. /.  WORLD TRADE  
ORGANIZATION   
G/TBT/N/USA/32/Add.10 
10 January 2013  
 (13-0123) 
Committee on Technical Barriers to Trade Original:   English 
  
 
NOTIFICATION  
 
Addendum 
  
 The following communication, dated 18 December 2012, is being circulated at the request of 
the delegation of the United States of America.  
 
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TITLE:  Small Entity Compliance Guide: What Y ou Need To Know About Registration of Food 
Facilities; Availability  
AGENCY:  Food and Drug Administration (FDA), Health and Human Services (HHS) ACTION:  Notice SUMMARY:  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 consumption in  the United States submit additional registration 
information to FDA, including an assurance that FDA will be permitted to inspect the facility at the 
times and in the manner permitted by the FD&C Act.  Section 415 of the FD&C Act, as amended by 
FSMA, also requires food facilities required to regist er with FDA to renew such registrations every 
other year and provides FDA with authority to susp end the registration of a food facility in certain 
circumstances. G/TBT/N/USA/32/Add.10 
Page 2  
 
  FDA has prepared this guidance to restate the le gal requirements in section 415 of the FD&C Act.  
Previously, this guidance restated the legal require ments of FDA's food facility registration regulation 
at 21 CFR Part 1, Subpart H (§§ 1.225 through 1.243 ), implementing section 415 of the FD&C Act, as 
added by the Public Health Security and Bioterro rism Preparedness and Res ponse Act of 2002.  This 
guidance also served as FDA's Small Entity Complia nce Guide for 21 CFR Part 1, Subpart H in 
accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act 
(Public Law 104-121).  Because section 415 of th e 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 inte nded to help any entity comply with the 
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 guidance, "Small Entity Compliance Guide: Wh at You Need To Know About Registration of 
Food Facilities," can be found at: http://www.fda.gov/Food/GuidanceComplianceRegul atoryInformation/GuidanceDocuments/FoodDef
enseandEmergencyResponse/ucm331957.htm  
DATES:  Comments can be submitted at any time. 
 URLs:  http://www.gpo.gov/fdsys/pkg/FR-2012-12-17/html/2012-30327.htm  
http://www.gpo.gov/fdsys/pkg/FR -2012-12-17/pdf/2012-30327.pdf  
 
  
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