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prior to the date of the enactment of this Act [Aug. 1, 1956], shall be applicable as though this Act [amending this section and section 371 (e) of this title] had not been enacted."

TRANSFER OF FUNCTIONS

All functions of the Federal Security Administrator were transferred to the Secretary of Health, Education, and Welfare and all agencies of the Federal Security Agency were transferred to the Department of Health, Education, and Welfare by section 5 of 1953 Reorg. Plan No. 1, set out in the Appendix to Title 5, Government Organization and Employees. The Federal Security Agency and the office of Administrator were abolished by section 8 of 1953 Reorg. Plan No. 1.

See, also, note under section 321 of this title.

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 343, 371 of this title.

§ 342. Adulterated food.

A food shall be deemed to be adulterated(a) Poisonous, insanitary, etc., ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; or (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 sections 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; (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which

may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 348 of this title.

(b) Absence, substitution, or addition of constituents. (1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.

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ch. 675, § 402, 52 Stat. 1046; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237; Mar. 16, 1950, ch. 61, § 3 (d), 64 Stat. 20; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F. R. 2053, 67 Stat. 631; July 22, 1954, ch. 559, § 2, 68 Stat. 511; July 9, 1956, ch. 530, 70 Stat. 512; Sept. 6, 1958, Pub. L. 85-929, § 3 (a), (b), 72 Stat. 1784; Mar. 17, 1959, Pub. L. 86-2, 73 Stat. 3; July 12, 1960, Pub. L. 86-618, title I, §§ 102 (a) (1), (2), 105 (c), 74 Stat. 397, 404; June 29, 1966, Pub. L. 89-477, 80 Stat. 231; July 13, 1968, Pub. L. 90-399, § 104, 82 Stat. 352.) AMENDMENTS

1968 Subsec. (a) (2). Pub. L. 90-399 added item (iv) in cl. (A) and cl. (D), respectively.

1966 Subsec. (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 manfuacture, 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 regulations 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-Subsec. (a). Pub. L. 86-618, § 102(a)(1), substituted "other than one which is (1) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (ii) a color additive" for "(except a pesticide chemical in or on a raw agricultural commodity and except a food additive)" in cl. (2) (A).

Subsec. (c). Pub. L. 86-618, § 102(a)(2), amended subsection (c) generally by 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 regulations as provided by section 346 of this title. and eliminated provisos which related to the use of color on oranges.

Subsec. (d). Pub. L. 86-618, § 105(c), substituted "authorized coloring" for "harmless coloring."

1959-Subsec. (c). Pub. L. 86-2 extended from March 1, 1959 to May 1, 1959, the period during which subsection is inapplicable to oranges which have been colored with

F. D. & C. Red 32, and inserted proviso requiring Secretary to establish regulations prescribing the conditions under which Citrus Red No. 2 may be safely used in coloring certain mature oranges, and providing for separately listing and for certification of batches of such color.

1958 Subsec. (a). Pub. L. 85-929, among other changes, inserted clause (2) (C) relating to food additive unsafe within the meaning of section 348 of this title, and to pesticide chemical, and added clause (7), relating to radiated food.

1956 Subsec. (c). Act July 9, 1956, added second proviso relating to the coloring of oranges.

1954 Subsec. (a) (2). Act July 22, 1954, provided in the case of any raw agricultural commodity bearing or containing a pesticide chemical, that such commodity shall be deemed to be adulterated if such pesticide chemical is unsafe within the meaning of section 346a of this title.

1950 Subsec. (e). Act Mar. 16, 1950, added subsec. (e).

EFFECTIVE DATE OF 1968 AMENDMENT Amendment of subsec. (a) (2) of this section 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 a note under section 360b of this title.

EFFECTIVE DATE OF 1960 AMENDMENT

Amendment of section by Pub. L. 86-618 effective, subject to the provisions of section 203 of Pub. L. 86–618. on July 12, 1960, see section 202 of Pub. L. 86-618, set out as a note under section 376 of this title.

EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, AND DESICCANT AMENDMENT OF 1959 Effective date of subsec. (a) (2) of this section 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, set out as a note under section 135 of Title 7, Agriculture.

