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
The Food Safety Modernization Act has introduced many new food safety requirements to the food industry. In particular, FSMA places a focus on performing a hazard analysis and using preventive measures in food manufacturing. The requirement to develop and implement supplier preventive controls for raw materials and ingredients to address hazards has renewed interest in methods for sampling and testing raw materials. In order for sampling and testing to be used to address pathogen concerns identified in the hazard analysis of raw materials, a valid sampling plan must be in place. 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
Technical Tuesdays: The Role of Sanitation in the Preventive Controls Rule For Human Food
Jeff Lucas /
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
Thirty two years ago, regular discussion about the field of food safety did not exist. Back then, information on food safety came from a limited number of sources. This included the ICMSF (International Commission for the Microbiological Specification for Foods) organized in 1962, the International Association for Food Protection (then called the International Association of Milk, Food and Environmental Sanitarians) organized in 1911, and a few loosely organized regional associations consisting primarily of academicians and state health departments. Sourcing information proved to be difficult, and books on the subject were limited and costly. 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
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