You don’t have to be a food safety professional to know that 2018 was a terrible year for fresh produce safety, especially romaine. The entire romaine supply chain, from growers, shippers, fresh-cut processors, through to those at retail and foodservice who interface directly with consumers, recognize that the public’s confidence has been shaken. The onus is on us to regain it.

Recently, the California Leafy Greens Marketing Agreement (LGMA) took a revolutionary step in mandating that growers producing under the LGMA requirements treat surface water that will be used for overhead irrigation of leafy greens within 21 days of harvest. (The required treatment of surface water recognizes the need to use EPA-approved sanitizers in accordance with label requirements. Further, the industry recognizes the importance of co-management of the environmental and food safety risk and provides notice that the sanitizers must be used in a manner that is in compliance with all applicable environmental protection criteria.) United Fresh commended LGMA’s action, which conceptually aligns with guidance we are developing for the breadth of the fresh produce industry relative to assessing the risk of agricultural water.

LGMA is administered by the departments of agriculture in California and Arizona, which are the two main leafy green-producing states. While participation is voluntary, once committed, growers must adhere to the detailed requirements contained in the metrics. State auditors verify compliance. About 99% of the leafy greens coming out of California and Arizona are produced under this system, which was developed shortly after the 2006 E. coli O157:H7 outbreak associated with spinach.

FDA is just beginning to conduct inspections of fresh produce-growing operations subject to the Produce Safety Rule (PSR). However, the requirements around managing and testing agricultural water are not yet in effect and are likely to change. The popular press and consumer groups tend to focus on this point, suggesting that the industry does not want to test water and is putting public health at risk. Nothing could be further from the truth. For reasons too complicated to explain in this column, United Fresh supports FDA’s reassessment of agricultural-water requirements and believes that the LGMA model should be considered as FDA considers a path forward. That said, not all produce is leafy greens.

The new California LGMA water standards were approved on April 19 and will likely be adopted in Arizona. While there is concern that these metrics may be applied to crops with different risk profiles, the risk-based approach to managing agricultural water has merit and is broadly applicable. Instead of debating how to augment the PSR requirements related to generic E. coli, what the test limits should be, and how many tests need to be taken to show that untreated surface water is safe, the updated LGMA water metrics flip the approach to water safety on its head. The new working assumption is that surface water has inherent risk, and treatment must demonstrate it is effective at reducing the risk of open water sources.

Food safety professionals agree that you can’t test safety into a product. The leafy greens industry is now applying that same philosophy to water: just because a test indicates that water meets certain criteria, we cannot trust that it’s always sufficient. Instead, the water source, conveyance system and the way the water will be used are factored into the risk equation. Thus, the framework, at its highest level, should be adaptable to the wide variety of situations used in fresh produce production.

When it comes to assuring leafy green safety, the change to the LGMA water metrics is not the end of the effort but is just the beginning of a new way of thinking about water. While overhead irrigation arguably presents the greatest risk if contaminated water is used, water is used in a variety of ways and the industry will continue to chip away at those factors that present the greatest relative risk. In the meantime, the rest of the produce industry should begin thinking about whether the LGMA approach has application for their commodities and their farms. FDA regulations for agricultural water are too far down the road to wait for a regulatory requirement. Read the LGMA guidelines.

By Lisa Lupo

We asked the pest management industry one question: Can a food processing facility be “pest free”? Then we asked for an explanation of the response:

• If yes, what does it take?
• If no, why?

Along with yes and no receiving an equal number of responses, a few experts did not commit to a solid yes or no, explaining that it depends on a number of variables.

But regardless of the side they took, the experts from the pest control companies and product manufacturers provided valuable insights on the potential causes of pest entry, critical steps that food facilities can take for control, and solutions for significantly reducing the food safety risks from pests.

Following are their responses.

YES

Absolutely! A properly maintained, inspected, and managed facility can be pest free, but only as long as these are continuously done. Most pest problems stem from a lack of maintenance, poor inspections, or poor management that leads to a failure in the “system” and a pest problem to develop. As individuals in a pest population gain access to a facility, the inspection and maintenance practices should intercept these individuals before they can become a large reproducing population, thus keeping the facility free of pest infestations. As Benjamin Franklin once said, “An ounce of prevention is worth a pound of cure!” – Janis Reed, Technical Services Manager, PCO, Control Solutions, Inc.

