What is the FSVP Rule?
The FDA Food Safety Modernization Act (FSMA) rule on Foreign Supplier Verification Program (FSVP) for large businesses is May 30, 2017, and for small businesses is March 19, 2018. Get a full list of FSMA compliance dates here.
The rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. Get the most updated information on this rule from the FDA here.
Who is the Importer?
For the purposes of FSVP, the FDA defines the importer as follows: “…an 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 of consignee at the time of entry, as confirmed in a signed statement of consent.” However, it’s not unusual for more than one party in the supply chain to act as the importer. Sometimes, the question becomes “Who should be the FSVP Importer?” According to Dr. Hilary Thesmar, the VP for Food Safety Programs at FMI, the FSVP Importer should be the party who meets the definition in the rule and can best assure that the imported food is produced in a manner that provides the same level of public health protection as food produced in the U.S.”
The best way to make a decision and to agree which party involved with importing the food will perform the functions of the FSVP importer is through communication with your supply chain partners. Your communication should consider which party…
- Is in the best position to assure the foreign supplier produces food that meets U.S. standards and is as safe as food produced by a U.S. supplier?
- Is most likely to have knowledge of food safety practices?
- Has control over the supply chain of an imported food?
- Controls the finances of the imported food (owner or consignee)?
- Controls the goods?
- Can best ensure that supplier verification activities are conducted for each food imported into the U.S.?
Responsibility of the Importer?
The importer is responsible for determining known or reasonably foreseeable hazards with each food that they import. Specifically, they should be conducting and documenting actions that include the following:
- Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
- Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
- Conducting supplier verification activities
- Conducting corrective actions
What Records Should be Kept?
Any record requested by the FDA must be available within 24 hours and could go two years back. If you don’t have an automated system, it’s likely time to consider one, as it’s really the only way to manage the range of documents required by FSMA across your supplier base. Here are the nine records that should make up your FSVP below. Looking for a one-pager? Quick Start: Creating Your Foreign Supplier Verification Plan (FSVP)
- Hazard Analysis
- Foreign supplier Approved list
- Foreign supplier performance evaluation
- Foreign supplier approval procedures
- Procedures assuring only approved foreign suppliers are used
- Verification activities & their frequency used to determine approved foreign suppliers
- Performance of verification activities
- Identified corrective actions needed
- Re-evaluation of FSVP by cause, or at least every 3 years
Have a few minutes…or longer? Check out the information provided in these archived complimentary webinars which includes a video, the presentation and any questions/answers documented during the sessions.
Shawn Stevens | Food Industry Counsel | Oct 10, 2017
Dr. Hilary Thesmar | FMI | Jan 10, 2017
Dr. Hilary Thesmar | FMI | Mar 14, 2016
Dr. Hilary Thesmar | FMI & Melanie Neumann, JD | The Acheson Group | Dec 14, 2015
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