By Allen Sayler, Senior Director for Food and Cosmetic Consulting Services
The U.S. dairy processing industry is facing a significant challenge as it moves toward compliance with the FDA Food Safety Modernization Act (FSMA). This is best captured by a conversation I had with a corporate quality assurance vice president about six months ago. When asked how many written food safety programs each of the dairy plants in his company had, the reply was, “Because of the current regulations, private certification systems, customer expectations and our own corporate food safety requirements, the number ranges between three and five per plant.
I asked how they could manage this number of different food safety programs, which one(s) the plant employees were trained on and how they kept the records required for each written food safety program separated and organized. While he may have had a solution, he did not provide an answer to my question. The challenge is exactly that; with so many demands on dairy plants today to operate in a multi-jurisdictional government world, a multiple customer world and competing, private food safety standards, can one written food safety program meet the requirements for all these different parties?
For many U.S. dairy processing plants, because of industry consolidation, their compliance enforcement deadline for the FSMA “Preventive Controls for Human Foods (PCHF)” regulation was September 2016. The regulation mandates a written food safety program that requires a risk-based hazard analysis incorporating “preventive controls” and development of a supply chain management program. Also, this regulation mandates radiological hazards be considered. The preventive controls program is to be supported by compliance with updated Good Manufacturing Practices (GMPs) found in 21 CFR 117, Subpart B. We will call this “Written Food Safety Plan #1”.
Starting in 2008, many larger dairy companies rebuilt their written food safety programs to comply with the requirements found in one of the Global Food Safety Initiative’s (GFSI’s) recognized third-party food safety certification schemes such as Safe Quality Foods (SQF), the British Retail Consortium (BRC), FSSC 22000 and the International Featured Standard (IFS). While the four GFSI schemes have differences, they all require a written food safety program that utilizes prerequisite programs to support the written HACCP Plan. The hazard analysis part of the HACCP Plan is supposed to incorporate “risk” into the decision-making process but does not require any recognition of potential radiological hazards. The GFSI schemes utilize specific prerequisite programs instead of GMPs to receive their certification. We can designate this as “Written Food Safety Plan #2”.
In May 2017, the U.S.-based National Conference on Interstate Milk Shipments (NCIMS) adopted the most significant changes for Grade “A” dairy plants since the early 1990s. These changes are likely to be accepted by the FDA in October 2017 and enforced in all “Grade A” dairy plants by October 2018. The new requirements will require a FSMA “Preventive Controls-like” written food safety program that will be evaluated by trained FDA Regional Milk Specialists once every three years, in addition to the routine GMP-like state inspections required once every three months. These NCIMS changes are similar, but not the same as required in the FSMA Preventive Controls regulation, with the FDA GMP requirements being somewhat superseded by the NCIMS Pasteurized Milk Ordinance (PMO) dairy plant operational requirements. In addition, the Preventive Control supply chain management requirements were modified to recognize the NCIMS strict requirements for utilizing only raw milk from Grade “A” licensed or permitted dairy farms and dairy ingredients from Grade “A” dairy plants. We recognize this as “Written Food Safety Plan #3”.
Finally, many large dairy companies have mandated policies and procedures on the content and details for a dairy plant’s written food safety plan. These mandated policies and procedures are “enforced” via corporate-based or private auditing companies hired to conduct plant-by-plant assessments. We can call this “Written Food Safety Plan #4”.
The problems related to multiple and possibly competing written food safety programs in dairy plants are significant. First, most dairy plants are challenged, like any food processing plant, with managing one written food safety plan. So how does a plant maintain and implement multiple written food safety programs? Second, how does plant management decide on the instructions and training for the plant staff that are responsible for delivering a safe finished product, based on multiple written food safety plans? Third, most plants are resource-challenged to support one written food safety plan, so where do the resources come from to maintain, implement and train staff on multiple written food safety plans?
A “revolutionary” process is required for a dairy plant with up to four different food safety programs to consolidate into one which contains the key requirements in one written food safety plan. This consolidated plan needs to use hybridization techniques to achieve a “Best in Class” food safety program. Such hybridization in nature many times produces much stronger off-spring with unique and new abilities to meet the challenges of the real world. This is the expectation for the “hybridized”, consolidated written food safety plan that will replace the multiples.
In conclusion, dairy plants need to conduct a hybridization exercise to move toward one “Best in Class” written food safety program that meets or exceeds government, private certification, customer and internal corporate requirements.