PUBLIC LAW 96-359—SEPT. 26, 1980
94 STAT. 1191
"(3) Before the first processing of any infant formula for commercial or charitable distribution for human consumption— "(A) after a change in its formulation, or "(B) after a change in its processing, which the manufacturer reasonably determines may affect whether the formula is adulterated as determined under subsection (a)(1), the manufacturer shall notify the Secretary of such changes and that the formula provides nutrients in accordance with subsection (g) and meets the quality factor requirements prescribed by the Secretary and that the processing of such infant formula is in compliance with the quality control procedures prescribed by the Secretary. "(c)(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 (g); or "(B)(i) may be otherwise adulterated or misbranded, and "(ii) if so adulterated or misbranded presents a risk to human health, the manufacturer shall promptly notify the Secretary of such noncompliance or risk to health. "(2) For purposes of paragraph (1), the term 'knowledge' as applied "Knowledge, 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. "(d)(1) If a recall of an infant formula is begun by a manufacturer, Recall. the recall shall be carried out in accordance with such requirements as the Secretary may prescribe under paragraph (2), and— "(A) the Secretary shall, not later than the 15th day after the Review. beginning of such recall and at least once every 15 days thereafter until 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 Report to the beginning of such recall and at least once every 14 days Secretary. thereafter 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 Regulations. extent of recalls of infant formulas necessary and appropriate for the degree of risk to human health presented by the formula subject to the recall. "(e)(1) Each manufacturer of an infant formula shall make and Records. retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the formula. No manufacturer shall be required under this subsection to retain any record respecting the distribution of an infant formula for a period of longer than 2 years from the date the record was made. "(2) To the extent that the Secretary determines that records are not being made or maintained in accordance with paragraph (1), the Secretary may by regulation prescribe the records required to be made under paragraph (1) and requirements respecting the retention of such records under such paragraph. Such regulations shall take effect on such date as the Secretary prescribes but not sooner than the 180th day after the date such regulations are promulgated. Such regulations shall apply only with respect to distributions of infant formulas made after such effective date.
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