FDA Food Traceability Final Rule Archives

Foreign Supplier Verification Program (FSVP): What It Means for FSMA

Posted on February 12, 2024February 14, 2024 by rfxadmin

The Food and Drug Administration Food Safety and Modernization Act (FSMA) is going to change how the U.S. food supply chain works. And not just for U.S. companies. When the law takes effect in January 2026, foreign companies that import food to the United States must also comply. This is what the FSMA Foreign Supplier Verification Program (FSVP) is all about.

If you’re an importer, you’re subject to the FSVP under FSMA. If you’re a U.S.-based company, you want to make sure your non-U.S. trading partners are compliant.

Here is everything you need to know about the FSVP so that you can achieve and maintain FSMA compliance.

What Is an Foreign Supplier Verification Program? What Is the Significance?

Technically, FSVP stands for Food Supplier Verification Programs (plural). An FSVP is a program that promotes traceability, food safety, and transparency across the entire food supply chain. It mandates that importers perform certain activities to facilitate public health protection and verify that imported food meets the FSMA safety requirements.

Under a Foreign Supplier Verification Program, importers are required to verify that the food they import meets U.S. safety standards. They must develop, maintain, and follow an FSVP for each food imported, unless an exemption applies. The goal, therefore, is to ensure that every imported food has been produced in a way that delivers the same level of public health protection as the applicable FSMA requirements, and that food is not adulterated or misbranded with respect to allergen labeling.

Why is the Foreign Supplier Verification Program necessary? The answer is simple: The United States imports billions in food each year. According to the USDA, the U.S. imported $148 billion in agricultural products in 2020. U.S. food also includes a huge amount of imported animal products.

By extending FSMA requirements to importers and their suppliers, the Foreign Supplier Verification Programs promote increased safety and accountability. It also provides insights into each foreign supplier’s performance, enabling U.S. food businesses to make informed decisions about their trade relationships and promote good manufacturing practices.

Who Is Covered by the FSVP?

It defines an importer as “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 isn’t a U.S. owner or consignee at time the product enters the USA, the FSVP defines the importer as “the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent.”

The important takeaway is that there must be a U.S.-based FSVP importer who takes responsibility for meeting the FSVP requirements.

Key Components of the FSVP

The Foreign Supplier Verification Program is built on widely accepted food safety standards and preventive controls rules. Key FSVP requirements include the following:

- - Hazard analysis: Importers must analyze hazards associated with each food.
  - Supplier verification: The FSVP outlines appropriate supplier verification activities that importers must complete.
  - Corrective actions: Procedures must be in place to address identified issues.

Requirements for Importers

An FSVP importer may need to perform the following activities, unless they’re exempt or subject to modified requirements.

Verify Suppliers

Conduct appropriate supplier verification to assure that the hazards requiring a control in the food you import have been significantly minimized or prevented. These activities may include annual onsite audits by a qualified auditor, sampling and testing food, and reviewing the supplier’s food safety records.

Perform a Hazard Analysis

Hazard analyses must include identifying “known or reasonably foreseeable hazards” and determining if they require a control. The FDA notes several types of hazards, including the following:

- - Biological (e.g., parasites and disease-causing bacteria)
  - Chemical (e.g., radiological hazards, pesticide and drug residues, natural toxins, unapproved additives, food allergens, and nutrient deficiencies or toxicities in animal food)
  - Physical (e.g., objects in food products such as glass)

Evaluate Risks

You must evaluate risks that the food itself and the foreign supplier’s performance could pose. In doing so, you must consider the following:

- - Your hazard analysis for the food
  - Who will apply the hazard controls (e.g., the supplier or its ingredient supplier)
  - The supplier’s food safety practices and procedures
  - Applicable U.S. food safety regulations and information about the supplier’s compliance
  - The supplier’s food safety performance history, which should include testing and audit results and the supplier’s record of correcting identified problems.

Perform Periodic Reassessments

You have to reassess your foreign suppliers every three years — or sooner if the FSVP importer becomes aware of new information about hazards in the food or changes in the foreign supplier’s performance.

