The U.S. Food and Drug Administration (FDA) requires most registered food facilities to comply with Food Safety Modernization Act (FSMA) Preventive Control regulations. Likewise, most U.S. food importers need to comply with Foreign Supplier Verification Program (FSVP) requirements. However, meeting the eligibility requirements for a Qualified Facility or a Very Small Importer (VSI) might exempt you from certain requirements under these regulations compliance regulations.

Keep reading to see if your business meets the requirements of a Qualified Facility or a VSI.

What is a Qualified Facility?

You may be eligible for the modified FSMA requirements if your facility averages less than $1,000,000 in human food sales or less than $2,500,000 in animal food sales plus the market value of food that is imported, manufactured, processed, packed, or held without sale, per year during the previous three calendar years across all affiliates and subsidiaries.

Not sure if your facility is eligible for Qualified Facility status? Take a look at Registrar Corp’s free Qualified Facility Wizard.

What are the Requirements for a Qualified Facility?

Your facility must submit a “Qualified Facility Attestation” to FDA to be recognized as a Qualified Facility. FDA requires facilities to resubmit their Attestation every two years during the biennial food facility registration renewal period, which begins on October 1st and ends on December 31st of each even-numbered year.

Along with the Qualified Facility Status, the Attestation also indicates that your facility is addressing food safety hazards. Qualified Facilities may be exempt from certain FDA Preventive Controls requirements, such as the development of Hazard Analysis and Risk-based Preventive Controls (HARPC) Food Safety Plans and Supply Chain Programs. However, you still must document either that you have identified potential food safety hazards and are implementing and monitoring preventive controls for those hazards or that your facility is in compliance with an applicable local food safety authority.

What is a Very Small Importer?

While a Qualified Facility manufactures, processes, packs, or stores food products, an importer is the owner or consignee of the products a foreign facility ships to the USA. A Very Small Importer (VSI) is an importer averaging less than $1,000,000 in sales of human food plus the market value of food that is imported, manufactured, processed, packed, or held without sale, per year during the previous three calendar years.

What are the Requirements for a Very Small Importer?

If you are a VSI, you may not need to complete a standard FSVP for all of your foreign suppliers. However, you may need to comply with a modified FSVP to assure FDA that your foreign suppliers are meeting FSMA food safety standards.

To maintain your status as a VSI, you must obtain written assurance at least every 2 years that your foreign supplier uses processes and procedures that provide at least the same level of public health protection as those required under the Preventive Controls for human or animal food.

If you learn that your foreign supplier is not producing food consistent with U.S. food safety standards, you must work with the supplier to address the problem or temporarily stop using that supplier until the problem is resolved. You must keep a record of all corrective actions your facility has taken against your foreign suppliers.

FDA requires documentation of your VSI eligibility before you initially import food into the USA. You must renew this status annually by December 31.

How to Determine Your Eligibility

To determine whether you are eligible for either Qualified Facility or VSI status, calculate your business’s total global food sales and market value of unsold food, including those from subsidiaries and affiliates. Adjust all calculations for inflation.

Include food not subject to FSMA in your calculations, such as seafood, juice, and dietary supplements. Although non-FSMA foods are included in calculations, facilities or importers only processing non-FSMA products cannot be considered a Qualified Facility or a VSI.

Only account for food intended for human consumption in your human food Attestation. If you or your supplier handles animal food, you will need to account for those calculations separately in an animal food Attestation. Likewise, exclude sales or market value of non-food items.

Assistance with the Qualified Facility or VSI Process

Registrar Corp’s Specialists can help you determine your eligibility as a Qualified Facility or a VSI. We can also provide guidance on qualified facility attestation to firms that designate Registrar Corp to manage their FDA registration or act as their U.S. Agent for FDA Communications. For more information, call +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.