On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Foreign Supplier Verification Programs for Food Importers (FSVP Rule). The new rule requires importers to ensure that imported food is produced in compliance with standards at least as rigorous as those required for food produced in the United States. The release of the FSVP Rule continues FDA’s rollout of seven rulemakings mandated under the FDA Food Safety Modernization Act (FSMA), and follows the September publication of the FSMA-mandated preventive controls for human and animal food (“Preventive Controls Rules”), discussed here. Prepublication versions of two other FSMA rules, regarding standards for produce safety (“Produce Safety Rule,” discussed here) and accreditation of third-party auditors and accreditation bodies (“Third-Party Certification Rule,” discussed here), were released on November 13.

What Importers and What Food Imports Are Covered by the FSVP Rule?

The FSVP Rule applies to all food that is imported or offered for import into the United States and to all importers of such food. An “importer” is the U.S. owner or consignee of food that is being offered for import or, if there is no such owner or consignee, the U.S. representative or agent of the foreign owner or consignee at the time of entry. In addition to some alcohol-related exemptions, the FSVP Rule does not cover importers of juice and fish or fishery products who are required to comply with already existing Hazard Analysis Critical Control Point (HACCP) regulations for those products; certain food imported solely for research; small quantities of food for personal consumption; food that will be transshipped through the United States or that is being imported solely for processing and export; food that was manufactured or processed in the United States that is being returned without further manufacturing or processing in a foreign country; and certain meat, poultry and egg products that are subject to regulation by USDA at the time of importation. The rule also sets forth modified requirements for importers of dietary supplements and dietary supplement components, very small importers, and importers of food from certain small foreign suppliers.

What Are Importers Required to Do Under the FSVP Rule?

Each importer must develop a foreign supplier verification program (FSVP) that ensures “foreign suppliers” are producing food in a way that provides the same level of protection as what is required under the Preventive Controls Rules and the Produce Safety Rule, if applicable, and in compliance with sections 402 and 403 of the Food, Drug, and Cosmetic Act (FD&C Act), regarding adulteration of food and allergen-related misbranding, respectively. A “foreign supplier” is an entity that manufactures, processes or grows food, or raises animals that are exported to the United States without further manufacturing or processing (except for de minimis exceptions).

What Is an FSVP and What Must Be Included?

An FSVP must be developed by a “qualified individual” who must perform the various activities required by the FSVP Rule and be able to read and understand the language of any records that must be reviewed. In developing an FSVP, an importer is required to conduct and document the following activities (which parallel the hazard analysis and supply-chain requirements imposed on food facilities under the Preventive Controls Rules):

  • Hazard Analysis : An importer must complete a written hazard analysis that identifies potential hazards for each food and each supplier, including biological, chemical (including radiological) and physical hazards. If the food being imported is a raw agricultural commodity (RAC) that is “covered produce” under the Produce Safety Rule, an importer need not determine whether there are any biological hazards for such food because those hazards will be addressed by the supplier’s compliance with the Produce Safety Rule. (The importer still must determine non-biological hazards for the food.)
  • Risk Evaluation : An importer must evaluate each foreign supplier’s performance and the risks for each food considering factors set forth in the regulations, develop a list of approved foreign suppliers based on the risk evaluation, and develop written procedures to ensure that only approved suppliers are used.
  • Verification Activities : Based on its hazard analysis and risk evaluation, an importer must determine what foreign supplier verification activities are necessary to provide “adequate assurances” that imported food is produced in a way that provides “at least the same level of public health protection” as the Preventive Controls Rules and the Produce Safety Rule, if applicable, and that food is not adulterated or misbranded.
  • Supply Chains : Consistent with the other FSMA rules, the final FSVP Rule accommodates certain aspects of modern supply chains. For example, an importer in some circumstances may rely on a hazard analysis conducted by another entity (including the foreign supplier) to meet its obligations, although the importer must independently assess the analysis and document that assessment. An importer may also rely on a third party other than the foreign supplier to conduct the risk evaluation and determine what verification activities are appropriate, but the importer must approve its own list of approved foreign suppliers. Finally, in some circumstances, an importer need not conduct a risk evaluation or supplier verification activities at all, e.g., if the importer determines and documents that the food could not be consumed without application of an appropriate control, or if the importer discloses to a customer that a hazard is not controlled and receives written assurances that controls will be applied later in the supply chain.

The risks evaluated as part of an FSVP must be promptly reevaluated upon the discovery of new information. In addition (paralleling a similar requirement in the Preventive Controls Rules), an FSVP must be reassessed for each food and each foreign supplier at least once every three years. Based on the results of any such FSVP reassessment, an importer must promptly adjust its supplier verification activities if necessary.

What Specific Supplier Verification Activities Must Be Conducted as Part of an FSVP?

At a minimum, an importer must conduct (and document) or obtain documentation of one of the following supplier verification activities prior to importing food and periodically thereafter: on-site audits by a qualified auditor, sampling and testing of food, review of the foreign supplier’s food safety records, or any “other appropriate activity” based on the risks associated with the food and the supplier. Except with respect to sampling and testing of food, an importer may not rely on the foreign supplier to conduct supplier verification activities.

For hazards for which there is a “reasonable probability” that exposure will result in “serious adverse health consequences or death to humans or animals” (SAHCODHA threat), an importer must conduct or obtain documentation of an on-site audit before importing the food and at least annually thereafter, unless the importer makes an “adequate written determination” that another verification activity is appropriate. As an alternative to conducting its own on-site audit, an importer may rely on an inspection by FDA or a comparable authority.

How Does the FSVP Rule Relate to the Preventive Controls Rules?

The Preventive Controls Rules apply to any domestic or foreign food facility that is required to register under Section 415 of the FD&C Act. Under the FSVP Rule, an “importer” may, but will not necessarily be, a “facility” covered by the Preventive Controls Rules. Similarly, a “foreign supplier” will not necessarily be a “foreign facility” that is required to register under Section 415. For example, “foreign suppliers” include establishments that raise animals or grow food – neither of these activities is covered by the registration requirements of Section 415, which focuses on entities that manufacture, process, pack or hold food. In other respects, the FSVP Rule is narrower than the Preventive Controls Rules. Foreign firms that only pack or hold food may be subject to the Preventive Controls Rules but not the FSVP Rule, which by statute is directed to focus on producers of foreign food. To avoid redundant obligations, the FSVP Rule provides that any importer who is subject to the Preventive Controls Rules and implements a preventive control, including a supply-chain program as necessary, is deemed to be in compliance with the FSVP Rule as well (except for requirements relating to identifying the importer at entry).

By What Dates Must Importers Comply with the FSVP Rule?

Importers must comply with the FSVP Rule by the latest of the following dates: 18 months after publication of the final rule (publication is currently scheduled for November 27, 2015); for importation from suppliers subject to the Preventive Controls Rules or the Produce Safety Rule, six months after the supplier must comply with those regulations; and for an importer that is subject to the supply-chain requirements of the Preventive Controls Rules, the date by which the importer is required to be in compliance with those regulations.