When vacuum packing needs a HACCP plan
Seal time/temperature control for safety food in a vacuum bag and you are doing what the Food Code calls reduced oxygen packaging, or ROP. Steak portions, marinating chicken, sliced ham, cheese for the board: all ROP. Most restaurant vacuum packing falls under 3-502.12(B):
FDA Food Code 2022, 3-502.12(B)Except as specified under ¶(F) of this section, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method shall implement a HACCP PLAN that contains the information specified under ¶¶ 8-201.14 (C) and (D) and that:
And it goes to your regulatory authority before you start, not after the inspector asks ((B)(7) and 8-201.13(B)):
FDA Food Code 2022, 8-201.13(B)Before engaging in REDUCED OXYGEN PACKAGING without a VARIANCE as specified under § 3-502.12, a PERMIT applicant or PERMIT HOLDER shall submit a properly prepared HACCP PLAN to the REGULATORY AUTHORITY.
If every bag is labeled with the time and date it was sealed, held at 41°F or less, and opened in your kitchen within 48 hours, 3-502.12(F) says no HACCP plan is required. Bagging tomorrow's portions or marinating overnight usually fits. Details below, or check your process in a minute.
The rules below are the FDA Food Code 2022. Your state may run an older edition or have its own ROP form; check your state.
What counts as reduced oxygen packaging
The definition is broad on purpose:
FDA Food Code 2022, 1-201.10(B), Reduced oxygen packaging (1)"Reduced oxygen packaging" means: (a) The reduction of the amount of oxygen in a PACKAGE by removing oxygen; displacing oxygen and replacing it with another gas or combination of gases; or otherwise controlling the oxygen content to a level below that normally found in the atmosphere (approximately 21% at sea level); and (b) A process as specified in Subparagraph (1)(a) of this definition that involves a FOOD for which the HAZARDS Clostridium botulinum or Listeria monocytogenes require control in the final PACKAGED form.
The definition then names vacuum packaging, modified atmosphere (MAP), controlled atmosphere (CAP), cook-chill and sous vide. This page covers food packed cold: paragraphs (B), (C), (E) and (F). Cooking in the bag or bagging hot is (D), covered in the sous vide and cook-chill guide.
Why the Food Code cares: botulism and Listeria
Paragraph (A) states the goal every ROP rule serves:
FDA Food Code 2022, 3-502.12(A)Except for a FOOD ESTABLISHMENT that obtains a VARIANCE as specified under § 3-502.11, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method shall control the growth and toxin formation of Clostridium botulinum and the growth of Listeria monocytogenes.
Pulling the air out stops the spoilage bacteria that make meat slimy and smell off. That is the problem: the warning signs go away while two dangerous organisms keep going. Clostridium botulinum grows without oxygen and makes a toxin that can paralyze and kill. Listeria monocytogenes grows slowly even in a fridge. Annex 3 says a fridge alone is not enough for either:
FDA Food Code 2022, Annex 3, public health reasons for 3-502.12Refrigerated storage temperatures of 5°C (41°F) may be adequate to prevent growth and/or toxin production of some pathogenic microorganisms but non-proteolytic C. botulinum and L. monocytogenes are able to multiply well below 5°C (41°F). For this reason, C. botulinum and L. monocytogenes are the pathogens of concern for ROP.
Annex 6 is blunter:
FDA Food Code 2022, Annex 6, section 2(D)Therefore, the food could be toxic yet appear organoleptically acceptable.
"Organoleptically acceptable" means it looks, smells and tastes fine. So ROP rules rely on things you can prove (a second barrier, a cold fridge, a hard shelf life), not on anyone's nose. One relief: Annex 3 says the ROP HACCP requirements apply only to time/temperature control for safety (TCS) food.
Which rule covers your bag
Work down the list for each food. The first answer that fits is the paragraph your plan, or your no-plan procedure, is built on.
- Does the food need time/temperature control for safety?No: no ROP HACCP plan needed (Annex 3). Yes: keep going.
