Food Processing, Allergen-Control and Recall Plans

FDU Guidance Document-Food Processing Plans, Allergen Control Plans and Recall Plans

Recent changes to regulations require that any wholesale food manufacturer create and maintain both a food-processing plan and a food recall plan. Food processing plans contain many elements of HACCP plans (and indeed, if a firm has a HACCP program, a separate food processing plan is not required) but are designed to document that a firm has a written document of its processes and has considered and addressed potential hazards. A recall plan is necessary in the event that an adverse event (undercooked product resulting in illness, samples reveal pathogens, undeclared major food allergens are present) makes it necessary to remove one or more lots of a firm's product(s) from the marketplace. Details and guidelines for plans can be found at the above link.

• New Regulations on Processing and Recall Plans in Part VI, Title 51, L.A.C. (updated 2011)
• New Regulations on Allergen-Control Plans in Part VI, Title 51, L.A.C. (updated 2020); 21 CFR 117 Subpart B 

For General Manufacturing Firms

Processing Plans

• Plans must be written, implemented, and maintained up-to-date with any changes made to the firm's operational procedures.
• Plans must be available for review by your inspector upon request.
• Plans must include the following elements:
  • list of steps in process, including potential biological, physical, chemical, or radiological hazards that may be introduced at each step;
  • description of controls used to address the hazards listed above;
  • description of methods used to monitor the controls noted above;
  • records of corrective actions taken as a result of monitoring above;
  • and records of changes to plan as a result of corrective actions documented above.

NOTE: If a HACCP plan is currently in use, a separate food processing plan is not required.

Additional Resources

There is no perfect analog to a processing plan, but it is similar to a HACCP plan or a food safety plan focussed on process-related hazards and controls. In this context, the FDA's Food Safety Plan Builder tool may be a useful starting point. 

Allergen-Control Plans

• Plans must be written and available for review by your inspector upon request.
• Plans must address the presence of the eight major food allergens in ingredients and finished foods.
• Plans must address workflows and circulation of products throughout the facility.
• Plans must address materials stored in morgue areas, pending QC approval, in-process products, and products in storage awaiting distribution.

Additional Resources

• University of Nebraska--Lincoln Allergen Control in the Food Industry
• Food Safety Magazine - December-January 2003-2004 - Writing and Implementing an Allergen Control Plan
• USDA FSIS Allergen Control Management presentation
• Maryland Department of Health - Developing An Allergen Control Plan

Recall Plans

• Plans must be written and available for review by your inspector upon request.
• Plans must have a provision to notify your inspector and/or the Central Office staff of the Food and Drug Unit in the event of a product recall. If goods are shipped interstate, additional provisions must be made to notify the local or regional federal Food and Drug Administration office.
• Plans must include the following elements: 
  • identity of products including brand name and lot/batch code;
  • reason for recall;
  • date and means of discovery of the reason;
  • total affected product produced and amount estimated to be in distribution;
  • list of consignees that may have received affected product;
  • contact information for the firm's recall coordinator;
  • and, proposed strategy for conducting the recall, including media notifications, method of evaluating whether the recall needs to occur at the level of wholesale distribution, retail distribution, or the consumer; method of checking the effectiveness of the recall, including follow-up store visits or telephone/email contacts; method of determining whether changes to the plan are warranted by the results of the effectiveness checks.

Additional Resources

• California Department of Public Health - Sample Recall Plan 
• USDA Recall Plan Guidance for Meat and Poultry Firms
• University of Florida - Food Recall Manual
• Michigan Department of Agriculture - Guidance for Industry on Food Product Recalls
• FDA General Guidance for Industry on Recalls of Regulated Products

For more info, contact the Food & Drug Program at 225-342-7533.