Page:United States Statutes at Large Volume 100 Part 4.djvu/396

 100 STAT. 3207-117



Regulations.

PUBLIC LAW 99-570—OCT. 27, 1986

"(ii) regularly scheduled testing, by the manufacturer of an infant formula or an agent of such manufacturer, of samples of infant formulas during the shelf life of such formulas to ensure that such formulas are in compliance with this section, "(iii) in-process controls including, where necessary, testing required by good manufacturing practices designed to prevent adulteration of each batch of infant formula, and "(iv) the conduct by the manufacturer of an infant formula or an agent of such manufacturer of regularly scheduled audits to determine that such manufacturer has complied with the regulations prescribed under subparagraph (A). In prescribing requirements for audits under clause (iv), the Secretary shall provide that such audits be conducted by appropriately trained individuals who do not have any direct responsibility for the manufacture or production of infant formula. "(3)(A) At the final product stage, each batch of infant formula shall be tested for vitamin A, vitsmiin Bl, vitamin C, and vitamin E to ensure that such infemt formula is in compliance with the requirements of this subsection and subsection (i) relating to such vitamins. "(B) Each nutrient premix used in the manufacture of an infant formula shall be tested for each relied upon nutrient required by subsection (i) which is contained in such premix to ensure that such premix is in compliance with its specifications or certifications by a premix supplier. "(C) During the manufacturing process or at the final product stage and before distribution of an infant formula, an infant formula s h ^ l be tested for all nutrients required to be included in such formula by subsection (i) for which testing has not been conducted pursuant to subparagraph (A) or (B). Testing under this subparagraph shall be conducted to— "(i) ensure that each batch of such infant formula is in compliance with the requirements of subsection (i) relating to . c such nutrients, and "(ii) confirm that nutrients contained in any nutrient premix used in such infant formula are present in each batch of such infsmt formula in the proper concentration. "(D) If the Secretary adds a nutrient to the list of nutrients in the table in subsection (i), the Secretary shall by regulation require that the manufacturer of an infant formula test each batch of such formula for such new nutrient in accordance with subparagraph (A), (B),or(C). "(E) For purposes of this paragraph, the term 'final product stage' means the point in the manufacturing process, before distribution of an infant formula, at which an infant formula is homogenous and is not subject to further degradation. "(4)(A) The Secretary shall by regulation establish requirements respecting the retention of records. Such requirements shall provide for— "(i) the retention of all records necessary to demonstrate compliance with the good manufacturing practices and quality control procedures prescribed by the Secretary under paragraph (2), including records containing the results of all testing required under paragraph (2)(B), ^ "(ii) the retention of all certifications or guarantees of analysis by premix suppliers, i.

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