II Tablet Competitive ** 1,327 2 39 0 1,366 2 0.146%
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 1,483 0 1,257 4 2,740 4 0.146%
Charm I/Cowside II Tablet -Beta-Lactams 38,564 18 121 3 38,685 21 0.054%
Charm II Tablet Competitive 401,028 277 2,495 15 403,523 292 0.072%
Charm II Tablet Quantitative 28,279 125 190 0 28,469 125 0.439%
Charm II Tablet Sequential 286,054 236 889 1 286,943 237 0.083%
Charm II Tablet Transit -Beta-Lactams 394 0 0 0 394 0 0%
Charm Rapid Inhibition Test ** 609 0 0 0 609 0 0%
Charm SL Beta-Lactams 992,167 417 1,100 1 993,267 418 0.042%
Delvo-X-PRESS -Beta-Lactams 17,820 19 248 0 18,068 19 0.105%
Delvotest P 5 Pack -Beta-Lactams 932 10 4,090 8 5,022 18 0.358%
Delvotest P/Delvotest P Mini 3,225 0 4,274 0 7,499 0 0%
Delvotest SP/Delvotest SP Mini 3,670 1 0 0 3,670 1 0.027%
Lak Tek -Beta-Lactams 195,317 90 311 0 195,628 90 0.046%
Parallux-Beta Lactam Assay 913 2 0 0 913 2 0.219%
Penzyme III Test -Beta-Lactams 36,567 9 0 0 36,567 9 0.025%
Penzyme Milk Test -Beta-Lactams 11,413 4 46 0 11,459 4 0.035%
Snap (Reader) -Beta-Lactams 626,271 665 400 18 626,671 683 0.109%
Snap (Visual) -Beta-Lactams 234,241 236 1,599 0 235,840 236 0.100%
CEFTIOFUR Lak Tek -Ceftiofur 74 0 266 0 340 0 0%
CLOXACILLIN Charm I/Cowside II Tablet -Cloxacillin 203 0 0 0 203 0 0%
Charm II Test for Cloxacillin in Milk 3,383 1 7 0 3,390 1 0.029%
CHLORAMPHENICOL Charm II Tablet Competitive 0 0 8 0 8 0 0%
ENROFLOXACIN Charm SL-Floroquinlone ** 410 2 214 0 624 2 0.321%
MACROLIDES Charm II Tablet Sequential -Macrolides ** 685 0 13 0 698 0 0%
NOVOBIOCIN Charm II Tablet Competitive -Novobiocin ** 32 0 0 0 32 0 0%
SULFONAMIDES Agri-Screen for Sulfonamides *** 232 0 0 0 232 0 0%
Charm II Tablet Competitive 77,023 9 791 0 77,814 9 0.012%
Charm II Tablet Sequential *** 5,847 1 70 0 5,917 1 0.017%
Cite Sulfa Trio *** 0 0 2,245 0 2,245 0 0.00%
SULFAMETHAZINE Charm SL - Sulfamethazine ** 417 0 0 0 417 0 0%
Lak Tek -Sulfamethazine *** 3,103 0 0 0 3,103 0 0%
TETRACYCLINES Charm II Tablet Competitive 20,612 8 990 0 21,602 8 0.037%
Charm SL -Tetracyclines ** 754 0 0 0 754 0 0%
Lak Tek -Tetracyclines *** 3,103 0 0 0 3,103 0 0%
Snap -Tetracyclines ** 19,109 8 1,318 0 20,427 8 0.039%
CHLORTETRACYCLINE Isocratic LC Tetracyclines 0 0 4 0 4 0 0%
TOTALS 3,015,261 2,140 22,985 50 3,038,246 2,190 0.072%

** 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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Percent Positive
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 979 0 7,677 2 8,656 2 0.023%
Charm I/Cowside II Tablet -Beta-Lactams 44 0 0 0 44 0 0%
Charm II Tablet Competitive 0 0 738 0 738 0 0%
Charm II Tablet Quantitative 603 0 0 0 603 0 0%
Charm II Tablet Sequential 2,328 0 1,543 0 3,871 0 0%
Charm SL Beta-Lactams 1,643 1 146 0 1,789 1 0.056%
Delvo-X-PRESS -Beta-Lactams 0 0 870 0 870 0 0%
Delvotest P 5 Pack -Beta-Lactams 525 0 36,710 0 37,235 0 0%
Delvotest P/Delvotest P Mini 0 0 4,787 0 4,787 0 0%
Lak Tek -Beta-Lactams 0 0 1,182 0 1,182 0 0%
Penzyme Milk Test -Beta-Lactams 11 0 156 0 167 0 0%
Snap (Reader) -Beta-Lactams 1,517 1 405 0 1,922 1 0.052%
Snap (Visual) -Beta-Lactams 172 0 71 0 243 0 0%
CEFTIOFUR Lak Tek -Ceftiofur 0 0 1,182 0 1,182 0 0%
SULFONAMIDES Charm II Tablet Competitive 144 0 6 0 150 0 0%
Cite Sulfa Trio *** 0 0 194 0 194 0 0%
SULFADIMETHOXINE ID Block -Sulfadimethoxine ** 141 0 0 0 141 0 0%
SULFAMETHAZINE                
TETRACYCLINES Snap -Tetracyclines ** 0 0 144 0 144 0 0%
CHLORTETRACYCLINE Isocratic LC Tetracyclines 0 0 1 0 1 0 0%
TOTALS 8,107 2 55,812 2 63,919 4 0.006%

** 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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Percent Positive
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 220,215 573 51,760 65 271,975 638 0.231%
Charm I/Cowside II Tablet -Beta-Lactams 602 0 240 11 842 11 1.306%
Charm II Tablet Competitive 9,751 3 24 1 9,775 4 0.031%
Charm II Tablet Quantitative 2,374 6 0 0 2,374 6 0.253%
Charm II Tablet Sequential 2,537 13 4,988 9 7,525 19 0.252%
Charm SL Beta-Lactams 5,802 38 49 6 5,851 44 0.752%
Delvo-X-PRESS -Beta-Lactams 3,221 0 0 0 3,221 0 0%
Delvotest P 5 Pack -Beta-Lactams 263,092 220 89,437 145 352,529 359 0.102%
Delvotest P/Delvotest P Mini 33,413 10 6,546 0 39,959 10 0.025%
Delvotest SP/Delvotest SP Mini 118 0 0 0 118 0 0%
Lak Tek -Beta-Lactams 1,086 2 0 0 1,086 2 0.184%
Parallux-Beta Lactam Assay 11 1 0 0 11 1 9.091%
Penzyme III Test -Beta-Lactams 946 1 0 0 946 1 0.106%
Penzyme Milk Test -Beta-Lactams 509 0 27 0 536 0 0%
Snap (Reader) -Beta-Lactams 3,298 38 291 10 3,589 48 1.337%
Snap (Visual) -Beta-Lactams 2,835 9 95 0 2,930 9 0.307%
CLOXACILLIN Charm II Test for Cloxacillin in Milk 2 0 0 0 2 0 0%
SULFONAMIDES Agri-Screen for Sulfonamides *** 685 1 0 0 685 1 0.146%
Charm II Tablet Competitive 3,050 1 119 0 3,169 1 0.032%
TETRACYCLINES Charm II Tablet Competitive 0 0 6 1 6 1 16.667%
Snap -Tetracyclines ** 11 0 5 2 16 2 12.500%
TOTALS 553,558 916 153,587 219 707,145 1,135 0.160%

