How to Comply with FSVP: A Guide for Importers of Food

You must be aware of the Foreign Supplier Verification Program (FSVP) if you import food for human or animal consumption in the United States. The Food Safety Modernization Act (FSMA), which aims to protect the safety and quality of the American food supply, includes the FSVP rule. The FSVP rule mandates that importers confirm the compliance of their foreign food suppliers with the relevant FDA food safety requirements.

“Today more than 200 countries or territories…supply approximately 32 percent of the fresh vegetables, 55 percent of the fresh fruit, and 94 percent of the seafood that Americans consume annually.”

FDA, FDA Strategy for the Safety of Imported Food

Complying with FSVP can help you protect your consumers and your brand reputation, as well as avoid costly penalties and disruptions in your supply chain. But how do you comply with FSVP effectively? In this blog post, we will answer some of the most common questions that importers of food have about FSVP and provide some tips and best practices for achieving FSVP compliance.

What is FSVP and who is subject to it?

FSVP stands for Foreign Supplier Verification Program. It is a program that requires importers of food to perform risk-based foreign supplier verification activities to verify that:

• The food is produced in a manner that provides the same level of public health protection as the preventive controls rules for human food or animal food, or the produce safety rule, if applicable;
• The food is not adulterated under section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act); and
• Human food is not misbranded under section 403(w) of the FD&C Act (concerning food allergen labeling).

To be recognized as the FSVP importer, they must be the U.S. owner or consignee of the food at the time of entry into the U.S., or the U.S. agent or representative of the foreign owner or consignee. It’s important to recognize that the FSVP importer may be different from the importer of record who is responsible for customs entry. And yes, the FSVP importer must have a separate FSVP plan for each food and each foreign supplier.

The FSVP rule applies to most importers of food. However, there are some exemptions and coexisting modified requirements. Some of the exemptions are:

• Food imported for research or evaluation
• Food imported for personal consumption
• Alcoholic beverages and certain ingredients
• Food that is transshipped or exported
• Certain meat, poultry, and egg products regulated by USDA
• Certain dietary supplements and dietary supplement components
• Certain low-acid canned foods
• Certain juice and seafood products subject to HACCP regulations
• Food from foreign suppliers in good compliance standing with a food safety system recognized by FDA
• Food from foreign suppliers that are certified under certain certification programs recognized by FDA

For more information on the exemptions and modified requirements, please refer to the FSVP regulation (21 CFR part 1, subpart L).

What are the main components of an FSVP plan?

An FSVP plan is a written document that describes how an importer will comply with FSVP for each food and each foreign supplier. An FSVP plan consists of four main components:

Hazard analysis

In this section, the importer will need to identify and evaluate the potential hazards associated with each food and each foreign supplier. These hazards can be biological, chemical, or physical, and can occur at any stage of the supply chain.

Supplier verification

Foreign suppliers must be verified to have adequate controls in place to prevent or minimize the identified hazards. This can be done through various methods, such as audits and inspections, sampling, testing, or review of records.

Corrective actions

What will the foreign supplier do if there are any problems with the foreign supplier or their food product? Corrective actions must be established and can include rejecting shipments, requesting corrective measures, or suspending business relationships.

Recordkeeping

This is the maintenance of records of the FSVP activities, such as hazard analyses, supplier verifications, corrective actions, and FSVP plans. These records must be accessible and available for inspection by FDA.

How do you conduct an FSVP hazard analysis?

A hazard analysis is a written document that identifies and evaluates the potential hazards associated with each food and each foreign supplier. But what’s the core of an effective hazard analysis? Let’s take a deeper dive.

Hazard identification

This is a listing of all the known or reasonably foreseeable hazards that could affect the safety of the food product. These hazards can be biological (such as bacteria, viruses, and parasites), chemical (such as pesticides, toxins, and allergens), or physical (such as glass, metal, and stones).

Hazard evaluation

This is an assessment of the severity and probability of each hazard. This should take into account factors such as:

• The type and characteristics of the food product
• The intended use and consumer
• The history and performance of the foreign supplier
• The nature and complexity of the supply chain

Hazard control measures:

You’ll have to describe all of the preventive controls or other measures that can prevent or minimize the hazards. If you’re unsure what could be considered a preventative control, here is a simple overview of some of the basic controls:

• Process controls (such as temperature, pH, and time)
• Sanitation controls (such as cleaning, disinfection, and pest control)
• Allergen controls (such as segregation, labeling, and cross-contact prevention)
• Supplier controls (such as verification, approval, and certification)
• Recall plan (such as identification, notification, removal)

Hazard reassessment

And finally, include a periodic review and update of the hazard analysis to reflect any changes in the food product, the foreign supplier, or the supply chain.

How do you verify your foreign suppliers?

Supplier verification is a verification that the foreign supplier has adequate controls in place to prevent or minimize the identified hazards. Supplier verification can be done through various methods.

Audits and Inspections

The first method is on-site audits or inspections. These are to be conducted by a qualified auditor at the supplier’s facility to assess their compliance with applicable food safety regulations and standards. Audits are typically required for high-risk foods or suppliers unless there is an alternative verification method that provides equivalent assurance.

Sample and Test

Another option is sampling and testing. Here, analyses are performed by a qualified laboratory on samples of the food product or its ingredients to detect any hazards or contaminants. Sampling and testing can be used as a primary verification method or as a supplement to other methods.

