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U.S. Department of Health and Human Services

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Guidance for Industry: Enforcement Policy Concerning Certain Prior Notice Requirements

Contains Nonbinding Recommendations

June 2011

Additional copies are available from:
Office of Compliance
Center for Food Safety and Applied Nutrition
5100 Paint Branch Parkway, HFS-600
College Park, MD 20740
Phone: 240-402-2359; Fax: 301-436-2717

 

U.S. Department of Health and Human Services
Food and Drug Administration

June 2011


Contains Nonbinding Recommendations


Guidance for Industry

Enforcement Policy Concerning Certain Prior Notice Requirements

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance

I. INTRODUCTION

This document provides guidance to submitters of prior notice of imported food on enforcement of FDA’s interim final rule, “Information Required in Prior Notice of Imported Food” (76 FR 25542, May 5, 2011). This guidance contains information regarding the Agency’s enforcement policy regarding the reporting requirement in the interim final rule. 

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s 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.

II. DISCUSSION

On May 5, 2011, FDA published an interim final rule “Information Required in Prior Notice of Imported Food” (76 FR 25542). The interim final rule amended the Agency’s regulations on prior notice of imported food. As required by section 304 of the FDA Food Safety Modernization Act (FSMA), FDA issued the interim final rule to require an additional element of information in a prior notice of imported food. The change requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry. Section 304 of FSMA also required that the interim final rule be published no later than 120 days following the date of enactment of the legislation and that the amendment made by section 304 take effect 180 days after the date of enactment. The effective date of the interim final rule is July 3, 2011. 

Because prior notice must be submitted electronically, the agency must make changes to several of its information technology systems including the Prior Notice System Interface (PNSI) and the Operational and Administrative System for Import Support (OASIS) in order to receive and process the new information. Because these changes will not be completed by the July 3, 2011, effective date, the agency does not intend to enforce the interim final rule’s requirement that the prior notice submission include the name of any country to which the article has been refused entry until September 6, 2011, when those changes will have been made. This compliance policy is limited to the new information required by the interim final rule. FDA’s compliance policy for the other prior notice requirements under 21 CFR 1.276-1.285, which were in effect prior to July 3, 2011, is contained in “Compliance Policy Guide - Guidance for FDA and CBP Staff: Prior Notice of Imported Food” (May 2009), available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/
FoodDefenseandEmergencyResponse/ucm153055.htm
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