- Is it opened in your kitchen within 48 hours, every time?Yes: label with time and date, hold at 41°F or less. No plan. 3-502.12(F)
- Is it fish?Frozen before, during and after packing, labeled keep frozen. Anything else needs a variance. 3-502.12(C)
- Is it cheese?Hard, semisoft or pasteurized process, commercially made, nothing added. 3-502.12(E)
- Is it cooked in the bag, or bagged hot after cooking?Sous vide or cook-chill rules. See that guide. 3-502.12(D)
- Does it have one of the four secondary barriers?HACCP plan, 41°F or less, 30-day shelf life, bold label. 3-502.12(B)
- None of the above?A variance from your regulatory authority before you pack it. 3-502.11(D)
The four secondary barriers in 3-502.12(B)(2)
Under (B), the cold fridge is the first barrier and the food brings a second. Your plan names the one each food relies on.
FDA Food Code 2022, 3-502.12(B)(2)PACKAGED FOOD shall be maintained at 5°C (41°F) or less and meet at least one of the following criteria
Why they work, from Annex 3 (Listeria needs a water activity of at least 0.92 to grow, so the 0.91 line stops both):
FDA Food Code 2022, Annex 3, public health reasons for 3-502.12C. botulinum will not produce toxin below an aw of 0.91, and the minimum aw for growth of L. monocytogenes is 0.92.
FDA Food Code 2022, Annex 3, public health reasons for 3-502.12Most foodborne pathogens do not compete well with other microorganisms. Therefore foods that have a high level of spoilage organisms or lactic acid bacteria that grow under ROP conditions can safely be packaged using ROP and held for up to 30 days at 5°C (41°F).
The 30-day shelf life and the label
(B)(4) caps the shelf life; (B)(3) says what goes on the bag.
FDA Food Code 2022, 3-502.12(B)(4)Limits the refrigerated shelf life to no more than 30 calendar days from PACKAGING to consumption, except the time the product is maintained frozen, or the original manufacturer’s “sell by” or “use by” date, whichever occurs first
The clock starts the day you seal the bag, not the day the meat arrived, and stops at 30 days or the supplier's date, whichever comes first. Freezer time does not count.
FDA Food Code 2022, 3-502.12(B)(3)Describes how the PACKAGE shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to:
FDA Food Code 2022, 3-502.12(B)(3)(a)Maintain the FOOD at 5oC (41oF) or below
FDA Food Code 2022, 3-502.12(B)(3)(b)Discard the FOOD if within 30 calendar days of its PACKAGING if it is not served for on-PREMISES consumption, or consumed if served or sold for off-PREMISES consumption
In plain words: served in your restaurant, staff discard it by day 30; sold to take away, the customer eats it by then.
Raw beef strip steaks
Keep at 41°F or below
Discard by Nov 11
- Packaged
- Oct 12, 2:40 pm
- By
- JK
- Barrier
- Raw meat, (B)(2)(d)
"Principal display panel" means the front of the bag. "Bold type on a contrasting background" rules out ballpoint on clear plastic; printed labels or a thick marker on a white label work.
What the plan must contain: (B)(1) to (B)(7)
Reviewers check (B) line by line, so build the plan in the same order.
| Rule | What it asks for | What to write |
|---|---|---|
| 8-201.14(C), (D) | A flow diagram and the ingredients, recipes, materials and equipment | Flow per food, CCPs marked; bag and sealer. |
| (B)(1) | Identifies the food | "Raw beef steaks", "USDA-cured ham", "raw carrots". |
| (B)(2) | 41°F or less plus one barrier | The barrier for each food, from (a) to (d). |
| (B)(3) | The label | Wording, placement, who writes it, a sample. |
| (B)(4) | Shelf life | 30 days or supplier date, and how you track it. |
| (B)(5)(a) | No bare-hand contact with ready-to-eat food | Gloves or utensils for ready-to-eat items (3-301.11(B)). |
| (B)(5)(b) | A designated work area, separation of raw and ready-to-eat, limited access to the sealer | Where you pack, how raw and ready-to-eat stay apart, who may run the sealer. |
| (B)(5)(c) | Cleaning and sanitizing of food-contact surfaces | Sealer chamber, bar, lid, table: how, how often. |
| (B)(6) | A training program | Who, on what, and how you record it. |
| (B)(7) | Given to the regulatory authority before you start | Submission date and who you sent it to. |
Then the 8-201.14(E) summary for each CCP, shown in the example below.
