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Datamyne Blog

Covering trade & transport, with tips on using import-export data to advantage

FSVP & Data Management: Two Keys to FDA Compliance

Category: Imports, Trade Policy

The FDA’s Foreign Supplier Verification Program (FSVP) implements provisions of the Food Safety Modernization Act. Leading businesses are enabling compliance, considering data management and implementing a holistic regulatory strategy. 

By Myra Reynolds, LCB, CCS, guest columnist

The FDA’s Food Safety Modernization Act (FSMA) rule on the Foreign Supplier Verification Program (FSVP) is now final and entering a ‘staged’ approach to full implementation. While many food importers are concentrating primarily on the complex hazard analyses and exemption aspects of the regulation, leading businesses are taking this a step further and homing in on the data management requirements of FSVP.

1 – D&B D-U-N-S® Numbers*

One of the core components of FSVP is to identify importers by a common reference system. Following the standard regulatory comment period, the U.S. Food & Drug Administration tapped the well-established D&B D-U-N-S Number as the system of record to fulfill this purpose. In regard to FSVP and data management, the regulation specifies that an importer must provide a D-U-N-S Number for each line entry of food product imported into the U.S.

While providing a D-U-N-S Number may seem like a straight forward endeavor, importers in today’s modern food industry often have a complex ecosystem of subsidiaries, affiliates and Doing Business As (DBA) divisions. An efficient method to quickly locate the D&B unique identifier for each of these entities is required to streamline processes.

– The Food Safety Verification Plan

An additional aspect of FSVP is supplier verification whereby suppliers must undergo periodic review and approval.  In order to perform an effective supplier hazard evaluation, suppliers must first be identified.

However, as a result of compound food formulations, the number of SKUs in a product line, and intricate supply chains; accurately identifying suppliers may not be a straightforward task.  In addition, a supplier ecosystem can change over time in response to cost variances and changing consumer demand. A supplier network is more often a multi-branched ‘tree’ rather than a straight line. Manually tracing these ‘branches’ could be costly and quickly drain resources.

An efficient method, list or process is required to help food importers better target suppliers to ensure compliance.  Such a process should feature periodic updates to adapt to changing supply chains. It should also provide methods to focus in on suppliers with higher shipment volumes so that compliance tasks can be prioritized and data management optimized.

FSVP & Customs Brokers

In many cases, it is the food broker that imports product into the U.S. on behalf of shippers. Should a food be subject to FSVP, a customs broker is required to enter the name, mailing address, email address and D-U-N-S Number of the importer, as provided to the broker by the Importer of Record (IOR). In turn, brokers would file this information with U.S. Customs & Border Protection (CBP) in the Automated Commercial Environment (ACE).  From there, the information would flow to the FDA as part of the Partner Government Agency (PGA) component of ACE.

Leading brokers recognize that the FDA’s consumer protection function is closely tied to and dependent on the entry process. As a result of this oversight, brokers know that there may be closer scrutiny of those shipments subject to FSVP-related information, and entries where an Unknown (UKN) is submitted. Since this information is provided to brokers by the IOR, a best practice is to document, in writing, the information provided. Such documentation may be of key importance should a broker be subject to an FDA Filer Review.

FSVP Best Practices

At a practical level, as part of a holistic FSVP compliance strategy, food importers require:

  • An efficient practice to quickly locate D&B D-U-N-S Numbers
  • An effective method, to identify and better trace a supplier network

In addition, importer self-filers and customs brokers require:

Food importers and customs brokers that can achieve these objectives via one technology provider may be better prepared for FSVP compliance.  Leading businesses are thinking beyond the FSVP initiative toward a more complete compliance strategy as goods cross borders, adopting a forward-looking, compliance approach to comply with future regulations.

About Myra Reynolds

Myra serves as the Director of Corporate Import Compliance for the John S. James Co.  She joined John S. James Co. in 1977, in Savannah, Georgia and has maintained responsibility for the company’s import operations and compliance for 27 years. Myra has served on several nationally recognized committees and boards in the customs brokerage industry. Currently, she is the Area 4 Representative for the Customs Committee for the National Customs Brokers & Forwarders Association of America (NCBFAA). Myra also serves as the southeastern representative on the Regulatory Affairs Committee, meeting monthly with the FDA and the CPSC on current issues affecting imports.  She was also selected as the Chairman of the ADD/CVD Subcommittee for the NCBFAA and works directly with the ADD/CVD Revenue Branch of CBP.

About John S. James Co.

John S. James Co. was founded in 1941 in Savannah, Georgia. Now in its 75th year, the company continues its mission to offer personalized service to the international transportation community. John S. James Co. is a leader in the international freight forwarding and customs brokerage industries. John S. James Co. maintains partnership agreements with a multitude of companies both in the United States and around the globe, allowing shipments to be handled from all international ports. The company provides unmatched expertise in the handling of customs document preparation and cargo coordination in the international arena. Please visit http://www.johnsjames.com for more information.

* D&B D-U-N-S Numbers are proprietary to D&B, are licensed from D&B and are for internal use only. D-U-N-S is a registered trademark of D&B.

Date posted: August 3, 2017

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