C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—FOOD FOR HUMAN CONSUMPTION › PART 110—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD › Subpart A—General Provisions

21 C.F.R. § 110.19

Exclusions

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(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.

Notes of Decisions
Cited in 1 case, 2012–2012 · leading case: United States v. Am. Mercantile Corp., 889 F. Supp. 2d 1058 (W.D. Tenn. 2012).
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United States v. Am. Mercantile Corp., 889 F. Supp. 2d 1058 (W.D. Tenn. 2012). “in Opp'n 3(stating that one of the issues of material fact at summary judgment was “whether AMC’s business operations involve food products that are subject to the FFDCA [sic] or does it involve the *1075 importation and distribution of raw agricultural commodities that is [sic]…”
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