Happy New Year and welcome to 2019 — a year when we will all improve our lots in life and continue to provide the best in food safety services to our employers and consumers.
Brought to us by FDA and FSMA, the Intentional Adulteration Rule is upon us. This new rule took effect in May 2016 and requires a Food Defense Plan that identifies actionable process steps for your operation and focused mitigation strategies for any actionable process steps that you identify. The program is along the lines of HACCP, requiring monitoring, corrective actions, and verifications.
Sounds easy, right? We’ve all completed HACCP and other risk assessments before — we’re good at it now. Simply complete a vulnerability assessment and set up your programs based on what you determine is reasonably likely to occur.
But, aren’t all of your process steps, from the farm to the package and distribution, vulnerable to some sort of tampering if you are not there watching all the time? How will you define what is a vulnerability; and then, how will you provide some sort of mitigation? Difficult questions, eh?
Luckily for us, FDA has helped out by providing a database of potential mitigation strategies for most steps of food handling processes, and we can all find that on the FDA website.
So, what happens when you suspect a tampering event — whether it be an intentional poisoning or an economically motivated adulteration (EMA), as covered in the Preventive Controls Rule? Or worse, you’ve been told of an event but don’t know what the product is or what it has been tampered with? What potential poison was added? What economically motivated adulterant was added or substituted? I’m starting to see a need for food sleuths — or as the police might call it: food forensics.
Who is your food forensics expert? Is it someone internal to your company, a consultant, FDA maybe? How do you know what to look for? Is there a test for that? What level of detection are you looking for? Maybe your food forensics expert can help.
According to Wikipedia, forensic science is defined as “the application of science to criminal and civil laws, mainly — on the criminal side — during criminal investigation, as governed by the legal standards of admissible evidence and criminal procedure.”
This new field for food scientists will involve collecting, preserving, and analyzing scientific evidence as part of an investigation to determine what food has been tampered with and how. This will mean trying to determine what has happened to the food (typically something added — a poison or economic hazard), what this means to the safety of the food, and what to do about it.
Not too long ago, milk powders were adulterated with melamine to make the protein levels look higher than actual. And now, we also know that many honeys are adulterated with other, less expensive, syrups. Our new food forensics specialists will need to understand the foods and how they are manufactured and routinely tested to know what could be done to them from a poisoning or EMA standpoint. There are good people out there sleuthing to help prevent the next incident.
I don’t have an answer to food defense concerns but hope each of you has a good food sleuth on staff (or retainer) so that you are ahead of the criminals. If you don’t have one, I’m hoping that some of our educational institutions will take this opportunity to create some graduate degrees in food forensics so that we can all have access to these newly minted specialists.
Why do poorly designed buildings become food plants? Why isn’t more equipment accessible for cleaning? Does executive management realize the resources it takes to keep a food plant free of foodborne pathogens? Have you asked yourself these questions?
Sure you have, and it doesn’t have to be this way. What is a practical solution? Sanitary design is a money maker, seriously.
Mark the words of the business author, Philip B. Crosby, “Every penny you don’t spend on doing things wrong or over becomes half a penny right on the bottom line.”
Profit is the highest priority of executive management and many emphasize food safety as a top priority. Therefore, sanitary design must be linked to profit and food safety.
Consider the words of the food safety and sanitation author, Thomas J. Imholte, “Sanitary design needs can be met with a minimum capital commitment, and the return in lower maintenance and sanitation costs will be tenfold.”
Profit increases as operating costs lower; food safety increases as recalls are reduced; improved product quality means fewer complaints; and sanitation improves when less time and effort are required.
A commitment to sanitary design comes from three primary sources; owner, operator, and designer. The better these sources understand the link between profit and food safety to sanitary design, the greater their commitment.
An absolute of sanitary design is prevention. Good Manufacturing Practices and HACCP have focused on prevention for many decades. More recently the Food Safety Modernization Act (FSMA) shifted the focus of federal regulators from responding to contamination to preventing it. A preventive foundation for creating profit and food safety simultaneously is through the sanitary design of food plants.
WHAT IS SANITARY DESIGN? Sanitarians generally agree that sanitary design is the application of design techniques that allow the timely and effective cleaning of a manufacturing asset, which will range for many years. But sanitary design is more than just cleaning; it is about profit, risk management, and efficiency. So, how does one link sanitary design to profit?
- Know your sanitation costs along with the costs of corresponding sanitary design failures, both internal and external. Internal failures are the costs encountered with a failure to meet requirements such as recleaning, rework, and regrading which result in subsequent production downtime. External failures are the costs corresponding to defects found by customers, such as complaints, recalls, product replacement, regulatory action, litigation, and customer loss. These costs will help justify an investment into sanitary design.
- Know how the Return on Investment (ROI) is calculated. Many company’s ROI timeframe is three years, but it should reflect the entire manufacturing asset over its useful life expectancy.
- Know the cost of your sanitary design needs beyond a sound food plant design. Strategic design coupled with knowledgeable engineering can balance the initial investment with longer term requirements related to food safety, sanitation, maintenance, quality, and operating efficiency.
There are many examples of not spending capital on sanitary design that result in higher cleaning costs. One of these is that of a bakery which decided to “save” $200,000 by not installing a dehumidification system on six new outdoor silos. A few weeks later, flour lumping blocked a pneumatic conveyance line with sticky and moldy material from inside the silos. It took three workers four hours to clean the inside of each silo once every two weeks to prevent a downtime occurrence and minimize the mold. The sanitation plan with the dehumidification system was three workers for two hours to clean the inside of each silo once per month. What is the ROI?
- 3 workers x 4 hours per silo x 26 weeks per year x 6 silos being cleaned = 1,872 hours/year
- 1,872 hours/year x $30/hour pay rate = $56,160/year to clean these silos each year
- Less 3 workers x 2 hours per silo x 12 months x $30/hour pay rate = $2,160/year yields $54,000/year
- The ROI of $200,000 divided by $54,000 = 3.70 years
If the $200,000 had been spent on sanitary design, it would have paid for itself in only 3.70 years by not having to spend an extra $54,000 each year on labor. Then, assuming a silo life of 50 years, that initial $200,000 investment would yield a savings of $2.5 million ($2,700,00 minus the initial investment). The long-term benefit of sanitary design over the life of the asset will reduce operating costs and increase profit and food safety.
Executive management typically thinks in terms of money, so ... show them the money. When all else fails, remember the average cost of a recall is $10 million. Profit increases as operating costs lower; food safety increases as recalls are reduced; improved product quality means fewer complaints; and sanitation improves when less time and effort are required. Sanitary design is a money maker, seriously.
Three years ago, we were talking about a disruptive industry, but today we are living in one. Change, be it regulatory evolution or consumer expectation, is constant. The food industry is challenged with an aging workforce, high attrition rates, operational challenges due to regulatory changes, customer demands, and cultural diversity, to name a few. Employees at the plant level are at the forefront of producing safe food for consumers. Empowering employees with the right information and the knowledge to succeed in their roles is the critical difference between a recall and ensuring customers’ trust in a product.
So how do we help those in charge of safeguarding our food understand this important role? Training and education programs that help people understand the why is often a common answer — empowering them to be responsible, make decisions and reach out for help when needed. With a myriad of training options available, it can be an overwhelming challenge to weave in company-specific practices.
A tried-and-tested solution is to use design thinking. Design thinking, often associated with R&D or innovation groups, is a creative and systematic approach to lay out all possible options and choose those that are most appropriate. It is a human-centered and prototype-driven approach, where you are constantly fine-tuning your thought process to create solutions that are desirable, feasible, and viable.
Following are the key components of integrating design thinking into your education and training process.
- Assemble: Building a design-thinking team is often a matter of assembling a multi-disciplinary team with people from different backgrounds. People who can take a 50,000-foot view are especially important in building holistically framed solutions.
- Understand: Empathize with and place employees’ needs and conditions ahead of the solution. Frontline workers put in long hours and are often on their feet performing repeated actions every day. Seeing things from their perspective is instructive for developing the right approach. Empathize with your employees by observing their behavior in the context of their lives, engaging them in conversations, and eliciting stories. Empathy is the centerpiece of a human-centered design process.
- Define: The goal of the define mode is to craft a meaningful and actionable problem statement. Based on your understanding of the problem, you can synthesize various thoughts into structured observations and powerful insights. Creating a user persona is helpful in preventing scope creep, and ensuring you stay on track. One example would be developing a training program to ensure plant employees are placing the right label on the right product during the manufacturing process.
- Explore or Ideate: Akin to conducting a hazard analysis, in which you list all potential hazards, this stage involves brainstorming and listing ideas. The focus is on quantity, not quality. Once you have conducted a successful brainstorming session, narrow down and select those options that fit the problem statement and persona. Use sticky notes, create mind maps, sketch, implement Draw Toast (https://www.drawtoast.com), or follow other similar approaches for ideation.
- Prototype: To avoid losing innovation potential, two or three ideas are selected for prototyping in response to the problem statement. In this iterative process, create an inexpensive, tangible version of the chosen idea(s) including how the training will look and the props it may require. Using sketches, mock-ups, or a small implementation are possible means to prototype trainings.
- Test: Typically conducted in tandem with the prototype phase, the test phase allows users to interact with the learning prototype. Testing is an opportunity to understand the user and empathize with a potential solution (rather than with the user, as in the empathy step). Get feedback by creating experiences or asking users to compare options.
- Evolve: Regularly reassess if the developed training solution is desirable, feasible, and viable. Even the most established training programs and manuals undergo updates to account for new technologies, information, or audiences.
