FDA: Food Safety Modernization Act (FSMA) and Foreign Supplier Verification Program (FSVP)

Posted on Aug 17

According to FDA.gov, about 48 million people, or 1 in 6 Americans become ill, and 3,000 die each year from food-borne diseases according to the data from the Centers for Disease Control and Prevention. The FDA Food Safety Modernization Act (FSMA) gives the FDA authority and new tools to strengthen the food safety system. The law requires that imported foods are held to the same standards as domestic foods through five key areas.

Importer Accountability: Importers will be explicitly held responsible to verify that their foreign suppliers have adequate preventive controls to ensure the food produced is safe.
Third Party Certification: The Act establishes a program for qualified third parties to certify foreign food facilities comply with food safety standards in the U.S. This certification may be used to facilitate the entry of imports.
Certification for high risk foods: High-risk imported foods must be accompanied by a certification or compliance assurance as a condition of entry into the U.S.
Voluntary qualified importer program: A voluntary program must be established by the FDA for importers that allows for expedited review and entry of foods from participating importers.
Authority to deny entry: If the FDA is denied entry to the facility or country where the food production facility is located, the FDA has authority to deny entry into the U.S.

The Foreign Supplier Verification Program (FSVP) pushes responsibility to importers that include:

Determining known or reasonably foreseeable hazards with each food.
Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance.
Using the food-based risk evaluation to approve and determine appropriate supplier verification activities.
Conducting supplier verification activities and corrective actions.
Written procedures for evaluation process.

The date of compliance with FSVP is as early as May 30, 2017, with additional date rollout based on a number of factors related to commodity, origin, supplier, and size of facilities. Further information about the date rollout can be viewed here.
The FDA has established guidance for the FSMA implementation through the Technical Assistance Network (TAN) at www.fda.gov/fsma.