Fact Sheet

Understanding the Relationship Between FDA Rules, Guidance, and Other Communications

July 2020   |   Extension Legal Services Initiative
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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.

For references and endnotes, please refer to the PDF version of this document.

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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.  

Sophia Kruszewski

Former Director, Food and Agriculture Clinic, Center for Agriculture and Food Systems

Sophia Kruszewski JD’13 is the Deputy Policy Director at the National Sustainable Agriculture Coalition (NSAC) and was formerly an assistant professor at Vermont Law School, where she directed the Food and Agriculture Clinic at the Center for Agriculture and Food Systems.

Elizabeth Newbold

Assistant Director, University of Vermont Extension, Northeast Center to Advance Food Safety

Elizabeth Newbold is the Assistant Director for the Northeast Center to Advance Food Safety (NECAFS), one of four USDA funded regional centers tasked with coordinating training, education and outreach related to the FSMA Produce Safety Rule and the FSMA Preventive Controls for Human Foods Rule. Her work focuses on coordination and facilitation of the Northeast regional network to support a national food safety training, education, extension, outreach, and technical assistance system among small and medium-sized producers and small processors.