You assemble your recall team and conduct your mock recall every year, maybe more frequently. But if a real crisis strikes, what’s the chance that the mock recall exercise will have prepared you? Unfortunately for most companies, it’s slim to none.
Most mock recalls are really mock traceability exercises. But since they are not reflective of the outbreak investigation process, they are better described as exercises that show which lot numbers contained a certain ingredient, or the distribution path of a finished product.
In an actual recall event, the traceback and trace forward are often the least of a firm’s worries.
Following are the key challenges that we have observed from working with scores of companies involved in recalls or other food safety crises:
- Unclear decision-making authority. Recall plans often identify the food safety/quality assurance staff as the “recall coordinator.” But when customers or the government asks if you will issue a recall, who makes the ultimate decision? And what if that person is on a week-long vacation with no cell service? (Yes, that actually happened once.) Who participates in the discussion? What if there isn’t consensus within the company? Are outside experts consulted?
Difficulty in deciding how much to recall. Once the decision is made to recall, the next challenge is deciding how much to recall. If the recall stems from a product that tested positive, do you recall just that lot? How can you be sure the issue didn’t stem from raw material that could be present in multiple finished product lots (especially if the finished product lacks a kill step, like fresh produce)?
If the contaminant is Listeria monocytogenes, could it have been an environmental contaminant from your facility? Is it still there? Scoping the recall can be very challenging.
Too little, too late communication. The communications function often catches recalling companies flatfooted because they start thinking about it too late in the process. From the moment a potential issue is identified, begin preparing for both reactive and proactive communications. Identify the various internal and external audiences who may contact you and those with whom you may need to communicate. Remember, communication is two way, so prepare for not only issuing statements and messages, but also receiving questions and comments from employees, consumers, customers, boards of directors, regulators, and others. Monitor social media and online news sources, especially local ones. Have a holding statement that is used on an as-needed basis and which changes as you learn more.
For every communication task, identify the person or persons who will carry it out, how it will be carried out, and when. For example, most food companies have multiple customer contacts (food safety, buyers or purchasing agents, category managers, management, etc.). Which one(s) will you contact about a recall? Who will contact each one, when, and how? What will they say — exactly? What documentation do you need to demonstrate that you notified customers?
- Having a plan isn’t enough. Finally, the greatest challenge to effectively and efficiently carrying out a recall is lack of planning, or increasingly, the lack of familiarity with the plan. Driven by investors, regulations, or awareness, more companies seem to have recall plans, but in most cases, plans sit on shelves and are never updated, tested, or used — even when there is a recall. No company wants to issue a recall often enough to get good at it; but being good at it could save the company. So, practice. Conduct an annual recall simulation and make it as real as possible: go beyond the trace exercise, include communications, test the plan, and involve every major business function in the company.
We could go on and on with examples of recalls gone wrong. While there will always be unanticipated twists and turns associated with an issue, you can absolutely prepare and practice the general process. Achieving regulatory compliance and passing an audit become secondary; when in crisis mode, true preparedness is what could make or break your company.
The new year is fast approaching, and many facility managers are hard at work developing strategies to make 2019 a success. While resolutions to be more productive and budget-conscious are imperative to the success of any business, a commitment to pest prevention is a resolution facility managers also need to make. Pests can cause widespread illness outbreaks, and coupled with poor sanitation, results can be disastrous. So, diligent pest control is one New Year’s resolution facility managers cannot afford to break.
Rodents present the biggest problem, as their droppings can transmit pathogens that cause diseases including Hantavirus and salmonellosis. The house fly can carry more than 100 kinds of disease-causing germs and moves from garbage and excrement to fresh food and other surfaces, contaminating processing equipment. Cockroaches are known to spread at least 33 kinds of bacteria, six kinds of parasitic worms, and at least seven other kinds of human pathogens, and they can pick up germs and debris on their legs and transfer them to food surfaces and processing equipment. Stored product pests can infest plant equipment and contaminate food by leaving body parts and cast skins which can get ground up into products or infest flour, grains, and cereals.
