Clients often ask me, “If I am certified to the Global Food Safety Initiative (GFSI), will I be ready for the FDA to inspect my operation for compliance with the Food Safety Modernization Act (FSMA) Preventive Controls Rule?” In the past, I have told many clients with certifications such as the Safe Quality Food (SQF) Code and British Retail Consortium (BRC) Standard, that because they went through the steps to become certified, they are well positioned to ensure compliance with the FSMA law requirements. However, there are similarities and differences between the two that must be taken into account. For companies that fall under the FDA regulatory jurisdiction and must become compliant with the FSMA Preventive Controls for Human Food Rule or the Animal Food Rule, taking the journey to become GFSI certified will help them meet the FSMA requirements. It will also change the working culture throughout the organization to prepare for FSMA implementation. Continue Reading

In May, the National Conference on Interstate Milk Shipments (NCIMS) voted Preventive Controls for Human Food (PCHF) as part of the Food Safety Modernization Act (FSMA) into the Pasteurized Milk Ordinance (PMO). The PMO sets forth standards and requirements to regulate dairy plants producing Grade “A” products. This includes milk, fluid cream products, sour cream, yogurt, manufactured products, such as cottage cheese and dry ingredients. Continue Reading

As the Food and Drug Administration (FDA) moves forward with Food Safety Modernization Act (FSMA) implementation, food companies are beginning to realize the need for effective environmental monitoring procedures to minimize microbial cross-contamination and allergen cross-contact. In developing the Preventive Controls Rule for Human Food, the FDA revised the antiquated Good Manufacturing Practices (GMPs) once contained in 21 CFR Part 110 and now published in 21 CFR Part 117. In doing so, the FDA has been very specific in addressing environmental contamination in the revised GMPs and in the new Preventive Control regulations.  Continue Reading

Food manufacturers who find an issue during an internal food safety audit need to perform a root cause analysis and take corrective actions in order to eliminate the problem. But what if subsequent internal audits reveal the same repeating issue? That is a good indication that the company did not find all of the root causes to place corrective actions against. And for many companies, the issue comes back repeatedly despite corrective actions.  Continue Reading

For over 20 years, the food industry has been steadfast in our view of the role of sanitation in classical Hazard Analysis Critical Control Point (HACCP) programs. Our experience with meat and poultry HACCP by way of the International HACCP Alliance and what came later with Global Food Safety Initiative (GFSI) HACCP requirements solidified the supportive role of sanitation as a food safety prerequisite program. We have managed sanitation as a separate prerequisite program, and then used these programs to eliminate the need for sanitation critical control points. However, compliance with the Preventive Controls Rule for Human Food (PCHF) as part of the Food Safety Modernization Act requires a different approach in how we manage sanitation procedures that directly addresses a food safety hazard identified in the hazard analysis. Continue Reading

Believe it or not, it’s been nearly five years since Canada approved its comprehensive food safety legislation known as the Safe Food for Canadians Act (SFCA). The legislation was developed to streamline Canada’s food safety regulations, improve regulatory oversight, and increase international regulatory alignment with its key trading partners, particularly the United States. To implement the legislation, Canada recently published the proposed Safe Food for Canadians Regulations. Continue Reading

If you are subject to the final rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule), then you should be aware of FDA’s new recommendations for controlling Listeria monocytogenes in ready-to-eat (RTE) foods. Manufacturers, processors, packers and holders of RTE foods will benefit from an understanding of the strategies and recommendations described within the new draft guidance.

Released this month, the draft guidance sheds light on the agency’s thinking regarding effective strategies for controlling L. monocytogenes in RTE foods, including identifying the risks associated with raw materials and ingredients, listericidal process control, environmental monitoring, product testing, and the analysis of verification data trends. Continue Reading

In 2016, various high profile recalls and minor scale recalls threatened the public safety of consumers across North America. Although it’s impossible to eliminate human error, and thus recalls entirely, it is paramount to understand the direct economic impact of recalls and related risks. Likewise, there are extensive efforts made by regulatory agencies to support food manufacturers as a supplement to the efforts your company should be making to ensure you remain off the recall lists in 2017. Continue Reading