Small Entity Compliance Guide: What You Need To Know About Registration of Food Facilities; Availability

The Food and Drug Administration (FDA) is announcing the availability of an updated guidance for industry entitled "What You Need To Know About Registration of Food Facilities--Small Entity Compliance Guide." FDA has prepared this guidance to restate the legal requirements pertaining to registration of food facilities in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). Previously, this guidance restated the legal requirements of FDA's food facility registration regulation. This document also served as FDA's Small Entity Compliance Guide for FDA's food facility registration regulation in accordance with the Small Business Regulatory Enforcement Fairness Act. FDA is revising this document to provide guidance intended to help any entity comply with the requirements pertaining to registration of food facilities in the FD&C Act, including the amendments made by FSMA. This document continues to serve as FDA's Small Entity Compliance Guide for FDA's food facility registration regulation. Further, this guidance is intended to set forth in plain language the requirements for registration of food facilities and help small businesses understand the requirements.