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Category: Food and Beverages Blog

FSMA Produce Safety Rule: Cultivating Compliance in Agriculture

Posted on by rfxadmin

The Food Safety and Modernization Act (FSMA) is going to have a major impact on the food industry. FSMA gives the Food and Drug Administration (FDA) enforcement capabilities to promote food safety, transparency, and quality, and the FSMA Produce Safety Rule is particularly important to the changes.

The FSMA Produce Safety Rule applies to commercial growers, harvesters, and packers of produce. The rule includes preventive controls designed to mitigate the spread of pathogens and foodborne illness through agricultural water, wild animals, and any raw agricultural commodity designed for human consumption. Here’s what you need to know.

Importance and Business Value of the FSMA Produce Safety Rule

In effect since January 26, 2016, the FSMA Produce Safety Rule (“Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption”) is a major step forward for agricultural traceability, food safety, and public health. As the FDA explains, it “establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. The rule is part of the Agency’s ongoing efforts to implement the FDA Food Safety Modernization Act.”

Familiarizing yourself with the FSMA Produce Safety Rule will help comply USDA and FDA regulations, avoid fines or other regulatory penalties, and promote business continuity. From a value-addition perspective, compliance means you’ll safeguard your products, appeal to consumer demands for transparency and accountability, and protect your brand reputation.

Key Components of the FSMA Produce Safety Rule

The FSMA Produce Safety Rule is built around Good Agricultural Practices. Those practices address the following areas:

Agricultural Water

Water, essential in agriculture, can be a major source of contamination. Both production and post-harvest water require careful management, which may include:

      • Regular testing and monitoring of surface and ground water for pathogens
      • Water treatment to meet safety standards
      • Maintenance and inspection of water sources

Strictly monitoring and protecting water is vital for ensuring compliance with the FSMA Produce Safety Rule.

Employee Health and Hygiene

Employee health and hygiene are paramount when dealing with produce for human consumption. When workers are sick or lacking training, they’re more likely to become (unintentional) sources of contamination.

Examples of health and hygiene requirements include instructing employees to notify their supervisors if they may have a health condition that may result in contamination of covered produce or food contact surfaces, using hygienic practices when handling such produce or surfaces (e.g., washing and drying hands, and taking measures to prevent visitors from contaminating produce and surfaces).

Domesticated and Wild Animals

Grazing animals (e.g., livestock), animals used for work applications, and wild animals (e.g., deer and feral swine), can compromise produce safety. The FSMA Produce Safety Rule requires farmers “to take all measures reasonably necessary to identify and not harvest produce that is likely to be contaminated.”

These measures include visually examining the growing area and all covered produce to be harvested and, in some circumstances, conducting an additional assessment during the growing season and taking reasonable steps to assist during harvest if significant evidence of potential contamination by animals is found, such as placing flags outlining an affected area.

Biological Soil Amendments

Biological soil amendments of animal origin (BSAAO) are soil amendments that contain materials of animal origin. These materials may include raw manure or non-fecal byproducts such as table waste, animal carcasses, or any combination thereof.

Though biological soil additives can enhance the quality and nutrient profile of soil, they also carry some risks. Therefore, make sure that any additives are properly treated to reduce pathogens.

Production of Sprouts

Sprouts are particularly vulnerable to contamination by dangerous microbes due to the warm, moist, and nutrient-rich conditions needed to grow them. The FSMA Produce Safety Rule has requirements to help prevent the contamination of sprouts, such as:

      • Taking measures to prevent the introduction of dangerous microbes into or onto seeds or beans used for sprouting
      • Treating seeds or beans that will be used for sprouting (or relying on prior treatment by the seed/bean grower, distributor, or supplier with appropriate documentation)
      • Testing irrigation water for certain pathogens and attaining negative results
      • Testing the growing, harvesting, packing, and holding environment for the Listeria species or Listeria monocytogenes
      • Taking corrective actions if spent sprout irrigation water, sprouts, and/or an environmental sample tests positive

Equipment, Buildings, Tools, and Sanitation

The condition and cleanliness of your farm’s infrastructure — greenhouses, germination chambers, and toilet and hand-washing facilities — play a crucial role in compliance and safety. The FSMA Produce Safety Rule establishes standards related to equipment, tools, and buildings to prevent them from contaminating produce, including from inadequate sanitation.

