Today FDA announced its strategy for training the food industry as part of the successful implementation of FSMA. This included awarding a $600,000 grant to the International Food Protection Training Institute (IFPTI) to establish a National Coordination Center. This center will serve an important function in the training process for the food industry.
“One size won’t fit all when it comes to training,” according to an FDA release. “The most important goal that the FDA expects of any training program is the outcome—that it advances knowledge among the food industry to meet FSMA requirements.” The agency indicated that there will be different options and delivery formats for the training, but wants all hands on deck—domestic and international stakeholders from government, industry and academia—to work with FDA on developing and delivering the training to food suppliers.
The alliances include the Produce Safety Alliance, the Food Safety Preventive Controls Alliance and the Sprout Safety Alliance
Alternate training options
Cooperative agreements, including a five-year agreement with the National Association of State Departments of Agriculture
Establishing the National Coordination and Regional Centers to support training delivery
Delivering the training
The three above alliances are developing a Train-the-Trainer program to provide training via an established process. A range of partners will be involved, including the Association of Food and Drug Officials, the Association of Public Health Laboratories, and the Association of American Feed Control Officials
A FSMA collaborative training forum co-chaired by FDA and USDA
Many food safety and quality assurance (FSQA) professionals are constantly on the go in the workplace. They can be found on the floor of a manufacturing facility, off-site conducting supplier audits, or out in the field performing pre-harvest inspections, just to name a few locations during their busy day. “To benefit from food safety automation, these folks need more than the capability of logging into a system through a desktop,” says Levin. “They need a true mobile app that provides automation support out in the field,” says Barbara Levin, senior vice president of marketing and customer community at SafetyChain.
While other industries have been quick to adopt mobile platforms, the food safety industry has been much slower. Adoption is, however, gaining traction. In a recent conversation with Food Safety Tech, Levin talks about the value of FSQA mobile apps in today’s environment, where access to real-time, actionable data is crucial for the food industry.
Food Safety Tech: What common challenges faced by FSQA teams do mobile apps specifically address?
Barbara Levin: Mobile apps allow collection of FSQA at the point of origin, along with immediate access to the information for analysis, CAPA and reporting:
Getting timely feedback on non-compliances for CAPA. When FSQA data is inspected at the end of the shift on paper, finding non-conformances often means rework. The instances in which this happens are too numerous to count. With mobile apps, you receive timely feedback. Information in the system is immediately analyzed to specs, so you’re catching non-compliances at the earliest point possible.
Consistency in following your FSQA programs. This could be your USDA HACCP plan, FSMA HARPC plan, GFSI program, customer quality attributes and other components of your FSQA programs. Program components change all the time (i.e., Specifications, processes, rules in HACCP, GFSI code, forms, workflow, etc). Are FSQA managers confident that everyone is following the most up-to-date program? Is everyone following the workflow and doing everything in the right order? Are they completing tasks accurately? Using the right forms? Unfortunately companies find out that steps are missed or outdated forms were used during an audit; or when missed steps result in expensive rework or in the worst case, a customer rejection, withdrawal or a recall.
Mobile apps will always have the most up-to-date forms, processes, specs and more. They act as a coach, leading the FSQA team member through the proper steps. When you enter incorrect or incomplete information on paper, it may not be detected until the end of the day or shift. A mobile app will issue an alert if incorrect information is entered; and it won’t let you submit a form if all fields aren’t complete. Because all of the updates are made in the system and pushed out to the app, if the specification changes while an FSQA team member is on the plant floor, when he or she logs in, the latest spec will always be there. You’re ensured that only the up-to-date program is being followed and that only the most up-to-date forms are being used.
A lack of information for continuous improvement trending. If you have multiple facilities and products (resulting in mountains of FSQA paper), it’s a huge, manual task to make all of the data useful and relevant. With mobile apps, all FSQA data is entered “once and done,” making it accessible and actionable for immediate FSQA result tracking, daily KPI reporting and continuous improvement.
Audit readiness. Mobile apps take audit readiness to a different level. With FSMA and GFSI, the saying is, if it’s not documented, you didn’t do it. By collecting FSQA data at the point of origin, all data is time and data stamped and uploaded to your permanent FSQA record. There’s no redundant data entry, mistakes are avoided, and there’s greater record efficacy that helps companies be audit ready, on demand.
Mobile forms capture safety and quality data at the point of origin; data is actionable and then uploaded into a central repository for reporting and audit readiness. Image courtesy of SafetyChain Software. (Click to enlarge)
FST: What is the biggest benefit that FSQA mobile apps offer?
Levin: The first benefit is real-time feedback. If you think about how things were done in the past, using an example of a pre-harvest inspection, you’re out there with a clipboard, making observations and recording non-compliances. Then you have to go back and enter the information into a spreadsheet, or turn it into a PDF, and send it to the food safety manager, who may or may not be sitting at his or her desk. Waiting to get a response equals time lost. And in the food industry, time equals money.
When you’re entering information into a mobile app, it analyzes that information in real-time and according to specifications. When there are non-compliances, alerts are pushed to the FSQA manager – wherever [he or she is located]. The manager can then generate a CAPA, which can then be completed, documented on the mobile device and electronically signed off by the manager. The process is expedited, and expensive rework is avoided.
The second benefit involves data efficiencies. When data is collected on a mobile device, it’s entered only once and is then immediately available for multiple uses, such as a customer’s certificate of analysis, attachment to GFSI code for audit, or to be produced upon demand for a regulatory inspector. With a manual system, there’s a tremendous amount of redundant data entry. We hear this all the time from food safety folks— that they feel like they’re managing paper instead of food safety programs. When data is entered into a mobile app, it’s accessible immediately to FSQA, operations, vendor purchasing, management – any stakeholder who has a need.
“The Power of FSQA Automation Via Mobile Applications” Download the whitepaperFST: What approach should be taken to encourage the investment in and implementation of an on-the-go FSQA mobile platform?
Levin: I would love to think that in an ideal world, the creation of operational efficiencies that enable a higher level of confidence that you are sending out safer food is enough. Food companies are businesses, and they have obligations to consumers, which they take very seriously. But they also have obligations to their shareholders. When we talk to folks who really want this, it’s very easy to create a business case to senior management based on ROI. When you can close the gap by hours and days in the food industry, that time equals money. Avoiding rework also saves money. And there’s ROI in faster sales throughput and increased shelf life by reducing hold and release times. We’ve heard from our customers that the solutions have paid for themselves and started to create ROI within three to six months.
To understand why an integrated informatics solution is important to manufacturers in the food and beverage industry, it helps to first consider the unique challenges this industry faces. Simply put, food production has scaled into a global business so rapidly that oversight has hardly kept pace. Even the stricter regulatory stances taken by the FDA and the European Union in the past decade are effectively catch-up efforts.
The broader food industry, which for purposes of this article will also comprise the beverage industry, has globalized quickly and, many would argue, haphazardly. It actually wasn’t that long ago that the products we purchased in our local food store were produced locally or regionally. Seasons determined selections as well—if you wanted a tomato in November, you would pay a premium for that indulgence.
Seasons and geography no longer constrain what we can buy and when. By far the world’s largest industry—with a combined revenue of more than $4 trillion, the food industry has used its massive scale to overcome historical limitations. We now take for granted that our grocery carts can be filled with fresh products that may come from thousands of miles away. And those products may have been grown, processed and shipped in multiple countries before they reach our local grocer.
The complexity and scale of this modern food supply chain is the industry’s greatest challenge and regulators’ greatest worry (on consumers’ behalf). How can growers, producers, processors, packagers, shippers and others in the global supply chain secure a food chain that’s so distributed? How can regulators ensure safety without restricting choice or inflating prices?
The Bits and “Bytes” of Food Safety
The food industry—and its regulators—would likely agree on one thing: A system this massive cannot operate on trust alone, as it once did. The grower with generations of experience on the land, for example, is now too far removed from end consumers. A finished product may contain one farmer’s product and those from five others, all from different regions worldwide.
Integrated informatics may seem like an unlikely fix for modernizing a highly distributed food chain, but it’s actually perfectly suited. An integrated informatics platform provides access to massive amounts of information in a timely fashion, dramatically improving decision-making. It does this by making information rapidly available to many stakeholders and by ensuring that it’s reliable.
Consider this example. A hypothetical lab uses an analytical instrument to detect pesticides in barley, and regulation dictates that this data be compared to allowable maximum residue limits (MRLs). If the barley sample exceeds allowable MRLs, the manufacturer must identify everywhere that ingredient is being used, quarantine it and determine who produced it. All this must happen quickly and according to strict procedures.
