With increasing numbers of Americans paying closer attention to the contents of the food they eat, food manufacturers are understandably eager to publicize the health benefits of their products. The FDA allows food manufacturers to make health claims on food labels, but, perhaps not surprisingly, it is strict about how manufacturers make those claims, and all health claims require pre-approval.
First, what qualifies as a health claim? A health claim is any claim on a label or labeling that expressly or impliedly characterizes a relationship between a substance and a disease or health-related condition. The claim may state that increased consumption of a particular substance reduces certain disease risks, or it may state that decreased consumption reduces that risk. The former claim would be associated with a product high in a particular substance, the latter with a product low in a particular substance. A health claim may not state that the substance diagnoses, cures, mitigates, or treats disease. Only pre-approved drugs and medications may carry those claims.
The statement “Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis,” is an example of the former type of health claim. It connects consumption of a higher amount of a particular substance (calcium) with the reduced risk of a particular disease (osteoporosis). In contrast, the statement “Diets low in saturated fat may reduce the risk of heart disease” is an example of the latter type of health claim. Note that health claims are different from structure/function claims, which don’t reference a specific disease. The statement “Calcium builds strong bones” is a structure/function claim, a type of claim that does not require FDA pre-approval.
You can find the list of currently approved health claims in the regulations at 21 CFR 101, commonly referred to as Subpart E. As an example, if your product contains calcium and vitamin D, you would look to 21 CFR 101.72 for guidance on how to make a claim on your label that consuming more of these substances reduces the risk of osteoporosis. You would look to §101.75 for guidance on making a claim about reduced saturated fat and heart disease.
Disqualifying Substance Levels
But before you make any health claim, you must first ensure that your product doesn’t contain disqualifying levels of certain substances, namely fat, saturated fat, cholesterol, and sodium. You can find those levels in 21 CFR 101.14. The reason for that requirement is, health claims lead the consumer to believe that the product they are consuming is “healthy.” If, for example, your readymade meal product contains 2,500 mg of sodium, the FDA frowns on you marketing it as healthy, even if you’ve manufactured the meal with increased levels of vitamin D.
Key Criteria To Support “Healthy” Labeling
If your product passes the initial test above and meets the following criteria, you can make a health claim:
All your statements are consistent with the detailed and specific requirements in Subpart E;
Your claim is limited to describing the value of either decreased or increased consumption of the substance as part of a total dietary pattern;
Your claim is complete, truthful, and not misleading;
All the information is in one place, without intervening material. Note that in place of making a direct claim on the label, you may instead refer the consumer to another location, such as a website, for information about the claim. If you include a graphic image to portray the claim, it must be immediately adjacent to the verbal claim or reference statement;
The claim enables the consumer to comprehend the information and understand its relative significance in the context of a total daily diet; and
The particular substance is either low enough or high enough to justify the claim.
These six requirements can be summed up in the following statement: Don’t offer false promises to the consumer. Reduction of disease risk is a lifelong process. No single food or group of foods can work miracles. Consuming a low fat dessert product will probably not protect the consumer from heart disease if she routinely consumes it after enjoying a fast-food meal. Your health claim shouldn’t suggest in any way that it will. After all, you’re selling a food product, not a magic bullet.
Chicken producers and processors must always pay close attention to listeria and E. coli. Their regulated to-market protocols incorporate intense testing and cleaning standards that help ensure the people who buy chicken sandwiches at fast casual restaurants, chicken fingers at sporting arenas and trays of fresh chicken legs at supermarkets don’t get sick.
The companies stay on top of listeria and E. coli because the USDA Food Safety and Inspection Service (FSIS) has considered them “adulterants,” or substances that should not be found in meat products, for decades. The federal agency banned listeria in 1987, and in 1994 listed E. coli as an adulterant in the wake of an E. coli outbreak at Jack in the Box restaurants that sickened 700 people in four states, and led to 171 hospitalizations and four deaths.
All along, however, another prominent bacteria, Salmonella, remained unregulated, despite its proclivity for making people ill—more than a 1.3 million cases of salmonellosis appear in the U.S. every year, leading to about 26,500 hospitalizations and roughly 400 deaths. It is the No. 1 cause for foodborne illness in the U.S., and most cases stem from chicken products.
But earlier this year the USDA announced that it now plans to consider Salmonella an adulterant in some chicken products. The matter is out for public comment now; if the USDA doesn’t change its clear intention to regulate Salmonella, federal food inspectors soon will be testing for it in select chicken products.
The chicken industry opposes the measure. In a news release issued shortly after the FSIS’ August announcement, the National Chicken Council (NCC) pointed toward the 1957 Poultry Products Inspection Act, which did not include Salmonella as an adulterant, as a set of standards worth upholding today.
Well, a lot has changed in industrial agriculture during the past 65 years, and that includes a dramatic expansion of chicken farming and consumption across the country. In the 1950s, the average American ate about 16 pounds of chicken a year, compared to 56 pounds of beef and 50 pounds of pork. But by this year, Americans were eating close to 112 pounds of chicken a year, along with 56 pounds of beef and 50 pounds of pork. In terms of meat consumption, chicken now rules the roost. Regulating it might not have been necessary back when Dwight D. Eisenhower was president. But today I believe it most definitely is.
As a professional in the food safety industry, I champion the FSIS’ decision. It’s about time the agency added Salmonella to its list of adulterants; the bacteria causes far too much illness and death in the U.S. every year. Many of those cases could have been prevented through regulatory oversight.
Addressing Poultry Industry Concerns
It is true, as opponents of the proposed regulation argue, that Salmonella doesn’t always emerge in the processing plant; humans can inadvertently introduce the bacteria in their own kitchens. Why, the industry asks, should it be penalized for conditions outside of its control? In addition, proper cooking methods will kill Salmonella. If people don’t follow cooking directions on the packages of chicken they buy, and get sick from Salmonella as a result, the chicken industry believes it should not be held accountable.
On the first issue, it is unlikely that cases revolving around individual consumers introducing Salmonella to their chicken products would ever lead to penalties. Federal regulators scrutinize public health data for clusters of outbreaks, which often point toward entire product lines being infected with bacteria; isolated one-off cases, many of which indeed could be the result of human error, do not concern them.
For the second point, yes, people should read labels and closely follow cooking directions. But in my opinion, that is irrelevant; dangerous levels of Salmonella simply should not dwell in foods, and it’s the job of regulators to make sure food is safe.
Toy manufacturers, for example, must eliminate choking hazards from products designed for kids under 3 years, thanks to federal regulations. It shouldn’t be up to parents to constantly monitor their toddlers while they play with toys, to ensure they don’t gag on something potentially dangerous found on the stuffed giraffe.
Should the rule become policy, the FSIS will focus on just one category: stuffed, breaded and raw chicken products. These products, including dishes like chicken Kiev and chicken cordon bleu, often are heat-treated to set the batter or breading, but are not fully cooked. They have been associated with 14 outbreaks and about 200 illnesses since 1998.
This represents a solid start. Next, I’d like to see the FSIS pursue regulating Salmonella in other chicken products. Even if the agency doesn’t, however, many processors will have to implement new practices and testing procedures for all of their products anyway, as in many cases it won’t make sense to just incorporate new protocols within a few discrete product lines. Among other things, I would anticipate boosted commitments among producers and processors to cleaning and sanitation processes, environmental monitoring (probably the most important pursuit) and overall facility food safety measures.
Will this action by the FSIS completely eliminate Salmonella from the targeted products? Absolutely not. The rule sets a maximum threshold for Salmonella in the food the agency tests; in many cases, chicken products that contain negligible amounts of the bacteria will still make it to market. It’s just products containing dangerous amounts of Salmonella that will be subject to penalties.
Food safety serves as one of the foundations of a healthy society. It also reinforces and bolsters public trust in the products consumers buy, which nurtures and strengthens the entire food industry. With this proposed Salmonella rule by the USDA, the U.S. takes another important step toward ensuring the health of its citizens, and further enhancing consumer trust in the chicken products they buy.
Mycotoxins are toxic compounds produced by several types of fungi. These mycotoxin-producing fungi grow on a variety of crops and foodstuffs, such as cereals, nuts, and coffee beans, contaminating up to 25% of the world’s crops every year.
In humans, ingesting even small amounts of some mycotoxins can lead to acute poisoning—research has also linked mycotoxin ingestion to long-term effects such as cancer and immune deficiency. In livestock, the situation is similar with mycotoxin exposure responsible for a greater incidence of disease, poor reproductive performance, and suboptimal milk production. With the health consequences so severe, it’s easy to see why mycotoxin contamination can harm the brand reputation of food producers and suppliers.
Mycotoxin contamination also poses a significant economic risk. The U.S. FDA estimates that mycotoxin contamination is responsible for an estimated annual crop loss of $932 million while, the Food and Agriculture Association estimates toxigenic fungi drive annual food and food product losses of ~1 billion metric tons, which includes losses due to reduced livestock productivity.
To minimize the risks posed by mycotoxins, robust mycotoxin testing is essential. Through rigorous testing, food suppliers can identify and remove unsafe products in the supply chain and indicate where preventive measures may need strengthening. Global regulations permit very low maximum levels of mycotoxins in foods, and international trade regulations make testing food and animal feed for mycotoxins a critical step before export.
Mycotoxins: A Significant and Growing Analytical Challenge
Mycotoxin testing is complex. Laboratories tasked with the endeavor face several hurdles, including:
Varied and complex matrices. Analyzing food samples for low levels of contaminants is inherently difficult, as complex matrices contain a myriad of other compounds that can interfere with analyte detection.
Greater testing burden than other contaminants. For example, with pesticides, testing after crop harvest is sufficient to ensure food safety, as foodstuffs are unlikely to acquire pesticide contaminants beyond this point. However, foods can acquire mycotoxin contaminants at several points after crop harvest—for instance, during transportation and storage. Testing at multiple points in the supply chain is therefore needed, which demands testing be easy to deploy, efficient, and cost-effective.
New, emerging threats. Mycotoxin contamination concerns go beyond the ‘big six’ classes most commonly encountered (aflatoxins, ochratoxin A, patulin, fumonisins, zearalenone, and nivalenol/deoxynivalenol). Emerging mycotoxins—lesser-known, novel mycotoxins neither routinely determined nor regulated—pose a threat to human and animal health, too. But new and emerging mycotoxins are not often reported or monitored due to limitations of current ELISA-based testing technology.
A warming climate. As average global temperatures rise, more regions will offer the warm, humid environments in which mycotoxin-producing fungi thrive. Some testing labs are already detecting classes of mycotoxins previously limited to other geographies. Moreover, rising temperatures may create ideal conditions for new mycotoxin-producing fungal strains and different combinations of mycotoxins. Thus, labs will increasingly need the flexibility to accommodate an expanding menu of known and unknown mycotoxin contaminants and mycotoxin combinations.
Broader, tighter regulations. Regulatory bodies are continually reducing the maximum permissible mycotoxin levels in food. For instance, in August 2022, the European Commission lowered the maximum levels of ochratoxin A in certain foodstuffs. Regulatory bodies will likely also expand analyte panels to accommodate new, emerging threats. Unless a laboratory’s testing equipment has sufficient sensitivity and flexibility to meet these continually changing requirements, labs may face unnecessary additional expenditure on new technologies each time regulations change.
