FDA proposes to exempt farms that sell directly to consumers from registration requirement.

  • Many requirements of the FDA Food Safety Modernization Act (FSMA) are linked to FDA’s facility registration requirement.  For instance, FDA registration is the key trigger for compliance with FSMA’s hazard analysis and risk-based preventive control (HARPC) requirements.
  • FDA has issued a proposed rule to amend and improve its food facility registration regulations.  The proposed rule would exempt from registration farms that only sell food directly to consumers (e.g., through roadside stands and farmers’ markets).
  • Although the novel aspect of the proposal applies only to farm-direct sales, it bears noting that FDA’s new rule would codify other FSMA requirements related to registration more generally, e.g., the requirement to include email addresses in the registration form, the biennial renewal requirement, and the requirement for facilities to expressly acknowledge that FDA is permitted to accept the facility in accordance with its existing legal authority.