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National Milk Drug Residue Data Base Fiscal Year 2002 Annual Report

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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 Sample Total Samples Number Positive Percent Positive Disposition per PMO (Pounds)
Bulk Milk Pick-Up Tanker 3,623,702 2,212 0.061% 80,043,000
Pasteurized Fluid Milk and Milk Products 56,596 3 0.005% 5,000
Producer 752,218 1,261 0.168% 4,657,000
Other 93,898 24 0.026% 998,000
Total 4,526,414 3,500 * 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 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 3,266,029 1,925 25,151 42 3,291,180 1,967 0.060% 72,178,000
Pasteurized Fluid Milk and Milk Products 5,522 0 50,153 3 55,675 3 0.05% 5,000
Producer 516,557 857 184,356 263 700,913 1,120 0.160% 4,547,000
Other 75,004 9 6,144 11 81,148 20 0.025% 818,000
NON-GRADE A Bulk Milk Pick-Up Tanker1 332,242 245 280 0 332,522 245 0.074% 7,865,000
Pasteurized Fluid Milk and Milk Products 24 0 897 0 921 0 0.000% 0,000
Producer 47,558 140 3,747 1 51,305 141 0.275% 110,000
Other 12,025 4 725 0 12,750 4 0.031% 180,000
TOTALS 4,254,961 3,180 271,453 320 4,526,414 3,500 * 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 Sample Total Tests Number of Tests Positive Percent Positive
Bulk Milk Pick-Up Tanker 3,701,967 2,450 0.066
Pasteurized Fluid Milk and Milk Products 56,865 10 0.018
Producer 757,916 1,306 0.172
Other 97,091 38 0.039
Total 4,613,839 3,804 *

* = See Table 1 for explanation

TABLE 3A -- Validated Tests Conducted
October 1, 2001 to September 30, 2002
Source of Sample Total Tests Number of Tests Positive Percent Positive
Bulk Milk Pick-Up Tanker 3,677,533 2,447 0.067
Pasteurized Fluid Milk and Milk Products 55,706 7 0.013
Producer 757,900 1,306 0.172
Other 95,237 38 0.040
Total 4,586,376 3,798 *

* = See Table 1 for explanation.

TABLE 3B -- Non-Validated Tests Conducted
October 1, 2001 to September 30, 2002
Source of Sample Total Tests Number of Tests Positive Percent Positive
Bulk Milk Pick-Up Tanker 24,434 3 0.012
Pasteurized Fluid Milk and Milk Products 1,159 3 0.259
Producer 16 0 0.000
Other 1,854 0 0.000
Total 27,463 6 *

* = 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 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 3,343,032 2,120 25,670 43 3,368,702 2,163 0.064%
Pasteurized Fluid Milk and Milk Products 5,707 0 50,237 10 55,944 10 0.018%
Producer 521,615 919 184,945 275 706,560 1,194 0.169%
Other 77,242 9 6,796 25 84,038 34 0.040%
NON-GRADE A Bulk Milk Pick-Up Tanker1 332,985 287 280 0 333,265 287 0.086%
Pasteurized Fluid Milk and Milk Products 24 0 897 0 921 0 0.000%
Producer 47,595 111 3,761 1 51,356 112 0.218%
Other 12,155 4 898 0 13,053 4 0.031%
TOTALS 4,340,355 3,450 273,484 354 4,613,839 3,804 *

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 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 3,327,682 2,117 17,323 43 3,345,005 2,160 0.065%
Pasteurized Fluid Milk and Milk Products 5,533 0 49,252 7 54,785 7 0.013%
Producer 521,599 919 184,945 275 706,544 1,194 0.169%
Other 75,657 9 6,796 25 82,453 34 0.041%
NON-GRADE A Bulk Milk Pick-Up Tanker1 332,248 287 280 0 332,528 287 0.086%
Pasteurized Fluid Milk and Milk Products 24 0 897 0 921 0 0.000%
Producer 47,595 111 3,761 1 51,356 112 0.218%
Other 11,886 4 898 0 12,784 4 0.031%
TOTALS 4,322,224 3,447 264,152 351 4,586,376 3,798 *