Accordingly, to meet the needs of today while best positioning themselves for tomorrow, mycotoxin testing labs need testing methods that are highly sensitive, with the flexibility to quantify multiple known and unknown analytes in complex matrices. To meet ever-growing demand for efficiency, these methods should also be easy to use, and maximize lab productivity.
The Promise of Advanced LC-MS Solutions
Thankfully, advanced, high-throughput liquid chromatography mass spectrometry (LC-MS) and liquid chromatography tandem mass spectrometry (LC-MS/MS) solutions can alleviate these challenges.
For example, Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERs) sample preparation kits can accelerate and simplify sample preparation across a variety of matrices prior to LC-MS analysis, helping facilitate high-throughput multi-residue analysis. To improve analysis of low abundance analytes in complex matrices, automated solutions are available that perform analyte pre-concentration and sample clean-up online, offering analytical confidence and greater speed compared to offline methods. Similarly, robust, high-performance liquid chromatography (HPLC) and ultra-HPLC (UHPLC) solutions can better resolve analytes in complex matrices, maximizing instrument utilization, and unlocking superior laboratory throughput.
When it comes to mass spectrometry (MS) systems, more productive, confident targeted compound quantitation is possible with advanced triple quadrupole MS (QQQ) instruments. QQQ systems offer analysts high sensitivity, selectivity, and specificity, making them ideal for the detection of multiple low-level compounds in the most challenging matrices. In addition, the fast data acquisition speeds and rapid polarity switching of these systems mean labs can greatly improve their workflow productivity. The latest QQQ systems are also easy to use, require minimal training, and facilitate streamlined method creation and optimization, enabling labs to better keep pace with changing regulations and emerging threats.
The advent of orbitrap mass spectrometry has transformed analytical testing workflows across a range of applications, including mycotoxin testing. Orbitrap mass spectrometers offer ultra-high resolution (figure 1) and accurate mass measurements, together with high dynamic range. These instruments can, therefore, better resolve the lowest-level analytes from background interferences in crowded matrices, as well as elucidate the fine isotopic structures needed for more confident analyte identification. Orbitrap instruments have significant productivity benefits too, being able to perform both quantitative and qualitative analyses of multiple analytes in a single platform, and often in a single run—all while maintaining high sensitivity.
Figure 1: Across a broad m/z range, orbitrap mass spectrometers offer superior resolution relative to other mass spectrometry systems, such as quadrupole time-of-flight (Q-TOF) instruments.
Perhaps most important, though, is the value of orbitrap systems for unknown analysis. Orbitrap systems can generate full-scan high-resolution accurate mass data during untargeted analysis, enabling analysts to capture information from all ions in the run. When this data is compared against extensive high-resolution spectral fragmentation libraries (such as the mzCloud™), labs can more easily and confidently identify novel compounds such as emerging mycotoxins. Even when no direct spectral match is available, analysts can now tap into advanced data analysis algorithms that provide the best candidate structures for unknown compounds.
Toward Multi-residue, Multi-panel Workflows
Recent studies have demonstrated the success of several advanced LC-MS and LC-MS/MS solutions and workflows for fast, economical, and highly sensitive multi-residue mycotoxin analysis. For example, one recent study looked at quantifying 48 myco- and phytotoxins (either currently regulated or under discussion for regulation in the EU) in cereal in a single analytical run. In the experiment, researchers used a UHPLC system coupled to a QQQ instrument, and cereals were extracted with acetonitrile/water, followed by evaporation and sample reconstitution.
The results demonstrated that sample preparation is simple, fast, and economical for this method. And, for all legislated mycotoxins, the limits of quantitation were lower than the maximum residue limits (MRL) established by regulations. Researchers also noted good precision and reproducibility across five replicates at the limit of detection. The authors therefore concluded that this method is suitable for the quantitation of all 11 legislated mycotoxins and 37 more that are either already legislated in feed or are prospects for further legislation.
Another study demonstrated the value of an orbitrap-based workflow for efficiently detecting a range of unknown food contaminants, including mycotoxins. In the study, researchers analyzed vegetables, fruits, nuts, and cereals, preparing samples using the Swedish ethyl acetate method (SweEt). In terms of equipment, the team used an UHPLC system connected to an orbitrap mass spectrometer, and analyzed data using a qualitative software tool. To help identify unknown compounds, the software used isotopic pattern recognition, fragments, and isotope distribution data to search spectral libraries for matches.
The results showed SweEt to be an effective generic sample preparation approach to analyze different compound classes, and the workflow enabled the team to successfully identify many unwanted contaminants, including pesticides, mycotoxins, and food additives. As a result, the researchers concluded that the method was a suitable and efficient way to find unexpected and unwanted multi-group analytes in complex food matrices. Researchers have increasingly sought such multi-group analysis methods in recent years, owing to the significant efficiency gains they can offer to analytical labs.
Meeting the Needs of Modern Mycotoxin Testing
Mycotoxin contamination in food has significant consequences for human and animal health, as well as the reputation of food producers and suppliers. But mycotoxin testing is inherently complex, and several factors make testing increasingly difficult—from emerging mycotoxin threats to tightening regulations and growing pressure for greater efficiency.
Advanced LC-MS and LC-MS/MS solutions have the potential to address these challenges and transform mycotoxin testing workflows, delivering unprecedented sensitivity, confidence, and productivity. By adopting these high throughput, high-resolution solutions, testing labs can better meet the needs of today, while optimally positioning themselves for the future. Ultimately, these advanced approaches will help ensure the safety of the global food supply, for a healthier, safer world.
The CDC is currently investigating two Listeria monocytogenes outbreaks. An outbreak linked to deli meats and cheeses has led to 16 illnesses, 13 hospitalizations and one death. A multistate outbreak related to Brie and Camembert soft cheese products announced in September had led to six illnesses and five hospitalizations to date and a widespread product recall.
