§ 346. — Tolerances for poisonous or deleterious substances in food; regulations.
[Laws in effect as of January 7, 2003]
[Document not affected by Public Laws enacted between
January 7, 2003 and December 19, 2003]
[CITE: 21USC346]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 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; 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.
(June 25, 1938, ch. 675, Sec. 406, 52 Stat. 1049; Pub. L. 85-929,
Sec. 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L. 86-618, title I,
Sec. 103(a)(1), July 12, 1960, 74 Stat. 398.)
Amendments
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 L. 86-618 repealed subsec.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.
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.
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, Sec. 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 note set out under section 41 of this title.
Section Referred to in Other Sections
This section is referred to in sections 342, 346a, 371 of this
title.
