As the enforcement of rules, regulations and inspections get underway at food production facilities, we are faced with maintaining production rates while looking for infinitesimal pathogens and cleaning to non-detectible levels. This clearly sets demand on the plant for new and creative methods to control and mitigate pathogens pre-production, during production and post production.
As this occurs, the term clean takes on new meaning: What is clean, and how clean is clean? Swab and plate counts are now critically important. What method is used at the plant, who is testing, what sampling procedure is used, and how do we use the results? As we look at the process from start to finish, we must keep several key questions in mind: What are harboring points in the process, and what are the touch-point considerations to the product? Let’s review the overall processing progression through the factory (see Figure 1).
Figure 1. The progression of processing of a food product through a facility.
Now consider micro pathogen contamination to the product, as we look deeper in the process for contamination or critical control points as used in successful HACCP plans. Consider contamination and how it may travel or contact food product. It is understood through study and research of both pathogens and plant operations that contamination may be introduced to the plant by the front door, back door, pallet, product, or by a person. In many cases, each of these considerations leads to uncontrolled environments that create uncontrolled measurements throughout, which lead to cleaning procedures based on time rather than science. This is certainly not to say that creating a preventive maintenance schedule based on a calendar is a bad thing. Rather, the message is to consider a deeper look at the pathogens and how they live and replicate. From the regulatory and control measures this should be a clear message of what food-to-pathogen considerations should be taken at the plant level as well as measurement methods and acceptable levels (which is not an easy answer, as each product and environment can change this answer). A good example to consider is public schools and children. Health organizations work to help the schooling system understand what immunizations children should have based on the current health risk tolerance levels. In food production, the consideration is similar in an everchanging environment. As we see contamination levels change the methods, techniques and solutions to proper food production must account for the pathogens of concern.
Contamination, Risk tolerance, Opportunity for Growth
Contamination, risk tolerance, and opportunity for growth are the considerations when looking at a plant design or a plant modification. Modification to modernization should be a top-of-mind critical quality control measure. If there are a few things we know, it is how to produce food at high rates of speed, measure and value production rates, and delays or failures can be measured by equipment and personnel performance. In the case of quality control, we must review, comprehend, and protect process risk. From a management or non-technical viewpoint, quality control can be very difficult to understand. When discussing pathogens, our concerns are not visible to the human eye—we are beyond a dirty surface, weare looking at risk tolerance based on pathogen growth in logarithmic measurement. When combining quality control and production, the measurement control and mitigation measures complement the effort. The use of quality control is expected and should coordinate with production to ensure the product is produced at the expected quality level.
Learn more about mitigate risks in the supply chain by attending the Food Safety Supply Chain Conference, June 5–6, 2017 in Rockville, MD | LEARN MOREEver heard of silver dihydrogen citrate (SDC)? The patented molecule is a new antimicrobial being used to kill potentially deadly pathogens in places from food processing facilities to restaurants. SDC is non-toxic and has an EPA toxicity rating of IV (the lowest category).
At the Food Safety Consortium last month, Hank Lambert, CEO of Pure Bioscience, talked about how the technology his company developed can help the food industry control pathogens (including Listeria mitigation), along with its differentiating characteristics versus other disinfectants. He also gave a preview of the applications in which the company will pursue FDA and USDA approval this year.
Between 1996 and 2016, sprouts have been responsible to 46 outbreaks in the United States, which has led to nearly 2500 illnesses and three deaths, according to FDA. They have presented a consistent challenge to operators, because sprouts are most often produced in conditions that are ideal for bacteria growth.
Today FDA issued a draft guidance to assist sprout operators in complying with the FSMA Produce Rule, which requires “covered sprout operations take measures to prevent the introduction of dangerous microbes into seeds or beans used for sprouting, test spent sprout irrigation water (or, in some cases, in-process sprouts) for the presence of certain pathogens, test the growing, harvesting, packing and holding environment for the presence of the Listeria species or Listeria monocytogenes, and take corrective actions when needed.”
Large sprout operators must comply with the Produce Rule (applicable provisions) by January 26. Small business must comply by January 26, 2018 and very small businesses by January 28, 2019.
The recalls involving powdered milk continue to pile up.
