The US Grade “A” dairy processing industry is facing strong headwinds, probably some of the strongest since I started my dairy regulatory career in 1982. Similar to this summer’s weather-related devastation along the Florida panhandle, as well in South and North Carolina, the entire farm part of the dairy industry is experiencing significant financial devastation because of international oversupply coupled with the challenges of international trade barriers.
In addition, the regulatory requirements by local, county, state and federal governments are increasing, adding to the industry’s resource demands and stress. The most significant new regulatory challenge for 2019 appears to be state and FDA enforcement of the Pasteurized Milk Ordinance’s (PMO) Appendix “T.”
The 2017 Pasteurized Milk Ordinance’s Appendix T requirements mirror FDA’s Food Safety Modernization Act’s Preventive Controls for Human Foods in that a proactive strategy, rather than a reactive strategy, is required for identifying and mitigating risk. For example, per Appendix T, a milk plant’s written food safety plan and its contents must include a written recall plan and a written hazard analysis of all processes and procedures to determine which require preventive controls.
Then in cases where additional controls are required beyond that of the PMO Appendix T ordinance, milk plants must develop a written preventive controls plan, a written supply-chain program, written procedures for monitoring the implementation of the preventive controls and written corrective action procedures and written verification procedures. This food safety plan must be signed and dated by the owner, operator or person in charge of the milk plant, both upon its initial completion and when any modifications are made.
Finally, a reanalysis of the milk plant’s written food safety plan as a whole must be conducted at least once every three years, or as necessary based on any updates or changes to product, processes or new safety requirements. Many of these written dairy plant operational documents were not mandated or required to be provided to state and FDA regulators under the Grade “A” program until the adoption of Appendix T.
Those dairy plants may have already seen an FDA field investigator conduct a PCHF-based compliance inspection on the non-Grade “A” operations. By early 2019, Grade “A” operations can expect Appendix T state and FDA enforcement to begin.
What does this mean for the average Grade “A” dairy plant? Simply put, during the initial review by either an FDA certified State Rating Officer or one of the FDA designated milk processing experts, the plant will be evaluated and must be found in substantial compliance with all aspects of Appendix T. The Appendix T compliance programs must be supervised by a Preventive Controls Qualified Individual (PCQI) or another person who has the education and skills background to have responsible authority to oversee these processes.
One of the major challenges many firms face is the establishment of acceptable written food safety programs and maintenance of required records that demonstrate compliance with Appendix T. The failure of a Grade “A” dairy plant to meet any of these requirements will result in either loss of its Grade “A” designation or a request for the state to remove its Grade “A” designation.
Prior to Appendix T, some reasons for the loss of a Grade “A” dairy plant designation were quickly fixed, with a dairy plant being regranted its Grade “A” designation within a few days after losing it. However, loss of a Grade “A” designation because of a failure to meet one or more of the Appendix T requirements may have no quick fix, and the dairy plant’s change in the status to non-Grade “A” and subsequent time making corrective actions that address Appendix T noncompliance could cause significant disruptions in plant operations, the transport of milk from dairy farms to dairy plants, the pricing received by dairy farmers, etc.
The new Appendix “T” enforcement by FDA and the state dairy inspection agencies will demand more attention and verification of food safety programs, documents and records than in the past. Grade “A” dairy plants need to be fully prepared for such enforcement and the potential loss of Grade “A” status for more extended periods of time.
Specific details on the National Conference on Interstate Milk Shipment’s (NCIMS) Grade “A” program can be found here. The new requirements of the 2017 Pasteurized Milk Ordinance (PMO) and Appendix T contents and enforcement can be found here. For assistance in preparing and maintaining the required documentation, questions on PCQI status or implementation of new procedures, you might want to seek the advice of EAS Consulting Group or another consulting firm with detailed and practical experience.