Food Safety Modernization Act (FSMA)/Foreign Supplier Verification Program (FSVP) became mandatory on May 30th, 2017. To aid in the initial transition, the U.S. Food and Drug Administration (FDA) took an “educate while they regulate” approach to enforcement. Now that the initial implementation has long since past, we strongly recommend that importers of food review the Final Rule on Foreign Supplier Verification Program and examine the internal processes in place to remain in compliance.
Two areas of compliance that we would like to highlight are the use of “UNK” in the place of the U.S. party’s Dunn & Bradstreet (DUNS) number and the use of the “FSX” disclaimer.
“UNK” Declaration
This declaration option was offered temporarily while U.S. parties were in the process of registering for a DUNS number due to the high volume of requests. Due to the number of “UNK” declarations that were received, the FDA began increasing enforcement in February of 2019.
If your company is still declaring “UNK” for any U.S. buyers, please advise those parties that importers of food products need to have a DUNS number assigned for their business. The DUNS number is available free of charge to importers. It can be obtained by contacting D&B by phone at 866-705-5711, via email at govt@dnb.com, by visiting. Failure to obtain a DUNS number may result in increased inspections, FDA holds, and the risk of monetary penalties for non-compliance.
FSX Disclaimer
Similar to the situation above, the FDA allowed for a phased in approach for disclaiming the FSVP requirement altogether. This disclaim is referred to as an “FSX Exemption.”
For FSVP importers whose foreign supplier is required to comply with the PC rule for human food, exemptions once included:
- Small businesses as defined in 21 CFR 117.3: Expired March 19, 2018
- Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3: Expired March 18, 2019
- Suppliers subject to the Pasteurized Milk Ordinance: Expired March 18, 2019
- “All Other” Businesses Suppliers: Expired May 30, 2017
FSVP importers whose foreign supplier is required to comply with the produce safety rule were required to comply with FSVP regulations as of the dates below:
- Small Businesses as defined in 21 CFR 112.3: July 29, 2019
- Very Small Businesses as defined in as defined in 21 CFR 112.3: July 27, 2020
- “All Other” Businesses: July 26, 2018
Please note, that FSX can be used with the following commodities as they are exempt from FSVP reporting:
- Juice (in compliance with part 120), or certain ingredients for use in juice products in compliance with part 123
- Certain alcoholic beverages, or certain ingredients for use in alcoholic beverages
- Certain meat, poultry, and egg products regulated by USDA
- Food imported for personal consumption
- Food that is transshipped
- Food that is imported for processing and export
- U.S. food that is exported and returned without further manufacturing/processing in a foreign country
If your company is using the FSX exemption improperly, this may result in increased inspections, FDA holds, and the risk of monetary penalties for non-compliance. If you have questions or concerns regarding the FSVP, please contact the Willson International U.S. Regulatory Team at transitionus@willsonintl.com