Identify the FSVP Importer

As an FSVP importer, you are required to provide the U.S. government with the following information about your organization:

- - Legal business name
  - Electronic mailing address
  - Unique facility identifier (UFI)

The FDA accepts the Data Universal Numbering System (DUNS) number as a UFI. FSVP importers temporarily unable to obtain a DUNS number have since May 2017 been permitted to transmit the value “UNK” (i.e., “unknown”) in the UFI field, allowing food to be processed through the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system, even if the importer has not yet provided a DUNS number.

Other Requirements

You must use a qualified person to develop an FSVP and to perform FSVP activities.

Furthermore, you must take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate). The corrective action will depend on the circumstances; for example, the best course of action may be to stop using the foreign supplier until the problem (e.g., noncompliance, adulteration, misbranding) has been adequately addressed.

Last, you’re required to maintain detailed FSVP records. A U.S. agent can request these records during an audit. Alternatively, they might review them during a randomized compliance assessment. Make sure you retain all digital records related to your FSVP compliance activities for at least two years.

Role of Technology in FSVP Compliance

Old-school compliance strategies can’t keep pace with the stringent recordkeeping and analytics mandates found in the Foreign Supplier Verification Program framework. Instead, you need a robust suite of technologies designed to accelerate and simplify compliance.

Adopting food supply chain software will empower your team to gather and manage key details about trading partners. With the right tools in place, you can transform food safety and regulatory compliance into an integrated part of your company culture.

Collaboration with Foreign Suppliers

FSVP compliance is a joint effort; you cannot achieve and maintain compliance without the support of your foreign suppliers. Reputable and successful foreign suppliers will embrace FSVP, as they understand that they cannot import their goods to the United States without complying.

Use this to your advantage. Reach out to your trading partners, relay what requirements apply to your organization and its operations, and develop a cohesive strategy to meet FSVP provisions. Building strong relationships with suppliers is key to a successful verification and hazard mitigation program.

FSVP Rollout and Influence

To date, compliance with the Foreign Supplier Verification Programs has been a challenge for many importers. According to a 2020 FDA report, in 2019 the Agency issued 340 citations to companies for failing to develop an FSVP — a 17 percent increase over 2018. In total, there were 354 non-compliance citations, including for failing to:

- - Follow or maintain the FSVP
  - Translate the FSVP into English when applicable
  - Sign and date the FSVP upon modification
  - Make adequate assurances of a supplier’s food safety

Over the last two years, the FDA has ramped up enforcement, which means that preparedness and diligence are more important than ever. As the Agency itself says, “Being prepared is key to avoiding a citation.”

Even with these challenges, the food industry should anticipate that FSVP will have a broader, sustained impact on global food supply chains. Along with FSMA, it encourages international suppliers to elevate their food safety standards, adopt best practices, and embrace food safety in a digital, traceable supply chain. This will lead to a more uniform global food safety system, enhancing consumer confidence in the safety of foods everywhere.

It’s likely that more and more countries will enact or continue rolling out similar food safety regulations on imported goods. When they do, it will accelerate the push toward safer, more sustainable food production practices.

Final Thoughts: Achieve Foreign Supplier Verification Program Compliance

As we’ve seen, the FSVP requires a lot of importers and their foreign suppliers, and many organizations have struggled with compliance.

The keys to success (and avoiding citations and fines) are preparedness and proactive implementation of FSVP practices and technologies that will yield a safer and more transparent food importation process.

If you don’t know where to start, contact us today to book a demo. Our traceability and transparency solutions for the food and beverage industries not only take the guesswork out of compliance — they transform all your supply chain data into true business value.

FSMA Warehouse Requirements: A Comprehensive Guide for Compliance

Posted on December 19, 2023 by rfxadmin

Passed in 2011, the Food Safety and Modernization Act (FSMA) is transforming the U.S. food supply chain. The law applies to most members of the food supply chain, including harvesters, coolers, packers, processors, distributors, and retail food establishments. The deadline to comply with the regulations, including the Final Rule on Requirements for Additional Traceability Records for Certain Foods, is January 20, 2026.

As the deadline approaches, it’s vital to ensure you’re making preparations to comply. Though this definitely includes rules regarding harvesting and transportation it’s important to remember that FSMA also addresses food storage and warehousing. With that in mind, let’s take a deep dive into FSMA warehouse requirements and what they mean for your business.

Understanding FSMA Warehouse Requirements

FSMA includes a set of rules that govern food production and distribution. FSMA 204, the Food Traceability Final Rule, established additional traceability recordkeeping requirements for persons who manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).

There are seven other rules, some that could affect operations and compliance at your warehouses and other facilities:

- - Preventive Controls for Human Food: Must meet Current Good Manufacturing Practice mandates, perform hazard analyses, and implement preventive controls.
  - Produce Safety Rule: Must establish science-based standards for packing, production, and storage of fruits and vegetables
  - Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to demonstrate that they are meeting U.S. food safety standards
  - Sanitary Transportation Rule: Establishes regulations for sanitary transportation of food items
  - Accredited Third-Party Certification Rule: Created a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.
  - Protection Against Intentional Adulteration: Aims to prevent foodborne illness by guarding against intentional adulteration
  - Voluntary Qualified Importer Program (VQIP): Optional fee-based program for foreign food facilities that want to import foods into the U.S.

We know it can be challenging to understand the FSMA rules. While focusing on the totality of the regulations — how they’ll affect your operations, your trading partners, the industry in general, and even consumers — always pay attention to the rules that pertain to your specific, day-to-day role in the supply chain.

For instance, if you operate food warehouses, be sure you understand the FSMA storage regulations just as well as you understand the FSMA 204 traceability requirements.

FSMA Warehouse and Storage Regulations

The primary goal of the FSMA regulations is to prevent foodborne illnesses and protect public health. Though this is the main driver for compliance, keep in mind that non-compliance can slow or stop your operations, damage to your brand reputation, and irk your customers and consumers.

With this in mind, here are the basics of FSMA warehouse requirements:

- - Pest Control: Food safety plans must protect food items from indoor and outdoor pests
  - Sanitation: Consumers must be protected from allergen cross-contact and pathogens
  - Temperature Controls: Especially important for animal foods like meat, eggs, and milk

Additionally, you’ll need to meet the FSMA 204 traceability requirements. Read more about those in our blog here.

Implications for Distributors

If you’re a distributor, FSMA warehouse and storage requirements directly affect your operations. The law requires you to keep and maintain records that show you and your partners are compliant and adhering to food safety requirements. This means you should be coordinating with your partners right now to make sure they’re preparing to share information and comply.

You’ll also need to closely monitor warehouse operations. Pay close attention to refrigeration guidelines, and take corrective actions immediately if you detect a deficiency. Also make sure you have the right sanitation controls in place, as this will help prevent cross-contamination.

Key Practices for Compliance

So what can you do to comply with FSMA? Beyond contacting us to discuss the requirements and the concrete steps you can take now, here’s a short list of things to keep top of mind:

Create a Food Safety Culture through Training

Your team is the first line of defense against outbreaks and compliance slip-ups, so make sure they have a foundational knowledge of the law. A well-trained team can help you be prepared for FSMA warehouse requirements and keep your facilities safe, compliant, and efficient. Training should include FSMA basics — traceability, modernization, food safety, etc. — as well as information about food processing best practices and your organizational commitment to safety and compliance.

Audit Your Processes

One key to compliance is to be audit-ready. The USDA or FDA may never come knocking, but you should act like it’s an inevitability. Conduct your own audits to identify compliance gaps in your storage and distribution processes. Internal audits will also reveal pain points and other inefficiencies that affect your operations.

Implement a Robust Recordkeeping System

FSMA stipulates that supply chain actors must maintain and share product information with their partners. The law also says that companies must share records with the FDA within 24 hours of a request (or within a mutually agreed-upon timeframe). If should you be audited, expect repercussions if you don’t have the required traceability information on hand.

Have a Plan for Safety — and More

Create a food safety plan and share it with your team. Anyone involved in maintaining food safety and preventing foodborne illness should know your plan inside and out.