Yes, but it requires the proactivity, education, and commitment of employees and service providers, including the PMP. Even if there is no rodent issue today, a lack of vigilance will lead to a problem tomorrow. All must know what conditions are conducive to pests and be able to report or take action when something is amiss. For example, the receiving department must be aware that rodents and pests can enter the facility as stowaways on incoming shipments and know how to identify and deal with problem deliveries. Ongoing exclusion is also essential. Entry points must be sealed with rodent-proof material and regular inspections conducted to ensure that entryways remain sealed and no new entryways have developed. – Dave Colbert, Vice President Sales, Xcluder

There will always be some type of pest pressure, but with diligence you can keep any type of infestation from becoming established. It takes monitoring for pests and a knowledge of past issues and conducive conditions that lead to pest pressure. For example, is there is a history of house fly problems? Have entry points been properly addressed? Are there enough light traps? Has sanitation outside the facility been addressed? Different facilities and locations have their challenges. Spending the right amount of time on an account, with the right materials and cooperation of customers is what makes a pest-free facility attainable. – Mel Whitson, Senior Field Technical Service Manager, Zoëcon Professional Products

Although pest pressures in food processing plants are always high, a facility can achieve a “pest-free” condition. To reach “pest free,” the partnership between the facility staff and the pest manager, throughout their respective organizations, must be committed to this goal. Key stakeholders on both sides must instill a sense of value and commitment to observation, reporting, communicating, and action when existing or conducive pest conditions exist. – Joe Barile, Technical Service Lead, Bayer Environmental Science’s Professional Pest Management Team

Yes. When you have proper sanitation programs, excellent pest exclusion, sanitary design, and a well-documented HAACP program, you can keep pests out. Protection from food contamination is a continual challenge for food manufacturers. However, it’s a beautiful thing when a pest management professional works closely with key personnel such as the quality assurance team, the sanitation manager, maintenance, and the plant manager who are all concerned with food safety and a pest-free environment. It also helps having FDA and its Food Safety Modernization Act as a regulatory body that holds food companies accountable for preventing food contamination. – Shane McCoy, Director of Quality and Technical Training, Wil-Kil Pest Control

IT DEPENDS

Being pest free can be a challenge. Inherent in Integrated Pest Management (IPM) are concepts of economic thresholds — the cost of pest control does not equal or exceed the cost of product damage. An IPM program includes action thresholds to prevent overreactions and underreactions to pest issues in order to not exceed economic thresholds. For instance, if you have a single rat inside of a food processing facility, immediate action will need to be taken as it poses a health risk to employees, could result in damaged products, and could negatively impact an audit. However, if you have house flies outside near trash containers, a higher number may infest the area before action is needed. – Jerry Heath, Entomologist, Industrial Fumigant Company

It depends. Birds pose problems for facilities on the interior and exterior. Most interior problems occur because birds are comfortable on the exterior, then find their way inside, through open doors, cracks, ventilation, etc. Birds should be discouraged from landing on exterior features (lights, signs, ledges) near ingress points. This is easily done with optical gel, spikes, and electrified track. Once inside, food and water should be eliminated. Birds should be removed using mist nets and live capture traps, and openings should be closed off. If it’s not possible to stop their entry, sensitive areas of the facility can be bird-proofed. More areas can be added going forward. – Cameron Riddell, President, Bird Barrier America

There are many factors that influence the presence of certain pests in a food processing facility. Although it is hard to see a 100% pest-free environment, our goal is always to keep pest populations in check and below expected levels. In a commercial facility of this nature, an integrated pest management approach that pays close attention to hygiene, exclusion, and prevention is crucial for a successful control program. In addition, it is very important that food processing facilities work together with a certified pest management professional to develop monthly pest control protocols and services that fit their needs. – Freder Medina, Technical Market Manager – Pest Control, BASF

