Impact on Food Importers and Exporters

The FDA Food Safety Modernization Act of 2011 (FSMA) mandates the creation of a food safety system in which the focus is on preventing contamination rather than primarily reacting to problems after they occur. The FSMA rules include those that create preventive controls for the production of human and animal foods, and establish science-based standards for produce grown on farms. These rules apply to domestic food producers and those in other countries who export to the United States.

The import community will be most impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers to verify that the food they import meets U.S. safety standards. FSVP importers are required to develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling.

Who Is Covered by the FSVP Rule?

The FSVP importer is the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it). If there is no U.S. owner or consignee at time of entry, the FSVP importer is the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent. The key is that there be a FSVP importer in the United States who takes responsibility for meeting the FSVP requirements

What Will I Have to Do Under the FSVP rule?

Unless exempt, or subject to modified requirements, an FSVP importer may need to perform the following activities:

  • Use a qualified individual to develop an FSVP and to perform FSVP activities.
  • Perform a hazard analysis that includes identifying known or reasonably foreseeable hazards associated for each imported food or type of food and determining whether they require a control. Potential hazards include:
    • biological hazards, including parasites and disease-causing bacteria;
    • chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved additives, food allergens, and (in animal food) nutrient deficiencies or toxicities; and
    • physical hazards, such as glass.
  • Evaluate risks posed by the food and the performance of the foreign supplier, considering:
    • the hazard analysis for the food;
    • the entity that will be applying hazard controls, such as the foreign supplier or the foreign supplier’s ingredient supplier;
    • the foreign supplier’s food safety practices and procedures;
    • applicable U.S. food safety regulations and information regarding the foreign supplier’s
      compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter or import alert; and
    • the foreign supplier’s food safety performance history, including results from testing, audit results, and the supplier’s record of correcting problems.
  • Conduct appropriate supplier verification activities to provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented. These activities may include:
    • annual onsite audits (must be performed by a qualified auditor);
    • sampling and testing of a food;
    • a review of the supplier’s relevant food safety records; and/or
    • other appropriate activities.
  • Take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate).
  • Reevaluate the food and foreign supplier every three years or sooner if the FSVP importer becomes aware of new information about the hazards in the food or the foreign supplier’s performance.
  • Identify the FSVP importer when filing for entry with U.S. Customs and Border Protection using the FSVP importer’s name, electronic mailing address, and unique facility identifier recognized as acceptable to FDA.

FSVP importers can meet key FSVP obligations by relying on analyses, evaluations, and activities performed by other entities in certain circumstances, as long as the FSVP importer reviews and assesses corresponding documentation.

When Would Modified Requirements Apply Under the FSVP Rule?

Importation of foods that cannot be consumed without the hazards being controlled or for which the
hazards are controlled after importation under specified circumstances
• Importation of dietary supplements and dietary supplement components that will be subject to certain
provisions of the dietary supplement Current Good Manufacturing Practice regulation, or other dietary
supplements
• Importation by a very small importer or importer of foods from certain small foreign suppliers
• Importation of certain food from a foreign supplier in good compliance standing with a food safety
system that FDA has officially recognized as comparable or equivalent to that of the United States

What Foods and Beverages Are Exempt from FSVP?

  • Juice and seafood from foreign suppliers that are in compliance with the respective HACCP
    regulations (21 CFR part 120 or 123) and any ingredients that are intended to be used by the importer in the manufacturing and processing of finished juice and seafood products in accordance with the respective HACCP regulations
  • Small quantities of food imported for research and evaluation purposes that are not intended for retail sale and are not sold or distributed to the public
  • Small quantities of food imported for personal consumption that are not intended for retail sale and are not sold or distributed to the public
  • Food produced in compliance with FDA’s low acid canned food requirements in 21 CFR part 113 (exempt with respect to microbiological hazards controlled by 21 CFR part 113 only)
  • Certain alcoholic beverages
  • Food that is transshipped through the United States or that is imported for future export and not sold or distributed in the United States
  • Food that is manufactured/processed, raised, or grown in the United States, exported, and returned to the United States without further manufacturing/processing
  • Certain meat, poultry , and egg products

What Are the FSVP Compliance Dates?

The date by which FSVP importers must comply with the FSVP regulations is the latest of the following dates. FDA will inspect FSVP importers to ensure they are in compliance:

  • May 30, 2017
  • For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations
  • For an FSVP importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions