Page:United States Statutes at Large Volume 100 Part 4.djvu/397

 PUBLIC LAW 99-570—OCT. 27, 1986

100 STAT. 3207-118

"(iii) the retention by a premix supplier of all records necessary to confirm the accuracy of all premix certifications and guarantees of analysis, "(iv) the retention of— "(I) all records pertaining to the microbiological quality and purity of raw materials used in infant formula powder and in finished infant formula, and "(II) all records pertaining to food packaging materials which show that such materials do not cause an infant formula to be adulterated within the meaning of section 402(a)(2)(C), "(v) the retention of all records of the results of regularly . scheduled audits conducted pursuant to the requirements prescribed by the Secretary under paragraph (2)(B)(iv), and "(vi) the retention of all complaints and the maintenance of files with respect to, and the review of, complaints concerning infant formulas which may reveal the possible existence of a hazard to health. "(B)(i) Records required under subparagraph (A) with respect to an infant formula shall be retained for at least one year after the expiration of the shelf life of such infant formula. Except as provided in clause (ii), such records shall be made available to the Secretary for review and duplication upon request of the Secretary, "(ii) A manufacturer need only provide written assurances to the Secretary that the regularly scheduled audits required by paragraph (2)(B)(iv) are being conducted by the manufacturer, and need not make available to the Secretary the actual written reports of such audits. "(c)(1) No person shall introduce or deliver for introduction into interstate commerce any new infant formula unless— "(A) such person has, before introducing such new infant formula, or delivering such new infant formula for introduction, into interstate commerce, registered with the Secretary the name of such person, the place of business of such person, and all establishments at which such person intends to manufacture such new infant formula, and "(B) such person has at least 90 days before marketing such new infant formula, made the submission to the Secretary required by subsection (c)(1). "(2) For purposes of paragraph (1), the term 'new infant formula' includes— "(A) an infant formula manufactured by a person which has not previously manufactured an infant formula, and "(B) an infant formula manufactured by a person which has previously manufactured infant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer. For purposes of this paragraph, the term 'major change' has the meaning given to such term in section 106.30(c)(2) of title 21, Code o,. Federal Regulations (as in effect on August 1, 1986), and guidelines issued thereunder. "(d)(1) A person shall, with respect to any infant formula subject to subsection (c), make a submission to the Secretary which shall include— "(A) the quantitative formulation of the infant formula, "(B) a description of any reformulation of the formula or change in processing of the infant formula,

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