The regime

Why process control and not testing

Updated October 2026

On this page8

The sentence What that means practically So the regime controls the process instead Which is why care is not a substitute And why home canning advice does not transfer Commercial sterility is the target The word spores is doing the work there References

One sentence in the regulation explains the entire architecture.

The sentence

Inadequate or improper manufacture, processing, or packing of thermally processed low-acid foods in hermetically sealed containers may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately determined after these foods have entered into interstate commerce.

What that means practically

You cannot open a jar, test it, and establish that the batch is safe. The hazard is sporadic, the organism is not reliably detectable by inspection, and a jar that looks and smells correct can be the dangerous one.

So the regime controls the process instead

A scheduled process established by a competent processing authority, equipment that can deliver it, instrumentation that records that it did, and an operator supervising. Every one of those is about the making rather than the product.

Which is why care is not a substitute

A careful cook producing a clean, delicious soup has addressed none of what this regime addresses, because the hazard is not about cleanliness or quality. That is the single most important sentence on this page.

And why home canning advice does not transfer

Home canning guidance for low-acid foods exists and it is built around a pressure canner and consumption by the person who made it. Selling into interstate commerce is a different activity with a different regime.

Commercial sterility is the target

Defined as the condition achieved by heat that renders the food free of microorganisms capable of reproducing under normal nonrefrigerated storage and distribution, and free of viable microorganisms including spores of public health significance.

The word spores is doing the work there

Because spores survive temperatures that kill the organisms themselves, and reaching them is why a retort rather than a boiling water bath is required. That is the physical reason the equipment matters.

References

21 CFR 108.35, Thermal processing of low-acid foods packaged in hermetically sealed containers. Paragraph (a) records that the harmful nature of such foods cannot be adequately determined after they have entered interstate commerce; (c)(1) requires a commercial processor to register with FDA on Form FDA 2541 not later than 10 days after first engaging in such processing, giving the establishment locations, the processing method in terms of equipment employed, and a list of the low-acid foods processed. law.cornell.edu

21 CFR 113.3, the definitions for thermally processed low-acid foods packaged in hermetically sealed containers. Paragraph (j) defines a hermetically sealed container as one designed and intended to be secure against the entry of microorganisms so as to maintain commercial sterility; (n) defines low-acid foods as those with a finished equilibrium pH greater than 4.6 and a water activity greater than 0.85, excluding tomatoes and tomato products below pH 4.7; (r) requires a scheduled process at least equivalent to one established by a competent processing authority. law.cornell.edu

21 CFR part 113 generally, which sets the equipment and procedural requirements for thermal processing systems, including instrumentation, venting, temperature and pressure records and operator supervision for each type of retort. law.cornell.edu

Written from federal regulation, not from a production kitchen. Nothing here is a scheduled process, and nothing here is a substitute for a competent processing authority. If you are considering a shelf-stable low-acid product, the first call is to a process authority rather than to a packaging supplier.