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. 

According to the United Nations Environment Programme (UNEP), we produce about 400 million tons of plastic waste every year globally. Approximately 36% of that plastic is used in packaging, including single-use plastic products for food and beverage containers.

The European Commission estimates that approximately 50% of plastic packaging in the European Union (EU) is used for the food and beverage industry. In the U.S., food packaging comprises approximately two-thirds of all packaging material produced, and correspondingly, the U.S. Environmental Protection Agency (EPA) cites that food and food packaging materials make up almost half of all municipal solid waste. 

Food packaging is used to help make food clean, safe, transportable, and shelf stable. Unfortunately, most of it is single use and is not recycled or reused. But there is a growing trend throughout the U.S., as well as in Canada and the EU, to increase the use of post-consumer recycled (PCR) materials in packaging products, including plastic.  

Regulatory Background

California enacted the first minimum recycled content laws in the U.S. in 1990 for fiberglass, glass containers, plastic containers, and plastic trash bags. Fast forward to late 2023, and the Association of Plastics Recyclers (APR) indicates that seven states are currently in various stages of developing and/or implementing state minimum recycled content laws, including California, Maine, Washington, New Jersey, Connecticut, Maryland, and New York.

In general, these laws establish incremental minimum recycled content requirements for various packaging materials and associated timelines for compliance. Impacted products include plastic beverage bottles, plastic carryout bags, trash bags, household cleaning and personal care products, and others. Some laws allow for averaging recycled content across a company’s covered products portfolio to meet requirements. Some states require third-party certification to ensure accountability.

The New Jersey Recycled Content Law, which recently came into effect on January 18, 2024, is considered one of the most ambitious recycled content laws to date, as it goes beyond traditional rules to cover rigid plastic containers.

Given current and potential upcoming legislation, manufacturers and retailers alike must be aware of which products are covered by recycled content standards, as there may be restrictions on the use and sale of products that do not comply.

Plastic Recycling for Food-Contact Materials

According to the Food and Drug Administration (FDA), there are only a few major varieties of plastic that meet the Agency’s guidelines for safe contact with food and that can be considered food grade and FDA-compliant. To be FDA-compliant, packaging must be able to withstand whatever environment it will be used in (e.g., extremely hot oven for cooking, freezing temperatures, and cleaning and sanitization). The packaging material must also be compatible with the type of food it will be in contact with and must not leach any chemicals if the food is acidic or has high moisture content.

The following plastics are generally considered safe for food:

• High-density polyethylene (HDPE), the most common household plastic, is used to make beverage bottles, butter containers, cereal box liners, and thicker food storage buckets. FDA evaluates the use of recycled HDPE on a case-by-case basis, as it can become unsafe in the recycling process.
• Low-density polyethylene (LDPE) is similar to HDPE but less rigid. It is used for products like squeeze bottles, plastic wrap, six-pack rings, etc. While LDPE is chemical-resistant and does not leach, recycled LDPE is not deemed safe for food contact.
• Polycarbonate resin (PCR) has presented some concerns about the presence of bisphenol A (BPA); however, FDA studies conclude that intake from BPA in plastic is very low and does not have apparent negative health impacts.
• Polypropylene (PP) is most often used for single-serve containers (e.g., yogurt, cottage cheese) and reusable food storage containers. It is microwave safe and nonvolatile.
• Polyethylene Terephthalate (PET) is used to make any plastic jars and beverage containers (e.g., 2-liter bottles, peanut butter jars, salad dressing containers, etc.). It repels microorganisms and does not corrode.

While many of these plastics are only FDA-compliant and food safe in their unrecycled state, recycled PET is an FDA-approved plastic for food contact. Most plastic food packaging that is not made of PET cannot be recycled into new food packaging due to missing processes (i.e., waste collection, separation, decontamination) and other safety concerns. These other types of plastic food packaging are typically only downcycled or not recycled at all.

Recycling Responsibilities

Manufacturers of food-contact packaging made from recycled plastic are responsible for ensuring that recycled material meets the same specifications for virgin material, as outlined in 21 CFR parts 174-179. The regulations state that any substance used as a component of articles that contact food shall be of a purity suitable for its intended use.

Because recycled food-contact materials have content that is recovered from waste, it may be contaminated with substances originating from previous use or other waste—and that contamination may end up in our food and be harmful to human health. The FDA cites the following main safety concerns with the use of PCR plastic materials in food contact articles:

• Contaminants from the PCR material may appear in the final food-contact product made from the recycled material.
• PCR material that may not be regulated for food-contact use may be incorporated into food-contact material.
• Adjuvants in the PCR plastic may not comply with the regulations for food contact use.

