On May 27, 2016, FDA finalized its seventh and final food safety rule under the Food Safety Modernization Act (FSMA). The Intentional Adulteration rule establishes requirements to help protect food against adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism. For the first time, domestic and foreign food facilities will be required to complete and maintain written food defense plans assessing their potential vulnerabilities to deliberate contamination where the intent is to cause wide-scale public health harm.
Under FDA guidelines, a bakery would need to register as a food facility if it's wholesale component is exceeds its retail component. There is no exception for size. Food facilities that qualify as "very small business" (sales less than $10 million annually) may have more time to comply with rules if specified.
From the FDA's Guidance for the Industry:
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