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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.

FSMA 204 and Food Safety: Examining Compliance Requirements

Posted on March 23, 2023December 7, 2023 by rfxadmin

The Food Safety Modernization Act (FSMA) is a sweeping set of regulations designed to revolutionize how we approach food safety in the United States. The Final Rule on Requirements for Additional Traceability Records for Certain Foods — also known as the “Food Traceability Final Rule” or “Final Rule”) implements FSMA Section 204. FSMA 204 establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold foods included on the Food Traceability List (FTL).

For the food industry, understanding and complying with FSMA 204 is not just a legal requirement: it’s a commitment to public health and safety. It also creates many value-add opportunities through leveraging supply chain traceability.

Let’s dive into the FSMA 204 rule and what it means for your business.

Understanding FSMA 204

FSMA’s overarching goal is to prevent foodborne illnesses; it has seven rules to govern food production and distribution. Section 204 focuses on enhancing the traceability of FTL food, ensuring that businesses can quickly identify and address potential safety issues. The rule emphasizes the need for detailed recordkeeping. It’s like a meticulous logbook of your food product’s journey from farm to table.

Specifically, FSMA 204 requires supply chain actors to maintain records of critical tracking events (CTEs) and associated key data elements (KDEs). Entities that manufacture, process, pack, or hold foods on the FTL (e.g., harvesters, packers, processors, and distributors) must maintain and share these electronic records. So it’s not a stretch to say that the Food Traceability Final Rule will affect almost everyone in the U.S. food supply chain.

Compliance Requirements

If you’re wondering whether FSMA 204 applies to you, consider the scope of your business. The rule primarily targets businesses that manufacture, process, pack, or hold foods listed on the Food Traceability List (FTL). Some items on the FTL include:

- Nut butters
- Deli salads
- Leafy greens
- Melons
- Shell eggs
- Tropical tree fruits
- Crustaceans
- Cucumbers
- Finfish
- Other fresh produce

To comply, you need to register with the FDA, providing detailed information about your business and the specific food products you handle. While there are exemptions, most members of the food supply chain will have to comply with FSMA 204, which also requires using traceability lot codes, developing a traceability plan, and sharing records with the FDA when requested.

Compliance Measures

Compliance with FSMA Section 204 might sound daunting, but it’s achievable with the right approach. Start by thoroughly understanding the Final Rule and its requirements. Develop a system for meticulous traceability recordkeeping. Training your staff on food safety practices is also crucial.

The goal is to make food safety part of your company’s DNA; you can’t treat the FDA Food Safety Modernization Act as an afterthought or a box you have to check.

Navigating the Countdown to Compliance

Let’s take a closer look at the FSMA 204 timeline. Traditionally, the FDA has rolled out major regulations using a phased approach. For FSMA 204, however, the Agency has set a single firm compliance date: January 20, 2026.

Although that’s a little more than two years away, the time to start preparing is now. Don’t wait. Start your compliance process early, and use the time to refine and perfect your systems. That way, if you encounter any unexpected hurdles, you’ll have time to sort them out.

The Importance of Traceability

Traceability is at the heart of FSMA 204. By maintaining and sharing CTEs, KDEs, and detailed records of each food item’s journey, businesses can know where every product came from, where it is right now, where it’s going next, and its final destination. With this rich traceability data, they can swiftly address safety concerns, recall affected products, and provide critical information during investigations. Improving traceability can also mitigate brand damage due to recalls and help maintain consumer trust.

Common Challenges and Solutions

As you work to implement FSMA 204 into your business model, you could encounter one of these challenges:

- Data challenges: Existing data-sharing strategies need to be supplemented with traceability data.
- Trading partners challenges: If your partners don’t send required traceability data, it will affect your ability to maintain and send CTEs and KDEs across your supply chain.
- Process challenges: Your system must be able to send and receive traceability data quickly and accurately. It must also be able to spot (and fix) errors and communicate effectively with your partners.
- Technology challenges: Legacy supply chain systems may not be equipped to capture and organize traceability data.

