Tag Archives: Focus Article

By Bob Lijana

Over the coming weeks, we will share a series of six brief articles on Listeria. They are intended for food science professionals, especially food safety and quality assurance people. The information presented in these mini-articles will also be of interest to people in all functions. To that end, we have kept the language as non-technical as possible.

On roughly a biweekly basis, we will present mini-articles starting with what Listeria is, and the regulatory governance of Listeria in food from FDA and USDA. We will share background on where the organism comes from, how it can move around a food plant, and how to find it. We will share techniques on how to eradicate the pathogen. We will also share some insights on how to communicate learnings and successes, including with senior management. There will be references for further study.

Some of the information will already be known by those who have had to fight Listeria for many years, as is usually the case when this pathogen becomes your enemy. Yet that same information will be new and useful to those for whom the fight is new. These are people who are new to food manufacturing, or for whom a job in food safety and quality assurance is new.

Hence, pick and choose articles of most use to your situation as the series moves along. Yet do look at each one with a fresh pair of eyes–all of us could use a refresher in how best to manage the risk of Listeria in a plant, regardless of experience level. All plants and situations are different, so there is no “cookie-cutter” solution. If there were, we wouldn’t keep seeing recalls due to possible Listeria contamination. And we wouldn’t keep repeating history in that regard. We need to avoid complacence.

The ultimate objectives of this series are to provide suggestions of what can be done to manage food safety risks in a plant, and, at the same time, increase the company’s capability at providing safe food products and protecting public health.

See the Related Articles below to read the series.

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June 18, 2025

Beltway Beat

Agenda Posted & Registration Opens for the 2025 Food Safety Consortium Conference

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Food Safety Tech and the American Frozen Food Institute (AFFI) are excited to announce that registration for the 2025 Food Safety Consortium Conference held at the Crystal Gateway Marriott in Arlington, Virginia, from October 19-21 is now open.

The 2025 event will focus on the convergence of policy, science, and best practices. With the conference being held near Washington, D.C., this year’s program places a renewed emphasis on policy discussions, reflecting the growing need to address regulatory and legislative issues. The program will also prioritize the sharing of best practices, offering attendees the chance to learn from one another and engage in collaborative problem-solving on hot-button issues. The 2025 conference will continue the Consortium’s mission to:

Facilitate the exchange of scientific information and best practices among food safety professionals.
Address current challenges and advancements in food safety, technology, and compliance.
Promote collaboration between industry, academia, and regulatory bodies to enhance public health outcomes.

Donna Garren, Ph.D, Executive Vice President of Science & Policy, AFFI, at the 2024 Food Safety Consortium

Guiding the 2025 program was a newly formed committee:

Jason P. Bashura, MPH, RS, PepsiCo R&D, Global Food Safety & Quality Assurance, Sr. Manager, Global Food Defense, PepsiCo
Rick Biros, Content Director & Publisher, Food Safety Tech (Committee Co-Chairperson)
Erika Blickem, Director of Food Safety, J.R. Simplot Company, Inc.
Benjamin Chapman, Ph.D., Department Head, Professor, Food Safety Specialist, Department of Agricultural and Human Sciences, North Carolina State University, NC State Extension
Byron D. Chaves, PhD., Associate Professor & Food Safety Extension Specialist, Department of Food Science and Technology, University of Nebraska-Lincoln
Donna Garren, Ph.D., Executive Vice President, Science & Policy, American Frozen Food Institute (Committee Co-Chairperson)
Melody Ge, Sr. Director, Food Safety & Quality Operations, TreeHouse Foods, Inc.
Sanjay Gummalla, Ph.D., Senior Vice President, Scientific Affairs, American Frozen Food Institute
David Hatch, Vice President, Digital Solutions Marketing, Neogen
Jill Hoffman, Senior Director, Food Safety and Quality, B&G Foods, Inc.
Justyce Jedlicka, NA Commercial Applications – Food & Beverage Regulatory, Science & Lab Solutions, BioMonitoring, MilliporeSigma
Barbara C. Kowalcyk, Ph.D., Associate Professor and Director of Institute for Food Safety and Nutrition Security, Milken Institute School of Public Health, George Washington University
Jeff Lucas, Technical Director, Mèrieux NutriSciences
Michael L Rybolt, Ph.D., Sr. Vice President, Food Safety & Quality Assurance, Tyson Foods

Donna Garren, Ph.D., Executive Vice President of Science & Policy at AFFI who co-chairs the program committee said “Last year’s attendees directed us to expand the program to support the education and learning of their entire food safety and quality assurance team. We responded by adding four new breakout sessions: Microbiological Track, Chemical Food Safety Testing Track, FSMA & Traceability Track and a Sanitation Track.” Garren added “I’m excited to announce our keynote speakers, Dr. Emilio Esteban and Ricky Dickson.”

