Currently, the first stages of FSMA are being implemented, and the FDA is beginning to inspect facilities according to the new rules. In anticipation, companies in all sectors of the food industry are adjusting their food safety plans to meet the new requirements and pass inspections. Certain segments of the food industry, such as farms growing and harvesting fresh fruits and vegetables, are adjusting to new federal regulatory oversight that they have not experienced before. In particular, the processed fruit and vegetable segments are struggling with consumers treating their products as ready-to-eat, instead of their traditional use as raw agricultural commodities. This, coupled with the fact that the new regulations do not address the cause of past outbreaks, leaves the produce industry in limbo and the consumer unprotected. Continue Reading

With summer vacation season upon us, most people can relate to the angst of the question, “Are we there yet?”  In fact, I suspect many food industry professionals have recently pondered this question when reflecting on the regulations of the Food Safety Modernization Act (FSMA), and then wondered what is “coming down the pike?”

Upon enactment of the FSMA law in January 2011, the U.S. Food and Drug Administration (FDA) implemented a few requirements immediately, but the most significant rules require years to develop.  The implementation phase of the FSMA regulations officially began two years ago with the beginning of Phase II of the FDA’s operational strategy for FSMA, which included regulator training and targeted risk-based inspection, sampling, testing and data collection activities. 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

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

Questions about the role of industry standards for complying with the Food Safety Modernization Act (FSMA) have existed since the law was enacted more than six years ago. Due to the upcoming requirements for foreign supplier verification, industry stakeholders are urging the FDA to extend the compliance date, and to clarify the role of private entities for supporting compliance with the new FSMA requirements for imported food.

The role of strategic partnerships for improving the safety of imported food was the focus of a two-day FDA public hearing held last week (February 14-15, 2017). The hearing followed public meetings held last year on imported food safety, which raised questions about the role of private certification schemes and third-party audits for supporting compliance with FSMA by foreign suppliers. Continue Reading

Years ago, I was in a production facility, and a worker threw some trash into a barrel of product destined for a local pig farmer. The worker thought his actions were acceptable because of the common belief that pigs eat anything.

Over the years, many production facilities have taken products and by-products failing to meet finished product specifications and have sold them to “pig farmers” or other animal food companies. As I witnessed, sometimes employees would throw foreign material into the “pig food” or “animal food” container. Often, this product would be offered for “free” to farmers, as long as they picked it up frequently. Commonly, these containers on the back dock or in a walk-in refrigerator would not be labeled. Workers would throw trash in them because they were not trained about the risk of mixing trash with potential animal feed. Continue Reading

Are you trying to determine where to start on your journey to Preventive Controls Compliance? Well, you are not alone. It seems every day uncovers a new, little nuance that does not fit in a neat FSMA box. Start on the path to Preventive Controls compliance with our five steps below:

1. Focus on what we already know. Many rules have yet to be implemented, and the guidelines are not available. So, focus on finding a Preventive Controls Qualified Individual (PCQI) training program. Attending a PCQI training program will jump start your efforts toward Preventive Controls compliance. After training, assemble your team to review the process flow chart, your raw material(s) and an ingredient hazard analysis. If a flow chart or hazard analysis has not been developed, this should be your first step. It is important to note that the preventive control rule does not require a flow chart, but it is almost impossible to perform a hazard analysis without one. Continue Reading

For more than four years, food industry stakeholders have been eagerly awaiting publication of the final versions of the “seven foundational rules” mandated by FDA Food Safety Modernization Act (FSMA). This month, the Food and Drug Administration (FDA) issued the two final rules requiring facilities to identify potential hazards and implement controls for human food and animal food.

In the simplest terms, the final rule for human food requires firms to identify significant food safety risks, implement controls to mitigate the risks, monitor and verify the effectiveness of the processes, manage supply chain risks, and document activities. Continue Reading