May 30th, A very Important Date for the FSVP Importer


Written by Mark FeDuke

Director of Operations & Regulatory Affairs at ArdoVLM

May 16, 2017

Identifying the FSVP Importer

Starting May 30th 2017, import shipments subject to FSMA regulation will need to be matched up with their corresponding “FDA Importer” or more correctly, their corresponding FSVP Importer. The FSVP Importer is to be identified at time of customs entry by way of its U.S. Dun and Bradstreet number (DUNs) and while this sounds simple enough, it will no doubt lead to some interesting supply chain discussions. After all, if you are a distributor or retailer contracting with foreign vendors you are at risk of being identified as the FSVP Importer with all the liabilities and obligations that entails.

FSVP Importer

FSVP Importer is different from the Customs Importer (Importer of Record)

To engage in these discussions, folks need to appreciate that the FSVP Importer is different from the Customs Importer (Importer of Record). The FSVP Importer is a brand new regulated party brought about by FSMA with the FSVP Importer being responsible for making use of qualified individuals to evaluate reasonably foreseeable physical, chemical and biological hazards which may be present in the foods they import. While the FSVP Importer’s obligations go well beyond this, the key point here is that the FSVP Importer must and can only be a U.S. person (read business).

Customs regulations do allow for foreign vendors and service providers like couriers and customs brokers to operate as Importers of Record, however, the FSVP rule makes no such allowances and FDA sees service provides as lacking the supply chain visibility and leverage to be held accountable for carrying out food safety risk assessments and foreign supplier verification operations.

 

FSVP Importer

FSVP Final Rule

Looking to the FSVP Final Rule, as published in the Federal Register on November 27th 2015, the FSVP Importer is the U.S. owner at time of customs entry with ownership including those instances when a U.S. entity already owns; has already purchased or has promised to purchase goods at or before entry. More specifically, the rule discusses a scenario in which a domestic retailer places a purchase order with a foreign vendor before customs entry and concludes that doing so makes the U.S. retailer, as the 1st U.S. owner in the supply chain, the de facto FSVP Importer.

In practical terms this means that regardless of what company in the supply chain might be operating as the Customs Importer (Importer of Record) the FSVP Importer is the 1st U.S. business that places orders with foreign vendors. For U.S. buyers accustomed to contracting with foreign vendors on a duty paid delivered basis to their door, merely placing a purchase order with a foreign vendor places you at risk of being deemed to be operating as the FSVP Importer with all the obligations and liabilities that brings.

As a U.S. business with staff in the U.S. and its own U.S. DUNs number, VLM operates as both the Customs Importer (Importer of Record) as well as the FSVP Importer. More importantly, VLM makes use of qualified individuals as part of our overall food safety and trade compliance activities. Having said this, we have long advocated for greater clarity regarding FSVP Importer identification given the potential regulatory exposure that foodservice distributors and retailers may face.

While May 30th marks the date for FSVP Importer identification at time of entry, the FSVP Importer’s actual food safety compliance obligations may be staggered from May 2017 to June 2020 based on such variables as the importer’s annual revenue and deadlines their foreign manufacturers are subject to regarding compliance with FSMA’s Preventive Controls Rule based upon their number of full time employees etc. Additionally, CBP and FDA have advised that they will initially allow use of an “unknown” code for DUNs numbers at time of entry, however, this should not be taken to mean they are shelving the requirement but instead as a means for CBP’s ACE system to accommodate what is a significant change to import operation procedures.

 

FSVP Importer

FSVP Importer – Be Prepared

Having said all this, FDA could very well issue notice on May 29th extending the requirement’s compliance deadline, however, the writing is on the wall and its been there for a little over 6 years. Signed into law on January 4th 2011, FSMA creates new rules and establishes new regulated parties necessitating that industry take a good hard look at regulatory obligations across the supply chain. Even if the May 30th deadline is extended, distributors and retailers need to appreciate the regulatory exposure they may face if their importers cannot or will not take on the role of the FSVP Importer.

Important food for thought.

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