New FDA Foreign Suppliers Rule Creates Challenges for U.S. Food Importers

U.S. food importers should be preparing to comply with a new FDA rule intended to assure the safety and compliance of imported food from foreign suppliers by requiring non-exempt importers to create and write standard operating procedures to evaluate the hazards and risks associated with each imported food product and foreign supplier. The ratification of the Food Safety Modernization Act (FSMA) in November 2015 will require U.S. importers to conform to the U.S. Food and Drug Administration (FDA) Foreign Supplier Verification Program (FSVP) rule by May 30, 2017. While setting up a FSVP may seem like a daunting challenge, the multi-step process is not too complicated to start.

The Food Safety Modernization Act (FSMA) mandated the creation of a food safety system with the primary focus of preventing problems versus reacting to problems after they occur. The provisions established under the FSMA include the creation of preventive controls for the production of human and animal foods, risk-based activities for verification of food safety standards, science-based safety standards for produce grown on farms, and preventive practices related to sanitary transportation of human and animal foods. The provisions apply to both domestic food producers and to those located in foreign countries who export food into the United States.

Verifying foreign suppliers and confirming they are producing imported food in compliance with U.S. safety regulations is a core component of the FSMA. This risk-based and accommodating process will ensure the FSVP Importer will be identified on entry documents moving forward. Additionally, the FSVP Importer is accountable for setting up foreign supplier verification programs to make certain the food is not tainted or misbranded. For the purpose of FSVP, the importer is defined as 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. Highlighted below are a few steps in this process.

Identify and Analyze Hazards
The FSVP process begins with U.S. food importers identifying all potential hazards relative to each of their food products. These hazards are categorized as physical, biological, or chemical. For example, glass is a physical hazard, while disease-causing bacteria and parasites are biological hazards. Chemical hazards include color additives, drug residues food allergens, food decomposition, pesticide, natural toxins, radiological hazards, and unapproved food. Most of these examples represent natural hazards, but importers should also recognize the addition or substitution of a harmful additive into food products are hazards to be mindful of as well. Hence, a variety of possibilities could exist as the source of a hazard. So, food importers have to think about every aspect of their supply chains beginning with the ingredients to storing the food product, as well as employee cleanliness and how a consumer may use the product. After importers identify and complete an analysis of all hazards, they must focus on developing controls to prevent or minimize each one.

Evaluate Risk and Compliance of Foreign Supplier
Based on the hazard analysis, the importer determines the risk a food product exhibits by the severity of the consequences which could stem from not controlling the hazard. So, the importer must assess who controls the hazard as a segment of the risk analysis. A customer of the importer, a foreign food supplier, or a raw material supplier, or an ingredient used in the food are just a few examples of an entity that an importer could choose to designate as the responsible party to control the hazard. Another significant part of the risk analysis is how well a foreign supplier complies with FDA food regulations and a clean record of food safety practices. Some of the influential factors which could be detrimental to foreign suppliers may include being a subject of import alerts or FDA warning letters or failing to implement corrective actions to previously recognized problems. Other factors include any FDA compliance-related action regarding food safety, such as results from FDA inspections conducted at the supplier’s facility, or food-borne illnesses traced back to the supplier. Please note, this new FSVP rule will require food importers to reevaluate their evaluations of risk every three years.

Impact on Food Importers
Complying with the FSVP rule presents many challenges for importers as they must evaluate several factors at each step, and then they must repeat each step for each foreign supplier and imported food product. Additionally, importers must also possess the expertise in the best practices for importing food and FDA compliance. Unfortunately, FDA regulations regarding food adulteration and misbranding, good manufacturing practices, preventative controls, and produce safety requirements are complicated subjects, which can lead to significant obstacles preventing importers from meeting these new requirements. However, the FDA rule is accommodating and flexible in helping importers comply by allowing third-parties to conduct the hazard analysis and risk evaluations, and create and monitor a food safety plan. Even though the FDA is offering some leeway in the risk analysis procedures through a third party, the responsibility for assuring the correct evaluations happen and reviewing the documentation from the process remains with U.S. food importer.

​Further questions or help with conducting a hazard analysis and risk evaluation, please contact OCEANAIR Compliance at (781) 286-2700.