The CDC notes that it is difficult for investigators to identify a single food as the source of outbreaks linked to deli meats and cheeses, because Listeria spreads easily between food and the deli environment and can persist for a long time in deli display cases and on equipment.
We spoke with Chip Manuel, Ph.D., Food Safety Science Advisor at GOJO about steps retail food establishments should be taking now to reduce the risk of Listeria contamination in their facilities.
With the multi-state Listeria outbreak happening in delis, what should retail delis and deli departments be doing to reduce the potential spread of Listeria until a specific food is identified?
Manuel: Since Listeria is a hardy bacteria that thrives in many food products and conditions, it’s vital that food retailers and operators not only understand the conditions in which Listeria can persist but also ensure that conditions are kept which help to minimize its growth. These best practices include ensuring that proper hot/cold temperatures for holding food are maintained; cleaning and sanitizing refrigerators, display cases and frequently used kitchen equipment (especially deli slicers!); and maintaining the sanitary conditions of your establishment.
Listeria can be found in various nooks and crannies throughout a facility, including those hard-to-reach equipment parts, such as blades, cart wheels, and even grease catches and drains. Lack of frequent sanitation of these locations can increase the risk of Listeria cross-contaminating food contact surfaces in these settings. Therefore, it is vital to:
Evaluate the conditions of your facility, equipment and tools. Are there issues with standing water or cracked tiles? These are notorious for harboring Listeria biofilms and need to be replaced and repaired. Similarly, are your cleaning tools in good condition without cracks? If not, consider replacing these. Research has shown that cleaning tools in poor condition, especially squeegees, can become a source of contamination.
Ensure your sanitation program is up to speed. First, ensure you are choosing products that are effective against Listeria. Make sure you give your employees the time needed to clean and sanitize equipment effectively, especially larger pieces of equipment such as deli slicers. Make sure they have the tools and knowledge required to clean and sanitize these pieces of equipment, including specifically in nooks and crannies where Listeria can hide.
Ensure that deli slicers are maintained properly. Repair and/or replace any components of slicers that are in disrepair, as these can become harborage sites for Listeria. Ensure deli slicers are completely broken down for cleaning and sanitization as required by the local regulatory authority (usually every four hours for deli slicers operating at room temperature).
Minimize the use of high-pressure hoses within a deli environment. Research has shown these tools can spread Listeria throughout a facility (for example, if sprayed directly into a contaminated drain).
Check that display, storage and refrigerator or cooler cases are set to an internal temperature of 41˚F or lower while ensuring adequate airflow.
Ensure raw and ready-to-eat products are stored in separate areas. RTE products can become contaminated if stored under raw products (due to dripping, etc.)
Looking at the soft cheese outbreak, what can retail food environments do to reduce the risk of distributing contaminated product to consumers and identify and respond to potential Listeria contamination in these higher-risk cheese products?
Having a supplier verification program and managing incoming ingredients with approved suppliers and approved sources is critical—particularly for soft cheeses which are at higher risk for contamination. Purchase solely from approved sources with food safety programs in place. Ensure that food safety is always part of your supplier specifications and requirements, and work with your suppliers to understand their pathogen prevention and environmental programs. If possible, visit their facilities to get a sense for how well their food safety program is operating.
Food safety and quality assurance leaders are competing for a finite number of dollars within their respective organizations. Securing support or funding for new equipment, training or personnel can be challenging. Understanding the competing pressures and needs of corporate leaders can help FSQA professionals get their message across and ensure a commitment to food safety.
At the 2022 Food Safety Consortium in October, Deb Coviello, CEO, founder and business advisor at The Drop In CEO, moderated a panel discussion “Communicating to the C-Suite.” Panelists Peter Begg, senior vice president of quality and food safety at Hearthside Food Solutions, Melanie Neumann, JD, executive vice president and general counsel of Matrix Sciences International, and Ann Marie McNamara, vice president of food safety and quality for supply chain, manufacturing and commercialization at U.S. Foods, shared their tips and best practices for getting your message across in the board room.
When approaching the C-suite with updates and asks for financial support, you want to be both confident and concise. “If you can’t explain in five to seven slides what you need and why, you will lose them,” said Begg. “And it is very likely that you yourself do not understand the issue or are unclear of the implications and what the C-suite needs to know.”
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McNamara tries to keep it to one slide and encourages FSQA professionals to: know your audience, stick to the facts, and communicate like an executive by using their terms and focusing on goals and metrics.
“You have to take off your FSQA hat and put on your business hat,” she said. “You can’t just be a technical expert, you need to be a translator and communicate the technical into business terms.”
Equate Risk to Dollar Amounts
If your consumers are at risk due to poor training, difficult-to-clean equipment or other concerns, you need to quickly equate the risk to a dollar amount when communicating with the C-suite. “You can use baseline data to quantify your risks,” said Neumann. For example, if you have a problematic piece equipment, look at the frequency and likelihood of inspection and the potential findings, and share this information as part of your presentation.
She follows a “go back to kindergarten” strategy to help develop a compelling presentation: learn and share the basic math, follow your ABCs by using clear, concise language and “do some show and tell,” said Neumann. In one instance, she brought a joint with multiple weld points from the floor to the board room to illustrate why this particular piece of equipment was so difficult to sanitize and had become a site of contamination. The leadership agreed to replace it.
“You need to be specific, and pick your battles,” said Neumann. “For example, if you need more ‘help,’ what does that look like—do you need more people, more training, a new system?”
Building Your Confidence
Standing in front of a group of executives to fight for your department can be intimidating. If public speaking is not your forte, practice speaking in front of a group. “Share your presentation with your team and ask what questions they would have to get feedback and input,” said McNamara.
