21 U.S.C. § 346 — Tolerances for poisonous or deleterious

Page 103 TITLE 21—FOOD AND DRUGS § 346 § 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 ac- cordance 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 condi- tion that such food is not adulterated or mis- branded under the provisions of this chapter upon removal from such processing, labeling, or repacking establishment. This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title. (June 25, 1938, ch. 675, § 405, 52 Stat. 1049; Pub. L. 101–535, § 5(a), Nov. 8, 1990, 104 Stat. 2362.) Editorial Notes AMENDMENTS 1990—Pub. L. 101–535 inserted at end ‘‘This section does not apply to the labeling requirements of sections 343(q) and 343(r) of this title.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1990 AMENDMENT Amendment by Pub. L. 101–535 effective six months after the date of the promulgation of final regulations to implement section 343(r) of this title, or if such regu- lations are not promulgated, the date proposed regula- tions are to be considered as such final regulations (Nov. 8, 1992), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101–535, set out as a note under section 343 of this title. CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535 Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Fed- eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title. Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator 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. § 346. Tolerances for poisonous or deleterious substances in food; regulations Any poisonous or deleterious substance added to any food, except where such substance is re- quired in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the applica- tion of clause (2)(A) of section 342(a) of this title; but when such substance is so required or can- not be so avoided, the Secretary shall promul- gate 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 appli- cation of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect lim- iting 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 dif- ferent 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 af- fected by the same or other poisonous or delete- rious substances. (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.) Editorial Notes AMENDMENTS 1960—Pub. L. 86–618 repealed subsec. (b) which re- quired 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. Statutory Notes and Related Subsidiaries 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. Executive Documents TRANSFER OF FUNCTIONS Functions vested in Secretary of Health, Education, and Welfare [now Health and Human Services] in estab- lishing 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 Environ- mental 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 Organiza- tion and Employees. For transfer of functions of Federal Security Admin- istrator 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. Page 104 TITLE 21—FOOD AND DRUGS § 346a § 346a. Tolerances and exemptions for pesticide chemical residues (a) Requirement for tolerance or exemption (1) General rule Except as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed unsafe for the purpose of sec- tion 342(a)(2)(B) of this title unless— (A) a tolerance for such pesticide chemical residue in or on such food is in effect under this section and the quantity of the residue is within the limits of the tolerance; or (B) an exemption from the requirement of a tolerance is in effect under this section for the pesticide chemical residue. For the purposes of this section, the term ‘‘food’’, when used as a noun without modifica- tion, shall mean a raw agricultural com- modity or processed food. (2) Processed food Notwithstanding paragraph (1)— (A) if a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a pes- ticide chemical residue that is present in or on a processed food because the food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title despite the lack of a tolerance for the pesticide chem- ical residue in or on the processed food if the pesticide chemical has been used in or on the raw agricultural commodity in conformity with a tolerance under this section, such res- idue in or on the raw agricultural com- modity has been removed to the extent pos- sible in good manufacturing practice, and the concentration of the pesticide chemical residue in the processed food is not greater than the tolerance prescribed for the pes- ticide chemical residue in the raw agricul- tural commodity; or (B) if an exemption for the requirement for a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a pesticide chem- ical residue that is present in or on a proc- essed food because the food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title. (3) Residues of degradation products If a pesticide chemical residue is present in or on a food because it is a metabolite or other degradation product of a precursor substance that itself is a pesticide chemical or pesticide chemical residue, such a residue shall not be considered to be unsafe within the meaning of section 342(a)(2)(B) of this title despite the lack of a tolerance or exemption from the need for a tolerance for such residue in or on such food if— (A) the Administrator has not determined that the degradation product is likely to pose any potential health risk from dietary exposure that is of a different type than, or of a greater significance than, any risk posed by dietary exposure to the precursor substance; (B) either— (i) a tolerance is in effect under this sec- tion for residues of the precursor sub- stance in or on the food, and the combined level of residues of the degradation prod- uct and the precursor substance in or on the food is at or below the stoichiometrically equivalent level that would be permitted by the tolerance if the residue consisted only of the precursor substance rather than the degradation product; or (ii) an exemption from the need for a tol- erance is in effect under this section for residues of the precursor substance in or on the food; and (C) the tolerance or exemption for residues of the precursor substance does not state that it applies only to particular named sub- stances and does not state that it does not apply to residues of the degradation product. (4) Effect of tolerance or exemption While a tolerance or exemption from the re- quirement for a tolerance is in effect under this section for a pesticide chemical residue with respect to any food, the food shall not by reason of bearing or containing any amount of such a residue be considered to be adulterated within the meaning of section 342(a)(1) of this title. (b) Authority and standard for tolerance (1) Authority The Administrator may issue regulations es- tablishing, modifying, or revoking a tolerance for a pesticide chemical residue in or on a food— (A) in response to a petition filed under subsection (d); or (B) on the Administrator’s own initiative under subsection (e). As used in this section, the term ‘‘modify’’ shall not mean expanding the tolerance to cover additional foods. (2) Standard (A) General rule (i) Standard The Administrator may establish or leave in effect a tolerance for a pesticide chemical residue in or on a food only if the Administrator determines that the toler- ance is safe. The Administrator shall mod- ify or revoke a tolerance if the Adminis- trator determines it is not safe. (ii) Determination of safety As used in this section, the term ‘‘safe’’, with respect to a tolerance for a pesticide chemical residue, means that the Adminis- trator has determined that there is a rea- sonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. (iii) Rule of construction With respect to a tolerance, a pesticide chemical residue meeting the standard