On October 1, 2024, the Food and Drug Administration (FDA) began implementing the largest reorganization in the Agency’s recent history, including launching a unified Human Foods Program (HFP) to oversee all activities related to food safety and nutrition and transforming the Office of Regulatory Affairs (ORA) into the Office of Inspections and Investigations (OII), amongst other modernizations. This reorganization is intended to enhance the FDA’s ability to protect the human food supply and make the Agency more efficient and prepared to respond to changes in industries, food and medical product technologies, and the impacts of globalization and climate change.

HFP: Priorities for 2025

The FDA regulates 80% of the U.S. food supply. The HFP was designed to help ensure that the FDA-regulated food supply is safe by taking a systematic, risk management approach to implementing the preventive measures outlined in the Food Safety Modernization Act (FSMA) and responding to food-related emergencies. Specifically, the HFP’s mission is to protect and promote the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure chemicals in food are safe.

To support this mission, FDA is implementing several operational changes, including developing enhanced risk modeling, advancing inspectorate training, establishing a Human Foods Advisory Committee, developing a performance management framework, improving recall communications, and integrating food laboratories to advance science.

The HFP has also prioritized key deliverables for FY2025 to strengthen regulatory oversight, advance science, and better leverage partnerships in the following risk management areas:

Microbiological Food Safety

Advancing strategies to prevent foodborne illness. Specific deliverables include:

• Finalizing an implementation plan for the FSMA Final Rule on Pre-harvest Agricultural Water.
• Advancing traceability tools and resources to remove contaminated products from the marketplace more quickly.
• Issuing final guidance for the Produce Safety Rule and developing associated compliance resources.
• Initiating a study to better understand Salmonella outbreaks linked to melons.
• Enhancing the use of GenomeTrakr to help identify and respond to outbreaks.
• Working with various stakeholder groups to develop strategies to prevent and mitigate microbiological foodborne risks.
• Enhancing communication and transparency, including publishing a new public outbreak report and facilitating information sharing related to fresh produce and seafood.
• Implementing regulatory partnerships with Ecuador, India, and Indonesia for imported seafood.

Food Chemical Safety

Ensuring exposure to chemicals in food is safe. Planned actions include:

• Reviewing inefficiencies in the current premarket review process for food or color additives to help prevent unsafe uses of chemicals.
• Updating the framework for post-market assessments of chemicals in food and publishing an updated list of substances prioritized for re-assessment.
• Establishing action levels and associated guidance for environmental contaminants in food intended for infants and young children.
• Releasing additional guidance on submitting new dietary ingredient notifications (NDINs).
• Issuing draft guidance for Preventive Controls for Human Food specific to chemical hazards.
• Completing external review and validation of the Expanded Decision Tree, which sorts chemicals into classes of toxic potential.
• Developing AI approaches to help monitor new data and trends.
• Evaluating and characterizing potential effects of PFAS exposure from selected foods.
• Partnering with international organizations on food chemicals and innovation to strengthen the global food safety system.

Nutrition

Elevating nutrition to improve health equity. Deliverables include:

• Issuing a final rule to update the definition of the claim “healthy” and educating the public.
• Proposing a rule to establish mandatory front-of-package nutrition labeling.
• Publishing a long-term national strategy to help facilitate the entry of new infant formula manufacturers and continuing education on safe handling of powdered infant formula.
• Advancing nutrition research to better inform food-related policy and regulatory decision making.

OII’s Focus on Inspections

Restructuring the ORA into the new OII is intended to allow the Agency’s field operations unit to focus on inspections, investigations, and imports to support its core mission to conduct rigorous, transparent, and science-based inspections and investigations, providing real-time evidence and insight essential in empowering fact-based regulatory decisions to protect public health. OII is charged with inspecting regulated products and manufacturers, as well as reviewing imported products.

This restructuring will enable the FDA to put more focus directly on inspections and investigations and, subsequently, create a more efficient compliance and enforcement process, clearer communication, and faster decision-making. As a result of this transformation, inspections have the potential to become more efficient—and more frequent. In addition, increased inspection resources may allow inspectors to specialize in specific product areas, which could lead to more thorough and knowledgeable inspections.

Keeping Up

As with any regulatory change, FDA-regulated companies need to get up to speed on FDA’s recent restructuring and its potential impacts:

• Educate staff on FDA’s reorganization and potential implications for your organization.
• Identify any new points of contact for your organization within the FDA (i.e., HFP, OII), anticipate how your interactions may change, and start building new relationships, where necessary.
• Review the HBP priorities and compliance expectations for FY2025 compared to internal programs, protocols, etc. and make any required updates to ensure alignment.
• Prepare for potential changes when it comes to inspections, including more frequent and more specialized inspections. This may include educating staff to get a deeper understanding of products/operations and the associated regulatory requirements and/or stepping up compliance efforts, where necessary.

“Best if Used by”, “Sell by”, “Expires on”, “Freeze by”…

Consumers see various versions of these phrases on food product labels all the time. But do they understand what these labels mean? Does industry? According to the Food and Drug Administration (FDA), it is estimated that the confusion over date labeling terms on food products accounts for about 20% of the food waste in the home. This is significant given that the U.S. Department of Agriculture (USDA) estimates nearly one-third of available food in the U.S. (i.e., 133 billion pounds) goes uneaten due to food loss or waste.

Why the confusion? Because open date labeling is still not mandated or standardized by federal law. In fact, the State of California just recently passed the first legislation of its kind in September 2024 to standardize the use of open date labeling on food products.

Nutrition Labeling vs. Open Date Labeling

The Nutrition Labeling and Education Act (NLEA) of 1990 requires that food manufacturers provide standardized nutritional information on their products. It also requires that food labels comply with certain requirements if they make nutritional or health claims. The FDA developed the Nutrition Facts Label to comply with the requirements of the NLEA.

The phrases mentioned above are considered open date labeling and are not part of the NLEA. Any open date labeling on food products is applied voluntarily by manufacturers or retailers to tell consumers when food is of best quality. With the exception of infant formula, these dates are not required and are not related to a product’s safety.

The USDA gives the following definitions of common phrases on open date labels:

• “Best if Used by/before” indicates when a product will be of best flavor or quality. It is not a purchase or safety date.
• “Sell by” tells the store how long to display the product for sale. This phase is for inventory management; it is not a safety date.
• “Use by” provides the latest date recommended for the use of the product while at peak quality. It is not a safety date (except on infant formula).
• “Freeze by” indicates when a product should be frozen to maintain peak quality. It is not a purchase or safety date.

A Question of Quality

For most, the confusion lies in understanding the status of a food product once the open date passes. While the quality of perishable products may deteriorate after a “Best if Used by” date, most products remain safe to eat, sell, or donate as long as they are handled properly (e.g., correct temperature and storage conditions) and show no signs of spoilage. In fact, the USDA suggests that food handling conditions are a greater predictor of spoilage than time (i.e., open date).

Sources including FDA, USDA, and a number if industry associations believe that food waste is due, in part, to fears about food safety and consumers not understanding that date labels refer to the quality of a product versus its safety to consume.

Call for Standardization

Despite this confusion and the associated ramifications (i.e., wasted food, economic loss), no mandatory federal labeling standard has been enacted, though attempts at standardization have been made:

• The Food Recovery Act of 2015 introduced the first language to standardize date labels, but it did not pass Congress. 
• In December 2016, the USDA Food Safety and Inspection Service (FSIS) updated its guidance on product date labeling, recommending that manufacturers and retailers use the phrase “Best if Used by” to indicate when a product is at peak quality.
• In 2017, industry stepped in, as the Food Manufacturing Institute (FMI) and the Consumer Brands Association (CBA) adopted joint industry guidelines to standardize open dates.
• The FDA issued a letter supporting industry’s efforts to standardize date labeling in May 2019. Consistent with the USDA, the FDA recommended using the “Best if Used by” date for manufacturers choosing to apply a quality date label.
• In 2019, the first Food Date Labeling Act (FDLA) was introduced in Congress and failed to pass. The FDLA was introduced again in 2021 and, most recently, in 2023.

California Leads the Way

In the meantime, the State of California has forged ahead, passing legislation in September 2024 to standardize the use of open date labeling on food products. Beginning July 1, 2026, the law implements the first mandatory food date labeling for companies selling food products in California by instituting the following changes:

• “Best if Used by” must be used to indicate the date when a product reaches peak quality.
• “Use by” must be used to indicate the date when a product’s safety can no longer be guaranteed.
• Retailers will be authorized to display “Packed on” labels on prepared food items, but they must also display the “Best by” or “Best if Used by” dates.
• Consumer-facing “Sell by” dates are prohibited and may only be used for inventory management.
• The phrases “Expires on” and “Freshest by”, which have inconsistent definitions, are prohibited.