Dr. Emilio Esteban, Chief Scientific Officer for Mérieux NutriSciences’ North America division, and Head of its Global Analytical Hub and former Undersecretary for Food Safety at USDA is the opening keynote speaker.

The closing keynote speaker is Ricky Dickson, Author and Former CEO of Blue Bell Creameries.

“The 2025 Consortium will build upon the success of previous events, which have featured high-level panel discussions, educational presentations, and pre-conference workshops.” said Rick Biros, Content Director and Founder of Food Safety Tech and co-chairperson of the program committee. Having the conference in the Washington DC area helps facilitate greater accessibility for FDA officials, other government representatives such as those from USDA and DHS, as well as industry associations.” Biros adds.

Women in Food Safety Networking Breakfast at the 2024 Food Safety Consortium

Table Top Booth at the 2024 Food Safety Consortium

“The committee’s collective expertise in food safety and leadership will be essential in shaping the conference program. The Consortium has always been a key platform for the convergence of policy, science, and best practices, and in 2025, we will ensure that policy discussions take center stage, especially given the proximity to Washington, D.C. AFFI’s work is always grounded in science, and our commitment to evidence-based solutions drives everything we do. This conference will continue to reflect that focus while fostering collaboration across all sectors of the food safety ecosystem.” said Garren.

The full program is available at FoodSafetyConsortium.org

May 5, 2025

Food Fraud Quick Bites

The Cascading Food Safety Risks from Tariffs on the Food Industry

By Benjamin Miller, Ph.D., MPH

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We’re now a month out from “Liberation Day,” the Trump administration’s launch to restructure global trade by increasing tariffs on imports into the US to levels not seen in over 100 years. While “reciprocal tariffs” for most countries are currently on “pause” until July 9^th, 10% across-the-board tariffs remain in place for many countries, with tariffs against Chinese products currently at or greater than 145%. These tariffs create interconnected challenges requiring systematic attention.

While it is inevitable that some buyers in tariffed countries will shift their purchases from U.S. suppliers to avoid the tariffs, it is just as expected that many U.S. food companies will shift their purchasing to domestic supply chains to save costs. And as those food companies move away from expensive imports, domestic growers and manufacturers may experience demand surges, creating a fundamental safety challenge where production pressures increase faster than the food safety infrastructure.

Increased Capacity Leads to Increase Risks

Processing facilities operating beyond designed capacity may compromise existing food safety management systems. Rapid workforce expansion typically outpaces adequate food safety training, increasing food safety handling risks, while quality assurance programs designed for standard production volumes become stretched if production volumes increase substantially. Companies expanding domestic production should conduct comprehensive risk assessments before increasing capacity, with particular attention to known or reasonably foreseeable hazards that may be compromised under accelerated production schedules.

Supply Chain, Traceability and Recording Keeping Concerns

The economics of high-value imported foods like avocados, mangoes, meat, and specialty cheeses will fundamentally change under the tariff structure. When legitimate import channels become prohibitively expensive, sophisticated black market operations emerge that specifically target food supply chains. These operations present unique food safety hazards, as products may be transported without temperature monitoring or verification; traceability documentation is often falsified, eliminating the ability to conduct recalls; and products may be “washed” through multiple intermediaries to obscure origin.

Food Fraud

Product substitution represents perhaps the most immediate economically motivated adulteration (EMA) risk in this environment. When high-value ingredients face substantial tariff increases, suppliers may substitute lower-value alternatives without disclosure. For example, we might see conventional produce falsely labeled as organic to command premium pricing that offsets tariff costs. Similarly, expensive oils like extra virgin olive oil might be diluted with cheaper oils while maintaining premium labeling and pricing. Food companies will need to enhance receiving processes specifically to identify potentially diverted products by implementing enhanced documentation verification, supplier approval processes, and potentially laboratory testing to verify product authenticity and safety.

Companies facing margin compression commonly target operational efficiency measures that inadvertently compromise food safety systems through extended production runs between sanitation cycles allowing biofilm formation and harborage point development, reduced preventive maintenance increasing equipment failure risks during production, and reformulation to extend shelf-life requiring additional validation.

Similarly, economic uncertainty may cause some international and domestic food companies to delay capital investments in food safety-related infrastructure, continuing to use equipment that may be past its useful lifespan or more difficult to clean and maintain, leading to increased microbiological or physical hazards during production.

