By David Anderson and Karina Martino

September 2016 marked the date that many food establishments were required to implement aspects of the Food Safety Modernization Act (FSMA). The Preventive Controls (PC) for Human Food rule (21 CFR part 117) and Animal Food PC rule (21 CFR part 507) are similar in many ways, with some deadline differences. The Human Food PC rule deadline was September 19 for most companies; for Animal Food, that deadline was applicalbe for compliance to GMPs, with the remaining compliance having an additional two years. Small and very small businesses may have more time to comply.

On August 23, FDA issued new draft guidance to help the food industry comply with the GMPs and the Human PC rule. Comments started August 24. The guidance included the first five of 14 chapters, and explained FDA’s current thinking on how to comply with the rule. (For more information, visit http://bit.ly/2bzMA8F.)

Two additional draft guidances were released August 24 to assist industry with the implementation of the Animal Food PC rule.

FOOD SAFETY PLANS. Both PC rules require that food processing facilities adhere to GMPs as defined in the FSMA regulations and develop food safety plans for any foods for which a preventive control is required by the hazard analysis. FSMA food safety plans share many similarities with HACCP plans. Both require hazard analysis, monitoring procedures, verification procedures, and records. HACCP prerequisite programs may be viewed as preventive controls in FSMA; and critical limits in HACCP may be defined as process controls in the food safety plan. A comparison of HACCP principles and FSMA requirements is shown in Table 1.

SCIENTIFIC/TECHNICAL BASIS. Scientific information may be used to conduct a hazard analysis or determine process controls and preventive controls. But what sources can be used for these? Some are noted in the preamble to the FSMA rules, published in the Federal Register. Others have been listed by Codex Alimentarius. Briefly, here are a few:

• Regulatory documents (such as performance standards). Processors familiar with USDA requirements for meat and poultry know this one. A required minimum reduction of pathogens is stated in the law.
• Published “safe harbor” processes. Some process times and temperatures have been well established and are known for food safety. The requirements for milk pasteurization are an example.
• Generally held historical knowledge. The ability of pH and water activity to control pathogen growth is well-known, generally held knowledge. When harmful bacteria are controlled by formulation, this knowledge could be helpful in a food safety plan.
• Published processing guidelines. Industry-group processing guidelines may be used by a processor. The GMA Science Operations group can assist with processing guidelines; the Almond Board of California published times and temperatures for dry roasting almonds to destroy pathogens.
• Peer-reviewed scientific literature or technical data. Microbiological and technical journals may be a source for data to support a food safety plan. Articles abound about process times and temperatures for pathogen destruction, limits to microbiological growth, and effects of process treatments.
• Scientifically valid experimental data, e.g., microbiological challenge study. A processor may wish to conduct its own study in the lab or plant.
• Previous validation studies. Perhaps a company has a library of prior studies that can be applied to a new product. If a prior study is substantially similar to a prior one, the determination may be made to use prior study data instead of conducting a new study.
• Scientific pathogen models; mathematical modeling. Models may be helpful in understanding pathogen growth, inactivation or destruction. Models may be used as guidelines to help determine the limits for experiments.
• Operational data and surveys. A plant may apply operational data or survey information to food safety plans. For example, microbiological sampling may help support a plant’s assertion that a “kill-step” process control is adequate. However, sampling data alone, in the absence of other controls, may not to be enough to show that a hazard is being adequately controlled.

NEXT: THE PLANT FLOOR. With the scientific and technical data in hand, the work moves to the processing area. That work may be described as an “in-plant validation.” The in-plant procedures and processes must be demonstrated to meet the requirements of the science. FSMA regulations allow 90 days for this in-process work, after a process has been introduced into a facility.

