FSMA Preventive Controls Rule FAQs

To comprehensively review the answers to each of the FSMA Preventive Controls Rule Frequently Asked Questions, please see the following:

• Does FSMA Affect My Food Business? (.pdf)
• Is My Food Business a Farm? (.pdf)
• Is My Business a Farm Mixed-Type Facility? (.pdf)
• Is My Non-Farm Food Manufacturing Business Covered by FSMA? (.pdf)
• Is My Non-Farm Food Distribution Business Covered by FSMA? (.pdf)
• Is My Food Business Required to Register with FDA? (.pdf)
• What Are the Basic Requirements of FSMA’s Preventive Controls for Human Food Rule? (.pdf)
• What Are the Special FSMA Rules for Low-Risk Processing? (.pdf)
• What Are the Special Rules for Qualified Exempt Facilities? (.pdf)
• What Are FSMA’s GMP Requirements? (.pdf)
• What Are the Requirements of HARPC and SCP under FSMA? (.pdf)
• Is My Produce-Packing Operation Covered by the Preventive Controls Rule for Human Food? (.pdf)
• Is My Business Covered by the FSMA Rule for Transportation of Food? (.pdf)
• What Are the Allergen Labelling Requirements Under FSMA? (.pdf)

All files have been updated as of Dec. 2019.

The Preventive Controls Rule FAQs were created by the Carolina Farm Stewardship Association and the National Farmers Union Local Food Safety Collaborative. Financial support for these documents was provided by the Local Food Producer Outreach, Education, and Training to Enhance Food Safety and the project described was supported by the FSMA Compliance Cooperative Agreement 1U01FD005770 from the U.S. Food and Drug Administration, which was awarded to the National Farmers Union Foundation. However, these documents have not been approved by the U.S. Food and Drug Administration and their contents are solely the responsibility of the authors and do not necessarily represent the official views of the U.S. Food and Drug Administration. These FAQs were written to provide you with accurate information on the limited subject matters covered. However, all content was not necessarily prepared by a person licensed to practice law in your particular jurisdiction. This guide is designed to provide general information on pertinent compliance topics, and the statements made here are for educational purposes only. These statements do not constitute legal advice.