DFK for Safe Food Environment

I have been delving into #HACCP and #FSMA programs lately, and my readings consistently affirm that the FDA’s Preventive Controls Rule is raising the bar for the Food Safety Plans and in food safety! The traditional HACCP approach—centered around Critical Control Points (CCPs)—has been the backbone of food safety for years and still. However, as supply chains evolve, it’s clear that relying solely the HACCP and GMP may leave critical non-process hazards unaddressed. When building a HACCP plan, the CCP decision tree helps identify CCPs. But what happens when significant hazards arise outside of process steps? or non-process related risks that don’t fit into the CCP framework? See for instance in Q1 of the attached Decision Tree. Here, the food safety team should be careful and consider the significance of the hazard (i.e. the likelihood of occurrence in the absence of control and the severity of impact of the hazard) and whether it could be sufficiently controlled by prerequisite programs which could be routine GHPs or GHPs that require greater attention to control the hazard (e.g. monitoring and recording). 🔶 AND this is where the FDA’s Preventive Controls (PC) rule steps in, modernizing the Food Safety Plan to go beyond the process steps and why the FDA’s PC rule that builds on HACCP, is a game-changer: ✔️ The Food Safety Plan underlines the true value of PRPs in the context of the Preventive Controls Rule. ✔️ It addresses hazards beyond the process, ensuring safety at every step. ✔️ It strengthens control over risks the CCP decision tree - or the food safety team using a the CCP decision tree- might miss. ✔️ It’s a forward-thinking framework for today’s complex food supply chains. The Food Safety Plan addresses risks before they hit the process and requires food facilities to treat non-process risks with the same rigor and precision as CCPs, making the food safety plan far more comprehensive. To become a #PCQI equipped with the essential knowledge to develop a Food Safety Plan based on a preventive controls approach, 👉check out the upcoming FDA-recognized PCQI program to support the food industry comply with the requirements for applying a science and risk-based food safety system. https://lnkd.in/e7DH4Pdy If you have any questions, don’t hesitate to reach out! DFK for Safe Food Environment / regulatory compliance specialists #HACCP #FSP #fsma #fsp #foodtrade #foodexport #regulatorycompliance #foodprocessing #foodsafety

Mistakes can be valuable learning opportunities, but #foodrecalls and #outbreaks are a different story—no one wants them to happen. However, when they do, we must learn from them. I often see in #hazardanalysis raw materials grouped together under broad categories like, as an example, "dry products" and advise against this practice—even when the list of raw materials is extensive. This is crucial because the raw materials may seem similar, but their risk profiles can vary significantly. Eventually, HACCP and Food Safety Plans are built on preventive measures and an effective prevention of contamination begins right here. Otherwise, overlooking the specific hazards associated with each raw material can lead to severe consequences. 🔶 Case in Point – Lessons to Learn from Flour Recalls: 📌 2019 E. coli Outbreak: A major recall affected millions of pounds of flour across the U.S., sickening 38 people due to E. coli contamination. Despite being a "dry" ingredient, flour—like many raw agricultural products—can harbor dangerous pathogens. 📌 2023 Salmonella Outbreak: The FDA and CDC investigated a multistate outbreak linked to recalled flour with “Better if Used by” dates in 2024 and 14 people in 13 states became ill due to Salmonella contamination. Even though flour appears "dry" and "safe," it requires thorough hazard analysis to identify these risks. In contrast, salt, also a dry product, has a high salinity that inhibits microbial growth, making it a lower risk for pathogen contamination. So, if you group these together in your analysis, you might overlook key hazards in high-risk ingredients like flour. If you have any questions or need further insights on food safety, feel free to reach out! "An ounce of prevention is worth a pound of cure." – Benjamin Franklin DFK for Safe Food Environment #compliancematters #HACCP #fsp #foodprocessing #foodsafety #riskassessment #riskmanagement #preventivecontrols #regulatorycompliance

