Beltway Beat

The Effectiveness of U.S. Food Laws Over Private Standards

By Sayed M Naim Khalid
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Introduction

The safety of our food supply is critical to public health, economic stability, and consumer confidence. The United States has developed a comprehensive regulatory framework for food safety that relies heavily on federal laws and oversight. This system involves multiple federal agencies, state and local governments, and numerous statutes designed to ensure food safety from farm to table. Private standards, such as those established by the Global Food Safety Initiative (GFSI), also play a role, but they are not a substitute for the regulatory power and public accountability inherent in U.S. food laws. This artilce argues that U.S. food laws are more effective than private standards and that businesses can achieve sufficient food safety by adhering to these laws without incurring additional costs associated with private standard implementation.

The Current U.S. Food Safety System

The U.S. food safety system is multifaceted, involving producers, processors, shippers, retailers, and consumers. The government, particularly through agencies like the FDA, USDA, EPA, and CDC, plays a critical role in establishing and enforcing food safety standards. These agencies work under numerous statutes and interagency agreements to ensure the safety of the food supply. The system, while complex and somewhat fragmented, is backed by legal enforcement, scientific research, and public accountability.

The Effectiveness of U.S. Food Safety Laws

The U.S. food safety regulatory system is extensive and multifaceted, involving numerous agencies with specialized roles. The Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the National Marine Fisheries Service (NMFS) of the Department of Commerce all play crucial roles in ensuring food safety. These agencies operate under a framework of more than 35 statutes overseen by 28 Congressional committees, reflecting the complexity and thoroughness of the system.

The FDA, for instance, regulates domestic and imported foods, except for meat and poultry products, ensuring they are safe, sanitary, and properly labeled. The agency has regulatory authority over more than $1 trillion in products sold annually—about 25 cents of every dollar spent by consumers, including surveillance, risk assessment, research, inspection, and education. Similarly, the FSIS is responsible for ensuring the safety of meat and poultry products, employing roughly 7,400 inspectors to oversee 6,200 slaughtering and processing plants through continuous and daily inspections.

The statutory mandates for these agencies are comprehensive. For example, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) enforces tolerances for pesticide residues, approves food additives, and ensures that food processing plants adhere to safety standards. The FSIS, by law, must conduct carcass-by-carcass inspection during slaughter, ensuring that meat and poultry products are safe for consumption. USDA) announced in 2021 that government will invest more than US$4 billion to improve the food system.

Government Enforcement and Public Accountability

U.S. food laws are enforced by federal agencies with the authority to conduct inspections, enforce regulations, and impose penalties for non-compliance. This legal backing ensures a high level of adherence to food safety standards. For example, the FDA and USDA conduct regular inspections and surveillance to ensure compliance with food safety laws. This system of oversight provides a level of public accountability that is essential for maintaining consumer trust and preventing foodborne illnesses.

Scientific Basis and Comprehensive Coverage

U.S. food laws are grounded in scientific research and are regularly updated to reflect the latest food safety information. These laws cover a wide range of food products and hazards, including microbiological contaminants, pesticides, and additives. This comprehensive approach ensures that all potential risks are addressed, providing a higher level of protection for consumers.

Economic and Consumer Protection

Effective food safety regulations prevent large-scale foodborne illness outbreaks, reducing healthcare costs and economic losses. By ensuring that food products meet safety standards, the government protects consumers from the dangers of contaminated or unsafe food. This protection is crucial for maintaining public health and economic stability.

Limitations of Private Standards

While private standards like those established by GFSI can complement public regulations, they are not a substitute for the robust framework provided by U.S. food laws. Private standards are voluntary and lack the enforcement power of government regulations. They often require third-party audits, which can be costly and lead to inconsistent implementation due to variability in auditor competency and interpretation of standards.

Cost and Market Pressure

Certification and compliance with private standards can be expensive, particularly for small and medium-sized enterprises. These costs can create barriers to market entry and place unnecessary financial burdens on businesses. Moreover, companies may feel pressured to adopt private standards to remain competitive, regardless of whether these standards offer additional safety benefits over existing regulations.

Transparency and Accountability

Private standards are enforced through independent third-party audits, which may lack the transparency and public accountability of government inspections. The results of these audits are not always made public, and there is less oversight to ensure that auditors maintain high standards of integrity and competence.

Limited Scope and Inequality

Private standards may not cover all aspects of food safety, especially those specific to local contexts or emerging threats. Additionally, smaller companies and producers in developing countries may face significant barriers to accessing certification due to costs and resource constraints, leading to inequality in market access and potentially restricting trade opportunities.

The Case for Relying on U.S. Food Laws

Given the comprehensive and enforceable nature of U.S. food laws, businesses can achieve sufficient food safety by adhering to these regulations without incurring additional costs associated with private standards. The legal framework provided by U.S. food laws is designed to protect consumers and ensure food safety across the entire supply chain. By focusing on compliance with these laws, businesses can avoid the complexities and expenses of private certification while still maintaining high standards of food safety.

HACCP Systems and FSMA

The implementation of Hazard Analysis Critical Control Point (HACCP) systems and the Food Safety Modernization Act (FSMA) has strengthened the U.S. food safety framework. HACCP systems focus on preventing hazards at critical points in the production process, while FSMA emphasizes proactive measures to prevent food safety issues. These regulatory approaches are widely recognized as effective means of ensuring food safety and can be more cost-effective than adhering to multiple private standards.

Comparison with Private Standards

Private food safety schemes, like those endorsed by GFSI, offer standardized protocols for food safety management across global supply chains. These schemes are often seen as more stringent and market-driven, providing a competitive edge and reassurance to consumers and business partners. However, these private standards come at a cost. Businesses must pay for certification, ongoing compliance audits, and the implementation of specific protocols that may overlap with existing regulatory requirements.

Comparison of U.S. Food Laws vs. GFSI Standards

Pros and Cons of GFSI Standards

GFSI Standards

Pros

Cons
  1. Global Recognition: GFSI standards are recognized worldwide, facilitating international trade and ensuring global food safety.
  2. Flexibility: GFSI standards allow for flexibility and adaptability to new food safety practices and technologies.
  3. Market Competitiveness: Certification to GFSI standards can enhance a company’s reputation and market access.
  4. Private Sector Leadership: GFSI involves private sector stakeholders, fostering innovation and industry-driven solutions.
  5. Standard Harmonization: GFSI standards harmonize various private food safety schemes, reducing duplication and confusion.
  6. Risk-Based Approach: GFSI emphasizes a risk-based approach to food safety, focusing on critical control points and preventive measures.
  7. Continuous Improvement: The GFSI framework encourages continuous improvement and regular updates to standards.
  8. Third-Party Audits: Independent third-party audits provide an objective assessment of a company’s food safety practices.
  9. Training and Resources: GFSI offers extensive training and resources to help companies comply with standards.
  10. Consumer Confidence: Certification to GFSI standards can enhance consumer confidence in the safety and quality of food products.