Since December, more than a dozen products containing powdered milk have been recalled due to the risk of Salmonella, including mini eclairs and cream puffs, mac & cheese products, chocolate-covered pretzels, potato chips, seasonings and white peppermint Hostess Twinkies.
Back in November, FDA seized more than 4 million pounds of dry nonfat milk powder and buttermilk powder produced by Valley Milk Products, LLC. The agency used whole genome sequencing to make the connection between the samples that were collected in the facility—Salmonella strains were found from samples taken in 2016 and back to 2010. FDA identified it as a persistent strain of the pathogen.
“FDA investigators observed residues on internal parts of the processing equipment after it had been cleaned by the company and water dripping from the ceiling onto food manufacturing equipment. In addition, environmental swabs collected during the inspection confirmed the presence of Salmonella meleagridis on surfaces food came into contact with after being pasteurized.” – FDA news release
National Steak and Poultry has recalled about 1,976,089 pounds of ready-to-eat chicken products over concerns of bacterial pathogen survival in its products. According to FSIS, the product was adulterated due to “possible undercooking”. The expanded recall (the original recall included more than 17,000 pounds of product) was a result of a food service customer compliant to an establishment on November 28 that a product appeared to be undercooked. The products of concern were produced from August 20 through November 30, 2016.
FSIS has provided a complete list of the expanded recall products on its website. There have been no reports of adverse events due to consumption of the products, but consumers are being urged to discard or return the items.
Don’t miss the Listeria Detection & Control Workshop at the 2016 Food Safety Consortium | December 7–8 | Schaumburg, IL | Learn MoreFDA has issued a consumer alert following the recall of Sabra Dipping Company’s hummus products. The agency began an inspection of Sabra’s manufacturing facility in Virginia on October 31, collecting nine environmental samples that test positive for Listeria monocytogenes; FDA collected 18 additional environmental samples near food handling equipment on November 18, which tested positive for Lm. It’s also possible that the strain of Lm found in the facility is persistent in the company’s production environment, according to FDA.
“One of the strains of Listeria monocytogenes found during the recent inspection matches a strain found in a retail product sample collected in 2015, indicating this strain of Listeria monocytogenes may be persistent in the production environment.” – FDA
Sabra initiated a voluntary recall of certain hummus products distributed in the United States and Canada with “Best Before” dates on or before January 23, 2017. “Subsequent to the inspection conducted with the FDA, we implemented a thorough and extensive factory-wide cleaning and sanitation procedure, and beyond that, we continue to work very closely with internal and external food safety experts to identify any additional steps we can take to even further enhance our efforts,” according to a Sabra press release.
Recalls are an inevitable reality of working in the food industry. Indeed, hardly a day goes by without one food company or another announcing a recall. According to the USDA, 150 food products were recalled in 2015. From large national brands like Tyson Foods and McCormick to smaller local manufacturers, no food company is immune from recalls.
Recovering from the sometimes devastatingly expensive recall process can be difficult, so it’s obviously best to avoid problems whenever possible. Understanding the top three reasons for food recalls is the first step toward greatly reducing how frequently they affect your food company.
1. Cross Contamination
Many food manufacturers process multiple products in a single factory. This can lead to cross-contamination issues involving foods to which people are commonly allergic, namely milk, wheat, soy and peanuts. Because cross contamination is sometimes unavoidable, manufacturers are permitted to sell cross-contaminated food, provided the potential contaminants are declared as allergens on the label. According to the USDA’s report, undeclared allergens accounted for 58 of the 150 food recalls in 2015, and milk has been identified as the number one offender.
How to Prevent Cross Contamination. Food is often contaminated because machinery isn’t properly cleaned between uses. Therefore, the most effective way to prevent it is to thoroughly clean equipment after processing food that contains common allergens. Visually inspecting the equipment following cleaning is important, but unseen residue can linger.
To overcome this, in-plant allergen testing of equipment, post cleaning, is recommended. Some tests utilize quick, non-allergen-specific colorimetric tests to identify sugars, proteins and other indicators that an allergen is present. More expensive enzyme-linked immunosorbent assay (ELISA) kits are more sophisticated and may be a better choice if cross contamination plagues your food manufacturing plant.