Fish: frozen before, during and after, or not at all
Fish carries its own strain of botulinum, and the rule is absolute.
FDA Food Code 2022, 3-502.12(C)Except for FISH that is frozen before, during, and after PACKAGING and bears a label indicating that it is to be kept frozen until time of use, a FOOD ESTABLISHMENT may not PACKAGE FISH using a REDUCED OXYGEN PACKAGING method.
FDA Food Code 2022, Annex 3, public health reasons for 3-502.12Unfrozen raw fish and other seafood are specifically excluded from ROP at retail because of these products’ natural association with non-proteolytic C. botulinum (primarily type E) which grows at 3oC (37-38oF). ROP of fish and seafood that are frozen before, during and after the ROP packaging process does not present this hazard.
Pack it frozen, keep it frozen, label it. Annex 6 gives label wording:
FDA Food Code 2022, Annex 6, section 2(G)(4)Foods, especially fish, that are frozen before or immediately after packaging and remain frozen until use should bear a label statement, “Important, keep frozen until used, thaw under refrigeration immediately before use.”
And it comes out of the bag before it thaws in the fridge (or by the end of thawing under running water):
FDA Food Code 2022, 3-501.13(E)REDUCED OXYGEN PACKAGED FISH that bears a label indicating that it is to be kept frozen until time of use shall be removed from the reduced oxygen environment: (1) Prior to its thawing under refrigeration as specified in ¶(A) of this section; or
Raw fish and parasites are a separate rule
Freezing for ROP is about botulinum. Fish served raw or undercooked (sushi, crudo, ceviche) must also be frozen for parasites under 3-402.11, to one of these:
| Option | Freeze and store | Section |
|---|---|---|
| 1 | -4°F or below for at least 168 hours (7 days) in a freezer | 3-402.11(A)(1) |
| 2 | -31°F or below until solid, then stored at -31°F or below for at least 15 hours | 3-402.11(A)(2) |
| 3 | -31°F or below until solid, then stored at -4°F or below for at least 24 hours | 3-402.11(A)(3) |
Bought frozen? A written supplier statement can stand in for your freezing records (3-402.12(B)). Freezing it yourself, the person in charge records the temperature and time (3-402.12(A)). See the frozen fish ROP sample plan.
Cheese: hard, semisoft or process, with nothing added
Some cheeses carry their own barriers (low pH, salt, low moisture, live cultures). Paragraph (E) lets you pack those, under tight conditions.
FDA Food Code 2022, 3-502.12(E)(1)Limit the cheeses PACKAGED to those that are commercially manufactured in a FOOD PROCESSING PLANT with no ingredients added in the FOOD ESTABLISHMENT and that meet the Standards of Identity as specified in 21 CFR 133.150 Hard cheeses, 21 CFR 133.169 Pasteurized process cheese or 21 CFR 133.187 Semisoft cheeses
- Which cheeses. Commercially made hard, semisoft or pasteurized process cheese that meets its federal standard of identity in 21 CFR 133.
- Nothing added. No herbs, no oil, no pepper crust, no truffle, no marinade. Not in your kitchen.
- Plan. 8-201.14(C) and (D), plus (B)(1), (B)(3)(a), (B)(5) and (B)(6).
- Label. A "use by" date no more than 30 days from packaging, or the maker's date if sooner.
- Discard. Anything not sold for take-away or eaten within 30 calendar days of packaging.
Annex 3 lists cheeses that fit:
FDA Food Code 2022, Annex 3, public health reasons for 3-502.12Examples of cheeses that may be packaged under ROP include Asiago medium, Asiago old, Cheddar, Colby, Emmentaler, Gruyere, Parmesan, Reggiano, Romano, Sapsago, Swiss, pasteurized process cheese, Asiago fresh and soft, Blue, Brick, Edam, Gorgonzola, Gouda, Limburger, Monterey, Monterey Jack, Muenster, Provolone, and Roquefort.
