FoodHACCP Newsletter



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01/16 2016 ISSUE:739

Produce growers to get help meeting new food safety regulations
Source : http://www.pikecountycourier.com/apps/pbcs.dll/article?AID=/20170114/NEWS01/170119986/0/MILESTONES02/Produce-growers-to-get-help-meeting-new-food-safety-regulations
By pikecountycourier.com (JAN 14, 2017)
Pennsylvania’s produce growers will get help implementing food safety systems from a $6.3 million grant awarded to the state’s Department of Agriculture, Governor Tom Wolf announced recently.
The grant will help Pennsylvania comply with the Food and Drug Administration’s Food Safety Modernization Act, which establishes science-based minimum standards for growing, harvesting, packing, and storing fruits and vegetables grown for human consumption. The funding will be spread across five years.
Pennsylvania was one of 42 states to receive a portion of the $21.8 million in total funding.
“Pennsylvania received a sizable share of this FDA funding, which will prove vital in implementing outreach to our entire produce industry,” said Wolf. “We produce a variety of fruits, mushrooms, and vegetables, grown by a diverse group of farmers, many of whom are part of the plain sect community. Our prior history with most of these growers in performing voluntary audits has built a critical rapport and trus.”
The department currently provides voluntary Good Handling Practices/Good Agricultural Practices audits to growers who need a third-party inspection to meet market demands for food safety and quality. The Food Safety Modernization Act inspections will expand to all non-exempt growers.
“We’ve been reaching out to growers, giving them the heads-up and addressing their concerns since before the rule was finalized in November 2015,” said Agriculture Secretary Russell Redding. "These new resources will help us to implement that plan to ensure producers and growers understand this new system for keeping our food supply safe.”
The cooperative agreement will allow the department to triple the staff at the Bureau of Food Safety and Laboratory Services Fruit and Vegetable Division. They will do audits and inspections and work with Penn State Extension staff to educate growers and ensure compliance.
Producers will first be audited. Department staff will work with producers to identify any corrections and improvements that need to be made in order to pass inspection. Staff will return later to perform the official inspection on the facility.
For more information, visit eatsafepa.com.

FDA Issues Revised Draft Guidance for Control of Listeria monocytogenes in Ready-To-Eat Foods
Source : http://www.foodsafetymagazine.com/news/fda-issues-revised-draft-guidance-for-control-of-listeria-monocytogenes-in-ready-to-eat-foods/
By FDA (Jan 13, 2017)
The U.S. Food and Drug Administration (FDA) is releasing an updated draft guidance, “Control of Listeria monocytogenes in Ready-To-Eat Foods,” which supports ongoing efforts by industry and government agencies to reduce the risk of Listeria monocytogenes (L. mono) in ready-to-eat (RTE) foods. L. mono, a pathogen that can grow even in cold, refrigerated environments, is particularly harmful to the elderly, pregnant women and/or their pregnancy, and those who are immunocompromised.
The emphasis on prevention in this draft guidance is consistent with the FDA Food Safety Modernization Act (FSMA) and reflects the FDA’s current good manufacturing practice (CGMP) requirements, as well as new requirements for hazard analysis and risk-based preventive controls, including verification of preventive controls.
All food facilities that manufacture, process, pack, or hold RTE foods will benefit from clear guidance on measures to control L. mono in the food processing environment, regardless of whether the facility is subject to CGMPs, preventive controls, or both CGMPs and preventive controls.
Industry best practices and the “seek and destroy” approach used by the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA) have been incorporated into the draft guidance. Integrating these approaches along with the food safety requirements under FSMA, should lead to more effective efforts to control L. mono in RTE products. RTE facilities that produce foods that are regulated by both USDA/FSIS and FDA will also benefit from a uniform federal approach to reducing the risk of environmental contamination with L. mono.
The guidance includes recommendations for controls involving personnel, cleaning and maintenance of equipment, and sanitation, as well as for treatments that kill L. mono and formulations to prevent it from growing during storage of the food between production and consumption. The updated draft guidance does not change or alter what constitutes an RTE food.
The FDA is accepting public comments beginning on January 17, 2017. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2008-D-0096 in the search box.
To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2008-D-0096 on each page of your written comments.

 


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Mitigation of Listeria monocytogenes in Ready-to-Eat Meats Using Lactic Acid Bacteria
Source : http://www.foodsafetymagazine.com/magazine-archive1/december-2016january-2017/mitigation-of-ilisteria-monocytogenesi-in-ready-to-eat-meats-using-lactic-acid-bacteria/
By Byron D. Chaves, Ph.D., and Mindy M. Brashears, Ph.D.
Nothing like a series of disease outbreaks and food recalls to put a pathogen at the forefront of the media and make processors fear the worst. Listeria monocytogenes has given us a lot to talk and think about over the last 5 years. Outbreaks of listeriosis associated with the consumption of contaminated caramel apples, ice cream and cantaloupes, as well as several multi-state recalls of bagged salads, frozen vegetables, school lunches, frankfurters, corn dogs and ready-to-eat (RTE) meals, among others, remind us of how far we are from having a full understanding of the ecology, transmission and control of L. monocytogenes in foods and food processing environments.
A Well-Founded Scare
We all know that L. monocytogenes can be a challenging pathogen to control. First, it is a common bacterium in natural environments, including vegetation, agricultural soils and livestock, so it may be brought into the plant in raw animal and plant materials, dust, water and even through plant employees. Secondly, it typically finds its niche in cold, humid environments, making it a potential nightmare to control in RTE meat processing facilities once it has established itself on the premises. Its ability to form biofilms and persist in this protective microbial community is one of the most common reasons for its difficult eradication, despite aggressive cleaning and sanitizing. Lastly, L. monocytogenes can survive and even grow in refrigerated, packaged RTE products, including those packed under low-oxygen conditions.
Unlike produce handling and processing facilities, where Listeria spp. is somewhat expected to be present from time to time, companies that process RTE meats cannot afford to have L. monocytogenes. Postlethality-treated product that comes in touch with contaminated direct-contact surfaces or product that is directly contaminated after a lethality treatment becomes adulterated as per the U.S. Department of Agriculture-Food Safety and Inspection Service’s “zero tolerance” rule under 9 C.F.R. Part 430—“Control of Listeria monocytogenes in post-lethality exposed ready-to-eat products.” The rule requires that manufacturers of medium- and high-risk RTE meat and poultry products develop written programs to control L. monocytogenes, followed by robust testing as a means of verification, and encourages plants to use new technologies and methods to eliminate or reduce the growth of L. monocytogenes, hence minimizing the risk of postlethality product contamination.
On average, an estimated 1,600 people are sickened by foodborne L. monocytogenes every year in the U.S., but this translates into nearly 19 percent of annual foodborne-related deaths. Furthermore, Listeria imposes an estimated $2.8 billion in economic burden in a typical year. Almost all of this, $2.1 billion, is due to deaths.[1] RTE meat and poultry products continue to be highly implicated in the transmission of foodborne listeriosis. The L. monocytogenes/deli meats pathogen/food combination is estimated to take the lives of 89 people in the U.S. every year and to cost $902 million per year in illness cases, ranking third in terms of economic burden of illness, surpassed only by Campylobacter in poultry and Toxoplasma gondii in pork.[2]
Control of L. monocytogenes in RTE Meats
As food safety scientists, we have come to a consensus that no single antimicrobial intervention will ever be perfect in eliminating the risk for a given pathogen, that is, risk cannot be zero given our current technological and knowledge limitations. The control of L. monocytogenes in RTE meat products, especially high-risk ones such as hot dogs and deli meats, relies on the use of intensive environmental sanitation programs, thermal processing, such as cooking or in-package pasteurization, and the incorporation of antimicrobial agents as part of the ingredient formulation (e.g., nitrites, acetates, citrates, diacetates, lactates and proprionates) and sometimes as surface sprays (e.g., lauric arginate and essential oils). Irradiation of RTE products has been explored extensively, and the U.S. Food and Drug Administration has deemed this technology safe for use in meat and poultry; however, it is not widely used mostly due to consumer distrust of irradiated foods. High hydrostatic pressure has also been evaluated for the control of L. monocytogenes in RTE meats with promising safety results but still compromised quality parameters. Are there any other options that we may want to explore as an industry? What about biocontrol?