Support from Industry

According to the Zero Waste Food Coalition, over 25 industry supporters have signed the Zero Food Waste Coalition’s open letter urging Congress to support the bipartisan Food Date Labeling Act of 2023…  Major food industry businesses, including Kroger, Walmart, and Nestlé USA, have signed the letter, which cites that standardizing and streamlining date labels is one of the most cost-effective methods to prevent the wasting of surplus, wholesome food.

Currently, it is at the food manufacturer’s/retailer’s discretion to use open date labeling as they see fit. As such, it is important for manufacturers and retailers to understand what the various open date labeling phrases mean before applying them to products. The available USDA, FDA, and industry guidance is meant to alleviate consumer confusion and should be used as best practice in absence of a federal standard. Using this guidance to standardize open date labeling practices to the extent possible may help manufacturers extend the shelf-lives of their products, prevent the corresponding economic loss of removing inventory from the supply chain, and reduce the amount of wholesome food being wasted.

Location: Chicago, Illinois or St. Lous, Missouri

KTL is seeking an experienced Safety Consultant based in the Chicago, IL or St. Louis, MO metropolitan area with a strong safety compliance background working as a consultant or in industry to join our team. This individual will have knowledge of general industry safety procedures and Occupational Safety and Health (OSHA) requirements. The Safety Consultant will have experience auditing, developing, and implementing OSHA safety programs in an industrial setting, and expertise helping organizations proactively manage their operational safety-related risks.

Responsibilities and tasks include the following:

• Conducting OSHA compliance audits in general industrial settings.
• Researching federal, state, and local regulatory requirements and helping maintain standards.
• Effectively managing and building client relationships, leading to repeat business.
• Developing and delivering training and coaching on safety.
• Performing site safety assessments, conducting incident investigation/root cause analysis, and implementing follow-up corrective actions.
• Working with a team to assess, design, implement, and audit safety management systems and related programs.
• Designing safety performance metrics to drive continual improvement.
• Applying quality and process improvement methods and tools.
• Writing technical reports, work plans, and proposals.
• Supporting other KTL professionals to effectively manage and deliver projects.
• Managing tasks remotely and at client sites.

Requirements

• B.S. degree in Environmental Science, Engineering, or Occupational Safety preferred.
• 5-10 years of consulting or relevant experience working in safety for industry/manufacturing.
• Associate Safety Professional (ASP) or Certified Safety Professional (CSP) preferred.
• Recent experience conducting safety audits.
• Strong knowledge of OSHA safety standards and programs.
• Experience with environmental compliance preferred.
• Experience in healthcare preferred.
• Previous project management experience and ability to manage multiple projects and clients.
• Excellent verbal and written communication, interpersonal, and presentation skills.
• Excellent research, analytical, writing, and organizational skills.
• Ability to work independently and as a part of a team.
• Proficient in Microsoft 365 software.
• Valid driver’s license.
• Ability to travel up to 50%.

How to Apply

Forward a resume to recruiting@goktl.com.

Company Description

KTL is a multidisciplinary consulting firm that specializes in providing environmental, health, and safety (EHS); food safety; and quality management and compliance consulting services to industry and government clients. Our primary focus is to build strong, long-term client partnerships and provide tailored solutions to address regulatory compliance requirements. KTL’s services include auditing and assessments, management system development and implementation, certification support, regulatory compliance assistance, information management solutions, and training. Our headquarters are in Madison, WI and Atlanta, GA, with satellite offices throughout the U.S.

KTL is excited to be joining the 2024 Food Safety Consortium in Washington, DC, October 20-24, 2024. The 13th Annual Food Safety Consortium provides food safety and quality assurance professionals with cutting-edge knowledge, practical skills, and a collaborative network to enhance their professional development as champions of food safety.

KTL will be leading the following breakout session as part of the workshop’s technical agenda:

The Big Secret…You already have the software you need to manage food safety
October 22, 2024 | 8:30-9:15 am | Presenter: Roberto Bellavia, Senior Consultant and Partner

This session will demonstrate how food companies are leveraging Microsoft Power Platform with SharePoint® to elevate the food safety management systems (FSMS) and more effectively manage food safety compliance documentation, data, and certification requirements.

