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Part III: FSMA IQ Test

By Food Safety Tech Staff
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Here are the results of Part II’s FSMA IQ Test. If you haven’t taken Part II yet, follow this link. Under the results is Part III of the IQ test, results of which will be posted next week.

  1. Written supply chain plans are not included in FSMA food safety plans. FALSE
    • 92% answered correctly
  2. Mandatory recalls are provided under FSMA as a new requirement. TRUE
    • 82% got this right
  3. Under FSMA, FDA cannot unilaterally issue administrative detention and must work through a court order. FALSE
    • 93% answered correctly
  4. Under FSMA verification and validation, a thermometer challenge and calibration for use is an acceptable example of an established validation program and controls. TRUE
    • 85% said “true”
  5. Dogs may be allowed into some areas of the plant under FSMA. TRUE
    • ONLY 27% answered this correctly!
  6. Verification effectiveness of the implementation of preventive controls needs to be evident but not documented under FSMA. FALSE
    • 92% answered correctly

Create your own user feedback survey

New Report Gives Failing Grade to Many Food Retailers on Pesticide Use

By Food Safety Tech Staff
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A recent report released by Friends of the Earth revealed that very few of the nation’s biggest food retailers have what it considers satisfactory policies and practices in pollinator protection, pesticide reduction and organic offerings. The organization graded 20 of largest retailers in the report, “Swarming the Aisles: Rating Top Retailers on Bee Friendly and Organic Food”.

In the category of publicly available policies on reducing or eliminating pesticides in order to protect pollinators, only Aldi, Costco and Whole Foods received passing grades.

“U.S. food retailers must take responsibility for how the products they sell are contributing to the bee crisis,” said Tiffany Finck-Haynes, food futures campaigner with Friends of the Earth, in a press release. “The majority of the food sold at top U.S. food retailers is produced with pollinator-toxic pesticides. According to Friends of the Earth, neonicotinoids (insecticides) are a leading cause of pollinator declines, while glyphosate (the most widely used herbicide) has been tied to monarch butterfly declines.

“To protect pollinators, we must eliminate pollinator-toxic pesticides from our farming systems and expand pollinator-friendly organic agriculture,” said Dr. Kendra Klein, staff scientist at FOE. “Organic farms support 50% more pollinator species than conventional farms. This is a huge opportunity for American farmers. Less than one percent of total U.S. farmland is in organic production — farmers need the support of food retailers to help them transition dramatically more acreage to organic.”

In conducting the report, FOE mainly used publicly available information sources such as company websites and annual reports, SEC filings, corporate social responsibility and sustainability reports, press coverage, and other forms of industry analysis.

Deirdre Schlunegger, CEO of STOP Foodborne Illness
Food Safety Culture Club

Time to Reflect and Honor Food Safety Heroes

By Deirdre Schlunegger
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Deirdre Schlunegger, CEO of STOP Foodborne Illness
Robert Tauxe, CDC
CDC’s Robert Tauxe will be honored by STOP Foodborne Illness at a fundraiser during the 2016 Food Safety Consortium.

STOP Foodborne Illness is honored again this year to be given the opportunity by Food Safety Tech to hold a fundraising event at the Food Safety Consortium on Tuesday, December 6 at 7 p.m. in Schaumburg, Illinois (Chicago area). We are honoring Robert Tauxe, M.D., MPH, deputy director of the CDC’s Division of Foodborne, Waterborne and Environmental Diseases at the National Center for Emerging and Zoonotic Infectious Diseases with the Advancing Science for Food Safety Award; Scott Horsfall, representing The California Leafy Green Marketing Association with the Food Safety Training Award; and Jeff Almer, whose mother died from foodborne illness for the Food Safety Hero award. We will have a silent auction, music and food. This is a time to pause and thank those who have positively influenced our food safety system and we hope you will join us.

STOP Foodborne Illness is a national nonprofit public health organization dedicated to the prevention of illness and death from foodborne pathogens.

  • Advocating for sound public policy
  • Building public awareness
  • Assisting those impacted by foodborne illness
Scott Horsfall Dan Sutton Jeff Almer
Scott Horsfall Dan Sutton Jeff Almer

Last year’s Food Safety Heroes were Nancy Donley, former spokesperson for Safe Tables Our Priority and STOP Foodborne Illness and Frank Yiannas, vice president of food safety at Walmart.

FDA’s Michael Taylor Joins in Honoring Food Safety Heroes

 

Part II: FSMA IQ Test

By Food Safety Tech Staff
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More than 400 people took Part I of the FSMA IQ Test. Read on for the results, and then take Part II of the FSMA IQ test (results of which will be posted next week).

Part I

  1. FSMA requires all records for the reevaluation of cGMPs every three years. FALSE
    • Only 31.8% got it right
  2. Implementation records are required for every FSMA requirement. TRUE
    • 77% answered correctly
  3. Plant borders not under the operator’s controls are not included within cGMPs. FALSE
    • 81% answered FALSE
  4. Under some circumstances, FSMA requires that conformance of a customer’s control of a hazard is required. TRUE
    • 85% got it right
  5. Under FSMA cGMPs, you must be able to identify at least 95% all possible contaminated product. FALSE
    • Results were almost split: 48% answered TRUE; 52% answered FALSE
  6. Monitoring of frequency of preventive controls must be conducted by the operation as part of the food safety plan. TRUE
    • 95% answered correctly.

Part II

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Katy Jones, Foodlogiq
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The Clock is Ticking: Technology to Effectively Manage Recalls

By Katy Jones
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Katy Jones, Foodlogiq

It seems there isn’t a day that goes by without a food recall being announced. National brands like General Mills, Kellogg’s and Kraft alone have all experienced major recalls over products contaminated with such hazards as E. coli or undeclared allergens in the last few months. Food recalls are incredibly costly to a company, but can be handled effectively and efficiently with good planning, proper execution and the right technology to back it up.

Fortunately, the food industry is moving in the right direction to encourage better recall management by way of regulations under FSMA. Underscored by these federal mandates, the industry as a whole is moving away from a reactive approach to quality and safety issues within the supply chain, instead adopting a preventative plan of action.

The Multiplier Effect: How One Ingredient Can Lead To Multiple Recalls | Learn more at the 2016 Food Safety Consortium | December 7-8 | Schuamburg, ILRecalls are inevitable in the food industry, and in reality every company has, or will, experience one at some point. What sets a company apart essentially boils down to how they prepare for and react to a recall situation. If a company has done its due diligence to prepare for the inevitable (i.e. putting a recall team in place and implementing the right traceability technology), dealing with a quality or contamination issue can be less painful. Additionally, taking the right preventative steps can ensure a recall situation is proactively handled, rather than leading to a brand’s nightmarish public meltdown.

Getting Beyond “One-up and One-Back”

The industry has relied on a more linear approach to supply chain transparency—the “one-up and one-back” method (OUOB). Knowing where a product has come from one step back in the chain and where it is being sent or sold one step forward is no longer enough. To properly prepare for a recall, and manage product quality, it is imperative that a company employ whole chain traceability software, rather than relying solely on the movement of product within its own four walls.

The OUOB traceability approach is especially dangerous when handling high-risk, perishable foods, like produce or meat—which are often the culprit for recalls. According to a recent study in the Journal of Business Logistics titled, “Tracing Bad Products in Supply Chains” by Kaitlin Wowak, assistant professor of management at Notre Dame, “perishable products, like fresh produce and meats, flow through the supply chain very quickly. And while federal regulations mandate that firms have traceability one step up and down the chain, this may not be sufficient for these perishable products. In those situations, there is often a gap in the information received about the product, say a positive Listeria test, and where that product went in the supply chain.”

Root Cause Analysis is Key

When faced with a recall situation, time is of the essence. The time it takes for the recall team to identify the root cause of an issue and remove it from the supply chain could be the difference between sick consumers and serious brand implications. Being fully cognizant of the entire supply chain via a whole-chain traceability solution allows you to visualize a contaminant’s exact location; this information ultimately helps a brand streamline and manage the issue quickly and effectively.