Biocontrol, or biopreservation, refers to the use of natural or controlled microorganisms, or their antimicrobial products, to extend the shelf life or enhance the microbiological safety of foods. Outside the food realm, biocontrol has seen multiple applications using predatory microbes and insects for the control of undesirable organisms, particularly in agricultural fields and urban environments. In foods, biocontrol is typically done by two groups of biological agents: bacteriophages, or viruses that specifically infect bacteria, and lactic acid bacteria (LAB). This heterogeneous group of bacteria may exert their antilisterial effect by means of two processes:
Competitive inhibition: When LAB products such as bacteriocins and other antimicrobial peptides, as well as organic acids from carbohydrate fermentation, create an inhospitable environment for Listeria to thrive, hence reducing its numbers.
Competitive exclusion: When LAB occupy space that Listeria may use for attachment or colonization, leaving the pathogen without a physical site to anchor and multiply.
Despite some research exploiting competitive inhibition and exclusion for the control of L. monocytogenes in RTE meats, there is a lack of published information on this topic. In the following paragraphs, we summarize two representative studies that exploited the competitive inhibition activity of LAB against L. monocytogenes. This is neither a comprehensive nor detailed list, but provides a good overview of recent work.
Amézquita and Brashears[3] screened a series of naturally occurring LAB in RTE meats for antilisterial effects. Three particular microorganisms—Pediococcus acidilactici, Lactobacillus casei and Lactobacillus paracasei—were added to frankfurters and cooked ham co-inoculated with L. monocytogenes, vacuum-packaged and stored at 5 °C for 28 days. Bacteriostatic activity (cells growing slower) was observed in cooked ham, whereas bactericidal (cells dying) activity was observed in frankfurters. Numbers of L. monocytogenes were 4.2 to 4.7 logs and 2.6 logs lower than controls in frankfurters and cooked ham, respectively, after the 28-day refrigerated storage. In all cases, numbers of total LAB increased by only 1 log cycle. The authors indicated that P. acidilactici was possibly a bacteriocin producer, whereas the antilisterial activity of the two other strains was due to the production of organic acids. Further studies over a 56-day period indicated that there was no impact on the quality of the product. The authors concluded that this method represents a potential antilisterial intervention in RTE meats, because it inhibited the growth of the pathogen at refrigeration temperatures without causing sensory changes.
Koo et al.[4] found that the combination of three LAB strains contained in Lactiguard®—Lactobacillus animalis, Lactobacillus amylovorus and P. acidilactici—was inhibitory to L. monocytogenes inoculated onto frankfurters not containing lactate/diacetate after 8 weeks of refrigerated storage (0.6-log reduction), and when a cell-free extract (CFE) of LAB was added with LAB, even higher inhibition was obtained (1.2-log reduction). In frankfurters containing lactate/diacetate, both the LAB and the LAB plus CFE were more effective in reducing L. monocytogenes after 8 weeks of refrigerated storage (2- and 3.3-log reductions, respectively). This study showed that it is possible to use LAB as an aid to further reduce L. monocytogenes throughout storage.
Now we see that there are applications of LAB to control L. monocytogenes in the product itself, but these have not been used extensively by industry despite their technological potential. A highly related application, the control of environmental L. monocytogenes by LAB, may see greater potential in the near future due to some promising results. We present two examples representative of this area of research.
