FDA Releases Small Entity Compliance Guide on FSMA Intentional Adulteration Rule

The Food and Drug Administration issued a guidance document to help small businesses comply with new Food Safety Modernization Act regulations on intentional adulteration of food, it said. The small entity compliance guide includes information on who must comply with the rule, when compliance is required, food defense and recordkeeping requirements under the final rule, and information on required education and training. Small businesses must comply with the final rule by July 27, 2020. Very small businesses are only subject to documentation requirements that take effect July 26, 2021. The May 2016 final rule requires domestic and foreign food facilities to develop plans to address terrorism risks, but does not apply to carriers nor does it address intentional adulteration such as by disgruntled employees or motivated by economic reasons (see 1605260013).