While most food items from Mexico and Canada that meet the United States-Mexico-Canada Agreement rules of origin remain tariff-free, the Canadian supply chain realignment (due to long-term uncertainty around US policies) may represent a more than temporary adaptation—it may reflect a fundamental restructuring of North American food trade that will have persistent effects even if tariffs are eventually removed. New supplier relationships will need to be established and a holistic assessment of food safety programs should be conducted as part of new supply identification and onboarding processes. Canadian companies may approach these changes as permanent structural adjustments requiring comprehensive revisions to supplier verification programs rather than as temporary workarounds. In preparing for these challenges, companies should implement a structured approach that includes:

Conducting systematic vulnerability assessments of supply chains to identify specific points where tariff pressures create food safety risks.
Developing enhanced verification processes for the specific risks of rapidly onboarded new suppliers.
Revalidating critical control points under new operating conditions.
Implementing targeted testing programs for high-risk imported products potentially subject to black market diversion.

In these uncertain times, navigating the complex intersection of international trade policy and food safety requires specialized expertise that combines regulatory knowledge, technical assessment capabilities, and strategic planning.

Editors Note: this article was originally published March 12, 2025 and was updated May 5, 2025

January 16, 2025

Beltway Beat

AFFI and Food Safety Tech announces 2025 Food Safety Consortium program committee, dates and Call For Abstracts

By Food Safety Tech Staff

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Food Safety Tech and the American Frozen Food Institute (AFFI) are excited to announce that the 2025 Food Safety Consortium will be held at the Crystal Gateway Marriott in Arlington, Virginia, from October 19-21. The 2025 event will focus on the convergence of policy, science, and best practices. With the conference being held near Washington, D.C., this year will place a renewed emphasis on policy discussions, reflecting the growing need to address regulatory and legislative issues. The program will also prioritize the sharing of best practices, offering attendees the chance to learn from one another and engage in collaborative problem-solving on hot-button issues.

The 2025 conference will continue the Consortium’s mission to:

Facilitate the exchange of scientific information and best practices among food safety professionals.
Address current challenges and advancements in food safety, technology, and compliance.
Promote collaboration between industry, academia, and regulatory bodies to enhance public health outcomes.

Notably, past FDA keynote speakers have included Jim Jones, Mike Taylor, Steve Ostroff, Frank Yiannas, and Erik Mettler, supporting the FDA’s industry outreach objectives to the food and beverage industry. In 2024, James “Jim” Jones, Deputy Commissioner for Human Foods at the FDA, was the keynote speaker. His participation was particularly significant, as the Food Safety Consortium was one of the first conferences following the agency’s reorganization where Mr. Jones addressed the food industry. “In 2025, we plan to include FDA leadership in the program. Having the conference in the Washington DC area helps facilitate greater accessibility for FDA officials, other government representatives such as those from USDA and DHS, as well as industry associations.” Biros adds.

Guiding the 2025 program is a newly formed committee that includes:

Jason P. Bashura, MPH, RS, PepsiCo R&D, Global Food Safety & Quality Assurance, Sr. Manager, Global Food Defense, PepsiCo
Rick Biros, Content Director & Publisher, Food Safety Tech (Committee Co-Chairperson)
Erika Blickem, Director of Food Safety, J.R. Simplot Company, Inc.
Benjamin Chapman, Ph.D., Department Head, Professor, Food Safety Specialist, Department of Agricultural and Human Sciences, North Carolina State University, NC State Extension
Byron D. Chaves, PhD., Associate Professor & Food Safety Extension Specialist, Department of Food Science and Technology, University of Nebraska-Lincoln
Donna Garren, Ph.D., Executive Vice President, Science & Policy, American Frozen Food Institute (Committee Co-Chairperson)
Melody Ge, Sr. Director, Food Safety & Quality Operations, TreeHouse Foods, Inc.
Sanjay Gummalla, Ph.D., Senior Vice President, Scientific Affairs, American Frozen Food Institute
David Hatch, Vice President, Digital Solutions Marketing, Neogen
Jill Hoffman, Senior Director, Food Safety and Quality, B&G Foods, Inc.
Justyce Jedlicka, NA Commercial Applications – Food & Beverage Regulatory, Science & Lab Solutions, BioMonitoring, MilliporeSigma
Barbara C. Kowalcyk, Ph.D., Associate Professor and Director of Institute for Food Safety and Nutrition Security, Milken Institute School of Public Health, George Washington University
Jeff Lucas, Technical Director, Mèrieux NutriSciences
Michael L Rybolt, Ph.D., Sr. Vice President, Food Safety & Quality Assurance, Tyson Foods

Donna Garren, Executive Vice President of Science & Policy at AFFI, who co-chairs the program committee, commented, “The committee’s collective expertise in food safety and leadership will be essential in shaping the conference program. The Consortium has always been a key platform for the convergence of policy, science, and best practices, and in 2025, we will ensure that policy discussions take center stage, especially given the proximity to Washington, D.C. AFFI’s work is always grounded in science, and our commitment to evidence-based solutions drives everything we do. This conference will continue to reflect that focus while fostering collaboration across all sectors of the food safety ecosystem.