EFFECTIVE DATE OF 1958 AMENDMENT Section 6 of Pub. L. 85-929, 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 [sections 321 (s) and (t), 321 note, 331(1), 451 note, and 348 of this title, and 210(g) of Title 42, The Public Health and Welfare] 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 subsec. (a) of this section and section 346 (a) 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 subsec. (a) of this section and section 346 (a) of this title] shall take effect

"(1) Either (A) one year after the effective date established in subsection (b) of this section, or (B) at the end of such additional period (but not later than two years from such effective date established in subsection (b)) as the Secretary of Health, Education, and Welfare 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 effective date of section 3 of this Act [adding subsec. (a)(2) (C), (7) of 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 effective date, not beyond June 30, 1964, under the authority of that clause (but subject to clause (2)) with respect to such use of the additive (or a more limited specified use or uses thereof) if, in addition to making the findings required by clause (1) (B), he finds (i) that bona fide action to determine the applicability of such section 409 [section 348 of this title] to such use or uses, or to develop the scientific data necessary for action under such section, was commenced by an interested person before March 6, 1960, and was thereafter pursued with reasonable diligence, and (ii) that in the Secretary's judgment such extension is consistent with the objective of carrying to completion in good faith, as soon as reasonably practicable, the scientific investigations necessary as a basis for action under such section 409 [section 348 of this title]: Provided, That if the Secretary has, pursuant to this sentence, granted an extension to June 30, 1964, he may, upon making the findings required by clause (1) (B) of this subsection and clauses (i) and (ii) of this sentence, further extend such effective date, 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." EFFECTIVE DATE OF 1954 AMENDMENT

Section 5 of act July 22, 1954, provided that: "This Act [sections 321 (q), (r), 342 (a) (2), 346a and 346b of this title] shall take effect upon the date of its enactment [July 22, 1954], except that with respect to pesticide chemicals for which tolerances or exemptions have not been established under section 408 of the Federal Food, Drug, and Cosmetic Act [section 3468 of this title], the amendment to section 402 (a) of such Act [subsec. (a) (2) of this section] made by section 2 of this Act shall not be effective

"(1) for the period of one year following the date of the enactment of this Act [July 22, 1954]; or

"(2) for such additional period following such period of one year, but not extending beyond two years after the date of the enactment of this Act [July 22, 1954], as the Secretary of Health, Education, and Welfare may prescribe on the basis of a finding that conditions exist which necessitate the prescribing of such additional period."

EFFECTIVE DATE OF 1950 AMENDMENT Amendment of section by act Mar. 16, 1950, effective July 1, 1950, see note set out under section 347 of the title.

EFFECTIVE DATE; POSTPONEMENT

Subsec. (c) of this section effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as a note under section 392 of this title.

EFFECTIVE DATE

Section effective twelve months after June 25, 1938, see section 902 (a) of act June 25, 1938, set out as a note under section 392 of this title.

SHORT TITLE

Section 1 of Pub. L. 88-625, Oct. 3, 1964, 78 Stat. 1002, provided: "That this Act [which amended provisions set out as a note under this section and section 135 of Title 7] may be cited as the 'Food Additives Transitional Provisions Amendment of 1964"."

TRANSFER OF FUNCTIONS

All functions of the Federal Security Administrator were transferred to the Secretary of Health, Education, and Welfare and all agencies of the Federal Security Agency were transferred to the Department of Health. Education, and Welfare by section 5 of 1953 Reorg. Pian No. 1, set out in the Appendix to Title 5, Government Organization and Employees. The Federal Security Agency and the office of Administrator were abolished by section 8 of 1953 Reorg. Plan No. 1.

See, also, note under section 321 of this title.

CROSS REFERENCES Appropriations for establishing tolerances for pesticide chemicals, see section 346b of this title.

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 334, 346, 346a, 346b, 347b, 348, 360b, 376 of this title.

§ 343. Misbranded food.

A food shall be deemed to be misbranded

(a) False or misleading label.

If its labeling is false or misleading in any particular.

(b) Offer for sale under another name.

If it is offered for sale under the name of another food.

(c) Imitation of another food.

If it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word "imitation" and, immediately thereafter, the name of the food imitated.

(d) Misleading container.

If its container is so made, formed, or filled as to be misleading.

(e) Package form.

If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count: Provided, That under clause (2) of this subsection reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the Secretary.

(f) Prominence of information on label.

If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(g) Representation as to definition and standard of identity.

If it purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by section 341 of this title, unless (1) it conforms to such definition and standard, and (2) its label bears the name of the food specified in the definition and standard, and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food.

(h) Representation as to standards of quality and fill of container.

If it purports to be or is represented as―

(1) a food for which a standard of quality has been prescribed by regulations as provided by section 341, and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

(2) a food for which a standard or standards of fill of container have been prescribed by regulations as provided by section 341 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard.

(i) Label where no representation as to definition and standard of identity.

If it is not subject to the provisions of subsection (g) of this section unless its label bears (1) the common or usual name of the food, if any there be, and (2) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings without naming each: Provided, That, to the extent that compliance with the requirements of clause (2) of this subsection is impracticable, or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.

(j) Representation for special dietary use.

If it purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses.

(k) Artificial flavoring, artificial coloring, or chemical preservatives.

If it bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact: Provided, That to the extent that compliance with the requirements of this subsection is impracticable, exemptions shall be established by regulations promulgated by the Secretary. The provisions of this subsection and subsections (g) and (i) of this section with respect to artificial coloring shall not apply in the case of butter, cheese, or ice cream. The provisions of this subsection with respect to chemical preservatives shall not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil.

