On May 25, 2018, the U.S. Food and Drug Administration (FDA) issued a Small Entity Compliance Guide (SECG) on food facility registration as well as additional information on the Voluntary Qualified Importer Program (VQIP).
Small Entity Compliance Guide
The SECG is intended to help food facilities meet their registration requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Act requires food facilities engaged in manufacturing/processing, packing, or holding of food for human or animal consumption in the U.S. to register with the FDA. The Food Safety Modernization Act (FSMA) added new registration provisions, which include the following:
- Facilities are required to provide FDA with assurance that they will be permitted to inspect their facility (in accordance with the FD&C Act);
- Facilities are required to renew their registration every other year;
- FDA now has the authority to suspend a facility’s registration.
The SECG explains which types of facilities are required to register, and when and how to do that. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, the guide explains when FDA can suspend a facility’s registration and the effect of a suspension order.
Additional information on the registration of Food Facilities can be found at the following address:
We strongly encourage Canadian SMEs exporting or wishing to export to the U.S. to review the guidance.
Voluntary Qualified Importer Program
In order to participate in VQIP (a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the U.S. for participating importers), U.S. importers are required to meet certain eligibility requirements, which include ensuring that the facilities of their foreign suppliers are certified under the Accredited Third-Party Certification Program.
So far, the FDA has recognized three accreditation bodies, ANSI-ASQ National Accreditation Board (ANAB), the American National Standards Institute (ANSI) and the National Bureau of Agricultural Commodity and Food Standards (ACFS) but there are currently no certification bodies accredited to conduct food safety audits of foreign facilities and issue the certifications that importers need to participate in the VQIP.
In the meantime, U.S. importers interested in participating in the program are encouraged to:
1) Submit a notice of intent to participate: through the FDA Industry System website by selecting VQIP under the FSMA Program options
2) Begin working on the application: Although importers will not be able to submit their applications now, they can begin the application process to prepare for next year. To assist with the application, the FDA created a step-by-step guide.
3) Review the Public Registry of Recognized Accreditation bodies to find links to Certification bodies: The Accreditation Bodies will be updating their websites with a list of available certification bodies as they become available.
Once certification bodies are available, U.S. importers participating in the program would be able to begin the process of working with them to obtain certification for the facilities from which they are importing (e.g. Canadian suppliers).
Specific questions on the VQIP can be directed to the VQIP Importer’s Help Desk via phone at 1-301-796-8745 or email at FSMAVQIP@fda.hhs.gov.