Ndahetuye et al.[5] evaluated the attachment of three LAB strains—P. acidilactici, L. amylovorus and L. animalis—to stainless steel coupons from a deli slicer and their ability to inhibit the attachment of L. monocytogenes. L. animalis exhibited the greatest hydrophobicity (26.3%), and its adherence increased sharply from 24 to 72 hours, whereas L. amylovorus yielded the lowest hydrophobicity (3.86%) and was weakly adherent. Although P. acidilactici had moderate hydrophobicity (10.1%), it adhered strongly. Three conditions were simulated to evaluate the ability of the LAB cocktail [108 colony-forming units (CFU)/mL] to competitively exclude L. monocytogenes (103 CFU/mL) on the surface of the coupons. The coupons were pretreated with the LAB cocktail for 24 hours prior to the addition of L. monocytogenes, simultaneously treated with the LAB cocktail and L. monocytogenes, or pretreated with L. monocytogenes 24 hours before the addition of the LAB cocktail. The LAB cocktail was able to reduce the attachment of L. monocytogenes significantly, indicating a possible role for LAB as a biosanitizer in the food industry.
Zhao et al.[6] determined that treating Listeria-laden biofilms with the two competitive exclusion isolates—Lactococcus lactis subsp. lactis strain C-1-92 and Enterococcus durans strain 152—individually at either 4 or 8 °C for 3 weeks substantially reduced or eliminated listeriae in the biofilms. Treatment with L. lactis subsp. lactis strain C-1-92 and E. durans strain 152 at 4 °C for 3 weeks reduced the population of L. monocytogenes in a biofilm from 7.1- to 7.7-log CFU/cm2 to 3.0- to 4.5-log CFU/cm2 and to 3.1- to 5.2-log CFU/cm2, respectively, and treatment at 8 °C for 3 weeks reduced L. monocytogenes from 7.5- to 8.3-log CFU/cm2 to 2.4- to 3.5-log CFU/cm2 and to 3.8- to 5.2-log CFU/cm2, respectively, depending on the coupon material. The researchers combined the isolates and evaluated the control of Listeria in floor drains of an RTE poultry processing plant. The results showed that treating the drains with the isolates four times in the first week eliminated detectable Listeria from five of six drains tested, and the drains remained free of detectable Listeria for 13 weeks following the first four treatments. The authors indicated that certain bacteria, including LAB, can effectively reduce Listeria contamination in biofilms and floor drains of a plant producing RTE poultry products.
Studies performed in our food safety laboratories have further demonstrated that LAB have the ability and potential to reduce L. monocytogenes in RTE meat processing environments. We evaluated the quantitative reduction of L. monocytogenes on deli slicer stainless steel surfaces mimicking retail settings. A cocktail of L. monocytogenes at 103 CFU/mL was inoculated onto deli slicer surfaces, blades and surrounding tables. Ten milliliters of an uncharacterized LAB cocktail were sprayed after L. monocytogenes was allowed to attach to the surfaces. Reductions of approximately 0.9-log CFU/100 cm2 were estimated 1 hour after treatment of the tables, whereas no Listeria was detected by culture methods on the blades.
Conclusions and Perspectives
The use of LAB for the mitigation and control of L. monocytogenes in RTE meats and processing environments has been studied to a very limited extent. Based on current data, it is possible to infer that LAB have the ability to reduce L. monocytogenes either as an ingredient in product formulation or as part of a biosanitizing program. Certainly, this seems to be a promising alternative to physical and chemical approaches for the control of this stubborn and resilient pathogen. However, it is now the role of researchers to continue to explore this option with all its limitations and concerns, particularly the potential effects on product quality, and it is the role of industry to implement novel solutions to the recurrent problem of L. monocytogenes in RTE meats and processing environments.  
Byron D. Chaves, Ph.D., is a postdoctoral research associate in the Department of Animal and Food Science at Texas Tech University.
Mindy M. Brashears, Ph.D., is a professor of food safety microbiology and director of the International Center for Food Industry Excellence at Texas Tech University.
References
1. www.ers.usda.gov/media/1837791/eib140.pdf.
2. Batz, MB et al. 2012. “Ranking the Disease Burden of 14 Pathogens in Food Sources in the United States Using Attribution Data from Outbreak Investigations and Expert Elicitation.” J Food Prot 75:1278–1291.
3. Amézquita, A and MM Brashears. 2002. “Competitive Inhibition of Listeria monocytogenes in Ready-to-Eat Meat Products by Lactic Acid Bacteria.” J Food Prot 65:316–325.
4. Koo, O-K et al. 2012. “Antimicrobial Activity of Lactic Acid Bacteria against Listeria monocytogenes on Frankfurters Formulated with and without Lactate/Diacetate.” Meat Sci 92:532–537.
5. Ndahetuye, JB et al. 2012. “Role of Lactic Acid Bacteria as a Biosanitizer to Prevent Attachment of Listeria monocytogenes F6900 on Deli Slicer Contact Surfaces.” J Food Prot 75:1429–1436.
6. Zhao, T et al. 2013. “Reduction by Competitive Bacteria of Listeria monocytogenes in Biofilms and Listeria Bacteria in Floor Drains in a Ready-to-Eat Poultry Processing Plant.” J Food Prot 76:61–67.

The Benefits of ISO 22000 to the Food Industry
Source : http://www.foodsafetymagazine.com/signature-series/the-benefits-of-iso-22000-to-the-food-industry/
By Susan Beech (Jan 11, 2017)
There is an international standard that is intended to be used within the food industry called ISO 22000.[1] It allows organizations to understand what traditional quality assurance and preventive food safety measures should be implemented within their industry.
The laws for food safety and control have been making progress since 1883 when Dr. Harvey Wiley became chief chemist for the U.S. Department of Agriculture. He spent his time campaigning for federal laws to be enacted. He was referred to as the “Crusading Chemist” and “Father of the Pure Food and Drug Act.”
Before laws were put into place to protect consumers from unsafe foods, ancient Greece—specifically Athens—had beer and wine regulations and inspections for purity. The evolution of food safety laws has come a long way since those ancient times.
ISO 22000 is the international standard today and is benefiting businesses in many ways. Companies that develop their products by following these rules and specifications are increasingly free to compete within many markets around the world. For trade officials, ISO 22000 levels the playing field within regional and global markets. This is due to technically refined international standards and placement of political agreements, and, when followed, they create successful practices that ensure the highest quality of food and safety. 
What Does This Mean for Developing Countries?
ISO 22000 has a strong consensus throughout the world and gives developing countries a source that represents what the food safety standards must be in each country, developed and developing countries alike. Such standards allow countries to have defined characteristics of what their product and service standards should be to meet export market expectations. Because developing countries are just that—developing—this gives them the ability to meet standards for exporting food, which helps them avoid squandering already scarce resources.
How Does ISO 22000 Benefit the World’s General Population?
Each individual’s quality of life will benefit from the rules and regulations of ISO 22000 by the provisions of the following:
Higher quality jobs in the food industry
Improved utilization of resources worldwide
Increased company profits
Potential increased economic growth
Insurance of safer food
Reduction in rates of foodborne disease
More efficient documentation of techniques, methods and procedures
Governments will also see great benefits, such as scientific and technological knowledge, which help the development of health, safety and environmental legislation. These benefits will also provide a way to educate and regulate food personnel.
Anyone involved in the food industry should be aware of the benefits that ISO 22000 has on the processing, storage, manufacturing and distribution of edible products. It provides companies with superior food safety and security, keeps profits from dropping and can be combined with other management system standards, such as ISO 9001:2000, for maximum effects on quality.
Knowing whether ISO 22000 is right for you and your organization is simple: It works for each company, regardless of size or location. Outlining best practices within your company will allow you to deliver results, convey confidence across the board and impress stakeholders and consumers.
When food safety practices fail, dangerous and often extremely expensive consequences may result. Preventing potential problems before they happen through the implementation of food safety standards can rescue an organization from, loss, attorney fees or even having to close its doors for good.