(1) Pesticide chemicals on raw agricultural commodities.

If it is a raw agricultural commodity which is the produce of the soil, bearing or containing a pesticide chemical applied after harvest, unless the shipping container of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the common or usual name and the function of such chemical: Provided, however, That no such declaration shall be required while such commodity, having been removed from the shipping container, is being held or displayed for sale at retail out of such container in accordance with the custom of the trade.

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(n) Packaging or labeling of drugs in violation of regulations.

If its packaging or labeling is in violation of an applicable regulation issued pursuant to section 1472 or 1473 of Title 15. (June 25, 1938, ch. 675, § 403, 52 Stat. 1047; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; June 29, 1960, Pub. L. 86-537, § 1, 74 Stat. 251; July 12, 1960, Pub. L. 86-618, title I, § 102(a) (3), 74 Stat. 398; Dec. 30, 1970, Pub. L. 91-601, § 7(c), 84 Stat. 1763.)

AMENDMENTS

1970 Subsec. (n). Pub. L. 91-601 added subsec. (n). 1960 Subsec. (k). Pub. L. 86-537, § 1(1), exempted pesticide chemicals when used in or on a raw agricultural commodity which is the produce of the soil.

Subsec. (1). Pub. L. 86-537, § 1(2), added subsec. (1). Subsec. (m). Pub. L. 86-618 added subsec. (m).

EFFECTIVE DATE OF 1970 AMENDMENT

Amendment by Pub. L. 91-601 effective Dec. 30, 1970, and regulations establishing special packaging standards effective no sooner than 180 days or later than one year from date regulations are final, or an earlier date published in Federal Register, see section 9 of Pub. L. 91601, set out as a note under section 1471 of Title 15, Commerce and Trade.

EFFECTIVE Date of 1960 AMENDMENT Amendment of section by Pub. L. 86-618 effective, subject to the provisions of section 203 of Pub. L. 86-618, on July 12, 1960, see section 202 of Pub. L. 86-618, set out as a note under section 376 of this title.

EFFECTIVE Date; PostponEMENT

Subsecs. (e) (1), (g)—(k) of this section effective Jan. 1, 1940 and such subsections effective July 1, 1940 as provided by regulations for certain lithographed labeling and containers bearing certain labeling, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as a note under section 392 of this title.

EFFECTIVE DATE

Section effective twelve months after June 25, 1938, see section 902 (a) of act June 25, 1938, set out as a note under section 392 of this title.

TRANSFER OF FUNCTIONS

All functions of the Federal Security Administrator were transferred to the Secretary of Health, Education, and Welfare and all agencies of the Federal Security Agency were transferred to the Department of Health, Education, and Welfare by section 5 of 1953 Reorg. Plan No. 1, set out in the Appendix to Title 5, Government Organization and Employees. The Federal Security Agency and the office of Administrator were abolished by section 8 of 1953 Reorg. Plan No. 1.

See, also, note under section 321 of this title.

STATE OR TERRITORIAL REQUIREMENTS

Section 2 of Pub. L. 86-537 provided that: "Nothing in the amendments made by the first section of this Act [amending subsec. (k) and adding subsec. (1)] shall affect any requirement of the laws of any State or Territory."

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 321, 371 of this title.

§ 344. Emergency permit control.

(a) Conditions on manufacturing, processing, etc., as health measure.

Whenever the Secretary finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with micro-organisms during the manufacture,

processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he then, and in such case only, shall promulgate regulations providing for the issuance, to manufacturers, processors, or packers of such class of food in such locality, of permits to which shall be attached such conditions governing the manufacture, processing, or packing of such class of food, for such temporary period of time, as may be necessary to protect the public health; and after the effective date of such regulations, and during such temporary period, no person shall introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by any such manufacturer, processor, or packer unless such manufacturer, processor, or packer holds a permit issued by the Secretary as provided by such regulations.

(b) Violation of permit; suspension and reinstatement.

The

The Secretary is authorized to suspend immediately upon notice any permit issued under authority of this section if it is found that any of the conditions of the permit have been violated. holder of a permit so suspended shall be privileged at any time to apply for the reinstatement of such permit, and the Secretary shall, immediately after prompt hearing and an inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued or as amended.

(c) Inspection of permit-holding establishments.

Any officer or employee duly designated by the Secretary shall have access to any factory or establishment, the operator of which holds a permit from the Secretary, for the purpose of ascertaining whether or not the conditions of the permit are being complied with, and denial of access for such inspection shall be ground for suspension of the permit until such access is freely given by the operator. (June 25, 1938, ch. 675. § 404, 52 Stat. 1048; 1940 Reorg. Plan No. IV. § 12. eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F. R. 2053, 67 Stat. 631.)

