. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/691/Add.12 
4 January 2013  
 (13-0023) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Addendum 
  
The following communication, received on 21 December 2012, is being circulated at the 
request of the Delegation of the United States of America. 
 
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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".  F DA has prepared this guidance to restate the legal requirements 
pertaining to registration of food facilities in the Federal Food, Drug, and Co smetic Act (the FD&C 
Act), as amended by the FDA Food Safety Moderni zation Act (FSMA).  Previously, this guidance 
restated the legal requirements of FDA's food faci lity 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 En tity Compliance Guide for FDA's food facility 
registration regulation. 
 The FDA Food Safety Modernization Act ( FSMA), enacted on 4 January 2011, amended 
section 415 of the FD&C Act, in relevant part, to  require that facilities engaged in manufacturing, 
processing, packing, or holding food for cons umption in the United States submit additional 
registration information to FDA, including an assu rance that FDA will be permitted to inspect the 
facility at the times and in the manner permitted by th e FD&C Act.  Section 415 of the FD&C Act, as 
amended by FSMA, also requires food facilities requi red to register with FDA to renew such 
registrations every other year and provides FDA with  authority to suspend the registration of a food 
facility in certain circumstances. 
 FDA has prepared this guidance to restate th e legal requirements in section 415 of the FD&C 
Act.  Previously, this guidance restated the le gal requirements of FDA's food facility registration 
regulation at 21 CFR Part 1, Subpart H (§§ 1. 225 through 1.243), implem enting section 415 of the 
FD&C Act, as added by the Public Health Secur ity and Bioterrorism Preparedness and Response Act 
of 2002.  This guidance also served as FDA's Sm all Entity Compliance Guide for 21 CFR Part 1, 
Subpart H in accordance with section 212 of the Small Business Regulator y Enforcement Fairness 
Act (Public Law 104-121).  Because section 415 of  the FD&C Act was amended by section 102 of 
FSMA in 2011, FDA is revising this document to provide guidance on section 415 of the FD&C Act, 
as amended by FSMA.  This updated guidance is intended to help any entity comply with the G/SPS/N/USA/691/Add.12 
Page 2  
 
  requirements of section 415 of the FD&C Act, in cluding the amendments made by section 102 of 
FSMA.  This document continues to serve as FDA's Small Entity Compliance Guide for 21 CFR 
Part 1, Subpart H. 
 The Federal Register Notice 77 FR 74582 notice, which published on 17 December 2012, can 
be found on http://www.gpo.gov/fdsys/pkg/FR -2012-12-17/pdf /2012-30327.pdf . 
 The guidance, "Small Entity Compliance Gu ide:  What You Need To Know About 
Registration of Food Facilities" can be found at either http://www.fda.gov/FoodGuidances ,  
"http://www.fda.gov/Food/GuidanceComplianceRegul atoryInformation/GuidanceDocuments/FoodDe
fenseandEmergencyResponse/ucm331957.htm ", or http://www.regulations.gov .   
This addendum concerns a: 
[ ] Modification of final date for comments 
[ ] Notification of adoption, publication or entry into force of regulation 
[X] Modification of content and/or scope of previously notified draft regulation 
[ ] Withdrawal of proposed regulation 
[ ] Change in proposed date of adoption, publication or date of entry into force 
[ ] Other:    
Comment period:  (If the addendum extends the scope of th e previously notified measure in terms 
of products and/or potentially affected Members, a new deadline for receipt of comments should be 
provided, normally of at least 60 calendar days.  Under other circumstances, such as extension of 
originally announced final date for comments, th e comment period provided in the addendum may 
vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) :  Submit comments at any time.  
Agency or authority designated to handle comments:  [ ] National Notification Authority, 
[ ] National Enquiry Point.  Address, fax num ber and e-mail address (if available) of other 
body: 
Submit electronic comments on the guidance to http://www.regulations.gov .  Submit written 
comments on the guidance to the Division of Do ckets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  Please indicate Docket 
No FDA-2012-D-1003 when submitting comments.  Submit written requests for single copies of the guidance to the Office of Compliance, Division of Field Programs and Guidance, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 5100 Paint Branch Pkwy., 
College Park, MD 20740. 
Text available from:  [X] National Notification Au thority, [ ] National Enquiry Point.  Address, 
fax number and e-mail address (if available) of other body: 
United States SPS National Notification Authority, US DA Foreign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 10 14, Washington D.C. 20250;  Tel:  +(1 202) 720 
1301;  Fax:  +(1 202) 720 0433;  E-mail :  us.spsenquirypoint@fas.usda.gov  
 
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