** 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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Percent Positive
AMINOGLYCOSIDES Charm II Tablet Competitive ** 770 0 0 0 770 0 0%
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 450 0 961 0 1,411 0 0%
Charm I/Cowside II Tablet -Beta-Lactams 4,356 6 0 0 4,356 6 0.138%
Charm II Tablet Competitive 6,946 1 602 0 7,548 1 0.013%
Charm II Tablet Quantitative 796 0 92 0 888 0 0%
Charm II Tablet Sequential 16,148 4 484 4 16,632 8 0.048%
Charm SL Beta-Lactams 25,278 4 150 1 25,428 5 0.020%
Delvo-X-PRESS -Beta-Lactams 0 0 113 0 113 0 0%
Delvotest P 5 Pack -Beta-Lactams 12,152 0 3,367 0 15,519 0 0%
Delvotest P/Delvotest P Mini 3,553 0 796 0 4,349 0 0%
Delvotest SP/Delvotest SP Mini 128 0 0 0 128 0 0%
Lak Tek -Beta-Lactams 102 0 280 0 382 0 0%
Penzyme III Test -Beta-Lactams 140 1 0 0 140 1 0.714%
Penzyme Milk Test -Beta-Lactams 0 0 8 0 8 0 0%
Snap (Reader) -Beta-Lactams 4,316 1 49 0 4,365 1 0.023%
Snap (Visual) -Beta-Lactams 4,895 3 50 3 4,945 6 0.121%
CEFTIOFUR Lak Tek -Ceftiofur 0 0 270 0 270 0 0%
CHLORAMPHENICOL Charm II Tablet Competitive 402 0 0 0 402 0 0%
ENROFLOXACIN Charm SL-Floroquinlone ** 8 0 4 0 12 0 0%
MACROLIDES Charm II Tablet Sequential -Macrolides ** 473 0 0 0 473 0 0%
NOVOBIOCIN Charm II Tablet Competitive -Novobiocin ** 402 0 0 0 402 0 0%
SULFONAMIDES Charm II Tablet Competitive 841 0 375 0 1,216 0 0%
Cite Sulfa Trio *** 44 0 0 0 44 0 0%
TETRACYCLINES Charm II Tablet Competitive 402 0 202 0 604 0 0%
Snap -Tetracyclines ** 77 0 0 0 77 0 0%
TOTALS 82,679 20 7,803 8 90,482 28 0.031%

** 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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Percent Positive
AMINOGLYCOSIDES Charm II Tablet Competitive ** 0 0 7 0 7 0 0%
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 2,633 0 0 0 2,633 0 0%
Charm I/Cowside II Tablet -Beta-Lactams 1,921 1 0 0 1,921 1 0.052%
Charm II Tablet Competitive 5,044 4 6 0 5,050 4 0.079%
Charm II Tablet Quantitative 0 0 1 0 1 0 0%
Charm II Tablet Sequential 11,618 10 15 0 11,633 10 0.086%
Charm II Tablet Transit -Beta-Lactams 2,426 0 0 0 2,426 0 0%
Charm SL Beta-Lactams 116,815 71 14 0 116,829 71 0.061%
Delvo-X-PRESS -Beta-Lactams 472 5 0 0 472 5 1.059%
Delvotest P 5 Pack -Beta-Lactams 209 0 48 0 257 0 0%
Delvotest P/Delvotest P Mini 452 0 0 0 452 0 0%
Lak Tek -Beta-Lactams 27,709 29 305 0 28,014 29 0.104%
Penzyme III Test -Beta-Lactams 22,325 2 0 0 22,325 2 0.009%
Penzyme Milk Test -Beta-Lactams 6,169 1 0 0 6,169 1 0.016%
Snap (Reader) -Beta-Lactams 99,164 153 1,270 2 100,434 155 0.154%
Snap (Visual) -Beta-Lactams 39,764 62 100 1 39,864 63 0.158%
CEFTIOFUR Lak Tek -Ceftiofur 0 0 28 0 28 0 0%
CHLORAMPHENICOL Charm II Tablet Competitive 0 0 4 0 4 0 0%
ENROFLOXACIN Charm SL-Floroquinlone ** 0 0 10 0 10 0 0%
SULFONAMIDES Charm II Tablet Competitive 1,581 1 0 0 1,581 1 0.063%
Charm II Tablet Sequential ** 0 0 5 1 5 1 20%
TETRACYCLINES Charm II Tablet Competitive 5 0 11 0 16 0 0%
Snap -Tetracyclines ** 2,936 5 0 0 2,936 5 0.170%
TOTALS 341,243 344 1,824 4 343,067 348 0.101%