Therefore, you should establish a routine for cleaning and sanitizing tools, equipment, and buildings. Regularly inspect and maintain equipment to prevent it from becoming a contamination source. Where possible, design facilities and equipment to be easily cleaned and to prevent harborage of pests and accumulation of dirt.

Compliance Guidelines for Farmers

The FDA provides resources explaining FSMA requirements, including the Produce Safety Rule. Let’s look at some practical tips for promoting and simplifying compliance.

One major hurdle is creating an actual compliance policy. If you run a farm, you need a comprehensive policy that addresses all facets of the Rule. This fact sheet from USDA is a helpful tool for designing and implementing your policy. If you operate a large farm, read the FDA’s “What to Expect Now That Larger Farms Must Comply with the FSMA Produce Safety Rule” here. Also check out the Sprout Safety Alliance at the Illinois Institute of Technology and the Produce Safety Alliance at Cornell University’s College of Agriculture and Life Sciences, for example.

Once you know which rules apply to your farm, develop a plan to address each relevant area. Remember, incremental improvements to enhance safety is a place to start; you don’t have to revamp your entire operation overnight.

Recordkeeping and Documentation

FSMA 204 establishes additional traceability recordkeeping requirements for companies that manufacture, process, pack, or hold foods included on the Food Traceability List (FTL). If the Produce Safety Rule applies to your business, you should also familiarize yourself with The Final Rule on Requirements for Additional Traceability Records for Certain Foods — also known as the “Food Traceability Final Rule.”

FSMA 204 requires you to maintain (keep) and share accurate records of your products as they move through the supply chain. If you get audited, you’ll have to produce these records. Download our food traceability white paper to learn more about these requirements.

Water Quality and Agricultural Practices

The water quality provision (and most other provisions) of the FSMA Produce Safety Rule went into effect in 2018. Since then, the FDA has been ramping up enforcement actions. They have paid particularly close attention to water quality. Under the rule, you have to test the untreated groundwater for generic E. coli. If you use water that has been treated with a validated process or from a public source, testing is not required. Additionally, you are prohibited from using any untreated surface water for harvest or post-harvest purposes.

Soil Amendments

The FSMA Produce Safety Rule includes other provisions regarding soil usage — specifically, the introduction of animal byproducts into your soil. If using raw manure or any other animal byproducts to enhance soil productivity, you must take precautions to mitigate the risk of contamination. Be careful when sourcing manure and other animal-based soil enhancements, and always verify that the provider is compliant with FSMA provisions.

Final Thoughts: Being Proactive Simplifies FSMA Compliance

The FSMA Produce Safety Rule is being enforced now, and the deadline to comply with FSMA 204 traceability requirements is January 20, 2026. As we’ve said all along, the key to FSMA success is to be proactive. Specifically:

      • Study the law and know your obligations and your trading partners’ obligations.
      • Talk with your trading partners to ensure they’re compliant now and preparing for January 2026.
      • Assess your operations for compliance with the FSMA Produce Safety Rule and Food Traceability Final Rule.
      • Make sure you’re working with a knowledgeable and reliable solution provider — someone who can help you comply while keeping your supply chain moving at peak performance and leveraging the FSMA regulations to create business opportunities.

This is where we can help. We offer a full-stack solution for the food industry. 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.

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

Posted on 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 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 Rules: A Guide to FDA Food Safety Modernization Act Regulations

Posted on by rfxadmin

The Food Safety Modernization Act (FSMA) is transforming the food supply chain in the United States. Learn about FSMA requirements and how they affect the food industry.

