According to FDA, the Food Safety Modernization Act (FSMA) is “transforming the nation’s food safety system by shifting the focus from responding to foodborne illness to preventing it.”

FDA chose seven rules in order to implement FSMA. The rules were enacted to prevent contamination, and write out a set of actions that must be taken at each point.

On September 21, FDA announced a new traceability rule as part of the New Era of Smarter Food Safety initiative. The proposed rule would standardize an approach to traceability recordkeeping, clearing the way for the food safety industry to use more “digital, tech-enabled traceability systems,” both now and in the future. FDA also released a Food Traceability List, which identified foods to which these new requirements would now apply.


Implementing FSMA rules

“Many of the companies we work with have a handle on major rules like identifying safety hazards and preventive controls for their Food Safety Plans,” says Matt Brown, CEO, Wherefour, Petaluma, CA. “Where we see companies struggling involves taming the paperwork burden with compliance documentation and record-keeping to meet FDA, third-party certification and other requirements.”

Traceability is a key driver right now, and a lot of current implementation urgency is being driven by the FDA’s [new] proposed rule requiring additional traceability records for certain foods, he says.

“These foods are common ingredients for many companies like eggs, herbs, tomatoes, peppers, tree nuts and peanuts. A lot of companies are taking passage of this rule for granted and putting the necessary procedures and technology in place now.”

“We’re also seeing interest in traceability solutions from new clients that don’t use any of the ‘certain foods’ on the FDA’s list,” he notes. “That’s because the FDA has made it clear that they encourage voluntary adoption of these practices by everyone. These companies are reading the writing on the wall and being proactive because they feel it’s better to be ahead of the game than playing catch up.”

Bernard Clement, PENN refrigeration product manager, Johnson Controls, Milwaukee, WI, says at this point, all companies regulated by FDA should have achieved compliance by meeting rule criteria.

“However, implementation has mostly been done on paper, which is causing inefficiencies and information gaps along the supply chain. An example of this is that a paper-based system doesn’t allow easy information sharing among food manufacturing facilities, limiting traceability along the entire supply chain. So now, companies are seeking advanced ways to meet FSMA requirements, such as adapting a digital system, to improve traceability and create operational efficiencies,” he notes.

This greater need for improved traceability can also be seen in the FDA's New Era of Smarter Food Safety, Clement says.

“This new initiative leverages technology and other tools to create a safer and more digital, traceable food system. As stated by the FDA, ‘Smarter food safety is about more than just technology. It's also about simpler, more effective, and modern approaches and processes.’ This new era will take more than a decade to usher in, but once complete, it will create a more responsive, safer and controlled food system. But companies can get ahead by digitizing their food safety system now,” he adds.

To put the benefits of a digital system in perspective: if a company is required to hand over food safety documentation in an event of an incident, the company only has 24 hours to collect, organize and showcase traceability/food safety data, which can be virtually impossible with a paper system, he shares.

“This data will be readily available with a digitized system, creating needed documents automatically for an easy 24-hour turnaround. This not only improves operational efficiency, but it also helps ensure reliable data if an incident does arise.”

Roger Landman, product operations manager, SYSPRO, says that the revised FSMA is looking to improve consumer safety from contaminated foods by overhauling and tightening up control right across the supply chain. 

“The revised FSMA is looking to improve consumer safety from contaminated foods by overhauling and tightening up control right across the supply chain. There are far more stringent requirements for the producers and handlers along the full supply chain, as well as increased regulatory powers of the regulator. This has moved the system to a risk-based system with risk mitigation as the main requirement rather than a response. The management of the CCP’s or Critical Control Points extended across the whole supply now become necessary,” he advises.

One of the key elements of this rewrite is the improved security of the end-to-end food supply chain by adding extra requirements for all of the participants involved in the manufacture and delivery of the product, Landman says. This will lead to industry accountability and not individual accountability in the case of a recall.

“The written Safety Plan will be required to be a lot more extensive and include all relevant detail. This will extend and share your detail with the other businesses and simplify integration within the industry and supply chain. Product testing and environmental controls are also required to be improved.”

Labeling and tracking are being improved across the industry through the PTI or Produce Traceability Initiative, he says. This initiative aims to standardize the labeling and the labels used across the industry.

