Source: https://www.govregs.com/uscode/21/348
Timestamp: 2020-08-10 11:14:48
Document Index: 359952198

Matched Legal Cases: ['§\u202f347', '§\u202f349', '§\u202f409', '§\u202f4', '§\u202f2', '§\u202f104', '§\u202f402', '§\u202f309', '§\u202f306']

21 USC 348 - Food additives
§ 347b. Contravention of State laws
§ 349. Bottled drinking water standards; publication in Federal Register
Unsafe food additives; exception for conformity with exemption or regulation
a notification submitted under subsection (h) that is effective.
Petition for regulation prescribing conditions of safe use; contents; description of production methods and controls; samples; notice of regulation
Approval or denial of petition; time for issuance of order; evaluation of data; factors
fails to establish that the proposed use of the food additive, under the conditions of use to be specified in the regulation, will be safe: Provided, That no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal, or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal, except that this proviso shall not apply with respect to the use of a substance as an ingredient of feed for animals which are raised for food production, if the Secretary finds (i) that, under the conditions of use and feeding specified in proposed labeling and reasonably certain to be followed in practice, such additive will not adversely affect the animals for which such feed is intended, and (ii) that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (f) and (g)) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal; or
Regulation issued on Secretary’s initiative
Publication and effective date of orders
Objections and public hearing; basis and contents of order; statement
In a case of actual controversy as to the validity of any order issued under subsection (f), including any order thereunder with respect to amendment or repeal of a regulation issued under this section, any person who will be adversely affected by such order may obtain judicial review by filing in the United States Court of Appeals for the circuit wherein such person resides or has his principal place of business, or in the United States Court of Appeals for the District of Columbia Circuit, within sixty days after the entry of such order, a petition praying that the order be set aside in whole or in part.
Notification relating to food contact substance
Subject to such regulations as may be promulgated under paragraph (3), a manufacturer or supplier of a food contact substance may, at least 120 days prior to the introduction or delivery for introduction into interstate commerce of the food contact substance, notify the Secretary of the identity and intended use of the food contact substance, and of the determination of the manufacturer or supplier that the intended use of such food contact substance is safe under the standard described in subsection (c)(3)(A). The notification shall contain the information that forms the basis of the determination and all information required to be submitted by regulations promulgated by the Secretary.
A notification submitted under paragraph (1) shall become effective 120 days after the date of receipt by the Secretary and the food contact substance may be introduced or delivered for introduction into interstate commerce, unless the Secretary makes a determination within the 120-day period that, based on the data and information before the Secretary, such use of the food contact substance has not been shown to be safe under the standard described in subsection (c)(3)(A), and informs the manufacturer or supplier of such determination.
The process in this subsection shall be utilized for authorizing the marketing of a food contact substance except where the Secretary determines that submission and review of a petition under subsection (b) is necessary to provide adequate assurance of safety, or where the Secretary and any manufacturer or supplier agree that such manufacturer or supplier may submit a petition under subsection (b).
The Secretary is authorized to promulgate regulations to identify the circumstances in which a petition shall be filed under subsection (b), and shall consider criteria such as the probable consumption of such food contact substance and potential toxicity of the food contact substance in determining the circumstances in which a petition shall be filed under subsection (b).
Food additives intended for use in animal food
In taking action on a petition under subsection (c) for, or for recognition of, a food additive intended for use in animal food, the Secretary shall review reports of investigations conducted in foreign countries, provided by the petitioner.
Not later than 12 months after August 14, 2018, the Secretary shall post on the internet website of the Food and Drug Administration—
the number of petitions for food additives intended for use in animal food filed under subsection (b) that are pending;
how long each such petition submitted under subsection (b) has been pending, including such petitions the Secretary has extended under subsection (c)(2); and
the number of study protocols that have been pending review for over 50 days, and the number that have received an extension.
In the case of a food additive petition intended for use in animal food, the Secretary shall provide information to the petitioner on the required contents of such petition. If the Secretary requires additional studies beyond what the petitioner proposed, the Secretary shall provide the scientific rationale for such requirement.
(June 25, 1938, ch. 675, § 409, as added Pub. L. 85–929, § 4, Sept. 6, 1958, 72 Stat. 1785; amended Pub. L. 86–546, § 2, June 29, 1960, 74 Stat. 255; Pub. L. 87–781, title I, § 104(f)(1), Oct. 10, 1962, 76 Stat. 785; Pub. L. 98–620, title IV, § 402(25)(B), Nov. 8, 1984, 98 Stat. 3359; Pub. L. 105–115, title III, § 309, Nov. 21, 1997, 111 Stat. 2354; Pub. L. 115–234, title III, § 306(a), Aug. 14, 2018, 132 Stat. 2440.)
cite as: 21 USC 348