HACCP and Bread Trays: Where Trays Fit in Your Food Safety Plan

Trays belong in your hazard analysis as equipment at five points: when new trays arrive, when used trays come back from stores, in the wash, on the loading line and on the route. Whether a tray is a food-contact surface depends on what it carries; a tray under unwrapped product is one, a tray that only ever carries sealed packages does not touch food, and a fleet that mixes the two is analyzed as the first. A tray step becomes a critical control point only if control at that step is what prevents the hazard and you can set a measurable limit there. Otherwise tray hazards are handled by prerequisite programs or, under FDA’s preventive controls rule, by sanitation controls, which count as preventive controls in their own right.

Which rules does your bakery’s plan answer to?

• A wholesale bakery that registers with FDA needs a written food safety plan under 21 CFR Part 117 (a hazard analysis, preventive controls, and monitoring, corrective actions and verification for them), unless an exemption in 21 CFR 117.5 applies, such as the one for a qualified facility. The rule covers “domestic and foreign food facilities that are required to register with section 415” of the Act (FDA, Preventive Controls for Human Food). FDA treats businesses averaging “less than $1 million per year (adjusted for inflation)” in food sales and value as very small businesses, which had a later compliance date; check which requirements apply to yours.
• A retail bakery or in-store bakery that meets FDA’s definition of a retail food establishment does not register (21 CFR 1.226), so Part 117’s food safety plan does not reach it. It works under the state or local code based on the FDA Food Code, and its inspector sets the expectations.
• Any bakery certified to a private food safety scheme also answers to that scheme’s requirements, which its own standard sets.

Part 117 is not a HACCP rule by name, but its parts line up with HACCP’s steps, and a retail code or private scheme may ask for a HACCP plan outright. FDA’s guidance lists HACCP’s seven principles: hazard analysis, critical control points, critical limits, monitoring, corrective actions, verification, and record-keeping (FDA, HACCP Principles and Application Guidelines).

Where do trays enter the flow diagram?

At five steps, and each one carries a different question. Part 117 requires the hazard analysis to consider biological, chemical and physical hazards, and to weigh, among other factors, the “condition, function, and design of the facility and equipment” (21 CFR 117.130).

Sources for the table: hazard categories from 21 CFR 117.130; controls follow 21 CFR 117.35 and 117.135 as quoted on this page and in the linked guides, and FDA’s sanitary transportation rule, 21 CFR 1.906.

Each row is covered in detail on its own page. The documents to get from a supplier are set out in the paperwork that proves a tray is food-contact compliant. The wash sequence, sanitizer limits and when trays must be washed are in cleaning and sanitizing trays on a schedule you can defend, and the crack rule in inspecting trays before they go back into service. Allergen trays have their own controls in keeping allergens from crossing between tray loads.

The return step deserves a plain rule because it is where exceptions creep in. This guide’s rule for direct-contact fleets, not a regulatory text: a tray used only as a stacking base on a store floor is still a returned tray: its bottom sat on the store floor, and once the empties are nested that bottom sits on the food surface of the tray below it. It goes through the wash like the rest.

Should a tray step be a CCP or a prerequisite program?

Start from the definitions. A critical control point is “a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level,” and a critical limit is “a maximum and/or minimum value” to which a parameter must be controlled at that step. Prerequisite programs are procedures, “including Good Manufacturing Practices, that address operational conditions providing the foundation for the HACCP system” (FDA, HACCP Principles and Application Guidelines).

Apply them to trays:

• Cleanliness depends on every wash, every drying step and every storage decision across the plant, not on one step with a limit. That makes it a sanitation program. Under Part 117 it is a sanitation control, which the rule says includes procedures for the cleanliness of “food-contact surfaces, including food-contact surfaces of utensils and equipment” (21 CFR 117.135).
• Physical damage is caught by inspection before loading. Inspection has a clear accept or reject rule, but it depends on a person seeing a defect, and your analysis should say why that is enough, or what else backs it up.
• Metal parts of trays, if your model has any, such as fasteners or reinforcing rods, can fall within the scope of a metal detection CCP if your line has one after the tray step. A metal detector finds metal; it does not cover plastic fragments, so it does not replace tray inspection.

Part 117 does not require a CCP to exist. Preventive controls include “Controls at critical control points (CCPs), if there are any CCPs,” and “Controls, other than those at CCPs, that are also appropriate for food safety” (117.135(a)(2)). Monitoring, corrective actions and verification apply “as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system” (21 CFR 117.140). Whatever you decide, write the reasoning into the hazard analysis, next to the decision.

What happens when a tray control fails?

Part 117 sets out what corrective action procedures must achieve: identify and correct the problem, act when necessary to reduce “the likelihood that the problem will recur,” evaluate all affected food for safety, and keep affected food out of commerce if you cannot ensure it is safe (21 CFR 117.150). For trays, plan for at least these three failures:

A broken tray found on the line. Hold the product that was in or near it. The rule does not set how far back the hold goes; our default is the last inspection that passed the tray, because that is the last point you know it was whole. Retire the tray, then find out how it reached the line: a missed inspection, a new handling problem, or a batch of trays reaching the end of their life.

Trays that fail a cleanliness check after washing. Send them back through the wash and check the wash itself: sanitizer strength, water temperature, cycle time, the washer’s condition. If the same failure repeats, stop rewashing and find the cause.

Returned trays mixed with clean ones. Treat the mixed trays as dirty, wash them, and fix the separation that failed. If product was loaded into them, it is affected food and has to be evaluated.

Each of these produces a record. The rule is direct: “All corrective actions (and, when appropriate, corrections) taken in accordance with this section must be documented in records” (117.150(d)). Where a preventive control requires monitoring, its monitoring and corrective action records must be reviewed “within 7 working days after the records are created” unless a longer timeframe is justified in writing (21 CFR 117.165).

Which tray records should the plan keep?

This is the full list for tray controls; the pages on cleaning, inspection and audits link here rather than repeat it.

• Supplier documents for each tray model: resin and colorant authorization, conditions of use, any guaranty and change notices.
• Wash records: date, shift, sanitizer type and measured strength, water temperature, and results of any cleanliness checks.
• Inspection records: trays inspected, trays removed and the defect found.
• Retirement records: which trays left service, when and why. These show whether one model or one route is failing.
• Allergen changeover records: the validation study for each allergen and tray type, and the verification at each changeover.
• Corrective action records as described above, including what happened to affected product.
• Verification records: record reviews, and calibration or accuracy checks of the instruments you monitor with, such as thermometers and test strips or meters (117.165(a)(1)).

Part 117 says: “All records required by this part must be retained at the plant or facility for at least 2 years after the date they were prepared” (21 CFR 117.315). Keep tray records that support your plan on that schedule. How these records line up with the rule for an audit-readiness check is set out in the tray evidence map for audit readiness.

When does the tray part of the plan need another look?

Part 117 requires a reanalysis of the whole plan “at least once every 3 years,” and of the relevant parts whenever “a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard” (21 CFR 117.170). For trays, the changes worth running through that test are a new tray model, a new supplier or resin, a new washer or wash chemistry, a new allergen product, a new route type such as frozen delivery, and a rise in broken trays found on the line.

A new washer is also a capacity decision; deciding whether an automated tray washer is worth it weighs the cost against the backlog it removes.

Where is your plan thinnest?

Put the five tray steps on your flow diagram and fill in the table above for your plant. Any step without a written control, or with a control and no record, is where the plan is thin. Start with returned trays, because that is the step where trays arrive from places you do not control.