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 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 15,350 3 8,347 0 23,697 3 0.013%
Pasteurized Fluid Milk and Milk Products 174 0 985 3 1,159 3 0.259%
Producer 16 0 0 0 16 0 0.000%
Other 1,585 0 0 0 1,585 0 0.000%
NON-GRADE A Bulk Milk Pick-Up Tanker1 737 0 0 0 737 0 0.000%
Pasteurized Fluid Milk and Milk Products 0 0 0 0 0 0 0.000%
Producer 0 0 0 0 0 0 0.000%
Other 269 0 0 0 269 0 0.000%
TOTALS 18,131 3 9,332 3 27,463 6 *

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/Drug Total Tests Total Positive
AMINOGLYCOSIDES 816 0
Neomycin 23 0
AMPHENICOLS 367 0
BETA lactams 4,506,089 3,766
Cloxacillin 1,628 1
MACROLIDES 433 0
NOVOBIOCIN 367 0
SULFONAMIDES 84,014 32
Sulfadimethoxine 133 0
Sulfamethazine 267 0
TETRACYCLINES 19,702 5
TOTALS 4,613,839 3,804
TABLE 5A -- Number of Validated Tests Conducted by Family/Drug
October 1, 2001 to September 30, 2002
Family/Drug Total Tests Total Positive
AMPHENICOLS 367 0
BETA lactams 4,506,004 3,766
Cloxacillin 1,628 1
SULFONAMIDES 69,952 31
TETRACYCLINES 8,425 0
TOTALS 4,586,376 3,798
TABLE 5B -- Number of Non-Validated Tests Conducted by Family/Drug
October 1, 2001 to September 30, 2002
Family/Drug Total Tests Total Positive
AMINOGLYCOSIDES 902 0
Neomycin 23 0
BETA lactams 214 1
MACROLIDES 482 0
NOVOBIOCIN 404 0
SULFONAMIDES 14,476 2
Sulfadimethoxine 133 0
Sulfamethazine 3,523 0
TETRACYCLINES 12,462 5
TOTALS 32,619 8

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/Drug Number of Tests Number Positive Percent Positive
AMINOGLYCOSIDES Charm II Tablet Competitive-N ** 816 0 0.000%
NEOMYCIN ID Block - Neomycin ** 23 0 0.000%
AMPHENICOLS Charm II Tablet Competitive 367 0 0.000%
BETA lactams Charm BSDA Tablet - Beta lactams 84,833 107 0.126%
Charm Farm - Beta lactams ** 85 0 0.000%
Charm I/Cowside II Tablet - Beta lactams 13,311 16 0.120%
Charm II Tablet Competitive 392,974 268 0.068%
Charm II Tablet Quantitative 32,256 125 0.388%
Charm II Tablet Sequential 250,120 227 0.091%
Charm SL Beta lactams 2,018,340 1,041 0.052%
Delvo-X-PRESS - Beta lactams 18,004 17 0.094%
Delvotest P 5 Pack - Beta lactams 640,632 1,054 0.165%
Delvotest P/Delvotest P Mini 75,540 56 0.074%
Delvotest SP/Delvotest SP Mini 2,212 0 0.000%
Lak Tek - Beta lactams 2,635 3 0.114%
Parallux Beta lactams Assay 99,845 32 0.032%
Penzyme III Test - Beta lactams 26,198 17 0.065%
Penzyme Milk Test - Beta lactams 6,116 1 0.016%
Snap (Reader) - Beta lactams 663,820 614 0.092%
Snap (Visual) - Beta lactams 179,168 188 0.105%
CLOXACILLIN Charm II Test for Cloxacillin in Milk 1,628 1 0.061%
MACROLIDES Charm II Tablet Sequential - Macrolides ** 433 0 0.000%
NOVOBIOCIN Charm II Tablet Competitive - Novobiocin ** 367 0 0.000%
SULFONAMIDES Agri-Screen for Sulfonamides *** 2,133 0 0.000%
Charm II Tablet Competitive 69,952 31 0.044%
Charm II Tablet Sequential ** 4,735 1 0.021%
Parallux Sulfa Trio (Reader)** 7,194 0 0.000%
SULFADIMETHOXINE ID Block - Sulfadimethoxine ** 133 0 0.000%
SULFAMETHAZINE Charm SL - Sulfamethazine ** 267 0 0.000%
TETRACYCLINES Charm II Tablet Competitive 8,425 0 0.000%
Charm SL - Tetracyclines ** 1,197 0 0.000%
Snap - Tetracyclines ** 10,080 5 0.050%
TOTALS 4,613,839 3,804 *

