Acidified and low-acid canned foods in Puerto Rico: FDA rules

Is my product acidified, acid or low-acid?

The definitions turn on the pH and water activity (aw) of the finished product (21 CFR 114.3 and 113.3):

• Acid food: natural pH of 4.6 or below.
• Low-acid food: finished equilibrium pH above 4.6 and aw above 0.85 (other than alcoholic beverages). Tomatoes and tomato products with pH below 4.7 are not classed as low-acid.
• Acidified food: a low-acid food to which acid or acid food is added, with aw above 0.85 and finished equilibrium pH of 4.6 or below. The rule lists beans, cucumbers, cabbage, peppers, tropical fruits and fish among its examples.

What part 114 does not cover

Part 114 excludes carbonated beverages, jams, jellies and preserves, acid foods (such as dressings and condiment sauces) that contain small amounts of low-acid food without significantly changing their pH, and foods that are stored, distributed and retailed under refrigeration (21 CFR 114.3(b)). Those products remain subject to other rules, such as 21 CFR 117.

Registration and process filing

A commercial processor must register the establishment with FDA on Form FDA 2541 no later than 10 days after first processing these foods (21 CFR 108.25(c)(1) and 108.35(c)(1)).

In addition, no later than 60 days after registration and before packing any new product, it must file the scheduled process for each product in each container size: Form 2541e for acidified foods, and 2541d, 2541f or 2541g for low-acid canned foods depending on the method. FDA states that filing does not constitute approval (21 CFR 108.25(c)(2) and 108.35(c)(2)).

If FDA finds a processor is not meeting these requirements, it may require a temporary emergency permit to keep operating (21 CFR 108.25(a) and 108.35(a)).

Trained supervision

Operators of acidified food processing and packaging systems must work under the supervision of a person who attended an FDA-approved school covering food handling, hygiene, sanitation, pH control and critical factors in acidification (21 CFR 114.10).

For low-acid canned foods, the requirement covers operators of retorts, aseptic and formulation systems, and container closure inspectors; the supervisor may only supervise the areas the school certified them for (21 CFR 113.10).

pH control, coding and records

The product must reach a finished equilibrium pH of 4.6 or below within the time set in the scheduled process, with frequent, recorded testing. If the finished pH is above 4.0, it is measured potentiometrically (with a pH meter) (21 CFR 114.80(a)).

Each container carries a permanent code identifying the establishment, the product, and the year, day and period of packing (21 CFR 114.80(b)). Acidified food records are kept for 3 years from the date of manufacture (21 CFR 114.100(e)); low-acid canned food records at least 1 year at the plant and 2 more years at the plant or another reasonably accessible location (21 CFR 113.100(g)).

What about the preventive controls rule (21 CFR 117)?

For low-acid canned foods that comply with part 113, subparts C and G of 21 CFR 117 do not apply, but only with respect to the microbiological hazards regulated under part 113 (21 CFR 117.5(d)). The exemption list in 117.5 includes no equivalent exemption for part 114 acidified foods.

Facility registration

Every plant in Puerto Rico that manufactures, processes, packs or holds food for consumption in the United States is a "domestic facility" to FDA and must register before it starts, even if its product never leaves the island (21 CFR 1.225 and 1.227). Registration is renewed every other year, between October 1 and December 31 of each even-numbered year (21 CFR 1.230).