The best method of pest control in food processing facilities is Integrated Pest Management (IPM), whereby facility managers work with their pest control professional partners to inspect, identify, recommend, treat, and evaluate pest hot spots to prevent infestations. In addition to contacting a licensed pest control professional to inspect your facility, you can address the following nine hot spots now to get a jumpstart on your New Year’s resolution:
- Equipment. One of the most frequent areas of infestations is within the equipment, as it has many nooks and crannies that provide ideal temperatures, humidity, and food supply to help pest populations flourish. Consider replacing metal cover cleaner plates with plexiglass to allow for easier inspection without having to disassemble equipment.
- Plumbing. Cockroaches prefer warm, moist, dark environments, and often enter structures through floor drains and utility pipes. Flies are similarly attracted to sinks, floor drains, and bathrooms, so these areas should be cleaned on a regular basis to prevent moisture and debris buildup that could be conducive to an infestation.
- Storage Areas. Proper storage and stock rotation are essential in preventing an infestation. All items should be stored up off the floor on pallets and at least 18 inches from walls to create an aisle, making pest inspections easier to conduct. Also consider painting the aisle white so that pests and their droppings are easily visible.
- Entry Points. Mice can fit through a hole the size of a dime and rodents through a hole the size of a quarter, so it’s imperative to seal any cracks or crevices in the structure, including entry points for utilities and pipes, with silicone caulk and steel wool. Institute a “no-prop” door policy, and install air curtains or screens to keep flying insects out.
- Waste Management. Ensure the facility has an adequate waste management system in place. Garbage should be stored in sealed containers at all times and disposed of on a regular basis. If there is a dumpster on the property, it should be kept away from entryways, have a working lid that remains closed, and be emptied regularly.
- Landscaping. Vegetation that is too close to the building can attract pests, increasing the likelihood that they will find their way inside. To prevent this, install a gravel or rock perimeter to discourage vegetative growth that could invite and harbor pests.
- Proper Drainage. Many pests are attracted to moisture, so make sure the building has proper drainage at its foundation to prevent moisture buildup. This includes installing downspouts, gutters and diverts to channel water away from the building and ensure excess water doesn’t accumulate.
- Lighting. Lighting plays a key role in either attracting or discouraging pests from setting upon a facility. Sodium vapor lights are the least attractive to pests and should be installed as far from the building as possible. Conversely, mercury-vapor lights are very attractive to pests and should not be used within 150 feet of any food processing facility.
- Structural Integrity. Repair fascia, soffits, and rotted roof shingles, as some insects are drawn to deteriorating wood. Replace weather-stripping and repair loose mortar around the building’s foundation and windows, as these also could serve as entry points if damaged or decaying.
Pest management is most effective when conducted in partnership with a licensed pest control professional, but that doesn’t mean you have to wait for an inspection to enact pest-proofing measures that could protect your facility from an infestation. So, as you reflect on 2018 and make resolutions for 2019, be sure to add proactive pest management at the top of your list.
Anyone who has ever worked in or with food processing facilities knows that many of the tasks can be rote and become monotonous over time. And monotony can all-too-easily result in “shortcuts.” But a number of recent occurrences have shown the consequences of cutting corners at all levels of the food industry: from FDA’s newly released guidance on FSMA-granted authority to mandate recalls (https://bit.ly/2RYmgd3), the Interagency Food Safety Analytics Collaboration (IFSAC) foodborne illness source report, and the allergen contamination-related manslaughter convictions (https://bit.ly/2RYmgd3). As these show, the consequences can be extremely serious for a business and life-altering for individuals.
With FSMA’s new mandatory-recall authority, FDA can order the recall of a food if there is a reasonable probability that it is adulterated or misbranded and could cause serious illnesses or death. The rule does provide that the responsible party first be given the opportunity to do a voluntary recall, and at least two producers have taken the option to do so when they were served with the written notice of FDA’s intent. In addition to that partial use of its authority, FDA has used it once to its full extent, issuing a mandatory recall order in April 2018 for food products containing powdered kratom, after several were found to contain Salmonella.