* = 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/Drug Number of Tests Number Positive Percent Positive
VALIDATED FOR SULFONAMIDES Charm II Tablet Competitive 69,952 31 0.044%
NON-VALIDATED FOR SULFONAMIDES Agri-Screen for Sulfonamides *** 2,133 0 0.000%
Charm II Tablet Sequential ** 5,149 2 0.039%
Parrallux Sulfa Trio (Reader)** 7,194 0 0.000%
VALIDATED FOR TETRACYCLINES Charm II Tablet Competitive 8,425 0 0.000%
NON-VALIDATED FOR TETRACYCLINES Charm SL -Tetracyclines ** 1,694 0 0.000%
Snap - Tetracyclines ** 10,838 5 0.049%

* = 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/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 88 0 0 0 88 0
Neomycin 23 0 0 0 23 0
BETA lactams 3,252,299 2,086 17,020 43 3,269,319 2,129
Cloxacillin 1,468 1 0 0 1,468 1
MACROLIDES 66 0 0 0 66 0
SULFONAMIDES 72,974 31 6,637 0 79,611 31
Sulfamethazine 148 0 0 0 148 0
TETRACYCLINES 15,966 2 2,013 0 17,979 2
TOTALS 3,343,032 2,120 25,670 43 3,368,702 2,163
TABLE 7-2 -- Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2001 to September 30, 2002
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 5,391 0 49,252 7 54,643 7
SULFONAMIDES 142 0 723 0 865 0
Sulfadimethoxine 100 0 33 0 133 0
Sulfamethazine 74 0 0 0 74 0
TETRACYCLINES 0 0 229 3 229 3
TOTALS 5,707 0 50,237 10 55,944 10
TABLE 7-3 -- Grade A Producer Testing
October 1, 2001 to September 30, 2002
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 519,280 918 184,817 275 704,097 1,193
Cloxacillin 160 0 0 0 160 0
SULFONAMIDES 2,159 1 128 0 2,287 1
TETRACYCLINES 16 0 0 0 16 0
TOTALS 521,615 919 184,945 275 706,560 1,194
TABLE 7-4 -- Grade A Other Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2001 to September 30, 2002
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 728 0 0 0 728 0
AMPHENICOLS 367 0 0 0 367 0
BETA lactams 74,499 9 6,274 25 80,773 34
MACROLIDES 367 0 0 0 367 0
NOVOBIOCIN 367 0 0 0 367 0
SULFONAMIDES 438 0 285 0 723 0
Sulfamethazine 45 0 0 0 45 0
TETRACYCLINES 431 0 237 0 668 0
TOTALS 77,242 9 6,796 25 84,038 34
TABLE 7-5 -- Non-Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2001 to September 30, 2002
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 331,856 287 280 0 332,136 287
SULFONAMIDES 528 0 0 0 528 0
TETRACYCLINES 601 0 0 0 601 0
TOTALS 332,985 287 280 0 333,265 287
TABLE 7-6 -- Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2001 to September 30, 2002
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 24 0 897 0 921 0
TOTALS 24 0 897 0 921 0
TABLE 7-7 -- Non-Grade A Producer Testing
October 1, 2001 to September 30, 2002
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 47,595 111 3,761 1 51,356 112
TOTALS 47,595 111 3,761 1 51,356 112
TABLE 7-8 -- Non-Grade A Other Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2001 to September 30, 2002
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 11,946 4 898 0 12,844 4
TETRACYCLINES 209 0 0 0 209 0
TOTALS 12,155 4 898 0 13,053 4

