NATIONAL MILK DRUG RESIDUE DATA BASE

FISCAL YEAR 2001 ANNUAL REPORT
October 1, 2000 - September 30, 2001
Submitted by:
GLH, Incorporated
2900 NE 46th Street
Lighthouse Point, FL 33064
954-783-9819

Contract Number: 223-01-4299
January 31, 2002

---

TABLE OF CONTENTS

• INTRODUCTION
• BACKGROUND
• SUMMARY
• SAMPLE RESULTS
  • TABLE 1 Sample Results
  • TABLE 2 Industry and Regulatory Samples
• TESTS CONDUCTED
  • TABLE 3 Tests Conducted by Sample Sources
  • TABLE 3A Validated Tests Conducted
  • TABLE 3B Non-Validated Tests Conducted
  • TABLE 4 Tests Conducted by Industry and Regulatory Agencies
  • TABLE 4A Validated Tests Conducted by Industry and Regulatory Agencies
  • TABLE 4B Non-Validated Tests Conducted by Industry and Regulatory Agencies
  • TABLE 5 Number of Tests Conducted by Family/Drug
  • TABLE 5A Validated Number of Tests Conducted by Family/Drug
  • TABLE 5B Non-Validated Number of Tests Conducted by Family/Drug
  • TABLE 6 Number of Tests by Method by Family/Drug
  • TABLE 6A Comparison of Validated and Non-Validated Tests
  • TABLE 7-1 Grade A Bulk Milk Pick-Up Tanker Testing
  • TABLE 7-2 Grade A Pasteurized Fluid Milk and Milk Products Testing
  • TABLE 7-3 Grade A Producer Testing
  • TABLE 7-4 Grade A Other Testing (milk from milk plant silos, over-the-road tankers, etc.)
  • TABLE 7-5 Non-Grade A Bulk Milk Pick-Up Tanker Testing
  • TABLE 7-6 Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
  • TABLE 7-7 Non-Grade A Producer Testing
  • TABLE 7-8 Non-Grade A Other Testing (milk from milk plant silos, over-the-road tankers, etc.)
  • TABLE 8-1 Number of Tests by Method by Family/Drug for Grade A Bulk Milk Pick-Up Tanker Testing
  • TABLE 8-2 Number of Tests by Method by Family/Drug for Grade A Pasteurized Fluid Milk and Milk Products Testing
  • TABLE 8-3 Number of Tests by Method by Family/Drug for Grade A Producer Testing
  • TABLE 8-4 Number of Tests by Method by Family/Drug for Grade A Other Testing (milk from milk plant silos, over-the-road tankers, etc.)
  • TABLE 8-5 Number of Tests by Method by Family/Drug for Non-Grade A Bulk Milk Pick-Up Tanker Testing
  • TABLE 8-6 Number of Tests by Method by Family/Drug for Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
  • TABLE 8-7 Number of Tests by Method by Family/Drug for Non-Grade A Producer Testing
  • TABLE 8-8 Number of Tests by Method by Family/Drug for Non-Grade A Other Testing (milk from milk plant silos, over-the-road tankers, etc.)

---

NATIONAL MILK DRUG RESIDUE DATA BASE
FISCAL YEAR 2003 ANNUAL REPORT
October 1, 2000 - September 30, 2001

INTRODUCTION

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

BACKGROUND

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

Subsequently, FDA awarded a contract to develop a National Milk Drug Residue Data Base.  The data base is operated by an independent third party, under contract to the FDA.  The data base design was developed in consultation with a project advisory group with members from the FDA and a NCIMS committee representing dairy producers, dairy processors, USDA, State regulatory agencies, and academia.  The data base was designed to promote maximum participation by the dairy industry to report on a voluntary basis all of their testing without compromising any confidential data.  Information regarding individual firm's data is not submitted to the data base contractor.  The data base includes results of the National Drug Residue Milk Monitoring Program (NDRMMP), a national drug residue in milk sampling program administered by FDA with the full cooperation by the States.  Results from this program are reported to the data base by the States.

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

SUMMARY

This report presents summary data on samples and tests conducted during the Fiscal Year 2001,  October 1, 2000 to September 30, 2001.  Fifty States and Puerto Rico submitted data for this report. However, California failed to submit data for the 4^th quarter of the fiscal year, Idaho only submitted data on its industry bulk milk pick-up testing, and Georgia only submitted industry bulk  milk pick-up tanker testing data if the sample was positive.  Some of the data submitted by Minnesota on its producer sample testing was incomplete. Also, some producer sample testing data from Tennessee was not submitted in time to be included in this report.

