Food

Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need to Know About the FDA Regulation; Small Entity Compliance Guide

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How to Comment

You may submit either electronic or written comments regarding this guidance at any time.

Submit electronic comments on https://www.regulations.gov to docket number FDA-2011-N-0143.

Submit written comments to:

Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852
All comments should be identified with the docket number FDA-2011-N-0143.

 

Contains Nonbinding Recommendations

January 2018

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 for Industry 

Page Last Updated: 09/15/2018
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