May 8, 2019

FSMA’s Rule on Foreign Supplier Verification Focuses on Produce

Based on data collected by the U.S. Department of Agriculture’s (FDA) Global Agriculture Trade System, it is evident that the importation of fruit and vegetables has dramatically increased in the last 10 years. As a result of a growing global produce industry combined with FDA’s newly implemented rule on Foreign Supplier Verification Programs (FVSP) for Importers, the focus on foreign produce suppliers is greater than ever.

In general terms, the FSVP regulation applies to entities that import food for consumption in the United States, with a few exemptions. In a nutshell, importers subject to this regulation are required to verify/approve foreign food suppliers to ensure this food is not adulterated or misbranded—and is produced or manufactured in a manner that meets applicable U.S food safety regulations for farms and/or registered facilities that process food for human or animal consumption.

With a complex global produce supply chain, the definitions of foreign supplier and importer under the FSVP regulations are becoming more relevant to companies that import produce.

The FSVP regulation defines an FSVP importer as the U.S. owner or consignee of a food offered for import into the United States at the time of entry. 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, as confirmed in a signed statement of consent. It is important to note that the importer of record for U.S. Customs and Border Protection (CBP) may not necessarily be the importer subject to this regulation. Importers responsible to comply with the FSVP regulation are commonly referred to as FSVP importers.

The FSVP regulation defines a foreign supplier as the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment. However, this does not apply to further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature.

In simpler terms, a foreign supplier is the actual entity that produces or manufactures food that is exported to the United States. Please note that a company’s actual foreign supplier might not be the entity from which the food is actually obtained from. For instance, if you obtain oranges from a packing house that only packs and holds the oranges (and does not perform manufacturing/processing on the oranges), the foreign suppliers would be the farms that grew the oranges.

With that said, if you are a grower or fresh-cut processor that obtains produce from foreign suppliers, you may be impacted by the FSVP regulation if you meet the definition of FVSP Importer. The majority of compliance dates related to this regulation have already passed, but it is not surprising to note that many entities do not know if they are subject to this regulation.

FSVP importers are responsible for verifying/approving foreign supplies, with some exceptions. They are required to have a FSVP for each foreign supplier and each food taking the following actions:

1.  Determining known or reasonably foreseeable hazards with each food;

2.  Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance;

3.  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;

4.  Conducting supplier verification activities; and

5.  Conducting corrective actions.

For additional details and information about specific requirements, review FDA’s final rule as well as the agency’s Technical Assistance Network and draft guidance to implement a FSVP.

While the agency is still supportive of education and outreach—both within and outside the U.S.—to promote awareness of the FSVP rule, compliance and enforcement activities are taking place. It is imperative that the entities with minimal knowledge of this regulation need to fully understand and comply with this regulation. FDA has developed several resources, such as decision trees that can help a produce company determine if it is subject to this regulation.

FDA is currently monitoring foreign supplier verification efforts and inspecting FSVP importers. The agency is reviewing the records FSVP importers must maintain to demonstrate compliance with FSVP requirements. We encourage you to determine if this regulation applies to you and to take steps to meet its requirements.

Western Growers will be hosting a webinar about this topic in July. If you have any questions about the FSVP regulation, contact me, Sonia Salas, at 949-885-2251 or by email at [email protected].