Imagine that a scientific article has shown that a given process time, process temperature, product water activity, and pH are sufficient to destroy pathogens in a product. Our job, then, is to determine that the plant’s formulation procedures give us a product that meets the water activity and pH limits. Further, we will confirm that the process meets the stated retention time in the equipment at the required temperature; and we will be sure that the plant has a calibration program in place for equipment used to monitor those formulation and process steps. We also may add a “safety margin” to each of the limits to use as plant operating limits. We will be sure that processing records clearly demonstrate how the limits are met, and determine how record review occurs. Corrective actions for an operator to take if a process does not meet the defined limits are also described. We will write a brief report of the activities of this in-plant validation, and include it with the food safety plan.

Implementation of food safety (and HACCP) plans in facilities require a knowledge of our products; an understanding of how scientific and technical information can be applied; and attention to preventive controls, process controls and recordkeeping. The requirements of FSMA regulations are causing some companies to think more thoroughly in each of these areas and to refine recordkeeping.

The authors: Anderson is senior science advisor; Martino is processing specialist science operations, GMA.

Food facilities have a variety of mechanisms for identifying food safety failures, including customer complaints, self-inspections, audits, and regulatory visits. The key to success is being able to take action to prevent recurrence of these failures, or at least reduce its likelihood, by identifying and addressing the root cause. There are several tools available to facilitate root cause analysis, such as Five-Whys, Fishbone Diagrams, and Pareto Charts, each of which is designed to facilitate a thorough investigation. Following are three of the most common mistakes made in root cause analysis:

1. TREATING THE SYMPTOM AS THE ROOT CAUSE. Let’s use the analogy of a patient visiting a doctor to understand how we must look past the “symptom.” The patient may present with several different symptoms such as headache, fever, and sore throat. The doctor does not treat each symptom with a different medicine, but asks, “Why is the system sick?” then seeks to find the root cause and treat that issue.

The same sort of approach should be taken when seeking to address a variety of food safety issues in a facility. For example, there may be several findings from a self-inspection that seem unrelated: e.g., improperly re-assembled equipment causing metal contamination; drain fly activity around waste material left in the production area; hold-area materials not clearly identified.

While each of these may seem like a different issue, a thorough investigation may find that they all have the same root cause: responsibilities were not clearly defined. In this example reassembly of equipment should have been done by maintenance, but sanitation was doing it; production personnel should have been removing waste containers at the end of their shift, but they left it for sanitation; production workers who moved the materials to the hold area should have identified the product, but they assumed quality would. By ensuring that the root cause, not just the previously surfaced symptoms, is addressed, future similar issues can be prevented.

2. THINKING OF ROOT CAUSE AS SINGULAR. We often hear the phrase, “perfect storm” after a failure. Rarely is the root cause a singular item or issue. Think of a decomposing rodent found in a trap in a warehouse. Upon investigation, we find that there were several contributing factors:

• The site next to the facility was an open field, but recently, construction began on the site, driving rodents toward the food facility.
• The food facility was having a new line installed, so there were contractors onsite, many of whom propped doors open to ease their movement from the installation area to their trucks.
• The facility made a significant change to its packaging, so the warehouse was overstuffed with obsolete packaging waiting for disposition. This caused the trap to be inaccessible during several scheduled device inspections.

If any one of these had not occurred, we likely would not have had the decomposing rodent.

3. FINDING FAULT WITH PEOPLE RATHER THAN THE SYSTEM. One of the most common preventive measures that tends to be identified for food safety deficiencies is “retraining,” which puts the blame on people rather than the system. It is the food facility manager’s job to ask, “How do we make it easy for our employees to succeed and hard for them to fail?” Following are some examples of issues that you may be tempted to treat with retraining, but that have better solutions that take the responsibility off the individual:

• A pedestrian door in the warehouse is left ajar, allowing pest ingress. Rather than simply retraining employees to keep doors closed, install self-closing devices (springs) on the door.
• Materials rejected by the metal detector are put back on the line without evaluation. You could train personnel to leave materials rejected by the metal detector for the QA team, but it’s better to install a locked container to capture rejected materials, and ensure only authorized personnel have access.
• Untrained employees cleaned line 4 conveyors with a chemical that is not approved for food-contact surfaces. Tell personnel to only use chemicals on which they have been trained, but also install a locked cage for chemicals accessible only by authorized persons.

Keep in mind that training may be a contributing factor. However, rarely is the solution to retrain an employee or set of employees. Rather, the solution is to redesign the training approach. I invite you to share these common mistakes with your management team and any others involved in resolving food safety issues within your organization. As you conduct your investigations to identify root cause and prevent recurrence, keep these “watch outs” in mind to improve your rate of success.

Stephanie Lopez is Vice President, Food Safety Services, Americas, AIB International.

Whole-genome sequencing (WGS) is a molecular technology or process that determines the complete DNA sequence of an organism. Sequencing the complete DNA of a foodborne pathogen, such as Salmonella, Listeria, E. coli, etc., plays an important role in public health protection. Historically, several molecular subtyping methodologies have been employed for this. But the methods were time consuming and expensive to use in foodborne illness outbreak surveillance systems. The new rapid sequencing methods (often referred as next-generation sequencing) that use WGS deliver results at low cost and turn time with wide applications that were previously not possible.

WHAT ARE THE ADVANTAGES OF WGS IN FOOD SAFETY? The information obtained from WGS helps investigators quickly identify the bacterial strain responsible for foodborne illness outbreaks. The data are reliable, efficient, and capable of providing location specificity. Other specific advantages are that it is easy to use and inexpensive; identifies the source of foodborne illness outbreak; helps in identification of related cases; helps in monitoring/tracking the transmission route; provides other useful information such as antibiotic resistance, virulence characteristics, serotype, etc.; helps in identifying the risks associated with these pathogens in our food; helps in determining intervention strategies.

HOW DO REGULATORY AGENCIES USE WGS? FDA is using WGS to link pathogens isolated from food and facility to human illness. FDA is spearheading the network of laboratories that can sequence the whole genome of foodborne pathogens collected from contaminated food products and environmental samples and upload the information in the open-access platform GenomeTrakr, a collaboration among FDA, public health, and university laboratories.

When the WGS of a pathogen isolated from food or environmental swab samples is available, GenomeTrakr checks the PulseNet database to identify possible links to DNA fingerprints from patients. These sequences (from source and patient) are compared, and the database will show if other people are sick from the same strain, and if this has been isolated from a specific food or manufacturing facility. Once a cluster is identified, PulseNet works with laboratory and epidemiological investigation teams at CDC, federal food regulatory agencies, and state and local health departments to determine the source and causal microorganism responsible. Depending on this result, FDA will take appropriate corrective actions such as recalling the products, stopping further distribution, issuing public notices/alerts, and overseeing the company’s corrective action plan.

HOW ARE FOOD MANUFACTURERS & PROCESSORS AFFECTED? WGS technology has been successfully used in foodborne illness investigations by FDA, FSIS, and CDC. It provides a strong scientific platform for investigators to connect the dots in the case of an outbreak and to come up with intervention strategies to stop outbreaks sooner. In the future, food manufacturers should expect that any isolate obtained from a food or environmental swab sample will undergo WGS. The data will be stored in the GenomeTrakr database to be trackable in the event of a food safety crisis. Hence, it is vital for food manufacturers to be aware of this technology and its regulatory applications in foodborne illness outbreak surveillance.

Lakshmikantha Channaiah IS Director of Microbiology, AIB International.

Shortcuts. Don’t you just love shortcuts? I’m sure we’ve all used them at some point in our lives. Shortcuts are amazing; why wouldn’t we take advantage of one that’s available? It’s almost instinctive and expected today that we want things to be easier, faster, and better. But shortcuts don’t guarantee success. Quite the reverse in fact. When we take shortcuts we tend to get careless and place more emphasis on efficiency than on quality. Is it worth the risk to take a shortcut when applying food safety practices?

Shortcuts are generally derived from indolence in an attempt to perform a job with the most minimal effort required. This creates the opportunity for negative results and possibly severe consequences.

