§342 Adulterated food

2005—Par. (i). Pub. L. 109–59 added par. (i). 2002—Par. (h). Pub. L. 107–188 added par. (h). 1996—Par. (a). Pub. L. 104–170 added subpar. (2) and struck out former subpar. (2) which read as follows: “(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; (iii) a color additive; or (iv) a new animal drug) which is unsafe within the meaning of section 346 of this title, or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 346a(a) of this title, or (C) if it is, or if it bears or contains, any food additive which is unsafe within the meaning of section 348 of this title: Provided, That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 346a of this title and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of section 346 and 348 of this title, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity, or (D) if it is, or it bears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of section 360b of this title;”. That part of Pub. L. 104–170 which directed the substitution of “or (3) if it consists” for “(3) if it consists” was executed by making the substitution for “(3) If it consists” to reflect the probable intent of Congress. 1994—Par. (f). Pub. L. 103–417, § 4, added par. (f). Par. (g). Pub. L. 103–417, § 9, added par. (g). 1993—Par. (a). Pub. L. 103–80, § 3(i)(1), substituted a period for “; or” at end of subpar. (1) and “If it” for “if it” at beginning of par. (3). That part of Pub. L. 103–80, § 3(i)(1), which directed the substitution of a period for “; or” at end of subpar. (2) could not be executed because “; or” did not appear. Par. (d)(1). Pub. L. 103–80, § 3(i)(2), substituted “, except that this subparagraph” for “: Provided, That this clause”. Par. (d)(3). Pub. L. 103–80, § 3(i)(3), substituted “, except that this subparagraph shall not apply” for “: Provided, That this clause shall not apply” and “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph” for “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause”. 1992—Par. (c). Pub. L. 102–571 substituted “379e(a)” for “376(a)”. 1986—Par. (d)(2). Pub. L. 99–252 inserted provision that this clause not apply to confectionery introduced or delivered for introduction into or received or held for sale in, interstate commerce if the sale is permitted under the laws of the State in which the confectionery is intended to be offered for sale. 1968—Par. (a)(2). Pub. L. 90–399 added cls. (A)(iv) and (D). 1966—Par. (d). Pub. L. 89–477 permitted the imbedding of nonnutritive objects in confectionery foods if in the judgment of the Secretary of Health, Education, and Welfare, as provided by regulation, the imbedding of the object is of practical functional value to the confectionery product and would not render it injurious or hazardous to health, raised to one-half of 1 per centum by volume the upper limit for the allowable use of alcohol derived solely from the use of flavoring extracts, allowed the use of safe nonnutritive substances in and on confectionery foods by reason of their use for some practical and functional purpose in the manufacture, packaging, or storage of the confectionery foods if the use of the substances does not promote deception of the consumer or otherwise result in adulteration or misbranding, authorized the Secretary to issue

on the use of particular nonnutritive substances, and removed reference to nonnutritive masticatory substances added to chewing gum and harmless flavoring, harmless resinous glaze not in excess of four-tenths of 1 per centum, natural gum, authorized coloring, and pectin. 1960—Par. (a). Pub. L. 86–618, § 102(a)(1), substituted “other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive” for “(except a pesticide chemical in or on a raw agricultural commodity and except a food additive)” in cl. (2)(A). Par. (c). Pub. L. 86–618, § 102(a)(2), amended par. (c) generally, substituting provisions deeming a food adulterated if it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376 of this title for provisions which related to food that bears or contains a coal-tar color other than one from a batch that has been certified in accordance with

as provided by section 346 of this title, and struck out provisos which related to the use of color on oranges. Par. (d). Pub. L. 86–618, § 105(c), substituted “authorized coloring” for “harmless coloring”. 1959—Par. (c). Pub. L. 86–2 extended from Mar. 1, 1959, to May 1, 1959, the period during which par. is inapplicable to oranges which have been colored with F.D. & C. Red 32, and inserted proviso requiring Secretary to establish

of 2005 AmendmentAmendment by Pub. L. 109–59 effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as a note under section 331 of this title.

of 1968 AmendmentAmendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Pub. L. 90–399, set out as an

and Transitional Provisions note under section 360b of this title.

of 1960 AmendmentAmendment 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.