Understanding the FDA Food Safety Modernization Act (FSMA)

The Food Safety Modernization Act (FSMA), signed into law in 2011, aims to reduce foodborne illness, protect the U.S. food supply, and ensure public health. The law gives the U.S. Food and Drug Administration (FDA) authority to regulate the production, processing, packing, and transport of food throughout the country.

The FDA has finalized nine major rules through FSMA that address different aspects of the food supply chain. FSMA covers both human and animal food, and the rules are designed to address issues such as traceability, sanitation, produce safety, and supplier verification.

7 FSMA rules and requirements

Through FSMA, the FDA has issued rules that govern food production and distribution. 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). Additionally, there are seven main roles that the FDA implemented in the final FSMA rules.

      1. Preventive Controls for Human and Animal Food: Require food facilities to meet Current Good Manufacturing Practice (CGMP) requirements, conduct hazard analyses, and establish risk-based preventive controls.
      2. Produce Safety Rule: Established science-based standards for the production, packing, and storage of fruits and vegetables on farms in the U.S. and other countries.
      3. Foreign Supplier Verification Program (FSVP): Requires foreign suppliers to show that they are meeting food safety standards required in the U.S.
      4. Sanitary Transportation Rule: Established regulations for the sanitary transportation of human and animal food.
      5. Accredited Third-Party Certification Rule: Created a program to accredit specific third-party certification bodies to conduct food safety system audits of foreign facilities.
      6. Protection Against Intentional Adulteration: Aims to address the probability of an outbreak due to potential food safety risks of intentional adulteration.
      7. Voluntary Qualified Importer Program (VQIP): fee-based program provided by the FDA FSMA to foreign food facilities that intend to import their products into the country.

Other rules concern protection against intentional adulteration of food and guidelines for the use of agricultural water.

Compliance strategies for FSMA

Navigating FSMA can be complicated, especially as rules are proposed, reviewed, and finalized. To implement effective compliance strategies, organizations should:

      • Review: Start by conducting a thorough review of FSMA requirements to understand which rules apply to your business.
      • Develop: Create a robust FSMA food safety plan that’s tailored to your operations, including hazard analysis and critical control points (HACCP).
      • Implement: Establish preventive controls and monitoring systems across the organization and have a plan in place for food recalls.
      • Verify: Use audits and validation procedures to ensure compliance.

Implementing FSMA’s Preventive Controls and Hazard Analysis

FSMA’s Preventive Controls for Human Food, finalized in 2015, was created to minimize and prevent hazards at food facilities. Key components of this rule include:

      • Current Good Manufacturing Practice (CGMP) revisions: FSMA updated FDA’s existing CGMP requirements to create binding requirements for employee education and training.
      • Food safety plans: The rule created new requirements for risk-based preventive controls and hazard analysis at food facilities, including sanitation practices and allergen controls.

Businesses covered under the Preventive Controls rule must perform a hazard analysis of their facilities and products, implement food safety practices, and provide ongoing monitoring and verification of all preventive controls.

Ensuring FSMA compliance in supply chain management

Even if you’re confident about your organization’s food safety practices, you need to know that your supply chain partners are holding themselves to the same standards. Establishing clear supplier approval and verification processes can help you thoroughly vet the growers, suppliers, processors, or distributors you work with.

By implementing traceability and documentation requirements, you’ll be able to track specific products and lots in real-time. As with your internal processes, conduct regular assessments to ensure suppliers and co-manufacturers are maintaining FSMA compliance.

Final thoughts: FSMA rules and regulations

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.

We understand the importance of complying with FSMA and other regulations for the food and beverage industry. We have extensive experience delivering tailored traceability, visibility, and transparency solutions that not only help ensure compliance, but also create added value for operational efficiency, brand protection, and customer loyalty. Contact us today and one of our traceability experts will show you how it works.

And be sure to download our “Traceability in the Food Supply Chain” white paper, which explains the FSMA Food Traceability List and the Food Traceability Final Rule in detail.

The Importance of Food Traceability: Impacts on Safety and Business

Posted on by rfxadmin

As food traceability regulations continue to evolve, it can be difficult to navigate requirements and ensure you remain compliant everywhere you do business. Find out more about the traceability of food products in this guide from Antares Vision Group and rfxcel.

Understanding food traceability

In broad terms, traceability is the process of utilizing data to know the history of everything in your supply chain — every input and ingredient, every finished product. Traceability empowers you to know where something came from, where it has been, and where it is right now. It’s the ability to find granular details about the past and present of an item.

No matter your role in the supply chain, food traceability can play a vital role in securing and improving your business, from ensuring you comply with regulations to helping manage risks (e.g., making recalls faster and more accurate) and connecting with consumers.

Benefits of food traceability

The advantages of a strong food traceability system for you, your partners, and your customers include:

      • Food safety: Traceability reduces the risk of foodborne illnesses and helps ensure your products are safe for consumption.
      • Risk mitigation: If a food safety issue does arise, traceability facilitates prompt, informed responses. For example, traceability speeds food recalls and targeted product withdrawals to minimize the impact on public health and lessen interruptions to your operations.
      • Operational efficiency: Food traceability solutions act across your supply chain to improve operations and make it easier to manage your inventory.
      • Trust: Food traceability can help build consumer trust and confidence through transparent processes and demonstrating that you are a reliable brand whose products are exactly what you say they are.

Key elements of food traceability

The primary components of a good food traceability system include:

      • Identification: Companies must be able to trace individual products and raw materials back to specific locations, batches, lots, etc.
      • Product tracing: Each product must be traceable from farm to fork, with granular documentation that captures its journey at every stage of the supply chain.
      • Data capture and management: A strong, centralized system is needed for collecting, analyzing, sharing, and storing traceability records.
      • Authentication: Verification tools ensure the accuracy and integrity of food traceability data and can help resolve errors before they affect other parts of the supply chain.

Implementing food traceability systems

Here are some things to consider if you want to implement a new food traceability solution or improve your existing systems:

      • Evaluate: Start by assessing traceability requirements and regulatory obligations. Examine what industry leaders are doing to identify best practices and opportunities.
      • Select tools: Choose the appropriate traceability technologies and systems for the type of products you grow, pack, process, distribute, etc. (Working with a reliable, experienced solution provider is essential.)
      • Implement processes: Establish your traceability protocols and standard operating procedures, training relevant staff. (Again, make sure you’re working with a solution provider that will work with you and your team to ensure implementation is quick and efficient.)
      • Collaborate: Work with partners and stakeholders to implement traceability measures across the supply chain.

Food traceability in action: U.S. FDA Food Safety Modernization Act

Passed in 2011, the Food Safety Modernization Act (FSMA) made sweeping reforms to food safety regulations in the United States. The legislation empowered the U.S. Food and Drug Administration (FDA) to create and enforce rules on how food is harvested, processed, stored, and distributed throughout the United States.

FSMA’s No. 1 goal is to reduce the rates of illness from foodborne pathogens; food traceability is an important component of the FDA’s strategy to achieve that goal. The Agency’s primary guidance for traceability is the Food Traceability Final Rule, which went into effect in November 2022. It establishes additional traceability recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the Food Traceability List (FTL).

These food supply chain stakeholders are responsible for establishing and maintaining critical tracking events (CTEs) and associated key data elements (KDEs) for events such as harvesting, cooling, packing, and receiving. CTEs and KDEs are the building blocks of food traceability under FSMA. Read our food traceability white paper to learn how they work.

What food products are required to be traced under FSMA?

