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21 U.S.C. § 346 — Tolerances for poisonous or deleterious substances in food; regulations

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 346 — Tolerances for poisonous or deleterious substances in food; regulations

Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim); but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim). While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim). In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

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Source file: Laws/federal/codes/united-states-code/title-21/section-346-tolerances-for-poisonous-or-deleterious-substances-in-food-regulations--6a8ac76350.md
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Source location: Title 21, Chapter 9, § 346; chapter-009-federal-food-drug-and-cosmetic-act.md

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 321 — Definitions; generally

For the purposes of this chapter— **(a)** (1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone. **(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body. **(c)** The term “Department” means Department of Health and Human Services. **(d)** The term “Secretary” means the Secretary of Health and Human Services. **(e)** The term “person” includes individual, partnership, corporation, and association. **(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. **(g)** (1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 379e — Listing and certification of color additives for foods, drugs, devices, and cosmetics

**(a) Unsafe color additives** A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless— (1) (A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or (2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section. While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim) if such article is a food, or within the meaning of [section 361(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361/a&num=0&edition=prelim) if such article is a cosmetic other than a

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 342 — Adulterated food

A food shall be deemed to be adulterated— **(a) Poisonous, insanitary, etc., ingredients** (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health.11 So in original. The period probably should be “; or”. (2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of [section 346 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346&num=0&edition=prelim); or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of [section 346a(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346a/a&num=0&edition=prelim); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of [section 348 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section348&num=0&edition=prelim); or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim); or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions wher

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 346a — Tolerances and exemptions for pesticide chemical residues

**(a) Requirement for tolerance or exemption** (1) **General rule** — Except as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed unsafe for the purpose of [section 342(a)(2)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/B&num=0&edition=prelim) unless— (A) a tolerance for such pesticide chemical residue in or on such food is in effect under this section and the quantity of the residue is within the limits of the tolerance; or (B) an exemption from the requirement of a tolerance is in effect under this section for the pesticide chemical residue. For the purposes of this section, the term “food”, when used as a noun without modification, shall mean a raw agricultural commodity or processed food. (2) **Processed food** — Notwithstanding paragraph (1)— (A) if a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a pesticide chemical residue that is present in or on a processed food because the food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of [section 342(a)(2)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/B&num=0&edition=prelim) despite the lack of a tolerance for the pesticide chemical residue in or on the processed food if the pesticide chemical has been used in or on the raw agricultural commodity in conformity with a tolerance under this section, such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concentration of the pesticide chemical residue in the processed food is not greater than the tolerance prescrib

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 4331 — Congressional declaration of purpose

The purposes of this chapter are: To declare a national policy which will encourage productive and enjoyable harmony between man and his environment; to promote efforts which will prevent or eliminate damage to the environment and biosphere and stimulate the health and welfare of man; to enrich the understanding of the ecological systems and natural resources important to the Nation; and to establish a Council on Environmental Quality.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 346 — Tolerances for poisonous or deleterious

Page 103 TITLE 21—FOOD AND DRUGS § 346 § 345. Regulations making exemptions The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in ac- cordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condi- tion that such food is not adulterated or mis- branded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title. (June 25, 1938, ch. 675, § 405, 52 Stat. 1049; Pub. L. 101–535, § 5(a), Nov. 8, 1990, 104 Stat. 2362.) Editorial Notes AMENDMENTS 1990—Pub. L. 101–535 inserted at end ‘‘This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101–535 effective six months after the date of the promulgation of final regulations to implement section 343(r) of this title, or if such regu- lations are not promulgated, the date proposed regula- tions are to be considered as such final regulations (Nov. 8, 1992), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101–535, set out as a note under section 343 of this title. CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535 Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary

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