In our August article, we discussed supply chain risk management and supply chain verification activities. In this issue we explore practical steps to help foreign suppliers comply with FSMA.


Supply chain verification is a key area in FSMA and is covered by the two Preventive Controls rules (PC Human Food and PC Animal Food) as well as the Foreign Supplier Verification Program (FSVP). All three rules are aligned in terms of supplier verification requirements; something that provides consistency across FSMA rules.

However, suppliers outside the US still have questions about FSVP and Preventive Controls. There appears to be some confusion around the term “foreign supplier” in the FSVP rule, which we hope this article will help clarify. This article focuses on non-farm facilities. We will cover farms and the produce safety rule in our next articles. 

FSVP vs. Foreign Suppliers

The FSVP rule is for US importers. The key principles of the rule are as follows, it:

  • Requires importers to share responsibility for ensuring safety of imported food
  • Is risk-based (according to types of hazards, importers, and suppliers)
  • Provides flexibility in meeting requirements (assessing activities conducted by others)
  • Is aligned with supply-chain provisions of the Preventive Controls rules

Therefore, if you are a foreign (non-US) food supplier, your US importer is likely to be covered by the FSVP rule and may have already contacted you (or will contact you) to collect information about your food safety system. US importers are required to have a product and supplier evaluation (risk assessment) process, supplier evaluation and approval systems, as well as a supplier verification program in place. Therefore, your importer will determine which verification activities are appropriate to the identified hazards through risk assessment.

US importers are addressing supplier verification requirements in different ways, and looking for assurances that their foreign suppliers are compliant with the preventive controls requirements. Therefore, foreign suppliers are expected to have a good understanding of the requirements of the Preventive Controls rules in order to ensure the foreign facility’s compliance with FSMA.

Training Foreign Facility Staff

Since foreign suppliers covered by the regulation are expected to comply with the Preventive Controls rules, it is therefore advisable that these foreign suppliers get expert training on FSMA Preventive Controls. This helps foreign facilities achieve three main objectives:

  1. Helps foreign suppliers develop in-house resource(s) such as PCQI (Preventive Controls Qualified Individual)
  2. Provides know-how to help foreign companies develop a food safety system that complies with US importer’s requests
  3. Makes it easier for the facility to go through a FSMA audit and/or a future FDA audit

PCQI training: One of the most popular courses is the FSPCA Preventive Controls course (also commonly known as PCQI course). Facilities covered by the rule are required to have a PCQI. The preventive controls qualified individual is crucial to the management and preparation of the food safety plan, validation of preventive controls and more. 

Training the food Safety team: In addition to the PCQI training, foreign suppliers can register their employees to attend Preventive Controls implementation courses. This will help the facility’s food safety team get a detailed understanding of FSMA preventive controls and how to implement them within their companies.

Training production employees: The FSMA Preventive Controls rules specify training in food hygiene as a basic requirement. This can be achieved by providing FSMA food hygiene training to these employees in their local language. 

Working with the Importer

Coordinating and communicating with the US importer is a critical success factor in building a compliant system. Foreign suppliers required to comply with Preventive Controls rules are encouraged to seek advice and communicate with their importers and make sure both parties are aligned in their compliance expectations. US importers have access to consultants, and can therefore facilitate their suppliers’ compliance journey by providing support and/or liaising them with consulting and training bodies that can help their suppliers. Another key challenge that importers can help with is reducing the language barriers and facilitating the communication and educational process for their suppliers.

Finally, importers will have an even bigger role to play with the Voluntary Qualified Importer Program (VQIP). VQIP offers expedited review and entry of food into the US. Once FSMA accredited certification becomes available, it will be the core of VQIP. In order to participate in VQIP, importers must import food from certified facilities.

For the complete range of SGS services and support visit SGS Food Safety.

For more information, please contact:

Hank Karayan
Global FSMA Program Director
t: +1 514 402-5810

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