According to the Wall Street Journal, President-elect Donald Trump is planning to nominate environmental lawyer Robert F. Kennedy Jr. to serve as Health and Human Services secretary. Kennedy’s nomination was not a surprise. Last month, Kennedy said Trump had promised him control of the department and its many subagencies, which include the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Centers for Medicare and Medicaid (CMS), and others. Trump himself pledged during the campaign to let Kennedy “go wild on health.”
To put things into context, the mission of the U.S. Department of Health and Human Services (HHS) according to it’s website is to enhance the health and well-being of all Americans, by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. FDA is an agency within the Department of Health and Human Services and consists of nine Center-level organizations and thirteen Headquarter (HQ) Offices including the newly reorganized Human Foods Program headed up by Jim Jones.
Kennedy’s website, Make America Healthy Again states that Kennedy has spent nearly 40 years fighting corrupt corporations and government agencies. During his tenure at RiverKeeper, he successfully sued dozens of municipalities to force compliance with the Clean Water Act. He won cases against corporate giants, including a suit against General Electric for toxic runoff from its corporate jet hangar and a court order against ExxonMobil mandating they clean up tens of millions of gallons of spilled oil in Brooklyn, NY. As of Dec 2022, the Monsanto lawsuits to which Kennedy has devoted much of the past decade have yielded $11 Billion for farmers, migrant workers, day laborers, and families exposed to the pesticide RoundUp.
If approved, what can the food industry expect from Kennedy?
According to Make America Healthy Again, Kennedy sees Big Pharma and Big Agriculture having an undue influence on what Americans eat and how they manage their health over time.
Kennedy says the public health establishment is too focused on infectious diseases and wants to redirect resources toward issues he characterizes as the chronic disease epidemic, including obesity, diabetes, autism and mental illnesses. He blames them on corporations including food producers using harmful pesticides and additives. He traces America’s high levels of chronic disease to the widespread availability of highly processed, non-nutritious food, which he blames in part on a broken agriculture policy.
Some of his food and agriculture ideas plans share the same pseudoscience as Kennedy’s views on vaccines. Kennedy recently posted on social media that the FDA had “waged a war on public health” by “aggressive suppression” of Americans’ access to raw milk, despite raw milk’s risk of causing life-threatening diarrheal diseases and now, bird flu,
Kennedy has labeled Trump’s fast food diet as “poison” and wants to reduce the amount of ultra-processed food in the American food supply. In recent interviews, Kennedy has suggested clearing out “entire departments” at FDA, including the Center for Food Safety and Applied Nutrition.
However, if Kennedy wants to restrict the use of already-approved food additives, he needs moreresources — not fewer: The process involves rigorous reviews of data, issuing public warnings, and actively monitoring the food supply. If Kennedy succeeded in closing the food safety office, that would reduce the number of people who could be dedicated to the job.
The European culture regarding food additives is generally the additive needs to be proven safe before allowed into the supply chain. Conversely, FDA’s position for years has been the additive is allowed to be used unless it has been proven harmful. Two opposite ways of regulating. Kennedy’s position on additives might move the U.S. to be more like the E.U.
Other actions could be taken by the Trump administration to reduce the amount of ultra-processed food in the American food supply, but many of them would be taken outside of HHS. The US Department of Agriculture (USDA) sets the guidelines that govern school lunch programs, which means much of what children eat is determined by that agency; Trump has not yet nominated a USDA commissioner. The USDA is also primarily responsible for overseeing farming, another industry Kennedy has heavily criticized throughout his public career and pledged to target if he were to take a role in the federal government. He would likely need to work with the USDA to follow through.
One Agency?
Kennedy is correct that food safety regulation in the US is currently a mess, says David Acheson, President of TAG. Meat, poultry, and egg plants are inspected daily under the auspices of the USDA, while every other kind of food production facility — including the farms whose produce is responsible for most of the food-borne illness in the US and the nation’s countless other industrial food manufacturers — are inspected by FDA inspectors at most once a year.
It would make far more sense to unify these functions under one agency and harmonize the frequency of food production facility inspections so none are falling through the cracks. That is the kind of organizational shake-up that could actually make a difference.
