NATIONAL MILK DRUG RESIDUE DATA BASE

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

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

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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 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.)

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

INTRODUCTION

The National Milk Drug Residue Data Base is a voluntary industry reporting program. Mandatory reporting is required by State regulatory agencies under the National Conference on Interstate Milk Shipments (NCIMS). Data are reported on the extent of the national testing activities, the analytical methods used, the kind and extent of the animal drug residues identified, and the amount of contaminated milk that was removed from the human food supply. The system includes all milk, Grade A and non-Grade A, commonly known as manufacturing grade. Grade A milk represents approximately 90% of the milk supply and is regulated through the NCIMS by State regulatory agencies. Manufacturing grade milk is under the direction of the regulatory agencies in the States where it is produced and may be subject to the standards recommended by the United States Department of Agriculture (USDA). Data reported to the National Milk Drug Residue Data Base are for educational and analytical purposes and are not intended or suitable for regulatory follow-up.

BACKGROUND

The National Conference on Interstate Milk Shipments (NCIMS) is a voluntary organization directed and controlled by member States to promote the availability of a high quality milk supply. The Food and Drug Administration (FDA) and the NCIMS through their collaborative efforts have developed a cooperative, federal-state program (the Interstate Milk Shipper program) to ensure the sanitary quality of Grade A milk and milk products shipped interstate. During the 1991 meeting of the NCIMS, the Conference authorized a national program to compile the results of residue testing by industry and regulatory agencies.

Subsequently, FDA awarded a contract to develop a National Milk Drug Residue Data Base. The data base is operated by an independent third party, under contract to the FDA. The data base design was developed in consultation with a project advisory group with members from the FDA and a NCIMS committee representing dairy producers, dairy processors, USDA, State regulatory agencies, and academia. The data base was designed to promote maximum participation by the dairy industry to report on a voluntary basis all of their testing, without compromising any confidential data. Information regarding individual firm's data is not submitted to the data base contractor.

It is important to recognize that the samples and tests reported do not necessarily represent one hundred percent of the milk supply from every State. However, as State and industry participation in the data base increased, reporting of the number of samples and tests similarly increased. Continuing efforts are being made to ensure that there is uniform reporting among all the States and the industry and to ensure that the drugs and test methods reported are correct.

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

SUMMARY

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

The Pasteurized Milk Ordinance (PMO), the rules which State agencies use to implement their milk program, requires that all bulk milk tankers be sampled and analyzed for animal drug residues before the milk is processed. Any tanker found positive is rejected for human consumption.

During this period 4,382,974 samples were analyzed for animal drug residues. Of these samples 2,945 were positive for a residue. A total of 4,456,141 tests were reported on the samples for 11 different groups of families or individual drugs. Thirty-four testing methods were used to analyze the samples for residues. Details are presented in the tables in this report.

SAMPLE RESULTS

A SAMPLE is defined as representing a load or lot of milk sampled and analyzed, e.g. a bulk milk pick-up tanker, producer, or over-the-road tanker, a silo, etc.

Table 1 shows the results of the samples tested by source.

Data are reported by four SOURCES OF SAMPLES:

1. Bulk Milk Pick-Up Tanker - bulk raw milk from a dairy farm.
2. Pasteurized Fluid Milk and Milk Products - after pasteurization; finished product in package form or bulk. Includes milk products such as milk, cream, condensed milk and dry milk products, and condensed and dry whey products.
3. Producer - raw milk obtained from the bulk tank/silo on a dairy farm. Samples are reported by the permitting State, rather than by the analyzing State.
4. Other - milk from milk plant silos, over-the-road tankers, etc.

A POSITIVE result, as used in this report, means that the sample was found to be positive for a drug residue by a test acceptable for taking regulatory action in a certified laboratory by a certified analyst or the milk was rejected on the basis of an initial test by the milk processor.

The DISPOSITION Per PMO column represents the amount of milk contained in the tank or lot found to be positive and disposed of in accordance with the PMO and/or applicable State regulations.

TABLE 1 -- Sample Results
October 1, 2002 to September 30, 2003

Source of Sample	Total Samples	Number Positive	Percent Positive	Disposition per PMO (Pounds)
Bulk MilkPick-Up Tanker	3,571,834	1,899	0.053%	70,106,000
Pasteurized Fluid Milk and Milk Products	54,932	8	0.015%	64,000
Producer	665,627	1,009	0.152%	4,881,000
Other	90,581	29	0.032%	1,319,000
Totals	4,382,974	2,945	*	76,370,000

The asterisk (*) notes that a summary of the percent positive cannot be provided because there is no uniformity in terms of sampling in the four categories. For example, the PMO sets forth specific sampling requirements for Beta lactams testing as follows:

1. Bulk Milk Pick-Up Tanker Samples -- samples are taken daily on receipt of every tanker;
2. Pasteurized Fluid Milk and Milk Products -- a minimum of four samples must be tested for each finished product from each plant every six months;
3. Producer -- each producer must be tested at least four times every six months; and
4. Other -- samples are conducted on a random basis.

Table 2 presents these results in greater detail and shows the number of samples conducted by industry and by regulatory agencies. Industry samples are taken by processing facilities, receiving and transfer stations, and marketing groups or cooperatives. Industry samples may be conducted to meet the industry requirements of Appendix N of the PMO which sets forth testing and reporting requirements for animal drug residues or for quality control purposes. Regulatory samples are taken by State and local regulatory agencies.

¹ It is a common practice in some States, including two large milk production States, that bulk milk pick-up tankers pickup milk from Grade A and non-Grade A milk producers on the same truck. Then, these loads are delivered to non-Grade A processing facilities. Because of this commingling of the two grades of milk, all data related to these loads are reported under non-Grade A.
² Note that this represents 0.0449% of the Totals milk supply of the annual production of 170 billion pounds.
*= See Table 1 for explanation

TESTS CONDUCTED

An objective of the National Milk Drug Residue Data Base is to record every test run on each sample analyzed. Since some samples are analyzed for more than one drug residue, the number of tests conducted (4,456,141) is greater than the number of samples (4,382,974). To avoid duplicate reporting of samples, the number of samples analyzed is reported separately from the number of tests run in the data base.

Table 3 presents summary results of the number of tests which were conducted during October 1, 2002 to September 30, 2003. The term, validated test, as used in this report, is a test used for the screening of raw milk for drug residue which has been evaluated in accordance with Appendix N of the PMO and found acceptable by FDA in accordance with the standards established for the evaluation of tests. In addition, FDA validated drug residue detection procedures for screening and quantitation of drug residues in milk may be used. Table 3A presents summary results using validated tests and Table 3B presents summary results using non-validated tests.

TABLE 3 -- Tests Conducted 
October 1, 2002 to September 30, 2003

Source of Sample	Total Tests	Number of Tests Positive	Percent Positive
Bulk MilkPick-Up Tanker	3,639,583	2,167	0.060
Pasteurized Fluid Milk and Milk Products	55,208	8	0.014
Producer	670,111	1,041	0.155
Other	91,239	30	0.033
Totals	4,456,141	3,246	*

* = See Table 1 for explanation

TABLE 3A-- Validated Tests Conducted 
October 1, 2002 to September 30, 2003

Source of Sample	Total Tests	Number of Tests Positive	Percent Positive
Bulk Milk Pick-Up Tanker	3,597,772	2,149	0.060
Pasteurized Fluid Milk and Milk Products	54,286	8	0.015
Producer	668,201	1,039	0.155
Other	90,948	30	0.033
Totals	4,411,207	3,226	*

 * = See Table 1 for explanation

TABLE 3B -- Non-Validated Tests Conducted 
October 1, 2002 to September 30, 2003

Sourceof Sample	TotalTests	Number of TestsPositive	PercentPositive
Bulk MilkPick-Up Tanker	41,811	18	0.043
Pasteurized Fluid Milk and Milk Products	922	0	0.000
Producer	1,910	2	0.105
Other	291	0	0.000
Totals	44,934	20	*

 * = See Table 1 for explanation

 

Table 4 presents additional details in terms of the tests conducted by industry and by regulatory agencies. Tables 4A and 4B present these data by validated and non-validated tests.