“Of the list of areas to address, the written safety plan is the most critical part of the act to address. Firstly, because any improvements to the food safety system should all be based upon the requirements of the safety plan, and how it integrates into the next business in the supply chain. It can be easily audited therefore making it the number one priority in the business. A working plan with a list of actions and progress against the plan is the first item the regulator will look for.”

With the focus on industry compliance, the alignment of systems will be a further critical part to be developed, Landman notes.

“This implies that the industry members will be collaborating on best practices to ensure that these include all participants. Here the simpler items like common barcode labeling and standardized barcodes, common data to be included on labels, etc. should be easily aligned.”

Another critical area will need to be an integrated traceability system from every participant in the supply chain, he comments.

“A business can only have a 1-up, 1-down system as that is the limit of the data, but the next person in the chain will also have a 1-up, 1-down system which will eventually cover the length of the supply chain.”

Enterprise Resource Planning (ERP), and especially the traceability functionality contained in an ERP system has therefore become a necessity within the food and beverage industry, to not only identify and respond to food safety issues but also to support supply chain optimization and the reduction of food loss, he says. It is however vital to select an ERP solution that not only provides visibility of your supply chain but also provides measures for action. This can be achieved through SYSPRO’s latest release, SYSPRO 8, which has a lot traceability and product recall module.

“A SYSPRO ERP customer that had successfully implemented Lot Traceability modules for greater visibility is Gorant Chocolatier. In September 2009, Gorant Chocolatier was sold to a private ownership group and was given a little over a month to find, purchase, and implement a new software system. Additionally, Gorant didn’t have a fully integrated manufacturing system in place and was recording data manually on spreadsheets,” Landman says.

“Before SYSPRO, we did everything manually—everything from spreadsheets to handwritten delivery notes to our customers and it took a lot of labor to do that. In addition, if we were ever faced with a recall, it would have taken us a great deal of time to trace where those finished products went,” says Gorant Chocolatier Purchasing Manager, Mary Ann Yerage.              

Angela Fernandez, vice president of community engagement, GS1 US, Ewing, NJ, says that numerous proactive food companies have been enhancing their traceability programs ever since the Food Safety Modernization Act was passed.

“Brands, distributors, restaurants and retailers have already been collaborating with trading partners to implement GS1 Standards through initiatives like the Produce Traceability Initiative and through two GS1 US initiatives focused on the retail grocery and foodservice channels. These groups discuss roadblocks to whole-chain traceability and have produced industry-wide guidance documents on many of the concepts outlined in the proposed Section 204 rule, including Key Data Elements and Critical Tracking Events,” she says.

For those not already ahead of the rule, implementing new traceability capabilities can involve several data standards that work in concert to make a products and locations more visible in the supply chain, Fernandez notes.

“The FDA first discussed the importance of companies ‘speaking the same language’ to communicate information about their products to enable better traceability in the New Era of Smarter Food Safety blueprint. This is also reflected in the proposed FSMA 204 rule,” she says.

Some examples of a common language for data include:

  • Unique product identification, or Global Trade Item Numbers (GTINs), identify the food being harvested, processed or manufactured and help eliminate any data silos caused by proprietary numbering systems.
  • Unique location identification or Global Location Numbers (GLNs) may be more widely used, as they identify locations such as a farm or field, a packing house, manufacturing plant, a distribution center, a supermarket or a restaurant. They help a company record each stop a product has made in the supply chain.
  • Automated data capture for traceability with GS1-128 barcodes applied to cases. Trading partners are able to encode data such as expiration dates, batch/lot/serial numbers, quantities, weights and other information into these barcodes, enabling expanded data to be shared with the full trading partner network wherever the case travels.

Used together, these and other standards are critical to tracking and tracing a product and leveraging emerging technology such as cloud, RFID, IoT, or blockchain-based solutions, Fernandez comments.

“They provide a foundation for data accuracy and consistency that is necessary when additional layers of automation are applied.”


Key aspects to improve food safety

Fernandez says that there are three key aspects that will contribute to a safer food system.

“First, the Food Traceability List outlines the priority sectors for enhanced food traceability, which will potentially lead to faster investigations for foodborne illness outbreaks. The CDC estimates that each year roughly 1 in 6 Americans gets sick from a foodborne disease. By identifying where the greater risks are, the FDA and industry are working to decrease these incidences by focusing on these high risk food categories,” she notes.

