After FDA delayed product inspections under FSMA to further prepare industry and ensure there was enough training and education, the agency is reminding farmers and other stakeholders in the produce industry that there are resources available to help them in preparing for the routine inspections—for large farms, these will start in the spring. The inspections will be conducted to verify compliance with the Produce Safety rule.
An FDA Voices blog by FDA Commissioner Scott Gottlieb, M.D., Deputy Commissioner for Food Policy and Response Frank Yiannas and Associate Commissioner of Regulatory Affairs Melinda Plaisier also discussed how the agency has been supporting industry work to comply with the rule, including:
Granting 46 states and one territory with more than $85 million through the State Produce Implementation Cooperative Agreement Program to aid in the development of state produce safety systems that offer education, outreach and technical assistance
With partners, supporting the training of more than 31,000 produce farmers globally on the Produce Safety rule requirements
With partners, the creation of a new inspection form that gives farms feedback and observations that occurred during the inspection, regardless of whether non-compliance issues were found, in an effort to help explain what they’re looking at and how observations apply to the produce rule
The food industry has been hard at work over the past few years implementing food fraud mitigation plans in response to Global Food Safety Initiative (GFSI) certification program requirements. GFSI defines food fraud as:
“A collective term encompassing the deliberate and intentional substitution, addition, tampering or misrepresentation of food, food ingredients or food packaging, labelling, product information or false or misleading statements made about a product for economic gain that could impact consumer health.” (GFSI Benchmarking Requirements, 2017)
GFSI then further defines the terminology of food fraud by citing seven categories (shown in the following diagram).
In the Food Fraud Database, we categorize food fraud records using the following terminology (with examples):
Dilution/substitution
Substitution of an entire fish fillet or partial dilution of olive oil with another oil
Artificial enhancement
Addition of melamine to artificially increase the apparent protein content of milk or the addition of coloring agents to spices
Use of undeclared, unapproved, or banned biocides
The use of chloramphenicol in honeybee populations (where not permitted) or the addition of hydrogen peroxide to milk
Removal of authentic constituents
The sale of “spent” spice powder (used in the production of an oleoresin) as a whole spice powder
Misrepresentation of nutritional value
Infant formula that does not contain the required nutritional content
Fraudulent labeling claims
Misrepresentation of label attributes related to production method (organic, kosher, halal, etc.)
Formulation of an entirely fraudulent product (using multiple adulterants and methods)
The sale of “100% apple juice” that consists of sugar, water, malic acid, flavor, and color
Other
This includes counterfeits, theft, overruns, etc.
Harmonization of food fraud terminology is frequently discussed, so I thought it might be useful to provide information on how our definitions relate to the GFSI terminology:
GFSI category “Dilution”: This category maps directly to our category dilution/substitution. The reason we combine these into one category is that the intent is the same: To replace the weight or volume of a product. This can occur either through partial or full substitution of a liquid product, a granulated product, or swapping an entire intact product such as a fish filet. One of the GFSI examples for substitution is “sunflower oil partially substituted with mineral oil”, which could just as accurately be described as dilution.
GFSI category “Substitution”: As noted above, this category maps directly to our category dilution/substitution. However, we would not consider the use of hydrolyzed leather protein in milk (one of the cited examples) to be dilution/substitution because it is not used to replace weight or volume. We would view that as artificial enhancement of the protein content of milk.
GFSI category “Concealment”: We do not include a category focused on concealment because all food fraud involves concealing some aspect of the true contents of the food. One of the examples cited in this category is “poultry injected with hormones to conceal disease.” The use of antibiotics, anti-fungal agents or other substances to reduce bacterial load or mask deterioration would be classified, in our system, as the use of undeclared, unapproved or banned biocides. The use of coloring agents on fruit to improve appearance would also be classified as artificial enhancement.
GFSI category “Mislabeling”: Since all food fraud is, to some extent, mislabeling, we reserve the use of the term fraudulent labeling claims to those label attributes that describe production processes (organic, kosher, etc.). With the exception of falsification of expiration dates, the other examples cited would not be classified by us as mislabeling. The sale of Japanese star anise, which is potentially toxic, as Chinese star anise (a different species) is dilution/substitution and a health risk to consumers. The sale of cooking oil that has been recovered from waste streams and illegally produced is also a form of substitution that poses a potential health risk to consumers.