TABLE 4 -- Tests Conducted by Industry and Regulatory Agencies
October 1, 2002 to September 30, 2003

Source of 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	3,309,812	1,923	22,575	42	3,332,387	1,965	0.059%
	Pasteurized Fluid Milk and Milk Products	5,178	1	49,525	7	54,703	8	0.015%
	Producer	474,638	734	149,735	214	624,340	948	0.152%
	Other	72,382	15	7,231	13	79,653	28	0.035%
NON-GRADE A	Bulk Milk Pick-Up Tanker 1	305,880	201	1,316	1	307,196	202	0.066%
	Pasteurized Fluid Milk and Milk Products	159	0	346	0	505	0	0.000%
	Producer	42,979	93	2,759	0	45,738	93	0.203%
	Other	10,662	2	924	0	11,586	2	0.017%
TOTALS		4,221,690	2,969	234,451	277	4,456,141	3,246	*

¹ It is a common practice in some States, including two large milk production States, that bulk milk pick-up tankers pickup milk from Grade A and non-Grade A milk producers on the same truck. Then, these loads are delivered to non-Grade A processing facilities. Because of this commingling of the two grades of milk, all data related to these loads are reported under non-Grade A.
* = See Table 1 for explanation

 

TABLE 4A-- Validated Tests Conducted by Industry and Regulatory Agencies
October 1, 2002 to September 30, 2003

Sourceof Sample		Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number ofPositive Regulatory Tests	Total Tests	Total Positive Tests	Total Percent Positive
GRADE A	Bulk Milk Pick-Up Tanker	3,274,178	1,905	17,329	42	3,291,507	1,947	0.059%
	Pasteurized Fluid Milk and Milk Products	4,883	1	48,898	7	53,781	8	0.015%
	Producer	472,728	732	149,735	214	622,463	946	0.152%
	Other	72,095	15	7,267	13	79,362	28	0.035%
NON-GRADE A	Bulk Milk Pick-Up Tanker 1	304,949	201	1,316	1	306,265	202	0.066%
	Pasteurized Fluid Milk and Milk Products	159	0	346	0	505	0	0.000%
	Producer	42,979	93	2,759	0	45,738	93	0.203%
	Other	10,662	2	924	0	11,586	2	0.017%
TOTALS		4,182,633	2,949	228,574	277	4,411,207	3,226	*

¹ It is a common practice in some States, including two large milk production States, that bulk milk pick-up tankers pickup milk from Grade A and non-Grade A milk producers on the same truck. Then, these loads are delivered to non-Grade A processing facilities. Because of this commingling of the two grades of milk, all data related to these loads are reported under non-Grade A.
* = See Table 1 for explanation

¹ It is a common practice in some States, including two large milk production States, that bulk milk pick-up tankers pickup milk from Grade A and non-Grade A milk producers on the same truck. Then, these loads are delivered to non-Grade A processing facilities. Because of this commingling of the two grades of milk, all data related to these loads are reported under non-Grade A.
* = See Table 1 for explanation

 

Table 5 shows the number of tests conducted by family and by individual drug. Tables 5A and 5B present these data by validated and non-validated tests.

TABLE 5 -- Number of Tests Conducted by Family/Drug
October 1, 2002 to September 30, 2003

Family/Drug	Total Tests	TotalPositive
AMINOGLYCOSIDES	1,290	1
Neomycin	1,858	2
AMPHENICOLS	201	0
BETA lactams	4,354,087	3,207
Cloxacillin	317	3
MACROLIDES	64	0
SULFONAMIDES	66,124	23
Sulfadimethoxine	4,478	3
Sulfamethazine	17,466	3
TETRACYCLINES	10,138	4
Tetracycline	118	0
TOTALS	4,456,141	3,246

 

TABLE 5A -- Number of Validated Tests Conducted by Family/Drug
October 1, 2002 to September 30, 2003

Family/Drug	Total Tests	TotalPositive
AMPHENICOLS	201	0
BETA lactams	4,353,594	3,205
Cloxacillin	317	3
SULFONAMIDES	52,547	16
TETRACYCLINES	4,430	2
TETRACYCLINE	118	0
TOTALS	4,411,207	3,226

 

TABLE 5B -- Number of Non-Validated Tests Conducted by Family/Drug
October 1, 2002 to September 30, 2003

Family/Drug	Total Tests	TotalPositive
AMINOGLYCOSIDES	1,290	1
Neomycin	1,858	2
BETA lactams	493	2
MACROLIDES	64	0
SULFONAMIDES	13,577	7
Sulfadimethoxine	4,478	3
Sulfamethazine	17,466	3
TETRACYCLINES	5,708	2
TOTALS	44,934	20

