Page:United States Statutes at Large Volume 100 Part 4.djvu/398

 100 STAT. 3207-119

Regulations.

PUBLIC LAW 99-570—OCT. 27, 1986

"(O assurances that the infant formula will not be marketed unless it meets the requirements of subsections (b)(l) and (i), as demonstrated by the testing required under subsection (b)(3), and "(D) assurances that the processing of the infant formula complies with subsection 03X2). "(2) Alter the first production of an infant formula subject to subsection (c), and before the introduction into interstate commerce of such formula, the manufacturer of such formula shall submit to the Secretary, in such form as may be prescribed by the Secretary, a written verification which summarizes test results and records demonstrating that such formula complies with the requirements of subsections (b)(D, (b)(2)(A), (b)(2)(B)(i), (b)(2)(B)(iii), (b)(SXA). (b)(BXC), and (i). "(3) If the manufacturer of an infant formula for commercial or charitable distribution for human consumption determines that a change in the formulation of the formula or a change in the processing of the formula may affect whether the formula is adulterated under subsection (a), the manufacturer shall, before the first processing of such formula, make the submission to the Secretary required by paragraph (1). ' (e)(1) If the manufacturer of an infant formula has knowledge which reasonably supports the conclusion that an infant formula which has been processed by the manufacturer and which has left an establishment subject to the control of the manufacturer— "(A) may not provide the nutrients required by subsection (i), or "(B) may be otherwise adulterated or misbranded, the manuiFacturer shall promptly notify the Secretary of such knowledge. If the Secretary determines that the infant formula presents a risk to human health, the manufacturer shall immediately take all actions necessary to recall shipments of such infant formula from all wholesale and retail establishments, consistent with recall regulations and guidelines issued by the Secretary. "(2) For purposes of paragraph (1), the term 'knowledge' as applied to a manufacturer means (A) the actual knowledge that the manufacturer had, or (B) the knowledge which a reasonable person would have had under like circumstances or which would have been obtained upon the exercise of due care. "(fKD If a recall of infant formula is begun by a manufacturer, the recall shall be carried out in accordance with such requirements as the Secretary shall prescribe under paragraph (2) and— "(A) the Secretary shall, not later than the 15th day after the beginning of such recall and at least once every 15 days thereafter luitil the recall is terminated, review the actions taken under the recall to determine whether the recall meets the requirements prescribed under paragraph (2), and "(B) the manufacturer shall, not later than the 14th day after the beginning of such recall and at least once every 14 days there£^»r until the recall is terminated, report to the Secretary the actions taken to implement the recall. "(2) The Secretary shall by regulation prescribe the scope and extent of recalls of infant formulas necessary and appropriate for the degree of risks to human health presented by the formula subject to the recall. "(3) The Secretary shall by regulation require each manufacturer of an infant formula who begins a recall of such formula because of

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