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/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-N ** 88 0 0 0 88 0 0.000%
NEOMYCIN ID Block - Neomycin ** 23 0 0 0 23 0 0.000%
BETA lactams Charm BSDA Tablet - Beta lactams 1,336 0 856 0 2,192 0 0.000%
Charm Farm - Beta lactams ** 25 0 0 0 25 0 0.000%
Charm I/Cowside II Tablet - Beta lactams 10,944 15 72 0 11,016 15 0.136%
Charm II Tablet Competitive 374,185 250 1,234 9 375,419 259 0.069%
Charm II Tablet Quantitative 25,918 109 138 0 26,056 109 0.418%
Charm II Tablet Sequential 218,376 187 840 3 219,216 190 0.087%
Charm SL Beta lactams 1,756,068 835 1,017 0 1,757,085 835 0.048%
Delvo-X-PRESS - Beta lactams 14,639 17 172 0 14,811 17 0.115%
Delvotest P 5 Pack - Beta lactams 3,194 19 3,914 22 7,108 41 0.577%
Delvotest P/Delvotest P Mini 5,134 1 4,416 0 9,550 1 0.010%
Delvotest SP/Delvotest SP Mini 1,848 0 0 0 1,848 0 0.000%
Lak Tek -Beta lactams 2,542 3 0 0 2,542 3 0.118%
Parallux Beta lactams Assay 99,010 32 6 0 99,016 32 0.032%
Penzyme III Test - Beta lactams 11,371 2 0 0 11,371 2 0.018%
Penzyme Milk Test - Beta lactams 4,848 1 4 0 4,852 1 0.021%
Snap (Reader) - Beta lactams 581,239 462 4,217 9 585,456 471 0.080%
Snap (Visual) - Beta lactams 141,622 153 134 0 141,756 153 0.108%
CLOXACILLIN Charm II Test for Cloxacillin in Milk 1,468 1 0 0 1,468 1 0.068%
MACROLIDES Charm II Tablet Sequential - Macrolides ** 66 0 0 0 66 0 0.000%
SULFONAMIDES Agri-Screen for Sulfonamides *** 2,119 0 0 0 2,119 0 0.000%
Charm II Tablet Competitive 66,256 30 166 0 66,422 30 0.045%
Charm II Tablet Sequential ** 4,599 1 0 0 4,599 1 0.022%
Parallux Sulfa-Trio (Reader)** 0 0 6,471 0 6,471 0 0.000%
SULFAMETHAZINE Charm SL - Sulfamethazine ** 148 0 0 0 148 0 0.000%
TETRACYCLINES Charm II Tablet Competitive 7,684 0 137 0 7,821 0 0.000%
Charm SL - Tetracyclines ** 1,197 0 0 0 1,197 0 0.000%
Snap - Tetracyclines ** 7,085 2 1,876 0 8,961 2 0.022%
TOTALS 3,343,032 2,120 25,670 43 3,368,702 2,163 0.064%

** 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/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 1,854 0 3,730 0 5,584 0 0.000%
Charm II Tablet Competitive 52 0 83 0 135 0 0.000%
Charm II Tablet Quantitative 590 0 76 0 666 0 0.000%
Charm II Tablet Sequential 0 0 1,304 0 1,304 0 0.000%
Charm SL Beta lactams 1,786 0 701 0 2,487 0 0.000%
Delvo-X-PRESS - Beta lactams 0 0 42 0 42 0 0.000%
Delvotest P 5 Pack - Beta lactams 871 0 37,394 5 38,265 5 0.013%
Delvotest P/Delvotest P Mini 0 0 5,609 0 5,609 0 0.000%
Delvotest SP/Delvotest SP Mini 39 0 0 0 39 0 0.000%
Snap (Reader) - Beta lactams 171 0 312 1 483 1 0.207%
Snap (Visual) - Beta lactams 28 0 1 1 29 1 3.448%
SULFONAMIDES Charm II Tablet Competitive 142 0 0 0 142 0 0.000%
Parallux Sulfa-Trio (Reader) ** 0 0 723 0 723 0 0.000%
SULFADIMETHOXINE ID Block - Sulfadimethoxine ** 100 0 33 0 133 0 0.000%
SULFAMETHAZINE Charm SL - Sulfamethazine 74 0 0 0 74 0 0.000%
TETRACYCLINES Snap - Tetracyclines ** 0 0 229 3 229 3 1.310%
TOTALS 5,707 0 50,237 10 55,944 10 0.018%

