What is FSVP?
FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling.
Who Is Covered by the FSVP Rule?
The FSVP importer is the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it at the time of U.S. entry). If there is no U.S. owner or consignee at time of entry, the FSVP importer is the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent. The key is that there be a FSVP importer in the United States who takes responsibility for meeting the FSVP requirements.
What Will I Have to Do Under the FSVP rule?
Unless exempt, or subject to modified requirements, an FSVP importer may need to perform the following activities: · Use a qualified individual to develop an FSVP and to perform FSVP activities. · Perform a hazard analysis that includes identifying known or reasonably foreseeable hazards associated for each type of food and determining whether they require a control. Potential hazards include: o biological hazards, including parasites and disease-causing bacteria; o chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved additives, food allergens, and (in animal food) nutrient deficiencies or toxicities; and o physical hazards, such as glass. · Evaluate risks posed by the food and the performance of the foreign supplier, considering: o the hazard analysis for the food; o the entity that will be applying hazard controls, such as the foreign supplier or the foreign supplier’s ingredient supplier; o the foreign supplier’s food safety practices and procedures; o applicable U.S. food safety regulations and information regarding the foreign supplier’s compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter or import alert; and o the foreign supplier’s food safety performance history, including results from testing, audit results, and the supplier’s record of correcting problems. · Conduct appropriate supplier verification activities to provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented. These activities may include: o annual onsite audits (must be performed by a qualified auditor); o sampling and testing of a food; o a review of the supplier’s relevant food safety records; and/or o other appropriate activities. · Take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate). · Reevaluate the food and foreign supplier every three years or sooner if the FSVP importer becomes aware of new information about the hazards in the food or the foreign supplier’s performance. · Identify the FSVP importer when filing for entry with U.S. Customs and Border Protection using the FSVP importer’s name, electronic mailing address, and unique facility identifier (UFI) recognized as acceptable to FDA. o The FDA has recognized the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP. A DUNS number can be obtained by visiting fdadunslookup.com. o The FDA has also issued guidance stating that for FSVP importers temporarily unable to obtain a DUNS number, FDA intends to temporarily allow filers to transmit the value “UNK” (to represent “unknown”) in the UFI field. This option will be available beginning May 30, 2017 so that food offered for import can be processed through the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system, even if the importer has not yet provided a DUNS number. FSVP importers can meet key FSVP obligations by relying on analyses, evaluations, and activities performed by other entities in certain circumstances, as long as the FSVP importer reviews and assesses corresponding documentation.