Annex 6 says what does not:
FDA Food Code 2022, Annex 6, section 2(H)(2)Soft cheeses such as ricotta, cottage cheese, cheese spreads, and combinations of cheese with other ingredients such as vegetables, meat, or fish at retail must be approved for ROP through an approved variance application and HACCP plan and be inspected by the regulatory authority.
That is the trap: herb-crusted chevre or marinated feta made in your kitchen needs a variance.
The 48-hour rule: ROP with no plan at all
The most useful line on this page: always open the bag within 48 hours, and you need no HACCP plan.
FDA Food Code 2022, 3-502.12(F)A HACCP Plan is not required when a food establishment uses a reduced oxygen packaging method to package time/temperature control for safety food that is always:
- Hour 0Seal. Label with the production time and date.3-502.12(F)(1)
- In storageHeld at 41°F or less.3-502.12(F)(2)
- By hour 48Out of the bag, in your kitchen.3-502.12(F)(3)
Annex 3 explains why:
FDA Food Code 2022, Annex 3, public health reasons for 3-502.123-502.12 (F) exempts refrigerated, ROP foods that are always removed from the package within 48 hours of packaging from the requirements in section 3-502.12 because growth and toxin formation by anaerobic pathogens in that limited time frame is not considered a significant hazard in such foods.
"Always" means every bag, every time; one forgotten bag puts you outside (F). The label needs the time, not just the date. And the bag is opened in your kitchen, so no sealed bags go to customers. Write it as a short procedure and train the line; the free checker writes it for you if (F) fits.
When you need a variance instead
TCS food that stays bagged past 48 hours and fits none of (B), (C), (D) or (E) needs a variance first:
FDA Food Code 2022, 3-502.11(D)Packaging TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method except where the growth of and toxin formation by Clostridium botulinum and the growth of Listeria monocytogenes are controlled as specified under § 3-502.12
Typical cases: fresh or smoked fish, soft cheese, cheese with added ingredients, cooked food with no barrier, or a longer shelf life than the code allows. The request (8-103.11) states what you want, why it is safe (usually lab data) and includes a HACCP plan. Your regulatory authority decides, and some do not grant ROP variances at all.
Worked example: vacuum-packed raw beef portions
A steakhouse breaks down strip loins on Monday, portions them, and vacuum packs each steak with a chamber sealer so the line can pull exactly what it needs all week. The bags sit in the walk-in for up to a week, so (F) does not apply. Raw beef has a high level of competing organisms, so the barrier is (B)(2)(d). This is a (B) plan.
Vacuum-packed raw beef portions
- 01 Receive Probe on arrival, reject warm product
- 02 Cold storage Raw, at 41°F or less, below ready-to-eat food
- 03 Portion and trim Designated area, separate from ready-to-eat 3-502.12(B)(5)(b)
- 04 Vacuum seal Chamber sealer, trained staff only 3-502.12(B)(5)(b)(ii)
- 05 Label every bagCCP Keep at 41°F or below; discard 30 days after packaging or supplier date, if sooner 3-502.12(B)(3), 3-502.12(B)(4)
- 06 Cold holdCCP 41°F or less, every bag, every day 3-502.12(B)(2)
- 07 Open and cookCCP 145°F for 15 s, or the steak rule 3-401.11(A)(1)
- 08 Serve On premises
| CCP | Significant hazard | Critical limit | Monitoring | If the limit is missed | Verification and records |
|---|---|---|---|---|---|
| Label and date | C. botulinum and Listeria monocytogenes growing past a safe shelf life | Every bag labeled to keep at 41°F or below and discard within 30 days of packaging, or by the supplier's date if sooner3-502.12(B)(3), 3-502.12(B)(4) | Packer writes product, packaging date, discard date and initials on each bag as it is sealed; entered on the ROP label and discard log | Unlabeled bag or unknown packaging date: discard. Wrong date: relabel from the log, or discard if the log cannot confirm it | Person in charge checks the log against bags in the walk-in once a dayROP label and discard log |