And be sure to stop by and visit us at Booth #11. We look forward to seeing you at the Food Safety Consortium!

Salmonellosis (i.e., an infection with the bacteria Salmonella) is the second leading cause of foodborne illness in the U.S. The (CDC) Center for Disease Control estimates over 1.35 million illnesses, 26,500 hospitalizations, and nearly 420 deaths annually are attributed to Salmonella. It is estimated that over 23% of those illnesses are from eating chicken or turkey.

On October 19, 2021, the U.S. Department of Agriculture (USDA) launched a comprehensive effort to reduce Salmonella illnesses associated with poultry products. Since then, the Department has completed several activities to move closer to the national target of a 25% reduction in Salmonella illnesses (see below). One of the most significant actions came on July 29, 2024, when the USDA issued its proposed rule and determination to more effectively reduce Salmonella contamination and illnesses associated with raw poultry products.

Salmonella 101

Salmonella are bacteria that live in the intestinal tract of humans and animals and can contaminate some types of food, including raw fruits and vegetables and raw or undercooked chicken, turkey, beef, and eggs. Salmonella is transmitted by consuming contaminated food products. It can also be transferred when handling pets, particularly birds and reptiles.

Controlling Salmonella contamination is tricky for several reasons. There are approximately 2,500 serotypes (i.e., distinct strains) of Salmonella bacteria, and their risks differ across all production systems. Salmonella can survive under extreme conditions and adapt to its environment. It can also survive in most animals without causing disease in the animal. In fact, Salmonella can be found just about anywhere, including in food, water, soil, and the air we breathe.

Regulatory History

USDA’s most recent proposed rule and determination represents the culmination of the Food Safety and Inspection Service’s (FSIS) three-year effort to better control Salmonella rates in poultry and protect American consumers. The following significant events have led to this latest action:

• October 2022: FSIS announces a draft regulatory framework for a new strategy to control Salmonella in poultry products.
• June 2023: The USDA Agricultural Research Service (ARS) launches the Salmonella Grand Challenge, bringing together a group of scientists from different specialties to learn more about how and where Salmonella causes the highest risk to meat and poultry products.
• April 2024: FSIS publishes a final policy to declare Salmonella an adulterant in raw breaded chicken products when they exceed a threshold of 1 colony forming unit (CFU) per gram of Salmonella contamination. This represents the first time the USDA has labeled Salmonella as a contaminating adulterant in food, alongside certain types of E.coli.

Requirements of the Proposal Rule

The July 2024 proposed framework presents a systematic approach to addressing Salmonella contamination at the poultry slaughter and processing stages. It includes the first enforceable standards for Salmonella, something that has not been established until now because previously available tools and technology were not sufficient to track the bacteria.

The rule can be broken into the following two parts:

Enforceable Limits

The proposed rule establishes final standards to prevent raw chicken carcasses, chicken parts, ground chicken, and ground turkey products that contain any type of Salmonella at or above 10 CFU per gram/mL from entering the market. It also requires facilities to test for the presence of the following, which have been deemed Salmonella serotypes of public health significance:

If the bacteria exceed the established threshold of 10 CFU per gram/mL and contain any detectable level of at least one of the identified serotypes, the poultry cannot be sold, and the product lot would be subject to recall.

 Monitoring, Sampling, and Testing

The final rule also requires poultry companies to establish microbial monitoring programs (MMPs) to identify and prevent pathogen contamination throughout the slaughter system. All poultry slaughter establishments would be required to develop, implement, and maintain written procedures to prevent contamination and maintain records documenting those procedures. More specifically, they must incorporate statistical process control (SPC) monitoring principles into their MMPs to monitor the quality of the manufacturing process. Facilities must also implement written corrective actions, including root cause analysis, when MMP results differ from the predefined criteria.

Finally, the proposed standard provides for a routine sampling and verification testing program for Salmonella in chicken parts, comminuted chicken, and comminuted turkey. FSIS would sample raw final products and analyze them for Salmonella levels and serotypes to determine whether the final product is adulterated. If test results detect Salmonella at a level of 10 CFU/mL or higher and at least one Salmonella serotype of public health significance, FSIS would consider products to be adulterated and the lot would be prohibited from entering commerce or a recall would be initiated.

