Specialized processes are processes or procedures requiring specific food safety controls not otherwise addressed in the Minnesota Food Code. These techniques often require specialized equipment, ingredients, or technology. Because of an increased potential health risk, specialized processes in retail food establishments must be conducted under strict operational procedures. Specialized processes conducted in retail food establishments require a preapproved Hazard Analysis Critical Control Point (HACCP) plan. Each physical facility conducting specialized processes must submit a properly prepared and approved HACCP plan prior to beginning operations. Often, a variance is also required.
Specialized processes include:
- Reduced oxygen packaging (ROP) including:
- Vacuum packaging time/temperature control for safety (TCS) food (e.g., cured meats, raw meat, raw poultry, raw vegetables, some cheeses)
- Cook-chill process
- Sous vide process
- Modified atmosphere packaging (MAP)
- Controlled atmosphere packaging (CAP)
- Curing food (e.g., adding nitrates to foods such as ham, bacon, summer sausage, salami, beef jerky/sticks, charcuterie)
- Smoking food for preservation, rather than for flavor enhancement (e.g., fish, meat and poultry)
- Using food additives or adding components, such as vinegar to preserve or render it a non-Time/temperature Control for Safety (TCS) food (e.g., sushi rice, sauerkraut, kimchi, yogurt, sausage)
- Operating a molluscan shellfish tank to store and display shellfish that are offered for human consumption
- Sprouting seeds or beans
- Preparing food any other way not described in the Minnesota Food Code (e.g., using different cooking times and temperatures for raw animal foods, or drying fish, meat, and poultry)
Wild Game Custom Processing
Custom processing of wild game is no longer regulated by the MDA's Retail Food Program and is now under the purview of the Dairy and Meat Inspection Division. For more information, visit the Wild Game Processing webpage.
Producing juice is not identified as a specialized process in the Minnesota Food Code, but does require a HACCP plan in these circumstances:
- Producing unpackaged juice on premises for highly susceptible populations.
- Packaging juice in the food establishment, unless label requirements in Minnesota Rules, part 4626.0367 B are met.
What is HACCP?
Hazard analysis and critical control point (HACCP) is a preventive and systematic approach to food safety. It identifies food safety hazards (biological, chemical and physical agents) in the food production process that are reasonably likely to cause illness or injury in the absence of their control. A HACCP plan provides the actions needed to reduce those hazards to a safe level. “HACCP plan” means a written document that delineates the formal procedures for following the Hazard Analysis and Critical Control Point principles developed by The National Advisory Committee on Microbiological Criteria for Foods.
What are the seven steps in HACCP?
- Conduct food safety hazard analysis.
- Identify critical control points (CCPs).
- Establish critical limits for preventative measures.
- Establish monitoring procedures for control points.
- Establish corrective actions.
- Establish effective record keeping systems.
- Establish procedures for verification that HACCP is working.
Using these seven principles, the HACCP plan identifies and addresses critical control points, or commonly referred to as CCPs, where illness or injury is reasonably likely to occur in the absence of the hazard’s control. Annex 5 in the FDA Food Code 2013 contains HACCP guidelines. Annex 6 contains food processing criteria.
What is the process to submit a HACCP Plan for review?
A HACCP plan must be submitted to the MDA prior to conducting a specialized process. A HACCP plan can be submitted electronically to firstname.lastname@example.org (preferred) or via US mail sent to MDA-FFSD 625 Robert Street N, St. Paul, MN 55155.
The following HACCP plan items must be submitted to the MDA or the plan will be returned with a letter indicating which items are missing:
- Firm name and address information
- HACCP point of contact (phone and email, if available)
- Equipment list
- Recipes (including name of cure and percent nitrite)
- List of specialized processes (ROP, curing, smoking, acidification, molluscan tank and molluscan tag removal)
- Food products that will be made using the specialized processes listed above Flow diagram identifying Critical Control Points (CCPs) for each process
- Standard operating procedure for each process
- HACCP plan components (each specialized process shall have these components)
- Hazard Analysis (identify the significant hazard such as biological, chemical or physical)
- List CCPs for the process
- Listing critical limits (ex. Cooking temperatures, cure amounts, and cooling temperatures)
- Monitoring for the critical limit
Once all the above listed items are submitted, a letter will be mailed and/or emailed to the applicant indicating that the submission has been received. HACCP plans are reviewed in the order in which they were received. An MDA HACCP specialist will be in contact with the applicant during the formal review process.
When the review is final and the HACCP plan is approved in accordance with MN Rule 4626.1735, a letter and/or email will be sent to the applicant notifying them of the approval. HACCP plans that have been completed and reviewed by MDA staff must be kept on-site and available for the area inspector to review during inspections.
The MDA provides editable templates to assist in the creation of many types of HACCP plans including curing, wild game processing, and reduced oxygen packaging. Templates must be specific for the facility conducting the specialized process. Contact the area inspector to obtain specialized process templates applicable to your operation.
A parent corporation may submit a single HACCP plan on behalf of several stores, provided all stores conduct the same processes and have the same procedures. Additionally, all stores must be under the jurisdiction of the MDA and with locations clearly identified. Stores falling under the jurisdiction of delegated agencies must have HACCP plans submitted to those agencies for review.
The Minnesota Food Code allows for a variance request to be submitted by a food establishment in situations when a firm seeks a deviation from certain regulatory requirements. Exceptions to specific parts of the Minnesota Food Code are granted on a case-by-case basis. Equipment, facility construction requirements, and food processes or practices that require a variance may represent a heightened risk for foodborne illness if not conducted under strict operational procedures.
Variances may require the person in charge and food employees to use specialized equipment and demonstrate specific competencies. The MDA provides variance templates to assist with common types of specialized processes including curing, wild game processing, reduced oxygen packaging, and acidified rice. Templates must be specific for the facility conducting the specialized process. Contact the area inspector to obtain specialized process variance application templates applicable to your operation.
What is the process to submit a variance application?
Variances applications relating to products in the HACCP plan must be completed, sent to email@example.com, and approved prior to conducting operations which vary from the Minnesota Food Code.
Once the variance application is submitted, MDA staff will notify the applicant if the variance has been approved or denied. If the variance is approved, a letter will be sent stating the approval and any conditions of the variance. The variance letter must be available for review during inspections.
Variances must be renewed annually and supporting documentation must be submitted with the variance renewal showing that the hazards are being controlled per specifications of the requirements listed in the variance letter.
If you are applying for a variance that is not related to your HACCP plan please click on the Plan Review page.