Although not required by law, recyclers of plastic intended for food-contact use may submit information on their recycling process to FDA for evaluation. In turn, FDA will consider each proposed use of recycled plastic on a case-by-case basis and issue informal advice as to whether the recycling process is expected to produce food grade, FDA-compliant PCR plastic based on the following:

• Complete description of the recycling process, including a description of the source of the PCR plastic, any source controls in place, and a description of steps taken to ensure the recyclable plastic is not contaminated at any point.
• Results of any tests performed to show that the recycling process removes possible incidental contaminants.
• Description of the proposed conditions of use of the plastic (e.g., temperature, type of food, duration of contact, repeated or single use).

Recycling plastic food packaging is widely seen as an opportunity to reduce our environmental impacts across the globe. While plastic food packaging recycling is limited extent due to material properties, waste management processes, and chemical safety concerns, legislation is pushing recycling forward where it is safe. Given this, manufacturers and retailers must be aware of which products are covered by recycled content standards and make plans to meet established timelines for minimum recycled content requirements to avoid restrictions on the use and sale of products that do not comply.

KTL will be joining industry experts at the 2024 Master Brewers Association of America’s (MBAA) District Carolina Technical Conference to discuss food safety and regulatory implications of producing nonalcoholic and low-alcohol beer (NALAB).

MBAA District Carolinas 2024 Spring Technical Conference
May 4, 2024
Hopfly Brewing Company | Charlotte, NC

KTL Presentation: Food Safety and Regulatory Implications of Producing Nonalcoholic and Low-Alcohol Beer (NALAB)

The demand for NALAB has increased significantly in the past few years and is projected to continue. KTL’s presentation will describe the complexities associated with adding a NALAB beverage to a product portfolio and break down the requirements and considerations into actionable pieces. It will also discuss relevant food safety risks in traditional beer, such as allergen cross-contamination, chemical inclusion, and foreign object inclusion. Specifically, the presentation will cover the following:

• Interpretation and breakdown of the regulatory requirements for NALAB products.
• Differences in FDA regulatory requirements for traditional beer versus NALAB products.
• Known or reasonably foreseeable food safety hazards associated with traditional beer and NALAB products. 
• Strategies that brewers can take to minimize food safety hazards.

As one of the premier events in the food industry, the Food Safety Summit provides a comprehensive conference and expo for attendees to learn from subject matter experts, exchange ideas, and find solutions to current industry challenges.

• When: May 6-9, 2024
• Where: Donald Stephens Convention Center, Rosemont, Illinois
• Who: Retailers, food processors, distributors, food manufacturers, growers, foodservice, testing laboratories, importing/exporting, law firms, and other food safety professionals
• Find KTL: Stop by our booth (#406) in the exhibit hall!

Tech Tent Case Study Presentation

Be sure to also update your agenda to attend KTL’s Tech Tent presentation on Thursday, May 9 at 11:15 am CT:

Case Study: Leveraging Existing Microsoft® Software to Develop a Robust FSMS

KTL will present a case study demonstrating how Italian Frozen Foods (IFF) USA is leveraging the company’s existing software—Microsoft Power Platform with SharePoint®—to elevate its food safety management system (FSMS) and effectively manage food safety compliance documentation, data, and certification requirements.

• Learn how you can use the software you already have to develop a robust FSMS.
• Understand the approach and process required to ensure successful development and implementation.
• Observe in practice how an integrated system can help organize, control, analyze, and visualize information so you remain in compliance and operate more efficiently.

Effective February 23, 2024, the International Organization for Standardization (ISO) is integrating climate change considerations into all management system standards through its Climate Change Amendments. These Amendments ensure climate change impacts are considered by all organizations in their management system design and implementation.

ISO’s recent action supports the London Declaration on Climate Change of September 2021, which establishes ISO’s commitment to combatting climate change through its standards and publications. The aim of the recent Amendments is to make climate change an integral part of management systems design and implementation to help guide organizational strategy and policy.

What are the changes?

