It has been one year since the Food Safety Modernization Act’s (FSMA) Preventive Controls rule went into effect, so it’s time to check on progress being made by retailers and their suppliers. The FDA is expected to start more actively enforcing the provisions, auditing companies that are most likely to incur food safety challenges due to the volume of food produced or the character of the product made and sold.
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With that in mind, here are 10 critical points you need to understand about the Preventive Control rule right now.
1. All covered facilities must now have a food safety plan in place. The plan must contain several key sections, including a hazard analysis, preventive controls to minimize those hazards, and an oversight and management program. The oversight and management program monitors the flow of product through the internal supply chain and is used to identify corrective actions that need to be taken on problems that occur during food production.
2. All covered facilities must now have a preventive controls qualified individual on staff. A preventive controls qualified individual, or PCQI, has successfully completed training or has job experience in the development and application of food safety programs.
3. Preventive controls rules are different from HACCP. While there are similarities between the FSMA preventive controls requirements and Hazard Analysis and Critical Control Points (HACCP), many provisions are different. HACCP systems apply controls at critical control points, for instance, but preventive controls include all control points appropriate for food safety.
4. Preventive controls plans must cover any food material processed or sold. Each facility must have a risk-based preventive assessment supply chain program for all ingredients and products, unless it either institutes preventive measures to deal with the hazard itself or passes the ingredient on to a customer who will implement their own preventive measures.
5. All foods must now be received from approved suppliers that have gone through hazard analysis for that particular food. Foods may be brought in temporarily from unapproved suppliers, but these products or ingredients are then subject to verification before they can be used.
6. Preventive controls are not required if any hazard will be controlled by another entity in the supply chain. The facility must disclose that the product or ingredient has not been processed to control its associated risk and must obtain written assurance that the trading partner will do so.
7. Other organizations, including brokers or distributors, can conduct supplier verifications. Any receiving facility must, however, review and assess that organization’s documentation of the verification.
8. Good Manufacturing Practices are constantly being updated. The FDA’s best practices mandate education and training on hygiene and food safety for employees and management, as well as addressing food allergy concerns.
9. Exemptions include farms that engage in low-risk on-farm activities and are small or very small businesses, plus operations already subject to HACCP requirements. There are also exemptions for companies that process low-acid canned foods, producers of dietary supplements, alcoholic beverages, or cosmetics and facilities that store raw agricultural commodities or packaged foods.
10. The date for compliance with Preventive Controls was last year for large businesses and now it applies to smaller ones with less than 500 employees. Small businesses with less than $1 million in sales have until September 2018.
The Preventive Controls rule, the first of the seven FSMA provisions, should have already changed the way retailers, manufacturers, processors, and others in the food supply chain do business. If it hasn’t impacted your company yet, don’t wait until the FDA forces you to make changes that at best will be very costly and at worse could prove existential.