Moving Forward

Setting limits on Salmonella levels has been difficult until now, because existing tools and technology were not sophisticated enough to track the bacteria. USDA Undersecretary for Food Safety Dr. Emilio Esteban has stated of this proposed rule, “It’s time to change our approach…We have the tools. We have the technology. We have the knowledge.”

The USDA also has the track record. The Department took similar action with E.coli in 1994 after deadly outbreaks tied to ground beef. As a result, the number of foodborne illnesses related to E.coli has fallen by more than 50%. The ultimate goal of the framework for Salmonella is similar—to get the U.S. closer to the national Healthy People 2030 target of a 25% reduction in salmonellosis cases.

USDA is accepting comments on the proposed final regulatory framework through September 29, 2024.

Safety Focus

Food chemical safety is an area that is becoming a growing public concern, especially with states including California, Illinois, and New York challenging the safety of certain food additives and other chemicals used in food. Is food safe to eat if it has chemicals?

Chemical Presence in Food

The truth is…all our food is made up of chemicals. Some naturally exist in whole foods and provide nutrition. For example, the potassium in bananas is a chemical. Some chemicals, like environmental contaminants, get into food when crops absorb them from soil, water, or air.  Process contaminants (e.g., undesired chemical byproducts) can also form during food processing, particularly when heating, drying, or fermenting foods.

Chemicals may also be added to food for a variety of reasons:

• Create additional nutritional benefits (e.g., vitamins A and D being added to milk).
• Provide protection from pathogens that could make people sick.
• Enhance food by adding flavor, improving texture, and changing appearance.
• Preserve quality by preventing spoilage or extending shelf life.

FDA Authorization

The Food and Drug Administration (FDA) must authorize any chemical added to food for use as a food or color additive before it may be used, unless the substance is generally recognized as safe (GRAS). Through its pre-market review programs, FDA reviews all relevant information about the chemical before providing its authorization, including information about:

• The identity of the chemical, including its chemical structure and data on other similar substances.
• How the substance will be used, its level of use, and the amount people may be exposed to in food.
• Toxicology, safety data, and other information to show the substance is safe at calculated exposure levels.

How Much Is Too Much?

The presence of a chemical does not determine whether a food is safe to eat. Rather, it is the amount that counts.

FDA scientifically assesses the safe amount of a chemical in food by comparing how much chemical is in the food and how much someone is likely to consume daily with other safety data to determine whether a food is safe to eat. Any chemical has the potential to be harmful at a certain level, which is why this multi-pronged evaluation and extensive calculations are important.

FDA determines an Acceptable Daily Intake level for the chemical. This level has a “built-in” safety margin to ensure the allowable daily amount is actually much lower than the level known to have a possible adverse health effect.

When Food Chemicals Become Unsafe

Authorized chemicals normally used in foods as additives and preservatives can become hazardous when they are unintentionally added or are present beyond the established limits. When this happens, it can cause immediate illness and/or long-term health effects on consumers. FDA monitors the food supply for chemical contaminants and takes action when the level of a contaminant causes a food to be unsafe. Situations such as this result in food safety alerts, recalls, and withdrawals from the market.

FDA helps safeguard the food supply by evaluating the use of chemicals as food ingredients and substances that come into contact with food (e.g., packaging, storing, handling). But ultimately, food manufacturers are responsible for marketing safe foods and ensuring that they meet FDA requirements. The manufacturers are required to implement preventive controls to significantly minimize or prevent exposure to chemicals in foods that may be hazardous to human health.

More information can be found on food chemical safety at the following websites:

• https://www.fda.gov/food/food-ingredients-packaging/food-chemical-safety
• https://www.fda.gov/food/food-ingredients-packaging
• https://www.fda.gov/food/buy-store-serve-safe-food/chemicals-foods-facts
• https://www.fda.gov/consumers/consumer-updates/food-safe-if-it-has-chemicals

KTL is excited to be participating in the 2024 World Brewing Congress (WBC) in Minneapolis, MN, August 17-20, 2024. WBC 2024 aims to provide a compass for the brewing community to chart its course through the challenges that brewers and brewing professionals encounter on a global scale.