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

of par. (a)(2) 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.

of 1958 Amendment Pub. L. 85–929, § 6, Sept. 6, 1958, 72 Stat. 1788, as amended by Pub. L. 87–19, § 2, Apr. 7, 1961, 75 Stat. 42; Pub. L. 88–625, § 2, Oct. 3, 1964, 78 Stat. 1002, provided that: “(a) Except as provided in subsections (b) and (c) of this section, this Act [amending this section, section 321, 331, 346, and 348 of this title, and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under section 321 and 451 of this title] shall take effect on the date of its enactment [Sept. 6, 1958]. “(b) Except as provided in subsection (c) of this section, section 3 of this Act [amending this section and section 346 of this title] shall take effect on the one hundred and eightieth day after the date of enactment of this Act [Sept. 6, 1958]. “(c) With respect to any particular commercial use of a food additive, if such use was made of such additive before January 1, 1958, section 3 of this Act [amending this section and section 346 of this title] shall take effect—“(1) Either (A) one year after the

established in subsection (b) of this section, or (B) at the end of such additional period (but not later than two years from such

established in subsection (b)) as the Secretary of Health, Education, and Welfare [now Health and Human Services] may prescribe on the basis of a finding that such extension involves no undue risk to the public health and that conditions exist which necessitate the prescribing of such an additional period, or “(2) on the date on which an order with respect to such use under section 409 of the Federal Food, Drug, and Cosmetic Act [section 348 of this title] becomes effective, whichever date first occurs. Whenever the Secretary has, pursuant to clause (1)(B) of this subsection, extended the

of section 3 of this Act [amending this section] to March 5, 1961, or has on that date a request for such extension pending before him, with respect to any such particular use of a food additive, he may, notwithstanding the parenthetical time limitation in that clause, further extend such

, but not beyond December 31, 1965. The Secretary may at any time terminate an extension so granted if he finds that it should not have been granted, or that by reason of a change in circumstances the basis for such extension no longer exists, or that there has been a failure to comply with a requirement for submission of progress reports or with other conditions attached to such extension.”

of 1950 AmendmentAmendment by act Mar. 16, 1950, effective July 1, 1950, see section 7 of act Mar. 16, 1950, set out as an

note under section 347 of this title.

PostponementPar. (c) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an

Postponement in Certain Cases note under section 301 of this title.

Pub. L. 88–625, § 1, Oct. 3, 1964, 78 Stat. 1002, provided: “That this Act [amending provisions set out as a note under this section and section 135 of Title 7, Agriculture] may be cited as the ‘Food Additives Transitional Provisions Amendment of 1964’.” Updating Guidance Relating to Fish and Fisheries Products Hazards and Controls Pub. L. 111–353, title I, § 103(h), Jan. 4, 2011, 124 Stat. 3898, provided that: “The Secretary shall, not later than 180 days after the date of enactment of this Act [Jan. 4, 2011], update the Fish and Fisheries Products Hazards and Control Guidance to take into account advances in technology that have occurred since the previous publication of such Guidance by the Secretary.” Guidance Relating to Post Harvest Processing of Raw Oysters Pub. L. 111–353, title I, § 114, Jan. 4, 2011, 124 Stat. 3921, provided that: “(a) In General.—Not later than 90 days prior to the issuance of any guidance, regulation, or suggested amendment by the Food and Drug Administration to the National Shellfish Sanitation Program’s Model Ordinance, or the issuance of any guidance or regulation by the Food and Drug Administration relating to the Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration (parts 123 and 1240 of title 21, Code of Federal

(or any successor

)[)], where such guidance, regulation or suggested amendment relates to post harvest processing for raw oysters, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report which shall include—“(1) an assessment of how post harvest processing or other equivalent controls feasibly may be implemented in the fastest, safest, and most economical manner; “(2) the projected public health benefits of any proposed post harvest processing; “(3) the projected costs of compliance with such post harvest processing measures; “(4) the impact post harvest processing is expected to have on the sales, cost, and availability of raw oysters; “(5) criteria for ensuring post harvest processing standards will be applied equally to shellfish imported from all nations of origin; “(6) an evaluation of alternative measures to prevent, eliminate, or reduce to an acceptable level the occurrence of foodborne illness; and “(7) the extent to which the Food and Drug Administration has consulted with the States and other regulatory agencies, as appropriate, with regard to post harvest processing measures. “(b) Limitation.—Subsection (a) shall not apply to the guidance described in section 103(h) [section 103(h) of Pub. L. 111–353, set out as a note above]. “(c) Review and Evaluation.—Not later than 30 days after the Secretary issues a proposed regulation or guidance described in subsection (a), the Comptroller General of the United States shall—“(1) review and evaluate the report described in (a) and report to Congress on the findings of the estimates and analysis in the report; “(2) compare such proposed regulation or guidance to similar

For

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