This bill changes the Federal Food, Drug, and Cosmetic Act to set new testing and notification rules for infant formula. It requires manufacturers to test their manufacturing facilities and finished infant formula products for specific pathogens and microorganisms. The Food and Drug Administration (FDA) must make a list of pathogens to test for, which must include clostridium botulinum, and must set how often environmental testing should happen, including in Zones 2 and 3 of facilities. Manufacturers must notify the FDA in writing within one business day after any positive test result for a listed pathogen in infant formula. Manufacturers must also keep records of any positive test results for pathogens found in the product or the facility. The FDA must establish consistent inspection and compliance standards for all infant formula products, no matter where they come from. The bill requires the FDA to issue final regulations carrying out these changes within 90 days of the law taking effect.
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