Seafood is regulated through a HACCP rule of its own, and that changes the shape of the paperwork an auditor expects. A sanitation chemistry does not pass an audit; a programme does — 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 seafood plant actually works to.
About claims on this page
EcoloxTech generators produce a hypochlorous acid solution on site. They are regulated by the EPA as devices, are not registered disinfectants, and we make no efficacy claims for them or for the solution they produce. The only EcoloxTech product with disinfection claims is HOCl-AS200 (EPA Reg. No. 101112-1), used according to its label. Research cited here describes published studies of hypochlorous acid and electrolysed water under their own test conditions; it is not a claim for any product.
The frameworks that apply
| Framework | What it expects of sanitation | Where HOCl appears |
|---|---|---|
| FDA Seafood HACCP (21 CFR 123) | A HACCP plan, plus sanitation control procedures under 123.11 monitoring the eight key sanitation conditions, with records | Named in the SSOP with concentration, method and contact time; water and ice quality records |
| 21 CFR 117.5(b) | Activities subject to part 123 are exempt from preventive controls (subparts C and G); CGMPs in subpart B still apply | Sanitation is documented through HACCP and SSOPs rather than as a preventive control |
| FCN 1811 | Hypochlorous acid in process water or ice, free available chlorine not exceeding 60 ppm, with a drain or potable rinse for product consumed raw | The authorisation for ice, chilled water, flume, thaw and glaze water |
| 21 CFR 178.1010 | Hypochlorite sanitising solutions on food-contact surfaces up to 200 ppm available chlorine, followed by adequate draining | The authority for surface work |
| National Shellfish Sanitation Program | Model Ordinance; the state shellfish control authority approves wet storage and depuration arrangements | Only what the authority has approved, on the terms it set |
| GFSI schemes (SQF, BRCGS, FSSC 22000) | Cleaning and sanitation programme, chemical control, validation and verification, training | Approved chemical list, SOPs, validation evidence, verification records |
| Export listings (e.g. EU) | The importing authority’s expectations as well as your own | Chemical documentation in a form a visiting inspector can read |
| OSHA HazCom (29 CFR 1910.1200) | SDS availability, container labelling, training | SDS for the solution and for brine or acid inputs |
The eight key sanitation conditions
Under 123.11 a seafood processor monitors and records eight sanitation conditions. Three of them are where a generated-solution programme shows up most directly.
| Condition | What the record looks like |
|---|---|
| Safety of water that contacts food or food-contact surfaces, and of ice | Water and ice treatment records, strength at the point of use, supply test results |
| Condition and cleanliness of food-contact surfaces | SOP per task, strength and pH logs, ATP and micro verification |
| Prevention of cross-contamination | Zoning, tool and traffic controls, hand and glove station records |
| Hand-washing, hand-sanitising and toilet facilities | Station checks; solution availability and strength where used |
| Protection from adulterants | Condensate and overhead controls, chemical segregation |
| Labelling, storage and use of toxic compounds | Approved chemical list, SDSs, secondary container labelling |
| Employee health control | Not a chemistry question, but part of the same record set |
| Exclusion of pests | Programme records |
Validation, verification and monitoring
Auditors use these three words precisely, and confusing them is a common finding.
| Term | Question it answers | Evidence in a seafood HOCl programme |
|---|---|---|
| Validation | Will this procedure achieve what we need, under our conditions? | Pre-implementation study: baseline and post-change swabs and water results, acceptance criteria agreed in advance, sign-off |
| Monitoring | Was it done, at the right strength, this time? | Strength and pH at the point of use and in the water, per shift, against a target range |
| Verification | Is the system still working overall? | ATP and environmental trends, water and ice testing, record review, calibration of test equipment |
Record which test strip lot or photometer was used and when it was last verified. An auditor who asks how you know a reading is right will accept an answer that is written down.