The concept of one agency is not new according to Frank Yiannas, former Deputy Commissioner for Food Policy and Response at the U.S. Food and Drug Administration. Yiannas, in his closing keynote presentation at last month’s Food Safety Consortium Conference said the idea has been proposed by the Obama and the previous Trump administration, however, it requires Congress to approve the combination of the two agencies.
It remains to be seen what impact Kennedy’s proposals will have on the food industry but they bear little resemblance to those of prior Republican administrations, which have typically favored cutting regulations, not increasing them.
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.
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 11th 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
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)
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
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
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.
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.
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.
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.
Everyone knows a “checklist” when they see it: a systematized tool that lists things, components, steps or criteria whose presence or quantitative amount are essential to the performance of a specific task. The order of items in a checklist may or may not be critical in terms of the sequence of tasks which need to occur.
Checklists serve the wonderful purpose of identifying the important and critical steps needed to manufacture fresh food, fly a plane, perform a surgery or run a nuclear plant. They serve the purpose of helping to make sure that no important step is forgotten, and all critical steps are performed in the right order. Having a high “checklist intelligence” means that checklists are used proactively and dynamically, and that they drive continuous improvement in practices and procedures. And this occurs regardless of personal or organizational biases.
Let’s review some of the published literature on checklists.
A popular book on checklists is “The Checklist Manifesto” (Picador, 2009) by surgeon Atul Gawande. As noted in the book, checklists are very useful when there is a lot to get right, that is, when there is a high degree of complexity for certain actions. For example, commercial airplanes have “become too much airplane for one person to fly.” Hence, the industry uses a number of checklists, especially pre-flight, to address possible risks before the airplane takes to the air. Food manufacturing is similar, especially given its impact on public health.
A distinct disadvantage is that checklists can drive a tyranny of the urgent, i.e., simply checking a box to be done with it.
A distinct advantage of checklists is that they can be built by the “wisdom of a group” of experienced people, and therefore do not rely solely on a single individual’s memory or experience base. A distinct disadvantage is that checklists can drive a tyranny of the urgent, i.e., simply checking a box to be done with it.
Western Michigan University (2017) has an Evaluation Checklist Project with a number of excellent resources showing how to develop checklists for evaluating programs and projects. These include a “checklist for formatting checklists” and scholarly presentations on the logic behind checklists. Their suggestions can easily be re-applied to the food industry.
There are many published articles which address bias in decision making. For example, Ely et al. (2011)[1] studied the use of checklists to reduce diagnostic errors in hospitals, clinics and emergency rooms. Of note, the authors delve into cognitive processes to identify the inherent biases and reliance on intuition that often drive decision-making. They remind checklist developers to take into account “Type 1” thinking processes which are fast, reflexive and intuitive (and usually subconscious) and “Type 2” processes which are analytic, slow and deliberate (and usually take very focused attention).
Application of Checklists in the Food Industry
Checklists are widely used in the food industry. The USDA (2014) has a label submission checklist that helps companies avoid common labeling mistakes, and clarifies what is needed. The agency also has a guideline checklist for the cooking of meat and poultry products.
In the food manufacturing setting, companies often conduct their FSMA-related GMP audits by having employees walk around the plant using a checklist of equipment, documents and practices to look for. Companies making prepared foods have checklists that operators must follow to ensure that proper cooking and cooling procedures have been followed (these are also called SOPs, or Standard Operating Procedures, which are, in essence, checklists). Similarly, sanitation teams follow strict SOPs/checklists to ensure the right sanitizers are used in the right concentrations and for the right durations. Line changeovers often use checklists to prevent allergen cross-contamination. The same is true for pre-production equipment assembly. And product development/chef teams use checklists to ensure that the right ingredients are used, with proper consideration given to allergens, glutens, GMOs and organic product needs.
Finally, some of the most widely used checklists in the food industry are standards, including those developed by the Global Food Safety Initiative (GFSI), Safe Quality Foods (SQF) and the British Retail Consortium Global Standard (BRCGS).
Checklists as an Indicator of Food Safety Audit Maturity
Companies going through the GFSI certification process (e.g., SQF) often follow a three-phase audit maturation process that highlights how checklists can help or hinder food safty. In the first phase, the company is new to the process and therefore may not have systems in place to handle all of the requirements inherent to the standard. Thus, the company may “shotgun” their approach based on where they think they have gaps (by their own evaluation and/or with the help of third-party consultants). In this phase, the SQF Code may not be looked at in its totality nor in its intent, and certain requirements may be looked at as more important than others (with the insidious side effect of some requirements being missed).
In the second phase of the growth curve, the company recognizes that the food safety requirements are laid out in a very organized and helpful manner: the SQF Code. They realize that if they can match each requirement in the code with practices and procedures, then they can essentially use the code as a checklist. Many companies in this phase build their programs and their audit readiness exactly in the order of the code, and solely to meet the specific requirements detailed in each section of the Code. This ensures that when the SQF auditor comes in, the company will have addressed each and every requirement. This approach serves those companies well who are still in the learning phase of building a strong food safety plan and food safety culture, and generally helps most companies “pass” their food safety audit.
The right culture drives the right entries on the checklists. Not the other way around.
All is well until there is a food safety incident, trade withdrawal or public recall, which can happen in spite of a company checking every box on the SQF “checklist.” A major negative event, or even the recognition that such an event could happen, can therefore rightly push a company into the third phase of using the SQF Code.
In the third phase, a company uses and views checklists as valuable tools (and likely still structures its audit readiness in the same order as the SQF Code). However, the company has critically realized that it needs to go beyond checklists to drive the right food safety culture in the organization. Additional practices, procedures, documentation and systems are put in place to drive the right culture. These in turn make sure that the checklists get checked. Said another way, the right culture drives the right entries on the checklists. Not the other way around.
A Checklist for Checklists
Let’s consider creating a checklist for checklists. Each of the following provides perspective on the value, and the warnings, of using checklists to drive and improve an organization’s food safety culture and therefore its “checklist intelligence.”
Checklists Can Speak the Truth. If the results from a completed checklist are pointing out significant issues, then at the basic level the checklist is working. This is not a time to alter the checklist, which can happen in low-maturity organizations as a way to hide an issue, or an excuse to fill out the checklist incompletely. Rather, complete results should be heralded as validation that the checklist is performing as it should.
Learn From Failures. Something going wrong despite the use of a checklist is a good clue that the wrong things are being checked or that something is missing. This should be discussed broadly and cross-functionally and drive a root-cause analysis, which can markedly point out what got missed, which in turn allows for continual improvement of the checklist.
There Is No “One-Off.” All experienced auditors have heard “this is the first time that this has happened.” Or “there are many unusual things going on at the same time, and this caused the issue; it won’t happen again.” There is no one-off! A root cause analysis should be performed. Checklists must be able to help the organization identify and diagnose root causes.
Check the Checker. Is the person filling out the checklist being driven by the checklist to look for the right food safety behaviors, or is the person merely checking the boxes since that’s the job? Perhaps more insidious, employees might follow a checklist quite diligently—observing just those tasks which are on the list—yet miss faulty or risky behaviors. This may not be the fault of the checklist, but it is certainly the fault of the organization and its training. Relying solely on a checklist can still allow egregious and unwanted behaviors. If the employees are trained only to follow the checklist and make sure it gets filled out, significant untoward behaviors get missed. In this regard, checklists become shackles.
Check the Documents. Critical to some checklists are documents which are meant to substantiate that a particular task on the checklist was taken care of. The utility of these documents is only as good as the value of having them on the checklist to begin with. Time must be taken to identify which procedures or cooking logs, for example, need to be checked as part of a checklist. This is independent of having these documented as part of the organization’s food safety plan.
Honor the System. Checklists are just that: lists. They are not roadmaps, graphs or linkages to knowledge bases. They are static, rather than dynamic systems that drive action and resolution of issues. In general, checklists can be ill-equipped to capture systemic behaviors and the culture of an organization. This is especially true if the checklists are from a third-party and/or have not been adapted to specific organizations and facilities. Hence, checklists should be used for what they can bring—no more, no less.