It depends on how you define “pest-free.” For example, it is completely realistic to expect food products manufactured inside modern facilities to be free from pests. In other words, no pests should be present in the food. However, pests are going to interact with, and likely penetrate, even the most structurally sound buildings through frequently used doors, inbound ingredients, utility penetrations and so on. The key is to have detection systems in place to forewarn pest professionals when pests infiltrate the facility. Perhaps more importantly, have a solid corrective action plan to proactively address pest activity when it is found. – Dan Collins, Regional Technical Director, McCloud Services

NO

I do not believe a food processing facility can be completely pest free, as we exist in a world where insects are all around us, including those that are too small to see. However, with dedication and adapting integrated pest management practices like exclusion and sanitation techniques, facilities can keep insect population levels at a very low level; one that will not cause economic loss. Constant monitoring and communication between on-site employees and pest professionals is key to maintaining control of insect pests. – Cassie Krejci, Animal Health Technical Field Specialist, MGK

A food processing facility can’t be truly pest-free just due to the nature of the business. You have people, raw ingredients, and packaging components moving in and out all day, increasing opportunities for pests to be transported into the building within a standard ingredient or process. We call this phenomenon the “trojan horse concept.” The trojan horse is a real danger to any pest control program because we cannot inspect 100% of every shipment or the people visiting. Additional challenges include the constant opening and closing of doors; or worse, doors not closing when they should, increasing risk; and the power of the building’s attractants to pests which includes smells, waste, warmth, and lighting. These factors cannot be eliminated entirely, so pest activity will always be a risk. – Dominique Sauvage, Senior Director of Quality, Training, and Field Operations, Copesan Services and Terminix Commercial

YES!...Now close the facility doors forever and write your pest management professional a blank check! No facility can become truly “pest free.” The real question should be “What modern techniques and programs would enable us to become ‘pest prevention oriented’?” I see those as being:

1. A properly performed facility risk assessment detailing every known risk observed and the potential for risk.
2. An integrated pest management (IPM) program with executive level backing, budgetary funding, and a focus on the pillars of IPM: detection, identification, biology, risk, etc.
3. A prevention-minded process for incoming goods and exterior pest pressures.

– James Miller, Market Manager-PCO, Trécé

The ultimate answer is no. In the real world of shipped raw materials, palletized goods, aging facilities, and human error, it is only a matter of time before an unwanted pest finds its way into the most secure food-processing operation. However, for practical purposes, it is possible to virtually eliminate risk to facility products with a proper reaction to pest pressure. The critical factor is early detection. This can be accomplished reliably with a thorough quarantine and monitoring protocol, regular inspections, and aggressive control measures when pest thresholds are breached. – Eric Paysen, Technical Services Manager, Professional Pest Management, Syngenta

A completely pest-free facility is probably not possible due to the large quantity of raw materials, packaging, and supplies being transferred into the facility. Even with very tight supply-chain specifications and controls, this is likely not realistic or at least cost attainable, though tight controls can minimize the likelihood of incoming infestations. It is possible for facilities to proactively prevent pest entry from the ambient environment and create an environment within the facility wherein any pests are eradicated before they create a hazard. Both would require an integrated approach including environmental, mechanical and chemical eradication, coupled with a strong monitoring program, sanitation and “pest proofing” specific susceptible processes and areas. A wide range of resources are available to create such a program. – Cisse Spragins, Founder/CEO, Rockwell Labs Ltd

No, food processing facilities are under constant pest pressure. Penetration or introduction into a site is always a threat. The problem is only mitigated through a complete partnership between the pest management professional (PMP) and the staff of the facility. That arrangement works on a day-to-day basis with both teams assessing and evaluating the site and working toward the goal of keeping pests out. – Ethan Vickery, President, VM Products

The author is Editor of QA magazine. She can be reached at llupo@gie.net.

By Lisa Lupo

The word “clean” can be idiomatically used to emphasize the completeness of an action or experience, e.g., “he was knocked clean off his feet.” Synonyms include words such as totally, thoroughly, and absolutely. When your cleaning and sanitation crew finishes its shift, are those words applicable to the state of your food processing facility? What does it really mean to be thoroughly/totally/absolutely clean? And why is that important?