You should also create a recall strategy. This should include how to share information with the FDA and other authorities and your trading partners. It should also include how to communicate with consumers about affected products and how to dispose of them safely.

Final Thoughts: Be Proactive with FSMA Warehouse Requirements

The best and quickest path to complying with FSMA warehouse requirements is to work with a reliable, experienced technology provider like us. Our supply chain solutions for the food and beverage industry will ensure you’re ready for January 2026 and the FSMA regulations for traceability, storage, and recordkeeping.

Connect with us today and one of our FSMA compliance and supply chain traceability experts can show you how it works. In about 15 minutes, you’ll have a better understanding of the law, how prepared you are, and how to get to full compliance by January 2026.

A Guide to Traceability Lot Codes and Food Safety

Posted on March 14, 2023December 6, 2023 by rfxadmin

Traceability lot codes are small but mighty tools that help to ensure food safety. Today, we’re going to look at traceability lot codes, including how they promote safety in the food industry and the important role they play in the Food Safety Modernization Act (FMSA) Section 204 compliance and securing public health.

What Is a Lot Code?

A lot code is essentially a passport for food products. It’s a unique identifier, usually a sequence of numbers and letters, that identifies a specific batch of products that were manufactured (or harvested) under the same conditions and in the same location. Lot codes help track products through the entire supply chain and are vital for troubleshooting quality issues and speeding recalls. Lot codes are assigned to products by the manufacturer.

Whether it’s a pallet loaded with cases of olive oil, a box of cereal, or even a raw agricultural commodity (RAC), the lot code tells you where an item came from and when it was made. This is vital for traceability, helping manufacturers and regulators such as the FDA and USDA keep tabs on products as they move from field to factory to consumers.

Using lot codes not only helps food companies comply with traceability and food safety regulations — they also promote supply chain transparency as part of an indelible provenance that tells where a food came from, who handled it (e.g., harvesters, packers, shippers, and receivers), and its expiration date.

How to Read a Lot Code on a Product

Typically, a lot code includes information about the production date, batch number, and sometimes even the manufacturing line. For instance, a lot code reading “20210305” could mean the product was manufactured on March 5, 2021. If it says “2021030515,” it could mean the product’s expiration date is March 15, 2021. Other numbers can indicate a unique product ID or the name of the grower, producer, or manufacturer.

Role of Lot Codes in Traceability

In the journey from farm to fork, lot codes act like breadcrumbs. They enable traceability at every step, from production to first land-based receiving interactions and beyond. If there is a foodborne illness outbreak or other problem, stakeholders can trace goods back to their sources.

And as we said above, they help you comply with food regulations, including the Food Safety Modernization Act (FSMA), which mandates recordkeeping and traceability requirements for certain foods. More on that below.

Ensuring Food Safety Through Lot Codes

Traceability lot code requirements, such as those in FSMA 204, promote better food safety and transparency across the supply chain. One of the biggest benefits of traceability lot codes is that they help companies and investigators quickly pinpoint the origins of foodborne illnesses.

If an issue occurs with one of your products, you can quickly determine which products have been affected and where they are in your supply chain or, if they’ve reached their final destination, what retail establishment they’re in. With this granular data, you can implement a focused recall strategy that protects consumers and public health while minimizing product loss. Such precision also helps protect your brand: You can communicate with consumers about the status of the recall, affected areas, and how to dispose of the recalled product.

Common Questions About Traceability Lot Codes

Let’s consider a few common questions about traceability lot codes.

Can a Lot Code Tell You Whether a Product Is Organic or Not?

Lot codes don’t directly convey this information; however, they can be used alongside other product details to let consumers know if a product is organic.

How Can Consumers Use Lot Codes?

Consumers can use lot codes to make informed decisions about the food they buy. They can check the lot code to determine whether their product is part of a recall. It’s also a handy way to gauge a product’s freshness.

Why Are Lot Codes Important for Food Safety?

Lot codes make tracking and tracing products faster, easier, and more accurate. If there’s a problem with a food item, such as a contamination issue, the codes help quickly identify which products are affected.

