PART 509—UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL - § 509.3 Definitions and interpretations - regulatory overview

Aug 25, 2026

Regulatory text from 21 CFR Part 509 addresses unavoidable poisonous or deleterious contaminants in animal food and food-packaging materials. It defines “act,” distinguishes naturally occurring versus added contaminants, and clarifies what “food” includes for enforcement. The document outlines how tolerances, regulatory limits, and action levels may be established, including conditions under which detectable amounts may be prohibited. It also describes petition procedures for proposing rulemaking and governs use of added substances and related controls.

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PART 509—UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL

Subpart A—General Provisions

509.3 Definitions and interpretations

509.4 Establishment of tolerances, regulatory limits, and action levels

509.5 Petitions

509.6 Added poisonous or deleterious substances

Subpart B—Tolerances for Unavoidable Poisonous or Deleterious Substances

509.30 Temporary tolerances for polychlorinated biphenyls (PCB’s)

Subparts C and D—Reserved

Pt. 509 21 CFR Ch. I (4–1–25 Edition) (3) The applicable assurance under: (i) § 507 .36(a)(2); (ii) § 507 .36(a)(3); (iii) § 507 .36(a)(4); (iv) § 507 .130(c)(2); (v) § 507 .130(d)(2); or (vi) § 507 .130(e)(2) . (b) A written assurance required under § 507 .36(a)(2), (3) or (4) must include: (1) Acknowledgement that the facility that provides the written assurance assumes legal responsibility to act consistently with the assurance and document its actions taken to satisfy the written assurance; and (2) Provision that if the assurance is terminated in writing by either entity, responsibility for compliance with the applicable provisions of this part reverts to the manufacturer/processor as of the date of termination. PART 509—UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL Subpart A—General Provisions Sec. 509.3 Definitions and interpretations. 509.4 Establishment of tolerances, regulatory limits, and action levels. 509.5 Petitions. 509.6 Added poisonous or deleterious substances. 509.7 Unavoidability. 509.15 Use of polychlorinated biphenyls (PCB’s) in establishments manufacturing food-packaging materials. Subpart B—Tolerances for Unavoidable Poisonous or Deleterious Substances 509.30 Temporary tolerances for polychlorinated biphenyls (PCB’s) . Subpart C—Regulatory Limits for Added Poisonous or Deleterious Substances [Reserved] Subpart D—Naturally Occurring Poisonous or Deleterious Substances [Reserved] AUTHORITY: 21 U. S. C. 336, 342, 346, 346a, 348, 371. SOURCE: 42 FR 52821, Sept. 30, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 509 appear at 88 FR 45066, July 14, 2023. Subpart A—General Provisions § 509.3 Definitions and interpretations. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) The definitions of terms contained in section 201 of the act are applicable to such terms when used in this part unless modified in this section. (c) A naturally occurring poisonous or deleterious substance is a poisonous or deleterious substance that is an inherent natural constituent of a food and isnot the result of environmental, agricultural, industrial, or other contamination. (d) An added poisonous or deleterious substance is a poisonous or deleterious substance that is not a naturally occurring poisonous or deleterious substance. When a naturally occurring poisonous or deleterious substance is increased to abnormal levels through mishandling or other intervening acts, it is an added poisonous or deleterious substance to the extent of such increase. (e) Food includes pet food, animal feed, and substances migrating to food from food-contact articles. § 509.4 Establishment of tolerances, regulatory limits, and action levels. (a) When appropriate under the criteria of § 509 .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 § 509 .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 § 509 .6, an action level for an Food and Drug Administration, HHS § 509.6 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 c

FAQs

What is the difference between naturally occurring and added poisonous or deleterious substances under § 509.3?

A naturally occurring substance is an inherent natural constituent of food and results from neither environmental nor industrial or other contamination. An added substance is not naturally occurring; it can also apply when a naturally occurring substance is increased to abnormal levels through mishandling or other intervening acts.

How can tolerances, regulatory limits, and action levels be established?

Tolerances may be established by regulation in Subpart B when criteria in § 509.6 are met, potentially prohibiting any detectable amount. Regulatory limits may be established by regulation in Subpart C to define adulteration levels, and action levels may be established to define contamination levels at which food is regarded as adulterated, with Federal Register notice and public comment when action levels change.

What must a petition include under § 509.5?

A petition may prompt a proposal to establish, revoke, or amend regulations. It must include an adequate factual basis, follow the form in § 10.30 of the chapter, and be published in the Federal Register for comment if it provides reasonable grounds for the proposed regulation.

Aug 25, 2026

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