Sec. 7. Environmental monitoring
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Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 341 et seq. ), as amended by section 3, is further amended by adding the following: A manufacturer of infant and toddler food (other than infant formula) shall establish and implement an environmental monitoring program to verify the effectiveness of sanitation and hygiene controls during the manufacturing and packaging process where the food has the potential to be exposed to pathogens. The environmental monitoring program shall be written and include procedures for determining sample location, number of samples to be taken, and timing and frequency of sample collection and testing.
The environmental monitoring program under subsection
(a)shall include testing for environmental pathogens or a reliable indicator organism. A manufacturer of infant and toddler food shall ensure that the sampling locations from which samples will be taken, and the number of sites to be tested during routine environmental monitoring are adequate to determine whether sanitation and hygiene controls are effective. The timing and frequency for collecting and testing samples shall be adequate to determine whether sanitation and hygiene controls are effective, and shall occur not less frequently than every 3 years. A manufacturer of infant and toddler food shall make all the records required under this section available promptly to the Secretary, upon request by the Secretary, for inspection and copying. Records of environmental sampling, testing, and monitoring conducted pursuant to this section shall be established and maintained by the manufacturer for not less than 2 years or the shelf life of the food, whichever is longer. Any records or other information that the Secretary may inspect under this section shall, upon the request of the Secretary, be provided to the Secretary by the manufacturer, in advance of, at the time of, or in the case in which an in-person inspection would be unsafe, in lieu of, an in-person, on-site 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 the records requested under paragraph (3), the Secretary shall provide to the manufacturer confirmation of receipt. Nothing in this section 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 section shall apply beginning on the date that is 2 years after the date of enactment of the Baby Food Safety Act of 2024 . Nothing in this section shall be construed to exempt any manufacturer from the requirements of this Act, including the requirements under section 418. .
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Sec. 7
Environmental monitoring
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