GFSI category “Unapproved enhancements”: This GFSI category aligns nicely with our category artificial enhancement, and both examples cited are nicely illustrative of the concept, which involves the fraudulent addition of a substance specifically for its function (not as a replacement for weight or volume).
GFSI Category “Gray market production/theft/diversion”: The production and sale of food products through unregulated channels would all be classified in our category called other. Because these forms of food fraud involve the sale of food outside of regulatory control, prevention measures will generally be substantially different from the prevention of fraud within legitimate supply chains.
GFSI Category Counterfeiting: This GFSI category is similar to the gray market production/theft/diversion category in that it involves intellectual property infringement and production outside of regulatory control. It would similarly be classified in our other category.
FDA has issued a final guidance that reviews the situations in which a company should warn the public about a voluntary food recall. This includes the appropriate timeframe for issuing the warning and what information a company should include in the warning. The guidance, “Public Warning and Notification of Recalls”, also discusses when the FDA may decide to take action to issue a public warning, should one that a company issues is not sufficient.
In an agency statement, FDA Commissioner Scott Gottlieb, MD., also addresses the buzz around folks feeling that there have been more recalls. “In actuality, for fiscal year 2018, there were a total of 7,420 recalls with 831 that were classified as the highest risk. That figure represents a five-year low in recalls. However, the reason why recall notices might seem to have increased is that our publicizing of these events has become more prominent,” said Gottlieb. “We’re routinely providing more information on recalls and other safety issues that have happened.” He added that the ability to detect, track and trace product issues has improved with the help of technology, including whole genome sequencing.
“Our labs are currently testing cutting-edge technology that can screen for multiple allergens simultaneously and even technology that shrinks the genetic testing of pathogens from machines that were once the size of an entire room to a device that’s smaller than many smart phones. We’ll also be working to improve product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health.” – Scott Gottlieb, M.D., FDA
In addition, the agency is looking at how new technologies can be used notify consumers about whether a product they purchased has been recalled.
It is one week before your scheduled audit. Are you running around from department to department crossing the T’s and dotting the I’s, or are you cool, calm and collected, as it is just another audit? More than likely you have been in both cases, but how does one finally get to the collected stage? It is not about being nervous—even as a lead auditor I get nervous (I am human, too)— it is about being ready!
Believe it or not, I can generally gage if the audit is going to flow well within the first hour of arrival. My questions from audit to audit of course change, but overall, I am asking for the same materials and results. If the team is getting baffled by questions in the beginning stages of the audit, I know I am in for a long ride. Why does this happen? If the situation has gone down hill rather quickly, I find that whomever at the plant is responsible for the implementation of the audit standard, has never taken the time to read or review it. That, my friends, is one of the most critical mistakes you can make. I know these standards are not world-class bestselling books that you are dying to binge read by the fireplace with a glass of wine—if this was your view, you would be an auditor already. HA! The standards are not always black and white as far as requirements, but just taking the time to read the standard will enhance your understanding of where the auditor is coming from.
Now you have read the standard, you understand it and are comfortable. You have a 200,000 square-foot facility, 200 employees and four different HACCP plans to watch over. How could you possibly score an excellent, “A”, pass, whatever the top score may be defined as? I am sure you have heard the expression, it is not all about you, and that holds true for audits. So many times I have witnessed that the quality manager (or equivalent) try to undertake the entire audit from start to finish and answer all the questions. This is not a best-practice approach. A good example here would be that many audits now talk about annual objectives and key performance indicators. As an auditor, I expect that your plant manager (or equivalent key person responsible) come talk about these with their senior management. Too often I see the quality department commit to answering these questions, but as an auditor, I am interested in your system and how it works throughout your entire facility. I do not just want to know about the quality department. Get all departments involved. They, too, then get firsthand experience of understanding what the audit requirements are, instead of just reading endless emails of what needs to be accomplished.
Teamwork and understanding are now established—great! How strong are your programs? There are a few programs I want to touch on here, including your internal audit program and procedures. I can not write this article and tell you “X” is the solution, as there is not a one-size-fits-all approach. If you are spending two hours on an annual internal audit for a facility like the one mentioned above, it is possible that your program is lacking robustness. When conducting an internal audit and a requirement is in compliance, do you write what made it in compliance, what you reviewed, and with whom you spoke? This is a great way for you to compare what you see in your plant versus what an auditor sees in your plant, especially if you built your internal audit from an audit standard. How about your sanitation program? I came from a background of meat inspection, so maybe I am a bit biased, but your sanitation is encompassed with other pre-requisite programs in the facility. If your facility has untidy locker rooms, cafeterias and bathrooms, what motivates the employees to be tidy on the production floor? Sometimes it is the small things that go a very long way. In talking about sanitation, I have observed that many site managers never go in to watch your pre-operational inspections that may take place very early in the morning. Just because it is not on first shift, does not mean it is not important, and it also does not mean that it will not be audited. Likely, it will be audited!
Lastly, take all nonconformities that you have found either through internal or external audits, respond to them in a timely fashion, and get the root causes and preventative actions in place! Nothing pains me more then to see sites repeat a nonconformance, just to possibly get a major conformity. It’s like shooting yourself in the foot and your audit score takes an unnecessary plunge that could have been avoided.
Audits are not a fad and are not going away. It does take way more time to get to the cool, calm and collected stage for audits, but in the end, being audit ready all the time looks good on you and your site!
When it comes to addressing food safety, did the industry really make any progress in 2018? In 2019, what new approaches or technologies can be successfully applied to prevent problems before they occur and minimize the consumer risk, minimize the market impact, and speed up the identification, isolation and recall of contaminated products?
Field-packed produce offers a unique challenge to the fresh food supply chain, as it is not processed and is not required to adhere to an FDA mandated HACCP (Hazard Analysis and Critical Control Points) process. It has been a challenge for field-packed produce suppliers to proactively identify or prevent contaminated produce from entering the supply chain. As a result, during serious contamination incidents, the reaction is to pull and destroy all suspect product from store shelves and supply chain. Due to the lack of data isolating the source of the contamination, this is the safest approach, but it’s costing the industry millions of dollars. Ultimately, our inability to prevent or quickly isolate these events causes confusion among consumers who don’t know who to trust or what is safe to eat, resulting in a prolonged market impact.
In response to the latest E. coli outbreak involving romaine lettuce, the industry has proposed a voluntary item-level label that reflects the harvest location and date, to help identify safe product to the consumer. At best, this is a stop-gap solution, as it burdens the consumer to identify safe product.
I work in the fresh produce supply chain industry. When I go to the grocery store, I examine the produce, noting the brand and various other factors. I was aware of the romaine problem and the voluntary labeling program, so I knew what to look for. But I’m an exception. Most consumers don’t know romaine lettuce is grown during the summer and fall in northern California and further south during the winter in regions that include Arizona and Mexico. Most consumers don’t know what the “safe date” for harvest really means—nor should they be required to know this information. They look to the industry to manage this. If we buy a car or microwave oven that is found to be unsafe, the manufacturer and the government are responsible for identifying the problem and recalling the product. Yet, in the produce industry, that responsibility seems to be moving to the retailer and consumer.
It’s an unfair burden, as the retailer and consumer do not have the necessary information to make a definitive judgement regarding food safety. The responsibility needs to be shared across the entire fresh food supply chain. Records about the produce need to be shared and maintained from harvest to retail.
Will 2019 be the year that we realize we can address this challenge proactively to improve the safety of our fresh food?
We need a new approach that leverages innovative technology to provide a more reliable solution. For example, irrigation water is often identified as a culprit in spreading bacteria. Yet even with regular testing of irrigation water, the results do not currently guarantee food safety. We see emerging technology that will make regular testing more reliable, accurate and affordable to facilitate more proactive management of the water supply. This will be a critical part of an overall solution for proactive produce food safety.