EFFECTIVE DATE

Section effective twelve months after June 25, 1938, see section 902(a) of act June 25, 1938, set out as a note under section 392 of this title.

TRANSFER OF FUNCTIONS

All functions of the Federal Security Administrator were transferred to the Secretary of Health, Education, and Welfare and all agencies of the Federal Security Agency were transferred to the Department of Health, Education. and Welfare by section 5 of 1953 Reorg. Plan No. 1, set out in the Appendix to Title 5, Government Organization and Employees. The Federal Security Agency and the office of Administrator were abolished by section 8 of 1953 Reorg. Plan No. 1.

See, also, note under section 321 of this title.

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 331, 333, 334, 371 of this title.

§ 345. Regulations making exemptions.

The Secretary shall promulgate regulations

exempting from any labeling requirement of this chapter (1) small open containers of fresh fruits and fresh vegetables and (2) food which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantities at establishments other than those where originally processed or packed, on condition that such food is not adulterated or misbranded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. (June 25, 1938, ch. 675, § 405, 52 Stat. 1049; 1940 Reorg. Plan No. IV. § 12, eff. June 30, 1940, 5 F. R. 2422, 54 Stat. 1237; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F. R. 2053, 67 Stat. 631.)

EFFECTIVE DATE

Section effective twelve months after June 25, 1938, see section 902 (a) of act June 25, 1938, set out as a note under section 392 of this title.

TRANSFER OF FUNCTIONS

All functions of the Federal Security Administrator were transferred to the Secretary of Health, Education, and Welfare and all agencies of the Federal Security Agency were transferred to the Department of Health, Education, and Welfare by section 5 of 1953 Reorg. Plan No. 1, set out in the Appendix to Title 5, Government Organization and Employees. The Federal Security Agency and the office of Administrator were abolished by section 8 of 1953 Reorg. Plan No. 1.

See, also, note under section 321 of this title.

§ 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 extend 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, § 406, 52 Stat. 1049; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; Sept. 6, 1958, Pub. L. 85-929, § 3(c), 72 Stat. 1785; July 12, 1960, Pub. L. 86-618, title I, § 103(a) (1), 74 Stat. 398.)

AMENDMENTS

1960-Pub. L. 86-618 repealed former subsec. (b), which required the Secretary to promulgate regulations for the 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 of section by Pub. L. 86-618 effective, subject to the provisions of section 203 of Pub. L. 86618, on July 12, 1960, see section 202 of Pub. L. 86-618, set out as a note under section 376 of this title.

EFFECTIVE DATE OF NEMATOCIDE, PLANT REGULATOR, DEFOLIANT, and Desiccant AMENDMENT OF 1959 Effective date of subsec. (a) of this section 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, set out as a note under section 135 of Title 7, Agriculture.

EFFECTIVE DATE OF 1958 AMENDMENT Effective date of 1958 amendment of subsec. (a), see section 6 (b), (c) of Pub. L. 85-929, set out as a note under section 342 of this title.

EFFECTIVE DATE

Section effective twelve months after June 25, 1938, see section 902 (a) of act June 25, 1938, set out as a note under section 392 of this title.

TRANSFER OF FUNCTIONS

All functions vested in the Secretary of Health, Education, and Welfare in establishing tolerances for pesticide chemicals under this section together with the authority to monitor compliance with the tolerances and the effectiveness of surveillance and enforcement and to provide technical assistance to the States and conduct research under this chapter and chapter 6A of Title 42, The Public Health and Welfare, were transferred to the Administrator of the Environmental Protection Agency by 1970 Reorg. Plan No. 3, § 2(a) (4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. set out in the Appendix to Title 5, Government Organization and Employees.

All functions of the Federal Security Administrator were transferred to the Secretary of Health, Education, and Welfare and all agencies of the Federal Security Agency were transferred to the Department of Health, Education, and Welfare by section 5 of 1953 Reorg. Plan No. 1, set out in the Appendix to Title 5, Government Organization and Employees. The Federal Security Agency and the office of Administrator were abolished by section 8 of 1953 Reorg. Plan No. 1.

See, also, note under section 321 of this title.

CROSS REFERENCES

Pesticide chemical regulations, see section 346a of this

title.

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in sections 337, 342, 371 of this title.

§ 346a. Tolerances for pesticide chemicals in or on raw agricultural commodities.

(a) Conditions of safety.

Any poisonous or deleterious pesticide chemical, or any pesticide chemical which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of pesticide chemicals, as safe for use, added to a raw agricultural commodity, shall be deemed unsafe for the purposes of the application of clause (2) of section 342 (a) of this title unless

(1) a tolerance for such pesticide chemical in or on the raw agricultural commodity has been prescribed by the Administrator of the Environmental Protection Agency under this section and

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