Doing regular check-ins with the CFO regarding future resource needs, rather than waiting for a quarterly or annual presentation opportunity, can help you get a headstart on coming asks. In fact, developing relationships with all C-suite leaders is key to keeping food safety needs top of mind. “Introduce yourself to new leaders and understand how they want to be communicated with (i.e., text, email, phone),” said Begg. “Do regular check-ins with leadership and recommend quarterly presentations to keep them up to date.”
While all three panelists encouraged FSQA professionals to avoid getting emotional and focus on the facts as well as dollars and cents, you do want to remind executives of the impact of failure to act on food safety concerns. “Explain the financial risks and speak in terms of the impact to them, ‘What we want everyone in the company to understand is your loved ones are eating this food,’” said Begg.
The FDA will officially implement a new food traceability rule on November 7, 2022. While the new rule requires a detailed account of food’s origin and movements throughout production, processing and shipping, the food industry still lacks international standardized guidelines that factor in countries’ varying health and agricultural priorities. As this continues to be one of the global food system’s biggest challenges, we spoke with Sara Bratager, Food Traceability & Food Safety Scientist at the Institute of Food Technologists, to discuss where the food industry stands currently, and opportunities to establish a global standard that is mutually beneficial (and achievable) for all.
The FDA is scheduled to finalize new FSMA traceability rule on November 7. What are some of the key changes that food manufacturers and suppliers will need to address with the new rule?
Bratager: The finalized rule will be published in November. Based on the proposed rule, it will go into effect in January 2023 (60 days after publication) and companies will have two years after that to make any adjustments needed to achieve compliance. Entities that produce, process, ship or receive any of the products on the Food Traceability List will need to capture and store the established Key Data Elements (KDEs) at each of the Critical Tracking Events (CTEs) relevant to their operation. The rule will also require companies to provide electronic traceability information to the FDA no more than 24 hours after a request is made, necessitating a significant transition from traditional paper-based traceability systems.
How prepared is the food industry to implement these changes?
Bratager: Preparedness differs throughout the food industry; some industry actors have been preparing since the release of the proposed rule, while others have chosen to forgo significant effort pending finalization of the rule. Some entities may have even engaged in unintentional preparation; companies or commodities that have been the subject of repeated recalls and subsequent traceability initiatives will likely find themselves better prepared than traceability newcomers. The food tech industry is prepared to deliver digital traceability solutions that facilitate compliance among supply chain actors, but implementation is likely to be a challenge for many. Some operations will achieve compliance with minimal disruption, whereas others will face a more burdensome effort.
How will this affect companies working with global suppliers?
Bratager: The proposed rule covers any ingredients or foods on the Food Traceability List that may be sourced from global suppliers. One of the biggest challenges for companies working with global suppliers will be coordination and communication between supply chain partners. Some companies may find themselves responsible for educating their international trading partners on FSMA requirements. However, understanding will not guarantee compliance. Some global suppliers are already reporting traceability data for domestic or other export requirements and will be hesitant to take on the burden of yet another traceability scheme. The increasingly globalized nature of our food system highlights the need for traceability standards that streamline data collection and reporting efforts through the supply chain.
Are there any efforts underway to develop global standards related to food traceability?
Bratager: Several standards exist currently. The International Organization for Standardization’s ISO 22005:2007 details basic requirements for the design and implementation of food/feed traceability systems at an organizational level. GS1, the organization best known for barcodes, provides several foundational standards for the identification, capture and sharing of data; their EPCIS standard that allows disparate applications to create and share traceability event data is particularly relevant.
Food operations are incredibly unique, and widespread standards uptake will likely require a degree of customization, which is why sector or commodity-specific efforts that build upon existing foundational standards are so important. The Global Dialogue on Seafood Traceability (GDST) provides a great example with their GDST 1.1 Standard for interoperable seafood traceability that is built upon GS1 foundations. A second example is the Produce Traceability Initiative (PTI).
How can the industry and regulators move toward developing a global standard for traceability in the food industry?
Bratager: A necessary first step is alignment around the definition of traceability. Regulatory agencies and industry actors across the globe adhere to different definitions but cohesive, global progress will require alignment around a common definition for traceability.
Industry can support the creation and uptake of pre-competitive, commodity-based traceability initiatives that drive adopters toward common practices and data standardization. Interoperability must also be prioritized. Demand for interoperable data sharing will necessitate and incentivize widespread adoption of data standards.
Managing and combating cybercrime is no small feat; it can take over 200 days for companies to detect a cyber breach. The reason being cyber criminals often stay hidden even after gaining access to systems. They lie in wait for the best moment to access the information they want. Once they have it, they may use it to steal money or proprietary information or to collect a ransom. They also may sell access and information to other criminals who will take more aggressive means to exploit the organization.
Preventing cybercrime requires education and cooperation throughout an organization. Following are seven key components of cybersecurity food businesses should embrace to protect their businesses and products.
1. Education and Awareness
One of the most effective countermeasures to cybercrime is building a culture of cyber defense and awareness that empowers all employees to ask for guidance and speak up when they see a suspicious situation. Educate employees on how they can prevent nefarious activity on their computers by:
Identifying suspicious applications with warnings and popups
Flagging suspicious emails with hyperlinks, attachments or unknown senders
Not clicking on links or ads from unfamiliar sources
Verifying the trustworthiness of a site before inputting credentials
Limiting activities on unsecured public Wi-Fi networks
This helps employees not only avoid breaches, but identify and report suspicious activity to help prevent cyber attacks.
Training should be top-down, beginning with the executive suite and department heads. This ensures that there is always someone accountable for implementing and maintaining security measures. From there, the rest of the team can be trained to assess and prevent cybersecurity threats and risks.
2. Implement and Enforce Mobile App Security
Mobile apps on smartphones and tablets are at risk of security breaches that can expose large amounts of user data. All mobile apps have security controls to help developers design secure applications, but it’s up to the developer to choose the right security options.
