Compliance & Audits — Food Processing

A sanitation chemistry does not pass or fail an audit on its own. What passes is a programme: the right product for the task, a written procedure, evidence it was followed, and a response when it was not. This page maps onsite hypochlorous acid into the frameworks a food plant actually works to, and lists the records that make it defensible.

The frameworks that apply

The food-contact and water rules

• 21 CFR 178.1010 — hypochlorite sanitising solutions on food-contact surfaces at up to 200 ppm available chlorine, used followed by adequate draining. Electrolytically generated hypochlorous acid is not named separately; it qualifies as available chlorine.
• FCN 1811 — FDA Food Contact Notification held by EcoloxTech for hypochlorous acid in process water or ice contacting meat, poultry, seafood, fruits and vegetables and shell eggs, at free available chlorine not exceeding 60 ppm, with a drain step or potable rinse for product consumed raw. An FCN is effective for the manufacturer named in it and for those who obtain the substance from them.
• 21 CFR 173.315 — washing or lye-peeling fruits and vegetables, which requires a potable-water rinse. It is not interchangeable with 178.1010.
• FIFRA — a product sold with claims to kill named organisms is a pesticide and must be registered. Generators are devices: no registered claims.

Full citations are on the regulations page.

Validation, verification and monitoring

Auditors use these three words precisely, and mixing them up is a common finding.

Two practical notes. Calibrate or verify the test equipment you rely on, and record the lot of test strips; an auditor who asks how you know the reading is right will accept an answer that is written down. And define the target range and the action limits before you start logging, not after the first out-of-range reading.

Chemical control

• Approved chemicals list that names the generated solution, the registered product and every detergent, with the area each is used in.
• SDSs available where the products are used — including the brine or acid inputs, which are the hazardous part of an onsite system.
• Secondary containers labelled with contents; closed, opaque containers for stored solution; white HDPE for any secondary container of HOCl-AS200, per its label.
• Segregation of incompatibles — acids and ammonia away from chlorine chemistry.
• Change control on generator set points, with authorisation and a record.

The records an auditor will ask for

1. Sanitation SOPs by task and zone, with set point, method, contact time and frequency.
2. Strength and pH logs for the outlets serving those tasks.
3. Verification results: ATP and environmental swabs, trended.
4. Corrective actions, with root cause and close-out.
5. Training records for everyone who operates the generator or applies solution.
6. Maintenance records for the generator, softener and filters.
7. Product documentation: generator manual, SDSs, HOCl-AS200 label, FCN 1811 where relied on.
8. Validation evidence for the change from the previous chemistry.

The HOCl Compliance Pack contains printable versions of most of these.

Audit day

Expect the auditor to pick one task and follow it end to end: show the SOP, the product and its documentation, a week of strength logs for the outlet that serves it, the training record of the person on shift, the verification results for the area, and one corrective action with its outcome. Expect questions about what you claim: describe what you do accurately, and do not offer generated solution when a registered disinfectant is specified. If a scheme requires listed or approved chemicals, have the documentation ready rather than an explanation.

What you can say

Under FIFRA a claim made “by labelling or otherwise” — on a website, spec sheet or customer handout — can turn a product into an unregistered pesticide, and the EPA reminded us in its acceptance letter of 10 December 2025 that website claims for HOCl-AS200 must not differ substantially from the accepted label. The same discipline protects you: describe the generator by what it produces (concentration, pH, output), and reserve organism claims for the registered product used per label. Staying compliant with HOCl has a table of acceptable and unacceptable phrasing.

Mapping to scheme clauses

Schemes word things differently, but they ask for the same four things about a sanitation chemistry. Use this as a checklist when you prepare a pack for an audit:

Change control when you switch

Moving a task from one chemistry to another is a change to the food safety plan, and treating it as one avoids most findings. Raise it as a change request, record the reason, define acceptance criteria, pilot with verification, update the SOP, chemical list and training records, then close the change with the evidence attached. Where the task sits under a preventive control or a critical control point, involve the person who signs the plan before the pilot, not after it. Keep the previous SOP version; an auditor asking “when did this change, and what did you check?” wants a dated trail, not a recollection.

The findings we see most

• SOP says one thing, the floor does another. Usually a contact time nobody can achieve in the time available, or a set point written before the distribution was finished.
• Logs with no target range. A column of numbers proves a test happened, not that the result was acceptable.
• No corrective action trail. Out-of-range readings with blank action fields are worse than no log at all.
• Unlabelled secondary containers. The easiest finding in any plant, and the easiest to prevent.
• Claims in marketing that the label does not support, including on a customer-facing spec sheet written years ago.
• Test strips out of date, or no record of which lot was in use.

Frequently asked questions