FSMA’s Food Traceability Final Rule sets the recordkeeping requirements for any business that manufactures, processes, packs, or holds foods on the Food Traceability List, which includes almost 20 types of food, such as:

  • Fresh fruits and vegetables
  • Leafy greens
  • Melons
  • Nut butters
  • Finfish
  • Crustaceans
  • Soft cheeses
  • Ready-to-eat deli salads

Final thoughts: food traceability

Traceability is essential to ensure the safety, transparency, and quality of the global food supply chain. Our goal is to equip businesses with modern food traceability solutions that improve operational efficiencies, comply with regulations, foster consumer confidence, and help create a more secure and transparent food industry. Offering end-to-end traceability, visibility, and transparency, our solutions for the food and beverage industry make it easy to track and trace products across every step of the supply chain. Contact us today to speak with one of our traceability experts and see a short demo of how our solutions work.

The U.S. Uyghur Forced Labor Prevention Act and Supply Chain Ethics

Posted on by rfxadmin

Signed into law on Dec. 23, 2021, the U.S. Uyghur Forced Labor Prevention Act (UFLPA) prohibits the importation of certain goods into the United States and aims to ensure that businesses are not complicit in human rights abuses. It’s one of many regulations around the world that aim to make supply chains more ethical, transparent, and sustainable.

Let’s see what the act says and examine why supply chain transparency is the key to making such legislation viable and successful. For another example of recent laws, see our blog post about Germany’s Supply Chain Due Diligence Act.

What is the Uyghur Forced Labor Prevention Act?

The Uyghur Forced Labor Prevention Act, or UFLPA, is a response to concerns over forced labor and human rights violations in the Xinjiang Uyghur Autonomous Region in northwest China.

It’s worth quoting the U.S. Customs and Border Patrol website at length for a thorough description. It says the act:

“establishes a rebuttable presumption that the importation of any goods, wares, articles, and merchandise mined, produced, or manufactured wholly or in part in the Xinjiang Uyghur Autonomous Region of the People’s Republic of China, or produced by certain entities, is prohibited by Section 307 of the Tariff Act of 1930 and that such goods, wares, articles, and merchandise are not entitled to entry to the United States.

“The presumption applies unless the Commissioner of U.S. Customs and Border Protection (CBP) determines that the importer of record has complied with specified conditions and, by clear and convincing evidence, that the goods, wares, articles, or merchandise were not produced using forced labor.”

Furthermore, the act required the Forced Labor Enforcement Task Force, chaired by the U.S. Department of Homeland Security, to develop a strategy for supporting the legislation. This strategy was published on June, 1, 2021, and includes the UFLPA Entity List, which names “entities in Xinjiang that mine, produce, or manufacture wholly or in part any goods, wares, articles and merchandise with forced labor.”

Key provisions

The Uyghur Forced Labor Prevention Act has provisions to combat forced labor and enhance supply chain transparency, including:

      • Import restrictions: As we noted above, the act bans the importation of goods produced wholly or in part in China’s Xinjiang Uyghur Autonomous Region, unless importers can provide clear and convincing evidence that the goods were not produced with forced labor.
      • Enhanced due diligence: The act places the responsibility on companies to exercise due diligence and conduct comprehensive risk assessments of their supply chains to identify any forced labor risks or links to Xinjiang.
      • Publicly available information: Companies must disclose information on their efforts to ensure their supply chains are free from forced labor, including the specific measures they have implemented and the results of their due diligence assessments.
      • Coordination with government agencies: The act requires collaboration between government agencies, including the Department of Homeland Security, Department of Labor, and Department of State, to ensure effective enforcement and implementation of the legislation.

