The Food and Drug Administration (“FDA”) Food Safety Modernization Act (“FSMA”), was signed into law by President Obama on January 4, 2011. The purpose of the Act is to ensure the safety of the U.S. food supply. FDA will implement its Foreign Supplier Verification Program (“FSVP”) beginning on May 30, 2017. According to the FDA, “the final FSVP rule requires that importers perform certain risk based activities to verify that food (unless exempted) imported into the United States has been produced in a manner that meets applicable U.S. safety standards.” It includes the verification (inspection) of foreign suppliers and the safety of the food that they produce.
FSVP importers must be well informed about the program requirements. Valuable information is available on the FDA website through the following links:
Text of the final rule: https://www.federalregister.gov/documents/2015/11/27/2015-28158/foreign-supplier-verification-programs-for-importers-of-food-for-humans-and-animals.
General Information: https://www.fda.gov/food/guidanceregulation/fsma/ucm361902.htm.
Frequently asked questions: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm#FSVP_Rule.
FSVP importer responsibilities include the following:
- conducting hazard analysis
- evaluating the food risk and supplier performance
- verifying their suppliers activities
- taking corrective actions when compliance issues are detected
The importer for FSVP is not necessarily the same as the importer of record for Customs purposes. The FDA FSVP importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner or consignee at the time of entry, however, a signed statement of consent is required to make this designation.
FDA recognizes the Data Universal Numbering System (“DUNS”) number as an acceptable facility identifier under the FSVP program. For information about looking up or obtaining a DUNS number please access the following link: https://www.fda.gov/downloads/ForIndustry/UCM483657.pdf.
For entry purposes, the DUNS#, as well as the name, physical address, and e-mail address of the FSVP importer are required. There will be a grace period for entities that have not obtained a DUNS number and a special code as an unknown identifier will be acceptable for the time being, but FDA will be contacting these FSVP importers to inquire about the reasons for not transmitting a DUNS number.
There are different compliance dates depending on the category of the FSVP importer. The first compliance date is May 30, 2017. For specific compliance dates please access the following link: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm.