The food safety rules under the Food Safety Modernization Act (FSMA) extend beyond the borders of the United States. Conceptually, any human or animal food imported into the U.S. must be produced under the same safety standards as food that is produced here. At a baseline level, foods from a foreign country must neither be adulterated nor misbranded with respect to food allergen labeling. The primary rule applying to imported food is referred to as the Foreign Supplier Verification Program (FSVP) for Importers of Food for Humans and Animals and was issued on November 27, 2015. While similar standards, analysis and verification processes are used to confirm the safety of foods manufactured overseas as those manufactured domestically, the distance and foreign borders make some safety controls for imported foods much more difficult.

Unlike the original or even the supplemental drafts, the final rules for preventive controls for both domestic and foreign foods (for humans and for animals) have evolved so that they mesh together in a way that provides consistency of standards and which will hopefully avoid duplication of efforts. Regardless of the rule, a food product must pass through a risk analysis and the application of preventive controls designed to minimize those risks before it reaches the American consumer. If wholly manufactured overseas, the importer of the finished product is responsible for insuring that these safety controls have occurred. If manufactured domestically, the U.S. facility must insure these safety controls.

Under the preventive controls rules for food products manufactured in this country, a facility must identify potential hazards that could occur not only during the manufacturing process within their own facility but those which are known or reasonably foreseeable to occur in either the supply chain (prior to the facility) or in the distribution chain (downstream from the facility). If hazards are identified in the supply chain, the U.S. manufacturer must implement preventive controls whether the supplied ingredients are domestic or foreign. This analysis is all a part of the U.S. manufacturer’s obligations under either the human or animal food preventive controls rules and will be documented in its written safety plan. An importer of food must determine that these same standards are being followed overseas.

The FSVP rule first looks to the importer. An importer is the U.S. owner or consignee of a food offered for import into the U.S. If the importer is a food manufacturer otherwise subject to the preventive controls rules, no FSVP program is necessary because the hazard is identified and managed under their preventive controls processes. If the importer is not a U.S. manufacturer subject to the preventive controls rules and does not meet one of the other enumerated exceptions, the importer must create and implement an FSVP.An FSVP requires the importer to vouch for the foreign supplier of an article of food. The foreign supplier is generally the foreign entity that manufacturers and processes the food being exported to the United States. If a foreign food passes through an intermediary packer, holder or re-labeler, the original manufacturer is still deemed to be the foreign supplier.

An importer’s FSVP must be a written plan which provides for three separate processes: 1) an evaluation of the potential hazards of the imported food; 2) an evaluation of the performance of the particular foreign supplier; and 3) a plan for the performance of periodic and appropriate supplier verification activities. Potential hazards may include any biological, chemical or physical hazards related to the food which are reasonably likely to cause illness or injury. If potential hazards are identified, the foreign supplier’s performance in controlling hazards must be evaluated. Once a foreign supplier is initially evaluated and approved, the supplier’s performance must be verified on a regular basis. If the potential hazard could cause serious adverse health consequences or death, the minimum standard is that a verification audit must be conducted at least annually. If an importer utilizes several foreign suppliers, a separate FSVP must be developed for each. If an importer obtains more than one food product from any foreign supplier, an FSVP analysis must be performed for each food product, although there may be some overlap making the process easier. The type and method of foreign supplier verification processes is flexible and may include on-site audits, sampling and testing, and/or reviews of the suppliers’ relevant food safety records.

The three processes referred to above in an FSVP may be conducted by the importer itself or the importer may rely upon other specified types of entities so long as the importer itself reviews and assesses the verification records, including the results of supplier verification activities.

• If performed by the importer, the processes must be performed or overseen by a qualified individual who has received approved curriculum training (still in development), has equivalent experience and/or both.

• An importer may rely upon a foreign government or agency if that government or agency requires the same level of public health protection as those required under the FSMA preventive controls rules. The U.S. Food and Drug Administration (FDA) is establishing a systems recognition program under which they will analyze and make a determination as to which foreign governments or agencies provide the “same level of public health protection.”

• An importer may rely upon third-party auditors.In conjunction with the FSVP Rule, on November 27, 2015, FDA issued its final rule on Accredited Third-Party Certification. This program provides a process for certifying auditors who can be relied upon to perform Hazard Analysis and verification activities overseas. It also discusses a Voluntary Qualified Importer Program (VQIP) under which an auditor can certify a foreign facility and/or certify a particular food. Certification will help to by-pass common delays in the importation process.

When auditing a foreign facility or one of its particular food products, certified third-party auditors can perform both consultative audits and regulatory audits. Consultative audits are performed in preparation for a regulatory audit and its results are for the facility’s internal use only. A regulatory audit can be provided to an importer to satisfy most of its FSVP obligations or a regulatory audit can be done to certify foreign facilities and/or can certify particular foods under VQIP.

Compliance dates vary. Generally, importers must comply with the requirements of the FSVP rule within 18 months after publication (11/27/15). If the foreign supplier is directly subject to FSMA preventive controls rules, compliance with FSVP must occur 6 months after the foreign supplier is required to meet those rules. If the importer is itself a U.S. manufacturer, the preventive controls rules contain the dates for both complying with preventive controls and for complying with “supply-chain programs” that would include verification of foreign suppliers.

There are numerous exceptions and nuances to the FSVP rule and an in-depth analysis should be made to determine whether and how the rule may apply to any human or animal food or food ingredient coming into the U.S. from a foreign country.

Kathy Hardee, Esq., is co-chair of the Food & Agriculture Industry Group at Polsinelli, PC, which is composed of a team of attorneys from every legal practice area and who each have a focused background in the food industry.

Author(s): Kathy Hardee, Esq.