Second, once finalized, the rule will help companies on the Food Traceability List more universally identify products, and standardize the formats in which they record and share data with external partners, she adds.

“For the larger industry players, this is nothing new. What will create true end-to-end traceability is how smaller suppliers are able to adopt the principles of the New Era of Smarter Food Safety.”

Once companies of all sizes embrace the value of the “common language” for exchanging product data and implement tech-enabled traceability, everyone in the food supply chain can interoperate with partners, she suggests.

“There will be a large effort to bring some of the small companies who are not exempt along to ensure traceability is a shared responsibility industry-wide. This can lead to immensely more efficient recalls and more proactive food safety practices.”

Third, although the proposed rule does not mandate the use of a digital platform, it does embrace and encourage the use of technology, continuing in the established precedent of the New Era blueprint, Fernandez expands.

“It shows that the FDA is responding to the needs of today’s consumers who expect safe food and to access product information from anywhere, anytime. The rule outlines ways to create a better foundation for consumer engagement technology, taking into consideration that existing standards are already playing a role in efficient data transmission. Industry partners will ideally instill better consumer confidence and optimize the recall process when focusing on data consistency and accuracy first by leveraging standards.”

Brown says that a lot of smaller companies struggle with traceability.

“In particular, those operating with paper-based systems like spreadsheets still must implement foundational practices like having a system for assigning lot codes. Tracking and tracing ingredients as they are comingled during processing along with the associated record-keeping that is required can quickly defeat not just paper-based systems but also stand-alone systems, such as inventory management, that only address one aspect of traceability.”

The FDA’s proposed traceability rule heightens any existing difficulties associated with shortcomings in the tracking system, he predicts.

“The new rule identifies Critical Tracking Events (CTE), which include receiving, processing and shipping. Each of these CTEs have Key Data Elements (KDE) for which records must be kept. These KDEs are business dependent, but include traceability and location identifiers and new traceability identifiers as the ingredient is processed. A host of location and traceability KDEs for shipment are required and nearly of all of that data must be sent to the recipient along with the product.”

Another key aspect to improve food safety is sanitation, which Clement says has become of the utmost importance during the Coronavirus outbreak.

“As companies work to make their food safety compliance systems more efficient, reliable and traceable, sanitation has taken precedence during the COVID-19 pandemic. Whether it’s for sanitary transportation, worker sanitation practices or sanitary storage, food supply chains are under the microscope as health and safety are more important now than ever,” he notes.

In addition to ensuring employees are washing their hands, keeping equipment clean, and handling material with the utmost care, companies are implementing monitoring and workflow tools to continuously observe safety practices, Clement adds.

“And by having the right digitized food safety system in place, sanitization and workflow monitoring can be achieved within one, all-purpose system.”

Randy Kohal, vice president of food safety & reliability, Nexcor Food Safety Technologies, Inc., Atlanta, says that some key aspects of FSMA rules that require attention include Current Good Manufacturing Practices (CGMPs), and Hazard Analysis and Risk-Based Preventive Controls for Human Food (HARPC). He expands on them below:

Current Good Manufacturing Practices (CGMPs):

  • Some provisions that used to be nonbinding, such as education and training, are now binding.
  • Management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties.
  • Such employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold food that is clean and safe. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene as appropriate to the food, the facility, and the individual's assigned duties.
  • The FDA’s longstanding position that CGMPs address allergen cross-contact is now explicit in the regulatory text.
  • CGMPs also now include a provision for holding and distribution of human food by-products that are used for animal food.


Hazard Analysis & Risk-based Preventive Controls for Human Food (HARPC):

