Specialized Processes in Retail Food Establishments

What Are Specialized Processes?

Specialized processes include any procedures that modify standard food preparation in a way that increases risk. They require prior approval from the Rhode Island Department of Health (RIDOH), Center for Food Protection (CFP). These processes include:

• Reduced Oxygen Packaging (ROP):
  • Vacuum packaging of time/temperature control for safety (TCS) foods;
  • Cook-chill processes;
  • Sous vide cooking;
  • Modified Atmosphere Packaging (MAP); and
  • Controlled Atmosphere Packaging (CAP);
• Curing foods (e.g., salami, jerky, charcuterie);
• Smoking foods for preservation, not just flavor (e.g., smoked fish or meats);
• Sprouting seeds or beans;
• Using food additives or components to preserve food (e.g., vinegar in sushi rice, fermentation in kimchi or sauerkraut);
• Operating a molluscan shellfish display tank; and
• Other processes not specifically authorized by the Rhode Island Food Code, such as:
  • Using alternative cooking times/temperatures; or
  • Drying meat, fish, or poultry.

When a Variance and/or HACCP Plan Is Required

The table below outlines when a variance and HACCP Plan are required for a specialized process with the regulatory reference from the Rhode Island Food Code. 

Note: A variance is not required for certain ROP processes that are fully compliant with RI Food Code §3-502.12.

Approval Requirements and Application

To conduct any of the specialized processes listed above, retail food establishments must obtain pre-approval from RIDOH, CFP. A completed Specialized Process Application that includes the following is needed:

• A statement of the proposal with Rhode Island Food Code section numbers;
• If process is not approved in the Rhode Island Food Code, provide scientific evidence to support the safety of the process and rationale for how food safety will be maintained by alternative means (e.g., lab results or process authority review);
• HACCP plan; and
• An operational plan that includes the following:
  • Detailed description of the preparation process that Identifies critical control points and critical limits and how they will be monitored;
  • Equipment needed for process;
  • Detailed description of how person in charge will oversee process;
  • Detailed description of the training plan for staff involved in process;
  • Provide sample log sheets that will be used;
  • Detailed description of the corrective action you will use when failures occur;
  • Document whether product is for retail sales or if you are serving it directly to the consumer;
  • Provide samples of labels for packaged products, if applicable;
  • Provide statement for how long logs will be maintained. This will depend on the shelf-life of the product. Logs must be maintained for a minimum of 180 days; and
  • If operating in shared kitchen, provide details on how food process will be protected.

RIDOH will only grant a variance if the establishment demonstrates that food safety is maintained through alternative methods. Both the HACCP plan and variance request must be reviewed and approved before beginning the process.

Requests are reviewed by RIDOH and may involve consultation with subject matter experts, including FDA specialists, especially for complex or multi-state operations. For complex processes, a process authority may be required for approval. The Association of Food and Drug Officials (AFDO) has a Food Processing Authorities Directory that can be used to identify a process authority. 

Complete the following Specialized Process Application[BV3] to obtain approval from RIDOH. Approval or denial will occur within 1 month, and operators will be notified in writing.

HACCP Plan: What It Is and Why It's Required

A HACCP plan is a written strategy based on the 7 principles of Hazard Analysis and Critical Control Points. It is required when conducting most specialized processes and helps ensure food safety by identifying and controlling potential hazards.

Seven Principles of HACCP:

1. Conduct a hazard analysis
2. Identify critical control points (CCPs)
3. Establish critical limits
4. Monitor CCPs
5. Establish corrective actions
6. Recordkeeping and documentation
7. Verification of the system

RIDOH uses the HACCP plan to verify that a food establishment has appropriate controls in place to ensure safe production and handling.

Post-Approval Compliance

Once a variance is approved:

• The decision is recorded in the establishment’s file and shared with the inspection team.
• The approved HACCP plan and variance must be followed precisely.
• A HACCP/Variance verification inspection may be conducted to assess compliance by:
  • Reviewing records;
  • Observing processes; and
  • Interviewing staff.

Failure to follow the approved variance or HACCP plan may result in revocation of the variance.