“A thoroughly/totally/absolutely clean food facility is a hygienic facility that serves as the foundation for manufacturing safe, high quality, and consistent food products,” said The Ohio State University Food Industries Center Program Specialist Steven Simmons. “It is a hazard-free facility at pre-op inspection, that allows for the continuous mitigation of pathogen cross-contamination and allergen cross-contact during operation.”

Unclean surfaces can and will contaminate product with spoilage, pathogenic bacteria, or allergens, so having an absolutely clean environment means that the sanitation process is capable and in control from a microbiological standpoint, preventing contamination from the plant environment, said FoodSafetyByDesign President John Butts. “Unfortunately,” he added, “there are harborage sites and growth niches below the surface in the equipment and facility that may emerge during the production process.” Because of that, words such as thoroughly, totally, and absolutely clean would mean the ability to keep subsurface growth niches and harborage sites from exuding their contents, he said. “Sanitary design is necessary to minimize this risk.”

The creation and maintenance of a hygienic food facility is arguably the most critical component of any effective food safety system, and the overarching goal of all food safety systems is to protect public health, Simmons said. “The U.S. food supply is commonly regarded as the safest in the world, largely due to the emphasis that food manufacturers place on sanitation.” Additionally, because unsanitary conditions resulting from deficient sanitation practices are often the root cause of inspection non-compliances, recalls, and foodborne illness outbreaks, USDA and FDA regulations stress the importance of food facility sanitation, such as through Sanitation Standard Operating Procedures (SSOPs) and Sanitation Preventive Controls, he said.

But, said DOZ Enterprises President Ole Dosland, the level of “clean” is in the eyes of the beholder: a plant maintenance worker would have a different level of clean than that of a microbiologist, yet both levels might be acceptable for their purpose; and cosmetic cleaning might fool a visitor, but deep cleaning is critical to meeting food safety expectations of no insects or harmful bacteria. Because of these varying perceptions, it is important to define an acceptable level of clean, based upon science and prevention of hazards, to provide clarity and consistency for the cleaning activity, Dosland said.

COMMON FAILURES. The three experts agreed that the areas most commonly missed in cleaning and sanitizing are those that are difficult to access. And when they are missed? “Product contamination and reduced shelf life are common results of failure,” Butts said.

These can include low areas, such as the underside of equipment, the wheels of material-handling equipment, the support structure of conveyor belts, and the interior of control boxes, as well as high areas, such as overhead utility piping, refrigeration equipment, and the underside of elevated walkways, explained Simmons.

©littlewolf1989 - stock.adobe.com

Overhead areas are of major concern because they are likely oriented directly above exposed product, product contact surfaces, or product contact packaging at some point in the manufacturing process, Simmons said. “It is possible for these areas to harbor environmental pathogens, with the ability to contaminate product or surfaces through a drop of condensate or as passengers on dust.”

Other common failures are:

• Lack of periodic deep cleaning of equipment through disassembly. In fact, a common failure is even knowing the proper level of disassembly, Butts said. This should be determined by measuring design risk areas visually and microbiologically in a seek and destroy (S&D) investigation. This is important because, he said, “Repeated S&D investigations yield data that is used to define normal and periodic levels of disassembly. This data also measures the effectiveness of the normal and periodic sanitation process.”
• Inattention to “touch points,” such as door handles; doorway curtains; control panels; hoses and nozzles; and the handles of utensils, tools, and material handling equipment. Touch points are key vectors for pathogen cross-contamination and allergen cross-contact and must be adequately cleaned and sanitized to minimize the risk of employees’ hands introducing these hazards to the product, product contact surfaces, or product contact packaging, Simmons said.
• Lack of sanitation of employee hands, gloves, uniforms, and personal protective equipment are also of concern, he said. If these become contaminated, they must be replaced with sanitary versions prior to continuing sanitation operations.
• Rushing to get the job done. “Often sufficient time is not allotted for the desired cleaning activity due to production overruns and early startups,” Dosland said. “A well-developed SSOP should identify the time frame needed to accomplish the task.” A solution is to provide an uncompromising time frame for the SSOP(s) start to finish. Then, periodically update each SSOP to maximize cleaning effectiveness and efficiency.
• “Sanitation crews are often overly aggressive when pre-rinsing and manually cleaning, using excessive water pressure or overly abrasive scrubbing tools, respectively,” Simmons said. This is an issue in pre-rinsing because the goal is to flush large soil particles from surfaces prior to cleaning, but excessive water pressure is likely to displace soil from one area to another as water oversprays, or casts off the sprayed surface. This is most problematic on food contact surfaces for allergens, and on floors and drains for environmental pathogens.
• In manual cleaning, sanitation crews tend to use overly aggressive scrubbing tools, such as scouring pads, inadvertently damaging equipment surfaces, Simmons added. This can be serious because the damage enhances the ability of food soils and microorganisms to adhere to the surface, while reducing the effectiveness of cleaners and sanitizers.

