The Foreign Supplier Verification Program (FSVP) rule is a component of FSMA that addresses the safety of foreign food that is imported into the United States. This rule was published on November 27, 2015 and gave importers the added responsibility of ensuring that the food they import meets the same level of food safety standards as products made in the United States.
Who does this Rule Apply To?
- Domestic manufacturing facilities that import food for processing
- Food brokers that import food
- Food distribution centers that import food
- Foreign manufacturers that arrange for the export of food into the US
What Imported Items Are Included?
- Most FDA regulated food products
- Dietary supplements
- Food contact packaging
- Food contact substances (plates, utensils, conveyor belts, etc.)
What Imported Items are Exempt?
- Meat, poultry, and eggs under the USDA
- Food for research use
- Food for personal consumption
- Food imported for processing that will be exported later
- Food that is transshipped throughout the U.S.
- Food that is imported and then exported without further processing
What Does an Importer Have to Do?
Food Importers must now identify an FSVP Importer on the customs and border protection entry filing and have a DUNS number. The FSVP Importer must be domiciled in the United States. If a foreign company does not have a representative in the United States, they must name a US Agent who has agreed in writing to be an FSVP Importer. The FSVP Importer is the person the FDA will hold legally responsible for complying with the FSVP rule. The rule allows the FSVP Importers to identify Qualified Individuals who have the education, experience, and training necessary to carry out all FSVP requirements.
What Does the Qualified Individual Need to Do?
The two main elements of the FSVP rule are an initial foreign supplier performance evaluation and then on-going verification to ensure imported food is safe. These activities are detailed below:
- Initial Evaluation:
- Conduct a hazard analysis of the food products
- Identify potential food safety hazards
- Ensure food safety hazards are adequately controlled
- Conduct an evaluation of the foreign supplier’s food safety performance
- Ensure the supplier is complying with FSMA Requirements if Applicable
- Preventive Controls for Human Food
- Preventive Controls for Animal Food
- Produce Safety rule
- Approve the foreign supplier
- Establish written procedures to ensure food is only imported from approved suppliers
- Determine appropriate verification activities based on risk level
- Retain records of initial approval and SOPs
- Review third party audits, COAs, test results, etc.
- Do corrective actions when necessary
- Reanalyze the food safety plan every 3 years or when a change occurs
- Retain verification records
What are the Compliance Dates for FSVP Importers?
Your compliance dates are generally 6 months after your individual foreign suppliers must comply with either the FSMA Preventive Controls Rule for Human Food, FSMA Preventive Controls for Animal Food, current Good Manufacturing Practices for Animal Food, or the Produce Safety Rule for either sprouts or produce. If your supplier is not subject to one of the FSMA rules then your compliance date is May 30, 2017. You may have several compliance dates depending on the types of products you import and their regulatory requirements. The charts below provide your timeline to conduct foreign supplier verification activities for each one of your suppliers depending on their size and the FSMA regulation they must comply with. The definition of the size of your foreign suppliers is defined below as well and is taken from 21 CFR 112.3, 21 CFR 117.3, and 21 CFR 507.3.