Food Safety Tech and AFFI are requesting presentation and panel discussion abstracts for consideration to be presented during the Food Safety Consortium Conference, Oct. 19-21, 2025, Crystal Gateway Marriott, Arlington VA.

Submit Your Abstract Abstract Submissions are due by March 17

July 12, 2024

Chinese fuel tankers being used to transport both fuel and food oil products, without any cleaning process between

By Food Safety Tech Staff

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On July 2, the Beijing News reported that the state-run oil and grain company, Sinograin was using the same tanker trucks to transport both fuel and food oil products, without any cleaning process between. According to the website, ChinaMediaProject.org, the tankers were transporting soybean oils and syrups together with coal-to-oil (CTL) products, which use coal as a raw material to produce oil and petrochemical products through chemical processing. The scandal has implicated other major Chinese companies including Hopefull Grain and Oil Group, a private conglomerate as reported in the Guardian.

In the Beijing News report, an undercover reporter interviewed a trucker who had driven a tanker of coal-derived fuel from Ningxia, a region in the west of China, to the east coast city of Qinhuangdao in Hebei, a journey of more than 800 miles (1,290km). The trucker told the journalist he was not allowed to return with an empty vehicle, and subsequently drove to a facility in another part of Hebei to load up with nearly 32 tons of soya bean oil, without cleaning the tanker. Several other tankers featured in the article made similar journeys without any washing or sanitizing of the tank in between.

The Beijing News is a state-run newspaper under Beijing municipal propaganda office that into the early 2010s was among the country’s more outspoken professional outlets. Stories like this have become a true rarity in the Xi Jinping era, as the leadership has emphasized “positive propaganda” and the need for media to abide by “correct public opinion guidance.”

There is no mandatory national standard at present for the transportation of edible oil in China. There is only a recommended Code for Bulk Transport of Edible Vegetable Oil, which mentions that special vehicles should be used for the transportation of edible vegetable oil in bulk. Because it is a recommended national standard, this means that it has limited binding force on manufacturers.

This week the office of the food safety commission under China’s State Council said it was investigating the claims and that “individuals found violating the law through improper use of tanker trucks will face severe punishment”.

It is not clear where the cooking oil in the fuel-contaminated tankers ultimately ended up. Follow-up reports tracking the truckers identified in the Beijing News article suggested that the tankers delivered oil to packaging facilities run by household brand names in China, intensifying concerns that people could be consuming toxic oil. The article also quoted an industry insider as saying that some of the oil may ultimately be packaged into small bottles for foreign sales.

Photo Credit: Rick Biros

June 27, 2024

Biros' Blog

Food Protection: Prepare for the Unexpected

By Rick Biros

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In a June 24 New York Times article, ‘It’s Happening Again’ the Supply Chain is Under Strain, the head of ocean freight for a logistics company said “I’m lovingly calling the (logistics) market now ‘Covid junior,’ because in a lot of ways we’re right back to where we were during the pandemic. It’s all happening again.”

The Covid supply chain disruptions hit the industry hard, forcing manufacturers to source new ingredient suppliers. Trying to quickly approve (or disapprove) new suppliers put a massive strain on food safety and quality assurance departments who were (are) tasked with doing more with less. Most of the industry really was not prepared for this magnitude of disruption. However, food and beverage industry will always face a myriad of threats to our FSQA organizations. How do we manage to reduce the risks of these threats from impacting our organizations? We evaluate, we assess, we PREPARE for the unexpected – through planning, workforce development and learning from the past. Pick your poison:supply chain disruptions, emerging and virulent pathogens, man-made and natural disasters, new regulations, bird flu, PFAS’, food fraud (think cinnamon tainted with lead and the cross-functional collaborations needed to protect the public’s health), just to name a few.

Food Safety Tech advisor and friend of mine, Jason Bashura, MPH, RS, Sr. Manager, Global Food Defense, PepsiCo has shared with me for years concepts related to the development of a Food Protection mindset. Food and beverage manufacturers companies are naturally concerned about protecting the public’s health and well-being, their brands and their own company’s financial bottom line. The phrase “Food Protection” requires a company-wide culture that incorporates the concepts of quality, food safety, food integrity ,food defense, EH&S, physical and cybersecurity concepts into the company’s approach to the envelope of “Food Protection.” Prior to FSMA, in 2007, the FDA released the Food Protection Plan which was founded on the themes of prevention, education & response all of which are key underpinnings of not only FSMA today, but as embedded within the New Era of Smarter Food Safety, for tomorrow. Today, the FDA funds Food Protection Task Forces across the U.S., and the use of the phrase Food Protection is more ‘prevalent’ than you think: how many uses of this term do you hear regularly? How many other Food Protection ‘elements’ there are? Please add your thoughts in the comments section below.