The Pasteurized Milk Ordinance (PMO) requires that all bulk milk tankers be sampled and analyzed for animal drug residues before the milk is processed.  Any tanker found positive is rejected for human consumption.

During this period 4,203,616 samples were analyzed for animal drug residues.  Of these samples 3,401 were positive for a residue.  A total of 4,314,181 tests were reported on the samples for 14 different groups of families or individual drugs.  Forty-seven testing methods were used to analyze the samples for residues.  Details are presented in the tables in this report.

SAMPLE RESULTS

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

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

Data are reported by four SOURCES OF SAMPLES:

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

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

The DISPOSITION PER PMO column represents the amount of milk contained in the tank or lot found to be positive and disposed of in accordance with the PMO and/or applicable State regulations.  The PMO governs the rules which State agencies use to implement their milk program.

TABLE 1 - Sample Results
October 1, 2000 to September 30, 2001

Source of Sample	Total Samples	Number Positive	Percent Positive	Disposition per PMO (Pounds)
Bulk Milk Pick-Up Tanker	3,280,036	2,191	0.067%	79,913,000
Pasteurized Fluid Milk and Milk Products	63,996	2	0.003%	79,000
Producer	758,380	1,175	0.155%	7,737,000
Other	101,204	33	0.033%	1,769,000
Total	4,203,616	3,401	*	89,498,000

The asterisk (*) notes that a summary of the percent positive cannot be provided because there is not uniformity in terms of sampling in the four categories.  For example, the PMO sets forth specific sampling requirements for beta-lactam testing as follows:

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

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

TABLE 2 - Industry and Regulatory Samples October 1, 2000 to September 30, 2001

Source of Sample		Number of Industry Samples	Number of Positive Industry Samples	Number of Regulatory Samples	Number of Positive Regulatory Samples	Total Samples	Total Positive Samples	Total Percent Positive	Disposition Per PMO (Pounds)
Grade A
	Bulk Milk Pick-Up Tanker	2,913,675	1,801	25,244	50	2,938,919	1,851	0.063%	69,109,000
	Pasteurized Fluid Milk and Milk Products	7,958	2	55,128	0	63,086	2	0.003%	79,000
	Producer	550,132	855	153,568	248	703,700	1,057	0.150%	7,729,000
	Other	79,206	18	6,720	8	85,926	26	0.030%	1,584,000
Non-Grade A	Bulk Milk Pick-Up Tanker1	339,346	336	1,771	4	341,117	340	0.100%	10,804,000
	Pasteurized Fluid Milk and Milk Products	228	0	682	0	910	0	0.000%	0,000
	Producer	52,440	117	2,240	1	54,680	118	0.216%	8,000
	Other	14,302	6	976	1	15,278	7	0.046%	185,000
TOTALS		3,957,287	3,135	246,329	266	4,203,616	3,401	*	89,498,0002

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

² Note that this represents 0.0524% of the total milk supply of the annual production of 165 billion pounds.

* = See Table 1 for explanation

TESTS CONDUCTED

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

Table 3 presents summary results of the number of tests which were conducted during October 1, 2000 to September 30, 2001.  The term, validated test, as used in this report, is a test used for the screening of raw milk for drug residue which has been evaluated in accordance with Appendix N of the Pasteurized Milk Ordinance and found acceptable by FDA in accordance with the standards established for the evaluation of tests.  In addition, FDA validated drug residue detection procedures for screening and quantitation of drug residues in milk may be used. Table 3A presents summary results using validated tests and Table 3B presents summary results using non-validated tests.

TABLE 3 - Tests Conducted
 October 1, 2000 to September 30, 2001

Source of Sample	Total Tests	Number of Tests Positive	Percent Positive
Bulk Milk Pick-Up Tanker	3,381,313	2,538	0.075
Pasteurized Fluid Milk and Milk Products	64,829	4	0.006
Producer	762,046	1,269	0.167
Other	105,993	38	0.036
Total	4,314,181	3,849	*

* = See Table 1 for explanation.

TABLE 3A - Validated Tests Conducted
 October 1, 2000 to September 30, 2001

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

* = See Table 1 for explanation.

