Foreign Supplier Verification Program
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 GL can help you with a variety of service offerings related to FSMA.
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 a 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 GL 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 GL 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 GL 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.
The “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 Certification (TPP) rule. This means that an accredited third-party can perform audits against the Food, Drug and Cosmetics Act and other FDA applicable regulations, and issue a certificate attesting compliance. DNV GL is currently pursuing its accreditation under the TPP rule.
Why is VQIP important?
· For US 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 US’ port of entry.
· For foreign suppliers:
o Reduces the extra work of proving to various clients your status as it relates to compliance to FSMA rules.
o Opens doors to new clients – by making it easier for a US important to choose your products versus your non-certified competitor.
DNV GL can help organizations by:
· Providing third-party certification. Weather you are a non-US supplier or if you want to manage your suppliers, DNV GL can help with its global presence
· Providing GAP Analysis, in preparation for the certification audit. GAP Analysis can be very helpful as a way to gauge a company’s level of preparedness towards a full audit.
· Organizing training in order to increase level of awareness within company’s staff, leading to a more successful certification audit.