KTL will be a panelist for the following session:

Food Safety: Requirements, Programs, Experiences & Culture in Brewing
August 20, 2024 | 10:00-11:15 am | KTL Panelist: Estefania Lopez

Beer is food. This session will introduce you to basic food safety programs and regulatory requirements needed in order to produce a safe and quality product that your customers will keep coming back to and enjoy time after time.

The produce industry handles an estimated six billion cases of produce in the U.S. each year. Because a significant portion of this produce travels through the supply chain to reach customers, many produce companies already have some level of traceability program in place. With the finalization of the Food and Drug Administration’s (FDA) Food Traceability Rule, the question is whether these existing traceability programs, systems, and procedures meet regulatory requirements. 

KTL’s recent article in Food Safety Tech walks you through how to conduct a gap assessment to 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.

On November 21, 2022, the Food and Drug Administration (FDA) published the Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule). With the effective date for updated recordkeeping approaching in January 2026, traceability is a top priority for most organizations working in the food industry. Produce companies are especially impacted by traceability requirements as the first step in the food supply chain.

KTL’s recent article in Food Safety Tech outlines four steps to help any produce company prepare to meet FDA’s traceability requirements.

The Food Safety Summit brings together the food safety community to learn more about today’s most crucial elements of food safety—from regulatory concerns and current industry trends to ongoing challenges and the latest technology and solutions.

This year’s Summit, held earlier in May, proved once again to be an engaging and informative meeting for those in attendance. Throughout the Summit, KTL’s food safety experts observed several common themes and challenges that the food industry is facing — challenges that your business may be encountering today. We sat down with KTL’s attendees—Roberto Bellavia, April Greene, Estefania Lopez, and Joe Tell—to get their key insights from the Summit.

What technical topics were covered at the Summit? What seemed to gain the most interest from participants (i.e., “hot topics”)?

The Summit covered a range of content, including food safety culture, artificial intelligence (AI), HACCP, collaborating with regulators, microbial process control and sanitary design, sustainability, root cause analysis, e-commerce, state laws and regulations, viruses and pathogens in foods, food code adoption/harmonization, software, produce safety, and women in food safety. Of these, there were two particularly hot topics we heard about time and again this year: food traceability and cannabis.

Food Traceability. The implementation date for the Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) Final Rule: Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule) is January 2026. Impending deadlines have a lot of people talking, as many companies are starting to realize that having multiple software solutions to handle their food safety information is going to make complying with the new traceability requirements a nightmare. Having a robust document/records management system is essential for maintaining the vast number of documents required by regulations and standards, particularly the Food Traceability Rule.

Cannabis. There have been multiple instances of cannabis-infused products with unlisted ingredients falling through the cracks of regulations, creating potential negative impacts on human health and significant reputational issues. This, coupled with the recent information asserting the Drug Enforcement Agency’s (DEA) plans to reschedule marijuana from Schedule I to Schedule III under the Controlled Substances Act (CSA), is pushing many states to protect consumers of food and beverages infused with cannabis in the absence of federal guidance. State regulatory agencies are essentially playing a game of “whack-a-mole” with cannabis companies as they try to navigate where cannabis products fall: Food? Drug? Dietary Supplement? One regulator at the Summit stated that cannabis regulation is a modern day wild, wild west.

Are there any *new* food safety trends you heard about that companies should have on their radar?

There were several talks focused on sustainability at the Summit this year. The FDA, U.S. Department of Agriculture (USDA), and Environmental Protection Agency (EPA) released a joint strategy for reducing food loss and waste for organics in December 2023. They are working to create multiple pathways to make it easier for restaurants, farms, and manufacturers to divert good, nutritious food from landfills to food banks. The strategy also focuses on educating consumers, so they understand how to handle food waste in their own homes.

In addition, there were multiple conversations regarding the significant impacts of global climate change on the food supply chain. ISO’s recent Climate Change Amendments, as well as the Securities Exchange Commission (SEC) Climate-Related Disclosure Rule (which was recently stayed on March 15, 2024) continue to emphasize the importance of accounting for and managing climate change impacts. Companies are at a pivotal point where they need to make decisions regarding their sustainability efforts and how they proceed to meet regulatory and supply chain drivers.

You talked to a lot of different people and companies. What are some of the biggest challenges they are currently facing?

