Specialized Processes — Variance & HACCP Plan — Nationwide (FDA Food Code)

What it is. Certain specialized food processes require prior approval (a variance) plus a HACCP plan under the FDA Food Code §3-502.11 & §3-502.12. These include reduced-oxygen packaging (ROP) / sous-vide for preservation, curing, smoking food as a method of preservation, acidifying to render it non-TCS, sprouting seeds/beans, offering live molluscan shellfish from a display tank, and custom-processing animals. You submit a HACCP plan and obtain a variance from your local regulatory authority before starting the process.

Who approves it. Your state/local health department issues the variance and reviews the HACCP plan. The requirement is uniform nationwide (FDA Food Code); the approving office is local.

How to comply. Identify whether your process triggers §3-502.11; prepare a HACCP plan (hazard analysis, critical control points, limits, monitoring, corrective actions, records); apply for the variance before operating the process.

What SpoonSeal tracks. Your approved variance and HACCP plan, plus the process monitoring records, uploaded and kept current.

References

• FDA Food Code — Variance Requirement (§3-502.11) & HACCP Plan (§3-502.12, §8-201.13/.14) — https://www.fda.gov/food/retail-food-protection/fda-food-code — Official source last checked: 2026-07-03