These standards allow the identification of responsibilities, tasks and associated timelines by creating a clear project plan; keep in mind that if something is working, it doesn’t make sense to change it. Communicate the benefits of ISO 22000 clearly with employees and understand that they will have questions about the changes made within your organization. Educate them on how ISO 22000 was created to benefit employers, employees and the general public, and how it will have a positive impact on the company’s short- and long-term successes.
Susan Beech is an environmental awareness writer at Bureau Veritas.
References
1. http://www.us.bureauveritas.com/home/our-services/certification/about-us/a-to-z-services/iso-22000-food-safety-certification.

Is Food-Grade always Food-Safe?
Source : https://foodsafetytech.com/column/food-grade-always-food-safe/
By Lance Roberie (Jan 10, 2017)
What? Why would food-grade not be food-safe?  What is the difference between food-grade and food-safe? Doesn’t it mean the same thing? These may be some of your initial thoughts. So, what is the difference between food-grade and food-safe? Food-grade means that the material is fit for human consumption or permitted to come in contact with food. 21 CFR 174-178 for example, can be used to verify if a component is an appropriately regulated indirect additive and considered GRAS (Generally Recognized as Safe) for its intended use. But are food contact materials sometimes utilized for something other than its intended use? You bet your 483 they are. This is an important component that is often overlooked. Just because that material is permitted to come in contact with food, it doesn’t necessarily mean it is food-safe. Food-safe means that the food-grade material is also fit for purpose for its intended use and will not create a food-safety hazard. For example, it may be fit for purpose to use a food-grade container to hold a dry ingredient but that same container may not be fit for purpose to be used to hold a hot liquid. Section 117.40 in Subpart B of FSMA states: “Food-contact surfaces must be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds, sanitizing agents, and cleaning procedures”. Processors will be called upon more than ever to prove that food contact materials are indeed safe and “fit for purpose” or safe for its intended use. The practice of simply having a certificate of conformance stating that your food contact materials are food-grade will likely no longer be good enough. If you are familiar with GFSI and its standards, you already know that simply having a certificate of conformance for food contact materials is unacceptable if the manufacturer/supplier doesn’t acknowledge that the material is safe to use under the conditions in which you will use them (i.e., for its intended use). So, asking your supplier a few more questions about your food contact materials can go a long way when conducting an in-depth hazard analysis and a food-safety risk assessment. Some common questions are:
What is the recommended safe temperature range for this material?
Is this material safe for the type of food that it is contacting (i.e., fat percentage, pH, moisture percentage, etc.)?
Will the material physically hold up to the manufacturing environment for which it is being used?
You also need to think about how the material is constructed. Does it have pieces/parts that can be accidently removed during use, such as a pail with an attached handle that often falls apart and can potentially make its way into the product stream? Or maybe a cleaning brush that often loses its bristles. Does the material/equipment have seams, and are those seams smooth and cleanable?  When evaluating equipment, always make sure it is designed for the intended use. If equipment is not designed for its intended use, it can often render it ineffective and depending on how critical the process, significantly increase a food-safety risk. Choosing materials that are “food-safe” can be just as important as choosing materials that are “food-grade”.
Have you ever heard someone say “it’s only a trash can if you put trash in it”?  What does that mean exactly? It usually means that containers designed for trash may be used to hold food ingredients or products intended for human consumption. What is the potential risk in that situation? Is that container safe for food contact? It is obviously not the intended use and adulterated product may be the end result. So how does someone determine if the food contact material is “food-safe”?  There are several third-party certification companies that verify food equipment and/or food contact materials are indeed “food-safe”, including HACCP International, NSF and 3A. If the material or product that you are evaluating does not have one of these certifications, then the burden is on you to properly risk assess the potential hazards of your operation and to prove to your customers and regulatory bodies that your process is food-safe. So, during your next food-safety team meeting, challenge your team members to take a good, hard look at everything that comes in contact with the food stream and ask, “is this truly ‘food-safe’?”

