Food Code Variances and Reduced Oxygen Packaging: A Restaurant Guide
Chefs are curing salmon, smoking meats, fermenting hot sauce, acidifying sushi rice and vacuum-packing ready-to-eat foods. All of these processes can be done safely, but the FDA Food Code treats them as specialized processes. Most need a variance, a HACCP plan, or both, before the health department will allow them.
This guide explains which processes need a variance, how a variance differs from a HACCP plan, and how to apply.
Variance or HACCP plan: the difference
A variance is a written document from the regulatory authority that authorizes a modification or waiver of one or more Food Code requirements. A variance is granted under section 8-103.10 when the regulatory authority determines that no health hazard or nuisance will result.
A HACCP plan is the written plan that shows how you will control the hazards of the process. Section 8-201.14 lists what it must contain.
In practice:
Processes listed in 3-502.11 need a variance, and the variance application must include a HACCP plan.
ROP done under the conditions of 3-502.12 needs a HACCP plan, but not a variance.
ROP done outside those conditions needs a variance.
Section 3-502.11: Processes that need a variance
A food establishment must obtain a variance from the regulatory authority before it does any of the following:
Smoking food as a method of preservation, rather than as a method of flavor enhancement.
Curing food.
Using food additives or adding components such as vinegar as a method of preservation, or to render a food so that it is not TCS food. Acidified sushi rice is the most common example.
Packaging TCS food using a reduced oxygen packaging method, except where the growth and toxin formation of C. botulinum and the growth of L. monocytogenes are controlled under 3-502.12.
Operating a molluscan shellfish life-support system display tank used to store or display shellfish offered for human consumption.
Custom processing animals for personal use as food and not for sale or service in a food establishment.
Preparing food by another method that the regulatory authority determines requires a variance.
Sprouting seeds or beans.
Fermentation used to preserve food, such as fermented vegetables, kimchi or fermented hot sauce, is usually handled under items 3 or 7. Many health departments treat it as a variance process.
Common restaurant variance processes
Acidified sushi rice
Cooked rice is a TCS food. Sushi restaurants keep seasoned rice at room temperature for service. To do so legally, they must either:
use time as a public health control under 3-501.19, with a written procedure, marking, and discard within 4 hours (no variance needed), or
acidify the rice with vinegar so that it is not a TCS food, which requires a variance and a HACCP plan.
For acidification, the critical limit is the rice pH. The regulatory boundary is pH 4.6. Many health departments expect a target of about 4.1 to 4.2, to leave margin. Your plan sets out:
a standardized recipe, with the vinegar-to-rice ratio
pH testing of each batch, using a calibrated pH meter
the corrective action when the pH is too high (re-acidify and retest, or discard)
the records
Curing and smoking for preservation
House-cured gravlax, bacon, pancetta and cold-smoked fish all require a variance. Hazards include C. botulinum, Listeria monocytogenes and parasites in fish. Typical controls are:
a parasite destruction freezing step for fish eaten raw or cold-smoked, such as freezing at −4°F (−20°C) or below for 7 days, or the alternative times in Food Code 3-402.11
salt and cure concentrations based on a validated recipe, with weighed ingredients
time and temperature during curing, drying or smoking
refrigerated storage and a defined shelf life
Products cured with nitrite need the cure measured accurately. A process authority's review or published processing data supports the critical limits.
Fermentation
Fermented foods are preserved by lactic acid bacteria, which lower the pH. Typical controls are:
a salt concentration in the brine
a fermentation temperature range
a final pH at or below 4.6, usually lower, measured with a calibrated pH meter
refrigeration after fermentation
Reduced oxygen packaging outside 3-502.12
Section 3-502.12 allows ROP with a HACCP plan in several situations. These include:
foods with a barrier to C. botulinum, such as a water activity of 0.91 or less, a pH of 4.6 or less, or meat cured in a USDA-inspected establishment
cook-chill and sous vide foods held at 34°F for up to 30 days, or 41°F for up to 7 days
certain hard and semisoft cheeses
ROP outside those conditions needs a variance. Two examples are packaging raw fish that is not frozen, which the Food Code does not permit, and holding sous vide food longer than the limits.
How to apply for a variance
Section 8-103.11 lists what the applicant must provide when requesting a variance. The application must include:
A statement of the proposed variance of the Food Code requirement, citing the relevant Code section numbers.
An analysis of the rationale for how the potential public health hazards and nuisances addressed by the relevant Code sections will be alternatively addressed by the proposal.
A HACCP plan, if required under 8-201.13, that includes the information in 8-201.14 as it relates to the proposed variance.
Most health departments have their own application form, a fee, and a review timeline that can run from several weeks to a few months. Some send complex applications to the state for review. Prepare for that review by including:
a complete HACCP plan, covering the menu categorization, flow diagrams, CCPs, critical limits, monitoring, corrective actions, verification and records
recipes, with exact quantities by weight
scientific support: published studies, extension service guidance, or a process authority's letter for your critical limits
equipment specifications: for example, the vacuum packager, pH meter, smoker, data loggers and refrigeration
sample logs you will use
a training plan for staff
After approval
When the variance is granted, you must:
follow the HACCP plan exactly as approved
keep records of monitoring, corrective actions and verification, and make them available to the regulatory authority
apply for an amendment before you change a recipe, process or equipment
The regulatory authority can revoke a variance if the plan is not followed. Records are the evidence, and the Food Code requires them to be kept for at least 6 months after the last date the product was sold or served.
A step-by-step approach
List your specialized processes. Go through the menu and mark each item that is cured, smoked for preservation, acidified, fermented, vacuum-packed or held in ROP.
Decide what each process needs: a variance and a HACCP plan, a HACCP plan only (ROP under 3-502.12), or neither (for example, sushi rice under time as a public health control, or ROP under the 48-hour rule).
Write a HACCP plan for each process, or one plan with a section for each.
Contact your health department for its application form and submission requirements.
Submit, respond to questions, and train your staff before you start the process.
Keep records from the first batch.
Get the plans and the variance package
Our Restaurant HACCP Plan for Specialized Processes includes:
SOP 7-101-RST When a HACCP Plan or Variance Is Required
SOP 7-103-RST Variance Application and Health Department Approval
worked HACCP plans for sous vide and cook-chill, vacuum-packed ready-to-eat foods, acidified sushi rice, gravlax and cold-smoked fish, and fermented vegetables and hot sauce
pH, curing and drying, freezing, and ROP logs
a variance and HACCP plan submission checklist
In total, the package contains 32 editable documents.
This guide is based on the FDA model Food Code. Your state or local code may differ, so check your health department's requirements before you apply.
Related guides: Do Restaurants Need a HACCP Plan for Sous Vide?; HACCP Programs for seafood, meat and poultry, juice and restaurants.
Official sources: FDA Food Code.
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