How to Conduct an Allergen Gap Assessment

Reviewed and Approved by Tim Lombardo, Senior Director, Food Consulting Services, EAS Consulting Group (A Certified Group Company) 

1-Minute Summary 

• Over half of U.S. FDA food recalls in 2023 were due to undeclared allergens, underscoring a significant challenge in allergen control within the industry. 
• Allergen Gap Assessments are essential for identifying and addressing weaknesses in allergen management in food production, as required by 21 CFR 117. 
• Compliance with key regulations like FSMA, FALCPA, and the FASTER Act is crucial, with Allergen Gap Assessments playing a pivotal role in ensuring adherence and identifying potential allergen-related hazards. 
• Conducting an Allergen Gap Assessment involves gathering regulatory documents, creating a checklist, evaluating processes, documenting gaps, and developing corrective actions, with annual assessments recommended to maintain compliance and adapt to changes. 

More than a decade after enactment of the Food Safety and Modernization Act (FSMA), the industry is still struggling to implement effective allergen controls. In fact, in 2023, 54% of U.S. FDA food recalls were due to undeclared allergens. Meanwhile, 36% of USDA recalls were for the same reason.  

While most issues with undeclared allergens are unintentional, the industry still must improve its understanding of allergen controls so we can work together to reduce recalls related to undeclared allergens.  

One vital tactic is to perform an Allergen Gap Assessment in your facility. It’s not only a regulatory requirement under 21 CFR 117, it’s good business to maximize safety for your customers. In this article, we explain how to perform an Allergen Gap Assessment.  

What is an Allergen Gap Assessment? 

An Allergen Gap Assessment is a systematic process used to identify and address potential weaknesses in allergen management within food production facilities. 

It involves a thorough review of the entire manufacturing process, from ingredient procurement to product distribution, with a focus on points where allergens could be unintentionally introduced or inadequately controlled.  

Understanding Critical U.S. FDA Regulations for Allergen Control Programs 

Food Safety Modernization Act (FSMA) 

Key regulations include the Food Safety Modernization Act (FSMA), enacted in 2011, which marked a significant shift in food safety approaches, emphasizing prevention over reaction. To implement FSMA, the FDA has established nine rules, including the vital Preventive Controls for Human Food: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 CFR 117).  

This rule mandates that all food facilities, both domestically and internationally, conduct hazard analyses to pinpoint food safety risks such as the introduction of allergens and create risk-based preventive controls. Implementing comprehensive allergen control programs forms a core part of this hazard prevention strategy. 

EAS Consulting Group independent consultant Steven Gendel, Ph.D, answers 5 questions food producers need to understand about allergen controls here.  

Food Allergen Labeling and Consumer Protection Act (FALCPA) 

In addition to FSMA, the Food Allergen Labeling and Consumer Protection Act (FALCPA) plays a critical role in allergen management. It requires the allergen to be listed using its common name, making preventive allergen controls a necessary part of your process. 

Food Allergy Safety, Treatment, Education, and Research (FASTER) Act 

The 2021 FASTER Act further expanded the scope of allergen awareness by recognizing sesame as the ninth major U.S. food allergen: 

• Milk 
• Eggs 
• Fish 
• Crustacean shellfish 
• Tree nuts 
• Peanuts 
• Wheat 
• Soybeans 
• Sesame 

For food manufacturers, understanding and integrating these regulations into your allergen control programs is paramount. To help, the FDA has issued several guidance documents to aid industry professionals in developing robust allergen controls.   

Regular Allergen Gap Assessments are instrumental in ensuring compliance with these regulations. Such assessments facilitate the identification of potential allergen-related hazards and verify that effective preventive measures are in place, adhering to the Hazard Analysis and Risk-Based Preventive Controls (HARPC) approach required by FSMA. 

How Do I Conduct an Allergen Gap Assessment? 

System breakdowns can occur at any point in your supply chain and manufacturing process, allowing undeclared allergens to contaminate products. In addition, gathering all the resources and understanding all the regulations is daunting.  

The best place to start is by conducting an Allergen Gap Assessment. The following outlines how to conduct this assessment, along with examples to illustrate the process. 