  • FSMA requires food facilities to have a food safety plan in place that includes an analysis of hazards and risk-based preventive controls to minimize or prevent the identified hazards.
  • In general, you are a covered facility if you are required to register with FDA under section 415 of the Federal Food, Drug, and Cosmetic (FD&C) Act. Covered facilities are required to have and implement a written food safety plan that includes:
  • Hazard analysis: The first step is hazard identification, which must consider known or reasonably foreseeable biological, chemical, and physical hazards. These hazards could be present because they occur naturally, are unintentionally introduced, or are intentionally introduced for economic gain (if they affect the safety of the food).
  • If the hazard analysis reveals one or more hazards that require a preventive control, the facility must have and implement written preventive controls for the identified hazards.
  • Preventive controls: Facilities have the flexibility to tailor preventive controls to address hazards that occur in the products they manufacture. The preventive controls, which must be written, must be implemented to ensure that any hazards requiring a preventive control will be significantly minimized or prevented and help ensure that the food is not adulterated. The rule includes the following preventive controls:
    • Process controls include procedures that ensure the control parameters are met. Process controls can include operations such as cooking, refrigerating, and acidifying foods.  They must include parameters and values (e.g., critical limits), as appropriate to the nature of the applicable control and its role in the facility’s food safety system.  
    • Food allergen controls are written procedures the facility must have and implement to control allergen cross-contact and ensure allergens are appropriately listed on the labels of packaged food products.
    • Sanitation controls are procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition to minimize or prevent hazards such as environmental pathogens, hazards from employees handling food, and food allergen hazards. 
    • Other Controls are controls that are not described above but are necessary to ensure that a hazard requiring a preventive control will be significantly minimized or prevented.

Landman says that the single biggest challenge of FSMA will be to coordinate the collaboration along the whole supply chain. This will require interaction and collaboration between all parties in the supply chain.

“The written safety plan needs to comprehensive and includes all of the detail of all of the relevant systems in the business. The regulator should be able to read this end-to-end safety plan and quickly understand how the business operates so that it can respond quickly to all potential issues. This will require the organization to fully understand and document every one of the systems, which is a huge task and very lengthy,” he notes.

In the case of imports, this becomes tricky as the products may not come from the same source or follow the approved routes, Landman comments.

“Special attention to this will be required, with some mitigation of risk being applied by robust testing of the products on arrival. This may even require dedicated laboratories which will add cost and delays. The net value of these imports will need to be carefully considered.”

The use of a risk-based approach is perfect, but to fully identify and mitigate all of the risks requires very knowledgeable personnel, on the systems, the business processes, and the potential risks of non-compliant foodstuffs, he recommends.

“The understanding of the business systems will be quite a lengthy process as well, including the requirement for a technically-savvy person to be involved to fully understand their capabilities, especially when the collaboration efforts begin and businesses in the same industry need to collaborate. This will quickly expose areas of non-integration and potential areas of no possible integration.”

One key piece of equipment that will be necessary to collect and manage all of the data across the business will be the ERP system, Landman predicts.

“There may well be a problem when it comes to sharing that information between different systems within the business, and between businesses in the same supply chain. For example, the Chinese language is not easily converted into the English language. Further globalization issues will occur on simple things like date formats between countries.”


Strategies for implementing solutions to achieve FSMA compliance

Kohal says that the first step in the FSMA compliance process would be to assess your current risks and prioritize where to start.

“An oft-overlooked aspect of success is developing a food safety culture,” he says. “Aspects include strong leadership, engagement across the organization, accountability, effective communication, and following best practices.”

Landman says the first strategy should be to combine businesses into an industry federation to align all of the critical elements that every business in that particular industry needs to standardize.

“Here agreement can be developed on elements like integration standards, e.g. data transfer protocols, date formats, barcode label standards, labeling information in the barcode, etcetera,” he notes.

The second strategy would be to identify which information is critical to the industry and ensure that all businesses can supply the same information. The high-level alignment will be required first before the detail can be addressed and agreed upon, Landman adds.

Clement says that to streamline FSMA compliance practices and ensure they are as efficient and effective as possible, companies should consider a digital solution.

“Digital food safety solutions are more reliable, accurate and efficient than traditional clipboards and pen and papers. A digital solution will help achieve enterprise-wide visibility and also increase accuracy and provide a traceable, historical view of data for easy retrieval. On top of that, these systems can help digitize other areas of the operation such as equipment maintenance, customer complaints and employee training,” he notes.

An example of a digital food safety system is PENN Connected Digital Food Safety from Johnson Controls, Clement says.

“PENN Connected Digital Food Safety replaces clipboards with digital tools to help retail, food service and manufacturing organizations adapt to today’s unique food safety standards. The cloud-based digital compliance management solution manages data monitoring, recording and reporting to ensure food is stored, prepared and consumed in a safe manner. The configurable and easy-to-use platform improves HACCP compliance, saves time and money and provides enterprise-wide insights that can be generated with just a few clicks of a button.”

