-CITE-

21 USC Sec. 346 01/19/04

-EXPCITE-

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT

SUBCHAPTER IV - FOOD

-HEAD-

Sec. 346. Tolerances for poisonous or deleterious substances in

food; regulations

-STATUTE-

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.

-SOURCE-

(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.)

-MISC1-

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 L. 86-618 repealed subsec.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.

-TRANS-

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.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 342, 346a, 371 of this

title.

-End-