 
  1. Cost: Certification and ongoing compliance with GFSI standards can be expensive, especially for small and medium-sized enterprises.
  2. Voluntary Nature: As a voluntary scheme, GFSI lacks the legal enforcement power of government regulations.
  3. Inconsistent Implementation: Variability in auditor competency and interpretation of standards can lead to inconsistent implementation.
  4. Complexity: The process of achieving and maintaining GFSI certification can be complex and resource-intensive.
  5. Overlap with Regulations: GFSI standards can overlap with existing government regulations, creating redundancy.
  6. Market Pressure: Companies may feel pressured to adopt GFSI standards to remain competitive, regardless of their actual necessity.
  7. Audit Fatigue: Frequent audits and certifications can lead to audit fatigue and a focus on passing audits rather than genuine food safety improvements.
  8. Limited Scope: GFSI standards may not cover all aspects of food safety, particularly those specific to local contexts or emerging threats.
  9. Transparency Issues: Private certification bodies may not be as transparent as government agencies in disclosing audit results and non-compliance.
  10. Access Inequality: Smaller companies, particularly in developing countries, may face barriers to accessing GFSI certification due to costs and resource constraints.

 

Pros and Cons of U.S. Food law

U.S. Food Laws

Pros

Cons
1.     Government Enforcement: U.S. food laws are enforced by federal agencies like the FDA and USDA, providing a robust and legally backed framework for food safety.

2.     Comprehensive Coverage: These laws cover a wide range of food products and hazards, including pesticides, additives, and microbiological contaminants.

3.     Public Accountability: Government agencies are accountable to the public, with transparent operations and public reporting of food safety issues.

4.     Standardization: U.S. food laws provide standardized regulations across the country, ensuring uniform food safety practices.

5.     Scientific Basis: The laws are based on scientific research and updated with the latest food safety information.

6.     Interagency Coordination: Multiple agencies collaborate, providing a multi-faceted approach to food safety.

7.     Consumer Protection: The primary goal is to protect consumers from foodborne illnesses and unsafe food products.

8.     Economic Impact: Government-regulated food safety can prevent large-scale foodborne illness outbreaks, reducing healthcare costs and economic losses.

9.     Legally Binding: Compliance is mandatory, with legal consequences for non-compliance, ensuring high levels of adherence.

10.   Educational Resources: Government agencies provide extensive educational resources and support to food businesses to help them comply with regulations.
  1. Bureaucracy: The complexity and fragmentation of the regulatory system can lead to inefficiencies and slow responses to emerging food safety issues.
  2. Resource Limitations: Federal and state agencies often face budget and staffing constraints, impacting their ability to perform inspections and enforce regulations.
  3. Inconsistencies: Variation in enforcement and standards across different states and localities can create inconsistencies in food safety practices.
  4. Regulatory Overlap: Overlapping jurisdictions between agencies can cause confusion and redundancy in regulatory efforts.
  5. Slow Adaptation: Government regulations can be slow to adapt to new food safety technologies and practices.
  6. Burden on Small Businesses: Compliance with complex regulations can be burdensome for small food businesses with limited resources.
  7. Limited Global Reach: U.S. laws apply primarily to domestic producers, potentially creating gaps in food safety for imported products.
  8. Focus on Compliance: The emphasis on regulatory compliance may sometimes overshadow the focus on innovative food safety improvements.
  9. Inspection Gaps: Resource limitations can lead to infrequent inspections, reducing the effectiveness of enforcement.
  10. Perceived Rigidity: Some stakeholders view government regulations as rigid and inflexible, stifling industry innovation.

 

Conclusion

While both U.S. food laws and GFSI standards have their strengths and weaknesses, their effectiveness depends on the specific context and needs of the food industry stakeholders. U.S. food laws provide a legally enforceable and standardized framework, ensuring a high level of consumer protection and public accountability. On the other hand, GFSI standards offer flexibility, global recognition, and industry-driven innovation, though they come with significant costs and may lack the enforcement power of government regulations.

The U.S. food safety system, despite its complexity and fragmentation, provides a robust and effective framework for ensuring the safety of the food supply. Federal regulations enforced by agencies like the FDA and USDA offer comprehensive coverage, scientific grounding, and legal enforcement, which are critical for protecting public health and consumer confidence. While private standards can play a supportive role, they cannot match the effectiveness and public accountability of government regulations. By adhering to U.S. food laws, businesses can achieve high standards of food safety without incurring the additional costs and complexities associated with private certification.

For optimal food safety, a balanced approach that leverages the strengths of both systems may be the most effective solution. This hybrid strategy would combine the stringent, enforceable standards of U.S. food laws with the flexibility and global perspective of private standards like GFSI, ensuring comprehensive protection for consumers while promoting innovation and international trade.

Further reading:

  1. (2023, July 13). FSMA Final Rule on Accredited Third-Party Certification. Retrieved July 18, 2024, from US Food and Drug Administration: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-accredited-third-party-certification
  2. Foulis, D. (2024, Feb 14). Four benefits of gaining GFSI certification. Retrieved July 18, 2024, from Ideagen: https://www.ideagen.com/thought-leadership/blog/four-benefits-gfsi-certification
  3. (2011, March). Enhancing Food Safety Through Third Party Certifications. Retrieved July 18, 2024, from Mygfsi.com: https://mygfsi.com/wp-content/uploads/2019/09/Third-Party-Certification-GFSI-White-Paper.pdf
  4. Kaylegian, K. (2021, April 13). The Food Safety Modernization Act (FSMA). Retrieved July 18, 2024, from PennState Extension: https://extension.psu.edu/the-food-safety-modernization-act-fsma
  5. Loucks, S. (2024, May 31). Why Should My Business Become GFSI Certified? Retrieved July 18, 2024, from FoodReady: https://foodready.ai/blog/why-should-my-business-become-gfsi-certified/
  6. Scott, J. (2023, Nov 8). FDA FSMA: Providing value beyond compliance. Retrieved July 18, 2024, from IBM: https://www.ibm.com/blog/fda-fsma-providing-value-beyond-compliance/
  7. Ng S, Shao S, Ling N. Food safety risk-assessment systems utilized by China, Australia/New Zealand, Canada, and the United States. J Food Sci. 2022 Nov;87(11):4780-4795. doi: 10.1111/1750-3841.16334. Epub 2022 Oct 26. PMID: 36285586; PMCID: PMC9828015.
  8. Halabi, Sam. 2016. The Battle between Public and Private Food Safety Standards. Yale Journal of Regulations. https://www.yalejreg.com/nc/the-battle-between-public-and-private-food-safety-standards/ (access on 6/29/2024)
  9. Soon JM, Baines RN. Public and Private Food Safety Standards: Facilitating or Frustrating Fresh Produce Growers? Laws. 2013; 2(1):1-19. https://doi.org/10.3390/laws2010001
  10. National Research Council (US) Committee on the Review of Food and Drug Administration’s Role in Ensuring Safe Food; Wallace RB, Oria M, editors. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington (DC): National Academies Press (US); 2010. 2, The Food Safety System: Context and Current Status. Available from: https://www.ncbi.nlm.nih.gov/books/NBK220410/
  11. Institute of Medicine (US) and National Research Council (US) Committee to Ensure Safe Food from Production to Consumption. Ensuring Safe Food: From Production to Consumption. Washington (DC): National Academies Press (US); 1998. 2, The Current US Food Safety System. Available from: https://www.ncbi.nlm.nih.gov/books/NBK209121/

 

Addressing Foreign Material Contamination in Food Products

By Kurt Westmoreland
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I’ve seen it all when it comes to foreign material contamination — from electrical wire to welding slag to a folded-up $50 bill in a block of frozen protein. Physical foreign material contamination isn’t isolated to one type of material, phase of the manufacturing process or point in your supply chain. Physical contaminants can enter food product anywhere, anytime, making reliable detection and actionable traceability vital for producers to ensure safe food to market. We typically trace the issue back to one of three “stops” on a food product’s journey to the end consumer.