In recognition of the theme for this year’s World Food Safety day – Prepare for the unexpected – underlines the importance of being prepared for food safety incidents, no matter how mild or severe they can be. Food Protection is all about being prepared. Many firms recognize, celebrate and embrace World Food Safety Day as a month long celebration.

Jason can both talk the preparedness talk and walk the preparedness walk! Prior to his work at PepsiCo where his full-time job is predicated on protecting PepsiCo’s worldwide consumers, , he also has organized the Food Defense Consortium, an informal working group of FSQA, physical security, academia and other Food Defense professionals who share best practices, lessons learned and simply share information amongst the group. The Food Defense Consortium meets regularly via zoom and once a year in person at the Food Safety Consortium conference. Jason has a history of “being prepared” as a Volunteer with the Storm Engine Company #2 & the Storm Ambulance Corps in Derby CT, having served as a public health emergency response coordinator at the Naugatuck Valley Health District (CT), and an avid volunteer with the Valley Chapter of the America Red Cross (CT). He is currently serves as a community volunteer member – with environmental health experience – of the Board of Health for the Howard County Health Department (MD).

Frank Pisciotta, Chair, ASIS Food Defense Community and Jason Bashura, Facilitator, Food Defense Consortium presenting me with a Certificate of Appreciation for hosting the Food Defense Consortium at the Food Safety Consortium conference as well as publishing the Food Defense Resource Center on Food Safety Tech.

Another example of preparedness is Rick Rescorla who was the epitome of thinking WHAT IF on the day to day, about how to prepare, educate and respond to a variety of situations that might arise. As director for security at Morgan Stanley in New York City on September 11^th 2001, he is credited with saving greater than 2,700 lives thanks to his relentless pursuits for countless hours of education and raising awareness of how to deal with adverse conditions in an evacuation environment.

I guess one should practice what you preach. I listen to Jason and am working to be better prepared for the unexpected. A few years ago, I was “volunteered” to be the Captain of the Chappaquiddick Island CERT (Community Emergency Response Team). We coordinate with the fire department in advance of storms like Nor’easters and have a plan in place for the power being out and no ferry service to get off the island.

As we close out World Food Safety month, we need to not only learn from the past to prevent future issues – so that “it” doesn’t happen again – we need to embrace the opportunities that we face every day that help us to be better prepared, for tomorrow. As Colonel John “Hannibal” Smith from the original 1980’s “A-Team” tv show used to say “I love it when a plan comes together.”

Food Protection Resources:

For more information on how you can PREPARE your business for the unexpected, visit READY.gov
For more information on the Food Defense Consortium, visit the Food Defense Resource Center on this website or contact Jason.Bashura@PepsiCo.com
Rick Rescorla Citizen Honors Reward
Jason Bashura will be co-presenting at the Food Safety Consortium Conference with Jon Woody, Director, Food Defense, CAPT, USPHS, FDA and Debby Newslow, President, D.L. Newslow & Associates on the critical importance of developing and implementing a food defense plan to comply with the FSMA rule 21 CFR Part 121 (IA Rule)

April 1, 2024

Proposed Collaborative for FSMA 204 Compliance Seeks Industry Support

By Food Safety Tech Staff

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On Tuesday, January 20, 2026, the food industry will need to be compliant with FDA’s FSMA 204: Requirements for Additional Traceability Records for Certain Foods (aka, Food Traceability Final Rule). Compliance with the final rule will require adoption of new technologies and streamlined communication and record-keeping throughout the supply chain. To help ensure compliance and success in meeting the intent of the rule, Leavitt Partners and Acheson Group are working with FDA to create a public-private governing body for food traceability, based on the medical industry’s Partnership for DSCSA Governance (PDG).

Eric Marshall, Leavitt Partners — Eric Marshall

Founded in 2019, the PDG is a collaborative of pharmacy industry members working together to help the industry implement the Drug Supply Chain Security Act (DSCSA) and develop a sustainable, effective and efficient model for interoperable tracing and verification of prescription pharmaceuticals in the U.S.

“DSCSA and FSMA do have significant differences. For example, there are unique requirements for bar codes, serialization and electronic interoperability in the medical industry,” said Eric Marshall, Principal at Leavitt Partners and Executive Director of PDG. “But at the core, they have a lot of similarities and they both have the same goal from the government’s viewpoint: modernizing industry’s data and recordkeeping practices to create supply chain traceability that helps industry and government together react faster and more effectively to risks in our food and drug supply chains.”