SOLUTIONS. How does the food facility correct these? “The solution to most sanitation program deficiencies is an effective employee training program,” Simmons said. “Sanitation employees must understand the importance of their responsibilities and buy in to the company’s food safety culture.” It is the responsibility of each employee to choose to perform their tasks properly, but management can support this through job performance rewards, often linked to monitoring and validation data.

It also is critical that sanitation employees are provided with the proper tools and supplies, he said. For example, if abrasive scouring pads are the only manual cleaning tools available, it is highly likely that sensitive equipment surfaces will be damaged.

Some best practices in sanitation the consultants have seen and recommendations they have developed from those include:

• Engaging sanitors who understand that they have the most important job in the facility; if they fail everything else is at risk. “Sanitation management must effectively engage sanitors while removing roadblocks from their success,” Butts said. “The most demoralizing situation is when a facility deploys a contingency of ‘QA Police’ to enforce visual cleanliness.”
• Clearly establishing a robust comprehensive microbiological environmental monitoring program, Dosland said.
• Reducing the monotony of sanitation work and enhancing employee vigilance. “There is a tendency for sanitation crews to get into daily routines, which may appear to be the ideal scenario for a properly implemented sanitation program. Unfortunately, routines tend to reduce employee vigilance when seeking out niches and other problem areas within a facility,” Simmons said. To break the routine, vary employee responsibilities from day-to-day or at least week-to-week, or have employees inspect the work of their coworkers to hold each other accountable for completing the work appropriately. This also helps each employee maintain familiarity with all areas and equipment in the facility.
• Similarly, Butts recommends that facilities measure and recognize the work of sanitors and expect microbiologically clean. “Make it a plant KPI,” he said.
• Sanitizer rotation is a practice that has the potential to improve the effectiveness of every sanitation program, Simmons said. Using a different sanitizer every other night, every other week, or even once weekly may enhance a program’s ability to combat the wide variety of spoilage and pathogenic organisms that may be present in a food facility. The theory is that each sanitizer has a different efficacy for each organism, so a simple rotation will minimize any deficiencies or gaps and reduce the likelihood of an organism becoming a problematic resident in a facility,” he said.
• “One job position I don’t hear much of anymore is a plant sanitarian,” Dosland said. “The best tip I can offer is to have one.” A clean facility is a longer-lasting facility reflecting an industry leader, he said. “That doesn’t happen by accident, it is the result of the intelligent effort that a sanitarian can provide.”

VALIDATION. How do you know if your facility is thoroughly/totally/absolutely clean? The first step is designing and developing a robust sanitation program and assembling a trustworthy, knowledgeable, and skilled team, Simmons said. Then, management must interact routinely with the team, including observations, discussions, ongoing education and training, and review of monitoring and verification records, such as adenosine triphosphate (ATP), microbiological, and allergen test data, he said.