Consumer Awareness and Lot Codes

If you want to establish your brand as transparent and customer-centric, you should educate consumers about traceability lot codes. Teaching consumers how to read codes and learn what information they provide will empower them to make informed choices regarding the food products they buy.

The FSMA Traceability Lot Code

The Food and Drug Administration’s (FDA) Food Safety and Modernization Act (FSMA) is the primary set of regulatory requirements governing the use of a lot code on food products. FSMA rules outline when to put a lot code on food products, what traceability data you must retain, and more.

The FDA Food Safety Modernization Act requires you to track key data elements (KDEs) and critical tracking events (CTEs) for certain foods like shell eggs, butter, tree-borne fruits, and more. The final rule’s requirements have a compliance date of January 20, 2026. However, some aspects are already being enforced.

What is the FSMA Traceability Lot Code?

The FDA defines the FSMA traceability lot code as “a descriptor, often alphanumeric, used to uniquely identify a traceability lot within the records of the firm that assigned the traceability lot code.”

Certain types of companies must assign, record, and share with their trading partners the traceability lot codes for foods on the FTL. These companies must also link the codes to information that identifies FTL foods as they move through the supply chain. (More on this below.)

A traceability lot code must be assigned when any of the following occur:

- - Initial packing of a raw agricultural commodity (RAC*), other than a food obtained from a fishing vessel
  - Performing the first land-based receiving of a food obtained from a fishing vessel
  - Transformation of a food

Section 201(r) of the Federal Food, Drug, and Cosmetic Act defines a RAC as “any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.”

FSMA Traceability Lot Codes in Action: CTEs and KDEs

To fully understand FSMA traceability lot codes, we have to talk about the cornerstones of FSMA traceability: critical tracking events (CTEs) and key data elements (KDEs), which are required for foods on the FTL.

In broad terms:

- - CTEs include events that happen during growing and processing, such as harvesting, cooling, initial packing, and distribution.
  - KDEs provide the granular details for food traceability, including time, location, unit measurements, and information about the businesses handling the food.
  - Different companies are responsible for different types of KDEs (e.g., for receiving, shipping, transformation).

A FSMA traceability lot code is typically assigned during the “initial packing” CTE, which the law describes as “packing a RAC, other than a food obtained from a fishing vessel, for the first time.” This means that a code is not assigned at previous supply chain nodes, such on a farm, during harvest, or at a cooling facility.

Once a traceability lot code has been assigned, the records required at each CTE must include that code. Furthermore, companies shouldn’t change the traceability lot code they receive from their partners (e.g., a shipper shouldn’t change the code it receives from an initial packager).

Do You Have to Comply? Are You Exempt?

The Final Rule does have exceptions to the requirements we’ve discussed above.

Overall, the law stipulates that “persons who manufacture, process, pack, or hold foods on the FTL [must] maintain records containing KDEs associated with CTEs” and “provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.”

Therefore, speaking generally, initial packagers, shippers, and receivers have to assign, record, and/or share include a FSMA traceability lot code. Companies that transform FTL foods into other products must include the traceability lot code for each ingredient received and a new traceability lot code for the product you’ve created.

However, companies that receive an FTL food from a partner that is exempt from the regulations must assign a traceability lot code if one has not already been assigned — unless the receiving company is a retail food establishment or a restaurant.

Again, we’re speaking generally. The FDA has an online tool to determine if you’re exempt from the Final Rule.

Final Thoughts About Traceability Lot Codes

This is a lot of information to digest, especially the FSMA requirements. The best option is to contact us and nail down your FSMA traceability lot code obligations — and to make sure you’re ready to comply with every FSMA requirement.

As we wrote in our last FSMA update about two weeks ago, the deadline to comply is January 20, 2026. That seems like a long way off, but it’s really not when you factor in the complexity of the Final Rule, the FTL, and the other mandates.

Antares Vision Group can help. We’ll answer your questions. We’ll demonstrate how our traceability and compliance solutions meet your exact needs. And we’ll show you how technology from rfxcel brings added value for brand protection, risk mitigation, customer engagement. Drop us a line today and let’s get started.