Stop 1: Raw Materials

Let’s start from square one: raw materials pose a foreign contamination threat, especially in the case of meat/poultry and fruit/vegetable products. If livestock consume inorganic material like stone or plastic, or metal pieces from plant harvest machinery find their way into plant/organic matter, contamination is immediately a concern. If physical contaminants aren’t detected by a raw ingredient supplier, the risks they pose can be passed downstream in the supply chain to other producers.

Stop 2: Processing

Most raw materials go through an initial stage of processing to turn them into usable ingredients for later-stage producers. This processing stage can involve a higher activity level, leading to more machinery interaction. Perhaps bone debris remains in protein after deboning, or a maintenance failure leads to a lost screw in plant matter. The activity levels at this stage in the supply chain call for increased scrutiny of physical contamination detection and prevention.

Stop 3: Production

Last, these processed ingredients are often turned into prepared or packaged foods. These processes typically include a more refined level of machinery involvement, but also include unique foreign material risks. Machinery, packaging and product breakage are all common challenges at this stage. In the past, we’ve found broken jars, missing pens, lost eyeglasses and more. No producer, no product, no process is immune to this threat—particularly when human beings are involved.

The modern food production environment is highly mechanized, and no matter how new and improved technology may be, the risk of foreign material exists from the machinery used to produce at high throughput. Line extensions, wear and tear, new construction and routine maintenance all play a role in introducing the problem of foreign material in the job of feeding our customers.

Counting the Costs of Foreign Material Contamination

There are many downstream impacts of foreign material contamination. Some are quantifiable, some are not—but all of them hold weight in their own right. Missed orders lead to dissatisfied customers. Storage challenges lead to sunk costs at your facility. Downgraded product leads to lost value and smaller profit margins.

While it’s nearly impossible to sum up the potential effects of foreign material contamination, the image below serves as a point of reference for the many considerations producers have related to this issue.

73% of companies we surveyed in 2024 reported a foreign material incident at least quarterly, many of them citing weekly challenges. Last year, 70 recalls occurred due to foreign material contamination. That frequency is noteworthy, but it doesn’t have to be a crisis. Foreign material contamination can be managed and addressed within any food safety program.

Taking a Closer Look: Technology in Food Inspection

If there’s one thing we know about our industry, it’s that technology is always expanding. More than 50% of food producers use X-ray technology in some form, but there are many other inspection options available:

  • Metal Detection. Metal detectors use electric signal disruption to detect metal within a food product. They are of limited use when food contains high moisture, salt, or sugar. They are most effective for aluminum and ferrous metals.
  • Vision Systems. These systems use machine learning to “teach” the system but are more often used for qualitative analysis than for foreign material detection, as their examination is only surface-level. Foreign material can and does appear both on and in product.
  • Hyperspectral. Hyperspectral systems emit photons of various wavelengths and use spectroscopic sensors to evaluate the energy directed back to identify the material type. While this system type only works at the surface level, it is one of the most reliable detection systems for rubbers and plastics.
  • Microwave. While used sparingly in the food and beverage industry, these systems use microwaves and disturbances in the resulting electromagnetic field to detect foreign material. These systems are excellent at detection but haven’t yet reached mass adoption.
  • Computed Tomography (CT). CT systems create a 360-degree rotational view of the product, overcoming the positional constraints of a 2D system. Production speeds are too fast for this to work in-line, but these systems are very effective for use off-line.

Embracing technology allows food producers to tailor their contamination prevention and detection strategies to meet their operations’ unique challenges. No matter how physical contaminants are found, once they’re known, the question becomes: What do we do now?

What To Do With a Product Hold

Producers have options to address foreign material contamination incidents. The instinctive reaction may be product disposal, which eliminates the threat of physical contaminants entirely. The ripple effects are lost revenue, potentially damaged retailer relationships and a negative impact to sustainability goals.

In some cases, internal inspection is the best option. Manufacturers use in-house resources and equipment to re-inspect products for contamination, but this option has its limitations. Food manufacturers’ core competency is just that—manufacturing. Plants are equipped, and employees are trained to produce as much food as profitably possible and not to slowly reinspect food, which increases the cost of labor, downtime and overtime.

Third-Party Inspection: A Secret Weapon

Another option exists: third-party inspection. In the majority of cases, a third-party inspection company can find foreign material contamination and limit product loss to only product that is contaminated. This allows companies to recapture revenue that would otherwise be lost at an extremely competitive ROI. It avoids concerns about hidden internal costs of rework, protects brand reputations, protects relationships, ensures manufacturing efficiency, meets or grows sustainability compliance, and upholds product and supplier quality.

Third-party providers are also typically able to provide data that helps you make the best decisions possible for hold and release—and, in some cases, can provide the data that aids your team in tracking down the issues that are contributing to physical contamination in your supply chain or at your facility. It’s not about scrubbing product clean, it’s about detecting objects at small sizes and providing producers with the opportunity to make better, risk-based decisions.

The two key points of difference between in-house reinspection and third-party inspection are the process and the technology.

Process

  • Line Speed: third-party inspection line speeds average 4-5 feet per minute
  • Multiple Inspectors: third-party inspection services operate multiple, concurrent inspection lines
  • Multiple Facilities: larger third-party inspection services operate multiple facilities across the U.S.
  • Trained Inspectors: third-party inspectors are trained specifically to find foreign material, not produce food

Technology

  • X-Ray Type: typical inline machines use a linear diode x-ray configuration while leading third-party inspectors use flat panel configurations that enable greater contrast and depth
  • X-Ray Size: inline detection technology is typically fixed in place and customized to the product size at a specific stage of production, whereas third-party can inspect product in various sizes and configurations using customized equipment built for that purpose
  • X-Ray Sensitivity: inline detection technology is typically built to detect known foreign material types, while third-party technology is designed to detect foreign material of all types

Here’s the bottom line: foreign material contamination isn’t a possibility, it’s a promise. The good news is, producers aren’t powerless. By taking a careful look at their operations, they can determine what tools and methodology will help safeguard their product and their profits, both short and long term.

Food prep gloves

The Foundation of Food Safety: Addressing Glove Selection & Implementation

By Darin Detwiler, Ph.D.
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Food prep gloves

The review in the July 2024 Journal of Food Protection, “Potential for Glove Risk Amplification via Direct Physical, Chemical, and Microbiological Contamination,” sheds light on critical issues within the glove manufacturing industry and their implications for food safety. As food industry executives and professionals, it is crucial to understand these challenges and implement effective strategies to mitigate glove risks. Purchasing gloves with FDA “food compliance” alone may not be a sound food safety strategy. In this article, I provide five key pieces of advice on glove selection and implementation to ensure they remain the foundation of food safety.

  1. Prioritize Quality & Regulatory Compliance

The review highlights how the pandemic demand revealed shortcomings in glove manufacturing, emphasizing the need for stringent quality control. Food Safety professionals should prioritize sourcing gloves only from reputable manufacturers that adhere to enhanced regulatory requirements for Acceptable Quality Limits (AQL) and bioburden standards.