TABLE 3B - Non-Validated Tests Conducted
 October 1, 2000 to September 30, 2001

Source of Sample	Total Tests	Number of Tests Positive	Percent Positive
Bulk Milk Pick-Up Tanker	42,485	19	0.045
Pasteurized Fluid Milk and Milk Products	479	0	0.000
Producer	701	3	0.428
Other	2,646	0	0.000
Total	46,311	22	*

* = See Table 1 for explanation.

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

TABLE 4 -  Tests Conducted by Industry and Regulatory Agencies
October 1, 2000 to September 30, 2001

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

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

* = See Table 1 for explanation; Table 2 shows data on the disposition of milk in compliance with the PMO.

TABLE 4A - Validated Tests Conducted by Industry and Regulatory Agencies
October 1, 2000 to September 30, 2001

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

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

* = See Table 1 for explanation.

TABLE 4B - Non-Validated Tests Conducted by Industry and Regulatory Agencies
October 1, 2000 to September 30, 2001

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

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

* = See Table 1 for explanation.

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

TABLE 5 - Number of  Tests Conducted by Family/Drug
October 1, 2000 to September 30, 2001

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

 

TABLE 5A - Number of Validated Tests Conducted by Family/Drug
October 1, 2000 to September 30, 2001

Family/Drug	Total Tests	Total  Positive
BETA-LACTAMS	4,155,701	3,806
Ceftiofur	1,919	0
Cloxacillin	3,595	1
CHLORAMPHENICOL	414	0
SULFONAMIDES	83,974	11
TETRACYCLINES	22,228	9
Chlortetracycline	5	0
TOTALS	4,267,870	3,827

 

TABLE 5B - Number of Non-Validated Tests Conducted by Family/Drug
October 1, 2000 to September 30, 2001

Family/Drug	Total Tests	Total  Positive
AMINOGLYCOSIDES	2,143	2
BETA-LACTAMS	1,168	0
ENROFLOXACIN	646	2
MACROLIDES	1,171	0
NEOMYCIN	9	0
NOVOBIOCIN	434	0
SULFONAMIDES	9,322	3
Sulfadimethoxine	141	0
Sulfamethazine	3,520	0
TETRACYLINES	27,757	15
TOTALS	46,311	22

Table 6 presents details on the tests used.  The data in this table are comparable to Table 5, but the data are arranged by tests within each family/drug.  Therefore, the totals are the same in both tables.  The tests with the largest use were Charm SL - Beta-Lactam and Snap (Reader) - Beta-Lactams used to test over 1.15 million  and 737 thousand samples respectively.  Charm II Tablet Competitive - Beta-Lactams  was used to test over 426 thousand samples.  Delvotest P 5 Pack - Beta-Lactams was used to test over 423 thousand samples.  Table 6A shows a comparison of tests conducted  using Validated and Non-Validated test methods for Sulfonamides and Tetracyclines.

TABLE 6 - Number of  Tests by Method by Family/Drug
October 1, 2000 to September 30, 2001

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

* = See Table 1 for explanation.

** Non-Validated Test Method

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

TABLE 6A - Comparison of Validated and Non-Validated Tests for Sulfonamides and Tetracyclines
October 1, 2000 to September 30, 2001

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

** Non-Validated Test Method

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

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

TABLE 7-1 --Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2000 to September 30, 2001

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

 

TABLE 7-2 - Grade A Pasteurized Fluid Milk and Milk Products  Testing October 1, 2000 to September 30, 2001

Family/Drug	Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	Total Tests	Total Positive Tests
BETA-LACTAM	7,822	2	54,285	2	62,107	4
Ceftiofur	0	0	1,182	0	1,182	0
SULFONAMIDES	144	0	200	0	344	0
Sulfadimethoxine	141	0	0	0	141	0
TETRACYLCINES	0	0	144	0	144	0
Chlortetracycline	0	0	1	0	1	0
TOTALS	8,107	2	55,812	2	63,919	4

 

TABLE 7-3 --Grade A Producer Testing
October 1, 2000 to September 30, 2001

Family/Drug	Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	Total Tests	Total Positive Tests
BETA-LACTAMS	549,810	914	153,457	216	703,267	1,130
Cloxacillin	2	0	0	0	2	0
SULFONAMIDES	3,735	2	119	0	3,854	2
TETRACYLINES	11	0	11	3	22	3
TOTALS	553,558	916	153,587	219	707,145	1,135