The Law of Unintended Consequences. An oft-quoted phrase is “you get what you measure.” And this is certainly in play for checklists. If the item on the checklist is wrong, or is directing the wrong behavior, measuring it regularly could serve the unwanted purpose of instilling that behavior as “correct.”
Defeating the Checklist
By now you realize that checklists in the food industry can serve as a crutch or as a divining-rod for continuous improvement of food safety practices and procedures. Following are some indicators that a checklist is not working or is not as effective as it should be.
Too burdensome. A very common checklist used in food manufacturing is the “GMP audit checklist.” This is typically a long list of behaviors and practices which the organization believes it should be engaging in to meet the GMP regulations and produce safe food. Most organizations commit to conducting such audit checklists as part of their promises to the auditing organization. The list gets longer and gets spread across more functions, and all of this work becomes quite burdensome. When it is time for the GFSI audit, missing or incomplete checklists may get pencil-whipped, leading the auditor to believe that the company has been using the checklists regularly.
Pencil-Whipping. As much as putting false entries on a form is unethical, and usually illegal, it can still occur under the right stressors or employee attitudes. Simply checking the boxes on a checklist does no one any favors and can provide a false sense of security.
Complacency. Organizations that rely on the data from checklists could develop a false sense of security and become complacent about corrective actions. Although not necessarily unethical or illegal, someone checking a box as “complete” just because it always has been in the past is misleading (if not outright wrong) if the checker really did not check. Understanding this risk can help define the items in the checklist, including those things needed to ensure that the checklist checker is focused and paying attention.
Pressure to “get back to work” can be one of the quickest means to defeat a checklist.
Inaccurate documents. Practices and procedures change over time, and often the documents that go along with them do not get updated on the production floor. Continual vigilance is needed to ensure that the most up to date documents are aligned with current practices and the details on the checklist. In fact, one of the items on a checklist might be checking the issue dates of key documents being used by operators.
Stress. Pressure to “get back to work” can be one of the quickest means to defeat a checklist. This could be due to senior management’s communications, a team’s own leadership or individuals believing they need to hurry up so that they can resume their “real job.”
The End-Game: A Game of Checkers
To win at the game of checkers (or draughts), there are a number of strategies which experts often espouse, most of which apply to checklists in the food industry.
Control the center: Focus on the stuff that counts, not the stuff on the edges.
Play offense, not defense: Attack the issues that strive to undermine the food safety program.
The goal is to get to the end of the board: The checklist must be completed in its entirety.
Be willing to sacrifice: If an item on the checklist is not working, take it off.
Advance as a group: Don’t just leave checklists to one group (e.g., QA); build and use them based on input from experts from all functions.
Realizing the value of checklists requires the right culture, rules and execution as well as recognition that checklists are tools to maximize risk identification and risk management. Building your organization’s “checklist intelligence” will help in the development of the checklists, the effectiveness of those checking the checklists and in increasing the assurance of those checking the checkers.
The game never ends, which means that with the right strategy you can win all the time.
References:
[1] Ely, John, Graber, Mark, and Croskeey, Pat (2011): Checklists to Reduce Diagnostic Errors, Academic Medicine, 86:307.
Developing an internal audit program does not have to be a dauting task. With a small amount of work upfront a program can be developed and implemented in a matter of weeks. In this article we discuss the key elements of a successful program and provide guidance to ensure that audits add value to the daily operations across the facility.
Have a Plan in Mind
The first step in any successful audit program is to identify the overall structure and format. Audit programs can be set up in a variety of ways ranging from an annual full system audit to monthly departmental audits. The format and structure should be unique to each individual organization. Determine what works best for the organization and stick with it.
Developing a concise schedule will help to ensure expectations are clear. This schedule should be communicated with team members via appropriate channels. Identifying a point person to routinely follow up on the progress of the audits will ensure the program is being managed as expected. Considerations should be made for potential scheduling challenges. Build in additional time for those areas that are known to encounter delays.
Staying consistent with the maintenance and review of the program will ensure all audit activities are conducted within the expected timeframe. This can be accomplished by establishing a routine review of the program. Monthly review meetings can be established to review the audit schedule, results of audits and pending action items. During this time necessary adjustments can be made as needed and communication plans can be established. This helps to drive engagement across the organization around the entire audit program.