Procedures are critical. Not only must the lab have a process for checking against current limits for a pesticide, for example, but also that analytical information must be carefully tracked with the appropriate sample, and the method used to deliver the result must be consistent between different samples and users. Without an integrated informatics solution, adhering to these procedures, defending the quality of the data, and making it usable would be nearly impossible.
The Role of Informatics in Compliance
Gathering the bits and bytes of data, following procedures and making the data useful enterprise-wide is important, but regulatory compliance is where most industry attention is focused today. This is another area where integrated informatics provides significant benefits.
As mentioned above, food industry growth significantly outpaced regulatory oversight in the past decade. Globalization was rapid and inevitable, but so too were food safety breaches, and with progress came stories of tainted fruits, vegetables, meats, cereals, nut butters and much more. Suddenly we had a trust issue. With a food chain that’s distributed across many borders and jurisdictions, how is the public’s trust best protected and by whom?
From the Food Safety Modernization Act (FSMA) to EU Regulation No. 178/2002, we’ve seen a heightened regulatory focus, and the most common themes are traceability, authenticity and risk-based approaches. The common denominator here is food chain security.
So what does all of this mean for multinational food and beverage producers? It means having to conform to multiple regulatory requirements for each distribution market, and there are often many. And this is a data management and reporting headache. Fortunately, however, common standards such as ISO 22000 exist that enable companies to standardize their processes enterprise-wide, achieving levels of operational rigor and quality that satisfy multiple regulatory authorities at once.
So where do informatics fit into this regulatory compliance landscape? In a typical multinational food producer, a significant amount of the quality data is delivered by the laboratory. Raw materials are analysed for pesticides, herbicides, nutritional content and so on. Packaged products are monitored for shelf-life compliance. Plant hygiene is monitored using microbiological samples taken from across the facility. Records from all of these distinct, but interrelated activities are critical for demonstrating compliance.
Defending Data
The shift in recent years has been toward prevention instead of crisis response. Regulators now focus on auditing food and beverage producers to assess their practices prior to any adverse event. For companies with good systems in place, time-consuming audits will be less frequent, so it pays to have systems in place that demonstrate that data is reliable and defensible.
Audits can be daunting. The producer must prove that activities were carried out correctly, that records are properly collected and that supporting information is accurate. Auditors typically pick a starting point in a process and follow the trail. They may start by looking at the data associated with a released batch of product; perhaps quality assurance samples; follow the trail to cleaning validation, and then review individual laboratory results, including entire methods, instrument calibration, user training, etc. At each point of the audit, producers must show evidence of compliance—even the smallest details.
With an integrated informatics solution, all evidence resides in a single platform. Hierarchies and relationships within the data records are automatically recorded and retained. Everything—from relationships between lots or batches of material; the connection between methods, specifications and results; the history of an instrument configuration, maintenance and calibration; and user training records—is in one place for easy retrieval and reporting.
Having one system of record not only codifies data capture, it also helps labs create standard operating procedures (SOPs). Establishing SOPs does several important things:
It ensures that all lab users are following the same process—no personal preferences for carrying out a specific test.
It makes sure that all necessary data is collected—by enforcing a series of data entry steps, labs can prevent a method from being marked complete until everything has been entered.
Labs can roll out updates to their processes by updating the method for all users at the same time.
Managing lab execution activities in this way means that data is more consistent; it is being collected in the same way for all users. It is also prone to fewer errors because users move stepwise through each stage of the measurement process, and they can stop a test whenever they encounter a problem.
Achieving Traceability
Traceability, the ability to verify the history, location or application of an item using documented information, has become increasingly more important for the food industry. And traceability is closely linked to compliance and data defensibility. Fortunately, traceability is another strength of an integrated informatics solution.
In practical terms, to demonstrate traceability we must be able to go either backwards or forwards within a set of process items and understand the complicated relationships. An integrated informatics solution lets us map relationships between “child” and “parent” batches, information that can also come from integrating ERP or process or production information management (PIMS) systems. By integrating all this information, manufacturers can trace a product back through intermediate products and raw materials and then forward again to any resultant batches that may be contaminated. In other words, with an integrated informatics solution, traceability is built in.
Brand Protection
Because of its size and fragmentation, the global food and beverage industry is a target for adulteration and counterfeiting. The Grocery Manufacturers Association estimates that these activities cost the industry $10–15 billion each year.