Last month, Erik Mettler of FDA joined Marshall and Laura Brown of Leavitt Partners and Ben Miller and Eric Edmunds of the Acheson Group for an informational webinar on the proposed project.

Eric Edmunds, Acheson Group — Eric Edmunds

The goal of the public-private partnership is to:

Help industry decide how to meet the core issues of FSMA 204, so stakeholders are not wasting money on different technologies that others are not using or accepting
Bring together divergent industry groups working on disparate plans for getting to compliance and bring this work together into one cohesive vision
Ensure all sectors of the industry have a voice in the process
Provide a decision-making mechanism for those key components of compliance that require a shared view throughout the industry
Develop a coordinated plan and timeline to get from today to the compliance date
Develop core requirements to which commercial solution/software providers can build
Hold collaborative interactions with FDA
Create a shared IP (i.e. industry lookup directory) needed to achieve compliance

The vision for the collaborative is to create “an independent, sector-neutral forum for the industry to come together to jointly define a shared vision for enhancement of traceability,” said Edmunds.

Recognizing that the deadline for compliance is fast approaching, Leavitt Partners and Acheson Group are currently seeking industry members to act as part of a working group to finalize the operating structure of the organization, which they envision as encompassing a general membership tier with elected officers and board members, and multiple committees. Their goal is to organize the working group and define key organizational aspects of the collaborative by end of June; secure 35 members, form the legal entity and hold Board elections by end of July; and by the end of 2024 begin awareness and education campaigns, committee work and blueprint development, and establish the 2025 budget.

Learn more about Proposed Collaborative for FSMA 204 at the Food Safety Consortium Conference, October 20-22 in Washington DC. Join us in this panel discussion which will provide an update on the status of the governing body, why there is a need for an overarching blueprint to drive food traceability processes and standards, the value in identifying a shared industry infrastructure for food traceability – and how you can become involved. Both Eric Edmunds and Eric Marshall are the presenters.

March 11, 2024

Five Tips to Prepare for Your Next Audit

By Nicole Keresztes James

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For food manufacturers, passing a third-party food safety and quality audit supports both business growth and the ability to obtain new customers. Many retailers have made certification to a GFSI-benchmarked standard a minimum requirement of their suppliers. Working towards compliance with a third-party audit, let alone a GFSI-benchmarked certification, is a journey that requires significant preparation. Understanding the typical mistakes companies make on this journey, and taking action to avoid them can go a long way in properly preparing for and successfully passing the audit. Here are five essential tips to help businesses prepare for a food safety audit.

1. Start Early

Procrastination is on one of the most common causes of an audit failure. Starting the preparation process too late can cause significant challenges. The first step in preparing for an audit should be to set a timeline well in advance, identifying key checkpoints and milestones to ensure activities meet compliance.

If you have the option, choose an audit standard that fits with the facility and meets the end goal. Some questions to ask in your selection process include:

Is the certification to a GFSI-benchmarked standard required?
Is a completed third-party food safety and quality audit sufficient?
Is a customer-specific audit needed?

Once you’ve decided on the audit standard, select a third-party certification body or audit firm to deliver an audit to the standard’s requirements. Ensuring that the certification body or audit firm you choose is qualified to conduct the audit (e.g., accredited or approved by the standard) is crucial.

Next, secure a copy of the selected standard. With GFSI-aligned programs (including GFSI and non-GFSI benchmarked standards), standard expectations are available freely and directly from the certification program owners. In the case of proprietary third-party audit and customer standards, the chosen certification body or audit firm can assist with providing the necessary expectations.

2. Get Up to Speed

It is extremely important to thoroughly review and familiarize yourself with the standard or expectations manual, especially if the standard or manual is new to the facility. If the audit is a reassessment, ensure you have the most recent version of the standard or manual and thoroughly read it, as updates may have been made since the last audit.

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One mistake we sometimes see is failing to designate an internal core team for the audit. Doing so can help ensure the timeline is followed and critical tasks are assigned accordingly. If you are doing a reassessment, ensure that all internal organizational changes have been documented and that organization charts and rosters have been updated.

For reassessments, it’s also important to revisit any nonconformances from previous audits and the reports of any other assessments or internal audits completed. Doing so ahead of time can confirm that corrective actions have been fully implemented and preventive actions put in place, minimizing the recurrence of nonconformances.

3.Complete a Self-Assessment

Conduct an internal audit using the audit standard or expectations manual to identify compliance gaps. Address any deficiencies through corrective actions, focusing on areas such as sanitation and cleanliness, facility condition, pest management programs and maintenance protocols. Looking at each of these areas, identify and address opportunities for improvement. Issues in these areas are very often cited as nonconformances during audits.