Implications and challenges for businesses

The act has very real implications for businesses operating in the United States. They must have the means to see into their partners’ operations, as well as into the often opaque landscape of secondary and tertiary suppliers. Other challenges include:

      • Not being able to produce audits that meet Forced Labor Enforcement Task Force credibility requirements
      • Traceability challenges in the supply chain (e.g., aggregated and commingled products with difficult-to-prove provenance)
      • Regulations in other countries that make compliance more difficult/complicated
      • Challenges related to sourcing (i.e., not being able to find a crucial raw material or item outside of China)

The government provides resources for businesses concerning the Uyghur Forced Labor Prevention Act. For example, see the U.S. Customs and Border Protection’s UFLPA Operational Guidance for Importers and its FAQs about the act.

Final thoughts

The Uyghur Forced Labor Prevention Act is part of broader regulatory efforts to eliminate forced labor and human rights abuses in global supply chains. Businesses must be prepared (and willing) to audit and assess their operations, engage with their suppliers (and their suppliers’ suppliers), and establish mechanisms to trace the origin of goods to ensure compliance.

And they should be proactive about it. A first step is contacting us to talk about supply chain transparency. Our transparency solutions enable companies to track and trace their supply chains in real time from virtually anywhere in the world. Our technology makes every product a “digital asset” with a certified, provable, and sharable provenance. We can show you how it works with a short demo.

If you’re interested in learning more about supply chain transparency, check out the articles below. “Transparency” means just about the same thing in every supply chain, so consider these as case studies about how it works, why it’s important, and the business benefits it can bring.

 

 

Understanding the German Supply Chain Due Diligence Act

Posted on by rfxadmin

The German Supply Chain Due Diligence Act (SCDDA) is a significant piece of legislation that aims to promote corporate responsibility and ensure human rights and environmental standards in global supply chains.

Let’s take a look at its key provisions, its objectives, and its potential impact on businesses operating in Germany and beyond.

Background and objectives

Enacted on Jan. 1, 2023, the German Supply Chain Due Diligence Act aims to hold companies accountable for their actions and foster transparency in global trade. Its overarching goal is to prevent and address human rights abuses, enhance sustainability, and create a level playing field for responsible businesses.

Broadly speaking, the law is based on major human rights conventions and uses those conventions to establish requirements or prohibitions to prevent child labor, forced labor, and slavery; maintain occupational safety and health standards; ensure adequate wages and workers’ right to form trade unions or representation bodies; and access to food and water.

By introducing mandatory due diligence measures, the law will enhance supply chain transparency, mitigate risks, and help ensure corporate accountability. While compliance may present challenges, it also opens opportunities for companies to embrace sustainability, protect their brands, and contribute to a more sustainable and ethical business environment.

What are the provisions of the Supply Chain Due Diligence Act?

The Supply Chain Due Diligence Act mandates that German companies (i.e., those with their central administration, principal place of business, administrative headquarters, legal registration, or branch office in Germany) are required to respect human rights by implementing defined due diligence obligations.

This year (2023), the law applies to companies with 3,000 or more employees in Germany; in 2024, it will apply to companies with at least 1,000 employees in Germany. It applies to the actions of companies, their contractual partners, and other suppliers. Practically, this means a company is responsible for everything that happens along its entire supply chain. Key requirements include the following:

      • Risk assessments: Companies are required to conduct regular risk assessments to identify potential human rights and environmental risks associated with their suppliers and business partners.
      • Preventive measures: Companies must implement appropriate measures to prevent or mitigate any identified risks. This could include engaging with suppliers, establishing and enforcing codes of conduct, and training employees to raise awareness and promote responsible practices.
      • Remediation and grievance mechanisms: Companies must have effective grievance mechanisms to enable workers and stakeholders to report abuses and seek redress. They must demonstrate their commitment to resolving issues and rectifying any harm caused.
      • Transparency and reporting: Companies must disclose relevant information related to their supply chains, including their risk assessment procedures, preventive measures, and the effectiveness of their due diligence efforts. Transparency helps stakeholders hold companies accountable and facilitates informed consumer choices.

How could the act affect businesses?

