21 C.F.R. § 109.4

Establishment of tolerances, regulatory limits, and action levels

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(a) When appropriate under the criteria of § 109.6, a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart B of this part under the provisions of section 406 of the act. A tolerance may prohibit any detectable amount of the substance in food.

(b) When appropriate under the criteria of § 109.6, and under section 402(a)(1) of the act, a regulatory limit for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart C of this part under the provisions of sections 402(a)(1) and 701(a) of the act. A regulatory limit may prohibit any detectable amount of the substance in food. The regulatory limit established represents the level at which food is adulterated within the meaning of section 402(a)(1) of the act.

(c)(1) When appropriate under the criteria of § 109.6, an action level for an added poisonous or deleterious substance, which may be a food additive, may be established to define a level of contamination at which a food may be regarded as adulterated.

(2) Whenever an action level is established or changed, a notice shall be published in the Federal Register as soon as practicable thereafter. The notice shall call attention to the material supporting the action level which shall be on file with the Dockets Management Staff before the notice is published. The notice shall invite public comment on the action level.

(d) A regulation may be established in subpart D of this part to identify a food containing a naturally occurring poisonous or deleterious substance which will be deemed to be adulterated under section 402(a)(1) of the act. These regulations do not constitute a complete list of such foods.

[42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990; 88 FR 45065, July 14, 2023]

Notes of Decisions

Cited in 5 cases (1 in the last 5 years), 1979–2025 · leading case: People Ex Rel. Brown v. Tri-Union Seafoods, LLC, 171 Cal. App. 4th 1549 (Cal. Ct. App. 2009).

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People Ex Rel. Brown v. Tri-Union Seafoods, LLC, 171 Cal. App. 4th 1549 (Cal. Ct. App. 2009). · cites it 2× “§ 346 ; 21 C.F.R. § 109.4 (a)-(c) (2008).) As well, the FDA is empowered to establish regulations to identify and list foods containing naturally occurring poisonous or deleterious substances which will be considered adulterated under the Act.”

State of Alaska v. U.S. Dep't of Transp. & Samuel K. Skinner, Sec'y of Transp., 868 F.2d 441 (D.C. Cir. 1989). · cites it 2× “21 C.F.R. § 109.4 (1986). The question in the case was whether the FDA’s action level for aflatoxin, a contaminant found in corn, constituted a legislative or interpretative rule.”

Cmty. Nutrition Inst., Laura A. Rogers v. Frank Young, Comm'r, Food & Drug Admin., 818 F.2d 943 (D.C. Cir. 1987). “21 C.F.R. § 109.4 (1986) (emphasis added).”

United States v. Boston Farm Ctr., Inc., a Corp., & James R. Gordon, an Individual, 590 F.2d 149 (5th Cir. 1979). “For example, FDA regulations state that the agency may take regulatory action “any time after an action level is established and need not await publication of the notice.”

McLean v. WalMart, Inc. (W.D. Ark. 2025). “See 21 C.F.R. § 109.4 (c). 2 https://www.fda.”

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