** 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/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 39,517 62 29,757 28 69,274 90 0.130%
Charm I/Cowside II Tablet - Beta lactams 494 0 0 0 494 0 0.000%
Charm II Tablet Competitive 9,329 7 279 1 9,608 8 0.083%
Charm II Tablet Quantitative 4,462 16 0 0 4,462 16 0.359%
Charm II Tablet Sequential 2,055 9 2,587 2 4,642 11 0.237%
Charm SL Beta lactams 6,811 57 5,944 18 12,755 75 0.588%
Delvo-X-PRESS - Beta lactams 3,150 0 0 0 3,150 0 0.000%
Delvotest P 5 Pack - Beta lactams 416,671 719 117,950 189 534,621 908 0.170%
Delvotest P/Delvotest P Mini 28,413 7 27,841 8 56,254 15 0.027%
Delvotest SP/Delvotest SP Mini 72 0 0 0 72 0 0.000%
Lak Tek - Beta lactams 93 0 0 0 93 0 0.000%
Penzyme III Test - Beta lactams 425 0 0 0 425 0 0.000%
Penzyme Milk Test - Beta lactams 319 0 0 0 319 0 0.000%
Snap (Reader) - Beta lactams 4,877 41 352 29 5,229 70 1.339%
Snap (Visual) - Beta lactams 2,592 0 107 0 2,699 0 0.000%
CLOXACILLIN Charm II Test for Cloxacillin in Milk 160 0 0 0 160 0 0.000%
SULFONAMIDES Charm II Tablet Competitive 2,159 1 128 0 2,287 1 0.044%
TETRACYCLINES Snap - Tetracyclines ** 16 0 0 0 16 0 0.000%
TOTALS 521,615 919 184,945 275 706,560 1,194 0.169%

** 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/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-N ** 728 0 0 0 728 0 0.000%
AMPHENICOLS Charm II Tablet Competitive ** 367 0 0 0 367 0 0.000%
BETA lactams Charm BSDA Tablet - Beta lactams 1,072 0 521 0 1,593 0 0.000%
Charm I/Cowside II Tablet - Beta lactams 961 1 0 0 961 1 0.104%
Charm II Tablet Competitive 6,425 0 430 0 6,855 0 0.000%
Charm II Tablet Quantitative 902 0 87 0 989 0 0.000%
Charm II Tablet Sequential 9,683 1 485 8 10,168 9 0.089%
Charm SL Beta lactams 30,002 4 127 0 30,129 4 0.013%
Delvo-X-PRESS - Beta lactams 0 0 1 0 1 0 0.000%
Delvotest P 5 Pack - Beta lactams 11,894 0 3,563 14 15,457 14 0.091%
Delvotest P/Delvotest P Mini 1,379 0 961 0 2,340 0 0.000%
Delvotest SP/Delvotest SP Mini 147 0 0 0 147 0 0.000%
Parallux Beta lactams Assay 0 0 4 0 4 0 0.000%
Penzyme III Test - Beta lactams 510 0 0 0 510 0 0.000%
Penzyme Milk Test - Beta lactams 85 0 0 0 85 0 0.000%
Snap (Reader) - Beta lactams 6,894 0 62 0 6,956 0 0.000%
Snap (Visual) - Beta lactams 4,545 3 33 3 4,578 6 0.131%
MACROLIDES Charm II Tablet Sequential - Macrolides ** 367 0 0 0 367 0 0.000%
NOVOBIOCIN Charm II Tablet Competitive - Novobiocin ** 367 0 0 0 367 0 0.000%
SULFONAMIDES Agri-Screen for Sulfonamides ** 14 0 0 0 14 0 0.000%
Charm II Tablet Competitive 424 0 285 0 709 0 0.000%
SULFAMETHAZINE Charm SL - Sulfamethazine ** 45 0 0 0 45 0 0.000%
TETRACYCLINES Charm II Tablet Competitive 367 0 237 0 604 0 0.000%
Snap - Tetracyclines ** 64 0 0 0 64 0 0.000%
TOTALS 77,242 9 6,796 25 84,038 34 0.040%

