Food safety rules for coffee roasters and dry food makers in Puerto Rico

What applies to a roaster or packer

A plant that manufactures, processes, packs or holds food for consumption in the United States must register (21 CFR 1.225), follow the good manufacturing practices in subpart B of 21 CFR 117 and, unless it is a qualified facility or another exemption applies, have a written hazard analysis and a food safety plan prepared by a PCQI (21 CFR 117.126 and 117.130).

The hazard analysis must be written even if it concludes there are no hazards requiring a preventive control (21 CFR 117.130(a)(2)).

Farm exemptions: which coffee activities they cover

The rule considers coffee beans separately from other fruits "to appropriately address specific hazards" of that food (21 CFR 117.5(g)(2)). For a small or very small business operating a farm mixed-type facility, subparts C and G do not apply if the only covered activities it conducts are low-risk combinations on the list. For roasted coffee, the list includes:

• Packing, re-packing and storing roasted coffee beans on the farm (21 CFR 117.5(g)(3)(v)).
• Grinding roasted coffee beans (21 CFR 117.5(h)(3)(vii)).
• Mixing roasted coffee beans (21 CFR 117.5(h)(3)(xxii)).
• Packaging roasted coffee beans (21 CFR 117.5(h)(3)(xxiii)).
• Labeling roasted coffee beans (21 CFR 117.5(h)(3)(viii)).

Other dry foods

For other dry foods, the rule distinguishes products dried without further processing (such as raisins or dried legumes) from those with additional processing, such as legume flours or sliced dried fruit (21 CFR 117.5(g)(2)(i) and (ii)). Establishments solely engaged in hulling, shelling, drying, packing or holding nuts without roasting them are not subject to subpart B (21 CFR 117.5(k)(1)(v)).

Qualified facility

Even without the farm exemptions, a very small business (less than $1,000,000 per year adjusted for inflation in human food sales plus the value of food made or held without sale, 3-year average) is a qualified facility: it does not have to comply with subparts C and G but must submit the attestations in 21 CFR 117.201 (21 CFR 117.3 and 117.5(a)).

If your coffee or dry product contains allergens (for example, blends with nuts or milk), allergen labeling applies as it does to any other food.

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).