While the risk to consumers of adulteration can be deadly, as in the case of milk solids adulterated with melamine in China, much of the impact comes in the form of trust erosion and fraud. An example is Manuka honey, a premium product with purported health benefits that commands a high price. The entry of fraudulent producers into the market affects legitimate producers by creating uncertainly about all products, depressing sales and lowering prices.
Having access to data from all critical points in the food production chain is the most important safeguard against product recalls and loss of revenue for food manufacturers. Having an integrated informatics solution in place provides data when it is needed for quality checks in the production process, for management metrics reporting or to adhere to regulatory requirements. (Click to enlarge)
This is only one example, but it illustrates the larger problem: Once consumer trust erodes, it’s hard to regain. As it happens, however, honey has unique chemical markers that can be used to determine whether it has been adulterated. But isolating these markers involves complex analysis, including ultra- high-performance liquid chromatography (UHPLC), and methods that are highly specific, consistent and defensible.
Consistency and defensibility are hallmarks of an integrated informatics solution. For the honey producers, an informatics solutions, such a LIMS, can automate processes so that no non-conforming product is missed, establish compliance rules and checks for instrument calibration so that results are defensible, and standardize methods through built-in laboratory execution system (LES) capability.
Conclusion
An integrated informatics solutions is designed to address multiple business needs in the food and beverage industry, from compliance and data defensibility to traceability and brand protection. The complexity and scale of the modern food supply chain demands it.
Growers, producers, processers, packagers, shippers and others in the global supply chain are now interdependent, but not necessarily integrated. The only way to protect consumers, however, is to achieve this integration through a combination of voluntary and imposed compliance. And to achieve this compliance without undue burden on the industry and imposing higher costs on consumers, we need technology that is built for integration at scale—and informatics solutions have proven they are more than capable.
Covered facilities must establish and implement a food safety system with a written food safety plan that includes hazard analysis, preventive controls, and the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification).
The “farm” definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm. Such farms that conduct produce activities will also have to comply with the Produce Safety Rule (to be finalized at the end of October).
A more flexible supply chain program, with separate compliance dates.
Update and clarification to CGMPs.
This year’s Food Safety Consortium conference will feature first-hand perspectives from FDA and USDA on FSMA implementation and enforcement. REGISTER NOWCompliance dates range between one and three years depending on the size and type of business. Several guidance documents will be created by FDA in an effort to further help companies with compliance, including on hazard analysis and preventive controls, environmental monitoring, food allergen controls, and the validation of process controls.
The Federal Register will publish the 930-page document on September 17. In the meantime, the pre-publication version can be viewed here.
CGMPs established for the production of animal food, taking into account the diverse types of animal food facilities.
Covered facilities must establish and implement a food safety system with a written food safety plan that includes hazard analysis, preventive controls, the oversight and management of preventive controls (this encompasses monitoring, corrective actions and verification), and a recall plan.
A more flexible supply chain program, with separate compliance dates.
The “farm” definition has been clarified to include two types of farm operations, primary production farm and secondary activities farm.
Feed mills associated with farms (vertically integrated operations) are not covered.
As with the preventive controls for human food, FDA will be creating guidance documents that address CGMP requirements, hazard analysis and preventive controls, human food by-products for use as animal food, and a small-entity compliance guide.
The Federal Register will also publish this 666-page document on September 17. The pre-publication version can be viewed here.
At this year’s Food Safety Consortium Conference, the industry will have the opportunity to hear directly from FDA and USDA on what companies need to know to be FSMA compliant and how the agency will be enforcing the regulation. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA, will delivery the opening plenary presentation, which will be followed by an “Ask the FDA” Q&A town hall meeting.
With publication of the first set of final rules for FDA’s Food Safety Modernization Act (FSMA) expected any day now, food safety teams are busy strategizing as to how they are going to prepare for compliance and be “FSMA-ready” on Day 1.
Across industry, it is generally agreed that being certified to a GFSI scheme is a solid foundation for FSMA compliance. In a new three-part online series, “GFSI in the Age of FSMA: How GFSI Schemes Align With and Prepare You for FSMA”, the North American leaders of the three major GFSI schemes – SQF, BRC and FSSC 22000 – will discuss the following topics:
How certification to their scheme prepares a company for FSMA compliance in terms of alignment with:
Supplier Controls
Building a food safety plan
Migrating from HACCP to HARPC
Being audit ready all the time
Environmental monitoring … human & animal food rules … and much more
What changes to the scheme have been made (or are planned) to better align with FSMA
Gaps the leaders see in FSMA that are filled by their scheme
What companies who are, or plan to be, GFSI certified should be doing now for Day 1 FSMA compliance
(left to right) John Kukoly of BRC, Jacqueline Southee of FSSC 22000, and Robert Garfield of SQFI are the featured speakers of the GFSI series.