The Climate Change Amendments explicitly require climate change considerations in all existing and future ISO management systems standards, as incorporated into the Harmonized Structure (Appendix 2 of the Annex SL in the ISO/IEC Directives Part 1 Consolidated ISO Supplement). More specifically, the Amendments add the following two new statements to Annex SL for organizations to consider the effects of climate change on the management system’s ability to achieve its intended results:

• Clause 4.1: The organization shall determine whether climate change is a relevant issue, as it relates to understanding the organization and its context.
• Clause 4.2: NOTE: Relevant interested parties can have requirements related to climate change, pertaining to understanding the needs and expectations of interested parties.

The broad scope of these Amendments (i.e., impacting all standards) reflects ISO’s commitment to integrating climate considerations across diverse operational areas (e.g., environment, quality, safety, food safety, security, business continuity, etc.).

What do these changes require?

The original intent and requirements of Clauses 4.1 and 4.2 remain unchanged; however, the Amendments now require organizations to consider the relevance of climate change risks and impacts on the management system(s).

Potential climate change issues will likely differ for the various standards. The Amendments ensure these various risks are considered for each standard and, if actions are required, allow the organization to effectively plan for them in the management system.

What do certified organizations need to do?

Organizations that are certified—or are planning for certification—need to make sure they consider climate change aspects and risks in the development, maintenance, and effectiveness of their management system(s).

The Amendments specifically require these organizations to evaluate and determine whether climate change is a relevant issue within their management system(s). If the answer is yes, the organization then must consider climate change in a risk evaluation within the scope of their management systems. Where relevant, organizations are further encouraged to integrate climate change into their strategic objectives and risk mitigation efforts. The Amendments do not require organizations to do anything about climate change beyond considering the impacts on the management system’s ability to achieve its intended results.

What is the timeline?

The Amendments are effective as of the date of publication. There is no transition for implementation.

Certification bodies and auditors will cover the Amendments in audit activities when assessing this section of a management system. The audit will ensure climate change is considered and, if determined to be a relevant issue, included in company objectives and risk mitigation efforts. If climate change is deemed not relevant, the audit will assess the organization’s process for making this determination.

Will new certifications be issued?

Because the changes are considered a clarification, ISO issued them in the form of an amendment. New standards will not be republished until new versions are released; therefore, the publication year of each ISO standard will not change, and no new certifications will be issued.

What are the benefits of these changes?

The Climate Change Amendments underscore the importance of understanding and addressing the impacts of climate change. By publishing the Amendments in Annex SL, ISO is leveraging the widespread adoption of all ISO management system standards across operational areas to integrate environmental stewardship into organizational practices, promote sustainability, and drive climate change action on a global scale.

For certified organizations, the Amendments are intended to enhance organizational resilience and adaptability to climate-related risks. Considering climate change in this way can significantly contribute to business sustainability and long-term success by:

• Ensuring regulatory compliance (e.g., emission limits, sustainability reporting, etc.).
• Creating positive brand reputation as a sustainable company and associated customer loyalty.
• Managing risks and opportunities associated with supply chain disruptions, energy efficiency initiatives, employee health and safety, natural disasters, etc.
• Engaging employees and attracting new talent who prioritizes sustainability.
• Providing access to markets and investors that have sustainability requirements.

Safety hazards exist in every manufacturing environment. The food industry is no exception. Between October 2018 and September 2019, the Occupational Safety and Health Administration (OSHA) issued a total of 1,168 citations resulting in over $7 million in fines to the food manufacturing industry alone.  

Occupational safety and health risks in food manufacturing are often heightened because of the nature of the product (i.e., food or drink) being manufactured. Even food safety measures taken to prevent contamination and ensure food safety can carry inherent occupational safety and health risks.

While food safety is paramount for any company operating in the food industry, a company cannot stay in business if they do not take the appropriate measures to keep employees healthy and safe.  

Common Safety Hazards in the Food Industry

Lockout/tagout and machine guarding recurringly top OSHA’s annual list of the most frequently cited standards in food manufacturing. In fact, the most expensive OSHA fines of 2023 involved two food manufacturers and violations concerning machine guarding and lockout/tagout.

Lockout/Tagout

Employees need to be protected against the unexpected startup or release of energy. Lockout/tagout involves properly de-energizing and securing equipment so it cannot be operated unsafely when a machine needs service or repair. When employees work in a fast-paced environment, they may not take the required steps to first properly de-energize the equipment. As a result, approximately 1,000 workers die each year due to unexpected operation of equipment and/or release of stored energy. Machines and electrical equipment must be properly shut down, de-energized, and locked when servicing.