** 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/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 I/Cowside II Tablet - Beta lactams 759 0 0 0 759 0 0.000%
Charm II Tablet Competitive 893 1 62 0 955 1 0.105%
Charm II Tablet Sequential 14,684 17 6 0 14,690 17 0.116%
Charm SL Beta lactams 205,682 117 72 0 205,754 117 0.057%
Delvotest P 5 Pack - Beta lactams 2,711 2 131 0 2,842 2 0.070%
Delvotest P/Delvotest P Mini 563 40 0 0 563 40 7.105%
Delvotest SP/Delvotest SP Mini 36 0 0 0 36 0 0.000%
Parallux Beta lactams Assay 818 0 0 0 818 0 0.000%
Penzyme III Test - Beta lactams 13,892 15 0 0 13,892 15 0.108%
Penzyme Milk Test - Beta lactams 860 0 0 0 860 0 0.000%
Snap (Reader) - Beta lactams 64,758 70 9 0 64,767 70 0.108%
Snap (Visual) - Beta lactams 26,200 25 0 0 26,200 25 0.095%
SULFONAMIDES Charm II Tablet Competitive 392 0 0 0 392 0 0.000%
Charm II Tablet Sequential ** 136 0 0 0 136 0 0.000%
TETRACYCLINES Snap - Tetracyclines ** 601 0 0 0 601 0 0.000%
TOTALS 332,985 287 280 0 333,265 287 0.086%

** 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/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 24 0 0 0 24 0 0.000%
Charm II Tablet Sequential 0 0 1 0 1 0 0.000%
Charm SL Beta lactams 0 0 7 0 7 0 0.000%
Delvotest P 5 Pack - Beta lactams 0 0 751 0 751 0 0.000%
Delvotest P/Delvotest P Mini 0 0 137 0 137 0 0.000%
Snap (Reader) - Beta lactams 0 0 1 0 1 0 0.000%
TOTALS 24 0 897 0 921 0 0.000%
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/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 5,288 17 789 0 6,077 17 0.280%
Charm II Tablet Sequential 0 0 13 0 13 0 0.000%
Charm SL Beta lactams 1,087 7 196 1 1,283 8 0.624%
Delvotest P 5 Pack - Beta lactams 38,771 84 2,282 0 41,053 84 0.205%
Delvotest P/Delvotest P Mini 433 0 481 0 914 0 0.000%
Snap (Reader) - Beta lactams 590 2 0 0 590 2 0.339%
Snap (Visual) - Beta lactams 1,426 1 0 0 1,426 1 0.070%
TOTALS 47,595 111 3,761 1 51,356 112 0.220%
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/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 89 0 0 0 89 0 0.000%
Charm Farm - Beta lactams ** 60 0 0 0 60 0 0.000%
Charm I/Cowside II Tablet - Beta-lactams 81 0 0 0 81 0 0.000%
Charm II Tablet Competitive 0 0 2 0 2 0 0.000%
Charm II Tablet Quantitative 0 0 83 0 83 0 0.000%
Charm II Tablet Sequential 3 0 83 0 86 0 0.000%
Charm SL Beta lactams 8,825 2 15 0 8,840 2 0.023%
Delvotest P 5 Pack - Beta lactams 0 0 535 0 535 0 0.000%
Delvotest P/Delvotest P Mini 0 0 173 0 173 0 0.000%
Delvotest SP/Delvotest SP Mini 70 0 0 0 70 0 0.000%
Parallux Beta lactams Assay 0 0 7 0 7 0 0.000%
Snap (Reader) - Beta lactams 338 0 0 0 338 0 0.000%
Snap (Visual) - Beta lactams 2,480 2 0 0 2,480 2 0.081%
TETRACYCLINES Snap - Tetracyclines ** 209 0 0 0 209 0 0.000%
TOTALS 12,155 4 898 0 13,053 4 0.003%

** Non-Validated Test Method

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