Before the audit, meet with your third-party service providers to ensure programs are up to date and that there is awareness of any issues. Even when programs, such as pest control, are outsourced to third-party organizations, the facility remains responsible for overseeing such programs.

4. Prepare Documentation and Ensure Implementation

Documentation is critical for audit success. Ensure a comprehensive review of your food safety systems (e.g., HACCP and FSMA PC) to ensure that they are current and valid. Review the efficiency of your process implementation and verify that the documentation and processes are aligned.

Training is a must-have for audit compliance; therefore, confirm that internal training has occurred and been documented. This includes training not just for the team escorting the auditor during the audit but for all employees, as during the visit employees in functions key to the audit’s scope may be called on by the auditor to answer questions. Remember, well-trained employees are confident in conducting and describing their processes and how they connect to food safety and quality. They must also follow the procedures as stated in the documented programs and policies.

5. Collaborate and Ask for Help

Failures occur when assumptions are made. Many audits are unsuccessful because facility management and employees assume they understand and have implemented the necessary requirements.

When in doubt, ask for help. As stated above, preparing for any audit is a significant undertaking. Expert resources can help with that preparation and assist with avoiding gaps and the rework that occurs when expectations are not clearly understood. Check with the certification body or audit firm that has scheduled the audit—many will offer separate consulting and training services to help with audit preparation.

It is important to note that one facility is just one point in the overall supply chain and that stakeholders include both suppliers and customers of the facility. These suppliers and customers can play a role in the success of an audit. Ensure that communication with all involved parties is part of the preparation.

Keep the Momentum Going

Once you complete an audit, celebrate and congratulate the team. At the same time, remember that the work doesn’t end once the audit is complete. Even after completing the corrective actions, you should start preparing for the next audit by keeping documents and records updated. Adequate food safety and quality assurance are only possible when activities connected to these concepts are carried out every day. Keeping compliance top-of-mind daily has the additional significant benefit of always being audit-ready.

As the adage says, “Fail to plan, plan to fail.” This certainly rings true with audit readiness. However, it is key to remember that an audit is merely a data point on the spectrum of a robust food safety and quality system that is constantly evolving and improving. This comprehensive system does not come about just because there is an audit to plan for. It is a product of daily work to ensure that procedures and policies are being followed and a cross-functional team that is striving to make a facility’s food safety culture stronger and ever more capable of preventing food safety and quality incidents.

February 20, 2024

Preparing for the USDA Strengthening Organic Enforcement Rule’s Implementation

By Liz Figueredo

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Businesses in the organic food supply chain have just weeks to prepare for the upcoming implementation of the United States Department of Agriculture (USDA)’s Strengthening Organic Enforcement (SOE) Rule. This updating regulation, which goes into effect on March 19, 2024, aims to fortify the integrity of USDA organic products. From manufacturers to retailers, businesses across the supply chain must adjust their procedures and practices to comply with the updated rule.

The SOE Rule calls for the implementation of more rigorous certification practices for various types of businesses, including key links in the organic supply chain such as importers, exporters, brokers, traders and storage facilities. Because these organizations have not historically been required to be certified, it’s likely there will be an increase in last-minute organic certification applications. To accommodate the incorporation of these new entities, USDA-accredited certifying agents are now offering expanded services, including on-site inspections with enhanced authority to prevent fraud and non-compliance.

Changes Throughout the Supply Chain

Business activities that encompass any form of aggregating, culling, packaging, repackaging, storing or related processes of USDA organic products are now required to obtain certified organic status. In addition to a broader spectrum of handlers throughout the supply chain requiring certification, low-risk businesses in the exempt category must still adhere to stringent contamination prevention protocols and maintain meticulous records. This underscores the integral role of record-keeping and anti-fraud systems throughout the supply chain. To find out if your business should seek organic certification, try NSF’s interactive online decision tree tool.

Next Steps to Compliance

The USDA estimates that 1,000 domestic businesses will need to achieve organic certification prior to the Rule going into effect. Businesses must work with an independent, third-party certification body that is accredited by the USDA, such as Quality Assurance International (QAI), an NSF company, to secure certification. Once certified, labels—including non-retail and bulk labels—must be updated to demonstrate compliance.

The organic certification process involves completing an application, submitting documentation, an on-site inspection and technical review. To achieve certification, the applying business must resolve any noncompliances in a timely manner. After successfully completing the inspection and technical review process, the business will receive an official, numbered certificate and can then use the organic mark on its product labels. The certificate will also be added to the Organic Integrity Database and will be downloadable by the public. Each certificate includes a Scope and Product Summary Addendum.

The SOE Rule also calls for a mandatory electronic National Organic Program (NOP) Import Certificate for any organic product entering the US, regardless of the country of origin.