Other tips to prevent a recall caused by allergen contamination include:
Establishing spill-cleanup protocols
Training personnel on allergen management
Designing equipment with sanitary principles in mind, including self-draining equipment, smooth edges and rounded corners
Carefully inspecting product labels for accuracy
2. Pathogens
Recalls from pathogen-contaminated products are highly damaging because they affect all consumers, not just those with specific allergies. Listeria, E. coli and Salmonella are the most common—resulting in a combined 17 food recalls in 2015, according to the USDA’s report. Several foods have been identified as being most at risk for carrying these pathogens:
Deli meats, soft cheeses and other foods that usually aren’t cooked
Poultry, eggs, undercooked beef, and unpasteurized milk or juice
Raw fruits and vegetables
Raw or undercooked shellfish
Home-canned foods with low-acid content — including asparagus, corn, green beans and beets
How to Prevent Pathogens. As with avoiding cross contamination, the best way to prevent a pathogen outbreak is to implement hygienic manufacturing practices. Four specific techniques apply here:
Separate raw products from cooked/ready-to-eat products. Your efforts should even go as far as separating employees who work in each area. They should use divided washing facilities, locker rooms and cafeterias.
Control the temperature and moisture level to reduce bacteria and mold growth. Anywhere condensation forms or moisture is left to pool, micro-organisms can potentially grow and create a contamination issue. Ventilation and air conditioning can help tremendously with this, as can air dryers used to sap moisture from steamy air.
Implement pest-control techniques. Rats, flies and cockroaches are significant carriers of Listeria, Salmonella, Vibrio cholera and other bacteria. Effective pest-control techniques include disposing of garbage properly, sealing pest entry points, and using air curtains and screens to keep flies out.
Choose durable, easily cleanable equipment for your manufacturing plant and wash all surfaces regularly. Mold and bacteria can start growing within a matter of hours, so keeping surfaces clean is essential. Proper hygiene among plant personnel is critical as well.
3. Physical Contamination
When non-food items are found in food products, a recall is inevitable. Metal, plastic, wood and even insect body parts are examples of physical contaminants. Food is also considered physically contaminated if it’s chemically or biologically tainted. According to a Food Standards Agency report, of the 107 physical contamination incidents in 2012, the most common malefactors were metal (37), pests (23) and plastic/glass (10 each).
How to Prevent Physical Contamination. Foreign objects often enter food products when malfunctioning equipment or human error breaks down the production process. Safeguards such as X-ray scanning, metal detection and filtration/sieving processes help catch foreign objects before they’re shipped, but these aren’t foolproof methods. You should also only work with trustworthy suppliers and take the time to examine raw materials before using them.
The general public expects food manufacturers to produce safe, untainted food. By following these tips, you help uphold your brand and avoid the expensive, reputation-damaging effects of food recalls.
Last month Food Safety Tech and Bob Ferguson, managing director at Strategic Consulting, discussed changes that are affecting the contract lab industry, from processor concerns in keeping pathogens out of their facility to operational challenges. In part II of our interview, Ferguson reviews how these factors are increasing competition among food contract laboratories.
Food Safety Tech: Since we published your article “Changing Landscape for Selecting a Food Contract Laboratory” you’ve mentioned that you have been getting quite a few questions about the piece, your study and your findings. What is the most common question you have received?
Robert Ferguson: It’s been interesting! I have received questions directly via email and many over various social media. People have been very interested in the overall impact that these changes will have on the market. As more and more companies outsource their food diagnostic testing, and as food contact labs companies capture a greater share of the testing market and also grow through consolidation of the market, testing labs will have greater market power. It is a common purchasing practice, of course, for buyers to commoditize services such as laboratory analysis to the extent that they can and then force the labs to sell on price. This has clearly been the case in the food lab market. But as more companies outsource, and the larger labs grow and consume greater share, the balance of bargaining power between the larger labs and processors will change.
FST: Is it just the relative size of the labs that is having the major impact?
