Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) rule on Foreign Supplier Verification Programs (FSVP) requires a U.S. importer of food to develop, maintain, and follow a Foreign Supplier Verification Program for Importers of Food for Humans and Animals (FSVP) (80 FR 74225) to ensure that each food it imports meets FDA food safety standards.

Who is covered?

Specifically, the FSVP regulation applies to importers of food into the United States. The FSVP rule defines an importer as the U.S. owner or consignee of a food offered for import into the U.S. The rule further defines an “importer” as a U.S. consignee of an imported food as a person who, at the time of entry, owns the food, has purchased it, or has agreed in writing to purchase it (21 CFR 1.500). In some cases, at the time of entry, there is no U.S. owner or consignee. In this situation, the FSVP importer can be an appointed U.S. agent or representative of the foreign owner or consignee.

What food is covered?

For the most part, the FSVP rule applies to all human and animal food, chewing gum, and food ingredients imported into the United States.

Some exemptions apply under 21 CFR 1.50 including:

  • Certain juice and seafood products
  • Food for research and evaluation (this exemption does not apply to food offered at trade shows and the food must be labeled “for research & evaluation”)
  • Food imported for personal consumption
  • Certain alcoholic beverages
  • Food that is transshipped through the U.S. to another country
  • U.S. food that is manufactured and processed in the U.S., exported, then returned to the U.S. without further processing in a foreign country
  • Certain egg, meat, and poultry products subject to USDA rules

What are importers required to do?

Importers and FSVP U.S. Agents covered by the FSVP regulation must have Standard Operating Procedures (SOPs) in place to verify that their foreign suppliers are producing food using processes and procedures that provide the same level of public health protection as those required under the preventive controls (for human or animal food) or produce safety regulations. Importers must also ensure that the supplier’s food is not adulterated nor misbranded with respect to allergen labeling (21 CFR 1.502(a)).

For most importers, the FSVP rule requires:

  • Conducting a hazard analysis to determine known or reasonably foreseeable hazards with each food that require a control (21 CFR 1.504).
  • Evaluating the foreign supplier’s performance and the risk posed by a food (based on the hazard analysis) (21 CFR 1.505(a))
  • Using that evaluation to approve suppliers and determine appropriate supplier verification activities (21 CFR 1.505(b))
  • Conducting foreign supplier verification and related activities (21 CFR 1.506)
  • Taking corrective actions (if necessary) (21 CFR 1.508)
  • Maintaining records of these FSVP activities (21 CFR 1.510)

A new section of the FDA Data Dashboard has been launched to help importers meet supply-chain requirements under the FDA Food Safety Modernization Act (FSMA) by helping them more easily find compliance and enforcement information related to specific firms.

To assist with the evaluation process, FDA created a Supplier Evaluation Resources page to help importers and manufacturers/processors find relevant compliance and enforcement information for their suppliers, but that page required them to search multiple data bases.

The FDA has improved the Supplier Evaluation Resources page, which is now available as a new section in FDA’s Data Dashboard. The Data Dashboard brings all the information from the Supplier Evaluation Resource page together, allowing importers and manufacturers/processors to search multiple data bases at the same time. The dashboard can be used to find information regarding warning letters, import refusal, import alerts, and other firm-specific information with one search.

What Importers subject to modified requirements?

Very small importers and importers of food from certain small foreign suppliers are subject to modified requirements under the FSVP regulation. Under these modified requirements, these importers do not have to conduct hazard analyses or evaluate the food and foreign supplier (21 CFR 1.512).

Importers of certain food from foreign suppliers in countries whose food safety systems FDA has officially recognized as comparable or determined to be equivalent to that of the United States (21 CFR 1.513). Currently, New Zealand and Canada’s systems have been found equivalent, and other systems are in process. Updates can be found at: http://www.fda.gov/food/newsevents/constituentUpdates/ucm498611.htm

Who Must Develop My FSVP and Perform FSVP Activities?

Importers subject to the FSVP regulation must ensure that their FSVP is developed and applied by a “qualified individual” as defined in 21 CFR 1.500 (21 CFR 1.503(a)). The qualified individual performing FSVP activities for you:

  • Must have the education, training, or experience (or combination thereof) necessary to perform the activity
  • Must be able to read and understand the language of any records reviewed in performing an activity. (21 CFR 1.503(a))

How Must I Identify the FSVP Importer at Entry?

For each line entry of food, you must ensure that your name, email address, and unique facility identifier recognized as acceptable by FDA are provided electronically to CBP at entry (21 CFR 1.509(a)). The Dun & Bradstreet Data Universal Numbering System (DUNS) number is an acceptable number to use as a unique facility identifier. You can obtain a DUNS number for free at https://fedgov.dnb.com/webform.