FDA 21 CFR 117.35(c) — Pest Control in Campus Food Manufacturing

Citation

21 CFR Part 117, Subpart B, Current Good Manufacturing Practice, §117.35(c); 21 CFR Part 1, Subpart H, §§1.226 and 1.227 (Food and Drug Administration). Read on the eCFR (Title 21 current through the September 22, 2026 issue) on September 24, 2026.

What It Says (Verbatim)

§117.35(c):

“(c) Pest control. Pests must not be allowed in any area of a food plant. Guard, guide, or pest-detecting dogs may be allowed in some areas of a plant if the presence of the dogs is unlikely to result in contamination of food, food-contact surfaces, or food-packaging materials. Effective measures must be taken to exclude pests from the manufacturing, processing, packing, and holding areas and to protect against the contamination of food on the premises by pests. The use of pesticides to control pests in the plant is permitted only under precautions and restrictions that will protect against the contamination of food, food-contact surfaces, and food-packaging materials.”

§1.227, definition, first three sentences:

“Retail food establishment means an establishment that sells food products directly to consumers as its primary function. The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers.”

§1.226, facilities that do not have to register, paragraph (c):

“(c) Retail food establishments;”

What It Means in Plain Language

The plant standard is absolute on its face: “Pests must not be allowed in any area of a food plant.” It adds an exclusion duty for manufacturing, processing, packing, and holding areas, and allows pesticide use only under precautions that protect food, food-contact surfaces, and packaging.

The primary-function test in §1.227 decides whether an operation is a “retail food establishment,” which §1.226(c) exempts from FDA food facility registration. The Subpart B exemptions in §117.5(k) do not list retail food establishments. How FDA and the local health department divide oversight of a campus operation that both manufactures and sells directly to consumers is not answered by these texts, and this page does not answer it. Utah campuses have such operations. Utah State University makes Aggie Ice Cream at the Gary H. Richardson Dairy Products Laboratory on the Logan campus and sells it at its own store; Brigham Young University describes its Culinary Support Center as its own food processing facility. This page does not determine which documents apply to either; that turns on facts about each operation's sales and registration that this reference has not established.

Who It Applies To

Facilities that manufacture, process, pack, or hold human food, except as exempted from Subpart B by §117.5(k). For meat and poultry processing under federal inspection, see 9 CFR 416.2.

Documentation Evidence

• Exclusion measures and their inspection record for manufacturing, processing, packing, and holding areas
• Pesticide use records showing the precautions taken to protect food, food-contact surfaces, and packaging
• The facility's own determination of whether it is a registered food facility, and which inspector reviews it

Confidence Notes

HIGH confidence for the regulatory text, read from the eCFR on September 24, 2026. The descriptions of the two campus operations are from the institutions' own published pages.