– Why This Matters: High-quality gloves are less likely to contain chemical, or microbiological contaminants that can compromise food and glove wearer safety. Gloves with improved durability are less likely to fail (rip) and cause foreign material contamination.

– Benefits: Ensures consistent protection for both food products and workers, reducing the risk of contamination and associated health hazards.

  1. Independent Supplier Audit Reports

Independent audits from your glove supplier will verify that manufacturers meet the necessary standards and employ robust quality control measures. These audits should include an evaluation of the manufacturing process, contamination control measures, and compliance with regulatory standards. With forced labor violations and U.S. Customs and Border Protection import bans against well-known companies, independent audits of ethical manufacturing standards are encouraged.

– Why This Matters: Identifies potential sources of contamination and ensures that suppliers maintain consistent high standards of hygiene and safety and robust workplace cultures over a focus on profit alone.

– Benefits: Builds a reliable supply chain, minimizes the risk of receiving contaminated gloves, and fosters trust in glove safety.

  1. Implement Comprehensive Training Programs

Proper glove use is critical in preventing contamination. Training programs should educate food handlers on the correct procedures for donning, using, and disposing of gloves. Emphasis should be placed on glove changing frequency, especially after tasks that involve raw food, meals and/or restroom breaks, or when gloves become damaged.

– Why This Matters: Prevents cross-contamination and ensures that gloves are used effectively to protect food and workers.

– Benefits: Enhances overall food safety, reduces the risk of foodborne illnesses, and promotes a culture of hygiene and safety within the organization.

  1. Utilize Gloves with Enhanced Performance

Advancements in glove technology have led to the development of gloves with improved durability and performance. Look for gloves manufactured with proven superior materials and quality systems and ensure commercial trials for proven resistance to punctures and tears.

–Why This Matters: Reduces the likelihood of physical failures that can lead to contamination.

– Benefits: Provides better protection for food products and workers, ensuring gloves perform effectively in various food handling tasks.

  1. Regularly Review & Update Safety Protocols

Food safety is an evolving field, and it’s crucial to stay updated with the latest research, regulations, and best practices. Regularly reviewing and updating safety protocols ensures that they reflect current knowledge and address emerging risks.

– Why This Matters: Keeps safety measures relevant and effective in protecting against new and evolving threats.

– Benefits: Ensures continuous improvement in food safety practices, enhances compliance with regulatory standards, and protects the organization’s reputation.

Conclusion

The review in the Journal of Food Protection underscores the importance of addressing the potential risks associated with glove use in food environments. By prioritizing quality and regulatory compliance, conducting thorough supplier audits, implementing comprehensive training programs, utilizing gloves with enhanced durability, and regularly reviewing and updating safety protocols, food industry executives can ensure that gloves remain a cornerstone of food safety.

As we continue to navigate the complexities of food safety, it is imperative to recognize that gloves are not a panacea but a critical component of a broader safety strategy. Ensuring their proper selection, use, and management will significantly contribute to the overall safety and quality of food products, protecting both consumers and workers in the process.

For further reading, I recommend reviewing the full article in the Journal of Food Protection to gain a deeper understanding of the issues and recommendations discussed. Together, we can build a safer food industry by staying informed and proactive in our approach to glove use and food safety.

Traceability in food manufacturing, Honeywell
Beltway Beat

Produce Traceability: Uncovering the Gaps in Your Program

By Samantha Humphrey
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Traceability in food manufacturing, Honeywell

The produce industry handles an estimated six billion cases of produce in the U.S. each year. [i] Because a significant portion of this produce travels through the supply chain to reach customers, many produce companies already have traceability program in place. With the finalization of the Food and Drug Administration’s (FDA) Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods [ii] (Food Traceability Rule), the question is whether these existing traceability programs, systems, and procedures meet new FDA requirements.

A gap assessment can do just that—determine what requirements your existing programs already meet and identify where improvements are needed to comply with the final Food Traceability Rule by the January 2026 deadline.

Steps for Conducting a Gap Assessment

Not surprisingly, many produce companies already have elements of a traceability program that fulfill some of the Final Rule’s requirements. A gap assessment serves as the starting point for:

  • Understanding your regulatory obligations compared to your current compliance status.
  • Determining if existing programs, procedures, and systems are good as is, need improvement, or are missing and need to be developed.

Performing a gap assessment will help you compare what you have to what you need. The following steps will get you started:

  1. Find the most current copy of the standard you will compare against your programs. You will likely want to use the Code of Federal Regulation (CFR) Title 21, Chapter 1, Subchapter A, Part 1, Subpart S [iii], as it outlines specific expectations for general provisions, Traceability Plan, records of Critical Tracking Events (CTEs), and more.
  2. After you are familiar with the rule, review the most current version of your own program. A systematic review over time may make conducting a gap analysis more manageable. Start by identifying which of your products are on the Food Traceability List (FTL) [iv], what CTEs you perform, and which Key Data Elements (KDEs) you are already collecting. Have you overlooked a CTE? Have you forgotten a KDE? Refer to the questions below as you conduct this gap assessment. Document all missing elements.
  3. Compare your Traceability Plan to what is required by the new rule. Document the items you have identified as missing from your Traceability Plan.
  4. Develop and document your strategy to address each gap identified in steps 2 and 3 above. There may be some items that can be addressed immediately, while others may require additional time and support. You may need to create new logs, enlist the help of other departments, or acquire approval from your supervisors to make the necessary changes. Set realistic goals to implement the required updates by the compliance date.
  5. Train or retrain employees. Tell them why the changes are happening, acknowledge the importance of compliance with the new rule, and empower them to make the necessary changes.
  6. Notify management, customers, and suppliers of changes to your program to ensure everyone involved is on the same page.

Turning Gaps into Opportunities: Key Questions to Ask

Asking the right questions is key to ensure your gap assessment identifies required missing elements in your programs compared to the rule. The following questions can help guide your food traceability gap assessment:

  • Do you manufacture, pack, process, or hold any of the foods found on the FTL? The FDA developed the FTL considering a few specific food safety factors, including frequency of outbreaks, occurrences of illness, severity of illness, likelihood of contamination, potential for pathogen growth, process contamination, consumption rate, and cost of illness. Comparing your products to the FTL may indicate the likelihood of your produce being implicated in a recall or outbreak event and will underscore the importance of your organization’s compliance with the Traceability Rule.
  • Are you performing CTEs? These include harvesting, cooling, initial packing, first land-based receiving (food obtained from a fishing vessel), shipping, receiving, or transforming any of the foods on the FTL. If so, specific data must be collected. Do you understand and are you meeting these data collection requirements?
  • Does your organization capture data that is considered a KDE? For example, do you apply lot codes to your products? Do you collect detailed location information about where your product is harvested (e.g., farm site A, field 7)? Determine if there is any specific information, data points, or additional KDEs you must capture and maintain to meet FDA requirements (e.g., date, harvest crew, common name of the commodity and variety, etc.). The data required is dependent on which of the CTEs you are performing. This guide from the FDA[v] can help determine whether you are collecting all the required data. Once you know what data you are missing, as identified by your gap assessment, you can determine how to best record it (e.g., developing new processes and procedures, implementing a new lot code sticker program).
  • Do you have a sufficient Traceability Plan? Does your Plan cover all the elements required in the Food Traceability Rule? The Traceability Plan must include the following, at a minimum:
    • Description of the procedures used to maintain required records, as well as how to format and where to store those records.
    • Description of how lot codes are assigned.
    • Assignment of and contact information for a point person who can answer questions about the Traceability Plan and/or traceability records.
    • Map identifying the farms where FTL produce is grown.
    • Updates to reflect updated or new practices.
  • What recordkeeping system are you using? Are there upgrades you need to make to your recordkeeping system to solve your data collection pain points? Can your system handle new requirements? Is required information readily retrievable? While hard copies in binders and Excel spreadsheets can work, an electronic document management system can create efficiencies and standardization, reduce human error, and improve accessibility when managing vast amounts of data. Your gap assessment can help you identify and better understand your needs and requirements prior to investing in an IT solution that helps streamline your traceability process and improve overall compliance efficiency.
  • How are you sharing data? What collaborative activities can you and your suppliers/buyers perform to ensure efficient data sharing? How do you communicate and with what frequency? What systems are your partners using? What is the best way to connect them to enable data sharing? It is important to ensure you have established processes, systems, and methods of communication throughout the supply chain to facilitate the required documentation, information sharing, and collaboration.