Let’s say you’re at home preparing a snack of fresh strawberries. After preparing and cleaning them you take them to the table, but a few berries fall to the floor along the way. You decide to go ahead and eat them. In this scenario, your decision to take the shortcut and not rewash the berries only affects you as the consumer – you’re assuming the risk of any consequences that may result.

Now let’s change it up a little bit. Let’s say you’re hosting a kid’s party with several in attendance. Deciding to not rewash the berries in this situation has the potential to negatively affect several children. Is the shortcut still worth the risk when others’ well-being is at stake?

The safety of the foods we consume relies on the everyday decisions of food processing handlers. One poor decision can potentially affect millions of consumers. Shortcuts can be taken at any point in time, but they tend to be more prevalent when someone feels no one will see them not following the proper procedures. As a result, this feeling of anonymity can create a false sense of security where an employee may believe it’s acceptable to take a shortcut. Many dangers can be presented as a result of taking shortcuts in regard to food safety.

LACK OF UNDERSTANDING. The lack of understanding can be a catalyst for many shortcuts. Frequently, this is the result of insufficient training that didn’t fully assure trainees understood the content. As a result, employees may believe they’ve discovered a shortcut that in actuality could be detrimental. For example, simply instructing employees that all egg-containing ingredients are handled with yellow containers and utensils would not be adequate unless they truly understand why these procedures are critical to preventing cross contact and the potential of injury or death to consumers.

If we don’t adequately address the why, what will stop employees from thinking they’ve come up with a brilliant new idea to use the blue containers and utensils (that are used for non-allergen products) instead of the required yellow ones? Ensuring that your employees understand why a specific procedure needs to be followed will likely improve overall conformance and inhibit shortcuts.

For successful understanding, develop and implement a comprehensive training program to ensure the delivery of training and education on prerequisite and food safety programs and procedures is provided to all personnel. Experience has demonstrated that many trainings take the approach of just stating what needs to be done rather than demonstrating the why and the associated consequences.

Comprehension of the provided training should be assured and can be accomplished through several methods such as testing with defined satisfactory criteria, on-the-job interviews, direct task observation, etc. Employees should be able to satisfactorily demonstrate that they understand their job requirements in relation to function and level of responsibility. In addition, supervision should routinely verify employee job performance to ensure procedures are being followed and enforced.

LESS WORK. The attempt to implement an approach that requires the least amount of work results in employees taking shortcuts. Ironically, when this happens the “shortcut” that was taken often results in more work and effort from others to correct the problems created from not following the outlined procedures. When it comes to food safety, there is no room for deviation from established procedures. Shortcuts are typically methods of doing something more quickly, but often not as thoroughly, as the ordinary procedures.

For example, let’s say an employee responsible for testing a metal detector has a test piece that isn’t identified and rejected by the device while performing the required check. Instead of implementing the required corrective actions, the employee decides to just pass the test piece through one more time. When it is not detected on the second attempt, the employee considers it to be acceptable and doesn’t believe corrective actions are necessary.

In this situation, the metal detector failed to detect a potentially hazardous piece of metal. This presents an opportunity for product contaminated with metal to proceed down the line and into finished packaging before or after this incident since no corrective actions were taken. Consequently, consumers may receive contaminated product that could result in serious health consequences or even death because the employee wanted to apply the least amount of work and, therefore, deviated from the established procedures.

Training and education discourage the minimal effort approach and play a key role in preventing blatant disregard for policies and procedures. When employees fully understand the implications of their job responsibilities they’re less likely to take shortcuts. Thorough screening and hiring practices, routine verification of job performance, and accountability may also discourage insubordination. In addition, be open to suggestions and feedback from your employees as they understand the true application of their jobs better than anyone and may have ideas for improvements that truly present a best answer to a situation.

HABIT FORMING. Shortcuts may eventually create bad habits. It may begin innocently enough, but it can quickly become extremely detrimental to consumers, yourself, and your company.

Let’s say we have a chocolate manufacturer whose nightshift production has run past the forecasted finish time. Sanitation is scheduled to be conducted upon completion of production, but now their allotted time for cleaning has been reduced if day shift wants to start on time. To further complicate matters, the sanitation crew is short-staffed and there’s pressure to get production started on time. As a result, some sanitation shortcuts are taken to speed up the process: equipment that is difficult to dismantle for cleaning is skipped, a less intensive pre-operational inspection is conducted, and equipment swabbing is not performed for verification. Let’s also assume that no immediate negative impact is readily noted, so the shortcuts start to occur more frequently because nothing bad happened the first time. The procedures have now become habit, and slowly the entire sanitation program begins to deteriorate.

How long do you think these habits can continue before the large-scale impacts begin to take effect? One positive pathogen result on a finished product? Two? Four reported illnesses? Twenty reported illnesses? Death of a consumer? Death of a child? How far does it have to go before we understand the impact that a single shortcut can have on food safety?

This scenario presents a multi-faceted approach for prevention. Again, training and education is important as well as hiring, verification, and accountability. However, it also appears that there may be an opportunity to improve equipment design to facilitate cleaning. The easier it is to dismantle a piece of equipment, the less likely employees will try to find shortcuts.

This is also an opportunity to solicit input from operators, sanitarians, and maintenance personnel to find a solution that works for all involved. Sometimes searching for a shortcut can require more work than simply following the procedure, especially if it causes problems requiring corrections by additional staff. Wouldn’t you prefer that your employees collaboratively focus on finding an agreeable solution that is not only a shortcut, but the best answer? There needs to be an organization-wide understanding and commitment to food safety that prioritizes these practices above operational efficiency and outputs.

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Implementation of shortcuts has been observed across multiple disciplines, departments, shifts, etc. Frequently nightshift operations get a bad reputation for being the most likely offenders, and it is generally assumed that this is the result of fewer employees, less oversight by upper management, and time constraints. But shortcuts that could lead to hazardous consequences can occur anytime, anywhere, by anyone.

SANITARY DESIGN. Sanitary design practices can be greatly impacted if established procedures are not followed and, as a result, can directly affect whether shortcuts are likely to occur. For example, in a food processing environment, smooth, complete welds are desired; however, tack welding may be performed if personnel are short-staffed and trying to perform a quick fix (shortcut) to get production back up and running. The tack welds create harborage points between the welds allowing food product/residues to accumulate and presenting a conducive environment for insect development and microbial growth.

Equal consideration should be provided for maintenance and food safety when performing maintenance tasks. The following sanitary design practices should be adhered to and shortcuts avoided to maintain a sanitary food production environment:

• Layout. The facility should be sized and constructed to allow sanitary operation. Size and layout should be predetermined, as such pre-planning will assist in the maintenance of a food-safe environment; prevent expensive modifications, adaptations and excess labor; and minimize other costs associated with poor planning and construction. The layout should provide efficient process flows and allow adequate space between equipment and structures for access for cleaning, inspection, and IPM activities. Also consider providing additional space for equipment dismantling, such as for extruder augurs or mixing shafts. It’s also encouraged that process flow in relation to layout is assessed for practices that may increase the likelihood of employees taking shortcuts (e.g., ingredient containers are required to be washed after every use, but the only wash station is located on the other side of the facility).
• Foundation. It’s important to know the construction of your building. Block walls have hollow cores that are ideal for pest harborage and travel. Concrete walls are solid and generally have fewer challenges, but must be maintained to prevent damage and cracks. In addition, the foundation must be designed to facilitate drainage and prevent ground water from accumulating.
• Floors. Floors must be suitable for the product environment, easy to clean, and able to withstand the anticipated traffic load and the cleaning products used. The floors must be maintained to allow drainage and prevent deterioration as damaged floors allow water and debris to accumulate, especially along floor/wall junctions and corners. Damaged floors cannot be adequately cleaned and can, therefore, lead to pests and microbial development. Avoid performing temporary repairs with incorrect materials that may lead to further damage.
• Walls. Similar to floors, walls must be able to withstand the intended production environment. They must be easy to clean and prevent dirt accumulation and pest or microbial harborage. Avoid performing quick fixes such as simply filling wall cracks with foam, especially in wet-processing environments.
• Ceilings and overhead structures. Ceilings and overhead structures also should be made of materials that are capable of being easily cleaned and maintained. Minimize overhead structures that contain harborage points and excess piping to facilitate cleaning practices. Ceilings and overheads should be maintained to prevent leaks and condensation.