Accurate maintenance of audit records is a crucial step in maintaining a successful program. Ensure all records are properly filed and protected by establishing a designated filing system. Developing an organized file structure aids in keeping files in one place and reduces frustrations around locating documentation in the future. Be sure to include records for both internal and external audits as they are a required input to management review and may be needed for future assessments.
Build a Strong Audit Team
Having a good pool of auditors to pull from is critical. The number of auditors needed will vary based upon the size of the business and complexity of the processes. When considering the format of your team consider the backgrounds of the team members selected. There should be a good mix of experienced and new auditors to provide balance among the group. When assigning auditors to specific areas consider technical knowledge for those complex processes that may require a deeper understanding. Pairing auditors together is a great way for auditors to learn from each other as they work through the review of the data.
Auditing is often a required responsibility for QA/RA. Recruiting internal auditors from departments outside of QA/RA is beneficial, as they bring a different perspective and may ask questions that seem obvious to QA/RA professionals. All of the standards require auditors to be trained and/or competent in the auditing process. Training can be done externally or internally, and companies must show proof of training.
Selecting auditors from varying backgrounds is a great way to incorporate diversity within the team. Each auditor brings their unique experience to the group which builds a richer audit. Varying viewpoints helps to push the team to dig deeper to identify issues that may otherwise go unnoticed. Encourage the audit team to work together to build audit checklists that are specific to the area being audited. Conducting a review of the process and supporting documentation prior to the audit will enable the team to gain an understanding of the area under review. Encourage auditors to not become locked into the checklist but rather think of it as a guide. If audit trails within the scope of the audit arise during the audit be all means explore if time allows. This approach helps to empower the audit team by providing a sense of autonomy over their work.
When building the audit team, management should be mindful of the workload. For the program to be successful you want to ensure that audit team members are not overloaded. Often audits will be delayed due to competing responsibilities of auditors. To mitigate this issue, develop the audit schedule so there is a balance across the assigned audits. Ensuring that the auditor has plenty of time to conduct the audits within the specified timeframe. Overall, the audit team should feel supported and appreciated for their efforts and not be overwhelmed and burdened with the task. A poorly balanced workload only leads to a lack of interest and a disengagement among the audit team.
Provide Opportunities for Education
Providing an understanding of quality management systems and the standard being audited is imperative to the success of any audit program. There are two groups that require education. Education for the auditors and those that are participating in the audits. The auditors need an in-depth understanding of the standard and the requirements which they are auditing against. While the employees need awareness of how the management system is structured and their role in supporting it.
These educational goals can be accomplished both formally and informally across the organization. Auditors will need a more formalized structured training program that focuses on the details of the standard and auditing principles. While employee training can be incorporated into departmental meetings or shared through one-point lessons. Building education programs into existing activities is a great way of incorporating the audit program into the organizational culture. This helps to educate as well as share information with those in the organization who may otherwise not have awareness. This could be conducted via training sessions around processes and their linkage to the standard in which the organization is certified. Providing an understanding of the connections between the departments helps build collaboration between working groups. Employees gain exposure to what others in adjacent departments are doing and obtain a sense of understanding of challenges that may be faced by those groups. This in turn results in a collaborative team approach to the management of the overall system.
Involving employees from all parts of the business helps to drive the message that the system cannot operate in one department alone. Through education, employees will be able to understand their role in the system. This will lead to more engagement in the internal audit program. Employees will become excited to aid in audit activities and improvement initiatives because they will see positive results. They will gain understanding of the impact of their actions and how it impacts the overall system. This value-added approach will result in a favorable outcome for both the organization and the individual employees.
Promote Continuous Improvement
The support of top management is a very important element in the success of any audit program. Establishing a culture of continuous improvement will motivate the team and build engagement across the organization. This can be accomplished by frequently sharing status updates around the management system activities. A simple 15-minute update during sitewide meetings goes a long way. It demonstrates a commitment to the program and growth of the organization and its people.