Common problems with mobile apps may include:
Storing or unintentionally leaking data that could be read by other applications
Using poor authentication and authorization checks that could be circumvented by bad actors
Using data encryption methods that are vulnerable or easy to break
Transmitting sensitive data without proper encryption online
A simple app may not seem like a big deal, but they can allow a hacker to gain access to employee computers and networks. The following measures help improve mobile app security:
Guard sensitive information. Confidential data stored in an app without security measures in place are a target for hackers using reverse-engineering codes. The volume of data on the device should be reduced to minimize the risk.
Consider certificate pinning. Certificate pinning is an operating process that helps with app defense against intermediary attacks that occur on unsecured networks. There are limitations to this process, however, such as lack of support for network detection and response tools. Certain browsers make certificate pinning difficult, making it more difficult for hybrid applications to run.
Minimize application permissions. Permissions allow applications to operate more effectively, but they also open vulnerabilities to cyber attacks. Apps should only be given permission for their key functions, and nothing more, to reduce this risk.
Enhance data security. Data security policies and guidelines should be implemented. Measures such as having well-implemented data encryption, security tools and firewalls can protect information that’s being transferred, for example.
Do not “save” passwords. Some applications allow users to save their passwords for convenience, but if a theft occurs, these passwords offer access to a lot of personal information. If the password is unencrypted, it has a better chance of being stolen. Ultimately, users should never save passwords on mobile apps.
Log out after sessions. Users often forget to log out of an app or website, which can increase the risk of a breach. Apps with sensitive information, such as payment or banking apps, often enforce session logouts after a certain period of time, but it’s important for users to also get in the habit of logging out of all apps when they’re finished using them.
Add multi-factor authentication. Multi-factor authentication adds another layer of security for users on an app. This method can also shore up security for users with weak or old passwords that are easy to breach. With multi-factor authentication, the user receives a code that needs to be entered with the password to log in. The code may be sent through email, the Google Authenticator app, SMS or biometric methods.
3. Analyze Logs for Suspicious Activity
Companies should continuously analyze security logs to identify unusual or suspicious activities, such as logins or application executions that occur outside of usual business hours. These measures not only help identify criminal activities, they can help companies determine the root cause of a breach and how it can be prevented in the future.
4. Keep Systems Patched and Current
Patches identify and correct vulnerabilities in software and applications that may make them susceptible to cyber attacks. All systems and applications should be kept up to date with the latest security patches to prevent hackers and cyber criminals from accessing systems through existing vulnerabilities. Patching and updates may also fix bugs, add new features or increase stability to help the app or software perform better and reduce access points for hackers.
5. Use Strong Passwords and Protect Privileged Accounts
Any password used in your organization should be strong and unique to the account. It’s also important for employees to change their passwords often. Most applications do not alert users to older or weak passwords. Accountability for password protection falls on the user.
If employees have multiple accounts and passwords, companies can create an enterprise password and account vault to manage and secure credentials. Encourage employees to avoid using the same password multiple times.
If employees have local administrator accounts or privileged access, that has a huge impact on organizational security. If a single system or user account is compromised, it can put the entire organization at risk. Your company should continuously audit and identify privileged accounts and applications that require privileged access and remove administrator rights when they’re not needed. You should also adopt two-factor authentication to prevent accounts from being hacked.
6. Do Not Allow Installation of Unapproved or Untrusted Applications
Organizations that allow users to have privileged access also allow these users to install and execute applications as needed, no matter where they source the installation. As a result, ransomware and malware are able to infect your system easily, and the cyber criminal can install tools to permit future access at any time.
Privileged users may read emails, browse sites, click on links or open documents that install malicious tools onto their devices. The criminal now has access and may be able to launch attacks throughout the organization’s system or demand ransom for unlocking proprietary data.
There are security controls that can prevent applications and tools from being installed. They include: Application Allowlisting, Dynamic Listing, Real-Time Privilege Elevation and Application Reputation and Intelligence.
7. Be Deceptive
Whether online or in person, predictability is a boon for criminals. Burglars stake out houses and look for residents with predictable routines, and the same is true of cyber criminals. Automation makes this even easier with scans that are run on a routine, and patches that are implemented on the same day every month, for example.
A predictable company is a vulnerable one, so it is vital to be deceptive. Use random activities and an ad-hoc approach for updates and assessments. With this method, hackers have a more difficult time staying hidden and it’s easier to detect cyber attacks as soon as they occur to mitigate their effects.
Cybercrime is a risk facing all businesses, and the food industry is no exception. Companies that take a proactive approach are in a much stronger position to protect against cyber threats and shore up security. No method is foolproof, but if a breach does occur, identifying it early and mitigating its effects can make a world of difference for your company’s financial health and reputation.
The FDA continues to make revisions and improvements to its Produce Safety Rule, with input from various stakeholders. One thing that is a constant drumbeat is that food growers and manufacturers need to do a better job of keeping consumers safe from foodborne illness arising from produce that was traditionally thought of by consumers as safe to eat (think spinach, romaine lettuce and red onions). Through the produce regulations (21 CFR 112.1-112.213), the FDA is attempting to come to grips with the seemingly endless parade of produce-based outbreaks, arming the food industry with an additional weapon for use in the constant battle with foodborne illness.
The regulations, broadly speaking, require farms of a certain size to develop processes relating to employee hygiene and training, agricultural water, biological soil amendments (compost, manure and the like), and buildings and equipment to decrease the risk of contamination of produce during growing, harvesting, packing and holding. But what does that mean for food manufacturers?
One way to understand the regulations is to consider them in the context of a dish that seems to be increasingly popular in restaurants: the beet salad. Starting with the beets, the regulations do not apply to them. Why? Because the regulations don’t apply to produce that is rarely consumed raw. The FDA has provided an exhaustive list of this kind of produce and beets are, not surprisingly, on that list.