Review the records

You may also elect to perform a review of records. These are documents provided by the supplier or a third-party entity that demonstrate their compliance with applicable food safety regulations and standards. Records can include certificates, test results, audit reports, or other relevant information.

Something to also consider is the frequency and method of supplier verification. Your decision should be based on the level of risk associated with each food product and each foreign supplier such as:

• The type and severity of the hazards
• The history and performance of the supplier
• The nature and complexity of the supply chain
• The intended use and consumer group of the food product

How do you take corrective actions?

Corrective actions are actions taken if there are any problems with the foreign supplier or their food product. Corrective actions you may elect to implement can include:

Rejecting shipments

This is refusing to accept or distribute any food product that does not meet the FSVP requirements or poses a safety risk.

Requesting corrective measures

Here you’d request the foreign supplier to implement corrective measures to address the problem and prevent its recurrence. This can include modifying their processes, procedures, or controls; conducting additional testing or verification; or providing additional documentation or evidence.

Suspending business relationships

You may elect to terminate or suspend the business relationship with the foreign supplier until they demonstrate their compliance with FSVP requirements.

The type and extent of corrective actions should be appropriate for the nature and severity of the problem. Corrective actions should be documented and verified for their effectiveness.

How do you keep records of your FSVP activities?

Recordkeeping is the maintenance of records of your FSVP activities, such as hazard analyses, supplier verifications, corrective actions, and FSVP plans. Recordkeeping is important for demonstrating your compliance with FSVP requirements and facilitating FDA inspection. Your recordkeeping should include:

• Keeping your FSVP records organized and up to date
• Keeping your FSVP records in English or have an English translation available upon request
• Keeping your FSVP records for at least two years after they are created or obtained
• Making your FSVP records accessible and available for inspection by FDA

5-Steps to prepare for an FSVP inspection or audit

An FSVP inspection or audit is a review of your FSVP records and activities by the FDA or a third-party entity to verify your compliance with FSVP requirements. An FSVP inspection or audit can be conducted at any time and without prior notice. You can prepare for an FSVP inspection or audit by:

1. Keep your FSVP records organized and up to date
2. Review your FSVP plan and procedures regularly
3. Conduct internal audits or self-assessments of your FSVP program
4. Communicate with your foreign suppliers and verify their compliance status
5. Address any issues or deficiencies identified by the inspector or auditor and implement corrective actions

What are some of the challenges and best practices for FSVP compliance?

Challenges

One of the biggest challenges of FSVP compliance is the complexity and diversity of the global food supply chain. Importers of food have to deal with different types of food products, foreign suppliers, and supply chain partners, each with their own characteristics and risks.

Another common hurdle is the variability and uncertainty of food safety regulations and standards in different countries. Importers of food have to keep track of the changing and sometimes conflicting requirements of the FDA and the foreign authorities and ensure that their foreign suppliers meet them.

You may also come across the challenge of the limited resources and expertise available for conducting FSVP activities. Importers of food may not have enough time, money, or personnel to perform all the necessary tasks, such as hazard analysis, supplier verification, corrective actions, and recordkeeping.

Finally, another challenge is the potential impact of FSVP noncompliance on business operations and reputation. Importers of food may face serious consequences if they fail to comply with FSVP requirements, such as product recalls, import alerts, legal actions, or loss of customers.

Best Practices

FSVP compliance can be challenging for many importers, as it involves various tasks and complex entities. However, there are some best practices that can help importers overcome these challenges and achieve FSVP compliance.

Optimize your FSVP Plan

First, develop a clear and comprehensive FSVP plan and procedures that outline the roles and responsibilities of the importer and the supplier, as well as the steps and methods for conducting the FSVP activities. A well-written FSVP plan and procedures can help importers avoid confusion, inconsistency, or omission in their verification process.

Build a good relationship with your suppliers

Establishing a strong and transparent relationship with the foreign supplier that facilitates communication and information exchange is another best practice that can enhance FSVP compliance. By building trust and rapport with the supplier, importers can obtain more accurate and timely information about the supplier’s food safety practices, as well as request and receive any necessary documents or records from the supplier.

Implement streamlining technology

Leveraging technology and tools to streamline and automate FSVP activities and reduce human errors is another way to improve FSVP compliance. For example, importers can use software or applications that can help them manage their supplier data, conduct hazard analyses, generate reports, or store records electronically.

With Certainty, you can conduct and document your audits and inspections for global supplier verifications all in one location. Maintain total control of your compliance management as you track and report your corrective actions and inspection results, and have access to results anytime and anywhere. Certainty also helps you generate and export reports and dashboards for supplier compliance and performance monitoring.

30+ Audit and inspection checklists free for download.

Explore Certainty’s Checklist Library

Ask for help

Seeking guidance and assistance from qualified experts or third-party entities that have experience and expertise in FSVP compliance is another option for importers who need help or support in their verification process. Importers can consult with experts or third-party entities who can provide them with advice, training, auditing, or certification services related to FSVP compliance.

Be prepared for updates and changes

Staying informed and updated on the latest developments and changes in FSVP requirements that may affect the importer’s obligations or expectations is another important best practice for achieving FSVP compliance. Importers should monitor the official sources of information from the U.S. Food and Drug Administration (FDA) or other relevant authorities, as well as subscribe to newsletters or alerts that can notify them of any new or revised FSVP rules or guidance.

You might also be interested in: