Complying with FSMA regulations or GFSI schemes isn’t always straightforward, but that also may not be the biggest challenge facing companies today. According to Marc Simony of the TraceGains Network, the large issue is change management and the culture shift that is happening within companies. In a quick video shot during the 2016 Food Safety Consortium, Simony explains.
The use of genomics tools are valuable additions to companies seeking to meet and exceed validation and verification requirements for FSMA compliance (21 CFR 117.3). In this installment of Food Genomics, we present reasons why microbiome analyses are powerful tools for FSMA requirements currently and certainly in the future.
Recall in the first installment of Food Genomics we defined a microbiome as the community of microorganisms that inhabit a particular environment or sample. For example, a food plant’s microbiome includes all the microorganisms that colonize a plant’s surfaces and internal passages. This can be a targeted (amplicon sequencing-based) or a metagenome (whole shotgun metagenome-based) microbiome. Microbiome analysis can be carried out on processing plant environmental samples, raw ingredients, during shelf life or challenge studies, and in cases of overt spoilage.
As a refresher of FSMA requirements, here is a brief overview. Validation activities include obtaining and evaluating scientific and technical evidence that a control measure, combination of control measures, or the food safety plan as a whole, when properly implemented, is capable of effectively controlling the identified microbial hazards. In other words, can the food safety plan, when implemented, actually control the identified hazards? Verification activities include the application of methods, procedures, tests and other evaluations, in addition to monitoring, to determine whether a control measure or combination of control measures is or has been operating as intended, and to establish the validity of the food safety plan. Verification ensures that the controls in the food safety plan are actually being properly implemented in a way to control the hazards.
Validation establishes the scientific basis for food safety plan process preventive controls. Some examples include using scientific principles and data such as routine indicator microbiology, using expert opinions, conducting in-plant observations or tests, and challenging the process at the limits of its operating controls by conducting challenge studies. FSMA-required validation frequency first includes before the food safety plan is implemented (ideally), within the first 90 calendar days of production, or within a reasonable timeframe with written justification by the preventive controls qualified individual. Additional validation efforts must occur when a change in control measure(s) could impact efficacy or when reanalysis indicates the need.
FSMA requirements stipulate that validation is not required for food allergen preventive controls, sanitation preventive controls, supply-chain program, or recall plan effectiveness. Other preventive controls also may not require validation with written justification. Despite the lack of regulatory expectation, prudent processors may wish to validate these controls in the course of developing their food safety plan. For example, validating sanitation-related controls for pathogen and allergen controls of complex equipment and for how long a processing line can run between cleaning are obvious needs.
There are many routine verification activities expected of FSMA-compliant companies. For process verification, validation of effectiveness, checking equipment calibration, records review, and targeted sampling and testing are examples. Food allergen control verification includes label review and visual inspection of equipment; however, prudent manufacturers using equipment for both allergen-containing and allergen-free foods should consider targeted sampling and testing for allergens. Sanitation verification includes visual inspection of equipment, with environmental monitoring as needed for RTE foods exposed to the environment after processing and before packaging. Supply-chain verification should include second- and third-party audits and targeted sampling and testing. Additional verification activities include system verification, food safety plan reanalysis, third-party audits and internal audits.
Verification procedures should be designed to demonstrate that the food safety plan is consistently being implemented as written. Such procedures are required as appropriate to the food, facility and nature of the preventive control, and can include calibration of process monitoring and verification instruments, and targeted product and environmental monitoring testing.
The new food defense regulations have caused quite a stir in the food industry and have left many scratching their heads. Many companies are worried about how to implement these programs. The regulations have created a format and structure in which many companies can adapt within their existing food defense programs to comply with the new law. Still, one of the biggest challenges of food defense is merely the idea of developing the food defense plan and coming into compliance with the FDA’s new Food Defense rule. The FDA received many comments from industry in response to the draft guidance. Many of these comments asked the agency for additional time to come into compliance, and the FDA responded by delaying the compliance dates well beyond what was proposed in the draft rules.
According to the regulations, companies are required to implement a food defense plan that focuses on the vulnerabilities in their facility. If you follow the FDA’s template, a food defense plan will look very similar to the traditional HACCP plan. The term, VACCP, Vulnerability Analysis Critical Control Points, is a term that is being tossed around as of late. The FDA wants companies to make sure that they consider an internal attacker, one that has inside access to the buildings, processes and products that are being produced. For many companies, this is stretching them beyond their current paradigms and may force some to implement new procedures. In reality, this paradigm shift is not insurmountable when the items to be controlled are within the four walls of their facility. Even subcontractors, such as pest control providers, maintenance subcontractors, auditors, etc., can be included in these programs. However, is this enough to ensure the safety of the product you are selling, the one you are putting your name on, and the one you are personally standing behind?
