FDU Guidance Document-Food Processing Plans, Allergen Control Plans and Recall Plans
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
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.
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.
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 for Processing Plans
There is no perfect analogue 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 Food Safety Plan Builder tool from FDA may be a useful starting point.
Additional Resources for Allergen-Control Plans
- 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
Additional Resources for Recall Plans
- California Department of Public Health - Sample Recall Plan
- North Carolina Food Safety Task Force - Model 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