When foreign matter gets into food, the consequences can be significant, particularly if that food makes its way to a consumer’s plate without detection. What liability does the food manufacturer have in an occurrence? According to Attorney E. Scott Austin, a member of Gentry Locke’s Criminal & Government Investigations practice group, liability and its repercussions will vary based not only on the steps taken in prevention, but on the type of matter in the food.
Regardless of the type, however, if foreign matter is detected in food and a consumer, customer, or the Department of Justice (DOJ) itself, wishes to bring legal charges against the manufacturer or other businesses in the food chain, a civil or criminal suit can be filed. (Note: Because regulations vary by state, Austin’s comments are based on those of Virginia, but are not to be considered legal advice for a particular situation.)
There are three types of foreign matter that can be found in food:
Naturally Occurring Foreign Matter. This is something that is naturally occurring but should not be in the food, such as bone in hamburger. While it shouldn’t be in the final product, it is something a consumer could expect to occur, so, in Virginia, there’s no liability on the manufacturer if you are taking steps to prevent such occurrences.
Non-Natural Foreign Objects. A foreign object is something that is not natural and should not be in the food, such as metal fragments in hamburger. It’s not supposed to be there; it’s irresponsible of the food producer for it to be there; and no consumer would expect it to be there. In such instances, Austin said, “You are strictly liable.”
Pathogens. Although disease-causing pathogens, such as Salmonella, E. coli, and Listeriaare naturally occurring in the environment, no consumer would expect to get a foodborne illness from their food. “This is the tip of the spear for FDA and DOJ,” said Austin, who represented former Peanut Corporation of America (PCA) owner and CEO Stewart Parnell in the criminal case on the 2008-09 Salmonella outbreak linked to PCA.
LIABILITY. Thus, it is foreign objects and pathogens for which a manufacturer is most likely to be charged with liability.
Foreign objects have been a leading cause of food recalls in recent years — and the problem is often discovered because of a customer complaint or injury. If you receive a complaint, the first thing to do, Austin said, is to identify the lot number and any customers to whom that run may have been shipped. If the lot is still running, stop production, clean, and find the cause.
The positive aspect of foreign objects is that there is generally a finite amount of impact; you may have only one complaint, so it’s fairly easy to control. But if the foreign object causes injury, the cost can still be high as it does come with liability.
Pathogen-contaminated food that makes it to market, however, can have significantly greater costs and consequences for both the business and individuals, particularly if there is an outbreak or if a death results.
Thus, the first thing that should be done if pathogenic contamination is detected by anyone or any means, is to immediately notify all your customers to stop selling product, and recall all affected lots. Although this can increase liability in the short-term because you are telling your customers of the contamination potential, Austin said, “You’re way better off, because a lot of this is avoiding something worse. That ‘something worse’ is doing nothing or not enough.” And that, he said, could lead to a criminal conviction.
Although criminal cases are rare, they become more prevalent when there is an outbreak. Ever since the publication of The Yates memo in 2015 (above), there has been a trend toward making it a criminal matter, Austin said. In fact, the memo’s statement, “Both criminal and civil corporate investigations should focus on individuals from the inception of the investigation,” makes it clear that employees would be prosecuted, not just companies.
“That type of environment could be considered consumer protection or overzealousness,” Austin said. But either way, anyone who is high up in a company linked to an outbreak should immediately consider the possibility of it becoming a civil or criminal issue. “If you’re talking biological agents, contact FDA immediately,” he said. Stop producing product, clean, and get FDA in to see that you’ve done this. “It’s not enough to say you did it, you have to have documentation,” he said.
Additionally, the cleaning and inspection needs to be done by someone more than the quality assurance team who was in place at the time of the contamination. If you go to court, it’d be hard to say you had great people in charge of the clean-up, when it is the same people who were in charge when it happened, he said.
TESTING. One critical caution Austin noted from the PCA experience is that if you are testing for a pathogen, “you have to abide by the test results. It’s not okay to retest,” he said. For example, you don’t have to test for Salmonella, but if you do and the result is positive, you cannot retest to a negative.
Although there are false positives, a second negative test does not mean that there is no Salmonella because it is usually not homogeneous; it clusters, he said. In fact, this makes it unlikely that you will get a second positive.
In the PCA case, for example, only 12 (0.33%) of more than 3,500 samples tested in 2007-2008 came back positive for Salmonella.
“You cannot retest,” Austin reiterated. “Trust me, we learned that lesson the hard way.” PCA was, in fact, the first such criminal case tried, Austin said. “This is a new and burgeoning area of criminal law that the government is getting its hands around.”
Citing the 1982 intentional poisoning of Tylenol capsules, Austin said, “Tylenol set the standard when they pulled every Tylenol product off the market. That was the right thing to do. It is the safest thing to do from a company standpoint and an individual liability standpoint.”