REDUCE THE TEMPTATION. The following design measures touch on the many ways in which sanitation practices can be improved and demonstrate how appropriate sanitary design can discourage employees from taking shortcuts that may have negative implications.

1. Always consider steps to make cleaning easier, such as using quick-release fasteners and couplings instead of bolts and screws that take considerable time to dismantle. Appropriate equipment design will also discourage shortcuts to cleaning methods.
2. Product zones should be nonabsorbent, nontoxic, and corrosion-free. All surfaces should be smooth and free of pits, cracks, and spot or tack welds.
3. Non-product zone surfaces should be maintained in a similar manner as product zones. Joints should be smoothly sealed and consideration should be provided for any loose parts or debris (such as equipment safety labels or nameplates) that could fall into product zones.
4. Construction materials should always be considered for potential contamination risks such as glass, brittle plastics, and ceramics. These materials should not be used except when essential and no alternative exists. If these materials must be used, then adequate controls must be implemented to contain pieces in the event of breakage such as reinforced or safety-coated glass.
5. Supporting framework should be installed so as to eliminate hard-to-clean crevices and hollow areas. There should be no open-ended structures or access to hollow areas. Fill voids where possible and raise equipment to appropriate levels to allow thorough cleaning on the underside of structures.
6. Inspect equipment for potential harborage points such as rolled-under edges and beams with edges that can collect product; take action to eliminate them.
7. Identify and eliminate dead-ends by filling and sealing the pockets or recesses or installing quick-release access points for cleaning. Equipment junctions should be smooth and flush with no seams or cracks that can harbor food products.
8. Equipment and drain covers should be capable of being easily removed for cleaning. Special consideration should be provided for tanks where only half the cover opens, because residues frequently accumulate on the non-removable underside. Adjust the design to allow full access for cleaning.
9. Drive guards should be able to be easily inspected and removed for cleaning. Consider designs with a semi-open bottom to allow debris to fall out or transparent covers to facilitate inspection without requiring removal.
10. Equipment food and non-food contact surfaces should be maintained to prevent flaking paint and rust. Painted surfaces and those prone to rust should be properly treated as appropriate to the materials used and should be inspected routinely for chipping, peeling, and bonding characteristics.
11. Equipment should be secured and sealed to the floor or elevated to permit cleaning. Caulking can be used to secure equipment mounting pads to the floor, followed by bolting of the equipment to the floor.
12. Catwalks, access platforms, and bridges crossing over product zones should not have an open-grate design to prevent contaminants and debris from shoes falling on or into product, and to facilitate cleaning. Deck plates should be solid with no holes and, ideally, the joints should be continuously welded. The decks should be equipped with kick plates approximately four inches high that are either coved or continuously welded to the deck.

SUMMARY. When it comes to food safety, there is no gray area. Taking a shortcut is not worth the risk when it comes to food safety practices. If workers have suggestions that they believe would constitute best practices, they should discuss them with their supervisor; supervisors should encourage direct reports to share their ideas with them. It’s best to review and discuss rather than having someone individually deciding to try a new shortcut that could have hazardous consequences.

How far can food safety be sacrificed for the sake of efficiency, production operations, and daily quotas? Food safety should never be sacrificed. When it comes to food safety, a true shortcut is not the fastest way to complete a task, but rather the fastest way to do it right and in a manner that doesn’t result in product contamination.

The author is project manager, product development, AIB International.