Food safety rules for food distributors and warehouses in Puerto Rico

Holding food is a regulated activity too

For FDA, "holding" includes storing food and activities needed to distribute it, such as breaking down pallets. The definition expressly mentions warehouses, cold storage facilities, silos and tanks (21 CFR 1.227 and 117.3). That makes a warehouse in Puerto Rico a domestic facility that must register.

Subpart B good manufacturing practices apply, and require that storage and transportation protect food against allergen cross-contact, biological, chemical and physical contamination, and deterioration of the food and its container (21 CFR 117.93).

Unexposed packaged food: the 117.7 exemption

A facility solely engaged in storing unexposed packaged food (packaging that does not leave the food exposed to the environment) is not subject to subparts C (hazard analysis and preventive controls) or G (supply chain) (21 CFR 117.7(a)).

Facilities solely storing raw agricultural commodities other than fruits and vegetables, intended for further distribution or processing, are also exempt from those subparts (21 CFR 117.5(j)).

If you hold refrigerated products: 117.206

If that facility stores refrigerated packaged food that needs time/temperature control to prevent pathogen growth, modified requirements apply (21 CFR 117.7(b) and 117.206):

• Establish and implement adequate temperature controls.
• Monitor those controls often enough.
• If temperature control is lost: correct the problem, evaluate the safety of the affected food and keep it out of commerce if you cannot ensure it is not adulterated.
• Calibrate (or check the accuracy of) temperature monitoring and recording devices.
• Review monitoring and corrective action records within 7 working days, or longer if a PCQI justifies it in writing.
• Keep monitoring, corrective action and verification records, subject to subpart F.

Sanitary transportation

The sanitary transportation rule (21 CFR 1, subpart O) applies to shippers, receivers, loaders and carriers, whether or not the food crosses state lines (21 CFR 1.900). Vehicles and equipment must be adequately cleanable, kept sanitary and, for food that needs temperature control, able to maintain that temperature (21 CFR 1.906).

The shipper must specify to the carrier in writing the sanitary requirements for the vehicle and, for temperature-controlled food, an operating temperature (21 CFR 1.908(b)). Those records are kept for 12 months after the agreements or procedures end (21 CFR 1.912(a)).

A shipper, receiver, loader or carrier with less than $500,000 (adjusted for inflation) in average annual revenue over the previous 3 years is not a covered business (21 CFR 1.904).

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).