NATIONAL MILK DRUG RESIDUE DATA BASE

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

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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.)

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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