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Allergen Controls and FSMA
Allergen Controls and FSMA

An effective allergen cross-contact prevention program requires a multidisciplinary approach during development and implementation, and ongoing validation.

Specific hazards that must be considered in assessing a food safety plan for hazard analysis and preventive controls are noted in section 117.126 of the Food Safety Modernization Act (FSMA). One of the key programs outlined is prevention of allergen cross-contact.

In most food manufacturing and distributing facilities, the success of an allergen cross-contact prevention program is most often attributed to ethical commitment, particularly by management. Ensuring customers are informed of the allergens present in their products has been successful due to ethical management. But with FSMA’s new rules, it has become essential to verify that implemented procedures and practices are fully documented with written hazard analysis, preventive controls, procedures for monitoring the implementation of preventive controls, corrective action procedures, and verification procedures

Hazard Analysis

Before a hazard analysis for allergens can be completed, you have to identify the allergens to be controlled. Ensure that the U.S.-regulated “Big 8” are included, as well as the allergens/sensitizing agents regulated by the countries where the product is distributed.

  • In a flow diagram, identify all product/traffic patterns that could cause potential cross-contact, and develop appropriate controls for each area of concern. Employee traffic patterns and equipment traffic/design should be included in this diagram.
  • Identify and develop controls for potential cross-contact points due to equipment or facility design. Examples are shared conveyor systems, points where open conveyor systems cross, hang-up points (where product can overflow), etc.
  • Map employee traffic to and from assigned work stations and identify shared areas such as toilet facilities and break rooms to determine if allergen cross-contact could occur. Preventive measures might include changing traffic patterns, changing uniforms/smocks before leaving allergen-areas, etc.

Written Preventive Controls

Allergen control is important at every step of food processing and throughout the facility. It starts with handling incoming raw materials in a way that ensures accurate information, so that allergens contained in the product are identified in the ingredient declaration on the finished product label. Some of the controls and process steps to be documented by quality assurance or food safety professionals include:

  • Procurement: What allergens are being purchased? Consider this for all raw materials (including ingredients and components, processing aids, and finished product packaging). For purchased labeling, document the development, initial shipment, and receipt of subsequent lots. For labels generated in-house, a second person should review data entry, and the saved files should be password protected.
  • Receiving: There are several tasks related to the receiving step that will help minimize allergen cross-contact. Mixed loads, partial pallets, and stacked pallets of different allergen content should be inspected in such a way as to ensure cross-contact has not occurred. Your supplier/distribution service should know what protective requirements are needed in transit to prevent allergen cross-contact. When allergen-containing items are received, a color-coded sticker identifying it as an allergen should be placed on the shipment. Corrective actions should be clearly documented so that receiving personnel know what to do if issues are identified.
  • Storage (ingredients, processing aids, and product-contact packaging): Materials in storage should be stacked with allergens in mind. This means that like-above-like or allergen stacking (any allergen in a material is also contained in the material stored directly below it) should be used. If containers are damaged in storage, nearby materials need to be assessed to determine if cross-contact occurred. Corrective action should be taken for materials where allergen cross-contact has occurred.
  • Production controls: Changeover procedures need to be followed before changing to a product with a dissimilar allergen content. If rework is allowed, there should be someone at the plant who determines what rework can be used, how it is generated, and what additional documentation is needed. Only like-into-like or sameinto-same rework should be used.

Tool controls should be followed for portable equipment, utensils, containers, shared tools (e.g., cleaning brushes, hoses), and testing equipment (e.g., thermometers, metal-detection test pieces). These controls should account for usage and ensure that utensils are stored in a way that prevents cross-contact.

Controls should also be in place to ensure that employee contact does not cause allergen cross-contact. Floaters, supervisors, and technicians are just a few of the employees who should be considered. If cross-contact is identified, corrective action should be taken immediately to determine the impact of the identified issue.

On the packaging line, employees should follow procedures to ensure the appropriate label or container is used for the product being packaged.

  • Changeover procedures: Raw materials (including rework) should be limited in production areas to just those to be used. Clear cleaning procedures are needed to ensure the previous product (with dissimilar allergen content) is effectively removed from the equipment and tools. All tools used with dissimilar allergens should be removed and effectively cleaned. •
  • Monitoring and verification of preventive controls: Employee training and education is essential for the allergen cross-contact control program to be effective. If the employees do not buy into the program or understand the controls, it will fail. Both monitoring (following the procedures) and verification (confirmation that procedures are followed and effective) need to be documented. A checklist of actions to take should be developed and completed for each allergen changeover to prove that the activities are conducted.
  • Written corrective action procedures: Not every adverse situation can be anticipated; however, corrective actions can be written based on the likelihood of errors occurring, past issues, and history in the industry. It is essential that corrective action be effectively communicated to the individuals who will most likely identify the issues, especially line operators.
  • Validation of the effectiveness of the controls: Validation is scientific proof that the program and practices are effective in preventing allergen cross-contact. This proof can come from a variety of sources, including:
    • Information about raw materials from suppliers, completed questionnaires about allergen content and the supplier’s controls, and web searches
    • Processing/packaging/facility: visual inspection of the equipment for hang-up points and potential cross-contact areas, identification of overflow areas in processing lines, history of complaints of mixed product, etc.
    • Effectiveness of changeover procedures by equipment or finished product allergen testing. FDA’s proposed frequency for validation of the effectiveness of the program is at least once every three years (annually is required by most audit standards), including: when there is a significant change that could create a new hazard; when there is new information about potential hazards associated with a raw material or product; and when a preventive control is not properly implemented or is found to be ineffective.

Exempt Businesses

The following types of operations likely will be exempt from FSMA’s preventive controls requirements:

  • Dietary supplements.
  • Alcoholic beverages.
  • Seafood and juice (HACCP) and low-acid canned food (these sectors must follow industry-specific requirements). 
  • Warehouses and distribution sites, based on:
    • Non-refrigerated warehouses.
    • Refrigerated and frozen warehouses (based on reason for refrigeration/freezing). 
    • Fully packaged foods (product not exposed to the environment).
    • Storage facilities for only raw, low risk, agricultural commodities (items such as grains); exemption is not for fruits and vegetables.


FSMA requires effective controls to prevent allergen cross-contact. Incorrect allergen content declaration, a potentially life-threatening situation, remains the primary reason for recalls in the U.S. and Canada. An effective allergen cross-contact prevention program requires a multi-disciplinary approach during development and implementation, and ongoing validation of the effectiveness of the practices.

Employees must understand and follow the controls, then clearly document their activities. Verification activities must be effective at catching potential issues and identify opportunities for additional training or improvement of activities. Validation proves that your controls are effective. Resulting documents are legal records that outline the history of the product and process.

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