The goal of current risk-based thinking is to find the weakest link in the process, evaluate the risk and likelihood of a threat to food safety, and respond appropriately to control the risk. Unlike the Preventive Controls rule and the FSVP rule, the Food Defense rule focuses on the processes occurring in a facility and does not take into account the processes involved in the supply chain. CargoNet Command Center found that there were 1500 security breaches in the transportation industry in the United States and Canada in 2015. The data was categorized by types of product and the highest percentage of any group of products was the food and beverage products which comprised 28% of the cargo thefts. On average, that is greater than one food or beverage cargo theft per day. CargoNet Command Center provides a nice map on their website showing the location of these instances and I encourage you to review this map. If your product passes along the hot spots of cargo theft, as well as having risk factors such as being valuable or in limited supply, it would be very beneficial to build systems and programs in place to address these additional risks to your product.
In another study presented at the Food Defense conference, there was a statistically significant link between breaches in IT systems to a follow-up cargo theft. Many quality and food safety professionals, much less executives, fully understand the interdependence of all business units on food safety. Many companies have problems with siloed departments, and unfortunately, this increases the vulnerabilities to attacks on the food we are trying to protect. This is a great example of how food safety is everyone’s job, and having this mentality is key to the success of food safety programs.
Of course, the requirement to the Food Defense rule must be addressed, but I challenge the industry to look beyond the walls of our facilities and instead, take a whole business approach and apply the principals of food defense to all inputs of the process that impacts the finished product. As food safety professionals, we need to work with our suppliers and our customers to ensure that the whole supply chain is protected from an attack.
After being informed by its supplier Deutsch Kase Haus, LLC that its specialty Longhorn Colby cheese may be contaminated with Listeria monocytogenes, Sargento Foods, Inc. recalled several retail cheese products. The recalled Colby and Pepper jack cheeses (available on the company’s website) were packaged at Sargento’s Plymouth, Wisconsin plant. The company also recalled several other cheeses that were packaged at the same time “out of an abundance of caution”.
The recall involving Deutsch Kase Haus is not limited to Sargento. Guggisberg Cheese, Inc., Meijer and Sara Lee have recalled their Colby and Pepper jack cheeses. According to a release by US Foods, the product recalls were initiated after a notification by the Tennessee Department of Agriculture that some products manufactured on November 3, 10 and 18 could be contaminated with Lm.
Taylor Farms also recalled products that contained the cheese products—the company’s Class I recall involved 6,630 pounds of chicken and pork salad products that were produced and packaged from February 6–9, 2017.
This year is being described as “the year of FSMA compliance,” as many compliance dates for the various FSMA rules fall in 2017. As one might expect, the FSMA law and rules include many aspects of the established Global Food Safety Initiative (GFSI) standard; however, there are also differences in how they are applied to create better food safety enforcement.
At the most basic level, GFSI is an industry conformance standard for certification, while FSMA is a compliance regulation that must be met. However, both work together to ensure companies are effectively managing food safety.
The GFSI is facilitated by the industry network of The Consumer Goods Forum. It provides a very solid foundation and supporting objective of “safe food for consumers everywhere”.
GFSI was originally established based on a growing pattern of food safety outbreaks throughout the international marketplace. This led to the proactive development of GFSI standards as an alternative to the more limited and less effective customer audits in place at the time. An important part of this outcome was that CEOs in the food industry—not a regulatory body—determined the need to address food safety through the GFSI food safety standard.
With its beginning as a benchmarking organization, GFSI has since evolved throughout the food supply chain as a strong means for achieving global food safety. It is now established, growing, and improving across the primary supply chains within the global food market.
As such, much work to address food safety has been accomplished by GFSI over the past sixteen years. In fact, the industry-driven aspect of GFSI along the food supply chain has led many companies to achieve levels of food safety comparable to those required to achieve FSMA compliance. Based on its collaboration of food safety experts, GFSI provides for a significant evolution of food safety programs and supports those requiring FSMA compliance.
