§ 346. Tolerances for poisonous or deleterious substances in food; regulations

Statutory text

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; 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. 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. 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.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1938
Pub. L. 75–675 § 406 · 52 Stat. 1040
Enacted · 21 U.S.C. § 346
June 25, 1938, ch. 675, § 406, 52 Stat. 1049
Source evidence
Code source credit
June 25, 1938, ch. 675, § 406, 52 Stat. 1049
Enacted provision · exact public law section
Sec. 406. tolerances for poisonous ingredients in food and certification of coal-tar colors for food (a) Any poisonous or deleterious substance added to any Tolerances for poisonous ingredients in food. 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) of section 402 (a); but when such substance is so required or cannot Ante, p. 1046. 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) of section 402 (a). 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 402 (a). 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. (b) The Secretary shall promulgate regulations providing for the Certification of coal-tar colors for food. listing of coal-tar colors which are harmless and suitable for use in food and for the certification of batches of such colors, with or without harmless diluents.
1958
Food Additives Amendment of 1958
Pub. L. 85–929 § 3(c) · 72 Stat. 1784
Substituted · 21 U.S.C. § 346(a)
Pub. L. 85–929 substituted “clause (2)(A)” for “clause (2)” in first sentence
Source evidence
Code amendment note
Subsec. (a). Pub. L. 85–929 substituted “clause (2)(A)” for “clause (2)” in first sentence.
Enacted provision · exact public law section
(c) The first sentence of section 406 (a) of such Act is amended by 21 USC 346. striking out “clause (2)” wherever it appears in such sentence and inserting in lieu thereof “clause (2) (A)”.
1960
Color Additive Amendments of 1960
Pub. L. 86–618 title I § 103(a)(1) · 74 Stat. 397
Repealed · 21 U.S.C. § 346
Pub. L. 86–618 repealed subsec. (b) which required Secretary to promulgate regulations for listing of coal-tar colors
Source evidence
Code amendment note
Pub. L. 86–618 repealed subsec. (b) which required Secretary to promulgate regulations for listing of coal-tar colors.
Enacted provision · exact public law section
(1) repealing subsection (b) of section 406 and striking out the subsection designation “(a)” after “Sec. 406.” in such section;
Effective date note
Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

3 of 3 references resolved to an enrolled provision

Editorial Notes

Amendments1958–1960 · 2 rounds

1960

Pub. L. 86–618 repealed subsec. (b) which required Secretary to promulgate regulations for listing of coal-tar colors.

1958

Subsec. (a). Pub. L. 85–929 substituted “clause (2)(A)” for “clause (2)” in first sentence.

Statutory Notes and Related Subsidiaries

Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date of Nematocide, Plant Regulator, Defoliant, and Desiccant Amendment of 1959

Effective date of subsec. (a) as in force prior to July 22, 1954, with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on a raw agricultural commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86–139, Aug. 7, 1959, 73 Stat. 288.

Effective Date of 1958 Amendment

For effective date of amendment by Pub. L. 85–929, see section 6(b), (c) of Pub. L. 85–929, set out as a note under section 342 of this title.

Executive Documents

Transfer of Functions

Functions vested in Secretary of Health, Education, and Welfare [now Health and Human Services] in establishing tolerances for pesticide chemicals under this section together with authority to monitor compliance with tolerances and effectiveness of surveillance and enforcement and to provide technical assistance to States and conduct research under this chapter and section 201 et seq. of Title 42, The Public Health and Welfare, transferred to Administrator of Environmental Protection Agency by Reorg. Plan No. 3 of 1970, § 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086, set out in the Appendix to Title 5, Government Organization and Employees.

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.

Credits

1938–1960 · 3 acts

1938June 25, 1938, ch. 675, § 406, 52 Stat. 1049
1958Pub. L. 85–929, § 3(c), Sept. 6, 1958, 72 Stat. 1785
1960Pub. L. 86–618, title I, § 103(a)(1), July 12, 1960, 74 Stat. 398.

Show as published

(June 25, 1938, ch. 675, § 406, 52 Stat. 1049; Pub. L. 85–929, § 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86–618, title I, § 103(a)(1), July 12, 1960, 74 Stat. 398.)