PREVENTION. To keep from being held liable in a food contamination case — whether it be a foreign object or pathogen — you want to put in place quality assurance mechanisms that prevent it, Austin said.
Not only did he recommend that you have GMPs that cover pathogens, metal fragments, etc., Austin said you need to have FDA check them. The agency is required to check GMPs, but they don’t always read them, he said. “I encourage people to have FDA read and understand these.”
In the PCA case, Austin said, the company noted that their GMPs said they would retest positives, but FDA responded that they didn’t really read the GMPs.
Thus, Austin recommends three key steps for prevention:
Have FDA read your GMPs.
Get them approved.
Follow them.
If you remember nothing else,” Austin said, “Make sure you have your GMPs thoroughly vetted and complete. And if there‘s a problem, you’ve followed them to the letter.” You want to have them in order before FDA knocks at your door.
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
You May Be the Food Supply’s First Line of Defense
Along with the requirement that food facilities develop a written Food Defense Plan for the first time ever, FSMA’s Mitigation Strategies to Protect Food Against Intentional Adulteration (IA Rule) requires that individuals assigned to work at actionable process steps and their supervisors be trained in food defense awareness. Why is this so critical? As is stated in the Food Safety Preventive Controls Alliance (FSPCA) course designed for these personnel: “You may be the food supply’s first line of defense.”
To determine what FDA-authorized training involves, QA Editor Lisa Lupo took two online courses. One was developed by FDA, the other by FSPCA and the International Food Protection Training Institute with FDA funding. The FSPCA course was updated more recently and includes more information on the IA rule.
Both courses are free and fulfill the training requirement of the IA rule. Like other aspects of FSMA, the requirement is flexible, and other similar food defense awareness training may be chosen to satisfy the requirement. Currently neither course is available in Spanish, and FDA is unaware of any alternative Spanish courses. In both courses, each module includes an overview of what participants will learn and brief “Knowledge Check” quizzes. Upon completion, the participant is instructed on the printing of a Certificate of Completion to be filed in the facility’s Food Defense Plan.
Following are overviews of each course to provide an idea of what FDA deems important and what participants will learn.
FSPCA. Food Defense Awareness for the Intentional Adulteration Rule (https://bit.ly/2JSVRKS). This is an interactive, recorded audio/slide presentation. The estimated completion time of 20-30 minutes was accurate for me, and there is accountability: clicking too quickly through the course will freeze it, requiring the participant to restart at the module where the quick-clicking began. There is a four-hour inactivity time-out, after which the course must be started from the beginning. With the objectives of introducing participants to food defense and discussing the IA rule, the course covers the importance of food defense, ways to protect food from intentional adulteration, and recognition and reporting of suspicious activity. It is divided into three modules:
Intentional Adulteration and Food Defense Overview. Includes explanations of intentional adulteration and food defense; distinguishing food defense from food safety; and the consequences of IA.
Implementation of Food Defense at a Facility. Focuses on the importance of a Food Defense Plan, and provides further detail on actionable process steps, mitigation strategies, and the importance of training.
Roles and Responsibilities. Details personnel roles in food defense and reporting of suspicious activity. Noting the diligence required of regulators and the industry in ensuring safe, unadulterated food, the importance of the course participant also is highlighted.
FDA. Food Defense 101 — Food Defense Awareness for Front-Line Employees (https://bit.ly/2z83GYP). This IA course is completely written, with no accompanying audio, although, like the FSPCA course, it includes interactive slides. Unlike that course, it has no checks to ensure the participant doesn’t click through to the certificate page. This course can be left at any time, simply clicking the navigation bar to return to the last viewed slide. With three sections, the objectives are for the participant to be able to define food defense and explain the differences between food safety and food defense; recognize the importance of the front-line employee in food defense; identify threats the front-line employee may encounter and how to respond; and understand FDA’s Employee FIRST acronym as an easy way to recall their responsibilities in food defense. The sections include:
Front-Line Employee’s Role in Food Defense. Following a brief discussion of the industry’s role in and requirements for producing safe food, the differences between food defense and food safety are stated, general protection measures described, and potential causes and motivations for adulteration listed.
Identifying Possible Threats. Presenting potential food defense situations a front-line employee may encounter, it includes interactive screens on which the participant clicks on topics for information on areas of concern, then finds potential threats in a food processing photo.
Who to Contact. Through discussion of intentional adulteration, the importance of the front-line employee, and key areas of potential threat, this lesson puts food defense directly in the participant’s hands stating: “You may be the only one to observe an unusual or suspicious situation, and the success of the food defense measures depend on you!”