Machine Guarding

Moving machine parts have the potential to cause severe workplace injuries, such as crushed fingers or hands, amputations, burns, blindness—and most food processing machinery includes pinch points (i.e., blades, rolling parts, presses, etc.) that can put workers at increased risk. Safeguards for machine parts, functions, and processes are essential for controlling hazards and protecting workers from these otherwise preventable injuries.

Other Common Safety Hazards

• Ergonomics. Many food manufacturing jobs involve repetitive motion that can cause musculoskeletal disorders.
• Slips, trips, and falls. Sticky or wet products and frequent cleaning can both contribute to slippery work surfaces that increase the risk for slips, trips, and falls. The high volume of liquids used in food manufacturing and processing creates regular employee exposure to wet surfaces.
• Chemicals and harmful substances. Food facilities rely on various chemical sanitizers and disinfectants to prevent contamination. In addition, anhydrous ammonia, a common refrigerant used in food facilities, is very hazardous (i.e., corrosive, flammable, and explosive), even in small spaces.
• Cut hazards. Knives and other blades are common equipment in food processing plants. Dull blades cause more accidents because they are harder to work with, require more pressure, and may slip more easily. Blades should be sharpened, and employees should wear appropriate PPE.

OSHA Response: Local Emphasis Programs

Between 2016 and 2020, OSHA investigated fatalities, amputations, fractures, and crushed hands and fingers at food manufacturing facilities and identified the primary causes as failure to control hazardous energy or implement adequate machine guarding. In Wisconsin, Bureau of Labor and Statistics (BLS) data from 2011-2020 show that food manufacturing injury rates were consistently higher than the averages for all Wisconsin manufacturing companies. In 2019, OSHA found that food production workers in Ohio had a nearly 57% higher rate of amputations and 16% higher rate of fractures; in Illinois, these rates were 29% higher for amputations and 14% higher for fractures compared to private sector manufacturing.

In 2022, OSHA Region 5 established two Local Emphasis Programs (LEPs)—one for Wisconsin and one for Illinois and Ohio— to encourage employers to identify, reduce, and eliminate exposure to machine hazards during production activities and off-shift sanitation, service, and maintenance tasks (i.e., machine guarding and hazardous energy control – lockout/tagout). These LEPs run through at least 2027 and focus on reducing fatalities and injuries through outreach, education, training, and enforcement activities.

The LEP empowers OSHA to schedule and inspect food industry employers whose injury rates exceed the state average among all manufacturers. The scope of inspections conducted under the LEP focus on reviewing:

• Production operations, sanitation processes, and working conditions.
• Injury and illness records (i.e., OSHA 300 logs), particularly injuries pointing to deficiencies in machine guarding or the hazardous energy control program.
• Machine guarding hazards associated with points of operation, ingoing nip points, and moving or rotating parts of food processing equipment.
• Deficiencies in the hazardous energy control program associated with equipment service, maintenance, setup, and sanitation.
• Hazards associated with chemical burns from corrosives, such as those used for cleaning and sanitizing.

Prepare Your Facility…Protect Your Workers

If you fall under an OSHA LEP, you need to prepare your facility. Even if you don’t, you need to protect your workers.

• Prepare and maintain your OSHA 300 log with any work-related injuries and illnesses. KTL’s OSHA 300 PowerApp can make it easier to collect, search, analyze, store, and aggregate data so it is available when needed.
• Conduct a thorough hazard analysis of the facility, operations, and processes to identify potential safety hazards. The hazard analysis should answer what could potentially go wrong, what the associated consequences are, and how they can be prevented or eliminated.
• Develop, implement, and maintain the appropriate safety programs, procedures, and instructions. A safety management system that aligns with current food safety systems can provide resources to help companies identify and manage safety risks and an organizing framework for policies, procedures, and practices, including:
  • Engineering controls for dangerous equipment, including machine guarding.
  • Written energy control program and lockout/tagout procedures specific to each piece of equipment.
  • Emergency response programs.
  • Proper maintenance, cleaning, and sanitation procedures and schedules.
  • Guidelines for proper use, care, and replacement of PPE.
• Train your staff. Workers need to have appropriate training, including use of PPE, hazards of extreme temperatures, material handling, hazard communication, lockout/tagout procedures, machine guarding procedures, etc. Initial safety training should be conducted when onboarding new employees, with refresher training provided annually to ensure competency. Training tracking systems allow for the centralized implementation, management, tracking, scheduling, assignment, and analysis of organizational training efforts.
• Provide proper PPE. Workers should be wearing proper footwear, gloves, safety glasses, ear plugs, aprons, etc. and be provided with anti-slip mats to ensure safety.
• Ensure safety data sheets (SDS) are current and available to help identify hazardous chemicals and protect employees from exposure. Train workers on the chemicals used in the workplace, including first aid, what to do in the event of a release, identifying characteristics, proper procedures for working around or with the chemical, and appropriate PPE.
• Use visual communication (e.g., labels, signage) to help protect workers from hot surfaces, exposed moving parts, pressurized systems, hazardous chemicals, slippery surfaces, and more.

