Foreign Supplier Verification Program
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The Food Safety Modernization Act is one of most comprehensive and broad legislations involving Food Safety to be developed in the United State’s history. It applies to a very broad category of products and companies, including those who manufacture/process, pack or store human or animal food. Also affected by FSMA are importers, agents, representatives of foreign companies and shippers/carriers.
How can you build trust and visibility in your supply chain?
If your organization performs any of the activities above, it’s very likely you are affected by FSMA. It’s very important you understand how these requirements affect your operations. DNV can help you with a variety of service offerings related to FSMA.
Foreign Supplier Verification Program – your product “passport to the USA”
What is an “Importer”?
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 at the time of U.S. entry). 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. See more on the FDA site here.
The Foreign Supplier Verification Program (FSVP) is an FDA program aimed at providing assurance that foreign suppliers of food products meet similar requirements to US-based companies.
Such public health protection requirements relate to the Food, Drug and Cosmetics Act sections 418 (Hazard Analysis and Risk-Based Preventive Controls - HARPC) or 419 (Standards for Produce Safety).
Under FSVP, US importers are required to monitor their foreign suppliers’ compliance to FDA statuses.
DNV can helpwith the following services :
· Identify the impact of FSMA in your organization: by understanding what products your organization manufactures, processes, imports, transports, etc, DNV can tell you what your organization needs to do to comply to FSMA requirements.
· Develop protocols to ensure adherence to FSVP: implement programs to manage risk and assess supplier’s compliance to FDA statuses and develop internal procedures for your own compliance to FSMA rules.
· Conduct FSVP compliance audits: if your organization has protocols in place aiming to comply with FSVP, let DNV be the independent “extra pair of eyes” to ensure your protocols are meeting regulatory requirements and, most importantly, are effective and reasonable to your organization.
· Conduct Supplier Audits: by independently auditing your suppliers to ensure they meet FDA requirements – ensuring your organization is meeting your obligations under FSVP.
· Train: both your organization and your suppliers on FSMA, its requirements, and how to implement them towards compliance with the law. This also includes the well-known Preventive Controls Qualified Individual (PCQI) training. (Link)
Whenever possible, auditing services can be incorporated as addenda into existing GFSI certification audits, lowering costs for both your company as well as your suppliers.
Expedited USA Entry Program Certification for Foreign Suppliers – your product “TSA lane into the US”
The FDA’s Voluntary Qualified Importer Program (VQIP) is a program which allows foreign suppliers to get expedited entry for their food products into the USA. VQIP is regulated by FSMA Third-Party Program (TPP) rule. This means that an accredited third-party can develop their own TPP and perform audits against the Food, Drug and Cosmetics Act and other FDA applicable regulations, and issue a certificate attesting compliance.
DNV is accredited under this TPP rule.
Our Expedited USA Entry Program for Foreign Suppliers certifies foreign suppliers, who went through the FSVP, for the seamless entry of their products into the US.
Why is Expedited USA Entry Program for Foreign Suppliers important?
· For USA importers:
o Assurance that a foreign supplier complies to FSMA rules, avoiding the need to further assess the supplier.
o Expedited entry of the product into the USA by potentially saving days for release in one of USA’s ports of entry.
· For foreign suppliers:
o Reduces the extra work of proving to various clients with your status, as it relates to compliance to FSMA rules.
o Opens doors to new clients – by making it easier for a US importer to choose your products versus your non-certified competitor.
DNV can help organizations by:
· Providing with the Expedited USA Entry Program for Foreign Suppliers certification whether you are a non-US supplier, or if you want to manage your suppliers, DNV is a global company, working in many parts of the world.
· Providing GAP Analysis in preparation for a certification audit, GAP Analysis can be very helpful as a way to gauge a company’s level of preparedness towards the full audit.
· Organizing training to increase level of awareness within the company’s staff, leading to a more successful certification audit.