 

Table 6 presents details on the tests used. The data in this table are comparable to Table 5, but the data are arranged by tests within each family/drug. Therefore, the Totals are the same in both tables. The testing methods with the largest use were Charm SL - Beta lactams used more than 2.3 million times followed by Delvotest P 5 Pack - Beta lactams used more than 624 thousand times, Snap (Reader) used more than 451 thousand times and Charm II Tablet Competitive - Beta lactams used for 334 thousand tests. Table 6A shows a comparison of tests conducted using Validated and Non-Validated test methods for Sulfonamides and Tetracyclines.

TABLE 6- Number of Tests by Method by Family/Drug
October 1, 2002 to September 30, 2003

Tests Used by Family/Drug		Number of Tests	Number Positive	Percent Positive
AMINOGLYCOSIDES	Charm II Tablet Competitive-N**	65	0	0.000%
	Charm II Tablet Sequential	1,225	1	0.082%
NEOMYCIN	ID Block - Neomycin**	1,858	2	0.108%
AMPHENICOLS	Charm II Tablet Competitive	201	0	0.000%
BETA lactams	Charm BSDA Tablet - Beta lactams	76,538	88	0.115%
	Charm I/Cowside II Tablet - Beta lactams	6,143	4	0.065%
	Charm II Liquid - Beta lactams	260	1	0.385%
	Charm II Tablet Competitive	334,532	173	0.052%
	Charm II Tablet Quantitative	26,509	109	0.411%
	Charm II Tablet Sequential	187,048	152	0.081%
	Charm Rapid Inhibition Test	493	2	0.406%
	Charm SL Beta lactams	2,,321,65	1,211	0.052%
	Delvo-X-PRESS - Beta-Lactams	4,064	2	0.049%
	Delvotest P 5 Pack - Beta lactams	624,467	880	0.141%
	Delvotest P/Delvotest P Mini	48,148	21	0.044%
	Delvotest SP/Delvotest SP Mini	1,316	0	0.000%
	Parallux Beta lactams Assay	102,864	42	0.041%
	Penzyme III Test - Beta lactams	13,271	11	0.083%
	Penzyme Milk Test - Beta lactams	6,378	3	0.047%
	Snap (Reader) - Beta lactams	451,179	388	0.086%
	Snap (Visual) - Beta lactams	149,227	120	0.080%
CLOXACILLIN	Charm II Tablet Quantitative	242	0	0.000%
	Charm II Test for Cloxacillin in Milk	75	3	4.000%
MACROLIDES	Charm II Tablet Sequential - Macrolides**	64	0	0.000%
SULFONAMIDES	Agri-Screen for Sulfonamides***	4,125	5	0.121%
	Charm II Tablet Competitive	52,547	16	0.030%
	Charm II Tablet Sequential**	3,443	2	0.058%
	Parallux Sulfa Trio (Reader)**	6,009	0	0.000%
SULFADIMETHOXINE	ID Block - Sulfadimethoxine**	4,478	3	0.067%
SULFAMETHAZINE	Charm SL - Sulfamethazine**	17,466	3	0.017%
TETRACYCLINES	Charm II Tablet Competitive	4,430	2	0.045%
	Charm SL - Tetracyclines**	2,075	0	0.000%
	Snap - Tetracyclines	3,633	2	0.055%
TETRACYCLINE	HPLC Tetracyclines - Tetracycline	118	0	0.000%
TOTALS		4,456,141	3,246	*

* = See Table 1 for explanation
** Non-Validated Test Method
*** FDA evaluated these tests and they do not perform as labeled-see M-I-99-4

 

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

 

Tables 7-1 to 7-8 present additional details of the testing conducted. These tables show the testing by family and by individual drugs and present results in terms of Grade A and Non-Grade A testing. Data on individual drugs listed in these tables, e.g., Cloxacillin, Sulfamethazine, etc., are not included in the Totals for the family, e.g, Beta lactams, Sulfonamides, etc.

