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NMPF Hosts NCIMS Liaison Committee and FDA

January 7, 2020

NMPF hosted the National Conference on Interstate Milk Shipments (NCIMS) Liaison Committee November 19 and 20 for a two-day discussion on how Grade “A” (GA) milk plants will be inspected under the Pasteurized Milk Ordinance (PMO) and the Food Safety Modernization Act (FSMA).

The Food and Drug Administration (FDA) and the Liaison Committee have been discussing the matter for several years without much success, but progress is finally being made. The long-term goal is to have a single inspection that will cover all products made at the facility, GA and Non-Grade “A” (NGA).  In 2018, FDA tried back-to-back inspections, first a PMO inspection, followed by an FSMA inspection. Plant personnel described that as an overwhelming experience and NMPF urged the FDA not to conduct inspections that way in the future.

The current concept is for the Office of State Cooperative Programs, Division of Milk Safety (DMS) Milk Specialists to be responsible for inspectional coverage and regulatory compliance of all food products manufactured at NCIMS-listed dairy processing facilities, with some exceptions. Those exceptions include infant formula, low acid canned food and seafood. Milk Specialists will expand their Preventive Controls for Human Foods (PCHF) review for compliance to all food products, GA and NGA products manufactured at GA plants. They will also use guidance provided by the Office for Food Safety (OFS) for decision making.

The Milk Specialist’s check rating and inspection may count as the Title 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food inspection (limited scope Preventive Control (PC) inspection), provided that the firm had an adequate food safety plan that includes environmental testing and monitoring, and was verified by the Milk Specialist during the PC inspection.

FDA’s Milk Specialists, as part of the Check-Rating (CR) every three years, must verify that the firm has adopted comprehensive controls for both GA and NGA products as part of a food safety plan, and that the state had been doing comprehensive inspections to address preventive controls for all dairy products. If these criteria are not met, the FDA Milk Specialist, or state under contract, will conduct a traditional PC inspection for the NGA products. In most cases, one FDA Milk Specialist staff performs the inspection and check rating for all listed manufacturing facilities.

The FDA, in collaboration with state liaisons, will pilot this approach this year.