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          Small Entity Compliance Guide: Foreign Supplier Verification Programs for Importers of Food for Humans and AnimalsSearch for FDA Guidance Documents SMALL ENTITY COMPLIANCE GUIDE
	Small Entity Compliance Guide: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
					
		
		January 2018


	Download the  Final Small Entity Compliance Guide
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2011-N-0143
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


The FDA Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On November 27, 2015, FDA published the final rule *Foreign Supplier Verification Programs for Importers of Food for Humans and Animals* (FSVP regulation) (80 FR 74225).

This regulation became effective on January 26, 2016. It creates new requirements for importers of food for humans and animals.

This regulation requires importers to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.  The regulation has a set of standard requirements for larger importers, and a modified set of procedures for importers that meet the definition of “very small importer.”  There are also modified procedures that can be used when importing from certain small foreign suppliers.

We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guide will focus on the modified procedures for very small importers or importers of food from certain small foreign suppliers. The FSVP regulation is binding and has the full force and effect of law.

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 recommendation, unless specific regulatory or statutory requirements are cited. The use of the word *should* in FDA guidances means that something is suggested or recommended, but not required.

**Purpose of This Compliance Guide**

This guide was developed to inform U.S. importers about the FSVP regulation and how to comply with it. It contains important information that may affect your firm.

**Key Requirements**

The FSVP regulation applies to importers of food into the United States and contains binding requirements for those subject to the rule. For purposes of this rule, an importer is the U.S. owner or consignee of a food offered for import into the United States. (A U.S. owner or consignee of an imported food is defined as a person who, at the time of entry, owns the food, has purchased it, or has agreed in writing to purchase it.) If there’s no U.S. owner or consignee at the time of entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee.

In general, the requirements of the FSVP regulation apply to all food imported or offered for import into the United States, unless an exemption applies under 21 CFR 1.501.

The FSVP regulation establishes requirements relating to:

Use of qualified individuals to conduct FSVP activities,
	Hazard analysis,
	Food and supplier evaluation,
	Foreign supplier verification,
	Corrective actions,
	Recordkeeping, and
	Importer identification for a food offered for entry into the United States*.***Download the Guidance**

Related Information

FSMA Rule on FSVP for Importers of Food for Humans and Animals
	Additional FSMA GuidanceSubmit 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-2011-N-0143.

                                                                                  Content current as of:
      01/25/2018
         
                  
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