IN SUMMARY. Both courses fulfill the IA training requirement, making it a matter of preference for facilities. Both impart food defense awareness and portray the importance of employee action; provide certification of the training; and provide free food defense education that can increase the awareness of all employees — whether required by regulation or not.
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
Equipment & Food Safety
Features - Facility Management
Your equipment may be costing you more than you know.
Would you like to save up to $1.5 million each year?
According to statistics cited by Remco Products Education and Technical Support Manager Amit Kheradia, having the facility, equipment, tools, and utensils be of sanitary design can help companies save about $0.5-$1.5 million annually by greatly minimizing the chances of costly product rejects, recalls, and associated expenses.
WHAT CAN GET IN WILL GET OUT. A crack that is barely visible to humans is like the Grand Canyon to pathogens, said Mérieux NutriSciences Senior Director of Technical Services Steve Decker. So gaskets, poor welds, metal-to-metal and plastic-to-metal interfaces are all perfect hiding places for contamination. And, he said, “What can get in will get out.” Due to poor sanitation practices, these harborage areas can grow into growth niches where food, water, temperature, and time will allow a transient pathogen to become established.
The two primary pathogens that will likely take up residence in equipment, and the facility in general, are Salmonella and Listeria monocytogenes, Decker added. Salmonella is predominate in dry, warmer food manufacturing facilities, while Listeria is associated with wet, cool, and cold environments. However, they can be found in both.
Thus, Kheradia said, “Sanitarily designed equipment is vital for ensuring safe and quality food products because the equipment is more easily cleanable, more durable, and less likely to carry contaminants,” which helps prevent or significantly minimize microbiological, allergen, and foreign particle cross-contamination incidences in a facility. Bacterial pathogens need to be controlled as they can survive and grow in the nooks, crannies, and other relatively inaccessible surfaces of equipment. Then, he said, “Contaminants may be transferred from the equipment surface to food through the environment, operating personnel, or even operational utilities like water, steam, or drains.”
Prerequisite and GMP programs — such as personnel hygiene practices, risk-based facility zoning, and structural and grounds maintenance — will complement the equipment design, installation, and operational procedures, Kheradia said.
Additionally, a well-developed and effectively implemented preventive maintenance program for the facility and equipment can assist in ensuring the sanitary integrity of the production processes. Any broken or non-functional equipment must be properly repaired or replaced to ensure sanitary operations in the plant.
MICRO-CRIME SCENE INVESTIGATION. To determine if equipment is causing a food safety issue, in-line processing samples can be taken at various points throughout the process and after any lethal step — with a test-and-hold program if production is occurring.
Another option is have the equipment extensively swabbed by a trained person, e.g., a micro-crime scene investigator (MCSI), Decker said. Places that the investigator cannot see but the product touches are red flags of potential harborage areas, especially if this area is not torn down during routine sanitation. “Allowing the equipment to run for several hours without product, then swabbing it will let the microorganisms be pushed out of their hiding places and get detected by the swabbing,” he said.
In the purchase of new equipment, he added, “Hygienic design should be, if not first in the decision making, at least in the top three criteria when evaluating new equipment.” The ability to easily break down the equipment so the operators and sanitation crews can properly inspect and clean, is crucial. “Often nuts, bolts, wrenches, and screwdrivers are needed for sanitation purposes if equipment is not easy to disassemble –— and it’s often not,” he said.
“Purchasing used equipment can be a risk,” Decker added. If the equipment was not maintained in a hygienic manner, the Trojan Horse syndrome may apply, as pathogens may be hiding inside to be carried in to your facility. To verify an equipment’s hygienic condition, he said, extensive swabbing and disassembly should be conducted before it is placed into production.
FOREIGN OBJECTS. It is the nuts and bolts of equipment that can be the basis of another potential equipment issue: foreign objects (metal, plastic, etc.) breaking or disconnecting from the equipment and falling into the food. This was, in fact, the basis of two observations in an FDA Warning Letter issued to the CEO of a baked-goods facility.
The mesh-belt conveyor carrying bagels through the proofer was seen broken or missing pieces in several places. The shape and size of the missing pieces of mesh-belt conveyor material was consistent with reported customer complaints the firm received.
Several metal spikes were seen broken and/or missing from the metal cylindrical aerator used to perforate the in-process dough. There was no metal detector or other protective measure in place to detect metal.
According to the Code of Federal Regulations (CFR) Title 21, “Effective measures shall be taken to protect against the inclusion of metal or other extraneous material in food.” While the CFR goes on to note that compliance may be accomplished by using sieves, traps, electric metal detectors, or other suitable means which detect and capture metal, it is even more advisable to prevent metal fragments in the first place.
According to an FDA report, one significant cause of this can be poorly maintained equipment and lines. Because pieces of equipment can break off and enter food products during processing if equipment is poorly maintained, routine or preventive maintenance, and other periodic checks of equipment, can minimize the risk from this safety issue.