Robert Ferguson, managing director, Strategic Consulting, Inc., will discuss the results of the survey at the 2016 Food Safety Consortium in December | LEARN MORE
Ferguson: Larger lab companies will certainly have economies of scale, operating efficiencies and bargaining power with their suppliers that the smaller labs will not that they will use to their advantage. But there is more to it than that. Close to 70% of the processors in our survey say that they outsource their pathogen samples to labs within 100 miles of their plant. Many of these processors are multi-site operations and will look to outsource their work with the fewest number of laboratory contracts. With growth and consolidation in the market, fewer and fewer lab companies will have laboratories in the right places to meet this 100-mile requirement. Fewer labs will qualify for the bidding process, and this will reduce competition.
FST: Will this change pricing?
Ferguson: Probably, especially over time. The other thing we heard from processors is that economics is not the main criteria in their decision to outsource. Traditionally, processors would “do the math” and those with fewer samples would outsource, as it would not be economical to maintain their own lab operation, while those with high sample volumes would run their own plant lab or a consolidated corporate lab. But what we hear from processors is a greater focus on food safety and a desire to get any work with pathogens out of their plant. We also hear more reluctance from processors to be “in the lab business.” Their core competence is food production, not maintaining lab accreditations, keeping up to date on more sophisticated analytical techniques, and everything else it takes to maintain an efficient lab operation. Neither of these goals is economic, and we are seeing more companies outsource their samples at a higher cost per sample than what it was costing at their in-plant lab. Less competition and more focus on qualitative goals and not just pricing will create longer-term increases in contract lab prices.
Ferguson: These changes will be a significant opportunity for some food contract lab companies and a significant risk for others. Those who can create the best lab network will qualify for the most outsourcing contracts and will likely be far more competitive. Single location labs, however, will find it harder to be competitive, and many will likely be acquired while others will fail. We will certainly see a continued high level of M&A activity in this market.
Some of the other questions people have asked are about the impact on lab companies’ strategies, outside of M&A. We have heard from processors that while the larger labs with the better networks are better outsourcing partners, they are also finding that these larger lab companies are more “industrialized” and have far less emphasis on customer service. This seems to introduce an opportunity for a laboratory company with a strong network that can also maintain a high level of customer service to gain a competitive advantage. We see some indication that this is already happening as more lab companies offer services such as auditing, onsite inspections and testing, and program development. In fact, our data shows that services, while still a small proportion of most food contact lab’s revenue, is nonetheless the fastest growing component, overall growing at nearly 15%. This seems to be a clear opportunity for food contract labs to differentiate themselves and stay competitive.
Food production facilities are facing greater scrutiny from both the public and the government to provide safe foods. FSMA is being rolled out now, with new regulations in place for large corporations, and compliance deadlines for small businesses coming up quickly. Coverage of food recalls is growing in the era of social media. Large fines and legal prosecution for food safety issues is becoming more commonplace. Improved detection methods are finding more organisms than ever before. Technologies such as pulsed-field gel electrophoresis (PFGE) can be used to track organisms back to their source. PFGE essentially codes the DNA fingerprint of an organism. Using this technology, bacterial isolates can be recovered and compared between sick people, contaminated food, and the places where food is produced. Using the national laboratory network PulseNet, foodborne illness cases can be tracked back to the production facility or field where the contamination originated. With these newer technologies, it has been shown that some pathogens keep “coming back” to cause new outbreaks. In reality, it’s not that the same strain of microorganism came back, it’s that it was never fully eradicated from the facility in the first place. Advances in environmental monitoring and microbial sampling have brought to light the shortcomings of sanitation methods being used within the food industry. In order to keep up with the advances in environmental monitoring, sanitation programs must also evolve to mitigate the increased liability that FSMA is creating for food manufacturers.
Paul Lorcheim of ClorDiSys Solutions will be speaking on a panel of Listeria Detection & Control during the 2016 Food Safety Consortium, December 8 | LEARN MOREPersistent Bacteria
Bacteria and other microorganisms are able to survive long periods of time and become reintroduced to production facilities in a variety of ways. Sometimes construction or renovation within the facility causes contamination. In 2008, Malt-O-Meal recalled its unsweetened Puffed Rice and Puffed Wheat cereals after finding Salmonella Agona during routine testing of its production plant. Further testing confirmed that the Salmonella Agona found had the same PFGE pattern as an outbreak originating from the same facility 10 years earlier in 1998. This dormant period is one of the longest witnessed within the food industry. The Salmonella was found to be originating from the cement floor, which had been sealed over rather than fully eliminated. This strategy worked well until the contamination was forgotten and a renovation project required drilling into the floor. The construction agitated and released the pathogen back into the production area and eventually contaminated the cereal product. While accidental, the new food safety landscape looks to treat such recurring contaminations with harsher penalties.