Finally, prioritize safety. Small steps can go a long way in making sure employees leave work safely versus becoming an OSHA statistic.

The Food and Drug Administration’s (FDA) Intentional Adulteration (IA) Rule aims to prevent acts targeting the food supply that are intended to cause wide-scale harm to public health. The IA Rule requires food businesses to assess and identify vulnerabilities in their processes, operations, and facilities; implement strategies to reduce those vulnerabilities; and then regularly monitor and verify the effectiveness of those strategies to reduce the occurrence of IA acts. A food defense “challenge” (also known as an intrusion test) is then used to assess how well those strategies are implemented throughout the organization.

What is the purpose of the IA intrusion test?

The purpose of an intrusion test is to evaluate a company’s existing food defense programs for proper implementation across the company by “challenging” the system’s efficacy. In an unannounced intrusion test, a food safety expert scopes out the facility and its vulnerabilities, attempts to gain access to sensitive areas, and tests how the food defense system works in practice.

The test helps facilities to:

• Assess whether food defense procedures are effectively implemented throughout the facility—and are being followed by personnel.
• Highlight facility strengths and implementation failures.  
• Close identified gaps and reinforce programs, where needed.
• Meet FDA regulatory and Global Food Safety Initiative (GFSI) certification standard requirements. 

Am I required to do one of these challenges?

To truly ensure food safety and defense programs work, they need to be challenged. The GFSI benchmarked certification standards all require some version of testing:

• SQF: The food defense program must be tested to ensure food defense strategies are effective, appropriate, and documented. This test can be based on a fictitious scenario that allows an intruder to enter the building and challenge the system.
• FSSC 22000: Organizations must conduct and document a food defense threat assessment based on defined methodology to identify and evaluate potential threats linked to processes and products.
• BRCGS: A documented risk assessment must be conducted to identify potential risks to the security of product and to ensure appropriate controls implemented to reduce the risk.
• IFS: The food defense plan must be tested for effectiveness and reviewed at least annually or whenever significant changes occur.

What does the process look like?

An important part of these tests is that they are unannounced, so personnel continue to operate as usual versus being on heightened alert. Tests are typically coordinated and scheduled with company leadership to take place at a time/date that is undisclosed to plant employees. Company leadership provides the food safety expert with documentation that confirms the test and outlines who to contact when/if “apprehended” to help keep the food safety expert safe.

Prior to conducting the test, the food safety expert will generally tour the facility to identify sensitive areas to target and opportunities to enter the facility. This is important since the first critical step in conducting the test involves gaining access to the building, whether through finding unlocked doors, pretending to be plant personnel, or even creating a cover story and walking through the front door.

Once the food safety expert is in the facility, the objective becomes to try to access as many sensitive areas as possible to truly “test” the system. The intrusion test is followed up with a detailed findings report that provides recommendations for closing gaps and strengthening the facility’s food defense program.

What does the IA intrusion test include?

An IA internal intrusion test evaluates company preparedness for intentional trespassing and internal attacks on sensitive areas inside the facility. The intruder will take advantage of employee movement (e.g., arrivals, breaks, lunches, departures); focus on physical controls of building access (e.g., employee entrances, garage doors, receiving/loading areas); and target sensitive internal areas within the building. The challenge will involve testing facility procedures and employee implementation, as well as the following food defense mechanisms:

• Card access/badge system/key protocol
• Reception area
• Visitor control/sign-in program
• Security guards
• Camera system
• Exterior door security
• Lighting
• Shipping/receiving areas
• Fencing
• Parking lot

What are common missteps identified in intrusion tests?