As companies look to implement a digital food safety system, they should keep in mind that not all systems will work for them, he says.

“Some systems will align with their needs more than others. Look for one that is flexible enough to be designed around your company’s specific needs and current food safety processes, not around what the system is capable of doing. PENN Connected Digital Food Safety, for example, can duplicate a company’s paper processes through its customizable software modules, eliminating the need for reconfiguration and force-fitting new processes,” Clement finishes.

Brown says that he is seeing a heightened interest in an ERP solution from companies of all sizes.

“Companies are looking for systems that provide them with start to finish traceability and full forward and backward ingredient tracing. Plus, record-keeping is streamlined with an unalterable 24/7 log that maintains data for all activity and greatly simplifies documenting verification activities as FSMA requires,” he notes.

All records, photos, and other information can be attached with keyword identifiers to received goods, production lots and shipments, and are available 24/7 in the cloud. This greatly reduces the time needed to access required information during audits, mock recalls or an actual recall, he notes.

“Having a system that is user-friendly also is a key must-have for a lot of companies that want to flatten the learning curve for new employees. An ERP can reinforce training efforts by bolstering adherence to standard operating procedures and giving only specified individuals the ability to alter those procedures. Any changes that are made are included in the activity log along with who made them.”

Wayne Ortner, general manager, FlexiBake, Vancouver, BC, says that having an ERP software system allows manufacturers the ability to track ingredients from the moment they are received through the production process.

“With proper batch control and data from their software system, manufacturers have the ability to track the lot numbers that are shipped from the manufacturing facility with ease.”

Tim Williams, co-founder/CEO, NanoThings, New York City, says that NanoThings [is] providing an innovative solution to a section of FSMA that addresses food safety during transportation.

“To summarize a very lengthy section of FSMA into a single sentence, FSMA gives the recipient (purchaser) the right to demand proof of temperature control throughout transit. It speaks to various types of solutions and technologies, but does not stipulate any particular methodology of technology. This ambiguity has resulted in mixed adoption of new technologies and methodologies by food purchasers,” he notes.

For example, Walmart has implemented a policy that requires suppliers to attach temperature recorders to each temperature controlled load, Williams says.

“Other major grocery chains use more antiquated methods of probing inbound loads upon arrival, while others still don't have any sort of protective measures/policies in place. The challenge with implementing new quality control standards is that it generally requires lots of training and even more enforcing, and we humans aren't very receptive to change,” he adds.

“Imagine the complexities a large grocery chain faces in educating and enforcing a new quality control procedure across thousands of employees (and high turnover employees at that). It's certainly not a simple task.”

“At NanoThings, we're addressing these issues with our contactless temperature monitoring solution. We invented a wireless temperature monitoring smart label called the NanoTag. It's applied to loads by the food manufacturer, and autonomously monitors and reports temperature throughout transit all the way down to a store,” he comments.

The NanoTag never needs to be removed, scanned, or returned (unlike other devices in the market), which means food retailers don't need to train their employees how to handle it, Williams expands.

“We call this temperature monitoring automation, and it's a major game changer for an industry that is still trying to implement FSMA four years after being enacted into legislation.”

Concerning the new FSMA rule, Fernandez says there are two possible strategies for implementing the rule successfully.

“The first is to focus on Deputy Commissioner Yiannas’ call for harmonization. Even when food companies and their partners have adopted modern technology solutions to facilitate traceability, it is rare that these systems are compatible with each other. We believe GS1 Standards have a proven track record of helping industry partners implement interoperable, efficient traceability programs.”

For example, what the grower records in their system is easily understood and accepted all the way downstream to the retailer’s system when each uses a system that leverages GS1 Standards, she says.

“In the event of a recall, this can mean gaining precious time to alert consumers, and isolate potentially harmful product with precision.”

Second, the industry should focus on the accuracy of the product data being shared with their partners, she recommends.

“The rule focuses on Key Data Elements and Critical Tracking Events, which for many partners will mean recording and sharing a host of information in their systems—such as batch/lot/serial numbers, specific details about where products came from and how they were transformed—that was not previously required. When the rule is finalized, demonstrating clear traceability information will keep more products visible in the supply chain and help the system shift into more of a proactive, vigilant state.”

Related - Slideshow: Implementing FSMA