One of the most discussed and documented cases of recurring contamination involves ConAgra’s Peter Pan peanut butter brand. In 2006 and 2007, batches of Peter Pan peanut butter produced in Sylvester, GA were contaminated with Salmonella and shipped out and sold to consumers nationwide. The resulting outbreak caused more than 700 reported cases of Salmonellosis with many more going unreported. Microbial sampling determined that the 2006 contamination resulted from the same strain of Salmonella Tennessee that was found in the plant and its finished product in 2004. While possible sources of the contamination were identified in 2004, the corrective actions were not all completed before the 2006–2007 outbreak occurred. Because of the circumstances surrounding the incomplete corrective actions, ConAgra was held liable for the contamination and outbreak. A settlement was reached in 2015, resulting in a guilty plea to charges of “the introduction into interstate commerce of adulterated food” and a $11.2 million penalty. The penalty included an $8 million criminal fine, which was the largest ever paid in a food safety case. While the problems at the Sylvester plant were more than just insufficient contamination control, the inability to fully eliminate Salmonella Tennessee from the facility after the 2004 outbreak directly led to the problems encountered in 2006 and beyond.
Many times, bacteria are able to survive simply because of limitations of the cleaning method utilized by the sanitation program. In order for any sanitation/decontamination method to work, every organism must be contacted by the chemical/agent, for the proper amount of time and at the correct concentration by an agent effective against that organism. Achieving those requirements is difficult for some sanitation methods and impossible for others. Common sanitation methods include steam, isopropyl alcohol, quaternary ammonium compounds, peracetic acids, bleach and ozone, all of which have a limited ability to reach all surfaces within a space, and some are incapable of killing all microorganisms.
Figure 1. Bacteria in a 10-micron wide scratch.
Liquids, fogs and mists all have difficulty achieving an even distribution throughout the area, with surfaces closer or easier to reach (i.e., the top or front of an item), receiving a higher dosage than surfaces further away or in hard-to-reach areas. Such hard-to-reach areas for common sanitation methods include the bottom, back or insides of items and equipment that don’t receive a “direct hit” from the decontaminant. Liquids, fogs and mists land on and stick to surfaces, which makes it harder for them to reach locations outside the line of sight from where they are injected or sprayed. Hard-to-reach areas also include ceilings, the tops of overhead piping lines, HVAC vents, cooling coils and other surfaces that are located at greater heights than the liquids, fogs and mists can reach due to gravitational effects on the heavy liquid and vapor molecules.
Another common but extreme hard-to-reach area includes any cracks and crevices within a facility. Although crevices are to be avoided within production facilities (and should be repaired if found), it is impossible to guarantee that there are no cracks or crevices within the production area at all. Liquid disinfectants and sterilant methods deal with surface tension, which prevents them from reaching deep into cracks. Vapor, mist and fog particles tend to clump together due to strong hydrogen bonding between molecules, which often leave them too large to fit into crevices. Figure 1 shows bacteria found in a scratch in a stainless steel surface after it had been wiped down with a liquid sterilant. The liquid sterilant was unable to reach into the scratch and kill/remove the bacteria. The bacteria were protected by the crevice created by the scratch, giving them a safe harbor location where they could replicate and potentially exit in the future to contaminate product itself.
Figure 2. Processing machinery
Processing equipment and machinery in general contain many hard-to-reach areas, which challenge the routine cleaning process. In sanitation, “hard to reach” is synonymous with “hard to clean”. Figure 2 shows processing equipment from an ice cream manufacturing facility. Processing equipment cannot be manufactured to eliminate all hard-to-clean areas. As such, even with all the sanitary design considerations possible, it is impossible to have equipment that does not contain any hard-to-clean areas. While sanitary design is essential, additional steps must be taken to further reduce the possibility of contamination and the risk that comes along with it. This means that in order to improve one’s contamination control and risk management programs, improvements must also be made to the sanitation program and the methods of cleaning and decontamination used.