| Cold hold | Listeria monocytogenes and C. botulinum growth if the bag warms | 41°F or less3-502.12(B)(2) | Probe a bag (or a product simulant next to the bags) at opening and close; read the unit thermometer | Above the limit: move bags to a unit that holds it, find out how long they were warm, and discard if that time is unknown or past what your plan allows. Fix the unit before using it again | Thermometers checked for accuracy (plus or minus 2°F) on a set schedule; person in charge signs the log weeklyCold holding log, thermometer calibration log, corrective action log |
| Cook | Salmonella and E. coli O157:H7 on raw beef | 145°F for 15 seconds for steaks and chops; intact beef steak served rare: seared to 145°F on top and bottom with a color change3-401.11(A)(1), 3-401.11(C)(3) | Cook probes or checks sear on each order per the plan | Keep cooking until the limit is met | Person in charge observes a cook check each shiftCooking log where your plan requires one |
How often you probe and who verifies are your choices, not the code's; make them specific and name a person. "Checked regularly" gets sent back. Full plan: the vacuum-packed raw beef sample plan.
What inspectors and plan reviewers look for
- The plan on site, matching what you do, and when it went to the health department.
- A bold label on every bag: keep-cold line, discard date within 30 days; time too under (F).
- Food that fits its barrier. A cooked item with a 30-day label is the classic write-up.
- Fish frozen solid and thawed out of the bag; cheese with nothing added.
- Filled-in logs and training records for everyone who runs the sealer.
- A clean sealer in the designated area.
Free printable logs: ROP label and discard log, cold holding log, thermometer calibration log, corrective action log.
Common mistakes
| Mistake | Why it fails | Fix |
|---|---|---|
| Vacuum packing fresh fish | 3-502.12(C) only allows fish frozen before, during and after packing. | Pack it frozen and keep it frozen, or open the bag within 48 hours under (F). |
| Adding herbs, oil or garlic to cheese before packing | (E)(1) allows no ingredients added in your kitchen. | Pack the plain cheese; add the herbs when you plate. |
| No label, or a date with no discard day | (B)(3) needs the keep-cold line and the discard instruction, bold, on the front. | Pre-printed labels with blanks for packaging date, discard date and initials. |
| Packing cooked food under (B) | Cooking kills the competing organisms, so barrier (d) is gone. | Use (D) for cook-chill or sous vide, or open within 48 hours. |
| Counting 30 days from delivery | The clock starts at packaging, and the supplier's earlier date wins. | Write both dates on the log; label the earlier one. |
| Thawing ROP fish in the bag | 3-501.13(E) says take it out of the reduced oxygen package first. | Cut the bag open before it goes into the walk-in to thaw. |
| Relying on (F) without the time | (F)(1) needs the production time and date. | "Sealed 3:00 pm Tue" on every bag. |
Not sure which route you are on? The free checker tells you which paragraph applies, including when you need no plan at all.
Frequently asked questions
Do I need a HACCP plan to use a vacuum sealer in a restaurant?
Do I need a variance for vacuum packing?
How long can vacuum-packed raw meat be kept?
Can I vacuum pack fresh fish?
Can I vacuum pack cheese?
Does a chamber sealer count, or only an external vacuum sealer?
Does marinating meat in a vacuum bag count?
Sources
- FDA Food Code 2022, full text (PDF)
- FDA Food Code 2022, overview page
- Hennepin County, MN: HACCP and ROP application (PDF)
- Northern Nevada Public Health: ROP without a variance, HACCP form (PDF)
- eCFR: 9 CFR 424.21, use of food ingredients and sources of radiation
- eCFR: 21 CFR Part 133, cheeses and related cheese products
Every temperature, time and pH on this page is quoted from the FDA Food Code 2022 with its section number. Your state or county may run an older edition or add its own rules, and only your regulatory authority approves a HACCP plan or grants a variance. This page explains the rules in plain words; it is not legal advice.