U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
February 10, 1997

SECTION

INTRODUCTION
BACKGROUND
SUMMARY
SAMPLE RESULTS
TABLE 1 Sample Results
TABLE 2 Industry and Regulatory Samples
TESTS CONDUCTED
TABLE 3 Tests Conducted
TABLE 4 Tests Conducted by Industry and Regulatory Agencies

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NATIONAL MILK DRUG RESIDUE DATA BASE

FISCAL YEAR 1996 ANNUAL REPORT

October 1, 1995 - September 30, 1996

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

NCIMS is a cooperative State-Public Health Service/Food and Drug Administration (FDA) Program for certification of interstate milk shippers. Its procedures, administration, and enforcement actions provide the framework for the nation's Grade A milk safety program. 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.

Two States, New York and Oklahoma, began submitting data in April 1993 to pilot-test the data base. At the end of July 1993, all States were requested to begin reporting their testing data and the testing data of their State's dairy industry to the data base contractor. As of October 31, 1994, all fifty States and Puerto Rico were participating in the data base program. 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 1996, October 1, 1995 to September 30, 1996. One State did not submit data during the first quarter of the fiscal year and one other State did not submit data for the fourth quarter of this period. Information on the status of reporting by individual States has been submitted to FDA and NCIMS.

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, 4,565,600 samples were analyzed for animal drug residues. Of these samples, 5,404 were positive for a residue. A total of 4,812,772 tests were reported on the samples for 22 different groups of families or individual drugs. Fifty-two separate 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 pickup 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 Pickup Tanker - bulk raw milk from a da iry 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, 1995 to September 30, 1996
Source of Sample	Total Samples	Number Positive	Percent Positive	Disposition per PMO (Pounds)
Bulk Milk Pick-Up Tanker	3,384,779	3,530	0.104%	115,952,000
Pasteurized Fluid Milk and Milk Products	78,557	2	0.003%	0
Producer	956,014	1,817	0.190%	8,868,000
Other	146,250	55	0.038%	2,405,000
TOTALS	4,565,600	5,404	*	127,225,000

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 Pickup 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, 1995 to September 30, 1996
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	2,988,814	2,961	17,820	153	3,006,634	3,114	0.104%	103,866,000
Pasteurized Fluid Milk and Milk Products	12,351	0	65,427	0	77,778	0	0%	0
Producer	655,079	1,227	216,803	357	871,882	1,584	0.182%	8,680,000
Other	119,366	43	8,550	0	127,916	43	0.034%	2,074,000
NON-GRADE A
Bulk Milk Pick-Up Tanker 1	377,853	414	292	2	378,145	416	0.110%	12,086,000
Pasteurized Fluid Milk and Milk Products	43	0	736	2	779	2	0.257%	0
Producer	78,109	231	6,023	2	84,132	233	0.277%	188,000
Other	17,580	10	754	2	18,334	12	0.065%	331,000
TOTALS	4,249,195	4,886	316,405	518	4,565,600	5,404	*	127,225,000 2
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 0.083% of the total milk supply of the annual production of 154 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, 1995 to September 30, 1996.

 

TABLE 3 -- Tests Conducted October 1, 1995 to September 30, 1996
Source of Sample	Total Tests	Number of Tests Positive	Percent Positive
Bulk Milk Pick-Up Tanker	3,590,232	4,314	0.120%
Pasteurized Fluid Milk and Milk Products	79,855	2	0.003%
Producer	968,775	1,963	0.203%
Other	173,910	60	0.035%
TOTALS	4,812,772	6,339	*
* = See Table 1 for explanation.

Table 4 presents additional details in terms of the tests conducted by industry and by regulatory agencies.

 

TABLE 4 -- Tests Conducted by Industry and Regulatory Agencies October 1, 1995 to September 30, 1996
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	3,176,928	3,627	32,560	205	3,209,488	3,832	0.119%
Pasteurized Fluid Milk and Milk Products	12,668	0	66,408	0	79,076	0	0%
Producer	659,990	1,327	218,807	366	878,797	1,693	0.193%
Other	143,773	44	11,315	2	155,088	46	0.030%
NON-GRADE A
Bulk Milk Pick-Up Tanker 1	380,296	480	448	2	380,744	482	0.127%
Pasteurized Fluid Milk and Milk Products	43	0	736	2	779	2	0.257%
Producer	83,652	263	6,326	7	89,978	270	0.300%
Other	17,607	11	1,215	3	18,822	14	0.074%
TOTALS	4,474,957	5,752	337,815	587	4,812,772	6,339	*
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.

To request the complete National Milk Drug Residue Data Base Fiscal Year 1996 Annual Report, please contact Ginger Levin, Project Director, at: GXL@CFSAN.FDA.GOV

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