Let’s keep it easy when it comes to regulatory compliance with FSMA! :) Recently, I have been receiving inquiries about the FDA registration process. For many SMEs in the food industry, registering with the FDA may seem like a daunting and costly task. But here's the truth: You can handle FDA registration on your own and it is free :) If you can do it yourself, you can save on fees that would otherwise be spent on third-party services or consultants. These savings can be reinvested into your business, allowing you to focus on critical areas such as strengthening operations, implementing preventive controls to ensure product safety, or providing targeted staff training on safety protocols. 🔶To get started, here are two important resources: 1- "Questions and Answers regarding Food Facility Registration" https://lnkd.in/e-y2cqNi 2- Food Facility Registration User Guide: Registration of Food Facilities – Step-by-Step Instructions https://lnkd.in/e2q2-7uy Important Reminder: During the registration process, your food facility must designate a U.S. agent. So you MUST to have a US agent. This agent, either a person or business, must be physically located in the United States. If you have any questions about compliance with FSMA ? feel free to reach out. #foodsafety #fsma #regulatorycompliance #foodprocessing #foodtrade #foodexport DFK for Safe Food Environment

🔶 Have you addressed the product shelf life when preparing your HACCP plan? this aspect is sometimes overlooked. Whether you’re launching a new venture or are new to food safety management systems, a comprehensive HACCP plan is crucial for novel foods, just as it is for conventional foods. This requirement is in addition to the other necessary information (see attached Figure). - As highlighted in Regulation (EC) No 852/2004, "Food business operators shall put in place, implement, and maintain a food safety management system based on Hazard Analysis and Critical Control Points (HACCP) principles." Important aspect to highlight is the inclusion of product shelf life in your HACCP plan. Referring to shelf life is of significant importance because the details of the information and control measures within the HACCP plan will vary depending on the shelf life of the products. - In this context, novel foods are subject to the same general food labeling requirements as outlined in the retained Regulation (EU) No 1169/2011. This regulation mandates that food labels must display specific information, including storage conditions and shelf life. Determining the shelf life of products is vital for managing risks associated with their storage and use, ensuring they remain safe throughout their intended shelf life. For example, if a novel food is susceptible to microbiological deterioration, its microbiological stability must be thoroughly understood and tested. For any queries related to your HACCP plan, for conventional and novel foods, feel free to reach out. Sharing your food safety hurdles makes them half as daunting! #foodsafety #HACCP #foodprocessing #novelfood #foodregulation #regulatorycompliance #foodsafetycompliance #riskassessment Fig.source: Ververis et al., 2020.

A spotlight on FDA food import refusals in 2023 for Arab countries: The following data are on key Arabic countries that faced a number of food import rejections when exporting to the US, revealing the challenges of meeting US food safety and quality standards: 🔹 Jordan: 32 rejections 🔹 Lebanon: 30 rejections 🔹 UAE: 26 rejections 🔹 Egypt: 22 rejections 🔹 Morocco: 18 rejections 🔹 KSA: 13 rejections 🔹 Tunisia: 11 rejections 🔹 Oman: 9 rejections Top Rejected Products: ✖ Egypt: Fruit and Fruit Products had the highest number of refusals, followed by Vegetables and Vegetable Products, Vitamins, Minerals, and Proteins, Soft Drinks and Waters, and Chocolate and Cocoa Products). ✖ Lebanon: Nuts and Edible Seeds had the most rejections, followed by Spices, Flavors, and Salts and Fruit and Fruit Products. ✖ KSA: Fruit and Fruit Products (dominated the refusals, with Soft Drinks and Waters and Food Sweeteners being less common. ✖ UAE: Vitamins and Dietary Specialties led the rejections, followed by Whole Grains and Starch and Chocolate and Cocoa Products. ✖ Jordan: Nuts and Edible Seeds were the most commonly rejected, followed by Spices, Flavors, and Salts, Bakery Products, and Gelatin and Pudding Mixes. ✖ Oman: Fishery/Seafood Products accounted for most of the refusals ✖ Tunisia: Bakery Products and Whole Grains and Starch  were the most refused categories. ✖ Morocco: Gelatin and Pudding Mixes topped the list, with Bakery Products coming second. Understanding FDA Regulations is vital for US Market Access and to meet the strict regulatory requirements. Many of the recent rejections can be traced back to non-compliance with the FDA’s Preventive Controls for Human Food under the Food Safety Modernization Act (FSMA). Failing to comply can lead not only to immediate rejections, but also financial losses, and reputational damage. Got questions about FDA food safety and labeling requirements? the risk assessment and preventive controls ? Just reach out—we’re here to help! After all, “A problem shared is a problem halved.” DFK for Safe Food Environment #foodsafety #foodtrade #foodexport #MENA #foodprocessing #regulatorycompliance #fsma #fda #fsp #foodstandards #riskassessment #riskmanagement