Chlorine Dioxide Gas
Food safety attorney Shawn K. Stevens recently wrote that “given the risk created by the FDA’s war on pathogens, food companies should invest in technologies to better control pathogens in the food processing environments.”1 One method that is able to overcome the inherent difficulties of reaching all pathogens within a food processing environment is chlorine dioxide gas (ClO2 gas). ClO2 gas is a proven sterilant capable of eliminating all viruses, bacteria, fungi, and spores. As a true gas, ClO2 gas follows the natural gas laws, which state that it fills the space it is contained within evenly and completely. The chlorine dioxide molecule is smaller than the smallest viruses and bacteria. Combined, this means that ClO2 gas is able to contact all surfaces within a space and penetrate into cracks further than pathogens can, allowing for the complete decontamination of all microorganisms with the space. It also does not leave residues, making it safe for the treatment of food contact surfaces. It has been used to decontaminate a growing number of food facilities for both contamination response and contamination prevention in order to ensure sterility after renovations, equipment installations and routine plant shutdowns.
Conclusion
“If food companies do not take extraordinary measures to identify Lm in their facilities, perform a comprehensive investigation to find the root cause or source, and then destroy and eliminate it completely, the pathogen will likely persist and, over time, intermittently contaminate their finished products,” wrote Stevens.1 Environmental monitoring and sampling programs have been improved in terms of both technology and technique to better achieve the goal of identifying Lm or other pathogens within a food production environment. The FDA will be aggressive in its environmental monitoring and sampling under the food safety guidelines required by FSMA. Food production facilities will be closely monitored and tracked using PulseNet, with contaminated product being traced back to their source. Recurring contamination by a persistent pathogen will be viewed more severely. While there are many reasons that pathogens can persist within a food manufacturing environment, insufficient cleaning and decontamination is the most common. Traditional cleaning methods are incapable of reaching all surfaces and crevices within a space. In order to eliminate the risk of pathogens re-contaminating a facility, the pathogens need to be fully eliminated from their source and harbor locations. ClO2 gas is a method capable of delivering guaranteed elimination of all pathogens to maintain a pathogen-free environment. With the new era of food safety upon us, ensuring a clean food production environment is more important than ever, and ClO2 gas is uniquely situated to help reduce the risk and liability provided by both the government and the public.
In the summer of 2015, multiple ice cream manufacturers were affected by Listeria monocytogenes contamination. Part two of this article will detail one such company that utilized ClO2 gas to eliminate Listeria from its facility.
Last week the CDC announced the end of its investigation involving Shiga toxin-producing E. coli (STEC) in General Mills flour and flour products. However, many consumers may still have these products in their homes, and thus the agency is warning that it expects to see more illnesses. As of September 26, 2016, the CDC recorded 63 infections with strains of STEC O121 or STEC O26 in 24 states, 17 of which resulted in hospitalizations, and no deaths. The agency continues to urge consumers to refrain from eating (this includes a simple “taste”) raw dough or batter. It is also advising against giving playdough made with raw flour to children.
CDC worked with FDA and used PulseNet to identify illnesses that were part of the outbreak. This investigation led General Mills to initiate several recalls of its branded flours (May 31, 2016, July 1, 2016 and July 25, 2016), affecting more than 10 million pounds of product.
“In an epidemiologic investigation, investigators compared the responses of ill people in this outbreak to those of people of similar age and gender reported to state health departments with other gastrointestinal illnesses. Results from this investigation indicated an association between getting sick with STEC and someone in the household using Gold Medal brand flour.
Federal, state, and local regulatory officials performed traceback investigations using package information collected from ill people’s homes and records collected from restaurants where ill people were exposed to raw dough. These initial investigations indicated that the flour used by ill people or used in the restaurants was produced during the same week in November 2015 at the General Mills facility in Kansas City, Missouri, where Gold Medal brand flour is produced,” according to the CDC’s outbreak summary.
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