 

TABLE 7-1 -- Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2002 to September 30, 2003

Family/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	1,290	1	0	0	1,290	1
BETA lactams	3,221,704	1,890	17,299	41	3,239,003	1,931
Cloxacillin	317	3	0	0	317	3
MACROLIDES	64	0	0	0	64	0
SULFONAMIDES	55,512	20	5,274	1	60,786	21
Sulfadimethoxine	4,478	3	0	0	4,478	3
Sulfamethazine	16,895	3	0	0	16,895	3
TETRACYCLINES	9,552	3	2	0	9,554	3
TOTALS	3,309,812	1,923	22,575	42	3,332,387	1,965

 

TABLE 7-2 -- Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2002 to September 30, 2003

Family/Drug	Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	TotalTests	Total Positive Tests
BETA lactams	4,744	1	48,780	7	53,524	8
SULFONAMIDES	139	0	498	0	637	0
Sulfamethazine	295	0	0	0	295	0
TETRACYCLINES	0	0	150	0	150	0
Tetracycline	0	0	97	0	97	0
TOTALS	5,178	1	49,525	7	54,703	8

TABLE 7-3-- Grade A Producer Testing
October 1, 2002 to September 30, 2003

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
NEOMYCIN	1,858	2	0	0	1,858	2
BETA lactams	470,186	730	149,640	214	619,826	944
SULFONAMIDES	2,542	2	93	0	2,635	2
Sulfamethazine	51	0	0	0	51	0
TETRACYCLINES	1	0	0	0	1	0
Tetracycline	0	0	2	0	2	0
TOTALS	474,638	734	149,735	214	624,373	948

TABLE 7-5 -- Non-Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2002 to September 30, 2003

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	304,478	200	1,316	1	305,794	201
SULFONAMIDES	1,397	0	0	0	1,397	0
TETRACYCLINES	5	1	0	0	5	1
TOTALS	305,880	201	1,316	1	307,196	202

 

TABLE 7-6 -- Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2002 to September 30, 2003

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	159	0	346	0	505	0
TOTALS	159	0	346	0	505	0

 

TABLE 7-7 -- Non-Grade A Producer Testing
October 1, 2002 to September 30, 2003

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	42,966	93	2,759	0	45,725	93
TETRACYCLINE	13	0	0	0	13	0
TOTALS	42,979	93	2,759	0	45,738	93

 

TABLE 7-8 -- Non-Grade A Other Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2002 to September 30, 2003

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	10,662	2	923	0	11,585	2
SULFONAMIDES	0	0	1	0	1	0
TOTALS	10,662	2	924	0	11,586	2

 

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.

** Non-Validated Test Method
*** FDA evaluated these tests and they do not perform as labeled - see M-I-99-4.

 

Table 8-2 -- Number of Tests by Method by Family/DrugGrade A Pasteurized Fluid Milk and Milk Products
October 1, 2002 to September 30, 2003

Tests by Method by Family/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	1,248	0	2,415	0	3,663	0	0.000%
	Charm II Tablet Competitive	0	0	305	0	305	0	0.000%
	Charm II Tablet Quantitative	780	0	27	0	807	0	0.000%
	Charm II Tablet Sequential	242	0	1,180	0	1,422	0	0.000%
	Charm SL Beta lactams	1,334	1	1,059	1	2,393	2	0.084%
	Delvotest P 5 Pack - Beta lactams	955	0	39,515	2	40,470	2	0.005%
	Delvotest P/Delvotest P Mini	0	0	4,205	4	4,205	4	0.095%
	Snap (Reader) - Beta lactams	185	0	48	0	233	0	0.000%
	Snap (Visual) - Beta lactams	0	0	26	0	26	0	0.000%
SULFONAMIDES	Charm II Tablet Competitive	139	0	21	0	160	0	0.000%
	Parallux Sulfa Trio (Reader)	0	0	477	0	477	0	0.000%
SULFAMETHAZINE	Charm SL - Sulfamethazine	295	0	0	0	295	0	0.000%
TETRACYCLINES	Snap - Tetracyclines	0	0	150	0	150	0	0.000%
TETRACYCLINE	HPLC Tetracyclines - Tetracycline	0	0	97	0	97	0	0.000%
TOTALS		5,178	1	49,525	7	54,703	8	0.015%

 

Table 8-3 -- Number of Tests by Method by Family/DrugGrade A Producer Sample
October 1, 2002 to September 30, 2003