** 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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Percent Positive
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 25 0 36 0 61 0 0%
Charm II Tablet Competitive 0 0 81 0 81 0 0%
Delvotest P 5 Pack -Beta-Lactams 0 0 517 0 517 0 0%
Delvotest P/Delvotest P Mini 1 0 48 0 49 0 0%
Penzyme III Test -Beta-Lactams 32 0 0 0 32 0 0%
Snap (Reader) -Beta-Lactams 8 0 0 0 8 0 0%
Snap (Visual) -Beta-Lactams 162 0 0 0 162 0 0%
TOTALS 228 0 682 0 910 0 0.0%

 

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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Percent Positive
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 37,748 95 389 0 38,137 95 0.249%
Charm II Tablet Competitive 198 0 0 0 198 0 0%
Charm SL Beta-Lactams 592 3 49 0 641 3 0.468%
Delvotest P 5 Pack -Beta-Lactams 10,462 19 1,521 1 11,983 20 0.167%
Delvotest P/Delvotest P Mini 589 0 280 0 869 0 0%
Lak Tek -Beta-Lactams 40 0 0 0 40 0 0%
Penzyme III Test -Beta-Lactams 248 0 0 0 248 0 0%
Penzyme Milk Test -Beta-Lactams 706 0 0 0 706 0 0%
Snap (Reader) -Beta-Lactams 386 14 0 0 386 14 3.627%
Snap (Visual) -Beta-Lactams 1,652 2 0 0 1,652 2 0.121%
SULFONAMIDES Charm II Tablet Competitive 41 0 0 0 41 0 0%
TOTALS 52,662 133 2,239 1 54,901 134 0.244%

 

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/Drug Number of Industry Tests Number of Positive Industry Tests Number of Regulatory Tests Number of Positive Regulatory Tests Total Tests Total Positive Tests Percent Positive
BETA-LACTAMS Charm BSDA Tablet -Beta-Lactams 12 0 59 0 71 0 0%
Charm Farm -Beta-Lactams ** 559 0 0 0 559 0 0%
Charm I/Cowside II Tablet -Beta-Lactams 254 0 0 0 254 0 0%
Charm II Tablet Quantitative 0 0 77 0 77 0 0%
Charm II Tablet Sequential 0 0 77 0 77 0 0%
Charm SL Beta-Lactams 7,215 6 3 0 7,218 6 0.083%
Delvotest P 5 Pack -Beta-Lactams 0 0 725 0 725 0 0%
Delvotest P/Delvotest P Mini 0 0 68 0 68 0 0%
Lak Tek -Beta-Lactams 9 0 99 0 108 0 0%
Penzyme III Test -Beta-Lactams 3,002 0 0 0 3,002 0 0%
Penzyme Milk Test -Beta-Lactams 79 0 0 0 79 0 0%
Snap (Reader) -Beta-Lactams 445 0 0 0 445 0 0%
Snap (Visual) -Beta-Lactams 2,395 3 22 1 2,417 4 0.165%
CEFTIOFUR Lak Tek -Ceftiofur 0 0 99 0 99 0 0%
NEOMYCIN ID Block -Neomycin ** 9 0 0 0 9 0 0%
SULFONAMIDES Charm II Tablet Competitive 3 0 0 0 3 0 0%
TETRACYCLINES Snap -Tetracyclines ** 300 0 0 0 300 0 0%
TOTALS 14,282 9 1,229 1 15,511 10 0.062%

** Non-Validated Test Method