Sec. 8. Environmental monitoring
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Section 412 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 350a ) is amended by adding at the end the following: A manufacturer of powdered infant formula shall establish and implement an environmental monitoring program to verify the effectiveness of sanitation and hygiene controls where the food has the potential to be exposed to Cronobacter spp. or Salmonella. The environmental monitoring program shall be written and include procedures for determining sampling location, number of samples to be taken, and timing and frequency of sample collection and testing.
A manufacturer of powdered infant formula shall ensure that the sampling locations from which samples will be taken, and the number of sites to be tested during routine environmental monitoring pursuant to an environmental monitoring program under paragraph (1), are adequate to determine whether sanitation and hygiene controls are effective. A manufacturer of powdered infant formula shall ensure that the timing and frequency for collecting testing samples pursuant to an environmental monitoring program under paragraph
(1)are adequate to determine whether sanitation and hygiene controls are effective. A manufacturer of powdered infant formula shall make all records required under this subsection available promptly to the Secretary, upon request, for inspection and copying. Records of environmental monitoring conducted pursuant to this subsection shall be maintained for not less than 2 years or the shelf-life of the infant formula, whichever is longer. Any records that the Secretary may inspect under this subsection shall, upon the request of the Secretary, be provided to the Secretary by the manufacturer of powdered infant formula, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such manufacturer. The Secretary’s request shall include a sufficient description of the records requested. Upon receipt of records requested under subparagraph (C), the Secretary shall provide to the person confirmation of receipt. Nothing in this subsection supplants the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act. The requirements of this subsection apply beginning on the date that is 180 days after the date of enactment of this subsection. Nothing in this subsection shall be construed to exempt an infant formula manufacturer from the requirements of this Act, including the requirements of this section and section 418. .
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Sec. 8
Environmental monitoring
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