Food company teams working in Regulatory, Food Safety & Quality Assurance, Operations, C-Suite, Legal and other related positions in companies who are – or are planning to become – certified in a GFSI scheme are encouraged to attend one, two or all three sessions.
The series is being sponsored by SafetyChain Software with media partner Food Safety Tech.
With cannabis-infused edibles gaining a bigger market share in 2014 (See the marijuana edibles regulatory update here), it comes as no surprise that cannabis-infused beverages are growing in popularity. Some of these beverage manufacturers operate in a very interesting legal environment because of the differentiation between compounds found in hemp and marijuana, two different varieties of cannabis.
“Under federal legislation, there is an exemption for hemp and as long as we process our CBD (Cannabidiol) molecules from the hemp plant, we are allowed to sell our products federally,” says Chris Bunka, CEO of Lexaria, a company that makes a hemp-infused tea.
Lexaria’s ViPova black tea infused with CBD oil made from industrial hemp
A number of scientific research studies have suggested that the compound CBD has medical properties that can help mitigate symptoms like inflammation, anxiety, chronic pain, and much more.
Because of the federal exemption for hemp, Lexaria can enjoy interstate commerce and other freedoms that manufacturers using marijuana flowers do not, such as access to banking services. Dried marijuana flowers contain the psychoactive compound, Tetrahydrocannabinol (THC). This compound is responsible for the regulatory and legal schism between the states that have legalized marijuana and the federal government, which still considers it to be a Schedule I narcotic.
Much unlike a number of marijuana edibles manufacturers operating in states where marijuana is currently legal, hemp-infused beverage manufacturers operate in full FDA compliance.
Michael Christopher, founder of Loft Tea, is working with a laboratory and bottler that are both 100% FDA compliant. “We definitely operate up to and abide by all FDA best practices with our laboratory and as far as producing and handling material we use best manufacturing practices and processes,” says Christopher.
“We have to partner with a bottler and laboratory who have the reputation to build trust with our brand as an industry leader in safety and quality,” says Christopher. “Until the FDA gives us complete guidelines on cannabis-infused products, we will continue to operate above and beyond best manufacturing practices with our infusions.”
Because these manufacturers view their hemp tea as a health and wellness product, it is only a matter of time before we see these types of products lining the shelves of health-food stores nationally. However, before this happens, an FDA regulatory framework specific to hemp-infused products is needed to address this growing industry.
“The hemp infusion industry has a lot of opportunity when presented in the right framework,” Christopher says. “There is still education needed in the marketplace to get it to the point where it will be on the shelves in stores like Whole Foods.”
Until that time comes, expect to see a steady growth of interest and inquiry from consumers, manufacturers, and regulators alike in the cannabis industry, whether federally legal or not.
FDA gives establishments another year to comply with the controversial rule.
Whether it was Congressional pressure or the heat felt from large retail businesses and industry associations, FDA decided to extend the date for compliance with the menu labeling rule by one year. The final rule, “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments”, was published on December 1, 2014 with the effective compliance date originally set for December 1, 2015. As announced in a Federal Register notice last week, covered establishments now have until December 2016 to make sure they comply with the requirements.
“The FDA agrees additional time is necessary for the agency to provide further clarifying guidance to help facilitate efficient compliance across all covered businesses and for covered establishments to come into compliance with the final rule,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, in an FDA notice.
“The final rule requirements are intended to ensure that consumers are provided accurate, clear, and consistent nutrition information for foods sold in covered establishments in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.” Source: Federal Register
“Covered establishments” are restaurants or similar retail food establishments that are part of a chain and have 20 more locations that conduct business under the same name and offer the same menu items. This can include individual franchises.
Since February, FDA has received four requests for an extension of the final rule’s compliance date. These concerns, which were submitted by a large retailer and industry associations, stated that there wasn’t enough time to fully implement requirements. The requests also detailed the extensive steps involved in compliance, which include:
Developing software and information systems that provide nutritional information
Training staff
Rolling out standard operating procedures
Developing and installing updated and consistent menus (across retail chain operations)
FDA plans to issue a draft guidance next month that will answer questions it has received about complying with the rule. The agency will also offer educational and technical help to businesses covered under the rule and will work with state, local and regulatory partners to support nationwide compliance.