The answers to these questions will identify elements that you need to implement to help ensure compliance. Getting started on your gap assessment now affords time for produce companies to identify compliance program gaps, test protocols and verify their effectiveness, implement corrective actions, and ensure adequate traceability processes are in place before the January 2026 deadline.

[i] The Produce Traceability Initiative. https://producetraceability.org/.

[ii] U.S. Food and Drug Administration. FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. June 27, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-requirements-additional-traceability-records-certain-foods.

[iii] Code of Federal Regulation. Title 21, Chapter 1, Subchapter A, Part 1, Subpart S. July 3, 2024. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-S?toc=1.

[iv] U.S. Food and Drug Administration. Food Traceability List. March 30, 2024. https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list.

[v] U.S. Food and Drug Administration. Food Traceability Rule: Critical Tracking Events (CTEs) and Key Data Elements (KDEs). https://www.fda.gov/media/163132/download?attachment.

Cybersecurity

Food Defense in the Age of AI: Are We Prepared?

By Radojka Barycki
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Cybersecurity

I watched a movie last year where a woman was being framed for murder using her facial features that were captured by a technology used in a bus that allowed passengers to get in based on facial recognition. In the movie, the woman, who was a cop, was investigating suspicious activity relating to the research of the facial recognition self-driven bus that a high-profile tech company was trying to approve for massive production and introduction into the market. The cop was getting too close to confirm her suspicions. So, the tech company got her face profile and embedded it in a video where another person was killing an executive of the company. This got me thinking about how we use face recognition nowadays and how technology is included in everything we do. So, I pose the question: are we at risk in the food industry in terms of Food Defense?

Recent cybersecurity attacks in the food industry have highlighted the urgency of this question. For instance, in 2021, the world’s largest meat processing company fell victim to a ransomware attack that disrupted its operations across North America and Australia. The company had to shut down several plants, leading to significant financial losses and potential supply chain disruptions.

Similarly, earlier that year, a cyberattack targeted a U.S. water treatment facility, where hackers attempted to alter the chemical levels in the water supply. Although this attack was prevented, it underscored the vulnerabilities within critical infrastructure systems, including those related to food production and safety.

Additionally, in 2022, a large fresh produce processing company experienced a cyber incident that disrupted its operations. The attack temporarily halted production and distribution of packaged salads and other products, causing delays and financial losses. The company paid $11M in ransom to the hackers to restitute order for their operations. This incident further underscores the importance of cybersecurity in the food industry and the potential risks posed by inadequate security measures.

These incidents illustrate the growing threat of cyberattacks in the food industry and the potential consequences of inadequate cybersecurity measures. As technology becomes more integrated into food production, processing, and distribution, the need for robust food defense strategies that encompass cybersecurity has never been more critical.

Understanding Food Defense
Food defense refers to the protection of food products from intentional contamination or adulteration by biological, chemical, physical, or radiological agents. Unlike food safety, which focuses on unintentional contamination, food defense addresses the deliberate actions of individuals or groups aiming to cause harm. In an era where technology permeates every aspect of food production, processing, and distribution, ensuring robust cybersecurity measures is crucial for effective food defense.

The Intentional Adulteration Rule, part of the FDA’s Food Safety Modernization Act (FSMA), mandates measures to safeguard the food supply from deliberate adulteration aimed at causing large-scale public health harm. Key requirements of this rule include conducting vulnerability assessments, implementing mitigation strategies, performing monitoring, verification, and corrective actions, as well as providing employee training and maintaining thorough records.

The Intersection of Technology and Food Defense
The integration of advanced technology into the food industry brings numerous benefits, such as increased efficiency, improved traceability, and enhanced quality control. However, it also introduces new vulnerabilities that can be exploited by cybercriminals. As technology becomes more sophisticated, so do the methods employed by those who seek to manipulate or sabotage our food supply.

AI and Technology: A Double-Edged Sword
Artificial intelligence (AI) and other advanced technologies are revolutionizing the food industry. Automated systems, IoT devices, and data analytics enhance productivity and provide real-time monitoring capabilities. However, these technologies also present new avenues for white-collar crime and cyberattacks. For instance, a cybercriminal could hack into a food processing plant’s control system, altering ingredient ratios or contaminating products, which could lead to widespread public health crises.

Pros and Cons of Using AI and Technology in Food Safety
The adoption of AI and technology in the food industry has both advantages and disadvantages:
Pros:
1. Enhanced Efficiency: Automation and AI can streamline food production processes, reducing human error and increasing output. This leads to more consistent product quality and improved overall efficiency.
2. Improved Traceability: Advanced tracking systems allow for real-time monitoring of food products throughout the supply chain. This enhances the ability to trace the source of contamination quickly, thereby reducing the impact of foodborne illness outbreaks.
3. Predictive Analytics: AI can analyze vast amounts of data to predict potential risks and prevent contamination before it occurs. This proactive approach can significantly enhance food safety.
4. Real-Time Monitoring: IoT devices and sensors can provide continuous monitoring of environmental conditions, ensuring that food storage and transportation are maintained within safe parameters.

Cons:
1. Cybersecurity Risks: As seen in recent cyberattacks, the integration of technology introduces new vulnerabilities. Hackers can exploit these weaknesses to disrupt operations or intentionally contaminate food products.
2. High Implementation Costs: The initial investment in AI and advanced technologies can be substantial. Small and medium-sized enterprises may find it challenging to afford these technologies.
3. Dependence on Technology: Over-reliance on technology can be problematic if systems fail or are compromised. It is essential to have robust backup plans and manual processes in place.
4. Privacy Concerns: The use of AI and data analytics involves the collection and processing of large amounts of data, raising concerns about data privacy and the potential misuse of sensitive information.