Additionally an FDA guidance document written for fisheries, but applicable to all food processors, notes that metal-to-metal contact (e.g., mechanical cutting or blending operations and can openers) and equipment with metal parts that can break loose (e.g., moving wire mesh belts, screens, portion control equipment, metal ties, etc.) are likely sources of metal that may enter food during processing.
It is the nuts and bolts of equipment that can be the basis of another potential issue: foreign objects falling into food.
In that document, FDA advises that periodic examinations of processing equipment for damage that can contribute metal fragments to food product can help prevent the hazard of metal inclusion. A visual inspection, however, may only be feasible with relatively simple equipment, while more complex equipment that contains many parts, some of which may not be readily visible, may require controls such as metal detection or separation.
ROBUST PREVENTION. For prevention, the deep cleaning of equipment at a set frequency (monthly, quarterly, or bi-annually) must be built into the sanitation schedule, Decker said. A robust environmental monitoring program (EMP) also will greatly assist in preventing pathogens from migrating to and into your equipment and is a primary defense when maintaining your equipment in a safe condition. And, he added, “If the environment has been identified as a risk likely to occur, it must be built into your food safety plan.”
Apart from following good hygiene practices, prerequisites programs, and SSOPs, the facility and equipment should be of appropriate sanitary design, Kheradia said, noting the 10 principles of sanitary design recommended by the American Meat Institute (AMI):
Cleanable to a microbiological level.
Made of acceptable material.
Accessible for inspection, maintenance, cleaning, and sanitizing.
No product or fluid collection.
Hollow areas of equipment are hermetically sealed.
No niches or harborage points.
Sanitary operational performance.
Hygienically designed maintenance enclosures.
Hygienic compatibility with other plant systems.
Validated cleaning and sanitizing equipment.
CLEAN FIRST. SANITIZE SECOND. “It is essential to understand that cleaning refers to the removal of product and residual soil, and sanitizing is about the reduction of micro-organisms to a safe level, normally with the use of an approved sanitizer,” Kheradia said, adding, “The cleaning step is always done before sanitizing, and never the other way around.”
Following are five factors that need to be considered:
Type of soil being cleaned: Is it organic, non-organic, sugary or fatty?
Nature of soil: Is it loose or stuck-on the surface?
Water quality and hardness: Is it potable and free from excess minerals that may affect sanitation?
Wastewater treatment: How is this disposed of or treated so it doesn’t re-contaminate equipment?
Corrosion resistance: Are the chemicals compatible with the surfaces being cleaned?
In conducting cleaning and sanitizing activities, there are many things to be considered, Decker said. Some critical factors are:
The ability to disassemble the equipment easily.
Proper selection, use, and monitoring of the sanitizer being used.
Training the team being challenged to perform the tasks.
Frequency of the sanitation and proper sequence of application of the rinse, detergent, and sanitizer.
Using a flashlight during pre-sanitation and post-sanitation.
Determining the chance for biofilm formation, and proper chemical selection to clean and remove it to ensure the sanitizer is effective.
Having a seek and destroy mission in place, allowing for additional EMP samples to be taken during shutdowns and clean breaks.
Knowing your equipment and which areas are difficult to clean so you can build it into the sanitation program.
Additionally, Decker said, “The use of high-pressure hoses will push food and pathogens deep into the equipment where they will become lodged and form a growth niche. Eliminating the use of these hoses, or at least educating the sanitation crew on the hazards (where and when they can be used), will be key in prevention.”
IS IT REALLY CLEAN? There are several ways to verify cleanliness, Decker said. The most widely used are visual, swabbing with a system to measure ATP, or swabbing with a sponge to determine microbial loads.
“The hardest areas to clean and sanitize should be the ones you are testing. Having someone other than the sanitation team perform the verification is highly recommended,” Decker said. Additionally, trending this data is always a good idea.
After completion of the sanitation process, the most common pre-operational inspection method is a detailed visual inspection, Kheradia agreed, adding, this is normally done by the operator or supervisor who can use mirrors, flashlights, cameras, etc. While microbial swabs can take several days to get the results, ATP bioluminescence swabs for organic residues can provide a rapid test of unclean spots. But, he cautioned, “Make sure to select a good sampling plan when taking swabs from equipment areas.”
Your equipment is the foundation of your facility’s food processing operations; but if it is not maintained in good, hygienic condition, it also can be the downfall of your business.
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
Surviving the Next “Big One”
Features - Industry News
Lessons learned from Florence, Michael, and other unnamed natural disasters.
With natural disasters occurring more frequently and extensively, food processors need to take a hard look at their disaster planning, in both preparation and recovery. As with so many practices of this industry, no two facilities will have the exact same plan as it will be based not only on the products and processes of the facility, but also on the disaster risk most associated with the geographic area (such as hurricanes, tornadoes, flooding, wildfires, etc.).