During a similar timeframe, the United States identified food safety as a major concern for the public. In the 1990s, a growing number of food outbreaks from biological contamination continued to spread, prompting the addition of controls within both the USDA and FDA. These brought the mandated requirement for Hazards and Critical Control Points (HACCP) and supporting Good Manufacturing Practices (GMPs) to specific industry sectors. However, these efforts were measured to have limited effect, as the outbreaks continued.
By the early 2000s, the public concern for food safety continued, and the FDA was determined to make changes. Along with Congress, the FDA commissioned research into the underlying issues that were resulting in the growing number and severity of food outbreaks. This research was being conducted and analyzed just as GFSI was determining its final group of benchmarked standards. At the same time, GFSI was positioned to be advanced into the U.S. market by food industry leaders, including Cargill, McDonalds, Walmart, Kroger, Coca Cola and Wegmans.
The outcomes from the FDA studies determined that the GMPs (in existence for the past 40 years) were not effectively implemented across the U.S. food industry. Further, the studies indicated that the ability to prevent food safety issues through specific controls would provide a means for reducing the number of foodborne illness.
This effort led to the development of FSMA, which passed in January 2011. Additional FSMA rules have since been published, starting in September 2016. The FSMA rules represent a rewrite of the existing FDA food safety regulations. However, with the FSMA law taking several years to roll out, the existing FDA laws remain in effect until they are replaced. These actions expand the FDA’s jurisdiction now and until full compliance of FSMA.
The presence of GFSI in the United States, as well as the GFSI certification of many suppliers to U.S. food importers, provides for a synergy between the GFSI standard and the FSMA law being enforced throughout the United States and its foreign suppliers. GFSI’s global focus provides the structure to adapt and meet many of the FSMA requirements, with the ability to expand to all FSMA requirements.
As one would expect, the FSMA law and rules include several aspects of the GFSI standard; however, there are many differences in how each is applied to encourage better food safety enforcement that must be considered. For instance, GFSI has the advantage of providing the time to develop programs, and thousands of companies are certified to the various programs under the standard. Conversely, FDA is implementing FSMA compliance over several years, with 2017 being a big year for compliance (based on the rules’ published dates, company size and industry segment).
In this new order of food safety in the United States, those companies that have achieved GFSI certification should have an advantage over those who do not, provided they can align their GFSI programs with the FSMA law requirements. There is also a benefit to starting with FSMA and moving to a GFSI certification.
Existing GFSI certifications provide an established framework, with many of the program requirements similar to those required by FSMA. For example, personnel are required by both to establish HACCP and Food Safety Plans, as well prerequisite procedures (PRPs) and current-Good Manufacturing Practices (cGMPs). The challenges are ensuring the complete development of these food safety procedures to guarantee they meet both GFSI and FSMA requirements.
As another example, personnel requirements are similar but different under FSMA and GFSI, which calls for training, updating and qualifying resources. Ultimately, advanced HACCP training under GFSI provides the means for establishing a Qualified Individual under FSMA, but it requires expanding the training to include FSMA Preventive Controls and procedures. The resulting plan is the food safety plan that can be based on HACCP but with the proper additions to meet FSMA requirements.
The upcoming Global Food Safety Conference (February 27 – March 3 in Houston, Texas) provides an opportunity for those seeking compliance to FSMA or certification to a scheme within the GFSI Standard to get a deeper understanding of food safety. With 2017 being the year of FSMA compliance, it is very appropriate that the Global Food Safety Conference be held in the United States this year. The conference will provide U.S. companies attending, as well as foreign supplier of products to the U.S. market, an educational opportunity and forum to reach out to experts from industry, government, and academia to better understand these two key areas for food safety program development. Some of the topics to be addressed at the conference include the following:
Kestrel has been a long-time advocate of GFSI, performing site certification program development support for hundreds of companies. We have served as a GFSI Stakeholder, Technical Working Group participation, and panelist at previous GFSI Global Food Safety Conferences. We look forward to seeing you at the 2017 GFSI Global Food Safety Conference and to helping you navigate GFSI conformance and FSMA compliance requirements.
Food recalls are not 100% avoidable, and they are costly. The hit to an individual food company or retailer, on average, can run to tens of millions of dollars. Annually, millions of consumers become ill as a result of contaminated food products, and the dollar costs in terms of lost productivity, medical treatment and deaths run into the tens of billions.1 More than 20% of consumers have said that they would not purchase any brands from a company suffering a food recall.2 At best, damage to a company’s brand and reputation could take a long time to repair. Clearly, the need to prevent food contamination is obvious and should be the ultimate goal of all food safety professionals.