Wowak’s research profiles a series of recall scenarios. One that was studied found that 50% of the food removed from the supply chain during that recall was actually affected—the other half was perfectly fine. Take the example of a batch of tainted tomatoes in your supply chain. Without being able to identify the root cause at the lot level, a company might be forced to remove all of the tomatoes from its supply chain.

Rather, by utilizing end-to-end traceability software, they can identify the specific farm, pack date and lot from which the produce originated. Tracing that information through each step in the supply chain—hether the tomatoes ended up on a pizza, in a can of salsa, or in a farmer’s market—allows the brand to manage the bad products without disrupting their entire chain or wasting perfectly good produce.

Unfortunately, without the visibility of whole-chain traceability, companies do not have the option to cherry pick tainted vs. untainted food from their chain. This is especially relevant as up to 40% of food in the United States goes to waste, according to the NRDC.1

Centralized Recordkeeping

When faced with a safety or quality issue, communicating information to relevant parties is necessary throughout the process. Especially with FSMA coming into play, if a company experiences a quality issue, they must promptly notify regulatory establishments and be sure to submit documentation and data in an immediate manner for investigative purposes. This can be hindered if a brand does not have a good handle on their supply chain data and must spend hours sorting through file cabinets, emails, or Excel sheets for proper documentation, or coordinating with suppliers for records. The longer it takes to comply with federal regulations and submit data around a recall, the more likely consumers, and the brand, are at risk.

The industry’s shift towards a preventative approach to safety is hitting a milestone as FSMA compliance periods have already taken effect. With this change, the FDA will no longer tolerate poor handling of contamination or quality issues. A company cannot get away with blaming a partner’s lack of transparency, or a supplier’s inconsistent records— the brand is now always accountable. In the coming months, we can anticipate added scrutiny from auditors, more mandatory recalls, even the shutting down of facilities due to noncompliance or negligence around safety concerns.

Having a robust supplier management system in place enables a company to be prepared for a recall situation. With all of your product and supplier data in one place, companies can quickly gather and allocate necessary data like audits and assessments to the appropriate officials, complying with the new required recordkeeping rules. By streamlining the availability of key information, and supporting seamless communication, a brand can be empowered to navigate a quality or safety issue.

As testing across the supply chain increases and the demand for fresh food rises, recalls are not going away. Fortunately, the move to a preventative approach to safety comes at a time where traceability technology is more comprehensive than ever. Food companies have the opportunity to invest in themselves with end-to-end traceability, arming the brand for the inevitable occurrence of a safety or quality issue. By enhancing visibility of the supply chain via an all-encompassing whole-chain platform, it is possible to track a product through each stopover to the consumer, from farm to fork. At the same time, housing all data in one efficient platform can ease the pressure of liaising with supply chain partners and regulatory bodies and streamline communications when faced with a safety situation.

While recalls are an inescapable part of the food industry, what sets a brand apart is how well they prepare and arm themselves with the technology to stay ahead. Implementing supplier management and whole-chain traceability software can help a company stay one step ahead of a recall, which makes all the difference when consumer wellness and brand reputation are on the line.

Reference

  1. Gunders, D. (August 2012). “Wasted: How America Is Losing up to 40 Percent of Its Food from Farm to Fork in Landfill”. NRDC Issue Paper. Retrieved from https://www.nrdc.org/sites/default/files/wasted-food-IP.pdf
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Test Your FSMA IQ Smarts

By Food Safety Tech Staff
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FSMA Preventive Controls: Are You Prepared? Use this self-diagnostic assessment tool to help determine your current state of planning for FSMA.With so many factors and new requirements to consider, have you and your team thought about how well you really know FSMA and all that the new regulations entail? Here at Food Safety Tech, we’ve heard from sources in the industry that many elements of FSMA are not fully understood.

Working with Bill Bremer, principal of food safety compliance at Kestrel Management, LLC, Food Safety Tech is introducing a six-part FSMA IQ test. Results will be posted each week in our Food Safety Consortium newsletter leading up to the 2016 event.

Take part I of the FSMA IQ Test.

Find out how you did on Part I, and then take Part II here.

Part III

Part IV

If you don’t receive our newsletters, sign up here!

