Food Safety Modernization Act - What Foreign Suppliers Need to Know

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In the United States (US), the Food Safety Modernization Act (FSMA) applies to Food and Drug Administration (FDA) registered facilities, including animal feed and pet food. It does not apply to meat, poultry and egg products that are regulated by the United States Department of Agriculture. Also, an exemption is granted to facilities in compliance with the FDA's juice, seafood and low-acid canned foods regulations.

There are several rules the FSMA has in place that affect US foreign suppliers. Exemptions to the rules exist and are based on commodity, risk, size of the facility, sales and others. To determine if a facility is exempt, please consult the U.S. Food and Drug Administration - FDA Food Safety Modernization Act. For facilities that are not exempt from the FSMA, a thorough understanding of the applicable rules is important. This information is a brief overview of the most important rules that will apply to foreign suppliers. To determine the current status for each rule, and timelines for compliance, refer to the FSMA webpage links below.

Rules in Place or Proposed by the Food Safety Modernization Act
(103) Preventive Controls for Human Food
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food
Applies to many domestic and foreign firms, including Alberta, that manufacture, process, pack or hold human food. Firms are required to identify and evaluate hazards, implement preventive controls, monitor and verify the controls, take corrective action when needed, validate the controls, and maintain a written plan and documentation including records.  
(105) Produce Safety
 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
The FDA is requiring those who produce fruits and vegetables to enact measures to ensure the safe production and harvesting of the produce. These requirements will apply to both domestic and imported produce.
(301) Foreign Supplier Verification Programs for Importers of Food for Humans and AnimalsThe burden for ensuring safety of imported foods is being shifted onto importers. The importer is the US owner of the food. Agri-businesses wishing to export food to the US must comply with the Preventive Controls rule and Produce rule (as applicable) and can expect the importer of their food to conduct verification activities.
(307) Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue CertificationsThe intent of this rule is to have a credible third-party program to allow the FDA to leverage industry audits, to help facilitate entry of certain imported foods, and to help create a path for working with foreign governments. This rule will have limited application under the FSMA with opportunities for a broader role in the future. Importers will not generally be required to obtain certifications, but in certain circumstances, the FDA may use certifications from accredited auditors in determining whether (1) to admit certain imported food into the United States that the FDA has determined poses a food safety risk or (2) an importer is eligible to participate in a voluntary program now under development for expedited review and entry of food (i.e., VQIP – Voluntary Qualified Importer Program).
(302) Voluntary Qualified Importer Program
The FDA is required to establish a voluntary program that would provide expedited review of food and ingredients from participating importers. The rule is dependent on having the third party certification rule in place.
Establish Good Manufacturing Practices and Preventive Controls for Food for AnimalsThe final rule establishes Current Good Manufacturing Practices that specifically address the manufacturing, processing, packing, and holding of animal food. The rule also establishes Hazard Analysis and Risk-based Preventive Controls for Food for Animals.
Food Defence
Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
Under this rule domestic and foreign facilities are required to address vulnerable processes in their operations to prevent acts on the food supply intended to cause large-scale public harm.
Recognizing that small and very small businesses may need more time to comply with the requirements, the FDA is proposing tiered compliance dates based on facility size.

Other rules that may affect foreign suppliers:

We are available to assist you in learning more about the FSMA and to provide resources and information to help you implement any food safety system. Please email the Food Safety Team.
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For more information about the content of this document, contact Kelly Sawka.
This document is maintained by Amrit Matharu.
This information published to the web on February 19, 2014.
Last Reviewed/Revised on February 8, 2019.