Acceptance into the Voluntary Qualified Importer Program serves as proof that your company has a best-in-class food safety program.
As is evident in the name, the Voluntary Qualified Importer Program (VQIP), is just that—voluntary. However, participants in the program are showing that they are going above and beyond the requirements (i.e., FSMA’s Foreign Supplier Verification Program), which in the long run, is good for business and their marketing.
“VQIP is meant to be a step up—it’s almost a push for regulators to offer incentive programs for those suppliers and a way to reward good behavior,” said Melanie Neumann, executive vice president and chief financial officer of The Acheson Group. “VQIP is looking for a best-in-class supplier control program, and it’s meant to incentivize those companies who have it and can prove it.” During a recent FSMA Fridays session organized by SafetyChain, Neumann and David Acheson, MD, CEO and president of The Acheson Group, discussed the basics of VQIP and the benefits of participating in the program.
Under FSMA, FDA is required to develop a voluntary and fee-based program that enables expedited review of foods from importers that have achieved specific criteria related to supply chain safety and security. The agency released the draft guidance in June. The annual fee to participate in the program is estimated to cost $16,400, and FDA has also requested comment as to whether this fee will pose a burden on smaller businesses. Applications are filed online.
To qualify for participation in the program, companies must meet several requirements. Businesses must:
Have a record of importing foods into the United States for at least three years
Have a Data Universal Numbering System (DUNS) number
Use a paperless filer/broker that has received a pass rating from its FDA filer evaluation
Have a quality assurance program and submit documentation of assurance program
Be compliant with FSVP
Businesses must not:
Have any imported food that is subject to either an import alert or Class I recall
Have any ongoing FDA administrative or judicial history of significant noncompliance
Be subject to any safety or security customs and border protection penalties and sanctions
One of the most important elements of the eligibility requirements is proof of a quality assurance program, according to Acheson. He highlighted several components that companies must have as part of their quality assurance program, including:
Corporate policy quality statements, relating to food safety and security explaining how a company is controlling risk in its supply chain
An organization chart (or a written explanation of management structure)
Policies and procedures that will be implemented to ensure a company’s system is producing safe food
Written description of the food defense system
Documentation of a company’s experience in employee training for those responsible for implementing the quality assurance program
Procedures for assuring the program is current and appropriately implemented
Written procedures for maintaining records relating to structures and process and procedures of the program
References to sources used to develop the quality assurance program
“The message here is that FDA is saying we really want to make sure you have a robust system,” said Acheson. He added that although businesses must apply each year, once the initial heavily lifting is done the first year (and assuming the company has maintained the required standards), reapplication should not be as onerous.
Once a company has been accepted into the program, it can expect expedited entry of imported foods into the United States and limited examination or sampling of VQUO foods (unless there is a “for cause” situation).
“If you have qualified for this program, you’ve really got the FDA gold star,” said Acheson. “That’s a marketable item. If you can say your product is VQIP approved, it’s a leverageable opportunity for the importer for their customers.”
The initial deadlines for Food Safety Modernization Act implementation are upon us, and while it will be a year or more before companies must comply with the regulations, now is an appropriate time to consider the happens next with food safety in the United States. Packaging requirements, issues with imports, the move toward clean labels, updating facility auditing requirements, and a wide set of compliance issues will be near-term time-consuming issues for food safety directors and executives all the way up to the c-suite.
FSMA is the most impactful set of safety regulations to hit the grocery and restaurant industries since before World War II. But there are other elements of consumer protection that will quickly capture the attention of supermarket and foodservice executives after August, and smart companies are already looking ahead to ensure a competitive advantage.
Packaging requirements aren’t just limited to country of origin labeling. Consumers are demanding full transparency from manufacturers and the retailers from which they buy their food. Shoppers are demanding clear descriptions of what they’re eating and voicing their displeasure for companies that are not providing the details they want by buying competitive items. A quick look at the comparative sales of the big processed food companies during the last few years verifies this isn’t a fad.
Tainted imported food (for both humans and pets) nearly a decade ago was a key trigger for the legislation that ultimately became FSMA. While the act addresses record keeping and some elements of lab testing, there are still several issues to tackle, including third-party validation rules and the voluntary program for importers that provides for expedited review and entry of foods.
