INTRODUCTION


The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates begin May 30, 2017.


The final 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. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s federal, state, local, tribal and international regulatory counterparts, academia and other stakeholders. The FDA first proposed this rule in July 2013.


After input received during the comment period and during numerous engagements that included public meetings, webinars, and listening sessions, the FDA issued a supplemental notice of proposed rulemaking in September 2014. The proposed revisions included providing importers flexibility in determining appropriate verification measures based on food and supplier risks, while acknowledging the greater risk to public health posed by the most serious hazards in foods.


The final rule has elements of both the original and supplemental proposals, with the addition of greater flexibility in meeting certain requirements to better reflect modern supply and distribution chains. For example, importers can meet key FSVP obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as those importers review and assess the corresponding documentation.


The FDA is committed to helping importers the FSVP requirements. In order to facilitate compliance FDA will provide guidance, outreach and training.


KEY REQUIREMENTS


1. Scope

  • Who is covered by the rule?

  • For the purposes of FSVP, 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. See Am I Subject to FSVP? (PDF: 69KB)for more information.

  • There are exemptions discussed below.

  • What is an FSVP? It is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.

  • Importers are responsible for actions that include (and are explained further below):

  • 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 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

  • Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.

  • Importers are required to develo