Milk Drug Residue Testing Requirements – Changes for NYS Producer-Dealers & Small Processors

Submitted by: Chip Lindberg, Dairy Program Manager, NY State Department of Agriculture & Markets and Steve Murphy, Sr. Extension Associate, Cornell University

Nearly all of the raw or prepasteurized milk in NY State is considered to be Grade “A,” which means it is produced under the sanitary guidelines of the Pasteurized Milk Ordinance (PMO), or equivalent, and meets all applicable requirements and standards.  The PMO is issued by the US Public Health Service’s (USPHS), Food and Drug Administration (FDA) and serves as the sanitary regulation and basic standard for the Cooperative State-USPHS/FDA Program for the Certification of Interstate Milk Shippers (IMS). The IMS program was developed to ensure uniformity and reciprocity across state lines.  NY State has adopted the PMO as its regulatory standard under the IMS program for milk and milk products served on interstate carriers as well as for non-IMS dairy operations; NYS also has additional regulations that go above and beyond the PMO (e.g., Part 2).  The PMO and related regulations are modified and updated as needed every 2 years based on proposals submitted and approved through the National Conference on Interstate Milk Shipments (NCIMS). Proposals, which can be submitted by anyone, are presented to committees and councils made up of state regulatory and industry personnel where they are subjected to review, deliberations, amendments (as needed) and action (support or not) prior to being sent to the NCIMS delegates (representing each state regulatory agency) for final vote to accept or reject the final proposal.  Representatives of FDA serve only as non-voting advisors throughout the process, but often submit proposals themselves.  FDA also has the option to “non-concur” with a conference action giving them “veto” authority, but this rarely occurs because of the cooperative process inherent in the NCIMS system.

Back to raw or pre-pasteurized milk: one of the requirements under the PMO is for the routine testing of raw milk supplies for animal drug residues (e.g. antibiotics). This is covered under Section 6, which addresses individual producer samples (tested monthly in NY), and Appendix N, which requires testing at the processor level.  Under Appendix N, previous versions of the PMO stated that “Industry shall screen all bulk milk pickup tankers, regardless of final use, for beta-lactam drug residues.” In NY State and elsewhere, producer-dealers (farmers processing their own milk) and small processors that do not receive “bulk milk pickup tankers” were exempt from the Appendix N regulation.

At the 2013 NCIMS conference, delegates passed a proposal designed to clarify the PMO to ensure that all Grade “A” milk, no matter how it arrives at a processing plant, is tested for animal drug residues. The affected portion of Appendix N in the 2013 PMO, which will become effective in NY State in November 2014, now reads:

Industry shall screen all bulk milk pickup tankers and/or all raw milk supplies that have not been transported in bulk milk pickup tankers, regardless of final use, for Beta lactam drug residues. ….

All raw milk supplies that have not been transported in bulk milk pickup tankers shall be sampled prior to processing the milk. The sample(s) shall be representative of each farm bulk milk tank(s)/silo(s), milk plant raw milk tank(s) and/or silo(s), other raw milk storage container(s), etc. Testing of all raw milk supplies that have not been transported in bulk milk pickup tankers shall be completed prior to processing the milk.

What this means is that Producer-Dealers or other small processors who purchase or otherwise obtain prepasteurized milk from a Grade A source for processing, including their own, will also be required to test a sample taken from the milk used prior to processing under the provisions of Appendix N. Failure to test the portion of milk may result in adverse actions against the producer (dairy farm) potentially resulting in the suspension of the ability to ship milk to a processor.

To meet the program requirements 1) a sample must be taken by a licensed milk receiver/sampler, which means someone needs to get licensed; 2) it must be analyzed in a laboratory certified under the NCIMS/FDA program; and 3) appropriate records must be kept including documentation of what is done if a milk is found positive (e.g., confirmation, disposition of the milk).  Plants may choose to take a representative sample to an existing certified drug residue testing laboratory for analysis prior to processing or they may set up their own laboratory on premises. If they choose to create their own laboratory, the laboratory and analysts will be required to meet all conditions for certification based on the NCIMS/FDA laboratory evaluation program including on-site evaluations of approved testing systems, procedures and records as well as participation in an annual proficiency testing program.

The Division of Milk Control will hold two workshops covering the regulations, approved testing procedures and laboratory guidance materials. Additionally, Laboratory Evaluation Officers will be available to provide detailed information on NCIMS/FDA laboratory requirements and assistance for those interested in creating a compliant animal drug testing laboratory.   The workshops will be held:

July 29, B82 Morrison Hall, Cornell University, Ithaca, NY 8:30 am to 5:00 pm
July 30, NY State Food Lab, Bldg. 6, Harriman Campus Rd., Albany NY 8:30 to 5:00 pm

For more information contact Chip Lindberg, NY State Agriculture & Markets:


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