From 2005-2015 there has been a sustained increase of recalls of FSIS regulated products for undeclared allergens. Over the last 10 years undeclared allergens has been the Number 1 reason for FSIS recalls. In the U.S. the Big Eight Allergens are; wheat, eggs, fish, peanuts, milk, crustacean shellfish (e.g. shrimp, crab, lobster), tree nuts (e.g. almonds, pecans, walnuts) and soybeans. Reaction to allergens can vary from mild to sudden and severe. Approximately 12 million pounds of meat products were recalled from 2005-2014 due to undeclared allergens.

In the November 2015 FSIS Compliance Guidelines on allergens three key areas that plants should focus on relative to allergens are identified.

  • Identify:  Inspection of incoming ingredients, cross-referencing components, separation
  • Prevent and Control: Equipment, sanitation and processing
  • Declare: Packaging, labeling, storage

Every plant should have an allergen policy, SOPs describing how you are going to handle allergens during processing and SSOPs describing how you are going to clean equipment after processing products containing allergens. Allergens should be addressed in the Hazard Analysis of any HACCP Plan that includes allergens in the Product Ingredients section of the HACCP Plan. Allergens should be addressed at the following steps often found in a HACCP Plan’s process flow diagram; receiving, storage, adding ingredients during manufacture, labeling and rework. A meticulous, comprehensive hazard analysis is the foundation of a strong successful HACCP Plan and HACCP System. Let’s consider allergen control in the three key areas FSIS identified.


  • Review a list of all ingredients and products used to determine if they contain allergens
  • Keep a list of ingredients and label records at receiving to compare against incoming ingredients
  • Ensure all incoming allergens or ingredients containing allergenic materials are clearly labeled and identified (use color coding)
  • Color coding of uniforms and utensils
  • Have letters of guarantee from suppliers

Prevent and Control

  • Do an establishment walk-through noting paths of allergenic ingredients
  • Have allergen cleaning procedures in place for equipment, utensils and food contact surfaces in SOPs and SSOPs
  • Have GMPs or SOPs addressing possible allergen contamination caused by employees
  • When possible process non-allergenic products before allergenic products
  • Have SSOPs for switching from allergenic to non-allergenic products
  • Have documented cleaning procedures with checklists and spill clean-up procedures
  • Have methods for verification of cleaning
  • Consider cooking mediums — non-allergenic and allergenic products should not be processed together in the same smokehouse
  • Careful evaluation of using rework containing allergens


  • Store allergenic materials in separate, designated, clearly identified areas
  • It is an establishments responsibility to ensure product is properly packaged, labeled and stored
  • Procedures in place for verification of labels
  • Conduct simulations with inaccurate labels to test systems, checklists and procedures

Remember: Be proactive in controlling allergens. You do not want to deal with an allergen recall.