Additionally, there will be variation in the planning for different natural disasters. As North Carolina’s Assistant Commissioner for Consumer Protection Joe Reardon explained, “Hurricanes allow for more advance planning in most cases. Other natural disasters don’t always allow for advance planning.”
Because of this, less predictive events emphasize the need for companies and businesses to have a prepared business continuity plan, said Lance Reeve, Nationwide senior risk management consultant for Food Safety and Food Defense Systems Agribusiness. “You can’t plan for every type of disaster, but you can have a plan of how you will respond to a disaster.”
NATURAL DISASTER PREPARATION. Natural disasters can affect the food industry in many ways, on the farm, in processing, through transportation, and at retail. As such, advance preparation for pending natural disasters may include protecting assets, moving assets such as valuable equipment out of harm’s way, and, when possible, harvesting crops in advance, moving livestock to safe locations, and/or moving critical pieces of equipment or specialty or limited supply raw materials and ingredients to safe/secure locations. Consider the key items that are necessary to resume operations as quickly as possible.
“The food industry, from farm to fork, needs to have a plan in place preparing for and recovering from natural disasters,” Reeve said. “Planning for these events should be done by all key business units of a company with a goal of protecting key business activities so the organization can continue to function.” (For a listing of resources that can help businesses be prepared for disruptive events, see Resources, page 26.)
As a general rule, disaster planning should address the most likely hazards associated with food safety issues, Reardon said. He recommended that the food processing facility consider having a well-developed continuity of operations plan (COOP) and food safety plan that address the ability to handle, store, and preserve food products that require temperature controls. In addition, he said, “A remote notification system that alerts management when the temperatures are out of specification can provide critical information.”
Employee communication also should be an integral component of the business continuity plan, Reeve said. Determine how the business will communicate before, during, and after natural disasters. For example: How will the company communicate with employees who are displaced due to the disaster to inform them when it is safe and the company is ready to resume operations? Consider several forms of communication, as standard communication lines may be damaged as a result of the disaster.
Water contamination and animal mortality also can be key concerns of natural disasters, particularly in the event of major storms such as hurricanes Florence and Michael. When water contamination is a potential concern, the use of an alternative water source during the major storm event can be beneficial. Once the storm is over, the testing of a compromised water supply by a private testing lab can facilitate recovery, Reardon said. And to help minimize animal loss of life, he said, “Predetermined processes to move animals out of areas that are expected to flood are important considerations.”
Other recommendations include having back-up generators on site or identifying and having contracts with companies that can provide back-up generators to prevent food product spoilage due to power loss. “A well-developed business continuity plan will challenge the company to work with all stakeholders of the operation. This would include internal personnel, suppliers, third-party vendors, insurers, transporters, co-packers and co-manufacturers, etc.,” Reeve said.
IMPACTED SUPPLIERS. Even if your facility isn’t in the disaster area, your suppliers’ facilities could be. Thus, beyond your own operations, food companies should be aware of any of your suppliers, co-packers, and co-manufacturers that may be in harm’s way of a natural disaster. Ask questions such as: Do I have back-up suppliers, co-packers, and co-manufacturers that can be utilized while the effected companies are working to resume operations? Are these back-up suppliers located in different areas of the country that would not be impacted by the disasters? Do I have pre-identified back-up facilities and companies that could produce the suppliers’ products until they are able to operate?
To tackle such issues, “a robust food safety plan should address supplier verification processes to assure that materials supplied are not adulterated,” Reardon said. “Additional checks can be implemented post disaster to ensure all ingredients, supplies, and foods are safe and have been maintained at the appropriate temperatures.”
Additionally, food companies should closely monitor their supplier approval program, Reeve said. “I would suggest there should be language within the contracts with suppliers that the supplier must notify them if their operations, farms, products, etc., have been impacted by events that may impact the food safety of those products or the availability of such products.”
“You can’t plan for every type of disaster, but you can have a plan of how you will respond to a disaster.” Lance Reeve, Nationwide
This is an important point of the business continuity plan which ensures the company has identified and pre-approved multiple suppliers so there will be alternate sources if their primary suppliers are impacted by natural disasters or other situations that could cause an interruption in supply.
Post-Disaster Recovery. The development of a food safety plan also can assist in recovery from natural disaster-related issues. “Pre-identified triggers and decisions regarding temperature controls can assist management with quick decisions,” Reardon said. “Pre-identified processes for post-disaster mitigation for cleaning and sanitizing can reduce the recovery time and assure adequate sanitation.”
Post-disaster, the quality assurance team should be an integral part of the process in evaluating the food safety of all affected products which should be placed on hold until properly evaluated.