Overcoming these hurdles requires a holistic approach. You must reevaluate your processes to ensure they promote compliance and, critically, collaborate with your partners to ensure you’ll be able to share all the required FSMA 204 data. Most important, you should determine if you need to replace or augment legacy tech with new solutions designed to modernize and simplify traceability.

Benefits of FSMA 204 Compliance

FSMA 204 compliance provides many, many benefits to your business, your trading partners, and the public. When you comply with FSMA 204, you help maximize traceability, food safety, and supply chain visibility. You also avoid penalties for non-compliance.

Implementing traceability technologies will also make your supply chain more efficient. You’ll gather robust item-level data insights about the flow of goods, which will help you to identify bottlenecks and “blind spots,” reduce spoilage, and even fight diversion, theft, and counterfeits. The more you know about your supply chain, the easier it will be to optimize it.

Complying with FSMA 204 requirements is also an opportunity to leverage rich traceability data to enhance your brand reputation, engage with consumers and build trust, and establish yourself as a leader in food safety. These benefits translate into customer loyalty and business growth.

Final Thoughts About FSMA 204 Compliance

The deadline to comply with FSMA traceability requirements is January 20, 2026. (That’s a Tuesday, if you’re wondering.) The FDA is giving the food industry the extra time because it wants all regulated businesses to come into compliance by the same date — and because it acknowledges that trading partners have to get their systems in place.

The worldwide food industry should monitor events in the United States as FSMA traceability requirements evolve. It’s not just about compliance and being able to sell products in America; it’s about being able to anticipate regulatory trends, keeping your supply chain moving at peak performance, and leading in the industry through adaptation and innovation. It’s also about leveraging the FSMA regulations to create business opportunities.

This is where Antares Vision Group can help. We offer a full-stack solution for the food industry. A “soup to nuts” solution, if you will. We can answer your questions, show you in concrete detail how we create end-to-end traceability in supply chains, and discuss how to use traceability to safeguard your brand and protect your bottom line. Contact us today to talk with us and schedule a demo.

And read this if you’re interested in learning about how rfxcel technology helped a major berry producer control the safety and quality of more than 1.5 billion products.

Why FDA Food Traceability Regulations Are a Business Opportunity

Posted on August 4, 2022August 4, 2023 by rfxadmin

It’s going to be a busy couple of years for the food industry as the Food and Drug Administration (FDA) formalizes key parts of its plan to modernize and further secure the U.S. food supply chain. The next milestone for FDA food traceability regulations is just four months away, so let’s take a look at the requirements — and why food companies should embrace them as an opportunity to improve their businesses.

But first, if you’re intrigued by the idea that opportunities are “hiding” in the FDA food traceability regulations, join us for our “Safety, Regulatory Compliance & Beyond: Leveraging Traceability to Optimize the Food & Beverage Supply Chain” webinar on Wednesday, August 10, at 1 p.m. EST. Our experts will break down the “whys” and “hows” of traceability, discuss the real-world applications and value-adds, and take your questions.

Recap of FDA food traceability regulations & upcoming deadlines

Here’s a quick rundown of what’s on the table and upcoming deadlines.

Food Safety Modernization Act (FSMA)

- - Signed into law on Jan. 4, 2011
  - Aims to ensure the food supply is safe by shifting the focus to preventing contamination rather than responding to it
  - Applies to human food as well as to food for animals, including pets

Proposed Rule (FSMA 204)

- - Establishes additional traceability recordkeeping requirements for people who manufacture, process, pack, or hold foods on the Food Traceability List
  - Food Traceability List contains foods with additional traceability recordkeeping requirements (see table below)
  - Stakeholders to establish and maintain records with key data elements (KDEs) associated with different critical tracking events (CTEs)

Key dates

- - Nov. 7, 2022: FDA to finalize and submit the Food Safety Modernization Act (FSMA) Proposed Rule to the Federal Register
  - January 2023: Proposed Rule goes into effect
  - Jan. 6, 2025: Deadline for full compliance

The FDA has also launched the New Era of Smarter Food Safety and an accompanying New Era of Smarter Food Safety Blueprint, which envision a modern approach to ensuring food safety through digital, tech-enabled traceability. Get more details in our blog here.