Dosland provided a three-step method for determining an acceptable level of clean. Assuming the Master Cleaning Schedule (MCS) and Sanitary Standard Operating Procedure (SSOP) were developed properly:

1. Verify the MCS and SSOP have been followed. If one is late with the MCS, the SSOP might not be adequate.
2. Examine the cleaned surface organoleptically for instantaneous feedback. If it doesn’t feel, look, or smell right, it probably isn’t right, he said.
3. If 1 and 2 are acceptable, confirm with microbiological testing. Microbiological testing/swabbing includes testing for target pathogen(s) and indicator microorganisms.

If any indications of failure are found, it is critical that they are corrected. Product contamination and reduced shelf life are common results of failure, Butts said, and it also could cause products requiring a COA to not be in compliance with the product specification, leading to rejection.

“The consequences are serious,” Dosland said. “Bacterial contamination of products can lead to foodborne illness, recall, product destruction, and facility closure.”

The author is Editor of QA magazine. She can be reached at llupo@gie.net.

By Lisa Lupo

Although it has been more than eight years since the passage of the Food Safety Modernization Act (FSMA), and July brings the last of the general compliance dates for the seven major rules of FSMA, it seems that it will be a long while — if ever — before we can say that FSMA is finally final.

Not only are there some requirements yet to be written (e.g., Produce Safety Rule water standards), small and very small business compliance dates outstanding, and inadvertent non-compliance to be corrected, FDA Deputy Commissioner for Food Policy and Response Frank Yiannas is transitioning the industry from a food safety modernization act to a food safety modernization culture. Following is an overview of the seven major rules of FSMA, where the industry stands with each, and how it is transitioning to a new era.

PREVENTIVE CONTROLS (PC) RULES (FOR HUMAN AND ANIMAL FOODS). As the foundation of FSMA, the PC rules are the most extensive and complex. As such, there are some sections of the rule which seem to be causing the most difficulty for the industry and are, said The Acheson Group Senior Manager of Food Safety Christopher Snabes, the most common areas of inadvertent non-compliance. These include:

• Incomplete hazard analysis such as failure to perform a process hazard analysis; to identify where any re-work is coming from and going to; and/or to include radiological concerns, EMAs, and recognition of inherently intrinsic pathogens for an ingredient.
• Process PC validation studies are either not being conducted, are incomplete, and/or do not have proof that they were reviewed by the PCQI for acceptability.
• Incomplete or non-existent signatures on the Food Safety Plan and verification records.
• Lack of facility ownership of a supply-chain preventive control (if it is called out for a facility). Currently, if a facility is depending on a supply-chain preventive control, the supply chain needs to be fully vetted and documented at the facility with a written list of approved suppliers, along with explanation and documentation of how approval is attained for the hazard being controlled. FDA is currently exploring a two-tier inspection system whereby a corporate headquarters can maintain the supply-chain system in place for all facilities under its umbrella.
• Lack of a recall plan. Facilities often either have no plan at all, have only an incomplete plan, or the business assumes that the traceability SOP is sufficient for a recall plan. (It isn’t.) Additionally, too many corporate headquarters assume the corporate recall plan is sufficient for every facility under its umbrella. Currently, each facility is required to have a recall plan in place. FDA is currently exploring a two-tier inspection system for this as well, whereby a corporate headquarters can have a recall plan in place for all facilities under its umbrella.
• Failure to practice/enforce GMPs. This is particularly challenging for facilities with high employee turnover rates.
• Failure to properly treat the human food to animal food stream. Any human food destined for animal food use needs to be properly identified, handled, and stored.
• Lack of or incomplete letters of assurance: Companies that are not controlling a known hazard and are depending on a downstream entity to control the hazard with a preventive control often have few to no written letters of assurance between the parties detailing this step.

With such failures being seen across a number of industry establishments, it is critical that facilities assess their practices and processes for compliance. To do so, Snabes said, “Take a holistic look at the entire plan, facility, and food safety culture. Don’t depend on an audit checklist; don’t depend on a single food safety scheme auditor to make sure you meet all aspects of FSMA.”

Rather, Snabes recommended that facilities have a trained, well-engaged preventive controls, food defense, or FSVP Qualified Individual (PCQI, FDQI, FSVP QI) or trained produce grower who works with an independent consultant. Together, they should review your facility and plans, openly work with your entire food safety team, and look for opportunities where the facility can improve and close the gaps of compliance.