If products must be destroyed, a formal program should be in place to ensure that the products are, indeed, destroyed, labels removed, etc. so they cannot be recaptured by someone and re-introduced into commerce.
Flooding and power outages (resulting in loss of refrigeration) can be significant food safety hazards and any affected crops, foods, equipment, transportation systems, etc. need to be dealt with post-disaster to ensure adulterated products do not enter commerce and proper cleaning and sanitation is conducted for facilities and equipment. Companies may have to utilize third-party services to help clean and decontaminate the food facility. Again, these services should be identified prior to a disaster and be part of the business continuity plan. Additional resources, such as laboratories, may also be needed for environmental/microbiological testing to ensure the contamination has been effectively dealt with.
In addition to the testing of water sources for contamination, food companies should think about alternative sources should their supply become contaminated. For example, if the municipality’s water supply will be down for a period of time, could you receive tankers of water to enable you to resume operations before the main water supply is restored?
The first half of 2018 alone racked up more than six billion dollars damage in the U.S. – and that is not even accounting for hurricanes Florence and Michael that raged over the southern and mid-Atlantic states in the fall. Your chances of experiencing adverse impacts from a natural disaster are, to a great extent, dependent on your geography. But not only have many of these increased in number, they have increased in intensity, so the level and range of damage can be greater as well.
Thus, when considering natural disasters, it is best to invoke the notorious Boy Scout motto: Be Prepared. Not only can it mean the difference between saving and losing your business, but, as Reardon said, “In many cases, advance planning will allow for faster response and recovery.”
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
Inside the Food Package
Features - Cover Profile
Innovating with Michigan State University School of Packaging
A key research area for MSU School of Packaging masters’ student Jack Fehlberg is the production and assessment of the new packaging to extend food shelf-life.
Photos by Jacob Lewkow
Although it is one of the last steps in production, a food’s packaging can be the most critical aspect of its safety and quality. But, in addition to simply protecting the food within, today’s food packaging materials are being asked to extend shelf-life, increase or decrease the food/packaging interaction, and/or be more sustainable and cost-effective — while still being attractive to customers. It is just such packaging fundamentals, improvements, and innovations that drive the Michigan State University School of Packaging.
The School of Packaging is represented by (from left) Associate Professor Eva Almenar and Director Susan Selke.
While the school focuses on packaging of all kinds, about one-half of all packaging manufactured is for food and beverage, said Professor and School of Packaging Director Susan Selke. So this is a primary focus of the school, whose research includes that which is funded by the university and by sponsorships, as well as that conducted directly for companies that pay fees for the university’s research. In fact, the school has worked with a number of food and beverage businesses to solve problems or innovate new packaging.
Established as a discipline in 1952, Packaging become an independent school within MSU’s College of Agriculture and Natural Resources in 1957 to be the first of its kind. Still a pioneer in packaging innovation, the school was ranked as The Best Packaging Science College of 2017 by Universities.com, and is the only one that offers a Ph.D.
In QA’s visit, the school’s purpose of “creating and advancing knowledge in the science of packaging through innovation, sustainability, and stewardship” was immensely evident, with bio-based material research at the core of multiple food-packaging projects. But, while such materials are often beneficial, they are not the simple answer for all foods.
SUSTAINABILITY. “One of the things we get into conversations with people about is making sure companies understand the decision they are making with sustainable packaging,” Selke said. There is a lot of marketing hype, such as “plastics bashing,” pushing manufacturers toward sustainable packaging. But, she said, you need to look at the whole life cycle of the food and its packaging to make an intelligent decision.
Sustainability is a relative term. A plastic bottle or bag may not be seen as meeting the consumer definition of “sustainable,” but if it means decreased food loss through lengthened shelf-life or reduced weight in transportation, it can be environmentally advantageous because less food is trashed or transportation fuel consumption lowered. “You really have to look at the whole system,” Selke said.
School of Packaging studies include both packaging-focused research (below) and processing equipment operation (right).
Additionally, the biodegradable aspects of food and its packaging are not well understood. “Companies want biodegradable packaging, but the food, itself, doesn’t degrade very fast,” Selke said. She cited the research of Rubbish!: The Archaeology of Garbage author William Rathje, who, in digging up landfills found that there is a great deal less biodegrading than one would expect. In fact, he found decades-old hotdogs, lettuce, corn cobs, and bread rolls still intact and easily identifiable, alongside dated newspapers and other biodegradable trash.
Moisture content is the primary factor for decomposition, but Selke said, modern landfills are well-constructed — designed to prevent water ingress — so all of it will degrade slowly. Thus, if a food manufacturer uses biodegradable packaging, but “the end of life (for the food) will be a landfill, then they’re not accomplishing what they think they are,” she said.
