FDA Releases Guidance on Allergen Management as Part of Hazards Guide

The FDA Hazards Guide is a document intended to help with the compliance of meeting specific Preventive Controls for Human Food regulations. It has been an ongoing effort, with FDA releasing sections as they are completed. This week, FDA released two new sections, one of those focused on allergen control. Chapter 12, Food Allergen Program, sets out to "is to explain how to establish and implement a food allergen program".

The Guidance can be found here - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food

From this Draft Guidance [https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-hazard-analysis-and-risk-based-preventive-controls-human-food]:

A food allergen program could include, as appropriate to the facility and its food products:

• CGMP measures that you take to comply with the requirements of part 117, subpart B, to prevent allergen cross-contact due to personnel, design and construction of the plant, sanitary operations, equipment and utensils, raw materials and other ingredients, manufacturing operations, and warehousing and distribution. Your hazard analysis should consider how your CGMP measures prevent allergen cross-contact, and the preventive controls that you establish and implement to address a food allergen hazard should complement and enhance your CGMP measures for preventing allergen cross-contact.
• Food allergen controls to provide assurances that any food allergen hazards requiring a preventive control will be significantly minimized or prevented. (See 21 CFR 117.135(a) and (c)(2).) Food allergen controls include procedures, processes, and practices that are: 
• Allergen cross-contact controls – i.e., procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact, including during storage, handling, and use (21 CFR 117.135(c)(2)(i)); and 
• Label controls – i.e., procedures, practices, and processes employed for labeling the finished food, including ensuring that the finished food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)). (21 CFR 117.135(c)(2)(ii).)
• A supply-chain program as required by part 117, subpart G for those raw materials and other ingredients for which a manufacturing/processing facility has identified a food allergen hazard that is controlled before its receipt. (See 21 CFR 117.405(a)(1).) See Chapter 15 for comprehensive guidance on how to comply with the requirements of part 117, subpart G for all hazards, not just food allergen hazards.

Breaking this down
A facility will have GMP measures that will mitigate, or apply basic control. One would take these into account as they conduct the hazard analysis. These measures will taken into account as one conducts their hazard analysis.

The Food Allergen Program
There are four primary areas to address.

1. Cross Contact Controls (11.6)
• Allergen Cleaning Procedures (11.6.1)
• Allergen Ingredient Procedures (11.6.2)
2. Label Controls for Label Content (11.7) -   Label development, ordering, production
3. Label Controls for Label Management (11.7) -  Storage, production staging, post-production
4. Supply Chain Program (11.8)

The program will include all of the procedures that are used to control.  

Label Controls is one of the important areas covered in the Guidance. 

From the document:

• "You are required to have written procedures for your label controls and for monitoring your label controls. (21 CFR 117.135(b) and 117.145(a).) We recommend that you organize any written procedures for controls on the content of the product label in a manner that will help communicate the overall framework and goals of these controls. For example, you could organize your procedures that address development of labels, ordering labels, production of labels, and receipt of labels, and associated preventive control management components (such as monitoring procedures), in a single document, or collect them in one file or folder. In this document, we refer to such procedures as the “Label Content Procedures.”
• "Likewise, we recommend that you organize any written procedures for controls for the management of product labels/packages, and for associated preventive control management components (such as monitoring procedures), in a single document, file or folder, because doing so will help communicate the overall framework and goals of these controls. In this document, we refer to such procedures as the "Label Management Procedures"."

The document discusses monitoring, verification, and corrective action/correction, and records for those appropriate aspects deemed to be preventive control.

Supply Chain Controls is another area with extensive coverage in the Guidance.  Key here is understanding the level of allergen control by the supplier.  There is also information on the use of precautionary labeling by the supplier.

Specific allergen training is recommended as part of required employee training in operations that have allergens.