US FDA Food Code 2026 3-502.12: 3-502.12 Reduced oxygen packaging without a variance

An establishment reduced oxygen packaging TCS food without a variance controls Clostridium botulinum growth and toxin formation and Listeria monocytogenes growth (P) and implements a HACCP plan (Pf) that identifies the food, keeps it at 5°C (41°F) or less and ensures it meets at least one barrier (water activity 0.91 or less, pH 4.6 or less, USDA-cured meat or poultry received intact, or high levels of competing organisms such as raw meat or vegetables), specifies prominent labels to keep at 41°F and discard within 30 days, limits refrigerated shelf life to 30 days or the maker's date if sooner (P), sets operational procedures (no bare hand contact, a designated area with separation of raw and ready-to-eat food, limited access to trained staff, cleaning and sanitizing of contact surfaces), describes training, and is given to the regulator before starting. Fish may not be reduced oxygen packaged unless frozen before, during and after packaging and labeled keep frozen (P). Cook-chill and sous vide require a HACCP plan given to the regulator in advance, consumption within the same business entity, cooking to 3-401.11, protection, sealing before cooking or before falling below 57°C, cooling in the package to 5°C and then either to 1°C (34°F) within 48 hours with 30 day use, 7 days at 5°C, a combination not exceeding 30 days, or frozen holding (P), continuous electronic temperature monitoring checked twice daily, monitored transport, labeling with name and date, records kept 6 months, and written procedures and training (Pf). Cheese may be reduced oxygen packaged only if commercially made hard, pasteurized process or semisoft cheese with nothing added on site, under a HACCP plan, labeled use-by within 30 days and discarded after 30 days. No HACCP plan is needed if the packaged food is labeled with time and date, held at 5°C or less and opened within 48 hours.