The Role of Cybersecurity in Food Defense
To safeguard against such threats, the food industry must prioritize cybersecurity as an integral component of food defense strategies. Here are key strategies to consider:
1. Conduct Regular Risk Assessments: Identify potential vulnerabilities within your technological infrastructure. Regular risk assessments can help detect weaknesses and prioritize areas needing immediate attention.
2. Implement Robust Access Controls: Ensure that only authorized personnel have access to critical systems and data. Use multi-factor authentication and monitor access logs for suspicious activity.
3. Invest in Employee Training: Employees are often the first line of defense against cyber threats. Provide comprehensive training on cybersecurity best practices, including recognizing phishing attempts and other common attack vectors.
4. Update and Patch Systems Regularly: Ensure that all software and hardware are up-to-date with the latest security patches. Regular updates can mitigate the risk of exploitation through known vulnerabilities.
5. Develop Incident Response Plans: Prepare for potential cyber incidents by developing and regularly updating incident response plans. These plans should outline specific steps to take in the event of a security breach, including communication protocols and recovery procedures.
6. Utilize Advanced Threat Detection Systems: Employ AI-driven threat detection systems that can identify and respond to unusual activity in real-time. These systems can provide an added layer of security by continuously monitoring network traffic and system behavior.
7. Collaborate with Cybersecurity Experts: Partner with cybersecurity professionals who can provide insights into emerging threats and recommend best practices tailored to the food industry’s unique challenges.

Current Efforts to Standardize the Use of AI
Recognizing the critical role of AI and technology in modern industries, including food production, international efforts are underway to standardize their use and ensure safety, security, and reliability. Two notable standards introduced recently are ISO/IEC 23053:2022 and ISO/IEC 42001:2023.
• ISO/IEC 23053:2022: This standard focuses on the transparency and interpretability of AI systems. It aims to make AI-driven processes understandable and explainable to users, which is crucial for maintaining trust and accountability. In the context of food safety, this standard can help ensure that AI decisions, such as those related to quality control and contamination detection, are transparent and can be audited.
• ISO/IEC 42001:2023: This standard provides guidelines for the governance of artificial intelligence, ensuring that AI systems are developed and used responsibly. It addresses ethical considerations, risk management, and the continuous monitoring and improvement of AI systems. For the food industry, adhering to this standard can help ensure that AI technologies are implemented in a way that supports food safety and defense.

As the food industry continues to embrace technological advancements, the importance of integrating robust cybersecurity measures into food defense strategies cannot be overstated. By understanding the potential risks and implementing proactive measures, we can protect our food supply from malicious actors and ensure the safety and security of the public. The scenario depicted in the movie may seem far-fetched, but it serves as a stark reminder of the potential consequences of unchecked technological vulnerabilities. Let us learn from fiction to fortify our reality

The author will be presenting Food Defense in the Digital Era at the Food Safety Consortium Conference. More Info

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Retail Food Safety Forum

Educating the Public on Food-Related Health Risks: The Critical Role of Nutritionists

By Ainsley Lawrence
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While most people think of nutritionists as general advisors who sit down with them one-on-one to create diet plans, their role goes far beyond that. Nutrition specialists play a critical role in educating the public with regard to food safety.

Some work with patients one-on-one, but they can also work in corporate settings, athletic facilities, food manufacturing centers, government organizations, hospitals, physician’s offices, schools, and more.

In this article, we will take a closer look at the connection between food safety and nutrition, including the important role nutritionists play in nutrition education, food safety, and mitigating food-related health risks.

The Connection Between Food Safety and Nutrition

Food safety and nutrition are inherently linked. Food safety refers to the prevention of food contamination, and for people to be healthy, they must have access to food that keeps them well-nourished and free from foodborne illnesses. In other words, to avoid food-related health risks, people must have consistent access to safe and healthy foods. Poor nutrition is one of the leading causes of illness in the United States. Without safe and equitable access to healthy foods, 600,000 Americans die each year.

By educating others on what to eat and where to get these foods, as well as helping organizations create better food safety and food security plans, nutritionists ensure people have access to the best foods possible for maintaining overall health and well-being.

What is a Nutritionist?

Before diving further into the role nutritionists play in food safety, it’s helpful to understand what they do exactly. Despite the connection between their work and the health of the public, nutritionists are not doctors.

Nutritionists can either be licensed or unlicensed, depending on their specific career goals and where they live, as licensure requirements can differ from one state to the next. When working with patients one-on-one out of a private practice, for example, a nutritionist might not need to be certified. However, if working with a hospital, a school, or a government organization, it is likely that they will be required to have a license — but again, this can depend on the specific requirements of the state they are working in.

However, doctors are often not routinely trained in nutrition. Thus, when a doctor does not have the knowledge needed to help a patient, they can refer them to a nutritionist for special guidance and support. If a patient is recovering from cancer or is dealing with diabetes, they may need to work with a larger medical team so they can learn to manage their condition and alleviate symptoms through a proper diet. In addition to educating patients on what foods to eat for their health, these specialists can also consider factors such as food allergies, dietary needs for athletes, personal tastes, and cultural and religious dietary needs.

What Role Do Nutritionists Play in Nutrition Education and Food Safety?

There are numerous ways that nutritionists work to educate others on food safety. Many organizations and companies are responsible for providing nutritious meals, such as nursing homes, hospitals, and restaurants. These facilities will often hire nutrition experts to help them craft menus and create healthy and flavorful meal plans.

The government also partners with and hires nutritionists for various programs. The USDA Food and Nutrition Service (FNS), for example, is responsible for offering science-based nutrition education to the public. Nutrition professionals will then work with the FNS to create educational programs and even policies that support the health and well-being of communities, families, and individuals.

Nutritionists also use their knowledge and expertise to help back up nutrition claims and work with food manufacturers to create nutrition labels and other important dietary information on food packaging They also use analytical data to calculate things like protein quality or food category contributions and share this information to ensure people are choosing the right food products for their individual health and nutrition needs.

Overall, you can find these specialists working with a wide range of organizations to help educate and ensure food safety, including:

  • Federal and local health departments;
  • Hospitals;
  • Private practices;
  • Nursing homes;
  • Schools;
  • Research facilities;
  • Food distributors and retailers;
  • Hotels and resorts;
  • Athletic organizations.

Some of the specific examples of what they can do in these settings can include researching and developing recipes, creating menus and meal plans, educating clients on nutritional food choices, ensuring plans align with weight, health, and nutrition goals, and creating nutrition-related care plans.

In schools, for example, nutrition professionals are responsible for ensuring meals abide by nutrition regulations, meet the taste preferences of diverse student bodies, are prepared properly, address food allergies, and are affordable.

They can also work with local organizations to assist with food security issues, such as communities that are considered food deserts where people lack access to healthy foods. For example, they can work with food vendors and distributors to ensure certain communities and their local grocery stores and markets have a good selection of fresh and nutritious foods.

Furthermore, nutritionists also play a vital role in educating the public to help reduce food-related illness and disease. Cancer, for example, is one of the leading causes of death worldwide but can be mitigated with better food and nutrition education. Nutrition professionals can also help alert the public to contamination and assist with handling food testing and recalls.

Nutrition Education and The Fight Against Cancer

45% of cancer deaths in the United States are linked to things like poor diet and obesity, thus, nutritionists play an important role in helping mitigate cancer risks. There are a number of carcinogens in everyday food products that are linked to cancer, such as acrylamide, which is a chemical that forms in foods placed under high heat, and aflatoxins, which are produced by food molds.

Nutritionists can offer guidance on testing for food safety. For example, nitrosamines or N-nitroso compounds (NOCs) can be carcinogenic and are known to compromise food quality and safety. Unfortunately, there are many ways NOCs can make their way into the food chain, including crop protection processes, meat preservation processes, food drying processes, and even via the consumption of nitrates in vegetables that react with stomach bacteria and acids to form NOCs. With this knowledge, however, nutritionists can advise on nitrosamine testing to ensure proper food safety.