On November 5, FDA released final guidance on the use of mandatory recalls. As noted in a statement from FDA Commissioner Scott Gottlieb M.D., the guidance is part of FDA efforts “to be as robust and transparent as possible and provide answers to questions that many have asked about the FDA’s mandatory recall processes. Our aim is to expand the appropriate use of our mandatory recall authority in cases where we have to intervene quickly to help protect consumers from unsafe products.”
That same week, the IFSAC report, “Foodborne Illness Source Attribution Estimates for 2016 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter,” was released. According to the report, for which IFSAC analyzed data from just over 1,000 foodborne disease outbreaks from 1998-2016:
- Salmonella illnesses came from a wide variety of foods.
- E. coli O157 illnesses were most often linked to vegetable row crops (e.g., leafy greens) and beef. The estimated attribution of Listeria illnesses to the row crops increased from 3.4% in 2013 to 12.5% in 2016 due to the 2015 multi-state lettuce outbreak.
- Lm illnesses were most often linked to dairy products and fruits — which also remain the top two categories with the highest estimated attribution percentages.
- Campylobacter illnesses were most often linked to chicken and unpasteurized milk.
Attention to this report is important, not only for industry to increase its focus in these areas and ensure it is not cutting corners, but also because the report notes that the estimates may help shape agency priorities and support the development of regulations and performance standards and measures, and other activities. (Read the full report at https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2016-report-TriAgency-508.pdf.)
While the recall mandate and IFSAC estimates are significant and serious, it is the mention of a manslaughter conviction for lack of allergen controls that likely most caught your attention. And if it didn’t, it should have.
Although it occurred in England, there’s nothing saying that such a judgment and conviction couldn’t, and won’t, be declared in the U.S., particularly because undeclared allergens continue to be a top cause for recalls by both FDA- and USDA-regulated facilities.
In the case, two food business managers in England were found guilty of manslaughter in the death of a 15-year-old girl who died after eating supposedly nut-free food from an Indian restaurant. The food was found to contain peanut protein to which she had a life-threatening allergy. The restaurant’s owner/chef and the take-out manager were convicted of manslaughter, not only because of the allergen presence, but because of the lack of food safety standards in the operation that could have prevented the teen’s death.
It can be tempting to take shortcuts, cut corners, and make allowances for “minor” mistakes here and there. But as these all show, there can be grave consequences to food safety concessions — both for your business and you, as an individual.
Eliminating Sugar-Seeking Wasps
PROBLEM: A sugar company’s late summer/early fall deliveries of granulated-sugar tanks were being rejected because wasps were found in the tanks upon delivery to the customer. The wasps were discovered dead and lying on top of the product in a filled car at the destination. “However,” said Zistos President Bob Levine, the company’s video inspection system supplier, “Tank inspection with the tank-vision system did not detect any sign of wasp intrusion in the product prior to shipment.” So, having been told that wasps can chew through the gasket material around the hatch on the manway into the rail tanker, the company then suspected that the contamination was happening en route. “Although the sugar company did consult with an entomologist, no confirmation was able to be made of where and how the wasps were getting in, so the company continued to be faced with the issue,” Zistos said.
SOLUTION. To determine what might be happening and how it could be solved, QA consulted with Bill Robinson of Urban Pest Control Research and Consulting. His response: “These are yellowjackets that are seeking carbohydrates/energy late in the season, as there are no larvae remaining in the colony to provide the sugar food for workers when they return with food for the larvae. (They feed the larvae; the larvae feed them.) Late in the summer, yellowjackets seek any source of sugar, usually liquid. They have chewing/lapping mouthparts, but I don’t think they are ‘chewing the sugar’; most likely there is enough moisture on the surface for them to use their lapping mouthparts. This large quantity of sugar might be a strong attraction for a local colony.
“Yellowjackets do not forage far from the nest site, but they can wander off. Even in late summer they return to the nest at evening. So, the yellowjackets causing this problem are local in a sense that the nest is close. It could be an above-ground nest or below ground. But, they are not chewing their way into the sugar source. The intrusion of these yellowjackets could occur at either end of the supply chain, but not in route from one to the other. Trucks may stop to rest, but that is usually at night when these wasps are not flying.