I am glad to announce the launch of the Food Safety Preventive Controls Alliance's (FSPCA) #IAVA program, designed to prepare the delegate to become a Food Defense Qualified Individual for the purpose of conducting vulnerability assessments for intentional adulteration of food. Conducting a vulnerability assessment is a critical component of developing a food defense plan, which is a requirement under the FSMA rule “ Mitigation Strategies to Protect Food Against Intentional Adulteration”  (21 CFR Part 121). ❗️This #FSMA rule applies to both, domestic and foreign food facilities(food exporters), unless exempted. It requires: 🔶 (1) food facilities to develop a #fooddefense plan that protects the facility’s most vulnerable points from acts of intentional adulteration intended to cause wide scale public health harm. The points in a facilities operation that have these significant vulnerabilities are referred to as “actionable process steps”. According to the IA rule, individuals assigned to work at actionable process steps, and their supervisors, are required to receive training in food defense awareness (21 CFR 121.4(b)(2)). The FSCPA offers Food Defense Awareness training FREE here: 👉https://lnkd.in/exbpRPtF 🔶 (2) certain activities must be completed by a “food defense qualified individual” who has successfully completed training in the conduct of a #vulnerabilityassessment (21 cfr 121.4). This IAVA course developed by the FSPCA is the “standardized curriculum” recognized by FDA; and successfully completing this course is one way to meet the requirements for a “food defense qualified individual” responsible for conducting a vulnerability assessment. More details on the IAVA and sceduled workshops is available in this link: 👉https://lnkd.in/evPwWHCF For information on FSMA compliance, check this link and feel free to get in touch: 👉 https://lnkd.in/eNh_VcXy #fooddefense #fspca #fsma #foodexport #foodtrade #regulatorycompliance #foodprocessing

Kudos to the newest group of #PCQIs who have successfully qualified through the unique #FSPCA program! What a fantastic, close-knit group—I've truly enjoyed every moment of our discussions and the incredible energy they brought to the workshop. They’re now fully equipped and confident, ready to fine tune their food safety system in alignment with the 21 CFR Part 117 and receive #FDA inspections with success! As a dedicated enthusiast and strong advocate for the FDA's cGMP, Hazard Analysis, and Risk-Based Preventive Controls rule, I believe it sets a new benchmark in food safety. And knowing that I was able to help continues to motivate me doing this work, especially when I receive such generous feedback from my clients: "Dima is an amazing instructor. The way she conducted the course kept me engaged, even on the longest days of training. She is always open to questions and discussions, and her interactive approach makes learning enjoyable" (Golshan Ghalibaf, QA Specialist). "I have really appreciated this course experience having Dima as instructor. She provided a well structured & interactive training, focusing on direct practicing of main learning points. She also provided a lot of material for future use & implementation of course learnings" (Nikolaos Charamis, Process Technologist, Nestle Nederland). Dr. Dima Faour- Klingbeil demonstrated the content very well and understandable. She was always open for questions and provided understandable answers. A great training with group work was provided (Annika - Quality Manager). Enjoy your weekend! Mine has started already :) #pcqi #fsp #riskassessment #riskmanagement #foodexport #foodtrade #foodprocessing #foodsafety DFK for Safe Food Environment

Here is to a well-deserved long weekend after a demanding, yet rewarding couple of weeks. Adding a personal touch to my LinkedIn post, here’s a glimpse of my favorite downtime at home—perfecting my Dido’s Falafel recipe. Dido’s is the imaginary brand of my future bistro :) and these falafels are nutritious and protein-rich traditional delights. Amidst this relaxing break, I am glad to share that I am now an FSPCA-trained IAVA Lead Instructor! This prestigious qualification expands my FSMA-related compliance services and positions me to better assist clients in achieving regulatory compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule (21 CFR Part 121). The IA rule mandates that food facilities develop a robust defense plan, and a crucial component of which is conducting a vulnerability assessment. The Intentional Adulteration Conducting Vulnerability Assessments (IAVA) course, developed by the FSPCA and recognized by the FDA, provides essential tools to evaluate and address vulnerabilities in food production processes to intentional adulteration. Completing this course qualifies me as a "food defense qualified individual," ready to conduct thorough vulnerability assessments and support robust defense strategies. I'll soon be posting the IAVA course schedules on my website. In the meantime, my advisory services and in-house or private group online workshops are available upon request. #foodprocessing #FSMA #IAVA #FDA #FoodDefense #internationaladulteration #foodexport #foodtrade #RegulatortCompliance #IntentionalAdulteration