In Summary

Nutritionists are vital when it comes to educating the public and helping to provide access to safe, healthy, and nutritious foods. There are many organizations in our country that heavily rely on the support and guidance of these specialists to better serve and protect the health and well-being of individuals, families, and communities.

Nutritionists will forever play a critical role in helping people make more informed nutrition decisions. Whether working at a private practice, with schools, hospitals, the government, or other organizations, these food educators are key to reducing food-related health risks.

Ask The Expert

Hygiene and Efficiency in Food Processing: Goodway Technologies’ Advanced Solutions

By Evan Reyes
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Q&A with Evan Reyes, Global Director of Sales, Sanitation Division, Goodway Technologies

Goodway Technologies provides cleaning and sanitation equipment for the food and beverage processing industry. They offer a range of products including dry steam cleaners, conveyor belt cleaning systems, industrial vacuums, and surface sanitizing equipment. They also specialize in innovative solutions such as CIP technologies and industrial vacuums. Their goal is to help improve hygiene and food safety, and increase production efficiency in food production plants.

QUESTION: Is steam safe to use around water sensitive equipment?

ANSWER: Thanks to the low moisture content of dry steam, we are able to use it to safely clean motors, conduit, control panels, and other areas where water use is typically not welcome. Some highly sensitive components like touch screen, power receptacles, and photo eyes should still not be directly steam cleaned, although you can steam clean in close proximity to these sensitive components without worrying about them getting wet.

Goodway Technologies

Link to case study

QUESTION: How can you get to a passing ATP level without introducing cleaning chemicals to aid in the process?

ANSWER: In the right applications, our belt cleaning systems will do the job of a cleaning chemical to break down the soils using dry steam, and then we follow up with vacuum extraction to physically remove the soil from the belt. This is a powerful cleaning combination that leads to a very clean and completely dry belt surface. 

Goodway Technologies PureBelt

We frequently see 0 ATP readings after the belt cleaning is completed, and are always within a passing ATP level after cleaning. One other benefit is that we provide a consistent cleaning across the entire belt surface, every time, eliminating the possibility of an operator missing a spot on the belt, failing a swab, and needing to re-clean.

Link to case study

 

Learn more from Goodway Technologies

Visit Goodway Technologies’ booth at the Food Safety Consortium Conference, Oct. 20-22, Washington DC

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Checklist

The Importance of Food Safety Auditing

By Jennifer Lott
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Checklist

To begin to understand the importance of food safety auditing, it is essential to know what a food safety standard comprises in terms of auditing.

Food safety standards are a set of rules and regulations established by regulatory agencies, such as FDA (21CFR117), international organizations, i.e., World Health Organization (WHO) or Global Food Safety Initiative (GFSI), and industry bodies, such as SQF, to ensure the safety and quality of the food supply chain.

These standards aim to reduce the risk of contamination, reduce the chances of foodborne illnesses, and protect the workers and customers who consume or use the product.

Food Safety standards contain requirements for food production, from sourcing ingredients and materials to production processes to packing and distribution.  Food safety standards add transparency, traceability, and accountability to your organization’s operations.

So why are food safety audits necessary?

Food safety audits are organized activities that aim to evaluate the extent of a food business’s food safety management system in the pursuit of protecting public health.

Public health can be at stake, and audits on food safety practices aim to evaluate how a food business management system can effectively protect against contaminated food getting released into the marketplace.

Food safety audits focus on critical areas of food manufacturing operations, such as the food safety management system, food storage, food preparation, sanitation, facility design, and employee hygiene.

How does the audit help?

Well, auditors examine a combination of intended practices and methods with the actual facility and design to gather how effective are the food safety management protocols, how the product is stored, how employees handle food preparation—as well as machinery and building safety, including facility design, sanitation, and employee’ personal hygiene practices.

Food safety audits come in three basic designs: first-party (internal), second-party (audit of your supplier), or third-party or accredited third-party (independent or certification). The type of audit chosen can be based on your needs and the auditing firm.

Audits provide a real-time assessment of the status of the operation and quality management system. More than looking at safety records and historical statistics, food safety audits look at problems that may be fermenting now – they can be proactive rather than reactive—reviewing areas where implementation of preventative strategies and reporting findings can bring value with improved efficiency and avoidance of future problems.

Food safety audits are also an excellent time to foster organizational communication.

Engaging with employees in interviews provides many points of view and is an opportunity to promote a sense of ownership and buy-in within the organization – this can go a long way in developing a strong food safety culture.

The unintentional contamination of food is one of the most significant risks associated with not complying with food safety regulations. If the source of contamination can be traced to the company, the organization may face hefty fines and consequences.

On top of that, with noncompliance with food safety standards, an organization risks sowing distrust from internal employees through to their customers. When companies don’t follow safety standards, customers will be hesitant to buy and consume their products, negatively impacting sales and overall company performance.

The author, Jennifer Lott is presenting Assessing Food Fraud using PAS 96 to Meet GFSI and FSMA Requirements at the Food Safety Consortium Conference, October 20-22, Washington DC. This presentation will use information from PAS 96, Guide to Protecting and Defending Food and Drink from Deliberate Attack, and real-life examples to provide insights and guidance when completing/reviewing your VACCP and TACCP programs. For more information visit FoodSafetyConsortium.org

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Jennifer Allen
Food Safety Attorney

Not a magic bullet: The dos and don’ts of dietary-supplement labeling

By Jennifer Allen
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Jennifer Allen

Dietary supplements are commonplace in the American diet. Indeed, so many Americans expect supplements to do most of the heavy nutritional lifting in their diets that “substitute” might be a more accurate name. But while many consumers view supplements as a magic bullet or cure-all, and supplement manufacturers happily reinforce that viewpoint through their labeling, the FDA does in fact set limits on the types of statements that supplement manufacturers may make. To ignore those limits is to run the significant risk of receiving a warning letter from FDA. Warning letters are made public, and being on the receiving end of one can damage a manufacturer’s brand. In February 2021, FDA announced that it had recently sent warning letters to ten supplement manufacturers who were claiming that their products could treat or cure depression and other mental health disorders.

No dietary supplement, no matter how effective it is, may contain labeling that claims to “diagnose, mitigate, treat, cure, or prevent” disease. Labeling is a broad term. It doesn’t just apply to the physical label affixed to the container. It also applies to marketing materials accompanying the supplement, or to statements made on the website selling the supplement. FDA explains what types of statements will be considered improper drug claims in 21 CFR 101.93(g). A statement will be considered an improper drug claim if it claims, explicitly or implicitly, that the product has an effect on a specific disease or class of diseases, or on their characteristic signs or symptoms, or on an abnormal condition associated with a natural state or process, if that abnormal condition is uncommon or can cause significant or permanent harm.

A statement will also constitute an improper drug claim if it claims that the product: belongs to a class of products intended to “diagnose, mitigate, treat, cure, or prevent” disease; is a substitute for a product that is a therapy for a disease; augments a particular therapy or drug; has a role in a body’s response to disease; treats, prevents or mitigates adverse events associated with a particular drug or therapy, if that adverse event is in itself a disease; or otherwise suggests an effect on a disease.