The German Supply Chain Due Diligence Act has significant implications for businesses operating in Germany. Regulated companies will need to invest in developing robust due diligence systems, which may require additional resources and expertise. Compliance costs will likely vary depending on how large a company is, the complexity of its supply chain, and its existing practices and procedures.

Benefits of compliance include improved brand reputation, trust among partners and stakeholders, and reduced risk of legal and reputational damage resulting from human rights violations. Moreover, companies that embrace responsible supply chain practices can gain a competitive advantage by attracting socially conscious consumers and investors who prioritize ethical sourcing.

Final thoughts

In the global context, the spirt of the German Supply Chain Due Diligence Act aligns with other international efforts, such as the United Nations Guiding Principles on Business and Human Rights and the Organisation for Economic Co-operation and Development (OECD) Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas. It also aligns with other legislation in Europe, such as France’s Duty of Vigilance Law, the UK’s Modern Slavery Act, and the proposed European Union mandatory due diligence legislation.

As we said in our article about the U.S. Uyghur Forced Labor Prevention Act, companies should anticipate the passing of more regulations aimed at eliminating forced labor and human rights abuses in global supply chains. They must be prepared (and willing) to audit and assess their operations, engage with their suppliers (and their suppliers’ suppliers), and establish mechanisms to trace the origin of goods to ensure compliance.

Supply chain transparency is the key to compliance. To see how it works, contact us today for a short demo of our transparency solutions, which will empower you to track and trace your supply chain in real time from virtually anywhere in the world and provide a certified, provable, and sharable provenance for your products.

And if you’re interested in learning more about supply chain transparency, check out our blog articles below. “Transparency” means just about the same thing in every supply chain, so consider them as case studies about how it works, why it’s important, and the business benefits it can bring.

 

FSMA 204 and Food Safety: Examining Compliance Requirements

Posted on 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.

A Guide to Traceability Lot Codes and Food Safety

Posted on 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.

Read More About FSMA:

 

FSMA Traceability: A Comprehensive Guide for Food Industry Compliance

Posted on by rfxadmin

The Food Safety and Modernization Act (FSMA) is the most significant development in food industry traceability. One specific set of requirements in the law, the Final Rule on Requirements for Additional Traceability Records for Certain Foods, is reshaping and modernizing the approach to food safety and food supply chain data.

Whether you’re a grower, processor, distributor, or retailer in the food industry, understanding and implementing FSMA traceability is vital. Let’s walk through FSMA traceability requirements so you can adapt to the FDA’s Food Traceability Final Rule and ensure your compliance.

What Is FSMA Traceability?

FSMA traceability refers to the ability to track every step of a food product’s journey from farm to table, as required by the law. It’s primary goal is to help prevent and mitigate foodborne illnesses

FSMA traceability requirements center around creating, maintaining, and sharing a clear record of where food comes from, where it was, where it is now, where it’s going, and who’s handling it. 

Under FSMA, the Food Traceability Final Rule defines additional recordkeeping requirements all those who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), which includes cheeses, shellfish, and certain fruits and vegetables. It provides you and your trading partners with clear guidance on what data you must keep and share as your products move across your supply chain.

The FDA’s Role in FSMA Traceability

The Food and Drug Administration plays a pivotal role in FSMA traceability: It sets FSMA traceability requirements, evaluates foods using a risk-ranking model, and holds stakeholders accountable for complying with the act. In addition to setting traceability recordkeeping requirements, the FDA also assesses penalties for non-compliance with the traceability program.

Compliance Requirements for Food Industry Professionals

FSMA 204 and other provisions of FSMA apply to:

  • Harvesters
  • Coolers
  • Packers
  • Processors
  • Distributors
  • Retail food establishments

The specific requirements for your business will vary based on your role in the food supply chain. Many requirements focus on initial packing and labeling; proper packaging and labeling promote FSMA traceability and streamline the flow of goods along the supply chain.

FSMA 204 also requires using traceability lot codes, developing a traceability plan, and sharing records with the FDA when requested.

