The last step of finalizing actions from the 2015 National Conference on Interstate Milk Shipments (NCIMS) occurred last week when the Food and Drug Administration (FDA) issued a detailed memorandum outlining the specific changes to the Grade “A” Pasteurized Milk Ordinance (PMO) and related documents.
The PMO incorporates provisions governing the processing, packaging and sale of Grade “A” milk and milk products, including yogurt, fermented milk products, whey, whey products and condensed and dry milk products. The NCIMS, in accordance with the Memorandum of Understanding with FDA, recommends changes and modifications to the PMO at its biennial conferences.
In efforts to align the PMO with the FDA’s Food Safety Modernization Act’s (FSMA) Preventive Controls for Human Food, five proposals were passed by the Conference Delegates and concurred with by FDA. They are:
- Proposal JC1 states that the specific procedures within the PMO shall constitute a milk plant’s Food Safety Plan as required by FSMA. In addition the milk plant shall have a written Hazard Analysis for each kind or group of milk and/or milk product processed.
- Proposal JC3 addresses food allergen control and a written food recall plan that shall include procedures as described in 21 CFR Part 7 (Subpart A and C).
- Proposal JC4 addresses environmental monitoring.
- Proposal JC5 addresses a supplier control program.
- Proposal JC7 addresses prerequisite and other program procedures as described in 21 CFR Part 7 (Subpart A and C) in Appendix K-HACCP Program of the PMO.
FDA’s Milk Safety Team is working to incorporate these changes in the new 2015 edition of the PMO, which is expected to be published early in 2016.
The majority of the finalized proposals will take effect on November 16, 2016, one year after issuance date of the memo. However, some proposals that changed the Conference Procedures and assigned tasks to NCIMS Committees, such as work on a pilot program for raw milk testing for drug residues other than beta-lactams, will take effect immediately.
The one proposal that addresses the PMO as a milk plant’s food safety plan (JC1) will take effect in one year. However, there will be a delayed implementation date for the other four proposals (JC3, JC4, JC5, JC7). Originally these FSMA proposals’ effective dates were specified as one year after the FDA final rule is published, which occurred on September 17, 2015. However, FDA recently provided a clarification in a Federal Register Notice that the compliance date for grade ‘‘A’’ milk and milk products covered by NCIMS under the PMO would be extended to September 17, 2018.
Additionally the NCIMS Executive Board submitted a request to FDA to “Exercise discretion on ratings and check ratings by not debiting firms on proposals JC3, JC4, JC5 and JC7 until after the September 17, 2018 implementation date of the Preventive Controls Rule for PMO-regulated facilities as specified in the Federal Register.” A response from FDA is still pending.
It is important to note that this extension from the implementation of FSMA Preventative Controls only applies only to Grade ‘‘A’’ milk and milk products covered by NCIMS under the PMO, and not to the manufacturing, processing, packing, or holding of other foods (non-Grade “A” products) at that facility. Dairy plants processing non-Grade “A” products such as ice cream, cheese, butter, ice tea or other foods will have to comply with FSMA regulations by September 18, 2016 unless they qualify as a small or very small business that receive extra time.
One proposal passed by the Conference to extend the allowable transit time for water samples before testing from 30 hours to 48 hours was once again not agreed to by FDA, which means it will be referred to the 2017 NCIMS conference.
Please login to view this member's only content.
Members may login to read a summary of passed proposals and their implementation dates can be found here, or read an overview of the 2015 IMS Conference actions from IDFA’s Regulatory Update.
Members with questions about the NCIMS program may contact Cary Frye, IDFA vice president of regulatory and scientific affairs, at email@example.com; John Allan, IDFA vice president of regulatory and international standards, at firstname.lastname@example.org or Clay Hough, senior group vice president and general counsel at IDFA, at email@example.com.