Food safety rules for juice and bottled water makers in Puerto Rico

What counts as juice for FDA?

The rule defines juice as the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of their edible portions, or concentrates of that liquid or puree. It applies to any juice sold as such or used as an ingredient in beverages, whether or not it has been shipped in interstate commerce (21 CFR 120.1(a)). So juice made and sold only in Puerto Rico is covered too.

The rule does not cover the operation of a retail establishment, which FDA defines as one that provides juice directly to consumers. A business that sells or distributes juice to other businesses as well as to consumers does not count as retail (21 CFR 120.3(j) and (l)).

Hazard analysis and HACCP plan

Each processor needs a written hazard analysis for each type of juice. At a minimum it should consider microbiological contamination, parasites, chemical contamination, unlawful pesticide residues, decomposition, natural toxins, unapproved additives, undeclared ingredients that may be allergens and physical hazards (21 CFR 120.7(c)).

If the analysis finds hazards reasonably likely to occur, you need a written HACCP plan specific to each location and each type of juice, with critical control points, critical limits, monitoring, corrective actions, validation and verification, and a recordkeeping system that captures the actual values observed (21 CFR 120.8).

The analysis and the plan must be developed by someone trained in juice HACCP under an FDA-recognized curriculum, or qualified by equivalent job experience. That person need not be an employee of the plant (21 CFR 120.13).

The 5-log reduction

The HACCP plan must include control measures that consistently achieve at least a 5-log (100,000-fold) reduction in the pertinent microorganism, which the rule defines as the most resistant microorganism of public health significance likely to occur in the juice (21 CFR 120.24(a)).

Two kinds of processors are exempt from that requirement: those subject to parts 113 or 114 (low-acid canned or acidified foods), and those using a single thermal step sufficient to make the juice shelf-stable, provided a copy of that thermal process is included in the hazard analysis. In every case, treatment and final packaging must happen in a single facility operating under good manufacturing practices (21 CFR 120.24(c)).

If your treatment does not come into direct contact with all parts of the juice (for example, citrus fruit surface treatments), the rule requires testing the finished product for biotype I E. coli on a set sampling schedule (21 CFR 120.25).

Sanitation (SSOP) and records

Each processor must have and implement a sanitation standard operating procedure (SSOP) and monitor eight areas (21 CFR 120.6):

• Safety of water that contacts food or food-contact surfaces, or is used to make ice.
• Condition and cleanliness of food-contact surfaces, including utensils, gloves and outer garments.
• Prevention of cross-contamination, including from raw to processed product.
• Hand washing, hand sanitizing and toilet facilities.
• Protection from lubricants, fuel, pesticides, cleaning compounds, condensate and other contaminants.
• Proper labeling, storage and use of toxic compounds.
• Control of employee health conditions.
• Exclusion of pests.

How long to keep juice records

For perishable or refrigerated juices, at least 1 year after the date prepared. For frozen, preserved or shelf-stable products, 2 years or the shelf life of the product, whichever is greater (21 CFR 120.12(d)).

If you comply with part 120 for those activities, the preventive controls and supply-chain subparts of 21 CFR 117 (subparts C and G) do not apply to those same activities (21 CFR 117.5(c)).

Bottled water

Bottled water has its own part, 21 CFR 129, on top of the good manufacturing practices in parts 110 and 117 (21 CFR 129.1). Product water must come from an approved source, and the plant must test the water from each source at least once a year for chemical contaminants and once every 4 years for radiological contaminants. If the source is not a public water system, it must be tested for total coliform at least once a week (21 CFR 129.35(a)(3)).

The plant must also keep records of inspections and effectiveness of its treatment equipment, and of the maintenance, inspections and performance of the mechanical washer for multiservice containers (21 CFR 129.80). Product names and quality ("spring water", "artesian water" and so on) are set by the identity standard in 21 CFR 165.110.

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).