FDA FSMA Rules for Preventing Cross Contact and Contact Contamination Allergens

Allergen cross contact and cross contamination can occur anywhere throughout the entire food supply chain.

Under the FDA’s FSMA preventive control rules, allergens get special attention. They cannot be seen and are rarely tested for in spite of the fact that allergens come from many sources and are often associated with cross contact and cross contamination. Preventive control, sanitation and transportation rule requirements are not yet in place to adequately protect consumers from the potential deadly impact of ingested allergens.

• Understand basic allergens
• Establish a potential hazard analyses throughout food processes (process flows)
• Identify preventive control measures
• Establish preventive controls
• Set up allergen monitoring procedures
• Develop procedures
• Take corrective action
• Document allergen cross contact and cross contamination plans and controls

• Allergen controls under the preventive control rules
• The difference between cross contamination and cross contact
• Farms, processing, packing houses, processing lines, truck trailers and containers
• Hazard analysis
• Sanitation
• Supplier qualification
• Packaging and labeling.

Allergens continue to play a significant role in causing human illness and death. While labeling requirements established by the FDA have been in effect for some time, recalled food in today’s marketplace is very often the result if inaccurate allergen labeling that does not declare allergenic ingredients.

Allergen cross contact and cross contamination can occur anywhere throughout the entire food supply chain.

Under the FDA’s FSMA preventive control rules, allergens get special attention. They cannot be seen and are rarely tested for in spite of the fact that allergens come from many sources and are often associated with cross contact and cross contamination. Preventive control, sanitation and transportation rule requirements are not yet in place to adequately protect consumers from the potential deadly impact of ingested allergens.

It is required that preventive control plans include hazard analysis for allergen plans include incoming, in-process and outgoing ingredients, packaging and labeling and cross contact prevention is validated in the validation plan.

Under FDA’s FSMA rules, no company can afford to ignore the need to prevent cross contact or cross contamination by allergens through any food process. Biological, chemical and physical hazards have the potential to spread through any process, any food handling operation or any transportation process with the likely result that traceability of the contaminant back to the source can become impossible. Under new preventive control rules, cross contamination by allergens has earned a special place in the training and food safety plan because of their ability to contaminate equipment, people and other food products. 

The need to understand what can happen and how to begin valid preventive planning that takes cross contact and contact contamination into account is critical to implementation of any food safety system.

• Upper and Mid-level personnel from all registered food operations
• Food safety team members
• Food quality personnel
• Managers and supervisors in food operations
• Sanitation specialists and teams
• Food packing, processing, distribution and handling personnel
• Incoming packaging personnel
• Labeling personnel
• Food ingredient suppliers
• Legal team members focused on food safety
• Food safety leads and implementation team members
• Maintenance operations personnel (sanitation)
• Food facility personnel
• Recall specialists
• US Food Importers and Exporters to the US
• Food Safety internal and external auditors and audit team members
• Distribution center operations personnel
• Carrier and food transportation management
• Food Buyers and Supply Chain Qualifiers.