This fact sheet describes the process for establishing and changing the Food Safety Modernization Act’s Produce Safety Rule and explains the relative legal effect of FDA regulations, guidance, and other FDA communications, particularly those that come through the Technical Assistance Network and Produce Safety Network.
Producers subject to the Food Safety Modernization Act’s Produce Safety Rule (FSMA PSR) have asked questions about the process for changing the FSMA PSR, and about the relationship between the Food and Drug Administration’s (FDA) rules, guidance, and other communications. This factsheet describes the process for establishing and changing the FSMA PSR, and explains the relative legal effect of FDA regulations, guidance, and other FDA communications, particularly those that come through the Technical Assistance Network (TAN) and Produce Safety Network (PSN).
Suggested Citation
Understanding the Relationship Between FDA Rules, Guidance, and Other Communications, NECAFS & Vt. L. Sch. Ctr. for Agric. & Food Sys. (July 1, 2020), https://elsi.necafs.org/sites/default/files/uploads/fda_rules_guidance_factsheet.pdf.