By: Hilary Thesmar, PhD, RD, FMI Vice President, Food Safety Programs, Food Marketing Institute 
Imports

According to USDA Economic Research Service, from 2000-2014 the volume of food imports increased 7.8 percent.  In the United States, some foods offered for sale are simply not available from domestic sources, for example, wines, premium coffee beans, some fruits and vegetables, and spices to name a few.  FDA regulates more than $49 billion worth of food imports and oversees more than 377,000 food facilities, 154,000 domestic food facilities and 223,000 international food facilities.  These facilities manufacture, process, pack, and/or hold food consumed by humans or animals.  FDA inspections of foreign food facilities cost significantly more than inspections of domestic food facilities.

In an effort to minimize cost and focus on the most high-risk foreign food facilities FDA has published draft guidance for the Voluntary Qualified Importer Program (VQIP).  VQIP is a voluntary, fee-based program and will serve as a means to expedite the process for importers of food who have demonstrated control over the safety of their supply chains. VQIP falls under the import provisions of FSMA which were designed to improve the safety of imported food.

To be eligible for VQIP, importers must have at least a three year history importing food into the United States without any FDA administrative, judicial actions nor have a history of non-compliance with food safety regulations by importer or supply chain.

Each foreign establishment participating in VQIP must be certified under FDA’s accredited third party audit program.  VQIP applicants must include as part of their application policies and procedures of their VQIP Quality Assurance Program (QAP).  VQIP QAP includes information about the organization such as a Corporate Quality Policy Statement and Organization Structure.  In addition, organizational food safety policy and procedures that will be implemented and food defense policy and procedures that are in place to protect against intentional adulteration and assure control of the safety and security of the food.

VQIP adds more documentation to the list of records to maintain for FDA Review.  These records will need to be maintained for at least two years and must be assessable within 24 hours of a FDA request. 

Comparison of records to be maintained for domestic suppliers and importers

*Records for Domestic Products

Records for FSVP

  • Responsible for all food safety records for your own company
  • Traceability one forward and one back

 

*Record requirements may get more specific when final rules are published.

  • Approved Foreign Suppliers
  • Hazard Analysis
  • Sampling and testing results
  • Foreign supplier verification activities
  • Investigations
  • Corrective actions
  • Onsite audit documentation
  • FSVP reassessments
  • Traceability - one forward and one back



With the likelihood of an increase in the number of records required to be maintained, the automation of records management is a must. 

ReposiTrak offers a solution that will help with compliance of the additional recordkeeping requirements of FSMA.  ReposiTrak enables grocery warehouses, supermarkets, packaged goods manufacturers, food processing facilities, growers, drug stores and drug manufacturers, and logistics partners to track and trace products and components throughout the global food, drug and dietary supplement supply chains.  ReposiTrak also reduces risk in the supply chain by receiving, storing, maintaining, sharing, and providing compliance reporting and proactive expiration alerting of audit, inspection and regulatory documentation required between supplier and customer, all from one convenient location. 

A webinar was presented on the FSMA import provisions on July 7 by ReposiTrak and FMI.  To view the webinar, slides and Q&A, please click here.