21 CFR 110.19 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 100.1 To § 169.182) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Parts 100 To 169) (§ 100.1 To § 169.182) — Food For Human Consumption (§ 100.1 To § 169.182) — Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food (§ 110.3 To § 110.110) — General Provisions (§ 110.3 To § 110.19) — Exclusions.

(a) The following operations are not subject to this part: Establishments engaged solely in the harvesting, storage, or distribution of one or more “raw agricultural commodities,” as defined in section 201(r) of the act, which are ordinarily cleaned, prepared, treated, or otherwise processed before being marketed to the consuming public.

(b) FDA, however, will issue special regulations if it is necessary to cover these excluded operations.