Also playing into this is consumer perception of biodegradable and composting which can add to littering. “Consumers think being biodegradable is a green check to litter,” said Associate Professor Rafael Auras. “So a behavior change needs to happen.”
All this is not to say that we should not be seeking to reduce the environmental footprint of non-sustainable packaging, but manufacturers need to consider many more factors in making such decisions.
PACKAGING FOR LONGEVITY. It is for such reasons that MSU’s School of Packaging researchers are studying and innovating bio-based packaging that also preserves and/or increases food quality and shelf-life. One such study is the research Auras is conducting for NASA on packaging that preserves or increases food quality and shelf-life but is composed of bio-based, biodegradable, compostable materials to be disposed in places that can be composted. The research focuses on food safety and quality as well as sustainability, which considers both recycling and composting. “If packaging can be cleaned, it is good for recycling; but if it can’t be cleaned, it should be able to be composted,” Auras said.
School of Packaging studies include both packaging-focused research (below) and processing equipment operation (right).?
The school has been conducting significant research on the development of compostable technologies, installing chambers which are environmentally controlled to simulate the time and temperature of a compost pile. As materials break down, they release carbon dioxide and researchers capture and measure the amounts of material converted to CO2. Up to 120 jars of material can be tested in its two chambers.
Versatility is necessary because many food products need to be packaged in materials that create a barrier against oxygen and moisture, for which plastic materials are currently one of the best options. Reiterating the points made by Selke, Auras said, “Packaging is important, but if the packaging isn’t doing its job, there will be a greater environmental footprint made from food waste. We need to protect the value of the food.”
At the same time, to reduce the environmental impact of packaging — including the build-up of plastics in the ocean, we need to develop better waste management systems on a global basis, he said. Research such as Auras’ NASA project shows the extent to which decisions on packaging need to focus on the characteristics of the food and the conditions to which it will be subject, along with consideration that “the environmental relationship of packaging to food should be no more than 10%,” he said.
The U.S. is, in fact, behind some other nations in such aspects of food packaging. Auras cited Japan as an example where foods may have a shelf-life as high as 10 years. A higher value is placed on protecting the food, with the understanding that the longer it can last, the less waste there will be.
IMPROVING BARRIER PERFORMANCE. Another area under development by the school’s Associate Director and Professor Laurent Matuana and his Ph.D. student Sonal Karkhanis is that of packaging for ready-to-eat meats as well as fresh-cut fruits and vegetables.
The research is seeking to replace current crude oil/petroleum-based packaging materials with a bio-based and biodegradable polylactic acid (PLA) material that also would provide long shelf-life. PLA currently lacks barrier performance against water and oxygen which cause spoilage. “If we can improve the barrier of the bio-based plastic and delay the permeation, we can delay the growth of microorganisms,” Matuana said.
To keep the bio-based biodegradability of the material but extend its barrier properties, the researchers have added cellulose nanocrystals (CNCs) from trees, particularly those which have been burned in forest fires. For the research, the CNCs are being extracted at the USDA Forest Products Lab in Madison, Wis., in collaboration with Ronald Sabo and Nicole Stark.
Even though CNCs are nanoparticles, they can impart valuable properties, and they are compatible with other bio-based materials, Matuana said. From that research, the team has developed a film with one percent CNCs, which has improved the barrier characteristics of the film by up to 50% for water and 75% for oxygen. Their research is now focusing on the extent to which it is improving the shelf-life of food, with the first test using water-sensitive saltine crackers.
Micro-robotics help students think in new ways.
Thus far, the team has found that even when exposed to 99% humidity, the food packaged in CNC-impregnated PLA films is three times as shelf-stable as the one packaged in PLA alone. Additionally, as a natural product, the CNC PLA is very safe. Toxicology studies have shown it to have no cytotoxicity, and both the pharmaceutical and food industries are looking into its use.
STUDENT RESEARCH. While the school’s research is being led by its faculty, graduate and upper-undergrad-level students are very involved in the work. Associate Professor Eva Almenar’s main work is on the development of packaging materials from renewable feedstock, with a focus on active packaging materials for the produce quality and safety. Working with her on an array of projects to extend the shelf life of foods through bio-based materials and active packaging that interacts with the food product are masters students Dylan Spruit, Jack Fehlberg, and Pramit Sawand; dual enrolled masters/undergraduate student Jennifer Le; and senior undergraduate Sydney McKay.
Spruit’s research focuses on a market-study comparison of e-commerce packaging against traditional packaging and potential new developments sponsored by UBE Inc. As an undergraduate researcher, Spruit worked with Almenar on completing a study of the water sorption characteristics of active packaging compounds. He interned at J.M. Smucker, testing packaging and conducting shelf-life studies.