But despite the best industry efforts, recalls inevitably occur. And since they aren’t 100% avoidable, suppliers and retailers must continue to look for ways to minimize the safety and financial impact of the recall events that do occur. It’s good to begin that process by understanding some statistics surrounding the most common recalls. Globally, 46% of food recalls are for chemical hazards or the introduction of non-food-grade ingredients. 79% of these are due to undeclared allergens. 26% of recalls are for food-borne pathogens, and 8% are due to physical hazards (metal, glass, plastic, paper, wood, etc.). The remaining 20% are generally quality-based recalls and withdrawals.3
Knowing the numbers helps suppliers and retailers home in on their most likely problem areas and get a leg up on potential product contamination problems. Since chemical hazards are the single biggest culprit, and because most of these instances are due to allergens, food companies should closely examine their cleaning and sanitation practices during production line changeovers. Keep in mind the potential role of contract service providers as sources of adulteration. Regarding pathogens, evaluate raw and ready-to-eat segregation procedures, staff access points, and good manufacturing practices and employee traffic patterns.
Many companies focus their efforts on passing food safety certification audits, but faithful adherence to food safety measures just to pass an audit misses the point. Focus on the development and implementation of comprehensive food safety systems to guard against contamination and food safety incidents, and not just avoid non-conformances to certification codes. Preventing food safety incidents and recalls before they happen must be the priority.
Manufacturers, suppliers and certification bodies have evolved a set of best-practice recommendations that will go a long way toward reducing the number of food safety incidents and recalls. These include conducting regular internal audits of food safety plans and procedures, including approved supplier programs and environmental monitoring programs, both to re-evaluate their effectiveness and discover new or previously overlooked gaps.
Suppliers should consider taking things to the next level. SQFI’s LeAnn Chuboff suggests that suppliers “make their retailers happy” through the use of mock trace exercises.3 These “dry runs” are invaluable for reinforcing the close examination and evaluation of recall plans and to become intimately familiar with the necessary procedures in the event of an actual adulteration event. Mock trace exercises should be intensive: They are particularly effective in identifying gaps when they occur during off shifts. Making the exercise challenging rather than check-the-box easy helps companies reveal and close critical gaps. Conduct the mock trace in both directions, from raw materials to finished goods, and vice versa.
Include every department in the company. For mock trace exercises to be completely effective, review all documentation for errors or omissions. All employees should be interviewed to determine whether they fully understand food safety and documentation procedures. Review training modules and observe manufacturing procedures for evidence of knowledge or operational gaps. Examine bulk material receiving and storage, employee and material traffic patterns, packaging materials and procedures, and cleaning and maintenance chemicals.
Speed as well as accuracy and thoroughness are critical in the event of an actual recall event. Companies should practice rapid response. Take advantage of all the accumulated experiences from the mock exercise to improve every aspect of the company’s food contamination response tools and practices.
The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses began in September 2016. Economically Motivated Adulteration (EMA) or food fraud is a component in the Preventive Controls Rule. As the global supply chain becomes more complex, preventing EMA and compliance to Preventive Controls for Human Food rule can be a challenging task.
A food company’s supply chain can be the weakest link in their food safety program. Learn strategies and how to mitigate risks at the Food Safety Supply Chain Conference | June 4–5, 2017 | Rockville, MD, LEARN MORELast year GMA and Battelle released EMAlert, a tool that enables quantitative evaluation of a company’s supply chain to economically motivated adulteration. USP also provides a platform to help companies with food fraud mitigation strategies. In a Q&A with Food Safety Tech, experts from the USP Food Program, Jeff Moore, Ph.D., science director and Karen Everstine, Ph.D., scientific liaison explain how the Food Fraud Database 2.0 works and how it can help companies with FSMA compliance.
Food Safety Tech: How does the Food Fraud Database 2.0 assist food companies in identifying hazards and vulnerabilities?
Jeff Moore, Ph.D.: We reengineered the database [previously Food Fraud Database 1.0] from the ground up, including the structure of the data. Users wanted not just a source of high quality data to inform of risks and vulnerabilities that were related to food fraud but also some ability to analyze the information and get alerts and real-time information to figure out what to do in real time.
Karen Everstine, Ph.D.: Since it was reengineered, we’ve been able to include a lot of fields that allow food companies to tailor their results to information that is most applicable to them (i.e., geographic location). Automated analytics give a visual of what’s happening to see trends more quickly.