A crucial component of compliance with the Rule is creating or updating an Organic Systems Plan (OSP). An OSP acts as both an economic management tool and a contract between certifiers and certified operations and comprises a description of practices, list of substances, monitoring practices, recordkeeping systems, contamination prevention plans and specific information pertaining to an operation. This document safeguards organizations through supply chain traceability and organic fraud prevention procedures and is required for organic certification.

In addition to the requirements for businesses under the SOE Rule, USDA–accredited certifiers will provide enhanced oversight through possible unannounced inspections, inspector training, trace-back and mass balance audits, and new rules specifically for grower groups.

QAI and NSF offer a free SOE Rule toolkit to support organizations across the supply chain. The toolkit includes an interactive decision tree, FAQs, readiness checklist and links to educational webinars.

February 13, 2024

Consumers: A New Food Labeling Authority

By Jennifer Allen

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Pop quiz. Who regulates food? You’re probably going through an alphabet soup of agencies in your head right now, and you wouldn’t be wrong. FDA, USDA, FTC, state and local agencies, all play a role in regulating the food we eat. But how many of you thought of the consumer? In recent years, consumers have increasingly become a de facto regulatory agency by harnessing the power of the courts. Statements on your labels that may pass muster with FDA and other agencies are falling afoul of consumer expectations, and consumers are seeking, and sometimes obtaining, redress in the courts. Although there have been some more promising rulings lately suggesting that some courts at least are beginning to rein in these types of claims, food manufacturers should nevertheless be vigilant.

Take, for example, the case of Mantikas v. Kellogg Company. There, a group of consumers sued the manufacturer of Cheez-It crackers. The crackers were available in a version that contained the language “Whole Grain” in large font in the middle of the principal display panel, with smaller language stating “Made with 8G of whole grain per serving” in the corner. But the ingredients panel showed that enriched white flour was the primary ingredient. The Second Circuit Court of Appeals held that the consumers had stated a claim under their states’ consumer protection laws. Even though the product did in fact contain 8 grams of whole grains, and even though the consumer could look to the ingredient panel to learn that the primary ingredient was white flour, the court explained that the purpose of the back and side panels is to offer more detailed information than that on the front panel, not to correct a misconception caused by a misleading representation on the front panel. The “whole grain” representation was clearly intended to mislead the consumer into believing that the product was made predominantly or entirely with whole grains when that was not in fact true. The fact that the consumer could figure that out by reading the ingredients panel was not enough to satisfy the court.

Consumers are also on the attack against terms like “real,” “natural,” “good for you,” “pure,” and “wholesome,” terms that are not explicitly regulated by FDA. What each of these terms has in common is that they are vague and hard to prove or disprove. What does “real” even mean? Under one definition, all food is real unless it’s the plastic food in a child’s toy box. Cyanide is natural, and may even be pure, but we wouldn’t want to eat it. And almost everything we eat could be good for us in the sense that it helps stave off starvation. You see where I’m going with this. These terms are wildly open to interpretation, and the chances of you and your consumer interpreting them the same way are slim. Better to stick to narrower terms that you can substantiate. For example, you might say that your popsicles are flavored with the juice of real fruit, though, like Cheez-Its, beware of making that claim if the majority of the flavor is not from real fruit juice.

And consumer suits go way beyond the content of the product. Take, for example, the case of Broomfield v. Craft Brew Alliance, Inc. In that case, a group of consumers sued over labeling that deceived them into believing that Craft Brew’s beer was made in Hawaii. While the defendant did manufacture beer in Hawaii, the beer it sold on the mainland was made on the mainland. The court sided with the consumers. While pictures of surf boards and the phrase “Liquid Aloha” weren’t enough to make the case, Craft Brew went far beyond that, with a map of Hawaii depicting the location of its brewery, a Hawaiian address, and an invitation to visit the brewery when in Hawaii.

So what’s a manufacturer to do? When coming up with that enticing label, first, think like a consumer. What might that consumer believe or, at least, what might they be able to convince a court that they believed? Second, conduct a risk/benefit analysis. Is that “all natural” label expected to generate enough extra sales to justify the risk of a consumer lawsuit. Finally, ask your attorney to check on the existing legal landscape. Has another manufacturer run into legal problems using the very same language you want to use? If so, did the court suggest ways in which the manufacturer could have cured the problem? If in doubt, use specific, verifiable statements over vague pronouncements of “healthiness.” And above all, don’t play games with the consumer. If you’re trying to make your product look healthier than it is, there are plenty of plaintiffs’ lawyers ready and waiting to challenge you in court.

Increased Capacity Leads to Increase Risks

Supply Chain, Traceability and Recording Keeping Concerns

Food Fraud

Keep the Momentum Going

Changes Throughout the Supply Chain

Next Steps to Compliance

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