In many cases, the issues encountered are seemingly small things; however, the small issues can quickly result in very big problems if an intruder is able to access sensitive areas. Some of these include the following:

• Employees forget to ensure the door is shut and fully latched when leaving an area.
• Employees do not question the presence of visitors and, in some cases, will even open the door for an unknown individual.
• Badges and uniforms are left unattended throughout the facility for intruders to steal and use as identification. With this identification, interior areas are relatively easy to access and contaminate.
• Doors are not locked—either inadvertently or because locking mechanisms are not repaired—or are propped open for ease of access.
• Equipment on the exterior of the facility (e.g., ladders, company vehicles, tools, etc.) is not adequately controlled.

What can facilities do to prevent IA?

Training staff to understand food defense risks, identify suspicious activities and individuals, and implement preventive measures is key to reducing IA risk. FDA and the Department of Homeland Security’s (DHS) See Something, Say Something Campaign reminds front-line employees of what to look for and how to respond if suspicious activity occurs.

Importantly, staff must feel empowered to notify management if they notice anything suspicious. This might include someone taking notes or videos in the plant; an individual attempting to gain access to restricted areas; theft of employee uniforms, badges, or packaging labels; unattended vehicles illegally parked near the facility; unattended items near the business (e.g., boxes, bags); and suspicious work behaviors/hours from employees.

Best practices to prevent this suspicious activity from causing wide-scale harm include the following:

• Post security personnel to serve as a deterrent for intruders.
• Properly maintain exterior doors, parking lots, and outside lighting.
• Keep doors locked and closed, including entrance, break room, and loading docks.
• Ensure visitor stickers are removed and disposed of upon checkout.
• Secure open containers of food/food ingredients.
• Control access of all employees, visitors, contractors, delivery personnel, etc. to sensitive areas.
• Make sure visitors to the facility are accompanied by an employee.
• Monitor products for evidence of tampering (i.e., seals, labels, packaging).
• Complete background checks on employees.
• Train personnel to report suspicious individuals or activities.

Location: Chicago, Illinois (other locations considered)

KTL is seeking a Food Safety Specialist with 5-10 years of professional food safety consulting or relevant food industry experience to join our team. This individual will work under the direction of KTL Project Managers and Senior Consultants to manage and execute tasks for KTL’s food safety projects and meet client expectations. The Food Safety Specialist must have working knowledge of FDA, USDA, and GFSI requirements as they apply to food/food packaging manufacturing, processing, and distribution, and experience implementing/maintaining food safety documents and plans.  

Responsibilities and tasks include the following: 

• Providing HACCP, SOP, and SSOP development and implementation support 
• Conducting gap assessments to FDA, USDA, and GFSI (i.e., IFS, BRC, FSSC22000, SQF) requirements 
• Conducting relevant food safety training for clients  
• Researching FDA, USDA, and GFSI regulatory requirements and maintaining standards updates 
• Researching labeling regulatory review 
• Interpreting third–party regulatory audits 
• Reviewing, recommending, and coordinating efforts for environmental contaminants and pathogen testing program 
• Working with clients and KTL senior staff to identify Food Safety Management System (FSMS) and program gaps and implement solutions for continuous improvement  
• Maintaining and updating documents to ensure conformance and compliance consistency 
• Participating in the development and management of KTL’s SharePoint® tools  
• Assisting in growing clients and other business development efforts, as requested 

Salary Range: $65,000 to $90,000 per year

Requirements

• B.S. degree in food science, biology, chemistry,  technology, microbiology, or other related life science  
• 5-10 years of related food industry experience in Quality Assurance/Control; experience in cooking, processing, manufacturing dairy, low-acid canned food, meat, or seafood preferred 
• Excellent communication and presentation skills  
• Excellent research, analytical, writing, and organizational skills 

 Preferred

• Microsoft SharePoint® and information management systems experience 
• High–risk food or ingredients experience  
• Understanding of food safety in food packaging 

How to Apply

Forward a resume to recruiting@goktl.com.

Company Description

KTL is a management consulting firm providing EHS, sustainability, food safety, and quality consulting services to a wide range of industry, municipal, university, and government clients. Our focus is to build strong, long-term client partnerships and provide value-added solutions that simplify management systems, improve compliance, and establish more sustainable operations. KTL specializes in developing and implementing strategies, processes, and tools that complement our clients’ investments in existing programs and resources. Our highly qualified personnel have an in-depth knowledge of U.S. federal, state, and international EHS requirements; global food safety compliance; ISO management systems; and information management tools. Our consultants possess the education, work experience, and professional registrations necessary to provide value-adding consulting services to our clients.