A successful design-thinking process is one in which people are willing to push boundaries and come up with out-of-the-box ideas. Since these ideas are tested continuously for their resilience through the brainstorming, prototyping, testing, and evolving stages, heavily supporting an idea or influencing it will not result in a favorable solution for frontline workers. So, thinking about how employees feel and what they need is key to developing effective solutions.
Anyone coming of age in the ’70s and ’80s and having a “certain inclination” could have learned about cooking with cannabis from the European editions of a cookbook by literary maven Alice B. Toklas. The Alice B. Toklas Cookbook, first published in 1954, was a collection of traditional French recipes including what might have been one of the earliest instructions for “haschich fudge” (“which anyone could whip up on a rainy day”):
“Take one teaspoon black peppercorns, one whole nutmeg, four average sticks of cinnamon, one teaspoon coriander. These should all be pulverized in a mortar. About a handful each of stoned dates, dried figs, shelled almonds and peanuts: chop these and mix them together. A bunch of Cannabis sativa can be pulverized. This along with the spices should be dusted over the mixed fruit and nuts, kneaded together. About a cup of sugar dissolved in a big pat of butter. Rolled into a cake and cut into pieces or made into balls about the size of a walnut, it should be eaten with care. Two pieces are quite sufficient.”
Today the inclusion of cannabinoids into foods and beverages, in states where adult use of cannabis has been legalized, ranges from cannabis butters and oils to cannabis-infused wine and seemingly everything in between. It has even gone upscale with restaurant chefs creating tasting menus of all sorts of foods crafted with cannabis — although no chefs worth their herbs and spices would consider recommending that raw cannabis be added to baked goods as Toklas’s recipe suggests. Brownies however are acceptable.
Brownies are good delivery devices because they are baked. The main psychoactive ingredient in cannabis is THC (delta-9-tetrahydrocannabinol), which naturally occurs only in very small amounts in the plant. The form that predominates is Tetrahydrocannabinolic acid (THCA) or THC-Acid. THC-Acid has little binding affinity at the body’s endogenous CB1 and CB2 endocannabinoid receptors, so it has little psychoactive effect. The neutral, decarboxylated form does, but it needs to be “toasted” at about 250°F to decarboxylate the material to make it available for receptor binding.
Cannabis consists of more than 420 components and at least 60 pharmacologically active cannabinoids with the two best-described cannabinoids being THC and cannabidiol (CBD). Many may have valuable medicinal properties, and medical research in these areas is proving promising for a number of disorders, but most of the other compounds are not yet well understood, and their physical effects are largely unknown. CBD does not produce any of THC’s psychoactive responses and actually appears to block some of the effects of THC by acting as an antagonist at the CB1 and CB2 receptors.
The body reacts to ingested cannabis differently than smoked. With edibles, the onset of effects is delayed and peak concentrations in the bloodstream are lower, but the duration of pharmacokinetic effects (the high) are extended. This is due to the phenomenon, first-pass metabolism: for there to be an effect, the cannabis needs to go through the GI tract, then be shunted to the liver where it is modified for excretion and gradually absorbed into the bloodstream. This results in a smaller fraction of the ingested cannabis extracts that circulates to the brain. But both the GI tract and liver contain certain drug-metabolizing enzymes and some have an interesting effect. As one is digesting the cannabis-containing food, some of the drug-metabolizing enzymes are creating another potent psychoactive metabolite of THC called 11-OH-?9-tetrahydrocannabinol (11-OH-THC), which has a longer half-life than THC. Because both it and the remaining THC circulating in the bloodstream are psychoactive, the two, together, may significantly add to the level of effect.
In contrast, when smoked, THC is absorbed directly through the lungs bypassing the liver, so virtually no metabolism takes place before it reaches the bloodstream and brain. The THC then quickly distributes to other body tissues and only a small fraction of it remains in the bloodstream to be converted to 11-OH-THC and other metabolites.
Because THC is fat soluble (highly lipophilic), the duration of effect also can be impacted by the fat content, whether the food is saturated or unsaturated, and whether the individual has an empty stomach. Thus, the effect can be prolonged and can last for several hours as it is slowly metabolized. Edibles also create other safety concerns. Many pesticides and extraction solvent residues are fat soluble, so they, too, linger longer. Because of this most, states mandate that raw materials, extracts, and finished edible products undergo laboratory testing for pesticides, heavy metals, and microbial contaminants, as well as appropriate THC concentration. This brings a wrinkle into the laboratory where additional extraction and analytical methods must be devised to be able to test for these materials in the presence of fats and carbohydrates which can mask or otherwise impede analysis.
Thus, food producers, chefs — and the edibles consumer — need to keep in mind that judging the duration and peak effect of edibles is complicated, as it is impacted by not only the amount of THC but also the fat content of the food. And whether or not required by state law, testing is important, as other unwanted chemical compounds can remain throughout processing that may have negative impacts.