But what about the rest of the salad. Typical beet salads often contain leafy greens like spinach and arugula, and other produce such as carrots and avocado. With the produce regulations in place, food manufacturers should expect, and even demand, a greater level of safety and accountability from their suppliers with respect to these kinds of produce. All of these salad ingredients are considered covered produce under the act. But even though the regulations cover these ingredients, whether they provide food manufacturers with greater guarantees of safety and accountability really depends on who is growing, harvesting, packing and holding the produce before it reaches the manufacturing facility.
Broadly speaking, the regulations only apply to farms, which are generally defined as those establishments that grow and harvest the produce. Facilities that pack and hold produce must also follow the new regulations if they are majority owned by a farm that grows and harvests the produce. Non-farm packing and holding facilities can choose between following the new regulations or following current good manufacturing practices generally applicable to all foods (you can find these practices at 21 CFR 117). Establishments that only hold or transport produce are not required to follow either regulation.
What’s more, not all farms are covered under the new regulations. Farms that on average sell less than $25,000 per year of produce, adjusted for inflation with 2011 as the baseline year, are not covered by the regulations at all. And farms that sell an average of less than $500,000 of food each year, adjusted for inflation, may seek an exemption from the regulations if the amount of food they sell each year direct to consumers—or to restaurants and retail establishments within the same state or less than 275 miles away—exceeds the amount of all other food sales. That means the smaller and more local the farms a manufacturer sources from, the less likely it is that the manufacturer must follow the new regulations. It also means that if produce is packaged and held by a middleman, that middleman may not have to follow the new regulations either.
How To Mitigate Risk When Sourcing Produce
How does a food manufacturer then develop the knowledge necessary to have some power over what enters its facility and what risks to accept in sourcing produce? Well, if produce comes directly from a farm covered under the new regulations, the manufacturer should make sure that its supply contract requires the farm to provide regular certification that its produce has been grown, harvested, packed and held in compliance with the regulations. The same goes for produce coming from a packing and holding facility that is majority farm-owned. But even if the produce comes from a non-farm packing and holding facility, manufacturers can seek reassurance of safety in several ways.
If a produce supplier is not covered under the FDA Produce Safety regulations, manufacturers can still require certification that their suppliers comply either with the produce safety regulations or with existing current good manufacturing practices. If manufacturers have strong bargaining power over non-farm suppliers, they might even consider requiring that the supplier voluntarily comply with all or some of the produce safety regulations. Or manufacturers could require that the supplier obtain certification from the grower that the produce was grown and harvested in compliance with the produce regulations or (for non-covered or exempt farms) that the grower otherwise complied with current good manufacturing practices.
Even if produce comes from non-covered or exempt farms, manufacturers may still consider asking the farm to follow basic practices that mitigate the risk of contamination. Although the produce regulations include certain larger-scale, and costly, measures, they also include some simple requirements that even small farms can implement cost-effectively.
Question manufacturers should consider include: Has a company representative visited the farm that grows its produce? If it has, did workers have access to bathrooms or handwashing facilities? How clean was the area where the workers sort and pack the produce?
Depending on the amount of bargaining power a manufacturer has, it might be able to convince the grower to install portable toilets or handwashing stations, or to clean up its sorting area. Even installing signs that instruct workers to wash their hands or report to a supervisor if they are sick, can go a long way toward mitigating the risk of contamination.
At minimum, manufacturers should keep good records showing who grew, harvested, packed and held their produce, so that in the event of an outbreak of a foodborne illness, they can provide FDA with essential information to help determine the source. Manufacturers should also ensure that their supply contracts contain provisions requiring suppliers to notify them promptly whenever the suppliers have reason to suspect that produce may have become contaminated.
The food manufacturing industry has seen a shift toward increased environmental monitoring testing to help mitigate risks in food processing. But it can be difficult for producers to build out environmental monitoring programs due to the lack of detailed regulatory guidance, particularly when looking at how many samples to collect and from which locations or surfaces they should be collected.
Below are five tips to help food manufacturers build more efficient and effective environmental monitoring programs.
1. There Is No “One Size Fits All” Approach to Environmental Monitoring
A successful environmental monitoring program is one that’s customized for each facility. When creating a program or evaluating an existing program, it is important to organize a cross-functional team that includes those who are most familiar with your products and processes. This cross-functional team can help determine critical program details such as determining from which areas samples will be collected and the frequency of sample collection.
One approach is to establish a comprehensive list of every site that will be tested over time, then evaluate how often those areas should be swabbed using a risk-based approach. A risk-based approach involves determining which sites within a manufacturing plant are the highest risk and which are the lowest risk, and then testing the highest risk sites more often and the lower risk sites less often.
Risk level is based on: the proximity of the test point to the food contact surface; how difficult the area or surface is to clean or sanitize; and/or historical data and knowledge of the facility and products. The goal is to collect data from all relevant areas in the plant over time, while spending the most time on those that are highest risk.
2. You Can’t Detect What You Don’t Collect
While it seems counterintuitive, food manufacturers should be seeking positive results when conducting environmental monitoring testing. It’s important to remember that all environments can and most likely will become contaminated with a pathogen at some point in time. If an environmental monitoring program does not detect a positive result for a common environmental contaminate throughout the course of a year, it may indicate that the right areas are not being swabbed or that they are not being swabbed well enough.
When environmental monitoring programs uncover contaminated areas through positive results, it offers the opportunity for producers to implement corrective and preventative actions to improve their programs long term. A food processor’s food safety program can be seen as stronger and more reliable when the goal is to find and address the positive.