McKay is studying material release from the perspective of microbial kill. She is currently determining the inhibitory concentration of the active compounds prior to their mixing with the polymer matrix. McKay interned at General Mills, collaborating with food scientists to ensure packaging matched the food.
Le is focusing on byproducts and the extension of shelf-life through the mixing of these with polymers to develop innovative packaging to reduce oxidation in food products. Le interned at Pepsi, working with the packaging group on new product launches and distribution testing.
Fehlberg is studying the reuse of agricultural waste in packaging including the production and assessment of new packaging to extend food shelf-life. As an undergraduate researcher, Fehlberg collaborated on some of Almenar’s ongoing projects including research on the use of a coating material to control fungal growth on blueberries, the efficacy of absorbing pads on reducing microbial growth in packaged food, and the thermal and optical properties of protein-based polymers.
Sawand’s focus is on the use of the thermoforming technique to form waste into food packaging and evaluation of the resulting trays.
Each of the student’s works builds on that of the others — and others that have come before. “It takes years to do the research, so different people work on each step,” Almenar said. With her background in food science, she is able to provide an in-depth understanding of the foods as well as the packaging. This is important because different foods spoil because of different interactions. For those subject to spoilage from oxidation, the development of oxygen-removing packaging is most effective; whereas produce is most likely to be contaminated by fungal growth, so antimicrobial packaging needs to address that. “You first need to know the food, then develop the packaging,” Almenar said.
Beyond that, there also needs to be an understanding of where and how the food will be marketed and what it will be exposed to, she said. Taking all this into consideration, the group’s research then focuses on the potential of bio-based materials to preserve food and reduce waste. That is, she said, “How can we use things that are growing in nature while reducing food waste as well?”
Senior Sydney McKay’s studies are currently focused on studying material release from the perspective of microbial kill.
THE SCHOOL. To get students to the point of conducting such research, a foundation of knowledge needs to be laid. Thus, the School of Packaging study begins with the classroom study of basic principles of physics, chemistry, mathematics, and materials science, along with specialized courses, such as food packaging. Students then participate in labs to create packaging materials with a focus on the speed and temperatures of the compounds and resins for the film; cutting, shaping, molding and measuring it in the right proportions to produce bottles, pouches, etc.; and conducting testing throughout. Such testing may include that of the environmental, production, and transportation impacts on the materials and packaging. To further their real-world knowledge, students operate actual food-processing equipment to simulate the processing and packaging of food and drink. “Currently they are separate machines, but the goal is to have all as mobile units, so various line configurations can be set up to simulate production plants,” Selke said.
The school has two full corridors of labs. Unlike many universities, the labs are not specific to a single researcher or professor, rather, Selke said, they are set up as shared space organized by function. This not only enables coordination of the work but provides for efficient utilization of space for students to work with and understand the functioning of the major types of equipment, and how they interact. Just a few of the lab areas in the school are the shock and vibration lab, filling lines, environmental chambers for different storage conditions, analytical chemistry lab, tensile tester, retail-simulation area, and materials labs.
Additionally, as demonstrated by the internships of Almenar’s team, “more than 90% (of the packaging students) will have had at least one six-month, paid internship by the time they graduate,” Selke said. “Increasingly students are doing two internships.”
Stretching a strip of material to its breaking point tests the tensile strengths of different packaging.
CONTINUED GROWTH. Since its 1952 origination, MSU’s School of Packaging has undergone a great deal of change and growth. Prior to Selke’s current role of director, which she took over in 2015, she was interim director from 2007 to 2009. One of the greatest differences she sees from then to today is the increased use of plastics and more complex structures. “A lot more pouches are being seen,” she said. “A lot of it is driven by cost, but that shows up in different ways.” For example, the use of plastic instead of glass eliminates weight and potential breakage and increases consumer convenience. Additionally, she said, as a relatively flat surface, “it’s a better billboard” for marketing.
In fact, shortly before Selke took over as director in 2015, the school undertook significant strategic planning. With enrollment increasing, a number of faculty retiring, and several years of no new tenured faculty, the school was having difficulty maintaining both its instructional and research requirements. “Despite some limitations on enrollment, we were growing beyond capacity,” Selke said. “We are a research-intensive land-grant university, but we didn’t have time for research because there were so many students we needed to teach.” So the school made its admissions requirements more stringent, and has hired three tenured faculty within the last three years.
The strategic planning also gave the school an opportunity to take a reflective look at itself and where it is going. “As the first school of packaging, we feel an obligation as stewards of the discipline,” Selke said. There are other packaging schools, but MSU is looked up to as having been first and has been ranked as best. To continue to hold that top spot and fulfill her own dedication to helping others and making a global impact, Selke said, “My main goal is helping develop the people who will be leaders in packaging and industry.”
The author is Editor of QA magazine. She can be reached at llupo@gie.net.