 

TABLE 7-4 - Grade A Other  Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001

Family/Drug	Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	Total Tests	Total Positive Tests
AMINOGLYCOSIDES	770	0	0	0	770	0
BETA-LACTAMS	79,260	20	6,952	8	86,212	28
Ceftiofur	0	0	270	0	270	0
CHLORAMPHENICOL	402	0	0	0	402	0
ENROFLOXACIN	8	0	4	0	12	0
MACROLIDES	473	0	0	0	473	0
NOVOBIOCIN	402	0	0	0	402	0
SULFONAMIDES	885	0	375	0	1,260	0
TETRACYCLINES	479	0	202	0	681	0
TOTALS	82,679	20	7,803	8	90,482	28

 

TABLE 7-5 --Non-Grade A Bulk Milk Pick-Up Tanker Testing
October 1, 2000 to September 30, 2001

Family/Drug	Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	Total Tests	Total Positive Tests
AMINOGLYCOSIDES	0	0	7	0	7	0
BETA-LACTAMS	336,721	338	1,759	3	338,480	341
Ceftiofur	0	0	28	0	28	0
CHLORAMPHENICOL	0	0	4	0	4	0
ENROFLOXACIN	0	0	10	0	10	0
SULFONAMIDES	1,581	1	5	1	1,586	2
TETRACYCLINES	2,941	5	11	0	2,952	5
TOTALS	341,243	344	1,824	4	343,067	348

 

TABLE 7-6--Non-Grade A Pasteurized Fluid Milk and Milk Products Testing
October 1, 2000 to September 30, 2001

Family/Drug	Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	Total Tests	Total Positive Tests
BETA-LACTAMS	228	0	682	0	910	0
TOTALS	228	0	682	0	910	0

 

TABLE 7-7 - Non-Grade A Producer Testing
October 1, 2000 to September 30, 2001

Family/Drug	Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	Total Tests	Total Positive Tests
BETA-LACTAMS	52,621	133	2,239	1	54,860	134
SULFONAMIDES	41	0	0	0	41	0
TOTALS	52,662	133	2,239	1	54,901	134

 

TABLE 7-8 --Non-Grade A Other  Testing (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001

Family/Drug	Number of Industry Tests	Number of Positive Industry Tests	Number of Regulatory Tests	Number of Positive Regulatory Tests	Total Tests	Total Positive Tests
BETA-LACTAMS	13,970	9	1,130	1	15,100	10
Ceftiofur	0	0	99	0	99	0
NEOMYCIN	9	0	0	0	9	0
SULFONAMIDES	3	0	0	0	3	0
TETRACYCLINES	300	0	0	0	300	0
TOTALS	14,282	9	1,229	1	15,511	10

Tables 8-1 to 8-8 present details on the number of tests conducted by industry and by regulatory agencies.  The data are arranged by test within each family/drug and present results in terms of sample type and Grade A and non-Grade A testing.

Table 8-1 Number of Tests By Method Family/Drug
Grade A Bulk Milk Pick-Up Tanker
October 1, 2000 to September 30, 2001

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

** Non-Validated Test Method

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

Table 8-2 - Number of  Tests by Method by Family/Drug Grade A Pasteurized Fluid Milk and Milk Products
October 1, 2000 to September 30, 2001

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

** Non-Validated Test Method

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

Table 8-3 - Number of  Tests Used by Family/Drug Grade A Producer
October 1, 2000 to September 30, 2001

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

** Non-Validated Test Method

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

Table 8-4 - Number of  Tests by Method by Family/Drug Grade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001

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

** Non-Validated Test Method

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

Table 8-5 - Number of Tests By Method by Family/Drug Non-Grade A Bulk Milk Pick-Up Tanker
October 1, 2000 to September 30, 2001

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

** Non-Validated Test Method

Table 8-6 - Number of  Tests by Method Family/Drug Non-Grade A Pasteurized Fluid Milk and Milk Products
October 1, 2000 to September 30, 2001

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

 

Table 8-7 - Number of  Tests by Method by Family/Drug Non-Grade A Producer
October 1, 2000 to September 30, 2001

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

 

Table 8-8 - Number of  Tests by Method by Family/Drug Non-Grade A Other (milk from silos, over-the-road tankers, etc.)
October 1, 2000 to September 30, 2001

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

** Non-Validated Test Method