Tests by Method by Family/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
NEOMYCIN	ID Block - Neomycin	1,858	2	0	0	1,858	2	0.108%
BETA lactams	Charm BSDA Tablet - Beta lactams	31,309	32	17,333	34	48,642	66	0.136%
	Charm I/Cowside II Tablet - Beta lactams	479	0	0	0	479	0	0.000%
	Charm II Liquid - Beta lactams	249	0	0	0	249	0	0.000%
	Charm II Tablet Competitive	4,286	2	195	0	4,481	2	0.045%
	Charm II Tablet Quantitative	706	0	0	0	706	0	0.000%
	Charm II Tablet Sequential	261	6	2,592	2	2,853	8	0.280%
	Charm SL Beta lactams	5,905	48	7,301	2	13,206	50	0.379%
	Delvo-X-PRESS - Beta-lactams	2,499	0	0	0	2,499	0	0.000%
	Delvotest P 5 Pack - Beta lactams	404,468	623	104,878	146	509,346	769	0.151%
	Delvotest P/Delvotest P Mini	14,104	3	17,123	13	31,227	16	0.051%
	Delvotest SP/Delvotest SP Mini	93	0	0	0	93	0	0.000%
	Parallux Beta lactams Assay	0	0	1	1	1	1	100.000%
	Penzyme III Test - Beta lactams	304	0	0	0	304	0	0.000%
	Penzyme Milk Test - Beta lactams	248	0	0	0	248	0	0.000%
	Snap (Reader) - Beta lactams	3,391	16	89	13	3,480	29	0.833%
	Snap (Visual) - Beta lactams	1,884	0	128	3	2,012	3	0.149%
SULFONAMIDES	Charm II Tablet Competitive	2,542	2	93	0	2,635	2	0.076%
SULFAMETHAZINE	Charm SL - Sulfamethazine **	51	0	0	0	51	0	0.000%
TETRACYCLINES	Snap - Tetracyclines **	1	0	0	0	1	0	0.000%
TETRACYCLINE	HPLC Tetracyclines - Tetracycline	0	0	2	0	2	0	0.000%
TOTALS		474,638	734	149,735	214	624,373	948	0.152%

** Non-Validated Test Method

 

Table 8-4 -- Number of Tests by Method by Family/DrugGrade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2002 to September 30, 2003

Tests by Method by Family/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
AMPHENICOLS	Charm II Tablet Competitive	201	0	0	0	201	0	0.000%
BETA lactams	Charm BSDA Tablet - Beta lactams	1,758	0	267	0	2,025	0	0.000%
	Charm II Tablet Competitive	4,088	1	389	0	4,477	1	0.022%
	Charm II Tablet Quantitative	978	0	0	0	978	0	0.000%
	Charm II Tablet Sequential	9,950	2	446	12	10,396	14	0.135%
	Charm SL Beta lactams	33,325	5	472	0	33,797	5	0.015%
	Delvo-X-PRESS - Beta-Lactams	16	0	0	0	16	0	0.000%
	Delvotest P 5 Pack - Beta lactams	11,517	0	3,945	1	15,462	1	0.006%
	Delvotest P/Delvotest P Mini	1,095	0	1,154	0	2,249	0	0.000%
	Delvotest SP/Delvotest SP Mini	315	0	0	0	315	0	0.000%
	Parallux Beta lactams Assay	0	0	72	0	72	0	0.000%
	Penzyme III Test - Beta lactams	874	0	0	0	874	0	0.000%
	Penzyme Milk Test - Beta lactams	0	0	3	0	3	0	0.000%
	Snap (Reader) - Beta lactams	4,242	1	58	0	4,300	1	0.023%
	Snap (Visual) - Beta lactams	3,125	6	36	0	3,161	6	0.190%
SULFONAMIDES	Charm II Tablet Competitive	334	0	334	0	668	0	0.000%
SULFAMETHAZINE	Charm SL - Sulfamethazine	225	0	0	0	225	0	0.000%
TETRACYCLINES	Charm II Tablet Competitive	277	0	85	0	362	0	0.000%
	Snap - Tetracyclines **	62	0	4	0	66	0	0.000%
TETRACYCLINE	HPLC Tetracyclines - Tetracycline	0	0	6	0	6	0	0.000%
TOTALS		72,382	15	7,271	13	79,653	28	0.035%