Shellfish: a separate conversation
If you handle molluscan shellfish, the National Shellfish Sanitation Program and your state shellfish control authority sit alongside everything above. Wet storage and depuration arrangements, including any treatment of tank water, are approved by the authority on terms it sets, and those terms are what an inspector checks against. Design the system with the authority in the conversation from the start; retrofitting an approval is considerably harder than obtaining one.
Chemical control
- Approved chemicals list naming the generated solution, the registered product and every detergent, with the area each is used in.
- SDSs available where products are used — including brine or acid inputs, which are the hazardous part of an onsite system.
- Secondary containers labelled; 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, authorised and recorded.
The records an auditor will ask for
- SSOPs by task and zone, with set point, method, contact time and frequency.
- Strength and pH logs for the outlets and water systems serving those tasks.
- Water and ice records, including supply testing and melt-water results where used.
- Environmental monitoring results, trended, with the sampling plan behind them.
- Corrective actions, with root cause and close-out.
- Training records for everyone operating the generator or applying solution.
- Maintenance records for the generator, softener, filters and the ice plant.
- Product documentation: generator manual, SDSs, HOCl-AS200 label, FCN 1811 where relied on.
- Validation evidence for the change from the previous chemistry.
The HOCl Compliance Pack has printable versions of most of these.
Audit day
Expect the auditor to pick one route and follow it end to end. In a seafood plant that route very often starts at the ice machine: show the authorisation you rely on, the treatment record, the strength measured in the water, the ice-store cleaning record, and then follow the ice onto the line. On an RTE line, expect the route to start at the environmental monitoring plan and work towards the slicer. Describe what you do accurately, and do not offer generated solution where a registered disinfectant is specified.
What you can say
Under FIFRA a claim made “by labelling or otherwise” — on a website, a spec sheet or a customer handout — can turn a product into an unregistered pesticide, and the EPA’s acceptance letter of 10 December 2025 requires that website claims for HOCl-AS200 not differ substantially from its accepted label. Describe the generator by what it produces, and reserve organism claims for the registered product used per label. Staying compliant with HOCl has a table of acceptable and unacceptable phrasing.
The findings we see most in seafood plants
- The water limit and the surface limit swapped. A 200 ppm figure quoted for ice, or 60 ppm written into a surface SOP. Two rules, two limits, and the SSOP should name which applies.
- Strength measured at the generator, not in the water. With seafood’s chlorine demand, those are different numbers, and only one of them is evidence.
- Ice treated but the ice store ignored. Clean water into a machine whose store and scoop are not on the schedule.
- Ice reused on the floor. The SOP says single use; the end of a busy shift says otherwise. Walk it rather than read it.
- Environmental monitoring that never finds anything. On an RTE line, that usually means the plan is sampling the easy places.
- Raw and RTE tools mixed. Colour coding that has drifted, or trolleys crossing a line nobody marked.
- Logs with no target range, and out-of-range readings with blank corrective-action fields.
- Unlabelled secondary containers, the easiest finding in any plant and the easiest to prevent.
Frequently asked questions
Are we under FSMA preventive controls or seafood HACCP?
Activities subject to 21 CFR 123 are exempt from the preventive controls requirements in subparts C and G of Part 117; the CGMPs in subpart B still apply. Mixed facilities can be subject to both for different activities, so check which rule covers which activity.
Can we rely on FCN 1811 for our ice?
Customers who obtain the substance from EcoloxTech may rely on it for the uses and limits it covers, which include process water and ice contacting seafood at not more than 60 ppm free available chlorine. Keep a copy in the compliance file.
Do we need our shellfish authority’s approval?
For wet storage and depuration water, yes. Involve them before you design anything.
What does a GFSI auditor want on validation?
Pre- and post-implementation data, the acceptance criteria you set in advance, and a sign-off. Validation is a documented decision, not a supplier brochure.
Do we still need a registered disinfectant?
If any task, customer or regulator requires documented claims, yes. Many plants keep HOCl-AS200 for exactly those tasks.