It’s finally here! For all those who import food and have been waiting and wondering if you qualify for the Voluntary Qualified Importer Program (VQIP), what it will really mean for you and, most importantly, what it will take to qualify – FDA has issued its guidance document on FSMA’s VQIP. The guidance is applicable to those who import food for humans or for animals and includes eligibility requirements for participation, instructions for completing an application and benefits to users, along with conditions that could cause revocation and what you would need to do to be reinstated. But before we provide summaries of those, let’s review exactly what VQIP is. Most importantly, it is a voluntary program and thus fee based, but your participation helps to expedite the review and importation of food through the issuance of facility certification that accompanies the food. To determine eligibility, FDA considers the risk of the food to be imported based on factors such as the compliance history of the foreign supplier and the food safety practices of the importer. So, how does it work? The VQIP System Any importer – defined as the manufacturer, owner, consignee, or importer of record of a food, who is located within or outside the U.S. and brings food, or causes food to be brought, from a foreign country into the customs territory of the U.S. – can apply for VQIP, provided you meet all of the following criteria: You have at least a 3-year history of importing food into the United States. You have a DUNS number. You use paperless filers/brokers who received acceptable results during their last FDA Filer Evaluation. No imported food, including a food you do not intend to include under VQIP, is subject to detention without physical examination under an Import Alert or a Class 1 recall at the time you submit your application. Neither you nor the non-applicant entities associated with a VQIP food are subject to an ongoing FDA administrative or judicial action or have a history of significant non-compliances relating to food safety. You, or the importer identified as the FSVP or HACCP importer of the food, as applicable, are in compliance with the supplier verification and other importer responsibilities of the applicable FSVP or HACCP regulations. You have a current facility certification issued in accordance with FDA’s third-party certification program for each foreign supplier of food you intend to import under VQIP. You develop, implement, and submit a VQIP Quality Assurance Program (QAP). (This is detailed in section III.F. of the guidance, and we will address it in a future newsletter). Within the past 3 years, you have not been the subject of any CBP penalties, forfeitures, or sanctions that are related to the safety or security of any FDA-regulated product that you imported or offered for import. You pay the annual VQIP user fee before October 1 of the year in which you intend to participate. You have facility certification (compliant with section 808 of the FD&C Act) showing accreditation of a third-party certification body for each foreign supplier’s facility from which you want to import a food under VQIP, and provide the certification number(s) in your application. You establish an online account on the FDA Industry Systems website (www.access.fda.gov), then, each year that you wish to participate, submit a Notice of Intent to Participate in VQIP and your application between January 1 and May 31 for participation beginning October 1 of that year. (VQIP follows the government fiscal year, so the participation years run October 1 through September 30.) In December of each year, FDA will send participating VQIP importers an email reminder to resubmit the Notice. FDA provides further information on each of these in the guidance document. If, after you are approved, FDA has credible evidence that you do not meet all VQIP requirements or that you are participating in fraudulent activity (such as smuggling), it can revoke your participation in VQIP. Revocation will apply to all foods you import under VQIP. You can apply for reinstatement by submitting documentation of actions you have taken to correct or resolve all of the deviations. However, FDA will not reinstate participation if revocation was based on evidence of fraudulent activity. It also is important to understand that a VQIP food may be subject to “for cause” examination when it is determined the food is or may be associated with a risk to public health, such as during an investigation of an outbreak or illness associated with the type of food or a foreign supplier covered by your approved VQIP application. Additionally, VQIP food may be subject to microbiological sampling related to specific risk-based surveillance assignments. However, surveillance sampling of a VQIP food will be a low priority and FDA may exclude VQIP food from such sampling if it can obtain adequate statistically-based, non-biased, non-VQIP food samples. Wow, a lot of information! So, what exactly are the benefits to you to go through all that? VQIP Benefits Importers participating in VQIP will receive the following benefits: Your VQIP-approved foods will receive expedited entry into the U.S. To enable this, FDA enters the eligible foods into its Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) import screening system to recognize shipments of that food, and release the shipment immediately after the receipt of entry information (unless examination and sampling are necessary for public health reasons as noted above). Examination and/or sampling of VQIP food entries will be limited to “for cause” situations, and to the extent possible, will be examine and sampled at the VQIP food destination or other location preferred by the VQIP importer. The laboratory analysis of “for cause” or audit samples will be expedited to the extent possible in accordance with public health priorities. An FDA VQIP Importers Help Desk will be available for questions and resolution of issues. dedicated to responding to questions and resolving issues raised by VQIP importers about VQIP food and this guidance document. FDA will post a publicly available list of approved VQIP importers on FDA’s VQIP webpage, from which VQIP importers opt out if they choose. Time will tell if the VQIP system will be of benefit to the food industry. In principle, it is a great program that has the potential to signal to your customers in the U.S. that you have hit a high bar with regard to FDA standards. But will the costs and hassles outweigh the challenges? Will having VQIP really be attractive to your customers? Will it materially impact the speed and ease of importation of foods? Currently, the amount of food that is held at the border for routine inspection is very small so a key question is whether VQIP will make a material difference? At this point it is not clear. So, lots of questions remain including the actual cost of signing up for the program, but at least we now have a good vision of FDA expectations around VQIP. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