Blockchain technology has been hailed as a savior of food safety and traceability. Early in 2018, it was all the rage, as various sources claimed that, by using blockchain, recall times could be cut from days or weeks to seconds. But was this an oversimplification? Perhaps so, as this early hype faded by the middle of the year amidst the various food safety outbreaks that went unresolved. Then last August, Gartner, a market analyst firm, declared that blockchain had moved into the “trough of disillusionment” on its 2018 Hype Cycle for Emerging Technologies as a result of over-hyped expectations. The firm predicts that the technology may reach the “plateau of productivity” within the next decade. Can we wait another 10 years before being able to benefit from it? Should we?
We expect that blockchain trials will continue in 2019. But, while blockchain has shown promise in terms of being a secure and immutable data exchange, questions remain. What data about the produce will be entered into the blockchain? How is that data collected? Is the data validated? Bad, inaccurate or incomplete data makes blockchain relatively useless, or worse, as it undermines a trusted platform. Further, without broad agreement and adoption of data collection, blockchain can’t be successful.
For proactive management of food safety, we will also need to address both forward and backward supply chain traceability. One of the challenges realized from recent outbreaks is that it takes time to figure out what is happening. Identifying the source of the illness/outbreak isn’t easy. Once we identify a source (or multiple sources) of the contamination, blockchain—assuming that all of the necessary data has been collected—only helps to more quickly trace back produce to its origin. But, for growers, quickly understanding where all product shipped from a specific location or date is just as critical in understanding and minimizing consumer impact. Tracing product forward enables a grower to proactively inform retailers and restaurants that their product should be recalled.
Blockchain currently does not directly support this forward tracing, but can be augmented to do so. But blockchain can maintain a food safety data item, or items, that could quickly and reliably communicate product status at the pallet-level, providing instant food safety status to the current product owner, even if they didn’t have direct contact with the grower. As such, a hybrid blockchain approach, as espoused by ChainLink Research, is optimal for forward and backward traceability.
Equally important, we need to fully digitize the supply chain to enable blockchain. To make comprehensive data collection feasible, we need to automate data collection by utilizing IoT sensors at the pallet level, to properly reflect how distribution takes place through the supply chain. We need reliable data collection to properly reflect the location and condition of product distributed through a multi-tier distribution network. That level of product data visibility enables proactive management for food safety as well as quality and freshness— well beyond the current trailer-level monitoring that only monitors transit temperatures with no benefit to managing food safety. Effective data capture will define the next generation of fresh food management, as it embraces proactive food safety, quality and freshness management.
Goals for This Year
For 2019, our goals should be to embrace new approaches and technology that:
Identify food contamination at its source and prevent contaminated food from ever entering the supply chain. We need to focus on developing new technologies that make this feasible and cost effective.
Accurately and consistently track product condition and authenticity of fresh produce from the time it is harvested until it is delivered. IoT sensors and proactive fresh food supply chain management solutions provide this capability.
Make it cost-effective and practical for growers, suppliers and grocers to use solutions to improve the entire fresh food supply chain. If we make the process burdensome or without a reasonable ROI, implementation will lag, and the problems will persist. But if we demonstrate that these solutions offer value across the fresh food supply chain—through reduced waste and improved operational efficiency—growers, suppliers, shippers and grocers will embrace them.
I oversee an executive search firm that specializes in placing food scientists in the food industries. In many of our searches, we are asked specifically for individuals who have food science degrees versus other scientific degrees. When we asked the universities how many students were graduating in the 33 universities approved by IFT, we received a variety of answers. So, in 2006 we started our Food Science Student Survey, asking the chairs of each of the departments to provide the answers to three questions: How many students are in the program, how many are seniors, and how many are pursuing a graduate degree. The survey has been completed every other year since 2006.
The good news is that the numbers have doubled. In 2006, there were only 462 seniors in 33 U.S. universities in food science programs. In 2018, there were 931. The departments vary in size, from UC Davis being the largest program with 249 undergraduate students in their program, to the smallest, Tuskegee University with only 15. The total number of undergraduates in 2018 exceeded 3400. This is good news for the food industry, as there has been a shortage of food scientists for many years, especially due to the baby boomers retiring. With stronger food safety regulations, and a constant need to innovate, the food industry needs more qualified food scientists. We appreciate the efforts of the universities to expand their programs.
Survey of Food Science Students in IFT-approved U.S.-based Universities (2018). Table courtesy of OPUS International, Inc.
Building a supply chain verification program can be a complicated task. In the following exclusive video with Doug Marshall, Ph.D., chief scientific officer at Eurofins, we learn the top questions that should be asking their suppliers during the process. Marshall also gives his perspective on the integration of data into the supply chain and how it can mitigate risk, along with where he’s sees the future of food safety testing headed.
Whole Foods Market has voluntarily recalled various products containing baby spinach following a recall by its supplier Satur Farms over concern of potential Salmonella contamination. The prepared foods have a Whole Foods Market scale label and were sold in eight states in the Northeast and Florida and include salads, pizza, sandwiches and wraps. No illnesses have been reported.
On-site rapid tests for allergens are an important part of any manufacturing facility’s allergen control plan. Several companies offer allergen test kits for day-to-day use, and it can be hard to tell the differences between them or determine which is the best fit for a given facility. What’s a busy QA professional to do?
One of the most overlooked factors when choosing an allergen test kit actually has almost nothing to do with the test kit itself. Instead, it’s much closer to home: The matrices being tested are just as—if not more—important to consider than the test kit itself.
Before you commit to any allergen test kit, you should talk to someone extensively about the types of products you plan to test. There are a variety of surprising and counterintuitive ways that your matrices can impact the functionality of a test, and you’ll save time and money by understanding information BEFORE you start testing. Below, we’ll review some of the most common matrix challenges.
High Fat Matrices
Let’s imagine a facility that makes ice cream and sorbet. Let’s assume they make a gourmet strawberry ice cream and a fat-free strawberry sorbet, both of which ought to be peanut-free—but since some of the ingredients come from a supplier who also works with peanuts, the QA team decides to run a rapid peanut test on the strawberry products.
Much to the team’s surprise, the sorbet tests positive for peanut but the ice cream does not. What could be happening? Of course, the simplest explanation is possible: The sorbet has peanut residue in it and the ice cream does not. However, there’s another, trickier possibility: They could have the same amount of peanut residue, but the full-fat ice cream could inhibit the test kit’s ability to detect the allergen.
In general, the higher the fat content of your matrices, the higher the detection limit on your test kit. It’s an imprecise spectrum: Using rapid tests to find traces of allergenic protein on an oil is nearly impossible, on fat-rich items like ice cream or cream-based soups it’s a challenge, on items with little or no fat it shouldn’t be an issue. That isn’t to say there couldn’t be other issues with low-fat items, as we’ll review below.
Matrices Processed with High Heat
Let’s say our ice cream facility starts making a peanut-butter-swirl flavor. Perhaps they will begin testing their rinsewater for peanut residue after running that flavor, to ensure satisfactory cleaning. The kit they use says it can detect peanut allergen to 5 ppm, and rinsewater is not a high-fat matrix, so they should be good, right?
In this exact example, it’s probably just fine. However, it’s important for the QA team to consider the temperature at which peanuts were roasted. While raw peanut might be detectable at 5 ppm, roasted peanuts could have a detection limit that is much higher. In fact, very strongly roasted peanuts could only be detectable at levels of 500 ppm or more. This doesn’t mean there is no reason to test—but it’s important to know that many antibody-based tests will respond differently to an allergen processed with high heat than one that is raw. The same detection challenge can sometimes be seen with canned or tinned items that are subjected to high heat in processing.
Fermented or Hydrolyzed Matrices
Two of the trickiest items when it comes to allergen detection are soy sauce and fish sauce. In both of these condiments—and many other common ingredients subjected to these types of processing—the allergenic material is subjected to heavy modification. As proteins get folded and broken in unpredictable ways, they become more challenging for antibody-based test kits to detect. In fact, soy sauce and fish sauce are nearly undetectable by most kits.
When validating a cleaning process after using one of these ingredients, often the safest thing to do is to test for a different allergen—formulated in a simpler way—that is also present. Sufficient cleaning after a product made with fish sauce and breadcrumbs, for example, could be proven with a gluten kit; that second allergen will be unaffected by the fermented allergens in the recipe.