Heat transfer, filtration

Safety in Food Processing: How to Select the Right Heat Transfer Fluid

By Christopher Wright, Ph.D.
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Heat transfer, filtration

It is critical that the heat transfer fluids (HTFs) used in the manufacturing sector are used appropriately and managed safely. Food-grade HTFs are highly refined petroleum mineral oils that are non-toxic, non-irritating and lack an odor. If a food grade HTF has been certified for use in food processing, it carries a HT-1 certificate (e.g., Globaltherm FG). Food-grade HTFs are commonly referred to as being non-fouling, which means that as they thermally degrade, they produce small carbon particles that are suspended in the HTF. This means the carbon formations are less sticky, thereby reducing the extent of adhesion to the internal surfaces of a HTF system. A recent report analyzed the test reports from HTF systems and showed carbon residue was lower for food-grade HTFs than mineral-based HTFs.1 This demonstrates the non-fouling nature of food-grade HTFs. The report recommended the independent assessment of HTFs to ensure food manufacturers and producers are using food-grade HTFs.

The HTF sector was estimated to be worth $2.8 billion in 2015 and is projected to grow by 6.8% over the next 5 years.2 Heat transfer refers to the transfer of thermal energy, and fluids are used to transfer heat energy from a heat source to processing equipment where heat is needed. This is a basic requirement in a wide variety of industrial processes, including the processing of foodstuffs such as crackers or any foods that come in a packet.

Food-grade HTFs are non-toxic, odorless and appear transparent like water, but they clearly should not be confused with water.1 Indeed, a food-grade HTF is a highly refined petroleum mineral oil and consists of a complex combination of hydrocarbons obtained from the intensive treatment of a petroleum fraction with sulphuric acid and oleum, by hydrogenation or by a combination of hydrogenation and acid treatment.

Food-grade HTFs are the most likely HTF to be used in the processing of foods provided they are judged to be safe for incidental contact with food. This certification is governed by two well-known bodies—the NSF and InS. In the case of the NSF, the components comprising a fluid are assessed for safety by a toxicologist and, if deemed safe, are awarded a HT-1 certification and can be used for incidental contact. In some cases the use of so-called food-grade HTFs is stipulated by insurers and food retailers, and certain manufacturers will be routinely audited to ensure that an appropriate HTF is being used in the processing of food. Another advantage of a HT-1 certification is that it is associated with fewer handling complaints than other fluids.

In the case of the United Kingdom, Global Heat Transfer, part of the Global Group of Companies, estimates that around 20% of all HTF systems are involved in the processing of food. The use of a food-grade HTF is recommended, but its use is not regulated. However, HTF leaks do occasionally occur. In 1998 more than 490,000 pounds of smoked boneless hams were recalled by Smithfield Foods after several customers reported a “bad taste” and “burning in their throat”, which lasted up to three hours.3 The cause was incidental contact with a non-food grade gear lubricant.

In the context of food processing, good manufacturing practice (GMP) prerequisites combined with the application of risk-based Hazard Analysis Critical Control Points (HACCP) according to Codex Alimentarius principles alongside first-, second- and third-party quality audits in the supply chain are used to ensure food is managed safely both during processing and when being distributed to the consumer. In addition, industrial insurers work closely with manufacturers to ensure commercial operations are adequately insured and as part of this process, may stipulate the use of a food-grade HTF and how it should be maintained.

There is no specific legislation to ensure that food grade HTFs are used in the processing of food, so it is the responsibility of the food business owner to ensure food safety throughout the supply chain and more pointedly to design plant, equipment and premises such as to protect against the accumulation of dirt, contact with toxic materials and the shedding of particles into food.

However, as outlined in the Smithfield Foods case, there is the potential for the food to come into contact with an HTF during processing. It is important to consider a few scenarios where a food may be contaminated with an HTF.

Scenario 1. The HTF may be managed by the manufacturer according to HACCP if directly involved in the processing of a product or by GMP prerequisites if the HTF forms part of the facility and services to the production line. Either system will not allow any amount of HTF to be present in food. In the event of incidental contact with food, the manufacturer may choose to dispose of all food. In this scenario, a mineral-based HTF may be used rather than a food-grade HTF.