Develop a format of communicating the details around the management system and any upcoming activities. This can be done by having a specific time each month when updates are provided. Putting this on the calendar will ensure that information is effectively communicated. Details should include both the negative and positive outcomes of internal and external audits. Include specifics around the audit findings and actions taken to address concerns. This will communicate to employees that the organization is serious about growing and is focused on improvement.
Sharing information helps to engage employees by bringing them into the improvement efforts rather than just being bystanders. These seemingly small actions can help drive excitement for the overall program and build a culture of quality. Lastly, be sure to celebrate the wins and ensure that team members are appreciated for their efforts. Building a successful internal audit program is a lot of work. Celebrating and acknowledging the efforts of the team is imperative.
Accomplish the Mission
There are many ways to build a successful internal audit program. Taking the time and effort to think through the process of identifying the format, structure and team members is critical. By reviewing these items upfront roadblocks can be identified early on. There will always be unforeseen challenges yet having a plan is key to developing a successful program. With a strong commitment from top management and a mindset of continuous improvement an organization can establish a robust internal audit program that exceeds expectations.
In the food processing and food service industry, glove wearing is meant to protect, not infect. That’s the theory, but not necessarily the reality.
Over 100 billion protective gloves—over 90% of the national supply—are imported into the U.S. each year from factories scattered throughout Asia. A good proportion of the gloves are destined for a substantial proportion of the 700,000 workers in meat and poultry processing and fresh produce sectors, as well as a proportion of the 14 million workers in the food service sector.
The FDA recently specifically classified gloves as Zone 1 Food Contact Surfaces, meaning in direct contact with ready to eat (RTE) ingredients or finished food products, and at the highest risk for product contamination.
The Food Safety Gap
However, there is a vital and contradictory gap in the oversight of quality assurance within FDA regulations. Here’s how the gap occurs. The FDA Compliance (21CFR177) for a glove to be called food-compliant involves a one-time single glove test conducted by overseas factories with an FDA-approved lab. The test is focused solely on chemical migration from the glove to food, and unless the manufacturer changes material ingredients, the test has no expiry date. “Food Compliant” gloves are not tested for bioburden, cleanliness or performance.
Complementary regulations also listed under FDA Title 21 Part 110 – Good Manufacturing Practice (GMP 21 CFR 110.10) require gloves to be “intact, clean, and sanitary” and “impermeable.” Upon arrival in the U.S. however, there is no requirement from the FDA for gloves to arrive “intact, clean, and sanitary” and “impermeable.” Gloves with FDA (21 CFR 177) compliance are imported “without the benefit of inspection.”
Why Does This Matter?
If you went down a food processing line and told every glove wearer that there was a 46% chance that the gloves they were wearing contained human fecal indicators, or potentially contained more than 250 unique and viable pathogens, what do you imagine the reaction would be? What would consumers think knowing the food on their dinner table might have been handled by potentially contaminated gloves?
The findings of a five-year study commissioned by Eagle Protect and undertaken by the B. Michaels Group revealed widespread risk of contamination in the disposable glove industry. The findings were presented at the 2019, 2021 and 2022 International Association for Food Protection (IAFP) annual meetings. Results found human fecal indicators on 46% of new and unused off-the-shelf gloves along with other foodborne pathogens and microbes including E. coli, Bacillus cereus, Bacillus anthracis, Listeria monocytogenes, Clostridiales difficile, Staphylococcus, Salmonella, Pseudomonas aeruginosa, Streptococcus pneumonia, and various fungi including Aspergillus.
Michaels, a leading microbiologist, ran the study, which involved independently testing 2,800 new and unused U.S. glove imports representing 26 different brands (approximately 25% of the ~100 SE Asian glove factories). Over 250 different viable microbial species were found on both the interior and exterior surfaces of the tested gloves.
Based on both observed conditions and events at SE Asian glove factories, as well as characteristics of microorganisms identified on or in disposable gloves, it was ascertained that microbes originate from contaminated water sources (rivers, drainage ditches and ponds). Once introduced into glove manufacturing facilities, contaminated rinse water circulates in and out of leaching or wash tanks, often not heated sufficiently, that are responsible for removing soluble chemical residues from glove surfaces.