3. Use the Right Tools
A major factor in the success of environmental monitoring testing lies in the types of tools being used to collect the samples and the techniques used to collect them. When investigating tools for an environmental monitoring program, there are two key traits to keep in mind. First, it is important to ensure a collection device uses a neutralizing buffer that is effective against the sanitizers in the environment. The collection buffer should keep organisms alive long enough to run an accurate test, while also having a wide enough capacity to neutralize the sanitizer on the surface being sampled. This is an especially important consideration in processing environments that are continuously experiencing sanitizer changeovers.
Second, collection tools need to effectively access and collect organisms from the surface of the sample area. Biofilms—protective barriers of bacteria where pathogens or other organisms can thrive—are a big challenge when collecting samples. If the collection devices are not well suited to collecting or penetrating biofilms, there is a risk that the biofilm as well as all the living organisms and potential pathogens within the biofilm are not collected. Using devices that have scrub dot technology allows producers to collect the biofilm itself, creating a better sample for an even stronger environmental monitoring program.
4. Don’t Forget to Re-evaluate
To ensure you are getting the most out of your environmental monitoring program, conduct regular re-evaluations of the program. Periodic reviews are important as environmental factors are always changing. In a single year, food manufacturers may introduce new employees, new equipment, new processes, new products and new vendors. All these factors can have an impact on the quality and hygiene of the environment and the products you produce. Therefore, environmental monitoring programs should be viewed as a continuous improvement program rather than something that’s set up once and left alone.
5. Take Advantage of Education and Training Resources
Providing proper training and education for the entire environmental monitoring program team can make a significant difference in the effectiveness of the program. There are numerous educational resources available for environmental monitoring program teams. These should be utilized as you build and assess your protocols and provided to new team members. Involve the sample collection team in the process of creating the program and ensure the program protocols are readily available and understood by all team members.
Creating robust programs to help mitigate food safety risks, such as those found within a manufacturing facility’s environment, is critical to protecting consumers and your company. Despite a lack of detailed regulations around environmental monitoring program development, food manufacturers can create successful programs by customizing their protocols to their facilities, conducting routine evaluations, searching for positives, utilizing proper collection tools and providing proper training and education. Sources of potential contamination are numerous, but a strong environmental monitoring program can help find them.
The 10th Annual Food Safety Consortium will take place in person October 19-21 in Parsippany, New Jersey. The 2022 program features panel discussions and breakout sessions that address key issues, challenges and opportunities for food safety and quality professionals.
Keynote “Leading with Science at FSIS” – Dr. Denise Eblen, Assistant Administrator, Office of Public Health Science, USDA, Food Safety & Inspection Service
The three-day consortium will open at 1:00pm on October 19. The keynote address and Q&A with Dr. Eblen of the USDA FSIS will be followed by panel discussions on the State of the Food Safety Industry, moderated by Dr. Darin Detwiler, Director of the Master of Science in the Regulatory Affairs of Food and Food Industries, Northeastern University, and Food Safety Culture: Communicating to the C-Suite, moderated by Deb Coviello, founder of Illumination Partners, followed by an opening night networking reception.
Days two and three feature panel discussions covering food safety culture, technology, supply chain and reformulation challenges and compliance concerns, as well as a presentation by Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response. Attendees can join the faculty of more than 25 top-level food safety and quality professionals to discuss:
Food Safety & Quality 4.0: Data Analytics and Continuous Improvement: Jill Hoffman, Senior Director, Food Safety and Quality, B&G Foods, Gina Kramer, Director Partnerships & Learning, Center for Foodborne Illness & Prevention, OSU, and Steven Mandernach, Executive Director, AFDO
Quality & Manufacturing Efficiency: How Does Quality Show Value to the Organization? Gary Smith, Vice President of Quality Systems, Gourmet Foods and Gift Baskets, 1800FLOWERS.COM and John Butts, Founder & Principal, Food Safety By Design
Food Defense & Cybersecurity: Jason Bashura, Senior Manager, Global Defense Pepsi Co.
Diversification of Supply Chain Capacity: Trish Wester, President, Association for Food Safety Auditing Professionals, and Allison Milewski, Sr. Director, US Brand Quality, Mondelēz International
COVID-19 & Food Supply (Research Presentation): Presented by Dr. Donald Schaffner, Rutgers University and Dr. Ben Chapman, North Carolina State University
Product Reformulation Challenges: April Bishop, Senior Director Food Safety TreeHouse Foods, Peter Begg, Vice President Quality and Food Safety, Hearthside Food Solutions and Ann Marie McNamara, Vice-President Food Safety and Quality for Supply Chain, US Foods
The Crossroads of Strategic, Tactical and Operational Planning in Food Safety Culture: Jill Stuber and Tia Glave, Co-Founders Catalyst
Biggest FSQA Challenges: Shawn Stevens, Attorney, Food Industry Counsel, Jorge Hernandez, VP, Quality Assurance, The Wendy’s Company, and Elise Forward, Founder & Principal Consultant, Forward Food Solutions
FSQA Technology: How Far is Too Far? How to properly analyze new FSQA technology before you sign the purchase order. Gary Smith, 1800FLOWERS.COM, Jorge Hernandez, The Wendy’s Company, and Peter Begg, Hearthside Food Solutions
Risk Assessment: Peter Begg, Hearthside Food Solutions, and Melanie Neumann, EVP & General Counsel, Matrix Sciences International
Audits: Blending in-person with Remote: Laurel Stoltzner, Corporate QA Manager OSI Industries, and Trish Wester, Association for Food Safety Auditing Professionals
Preparing the Next Generation of FSQA Leaders: Dr. Darin Detwiler, Northeastern University, Ann Marie McNamara, US Foods, and Dr. Don Schaffner, Rutgers University
Don’t miss out on opportunities to network with other food safety and quality professionals during the opening night reception, networking lunches and coffee breaks, and the Women in Food Safety cocktail reception on October 20.
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