So how can a dietary supplement manufacturer promote the health benefits of its products if it can’t make any of these types of claims? Broadly speaking there are three types of claims that will not violate the regulations: 1) classical nutrient deficiency claims; 2) structure-function claims; and 3) FDA-approved health claims. Let’s look at each of these in turn.

A classical nutrient deficiency is a disease or condition caused by a deficiency in a particular nutrient. Diseases such as pellagra and scurvy fall into this category. Dietary supplement labeling may inform consumers that use of the product can cure or prevent classical nutrient deficiencies if the manufacturer provides notice to the FDA that complies with the requirements in 21 CFR 101.93(a) within 30 days of first marketing the product, and if the product bears the following disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Section 101.93(b)-(e) contains specific requirements about the placement and prominence of the disclaimer.

Structure-function claims are also permissible. These types of claims suggest an effect of the product on the body’s normal structure or function. Emphasis here is on the use of the word normal. So, rather than saying, for example, “this product prevents heart disease,” which is an obvious example of an improper drug claim, the labeling could state, “this product helps promote healthy heart function.” Like classical nutrient deficiency claims, however, the manufacturer must provide the required written notice to FDA within 30 days, and also include the disclaimer language.

The third type of permissible claim is an FDA-approved health claim. Manufacturers can find such approved claims at 21 CFR 101.72-83. An example of the type of health claim that is permissible would be a claim linking vitamin D or calcium to reduced risk of osteoporosis. But if the FDA hasn’t approved a claim, manufacturers may not make that claim, even if the science shows it is true. If a manufacturer believes that the science supports the use of ginger root for reducing symptoms of Crohn’s Disease, for example, it may not make any such claim, even if it is true, without petitioning FDA to approve such a claim.

While it is true that dietary supplements are regulated with more leniency than regular foods, this is not a license to sell unapproved drugs. Supplement manufacturers would be well advised to have their marketing folks work closely with legal counsel to craft labeling language that promotes the benefits of the product while staying within the FDA’s guardrails.

 

 

 

Predictive Analytics for Proactive Food Safety

By Emily Newton
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Many of the most popular predictive analytics use cases revolve around risk assessments and optimization. While businesses largely use them to drive efficiency and financial gains, the same tech can help make the food and beverage industry safer.

Predictive analytics could benefit virtually any industry that applies it. While that means monetary improvements in most sectors, this technology could impact people’s health and well-being in others. Applying predictive analytics in food safety in one such use case.

The Importance of Proactive Food Safety

Foodborne illnesses affect 48 million people each year in the U.S. alone. These diseases are easily treatable in many instances, but as hospitals become more crowded and the population grows, more could result in worse outcomes. Already, 128,000 of these cases hospitalize their victims and 3,000 end in death.

These outbreaks may become a more prominent threat over time, too. Climate change can make certain foodborne pathogens more common and affect food’s nutritional value. The global population is also growing, so available resources must spread further to cover everyone. That could result in more people being unable to access the care they need if they contract a foodborne disease.

Given these concerns, food safety must be proactive. Organizations need to stop outbreaks before they occur to reduce the burden on the health care system and ensure a healthier world. Predictive analytics can support that goal by optimizing several aspects of food safety.

Emily Newton,

Preventing On-Farm Contamination

Food safety starts with food’s farm origins. Some diseases can spread through pest contamination, and predictive analytics may provide more reliable proactive anti-pest measures than conventional alternatives.

Pest outbreak modeling begins by collecting data on weather patterns, past outbreaks, and known interactions between certain pests and other chemicals or plants. Machine learning models can then predict when rising pest populations are likely and what could stop them. Farmers can then respond as necessary, whether that means spraying the optimal amount of pesticide or companion planting to repel animals before they arrive.

Early experimental models under this umbrella have accurately predicted outbreaks up to seven years in the future — more than enough time for farms to adapt. Even if these warnings spur little more than increased attention to contamination risks, they could significantly impact food safety.

Protecting Food Products in Transit

Predictive analytics can guard crops or animal products in transit once they leave the farm. Unlike pest prevention, this application is less concerned with long-term trends, instead centering around real-time data.

Internet of Things (IoT) sensors can track metrics like shipment temperatures and humidity in real time. With this data, predictive models can identify when current conditions may lead to food safety concerns, such as temperatures rising above safe levels. Once they identify these trends, they alert drivers and other stakeholders to take action before spoilage occurs.

Some available solutions today can monitor core temperatures up to 1 meter away, while others can detect bacteria and gas associated with spoilage. Whatever the specifics, real-time data and machine learning enable fast responses to prevent contamination or stop spoiled products from reaching consumers if prevention is impossible.

Refining Manufacturing Processes

Predictive analytics can also promote proactive food safety in the manufacturing stage. Many manufacturers today are already investing in AI to optimize their production workflows, and the same technology can yield safety improvements.

Take the production of dry pet food — which accounts for 60% of all pet food sold today — for example. These products are prone to cross-contamination from additives or surface contact during extrusion, but these hazards are difficult to identify in a large facility. Predictive analytics can analyze digital twins of these facilities to pinpoint where this kind of contamination is most likely, informing workflow changes to remove or mitigate the risk.

Just as predictive analytics can highlight production bottlenecks, it can alert manufacturers to processes prone to bacterial infection or other health hazards. Advanced models can even suggest alternative workflows to make it easier to ensure the safest possible production process.

Pinpointing Supply Chain Vulnerabilities

Similarly, food and beverage companies can use predictive analytics to identify hazards in their supply chains. Third-party health and safety risks are hard to pinpoint manually, but AI can monitor real-time conditions and analyze past trends to predict vulnerabilities.

Businesses can apply predictive analytics to food supply chains in a few ways. One effective option is to analyze past health department reports to identify suppliers with a history of health and safety violations. Some solutions today can even highlight common themes between reports to reveal what kinds of hazards a company struggles with.

Other supply chain analytics engines can analyze real-time data to predict potential outbreaks in a region’s food supply or growing cross-contamination threats in an area. Food companies can then adjust their supply strategy to avoid sourcing from these problem areas and prevent outbreaks.

Learning From Past Outbreaks

Many supply chains have also embraced predictive analytics for scenario modeling. Applying this practice to food safety can help experts learn where past outbreaks came from to inform preventive measures in the future.

With enough data on past foodborne disease outbreaks, machine learning models could identify trends in their early warning signs. Alternatively, they could highlight how some logistics or manufacturing practices contributed to the disease’s spread. Predictive models can then apply these insights to real-time farm, production facility and health report data to predict incoming cases.

Food processors already use hyperspectral sensors that could help detect early warning signs of undesired microbes, like the release of some gasses. Feeding this data to predictive models alongside information on how past foodborne illnesses emerged and evolved could let them predict new diseases before they affect anyone. Global health agencies and food and beverage companies could enact much more effective mitigation measures as a result.

Predictive Analytics Takes Food Safety Further

Many of the most popular predictive analytics use cases revolve around risk assessments and optimization. While businesses largely use these applications to drive efficiency and financial gains, the same technology can help make the food and beverage industry safer. That will become increasingly crucial as the population grows and climate change worsens the threat of foodborne illnesses.

The use of predictive analytics in proactive food safety is still in its infancy, but early signs are promising. As this technology evolves and more brands capitalize on it, it could make the world a safer, healthier place.