Implementation of FDA’s Food Safety Modernization Act (FSMA) is fostering new expectations of food-safety programs in food manufacturing facilities. Bakers should already be preparing to ensure that all their food-processing operations are in control, beginning with basic sanitation practices.
Manufacturers that receive recall notifications know that undeclared allergens occur frequently and more often in certain types of foods. Any preventive programs controlling undeclared allergens label verification at packaging, allergen cross-contact during processing, proper allergen changeover cleaning or supplier verification for undeclared allergens should be directed by a risk-based hazard analysis.
A facility’s layout can impact allergen control. Control measures ensure materials are properly separated. Raw materials and finished products should be stored in different areas, and all allergens should be identified and segregated from other raw materials.
Designated production lines in close proximity that do not share a common allergen could be a poor line layout for allergen control. Manufacturers can improve such layouts by adding barriers between the lines, using dedicated utensils, avoiding compressed air usage during cleaning, restricting personnel movement between lines and enhancing Good Manufacturing Practices.
A significant change under FSMA?and a huge shift for food companies without prior experience with FDA’s HACCP programs?is record access. Under the old procedures, FDA could only see what companies were doing on the day of inspection. With expanded access to records, FDA can examine records from the previous week, month or year, depending on the specific records or if FDA has reasonable belief of food-safety issues. FDA will be able see when something went wrong and what corrective actions were taken. Some records, such as product formulas and financial information, are still off limits to FDA.
The physical condition of a bakery is another food-safety program component. There are still 100-year-old bakeries in operation, and coming regulatory changes make such facilities more difficult to maintain and clean. At some point, companies will have to determine whether it is economical to continue upgrading older facilities.
A Supplier Verification Program (SVP) is a new requirement to ensure that manufacturers use only approved suppliers for raw materials with significant hazards. The evaluation for having a Supplier Control Program would be based on the identification of a “significant hazard” during hazard analysis and then deciding which entity will control the identified hazard.
Currently, options for controlling significant hazards associated with raw materials involve the supplier to the receiving facility (processor) controlling the hazard; the supplier to the processor’s supplier (sub-supplier) controlling the hazard; the receiving facility controlling the hazard; the customer of the receiving facility controlling the hazard; or a combination of the above options controlling the hazard through supplier verification or other verification activities.
If a company identifies significant hazards in raw materials and ingredients controlled by the supplier or sub-supplier, the receiving facility must have a documented SVP that includes documented hazard analysis and supplier verification procedures, and an annual on-site audit by a “qualified auditor” to review the supplier’s procedures, audit conclusions and effectiveness of any actions.
If the processor does not get product directly from the supplier, then it must conduct verification activities with that supplier that are based on severity of the hazard, a review of preventive controls at the point they are applied, effectiveness of the supplier’s food-safety programs, the supplier’s compliance with FDA regulations and other factors for controlling the significant hazard.
Understanding the regulations and requirements?and developing programs that support these requirements?will help bakers ensure they meet their legal obligations.