In addition, gloves made of poor-quality materials can rip and tear, with particles finding their way into food products. Glove toxins can also contribute to a range of potential health issues including carcinogenicity, endocrine disruption, fertility impairment, metabolic disorders and skin diseases including dermatitis. For companies, there are issues with potential recalls, liability, worker compensation and consumer health.
How Can This Be?
In addition to dirty, polluted, contaminated water sources at factories, poor filtration, poor raw materials, unhygienic packing, poor hygiene practices by factory staff, lack of oversight and care by factory owners and, most important, lack of procurement standards on the part of U.S. corporate, business and institutional glove purchasers allow this to go on.
What Is the Solution?
There is little pressure on foreign glove manufacturers to self-regulate and improve their practices, unless businesses refuse to purchase from companies that cannot demonstrate acceptable standards. Therefore, the onus is on corporate and business purchasers of gloves. They need to be better educated about glove safety, including the risks of billions of potentially contaminated gloves on the hands of their workers in factories and plants, the potential risks to end consumers, and the value of adopting of clear standards for procurement that supersede the overwhelming criteria of “how cheap can we get them?”
Ask 1:Do manufacturers use Safe Ingredients? Are the raw materials tested to ensure consistency of manufacturing and to ensure the gloves are free of potentially toxic chemicals that might impact user and consumer health or contaminate food?
Ask 2:What is the Performance of the glove? Strength and durability tests and Acceptable Quality Level (AQL) further ensure consistent glove performance. AQL (maximum pinhole defects per 100 gloves) levels are required for medical and sterile gloves. There are no stated requirements by the FDA for Food Compliant Gloves. However, the standard should be at 2.5 (examination grade) or lower for food safety.
Ask 3:Are the gloves Clean? Bioburden on both the inside (skin contact) and outside (food and patient contact) can be tested to identify fungal and microbial contaminants that could pose a threat to the glove wearer, and the product handled.
Ask 4:Are the gloves Skin Tolerant? Poor quality gloves are often the cause of skin irritation. FDA Food Compliance does not ask for cleanliness, physical standards or toxicity tests. Gloves can be tested for a wide variety of chemicals and toxic exposure that could result in dermal or systemic toxicity, ensuring against skin irritation and occupational skin diseases of the wearer.
Ask 5:Is the factory making your gloves independently certified and does it use child or forced labor? Does your supplier or distributor have credentials such as being a registered B-Corp or accreditation by WRAP (Worldwide Responsible Accredited Production) organization, SEDEX (Supplier Ethical Data Exchange) or similar independent labor and quality verifications?
Ask 6: Is the product traceable? Does your glove box come with a QR code in which manufacturing activity is captured, secured and shared across the supply chain?
Consortium of Agreement to be Better Informed
The sight of blue gloves on a production line is universal. So too is the assumption that these gloves are safe by being “intact, clean, and sanitary.” Yet, we have learned that this is not always true. The only realistic action that can improve glove safety is for corporations to adopt standards, for glove wearers to demand quality gloves and for consumers to start asking “What’s in your gloves?”
Although regulators can set the tone that encourages industry to do the right thing, ensuring glove safety really does come down to suppliers and buyers uniting in a full-throated demand that there be a reduction in the risk of glove contamination in the U.S.
There needs to be a consortium of agreement from purchasers of protective gloves to shift from the lowest common cost denominator (cost) to a higher standard. The top 15 food producing companies in the U.S. have a combined market capitalization of $1.4 trillion so there is room to take some extra safety steps to implement a Supplier Code of Conduct using a system to conduct assessments and lab tests and to monitor outcomes.
Better and more informed decisions can be made by procurement departments. Food processing and food service companies all have safety and sustainability criteria; glove safety should be among the standards to adhere to.
We should be able to feel more at ease knowing that the gloves our food processing and service personnel put on are of the highest standards. This should be a paramount concern, not just to experts, but also the public who remain mostly unaware of the risks and dangers in glove manufacturing. Therefore, it is incumbent on all the industries involved in the making, selling and purchasing of gloves to adopt and advocate for a robust system for the manufacturing, tracking and quality assurance of gloves.
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