Benefits of FSMA Traceability

Embracing traceability promotes better food safety and protects consumers from foodborne illnesses. If an issue arises with one of your products, you can use traceability data to quickly find where it came from and where it is now. This granular, read-time information expedites recalls and ensures that all affected products are removed from store shelves as quickly as possible.

From a business perspective, FSMA 204 helps you protect your brand image, as you can ensure the quality, integrity, and safety of food products. In addition to enhancing your reputation, you can use FSMA traceability to identify bottlenecks within the supply chain and eliminate waste.

Technology and Tools for FSMA Traceability

FSMA gives the FDA the authority to establish modern, science- and risk-based requirements, including all the traceability requirements in Section 204. 

The law dovetails with the Agency’s New Era of Smarter Food Safety, which is “a new approach to food safety, leveraging technology and other tools and approaches to create a safer and more digital, traceable food system.” It will the FDA identify ways to further its modernization goals and help ensure that the regulations evolve with the industry and available technology to reduce foodborne illness.

So, what we’re seeing with FSMA 204 is part of the FDA’s plan to secure the food supply chain using technology. FSMA traceability, anchored by requirements for food companies to record and share Critical Tracking Events (CTEs) and Key Data Elements (KDEs), is attainable with currently available digital supply chain technology. 

Other requirements, such as using traceability lot codes and having systems to share electronic sortable spreadsheets with traceability information to the FDA, are also part of a strategic approach to leveraging technology for FSMA compliance.

Food supply chain traceability software is the best road to meeting technological requirements and FSMA compliance. It’s also the best way to ensure you remain compliant and competitive as regulations, food trends, and consumer attitudes evolve. 

Common FSMA Traceability Challenges 

Challenges to complying with FSMA traceability regulations include the following:

  • Integrating traceability systems with existing processes: Adding any new tech tool to your established systems/process could disrupt operations, including interactions with trading partners.
  • Ensuring your partners are preparing: Traceability requires participation from everyone in the supply chain. Talking with your trading partners about FSMA readiness is vital to being ready to comply by the January 2026 deadline.
  • Training staff: You’ll need to educate and train staff on FSMA 204 compliance and the effect it will have on your business. Training is also necessary to create a culture of food safety in your organization.
  • Managing data: Complying with FSMA means you will be creating, sharing, accessing, and storing massive amounts of data. Your systems not only have to handle the volume — they must ensure the data is compliant.

Navigating the challenges requires a holistic approach. First and foremost, you need to get your team on board by being transparent about the regulations, how they will affect your daily operations, people’s roles and responsibilities, and what you are doing to prepare. 

The Importance of Data Security and Privacy

With so much sensitive data being generated, security and privacy are paramount. You need to make sure that your traceability data is protected from unauthorized access and breaches. This means investing in secure systems and being mindful of privacy laws and regulations.

Additionally, you must ensure that your partners are doing their part to promote data security. Remember, you’ll need to integrate some of your technologies with theirs to expedite the flow of traceability data. You don’t want to inadvertently create a blind spot or weak link in your data infrastructure by partnering with a vendor that does not take data security as seriously as you do.

Anticipating Regulatory Audits

Nobody wants to be audited, but everybody should be prepared. The key to passing an audit is to make food safety and FSMA compliance part of your company culture. If these are only afterthoughts or simply a box to check, the chances of failing an audit are much higher. In contrast, being proactive means an audit will essentially be a formality (and become an opportunity to stand out among competitors).

Final Thoughts: FSMA Traceability with rfxcel

Familiarizing yourself with FSMA traceability requirements will help you achieve and maintain compliance, improve food safety, and preserve your brand image. Prioritize compliance and implement effective traceability practices by partnering with rfxcel. We’ve been a leader in traceability (and compliance) technology for 20 years, and we will work with you to develop a solution suited to your needs.

Book a demo to learn more. We also invite you to explore our other FSMA resources.

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