The PC Rules are not the only ones for which (often inadvertent) non-compliance is being seen:

• Sanitary Transport. “We have seen some companies under the Human and/or Animal Food Preventive Controls Rule not fully complying with or understanding what they need to do with the Sanitary Transport Rule,” Snabes said. This is evident in the documentation of training and understanding of which party is responsible for the training.
• Produce Safety. As the Produce Safety Rule (PSR) had the compliance dates for the agricultural water provisions delayed until 2022 for the largest companies, this rule remains incomplete. However, Snabes said, “It is encouraging to note that several leafy green producers are taking proactive steps now, and not waiting for the compliance date to go into effect, to produce safe crops.”

From the regulatory side of the picture, PSR inspections began this spring, largely conducted by the states, said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas in the Town Hall presentation at the Food Safety Summit in May. He also noted that FDA is taking a hard look at the water standards and is working with trade groups on developing these. Both of the recent romaine lettuce outbreaks had a water connection, he said, adding, “This water connection is very important. I can’t overstate the importance of water.”

• Intentional Adulteration (IA). With general compliance to the IA Rule due in July, large businesses are expected to have a written Food Defense Plan in place along with other requirements of the rule. However, this is currently the most incomplete rule by the industry, Snabes said. Part of the reason is that many companies are waiting for FDA to publish the third and final guidance document for the rule; additionally, the vulnerability assessment training has just been released, which many companies need to have a Food Defense Qualified Individual — as required by the rule.

Because of this lack of readiness, FDA received numerous letters asking for an extension on compliance, Yiannas said. However, FDA decided to keep the date as set, he said, but the agency will hold off on IA inspections until Spring 2020, and inspectors will educate while they inspect.

• FSVP. Although most food companies are aware of FSMA, many importers who do not process food still need a Foreign Supply Verification Plan. “From my experience,” Snabes said, “This is one of the most overlooked rules.”

And it is an area on which FDA is focusing. FSVP inspections began in June 2017 with almost 1,500 conducted to date, and, Yiannas said, “We will do more FSVP inspections this year than last.”

• Accredited Third-Party Certification. Certification bodies are continuing to be accredited under FDA’s voluntary Accredited Third-Party Certification Program. This accreditation means that the companies have been given the authority to conduct food safety audits and issue food and facility certifications for foreign food facilities. The certifications can establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food, and fulfills the “rare and specific circumstances” under which FDA may require that an imported product be certified to prevent a potentially harmful food from entering the U.S.

FSMA FINAL? While various aspects of FSMA may be complete or nearing completion, FSMA compliance can never really be “finally final” in a food facility. As Snabes explained, “FSMA specifically states that the plans, and all moving parts, need to be reviewed and updated when needed, and all verification records need to be reviewed appropriately by the appropriate trained individual within the proper time frame (usually within seven days).”

Additionally, Yiannas has made it clear that the modernization of food safety will be an ongoing endeavor. “For me,” he said, “food safety modernization was never an act that was passed in 2011, it was a vision. It’s the idea that together we have to continue to improve our food safety approach.”

Additional evidence of this is FDA’s current focus, led by Yiannas, on the Blueprint for a New Era of Smarter Food Safety which, he said, “Will continue to be FSMA-based, but has to be technology enabled.” The world is becoming so digitized and food safety needs to keep pace with that. Digitization won’t solve everything, but it will help, he said. While blockchain, which Yiannas spearheaded during his previous global food safety role at Walmart, is likely to be at least an option in FDA’s traceability initiatives, he also noted the potential application of artificial intelligence (AI), for which a pilot is currently being conducted on imports. The goal is to determine if the system can be augmented to learn dynamically and be a predictive tool — which would then be shared with the industry.

Seeing the lack of traceability as the “Achilles heel of the industry,” Yiannas said, “We will advance track and trace of foods in a significant way.” But, he added, “It’s transparency we’re after, not just traceability.”

The author is Editor of QA magazine. She can be reached at llupo@gie.net.