21 U.S. Code § 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.

Source

(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.)
Amendments

1960—Pub. L. 86–618repealed subsec. (b) which required Secretary to promulgate regulations for listing of coal-tar colors.
1958—Subsec. (a). Pub. L. 85–929substituted “clause (2)(A)” for “clause (2)” in first sentence.
Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618effective July 12, 1960, subject to the provisions of section 203 ofPub. L. 86–618, see section 202 ofPub. 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) ofPub. 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) ofPub. 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, § 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.

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


21 CFR - Food and Drugs

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS

21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS

21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

21 CFR Part 109 - UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL

21 CFR Part 120 - HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

21 CFR Part 123 - FISH AND FISHERY PRODUCTS

21 CFR Part 176 - INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

21 CFR Part 509 - UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL

21 CFR Part 561

21 CFR Part 570 - FOOD ADDITIVES

21 CFR Part 571 - FOOD ADDITIVE PETITIONS

40 CFR - Protection of Environment

40 CFR Part 2 - PUBLIC INFORMATION

 

LII has no control over and does not endorse any external Internet site that contains links to or references LII.