“Thus, as a prevention/precaution, both ends of the supply chain should use wasp traps starting in mid-summer and continuing to the second frost. These traps will pull in workers as they forage in the fall and slowly reduce colony size.”
LESSON LEARNED. While it is not known, without further inspection, whether the wasps were nesting near the sugar company or its customer’s facility, both ends can initiate means of control to prevent a further issue.
Detail Cleaning For Control
PROBLEM. In providing consultation for both food facilities and pest control companies, Technical Directions Consulting Entomologist Mike Holcomb recently received a photo and information on warehouse beetle (Trogoderma) larvae found in accumulations of product fines. A contract pest control operator (PCO), with whom Holcomb has work for more than 15 years, had found the dozens of yellow/white worms in the accumulated fines of a food facility. “These are the kind of infestations we are finding in equipment, slide gates, dead ends of conveyors and on ledges of equipment, on wall and ceiling beams, conduit, and pipes in difficult to access areas,” the PCO stated.
SOLUTION. In addition to describing the problem, the PCO explained his solution. “We have been cleaning and treating these areas, which the pheromone trap counts are reflecting. It is labor intensive, but effective. It also reduces hundreds of gallons of non-ecofriendly fogging materials from being introduced into the facility.” Furthermore, he said, fogging the plant without the inspection, cleaning, and treating did not prove to be as effective when compared to historical trends.
LESSON LEARNED. “This example clearly demonstrates the importance of ‘detail cleaning’ to the success of your integrated pest management program,” Holcomb said. The hard-to-reach areas where organic debris accumulates (insect resource sites such as overhead ledges, corners, inside equipment, etc.) can become hot spots of insect activity if left unattended. But detail cleaning is not easy; it requires more time and resources than general or aesthetic housekeeping, and it is made more difficult by insanitary design of equipment and facilities.
“In my experience working with various milling industries, I have observed that structural features and food manufacturing equipment that are difficult to access and clean, won’t get cleaned. At least they won’t get cleaned with the intensity and frequency necessary to disrupt the insect breeding life cycle,” Holcomb added. But, as the PCO pointed out, detail sanitation leads to reductions in pheromone trap counts over time. Thus, he relies on monitoring tools to orient sanitation effort toward insect resource sites, and to trend his progress week to week and season to season. “Whether he is aware of it or not,” Holcomb said, “this proactive sanitation approach — resource reduction — helps the plant to comply with two of FSMA’s most important food protection requirements: continuous improvement and prevention, and one of GFSI’s most strident food protection standards: verification.”
Not only does such an organized detail cleaning program enable food processors to use less intrusive pest control techniques and have a “more ecofriendly,” reduced dependency on pesticides, it reduces non-productive downtime that results from reactive pest control such as fogging or fumigation. “After all, when the plant is shut down and commandeered by the pest control operator to correct an epidemic insect infestation, deep-dive sanitation, preventive maintenance, and general plant and equipment re-tooling opportunities are lost,” Holcomb said.
A Sensitive Situation Solution
PROBLEM. Indianmeal Moths (IMMs) are a common pest of dry pet food and, in turn, the pet stores that sell it and the areas in which the food is stored. Like sensitive areas of food processing plants, pet-food stores are particularly challenging as the methods of prevention and reactive control are restricted, in this case to avoid harm to non-target animals – the pets. One such pet store had hundreds of IMMs flying in the store, which resulted in a call to McCloud.
SOLUTION. “Due to the sensitive nature of the establishment, we decided to use non-chemical methods of control to minimize the impact on non-targets,” said McCloud Services Training Manager and Entomologist Anna Berry. “Our first step was to narrow down the probable source.”