Moore: We have a team of dedicated analysts that are constantly scouting the public domain and looking for information globally to add to the database to make sure it’s the most comprehensive, up-to-date global database of food fraud information.
FST: What tools within FFD 2.0 can help companies with FSMA compliance?
Everstine: One of the things in the FSMA PC rule is the fact that food companies now have to identify potential hazards, whether they are intentional or unintentional, which includes food fraud-related hazards. One of the tools we built into the database is an EMA (Economically-Motivated Adulteration) hazard identification report. It allows users to input a list of their ingredients (those sourced and brought into the facility to create a finished food product), and then the report output identifies which ingredients are associated with potential hazards (i.e., adulterants that might pose a health threat to consumers). That’s the main tool we’ve built to target FSMA compliance.
Moore: One of the key parts of the PC rule as related to EMA is a question of whether the ingredient has a history of association with potentially hazardous adulterants. We put together an expert panel at USP and Karen [Everstine] was responsible for working with the panel to develop a classification system to identify adulterants that are potentially hazardous.
Building the right food safety culture around environmental monitoring requires a realistic approach to your processes. “Culture starts with understanding your process,” Zephyr Wilson, product manager at Roka Bioscience told Food Safety Tech at the 2016 Food Safety Consortium. “You need to ask questions—a lot of questions.”
In the following video, Wilson talks about food safety culture in the context of environmental monitoring and how companies should approach environmental monitoring. “Understand all of your processes,” she said. “Take an honest look at your metrics and make sure you’re encouraging your employees to find the Listeria.”
She also reviews the steps a company should take when undergoing self-auditing, and encourages companies to work under the direction of an attorney to ensure that all results are confidential.
As the enforcement of rules, regulations and inspections get underway at food production facilities, we are faced with maintaining production rates while looking for infinitesimal pathogens and cleaning to non-detectible levels. This clearly sets demand on the plant for new and creative methods to control and mitigate pathogens pre-production, during production and post production.
As this occurs, the term clean takes on new meaning: What is clean, and how clean is clean? Swab and plate counts are now critically important. What method is used at the plant, who is testing, what sampling procedure is used, and how do we use the results? As we look at the process from start to finish, we must keep several key questions in mind: What are harboring points in the process, and what are the touch-point considerations to the product? Let’s review the overall processing progression through the factory (see Figure 1).
Now consider micro pathogen contamination to the product, as we look deeper in the process for contamination or critical control points as used in successful HACCP plans. Consider contamination and how it may travel or contact food product. It is understood through study and research of both pathogens and plant operations that contamination may be introduced to the plant by the front door, back door, pallet, product, or by a person. In many cases, each of these considerations leads to uncontrolled environments that create uncontrolled measurements throughout, which lead to cleaning procedures based on time rather than science. This is certainly not to say that creating a preventive maintenance schedule based on a calendar is a bad thing. Rather, the message is to consider a deeper look at the pathogens and how they live and replicate. From the regulatory and control measures this should be a clear message of what food-to-pathogen considerations should be taken at the plant level as well as measurement methods and acceptable levels (which is not an easy answer, as each product and environment can change this answer). A good example to consider is public schools and children. Health organizations work to help the schooling system understand what immunizations children should have based on the current health risk tolerance levels. In food production, the consideration is similar in an everchanging environment. As we see contamination levels change the methods, techniques and solutions to proper food production must account for the pathogens of concern.
Contamination, risk tolerance, and opportunity for growth are the considerations when looking at a plant design or a plant modification. Modification to modernization should be a top-of-mind critical quality control measure. If there are a few things we know, it is how to produce food at high rates of speed, measure and value production rates, and delays or failures can be measured by equipment and personnel performance. In the case of quality control, we must review, comprehend, and protect process risk. From a management or non-technical viewpoint, quality control can be very difficult to understand. When discussing pathogens, our concerns are not visible to the human eye—we are beyond a dirty surface, weare looking at risk tolerance based on pathogen growth in logarithmic measurement. When combining quality control and production, the measurement control and mitigation measures complement the effort. The use of quality control is expected and should coordinate with production to ensure the product is produced at the expected quality level.
Stored product insects (SPI) can cause a revenue loss of 1–9%, according to recent research by the Centre for Economic and Business Research. The following infographic outlines the impact SPIs can have, which are the world’s most expensive pests, according to Rentokil.
