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          Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)
					
		
		August 2018


	Download the  Final Guidance Document
	    
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    PrintDocket Number:
		    FDA-2012-D-1002
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Center for Food Safety and Applied Nutrition


On October 10, 2003, the Food and Drug Administration (FDA or we) issued an interim final rule to implement amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act) (Pub. L. 107-188) (68 FR 58894). Section 415 of the FD&C Act (21 U.S.C. 350d) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with FDA. This guidance was developed to answer frequently asked questions relating to the registration requirements of section 415 of the FD&C Act.

The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353), enacted on January 4, 2011, amended the food facility registration requirements in section 415 of the FD&C Act.

The first edition of this document was issued as Level 2 guidance pursuant to Title 21, Code of Federal Regulations (CFR), Section 10.115 (21 CFR 10.115) and was made available on FDA's website on December 4, 2003. The second, third, fourth, and fifth editions of this document were issued as Level 1 guidance documents pursuant to 21 CFR 10.115 and were made available on FDA’s website on January 12, 2004, February 17, 2004, August 2004, and December 2012, respectively. The sixth edition was issued as Level 1 guidance and included one additional question and answer relating to a proposed change to the “farm” definition in 21 CFR 1.227 (79 FR 58524; September 29, 2014). The new question and answer was identified with the date that it was added to the guidance. The sixth edition was immediately effective because FDA had determined that prior public participation was not feasible or appropriate.

This revision (Seventh Edition) is being issued as Level 1 guidance pursuant to 21 CFR
10.115 and includes additional questions and answers relating to issues regarding food facility registration, including issues related to the following rulemakings: the Amendments to Registration of Food Facilities final rule (Registration Final Rule) (81 FR 45912; July 14, 2016) that revised FDA’s registration regulation; Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (80 FR 55907; Sept. 17, 2015); and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (80 FR 56170; Sept. 17, 2015). We also revised information in existing questions and answers, deleted some questions and answers, and made editorial changes (e.g., reorganized existing questions and answers) to improve clarity.

“I”, “you,” “your” or “registrant” are used in this guidance to refer to the owner, operator, or agent in charge of a facility that manufacturers/processes, packs, or holds food for consumption in the United States.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word *should*in Agency guidances means that something is suggested or recommended, but not required.

**Download the Guidance**

Related Information

Supplemental Questions and Answers
	Registration of Food Facilities
	Guides on Online Registration of Food FacilitiesSubmit Comments
	   		  			    		Submit Comments Online
					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
							Food and Drug Administration
							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2012-D-1002.

                                                                                  Content current as of:
      08/20/2018
         
                  
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