The move toward clean labels or reducing the number of ingredients in processed food is taking form in several different ways. For example, many manufacturers, particularly those that make products targeting young consumers, are eliminating high-fructose corn syrup from their product lines to address consumer concern about the impact the ingredient is having on obesity and other health issues.
Updating facility auditing requirements, at retail, foodservice and manufacturing operations, has been largely left to trade associations and the companies themselves. A single incident of foodborne illness or death linked to a store commissary, a restaurant or a processing facility is all it will take for consumers to demand government action to raise standards and increase inspections.
On compliance issues, FSMA requires companies to collect verification data of their supply chain’s adherence to regulations for up two years and have it accessible within 24 hours. Similar to Sarbanes-Oxley, CEOs are responsible for verifying the compliance of their supply chain under FSMA. Given these risks, companies have started to automate their management of compliance documentation. Now forward-thinking companies are applying the same technology to ensure that information supplied by trading partners on products such as gluten-free goods or items containing nuts is frequently updated to avoid lapses that could lead to lawsuits and worse.
There certainly are a few different visions of the future of food safety. One commonality is that consumers will continue to demand an even safer food supply chain. If companies don’t pursue this goal, legal action or governmental regulation will step in to encourage change.
The product recall at Blue Bell Creameries earlier this year is yet another example of food safety issues negatively impacting food marketers, growers, processers and manufacturers. We all remember the Peanut Corporation of America’s salmonella outbreak in 2008 and the Jensen Farms listeria outbreak in 2011. Salmonella-tainted eggs in 2010, E. coli in strawberries in 2011, and listeria in caramel apples last Halloween combined with dozens of others during the last six years, have sickened thousands and killed dozens of people.
The brand reputation impact from the incidents at Peanut Corporation of America and Jensen Farms was terminal—both companies went bankrupt. The effect on Blue Bell, while likely not fatal, is expected by industry experts to be substantial and include loss of revenue and market share. The company has already announced plans to lay off more than 1,000 workers as a result of the recall.
In addition, growers saw cantaloupe consumption take a nosedive after the Jensen Farms listeria outbreak, which was one of the worst foodborne illness outbreaks in U.S. history in terms of number of deaths. They are only now seeing sales levels return to those before the incident. And because the farm itself went out of business, personal injury lawyers went after the companies that sold the disease-ridden cantaloupes—the retailers. By virtue of last year’s out-of-court settlement by Walmart on the Jensen Farms lawsuit, both suppliers and retailers are now responsible for everything they sell.
Enter the Food Safety Modernization Act, signed in 2011 and about to begin finalization in August. FSMA mandates that retailers and suppliers have documentation that verifies their supply chain’s regulatory compliance is readily accessible for government inspection. Add these records to the business relationship records that retailers and suppliers should already be maintaining (including indemnifications and certificates of insurance that help manage brand risk), and you’d think our risk of foodborne illness is about be eradicated.
Although FSMA represents the most sweeping change to our food safety laws in the last 70 years, it may not have the greatest impact where the supply chain is most vulnerable. Today the largest suppliers that sell the majority of our food have very sophisticated systems to ensure safe food production and transportation. This group will have the easiest path to compliance with FSMA, and they most likely already hold themselves to a higher standard. It’s actually the smaller suppliers, which likely do not have the available resources or sophistication to comply with FSMA requirements, that will be exempt from certain documentation under FSMA based on their size. This group of suppliers is growing rapidly to meet consumer desire for fresh food that is locally grown and produced. Unfortunately for them, it’s only a matter of time before wholesalers and retailers decide that the risk is too great to continue to do business with these small suppliers.
The good news is that technology exists that can help small suppliers reduce risk in their extended supply chains. Affordable, interoperable systems have been developed to address the market need for receiving, storing, sharing and managing regulatory, audit and insurance documentation. Suppliers of any size can also track products as they move through the supply chain and trace them back in the event of a recall. This move to automation will help all suppliers not only meet the demands of FSMA, but also establish a base for retailer and consumer demands for transparency in the supply chain going forward.
Having a comprehensive food safety system is quickly becoming a competitive advantage. Retailers and consumers are looking for those suppliers that have an unblemished safety record and are transparent about their safety processes, so the time is now for small suppliers to hold themselves to a higher standard than FSMA requires for future business opportunities. The stakes are just too high for retailers and wholesalers to not verify that everything they sell to consumers is produced and transported safely.
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