A process authority letter is a written review of your recipe and method by a qualified food scientist, setting out the scheduled process that makes the product safe: the pH it must reach, the heat treatment, the hold times, the container, and the checks you must do on each batch. Makers of acidified foods (hot sauces, pickles, salsas and similar products made safe by adding acid to low-acid ingredients) need one, because FDA requires the scheduled process to be established by a qualified person, and that process is what you file with FDA. Costs vary with the product and the testing, so get quotes. Below is when you need one, what the letter covers, how to get one, and the records that follow.
The short version
- A process authority is a qualified person who sets the scheduled process for your product.
- Acidified foods need one: low-acid ingredients made safe with acid, finished at pH 4.6 or below.
- The letter sets pH, heat treatment, hold times, container and batch checks for each product and size.
- You file the scheduled process with FDA, after registering as a processor.
- Follow it exactly, and keep the processing and pH records it asks for.
- Any change to the recipe, process or container usually means a new review.
- TaroStack keeps the batch records the letter asks for, with readings flagged outside their limits. More below.
When you need one
FDA defines acidified foods as low-acid foods to which acid or acid foods are added, with a water activity above 0.85 and a finished equilibrium pH of 4.6 or below, and excludes some products, such as refrigerated foods and acid foods with only small amounts of low-acid ingredients (21 CFR 114.3). The scheduled process for an acidified food has to be established by a qualified person with expert knowledge of acidification and processing (21 CFR 114.83), and a commercial processor files that process with FDA within 60 days of registering, and before packing any new product (21 CFR 108.25). The process authority's letter is how most small makers get there.
| Product | Usually needs a process authority? |
|---|---|
| Shelf-stable hot sauce made with peppers and vinegar | Yes |
| Pickled vegetables, shelf-stable | Yes |
| Salsa in jars, shelf-stable | Yes |
| Fruit jam or jelly | Usually not under the acidified rules, though some states ask for a review |
| Refrigerated sauce or salsa | Not under the acidified rules; your state may still ask |
| Fermented pickles or kimchi | Depends; ask, because fermentation is treated differently |
Many state cottage food programs and co-packers ask for a process review too, even when FDA's rules don't apply. This is general information, not legal advice.
What the letter covers
| Part | Example |
|---|---|
| The product and recipe, by weight | Chili pepper water hot sauce, recipe version 3 |
| Container and size | 5 fl oz glass woozy, metal cap |
| Critical factors | Finished pH at or below a set value; ingredients and proportions as stated |
| The process | Heat to a set temperature, hold a set time, fill hot, invert |
| Batch checks | pH of every batch, recorded; fill temperature recorded |
| What to do if a check fails | Hold the batch; re-acidify and reprocess, or discard |
| Limits of the letter | Valid for this recipe, method and container only |
How to get one
- Write the recipe down by weight, with every ingredient's source, and the method step by step.
- Find a process authority: university food science programs, extension services and private labs offer reviews.
- Send the recipe, method, container and a sample if asked; the lab may test pH and other factors.
- Receive the letter with the scheduled process, then follow it exactly.
- Register as an acidified foods processor and file the process with FDA, if the federal rules apply to you.
- Have the person supervising production complete an approved acidified foods course.
Cost depends on the product, the testing and who does it; university programs and private labs price differently, and a product that needs extra testing costs more. Ask two or three for quotes, and budget for a new review whenever the recipe or container changes. The full plan around a hot sauce, including this step, is in hot sauce business plan, and the starting costs are in sauce business startup cost.
After the letter: the records
The letter turns into a batch record for every batch: date, lot code, recipe version, ingredient lots, the pH reading, temperatures, the container, who supervised, and what happened if a check failed. Acidified food processors keep processing, deviation and pH records for three years (21 CFR 108.25). How a batch record is laid out is in what is a batch record.
Where this stops working
The letter lives in a folder, the batch records in a binder, and the recipe in someone's head. A new supplier's peppers are a little less acidic, someone tweaks the recipe "slightly", a batch reads a little high and gets bottled anyway because nobody wrote down the limit next to the pH meter. The letter is only as good as the batches that follow it.
How TaroStack does it
TaroStack keeps the batches the letter asks for, the same way every time, and catches a reading that's out of limits.
The recipe is versioned. Recipes have versions, so the batch made to version 3 is recorded as version 3, and a change is a new version you can take back to the process authority. Each batch takes ingredients from the lots used and notes them in the batch record automatically.
Batch records with limits. Batch record forms are filled in when the batch is recorded, with your own fields: pH, fill temperature, hold time, initials and sign-off. Number fields carry units and limits, so a pH above the letter's limit is recorded and flagged, and the flag is marked reviewed with what was done about it. A batch waiting on a recheck can sit on hold, apart from stock that's available to sell.
And the records keep. Every batch is a permanent record with its lot, its readings and who made it, and one report walks any lot to the customers who got it. TaroStack keeps the records; it doesn't write your scheduled process or file anything with FDA.
| The job | Folder and binder | In TaroStack |
|---|---|---|
| Which recipe version was used | Someone's memory | Recorded with the batch |
| pH against the letter's limit | Written down, maybe | A field with a limit, flagged outside it |
| A batch that failed a check | Bottled anyway, sometimes | On hold until it's resolved |
| Three years of records | A shelf of binders | Every batch, searchable |
Lots, holds and recalls are on every plan, from $49 a month; recipes with versions and batch records with limits are on Standard at $99. The first 30 days are free, with no credit card. If you'd like a hand setting up, ask, and we'll do it with you.