There is a lot of frustration amongst companies, federal regulatory authorities (e.g., FDA, USDA), and state regulatory bodies regarding regulations and guidance for emerging issues like new contaminants (e.g., pathogens, viruses, etc.) and security concerns not being addressed quickly enough. One example brought up during the Town Hall: Real-Time Conversation with FDA, CDC, USDA, and AFDO was the new strain of avian flu being found in raw milk. Because it takes time for testing to be completed—and then subsequent guidance to be created—companies are left wondering what to do about this risk. Most companies cannot very well just stop production during this window of uncertainty without significant impacts. During the presentation, regulators said they are trying to figure out ways to keep up with the speed of change and the associated risks that are constantly present in the food industry.

Lack of support and resources for those managing food safety programs remains an ongoing challenge for many organizations. It is not uncommon for a company’s food safety and quality assurance (FSQA) team/department to comprise only one individual. And while companies seem willing to provide information technology (IT) tools to help manage food safety requirements, many attendees expressed frustration with the lack of harmonization between the various IT solutions, making them ineffective and inefficient to use. See more below.

KTL presented on using existing Microsoft solutions to develop a food safety management system (FSMS). What role do you see IT solutions playing in the food industry?

As stated above, we talked with many companies that have purchased various software solutions with the expectation they would work together; in reality, many of these tools operate independently. As a result, companies are getting frustrated because they have invested time, money, and effort in these tools but have not realized business efficiencies.

There are significant benefits to implementing IT tools that “talk” to each other versus these siloed systems. As our presentation demonstrated, KTL focuses on leveraging Microsoft 365—which most companies are already using—to create integrated systems with various apps/tools that address specific FSQA and operational needs. This approach allows companies to manage various compliance and certification requirements, enables staff to carry out daily tasks and manage operations, and supports operational decision making by tracking and trending data more effectively and efficiently.

Given what you heard, what should companies in the food industry be doing now to plan for the future?

We walked away from the Summit with some key takeaways in some key areas:

Traceability. Companies throughout the supply chain will be impacted by the Food Traceability Rule—potentially even if they don’t have products on the Food Traceability List (FTL). Take time to understand the Rule requirements and how they apply to your operations and to train employees at all levels so they understand their responsibilities. This is an excellent time to perform traceability exercises for everything to help identify gaps, test protocols and verify effectiveness, implement corrective actions, and ensure adequate traceability processes are in place before the January 2026 deadline. It will be especially important to begin or renew communication with contacts throughout the supply chain to facilitate documentation, information sharing, and collaboration. Investing in a good IT solution that integrates with your FSMS will help to further streamline the process.

Cannabis. Companies getting involved in the growing cannabis industry need to stay on top of the rapidly changing regulatory environment. Assess operations, determine what standards might be appropriate, identify gaps in existing programs, prepare for a new regulatory framework—state and/or federal—and begin implementing solutions to eliminate risks.

Food loss and waste. We have all heard reduce, reuse, recycle from the EPA. Now the USDA, FDA, and various food safety certification schemes are holding companies in the food industry accountable for reducing food waste and preventing food loss. Before this becomes mandatory, companies should begin the process of identifying targets and associated methods for reducing food loss and waste.

Food safety outbreaks and recalls. Food safety professionals should be continually monitoring information regarding foodborne illness outbreaks. Companies can reduce their risks by staying informed about emerging food safety threats, identifying and assessing vulnerabilities in their facilities, implementing protocols to help mitigate impacts to consumers, challenging food defense programs by conducting intrusion tests, and developing a comprehensive Crisis Management Plan to manage human health and reputational impacts.

Produce safety. In July 2022, FDA extended the compliance dates for the pre-harvest agricultural water requirements for non-sprout covered produce. Covered farms are subject to the requirements of 21 CFR Part 112 Subpart E if they use water during the growing, harvesting, packing, or holding of covered produce in a way that meets the definition of “agricultural water.” If you fall under this category, note the new compliance dates, which differ depending on farm size:

• January 26, 2025: Very small businesses.
• January 26, 2024: Small businesses.
• January 26, 2023: All other businesses.

Companies receiving produce need to establish the criteria for information that will be requested from the farm upon delivery of produce, such as Certificate of Analysis (CoA). If conducting supplier audits for farms, include the requirements of the Rule into audit criteria. 

With all these challenges and trends simultaneously competing for attention—and with fewer resources to manage it all—companies need to assess priorities, needs, and requirements and create a plan for how to meet them.