Just as Intentional Adulteration is a check on internal processes and vulnerabilities, the Foreign Supplier Verification Program Rule or FSVP is an external check on overseas suppliers. When considering the implementation of any new FSMA rule, it’s important to get a baseline understanding of what the government is requiring including what the rule entails, and how it affects food processors. Let’s find out.
The first obvious question with any new regulation is, who has to comply? To help guide you, the FDA has provided this table as a tool to determine if compliance is required.
Simply stated, the FSVP importer, whom the FDA holds responsible for the compliance, is the U.S. owner or consignee of products for import. In essence, you are held accountable if your DUNS number is used.
What’s a DUNS number? A DUNS number is a Data Universal Numbering System number and is a unique and universal number used to identify and verify business information for a specific company. Plainly put, this number is used to track products coming into the country for the FDA.
Because of the significant risk associated with FSVP compliance, we highly recommend that any food importers attend a voluntary FSVP course. According to FDA inspectors, nearly half of all importers audited this year had significant gaps in compliance with the regulation. Companies are clearly struggling to effectively implement this rule. Attend training to avoid a stressful audit later.
The FSVP Rule’s Intent
Each rule in the Food Safety Modernization Act focuses on a different portion of the food industry. The Foreign Supplier Verification Rule’s purpose is as follows:
“To ensure that imported foods are produced as safely as products made in the U.S., and are following FSMA regulations.”
As an importer, it is your responsibility to verify your Fsvp program and meet the rule’s intent. Additionally, your suppliers need to comply with the Preventive Controls Rule or the Produce Safety Rule.
Learn more about the Produce Safety Rule with this article “How to Prepare for Your Produce Safety Rule Audit”.
As with most FDA regulations, compliance dates vary based on the type of operation, size, and revenue generated. When it comes to FSVP, importers are put into different categories based on these parameters. The following is a list of compliance dates provided by the FDA for human food products which fall under the FSVP rule.
- FSVP importer whose foreign supplier is not subject to the PC or produce safety rules: May 30, 2017
- FSVP importer whose foreign supplier is required to comply with the PC rule for human food.
- Small businesses: March 19, 2018
- Qualified Facilities (including Very Small Businesses): March 18, 2019
- Suppliers subject to the Pasteurized Milk Ordinance: March 18, 2019
- “All Other” Businesses Suppliers: May 30, 2017
- FSVP importer whose foreign supplier is required to comply with the produce safety rule, except for the requirements applicable to sprouts.
- Small Businesses: July 29, 2019
- Very Small Businesses: July 27, 2020
- “All Other” Businesses: July 26, 2018
- FSVP importer whose foreign supplier is required to comply with the requirements in the produce safety rule applicable to sprouts.
- Small Businesses: July 26, 2018
- Very Small Businesses: July 29, 2019
- “All Other” Businesses: July 26, 2017
- FSVP importer whose foreign supplier is subject to the produce safety rule and eligible for a qualified exemption (other than when the foreign supplier is a farm producing sprouts).
- Small Businesses: July 29, 2019
- Very Small Businesses: July 27, 2020
In the FSVP rule, there are seven key activities. Most importantly, “Qualified Individuals” must complete key activities.
- Identify and evaluate potential foodborne hazards based on current scientific understanding.
- Conduct an assessment of suppliers
- Identify appropriate verification steps to ensure suppliers’ compliance
- Conduct these verification activities and review their results
- Apply corrective actions as needed
- Develop and maintain documented procedures for the above
- Maintain required records
For more information about the requirements of the Foreign Supplier Verification Program Rule, there is a great fact sheet here.
Selecting A Qualified Individual (“QI”)
A key concept within the FSMA rule is the “Qualified Individual,”. The idea is that anyone with a critical responsibility that may impact food safety of products should be specially qualified for that role through a combination of job experience, knowledge, and training. In essence, it comes down to employee competence, similar to any GFSI audit or ISO-based audit. It makes sense if you consider it; anyone who approves or verifies suppliers, assesses hazards, or maintains documentation, should be qualified to do so.
It’s also worth noting that you can use contractors or third-party service providers to conduct some of the functions required by the regulation. If you require such assistance, feel free to contact Safe Food Alliance for help.
Implementing The FSVP Rule With Preventive Controls
For companies who not only import but also process, there is an important consideration regarding the FSVP rule. In short, companies who have programs in place to comply with the Preventive Controls rule are considered in compliance with the FSVP rule if they fully comply with the PC rule supply chain requirements. The requirements are ultimately equivalent, although not the same word for word. That being said, import documentation requirements still must be complied with.
What The FDA Is Saying About FSVP
In 2018, members of the Safe Food Alliance staff attended a train the trainer course where the FDA pointed out areas of concern for implementing the FSVP rule. As a result, we wanted to share a few notable items from the training.
- It’s essential to identify which U.S. regulations your imported items fall under.
- If the FDA requests records, you must submit them within 24 hours of the request. Cloud-based systems are extremely effective for this reason.
- Many importers need to seek outside help to comply with all the aspects of the regulation.
- The FSVP party regulated by the FDA is not necessarily the importer of record.
- Supplier verification records must be in English. If said documents are not in English, they must be translated.
- First, make sure you understand the requirements of the regulation. If this involves training, be sure to get it.
- Next, identify critical roles required by the regulation, and whom your organization relies on to complete those roles.
- Last, ensure that you have a sound system for tracking documents and records. We strongly recommend a cloud-based system, whether something like Dropbox, Google Documents, or a paid provider. You need to have records readily available.
To summarize, the Foreign Supplier Verification Rule is complex. It is important to get the proper training and implement the rule properly, not only to prevent liabilities for your organization but also to create safer food for our communities.
For more information about the Foreign Supplier Program rule, reach out to us at firstname.lastname@example.org, for on-site training where Safe Food Alliance can create a custom course for you and your employees when you want and how you need it.