Scenario 2. The HTF is managed according to the stipulations from the retailer. In this scenario the retailer may stipulate that a food-grade HTF is used. The HTF would be checked during auditing. However, this would be a paper-based audit, and so the HTF would never be physically sampled and analyzed.

Scenario 3. The insurer stipulates the use if a food-grade HTF. Like scenario 2, adoption would be assessed during audits of a facility and paper-based checks would be conducted. Like scenario 2, however, the HTF would never be physically sampled and analyzed. In this case the insurer may be more concerned with the safety of the system and may be more interested in the sampling reports and parameters, such as annual sampling frequency and flash point temperature of the HTF.

The gap highlighted in scenarios 2 and 3 is that a food-grade HTF would never actually be physically analyzed onsite. HTF sampling and chemical analysis is quick and easy to conduct, and can be conducted by professional companies without interrupting production.

This article makes the case for checking that non-fouling, NSF or InS certified food-grade heat transfer fluids are being used in food production. This can be achieved using independent sampling that can be conducted on-site as requested and shared with all stakeholders including the insurer, to show the HTF is being managed and that the HTF system is safe; the retailer, to demonstrate that an appropriate food-grade HTF is being used during the processing of food; and external auditors, to demonstrate that production is consumer safe.

References

  1. Wright CI, Bembridge T, Picot E, Premel J, Food processing: the use of non-fouling food grade heat transfer fluids. Applied Thermal Engineering 2015: 84; 94-103.
  2. Global Industry News (March 18, 2016). “Europe Became Largest Market for Heat Transfer Fluids in 2015, With 33.6% Share in Terms of HTFs Consumption” Retrieved from http://globalindustrynews.org/2016/03/18/europe-became-largest-market-for-heat-transfer-fluids-in-2015-with-33-6-share-in-terms-of-htfs-consumption/
  3. Gebarin S,. (January 2009). The Basics of Food-grade Lubricants, Machinery Lubrication. Retrieved from http://www.machinerylubrication.com/Read/1857/food-grade-lubricants-basics
Hand

Consumers Drive GMO Debate, Chicken Playtime and Tech Innovation

By Maria Fontanazza
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Hand

Last week several leading organizations in the food industry gathered to discuss trends and key issues facing the industry at The Wall Street Journal Global Food Forum. From the GMO debate to small farming and humane practices to sugar preferences, it’s clear that consumer demand for more control over what they’re consuming will continue to drive industry practices and future policies.

Industry leaders will gather at the 2016 Food Safety Consortium, December 5–9 in Schaumburg, IL | LEARN MOREAgriculture in the Global Landscape

The agricultural sector is often one of the most protected markets, according to Darci Vetter, ambassador and chief agricultural negotiator at the Office of the U.S. Trade Representative. Vetter strongly advocated for moving forward with free trade agreements in the United States for fear of falling behind in such a competitive global market.

When the audience was asked which country would see the biggest increase in agricultural exports in coming years, 40% selected China. To this observation, Vetter commented that while China has invested a great deal into basic research in the field of agriculture, the country has not been able to turn discoveries into viable technologies for farmers.

“China’s vision of national security is very much tied to food security.” – Darci Vetter, ambassador and chief agricultural negotiator at the Office of the U.S. Trade Representative

Antibiotics: Not in My Chicken

As industry faces unprecedented scrutiny from consumers, the use of antibiotics in livestock remains a hot button issue. Nearly 15 years ago, Perdue Farms saw evidence that consumers were concerned about antibiotics, and the company has made significant strides to reach today’s slogan, “No Antibiotics Ever”. This means that 100% of the chickens are not receiving antibiotics unless they’re sick, which is about 5%, according to company Chairman Jim Perdue. Measures the company has taken to reduce the incidence of illness in birds includes wiping every egg that comes into a hatchery with a baby wipe (Perdue says that the company is the biggest user of baby wipes); using herbs such as oregano in feed, because it has been shown to help condition the gut; and engaging in “chicken playtime” (a controlled atmosphere for chickens to play), which is said to reduce stress in chickens.