FDA food traceability regulations: What to know now and how to seize opportunities

This is really just a preview of our August 10 webinar about leveraging traceability. We’ll touch on a few key points below; sign up for the webinar to take a deep dive.

Just the facts

The FSMA 204 deadlines are set. You’ll have to be fully compliant in about two years, so the time to prepare is now.

The Food Traceability List is a living document. More and more food items are sure to be added over time.

The FDA is committed to modernizing and securing the U.S. food supply chain. Expect the Agency to continue promoting (and regulating) traceability in a digital supply chain. This includes improving recall management.

Where’s the opportunity?

End-to-end traceability makes everything better. With the right solution, you’ll not only be compliant — you’ll make your supply chain faster, leaner, and more cost-effective.

“1-up, 1-down” is useful, but antiquated. Today, 1-up, 1-down traceability is merely a facet of end-to-end traceability (and visibility and transparency) in a digital supply chain. The right solutions transform your supply chain into an ecosystem that optimizes operations and creates opportunity and value beyond the point of sale.

Serialization is the building block of compliance — and added value. Serialization turns every product into a “digital asset” that can be traced in real time from virtually any location, yielding practical benefits to your operations. But these digital assets can accomplish much, much more, including brand protection and consumer engagement.

Traceability enables precise, targeted recall management — which means better outcomes for your brand. We’ve all heard the statistic that the average food recall costs $10 million. With traceability, you can locate specific items quickly, identify where they came from (e.g., grower, warehouse), take clear, decisive action to remove only those items from circulation, and protect consumers and your reputation.

Traceability in a digital supply chain means less clutter — literally. Do you have nightmares about back rooms full of boxes stuffed with paperwork? Traceability turns your nightmare into an operational dream. Get rid of all the paper and gain the power to quickly dial up any document, any time, from any location, including from mobile devices.

Traceability and added value

Traceability is the key to keeping consumers happy and inspired. Consumers are thinking deeply about the things they buy — where they come from and what goes into making them. They also expect to interact with the brands they trust. We wrote way back in October 2020 that supply chain traceability was building a new kind of consumer kingdom; it was true then, it’s true today, and it will be true tomorrow.

The era of digital assets and smart products is here. Products are no longer just products. With serialization and traceability, products are gateways to experiences. They’re beacons to broadcast information. They are conduits for hyper-targeted and hyper-personalized consumer engagement.

Final thoughts

FDA food traceability regulations are center stage in FSMA, the Food Traceability Proposed Rule (FSMA 204), the Food Traceability List, and the New Era of Smarter Food Safety. The deadlines are coming and you should be preparing.

But now you know that savvy companies will see traceability as more than a compliance mandate from the government — they’ll see it as a technology that creates a universe of opportunities for their businesses and brands.

Companies that are thinking only about the mechanics of complying with FDA food traceability regulations will miss these opportunities to be proactive about ensuring food safety and quality, reducing risks, protecting and building their brands, and leveraging every single product to connect with individual consumers in exciting, meaningful ways.

We don’t want you to miss these opportunities. To get started, sign up for our food traceability webinar to see how traceability works and how it delivers value.

Next, contact us to schedule a short demo of our food and beverage solutions, including our award-winning Traceability System and Mobile Traceability App. In about 15 minutes, our supply chain experts will show you how we create end-to-end traceability in a fully interoperable digital supply chain that’s visible anytime, anywhere.

Last, take a look at our other food traceability materials, some FDA links, and our shortened version of the Food Traceability List.

Our FSMA & Food Traceability Resources

Other FDA Resources

Food Traceability List

Tag: FSMA 204