** Non-Validated Test Method

 

Table 8-5 -- Number of Tests by Method by Family/DrugNon-Grade A Bulk Milk Pickup Tanker
October 1, 2002 to September 30, 2003

Tests by Method by Family/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	304	0	0	0	304	0	0.000%
	Charm II Tablet Competitive	744	0	0	0	744	0	0.000%
	Charm II Tablet Sequential	1,944	3	3	0	1,947	3	0.154%
	Charm SL Beta lactams	221,945	120	980	1	222,925	121	0.054%
	Delvotest P 5 Pack - Beta lactams	7,451	8	3	0	7,454	8	0.107%
	Delvotest P/Delvotest P Mini	545	1	23	0	568	1	0.176%
	Parallux Beta lactams Assay	516	0	0	0	516	0	0.000%
	Penzyme III Test - Beta lactams	2,087	5	0	0	2,087	5	0.240%
	Penzyme Milk Test - Beta lactams	859	0	0	0	859	0	0.000%
	Snap (Reader) - Beta lactams	44,040	48	273	0	44,313	48	0.108%
	Snap (Visual) - Beta lactams	24,043	15	34	0	24,077	15	0.062%
SULFONAMIDES	Agri-Screen for Sulfonamides*	931	0	0	0	931	0	0.000%
	Charm II Tablet Competitive	466	0	0	0	466	0	0.000%
TETRACYCLINES	Charm II Tablet Competitive	5	1	0	0	5	1	20.000%
TOTALS		305,880	201	1,316	1	307,196	202	0.066%

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

 

Table 8-6 -- Number of Tests by Method by Family/DrugNon-Grade A Pasteurized Fluid Milk and Milk Products
October 1, 2002 to September 30, 2003

Tests by Method by Family/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	20	0	0	0	20	0	0.000%
	Charm SL Beta lactams	0	0	5	0	5	0	0.000%
	Delvotest P 5 Pack - Beta lactams	139	0	241	0	380	0	0.000%
	Delvotest P/Delvotest P Mini	0	0	100	0	100	0	0.000%
TOTALS		159	0	346	0	505	0	0.000%

 

Table 8-7-- Number of Tests by Method by Family/DrugNon-Grade A Producer Sample
October 1, 2002 to September 30, 2003

Tests by Method by Family/Drug		Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	Total Tests	TotalPositive Tests	Percent Positive
BETA lactams	Charm BSDA Tablet - Beta lactams	2,366	11	443	0	2,809	11	0.392%
	Charm II Tablet Competitive	0	0	6	0	6	0	0.000%
	Charm SL Beta lactams	707	6	481	0	1,188	6	0.505%
	Delvotest P 5 Pack - Beta lactams	37,696	72	1,316	0	39,012	72	0.185%
	Delvotest P/Delvotest P Mini	291	0	485	0	776	0	0.000%
	Snap (Reader) - Beta lactams	1,763	4	0	0	1,763	4	0.227%
	Snap (Visual) - Beta lactams	143	0	28	0	171	0	0.000%
TETRACYCLINE	HPLC Tetracyclines - Tetracycline	13	0	0	0	13	0	0.000%
TOTALS		42,979	93	2,759	0	45,738	93	0.204%

 

Table 8-8 -- Number of Tests by Method by Family/DrugNon-Grade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2002 to September 30, 2003

Tests by Method by Family/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	10	0	0	0	10	0	0.000%
	Charm II Tablet Competitive	0	0	22	0	22	0	0.000%
	Charm II Tablet Sequential	17	0	1	0	18	0	0.000%
	Charm SL Beta lactams	7,294	0	114	0	7,408	0	0.000%
	Delvotest P 5 Pack - Beta lactams	180	0	562	0	742	0	0.000%
	Delvotest P/Delvotest P Mini	0	0	148	0	148	0	0.000%
	Parallux Beta lactams Assay	0	0	65	0	65	0	0.000%
	Snap (Reader) - Beta lactams	1,080	1	0	0	1,080	1	0.093%
	Snap (Visual) - Beta lactams	2,081	1	11	0	2,092	1	0.048%
SULFONAMIDES	Charm II Tablet Competitive	0	0	1	0	1	0	0.000%
TOTALS		10,662	2	924	0	11,586	2	0.001%