Debating GMOs and Technology

In order to address the growing population, industry must look at the entire suite of tools available, said Vetter. According to Mike Frank, senior vice president and chief commercial officer of Monsanto Co., 60–70% more food needs to be produced to feed the future population. Global warming, affordability and consumer education are just a few challenges that farmers face while trying to improve productivity and efficiency. This is where technology plays a key role, said Frank. Industry needs innovation to address the challenge of producing more food and managing the environmental footprint.

“We need every farmer, whether organic or not, to be successful.” – Mike Frank, senior vice president and chief commercial officer, Monsanto Company

Frank predicts that big data will dramatically change agriculture within the next five to six years by allowing farmers to farm by the square meter, thereby improving productivity in areas such as seeding and pest management. Farmers will also be able to leverage data to gain a better understanding of soil conditions and weather, and how it will ultimately impact their harvest.

Closing the Food Safety Loop

“Food safety doesn’t magically happen,” said Frank Yiannas, vice president of food safety at Walmart. He emphasized how companies must work hard to reduce risk early in the process, citing Walmart’s guiding principles: Is it safe? Is it affordable? Is it sustainable? He also touched on the company’s program to reduce the incidence of Salmonella in chicken parts and how companies should approach risk not just from the scientific point of view but also consider the regulatory requirements and perceived risk in making risk management decisions.

“We as leaders need to shift the conversation and let food unite us.” – Frank Yiannas, vice president, food safety, Walmart

The discussion between FDA commissioner Robert Califf, M.D. and Susan Mayne, director at CFSAN, focused more on chronic disease and healthy eating, however Califf expressed a need for more interrelated data sources within FDA. He also encouraged that industry conduct more research to ensure that decisions are based on good evidence.

Eliminating Listeria: Closing the Gap in Sanitation Programs

By Kevin Lorcheim
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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.

Bacteria
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.

Processing machinery
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.

Reference

  1. Stevens, S.K. (June 3, 2016). “Find Contamination, Reduce Pathogens, and Decrease Criminal Liability”. Retrieved from https://foodsafetytech.com/column/find-contamination-reduce-pathogens-decrease-criminal-liability/
Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC
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Post-FSMA Food Safety Inspection: Are You Ready?

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Note: FSMA will include the scheduled compliance inspection as part of the implementation of rules. This will occur in the next several years for many food companies.

With FSMA rules moving to the compliance stage, food companies must prepare appropriately to best respond to the requirements and, correspondingly, to additional inspections. These inspections are in addition to others, including GFSI with its emphasis on unannounced level audits for some schemes. For example, these audits may be required by the code (as with SQF) or as part of customer arrangements per certification contracts.

Learn more about FSMA Inspection Readiness at this year’s Food Safety Consortium in Schaumburg, IL | December 7-8, 2016 | REGISTERWith the growing potential for inspections and audits, a well-planned program and response must be developed, implemented and tested to achieve a most successful outcome. This is an important area to address, especially given the many changes in compliance under FSMA, greater scrutiny under GFSI, and a rapidly changing responsibility for food safety management resources.

For companies experienced with past FDA compliance audits, the new rules and Section 117 cGMPs will require more formalized programs and strong evidence of compliance through internal audits and oversight by Qualified Individuals (QI). The inspectors will look to focus heavily on new requirements and the “letter of the law”. Additionally, organizations under the Preventive Control Rule must have multiple Food Safety Plan QIs, qualified audit resources and competent sanitation management, along with competent plant operators. It is critical to have established roles, planning and testing as part of any inspection readiness program.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning when it comes to developing inspection readiness. To complete your own planning assessment, review your progress compared to the questions in Table I.

FSMA Inspection checklist
Table I. Kestrel Management’s self-diagnostic tool can help a company assess its level of inspection readiness and preparedness for FSMA compliance.

Get Compliance-Ready

Companies must have the appropriate plans and resources to comply with FSMA and certifications or face possible violations that can include fines and penalties under FDA enforcement. The questions in Table I will help companies identify areas to consider for Inspection readiness. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage all of your food safety requirements—and change “No” responses into “Yes” responses that promote best practices for FSMA and food safety compliance.