Regulatory Round-Up: The Seventh Year of FSMA – Are We There Yet?

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 Regulatory Round-Up: The Seventh Year of FSMA – Are We There Yet?

Technical Tuesday: 5 Steps to Establish an Effective Environmental Monitoring Program

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 Technical Tuesday: 5 Steps to Establish an Effective Environmental Monitoring Program

Technical Tuesdays: The Role of Sanitation in the Preventive Controls Rule For Human Food

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 Technical Tuesdays: The Role of Sanitation in the Preventive Controls Rule For Human Food

Regulatory Round-Up: Third-Party Audits, GFSI and FSMA – FDA Seeks Strategic Partnerships for Imported Foods

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 Regulatory Round-Up: Third-Party Audits, GFSI and FSMA – FDA Seeks Strategic Partnerships for Imported Foods

Technical Tuesdays: Protect It – It’s Going to Animal Food

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 Technical Tuesdays: Protect It – It’s Going to Animal Food

FSMA Roadmap: 5 Steps to Preventive Control Compliance

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 FSMA Roadmap: 5 Steps to Preventive Control Compliance

Keys to Understanding the Preventive Controls Rule for Human Food

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 Keys to Understanding the Preventive Controls Rule for Human Food

4 Common Approaches to Consider for Process Validation Studies

Under the Food Safety Modernization Act (FSMA), food manufacturers are charged with employing processes that mitigate risks and aid in the delivery of safe and stable products. Manufacturers employ a wide range of thermal processes to inactivate spoilage microorganisms and pathogens that can affect product shelf-life. Verifying the effectiveness of these processes through well-designed and executed validation studies is essential in today’s regulatory environment.  Continue reading 4 Common Approaches to Consider for Process Validation Studies

Environmental Monitoring Systems: Making Prevention Cost-Effective

One of the centerpieces of The Food Safety Modernization Act (FSMA) focuses on preventative sanitation control, requiring manufacturers to implement a food safety plan to control hazards that can potentially introduce microorganisms into the finished product. Due to the heightened emphasis on prevention, an effective environmental monitoring system (EMS) provides manufacturers with critical data and information on the microbiological condition of their plants. When these systems are not correctly implemented and maintained, plants are at a greater risk of encountering safety issues that can result in increased liability exposure. Continue reading Environmental Monitoring Systems: Making Prevention Cost-Effective