Matrices without Multiple Proteins
Some kits look for a variety of proteins commonly found within one allergen. Other times, though, each test kit will be looking for one specific protein. It’s important to confirm that the allergenic protein your facility works with is in fact an allergenic protein that your test kit is trained to recognize.
Perhaps the most common FALCPA allergen where this plays a role is milk. While there are a number of proteins in milk, casein is the most common and accounts for approximately 80% of the protein in milk, making it a common target for allergen test kits (both rapid and ELISA). The remaining 20% of protein is comprised of various whey proteins, most commonly beta-lactoglobulin.
In the case of our ice cream and sorbet facility mentioned above, a kit that detects casein OR beta-lactoglobulin OR both proteins together could be suitable for confirming that the sorbet is truly milk-free. However, there are other types of product that contain only whey proteins, which are a popular way to increase protein content in a variety of foods and beverages. If a facility that works exclusively with whey proteins uses a kit that only detects casein, they will never have a true understanding of their allergen contamination risk.
Another challenging FALCPA allergen is fish, as there are many different species of fish with quite divergent protein structures. If you are testing for fish contamination, it’s important to understand which species of fish the test you are considering can detect, and which species may pose a problem. If there is a mismatch between kit and matrix, then you’ll need to find a different way to ensure safety.
How to Troubleshoot Your Matrices
If you are beginning an allergen testing program, find time to talk with the manufacturers of any allergen kits you are considering. You may also want to talk with the representatives of any labs that are doing third party testing for you. Some questions to ask include:
What matrices have you validated your tests for?
Do you anticipate any issues with my matrices?
How should I validate your tests for my products?
What factors impact the sensitivity of this kit?
Does the detection limit change based on the matrix?
Your kit manufacturer (or third-party testing lab) should make you feel confident that they understand the quirks of your specific matrices—and they should have ideas for how to troubleshoot any challenges that they foresee. If a supplier tells you that their kit will work equally well across all matrices and declines to offer proof that corresponds to your needs, beware (or at least be prepared to conduct rigorous validation on your own). Allergen detection is complicated, and as with so much of life: If it sounds too good to be true, it probably is.
Beyond reducing liability or checking a regulatory box, investing in robust training can reap measurable business impact. The FSMA regulation requires that Preventive Control Qualified Individuals (PCQIs) “have successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system,” as per Subpart C Section 117.180 (c) (1). Even if the person serving in the role of PCQI is qualified through job experience, FDA investigators will expect adherence to development and application of risk-based controls as contained in the standardized PCQI curriculum material or the alternative training allowed in the regulation.
Let’s face it: Our employees serving in the role of PCQI come from a spectrum of food safety plan experience. In addition, many are mentoring new members as Qualified Individuals on the food safety team. Others are building a whole new team from scratch. Team members may be specialized department heads or hold several titles and job duties within a manufacturing facility. Your PCQI is charged with overseeing the development and analysis of the food safety plan. The PCQI needs a team that has had consistent training in the language of the new rules and how to comply to support the PCQI’s charge.
Beyond meeting the regulation, companies should train at the PCQI level to safeguard a company’s product quality, brand and customer base. The fewer food safety-related claims you have, the more you save in costly recalls, loss of current or potential customers, and your brand’s reputation. A company with a robust safety culture has a competitive advantage over competitors who are more lax in their food safety and may suffer financially and reputationally from recalls and customer quality assurance complaints. In an era when customers are seeking more information about the food they consume, being a trusted food safety brand can make your company stand above the crowd.
In addition, consistent training can help with internal culture change and worker productivity. Working on hazard analysis and defining preventive controls requires that employees show critical thinking and problem-solving skills. Team members taking a curriculum with standardized material and consistent learning objectives can reflect together to identify and document gaps and corrections to practices or processes. They can quickly apply their learning for more accurate analysis of the components of the food safety plan. This is the true impact from investment in high quality instruction—motivating employees to learn updated food safety practices, change their behavior, and make more efficient and effective decisions to keep the quality and safety of your products. Well-trained food safety employees are a key factor in the protection of your customers, your company’s brand and the prevention of costly food recalls. The investment in training at the PCQI level is strategic on all fronts.
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