- As previously covered on this blog, the general compliance date for the foreign supplier verification program (FSVP), under the Food Safety Modernization Act (FSMA), is May 30, 2017. The U.S. Food and Drug Administration recently issued updated fact sheets, and new guidance on how to identify the importer under the FSVP Rule.
- The May 30th deadline generally applies to importers whose foreign supplier falls into one of the following categories:
- Will not be covered by the FSMA preventive controls or produce safety rules;
- Is subject to the Preventive Controls for Human Food rule or Produce Safety rule, and is not a “small business,” “very small business,” “qualified facility,” or subject to the Pasteurized Milk Ordinance; or
- Is subject to current good manufacturing requirements in the FSMA Preventive Controls for Animal Food rule, and is not a “small business” or “qualified facility.”
- Although not reflected in the newly-issued guidance, FDA announced in August 2016 that with respect to food contact substances (FCSs), importers have an additional two years to meet the FSVP requirements; as a result, the earliest FSVP compliance date for FCSs is May 28, 2019.
- In the guidance, FDA has clarified that it will be permissible to use the code “UNK” (to represent “unknown”) in the unique facility identifier (UFI) field if the FSVP importer is temporarily unable to obtain a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number.
- We will continue to monitor and report on FDA’s activities to implement the FSVP rule and other FSMA related activities. Please feel free to contact us at fooddrug@khlaw.com with any questions.