Step 1: Gather Documents 

• Current Good Manufacturing Practices, Hazard Analysis, and Risk Based Preventive Controls for Human Food (21 CFR 117) 
• Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Chapter 11 – Food Allergen Program) 
• Compliance Policy Guide (CPG) Sec 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact
• Your facility’s third-party audit standard
• Your Food Safety Management System, including process flow diagrams

Step 2: Create an Allergen Gap Assessment Checklist 

• Develop a checklist to capture each requirement given in the regulations and your third-party audit standard (if applicable). Below is a simple example: 

Step 3: Conduct the Allergen Gap Assessment 

Unlike pathogens, allergens cannot be removed at a critical control point. It’s vital to examine your entire process.  

• Cover each step from ingredient receipt to finished product storage
• Focus on allergen movement potential throughout the process

• Examine procurement of ingredients and sub-ingredients
• Note allergens not in your ingredients but present at the supplier's facility
• Review R&D ingredients not used in production, if applicable

• Analyze how ingredients are handled, weighed, mixed, and stored

• Production and transient employees (quality control, maintenance, etc.) 
• Ingredient movement 
• Work-in-progress and finished products 
• Trash removal 
• Verify Preventive Control activities as per the Food Safety Plan

• Check for color-coded utensils usage
• Evaluate handwashing, uniform exchanges, and traffic patterns

• Inspect cleaning procedures, chemicals used, and their concentrations
• Conduct visual inspections and swabbing for verification
• Review equipment disassembly and maintenance protocols

• Analyze allergen swab sample sites, sampling frequency, and justifications
• Evaluate verification and validation data, including action limits and corrective actions

• Assess the facility's system for corrective and preventive actions 

Step 4: Document the Gaps 

Note all observations for each section on the Allergen Gap Assessment Checklist. Based on the appropriate standard, note any gaps. Some may be present at multiple stages, which can be combined in your corrective action plan.  

Step 5: Address the Gaps 

Next, conduct a root cause analysis and develop a Corrective and Preventive Action Plan, or CAPA. A common approach is the “5 Whys” approach, which requires asking "Why?" five times to uncover the root cause. Alternatively, the Fishbone (Ishikawa) diagram visually traces cause and effect, guiding through branched paths to pinpoint the problem's source. 

Here is an example:

Step 6: Ensure the CAPA Plan Includes the Following:

Processing Controls: 

• Implement process scheduling, traffic control, and air filtration
• Design facilities and tools to minimize allergen cross-contact

Education and Training: 

• Train staff in allergen identification and cross-contact prevention

Receiving and Storage Controls: 

• Check labels and ingredients on receipt 
• Use clear allergen labels and segregate allergen-containing materials

Production Scheduling: 

• Separate allergen and non-allergen product runs

Supplier Audits: 

• Conduct detailed audits of suppliers' allergen controls and ingredient specifications

Step 7: CAPA Verification Review 

Effectiveness checks in CAPA plans validate solutions and reduce recurrence risks by ensuring that identified problems are fully resolved. Key methods for effective checks include: 

• Trend Analysis: Analyze data over time to see if issues like human error or cleaning inefficiencies reoccur post-correction. 
• Periodic Checks: Schedule regular reviews by quality units on remediated processes, like observing updated footwear practices in allergen-sensitive areas. 
• Surprise Audits: Conduct unexpected audits to ensure adherence to documented corrective actions in CAPAs. 

• Sampling: Use sampling and testing, especially during allergen changeovers, to confirm cleaning efficiency and environmental control. 

It's crucial to implement multiple checks over time for thorough verification, as CAPAs often address complex issues requiring more than just simple updates or retraining. Plus, verification must be documented, like in this example: 

How Often Should Allergen Gap Assessments Be Conducted in Food Facilities? 

The frequency of conducting Allergen Gap Assessments in food facilities is not universally fixed but should be determined based on several factors, including… 

• Size of the operation 
• Complexity of the manufacturing processes 
• Diversity of products manufactured 

As a best practice, it’s advisable to conduct these assessments annually or whenever there are significant changes in the production process, raw materials, or regulatory requirements. 

For example, facilities that introduce new products or change suppliers might face different allergen risks, necessitating a fresh assessment. Similarly, regulatory updates require reassessments to ensure ongoing compliance. 

Get Help With Your Allergen Gap Assessment 

If you need help with your assessment, contact our regulatory consulting arm, EAS Consulting Group, for assistance; our industry experts are happy to help you develop your program.  

If you need allergen testing, Certified Laboratories and Food Safety Net Services (FSNS), both Certified Group companies, can provide what you need.