Use of pheromone monitoring traps pointed to the dog-food section, but it was two aisles long with over 500 bags of product. So to find the source, they considered the behavior of the pest, the consumer, and the store. IMMs need 30 days or more to develop from egg to adult, so the longer a bag sits in storage, the larger the population becomes, and the more likely it will spread. “Upon assessing the inventory, we saw that medium-sized bags were purchased more often than the large and very large bags,” Berry said. This is primarily due to size as it is more challenging for customers to move a 25-pound bag of dog food than a 10-pound bag, so the larger bags typically stay on the shelves longer, she added. Though some establishments strictly follow first in/first out (FIFO) protocols and move older bags to the front of newer ones, the larger bags still sit on the shelves longer. So, focus was placed on the inspection of the shelves with larger bags. Because there also is likely to be more evidence of IMM activity the longer a bag stays in storage, the outside of the large bags was inspected. Two were found with webbing in the seams — characteristics of IMM activity — as well as pupal casings, indicating larvae had left the food, pupated, and emerged as adults. “When we opened these two bags, we found over 500 Indianmeal moth larvae in both,” Berry said. “The solution was then simple: freeze and dispose of these two bags, thereby eliminating the source.”
LESSONS LEARNED. “Never underestimate the power of a systematic inspection coupled with knowledge of the pest and facility,” Berry said.
It can be overwhelming to have an infestation and intimidating when typical tools (such as chemicals) are not applicable, as is often the case in sensitive areas of food processing plants as well. Knowing the behavior and preferences of the pests and details of an establishment’s practices can often enable the discovery and efficient elimination of the source of the infestation.
Sanitary Design To Combat PestsTHE PROBLEM. Food producers and distribution centers have an obvious struggle with stored product insects — as one of Insects Limited’s Pennsylvania food company customers recently found. If you’re not convinced — deploy a multi-species pheromone trap and check it the following week, said National Sales and Marketing Manager Tom Mueller. Depending on the condition of the facility, you’ll find an alarming number of food-infesting insects and many different species. “One reason is the difficulty sanitation managers have removing the food debris from the footers needed to hold up sturdy shelving,” Mueller said.
Citing Reducing Customer Complaints in Stored Products by David Mueller, he said that one solution could be to vacuum the collection of food, but the time it takes to go through a one- to two-million square-foot food warehouse and vacuum all the boots is quite considerable, he explained. Another solution could be to spray the footers with insecticide which also takes a great deal of time and does not eliminate the food source. But the insects will simply return after the residual has disappeared, he said. This problem was enough for the Pennsylvania food company to make some changes.
THE SOLUTION. The facility already had a sanitation schedule where sweeping, utilization of a scrubbing machine, and rubbish removal happened regularly, but no matter what, food debris still found its way into the racking footers. “The solution was to insert concrete with a slanted top into the racking, preventing the accumulation of food build up and making it far easier to keep the facility clean,” Mueller said. Any food that made its way to the void fell off the concrete slant and was swept up with the facility’s sanitation program. Now pheromones are used to locate where construction modification is needed rather than simply to monitor for increased populations.
LESSON LEARNED. Although construction engineers are not sanitation managers or entomologists, Mueller said, with a little creativity and a simple modification to existing equipment, effective pest management can become much easier. Insects are a symptom of a condition. “Eliminate the condition to eliminate the insects and effectively reduce customer complaints,” he said.
Leave No Stone Unturned
THE PROBLEM. A spice factory was having a severe infestation of cigarette beetles and called on Syngenta Professional Pest Management Technical Services Manager Chris Keefer to investigate. The factory, which was thousands of square feet, received spice shipments on a nearly daily basis and was in operation 24 hours a day. The only scheduled downtime was for full-scale regular sanitation events, and the sanitation was superior at this facility. After several thorough inspections with the quality control and entomology personnel, the infestation was discovered to be on the top of rafters above the plant processing floor (unseen from below), where spice dust was settling from the milling process. These small volumes of food dust were enough for the cigarette beetles to complete their life cycles. After copulation, the adult females would fly up onto the rafters to lay their eggs. Larvae would hatch and feed on the spice dust on top of the rafters, pupate, and then emerge as adults.
THE SOLUTION. To eliminate the infestation, the suspected food was removed and quarantined. The plant floor was fogged twice, and some of the equipment and spices were fumigated. The plant then changed its inspection/sanitation process to include sanitizing the rafters on a more regular basis.
LESSON LEARNED. It’s important to understand that insects only need minimal resources and a short amount of time to be successful. Thus, the lesson learned from this infestation is to leave no stone unturned during your inspection.
The author is Editor of QA magazine. She can be reached at firstname.lastname@example.org.