Food Safety: What American Companies Bring to the Table
Source : http://www.chinabusinessreview.com/food-safety-what-american-companies-bring-to-the-table/
By Zoe Sophos (Jan 9, 2017)
Despite the increase in regulatory attention after several recent high-profile food safety scandals, China’s food industry is continually challenged to keep food safe. Vague policy directives and lack of interagency coordination lead to confusion about what is expected of stakeholders. The prevalence of small players creates a diverse, disjointed agricultural supply chain that is difficult to oversee—creating compliance concerns for multinational companies in the food and beverage space.
At the same time, promoting and enforcing shared responsibility across the supply chain to keep food safe is not a broadly entrenched value in China. And, inflated complaints by professional consumers—individuals incentivized by financial gain to report food safety violations—are a step toward a more transparent system, but distract from tackling core food safety reforms.
All companies involved in food and beverage production aim to deliver safe products to customers, and every link in the food value chain provides opportunities to strengthen food safety and food security. From farm to table, from seed to storage, and from the production line to the test lab, companies are constantly working to guarantee that food is safely produced, processed, and delivered to the public. By using proven technologies, global standards, innovative methods, and collaborative practices throughout the supply chain, US companies operating in China are helping contribute to a more plentiful supply of safer food.
In 2016, USCBC conducted more than 40 interviews in China and the United States with its member companies, Chinese and US government officials, and other stakeholders in China’s food industry about approaches to mitigating food safety risks, best practices for engaging with the public and private sectors, and the surrounding policy and regulatory environment. The interviews included professionals in farming, processing, packaging, retail, foodservice, and ecommerce industries.
Through this research, USCBC found that robust transparency in policy creation and implementation—paired with even enforcement—is critical for companies to efficiently operate and successfully provide safe food. A transparent, healthy regulatory approach leads to policies that are balanced, implementable, and effectively achieve food safety outcomes that help create a greater supply of safe food.
USCBC also found that US companies are responding to food safety challenges in China in ways that are collaborative and innovative, and help promote food security across the whole supply chain. For example, US companies in the agriculture and food space provide significant, ongoing training on food safety considerations for their employees, their suppliers, and Chinese regulators at the provincial and local levels. They also bring high, global standards and a comprehensive perspective on what it takes to keep food safe. Not only are they able to improve best practices for food safety, but US firms can be effective partners with regulators and lend their unique expertise in collaborative ways. Companies operating in China have tailored strategies for engaging with regulators on critical food safety issues, enabling them to effectively respond to food safety incidents.
In addition, US companies work closely with their suppliers—often Chinese firms—to share best practices and modern technology. For example, they may help suppliers establish foreign object control programs that use x-ray and de-shelling technology to prevent contaminants such as nutshells from ending up in finished food products. A meat products company pre-approves antibiotics that its suppliers use on their farms, helping moderate notoriously heavy antibiotics usage by small farms in China. One company reported working to train the truck driving companies that transport its product on best practices for cold storage management. Another company helps educate farmers on proper disposal of pesticide packaging so runoff doesn’t end up in rivers and water supplies. By employing international best practices in these instances and others, companies are able to reduce the amount of food lost in the supply chain due to unsafe practices, thus making sure more food is available to consumers.
Food safety in China has made tremendous progress. Regulatory efforts to encourage the production and sale of safe food; developments in testing, manufacturing, and cold chain technology; growth of the food industry as a whole; and enhanced consumer awareness of food safety all played a role in that progress. As China’s food industry continues to develop, the ways in which regulatory transparency, interagency coordination, disjointed supply chains, and overall culture are addressed will determine the safety and security of China’s food supply.
For the complete results of USCBC’s research, please see our report on Food Safety in China.
About the author: Zoe Sophos was a business advisory services manager for the US-China Business Council. USCBC is a private, nonpartisan, nonprofit organization of more than 200 American companies that do business with China. Founded in 1973, USCBC has provided unmatched information, advisory, advocacy, and program services to its membership for more than four decades. Through its offices in Washington, DC, Beijing, and Shanghai, USCBC is uniquely positioned to serve its members’ interests in the United States and China.

FDA warnings: Tofu, supplements and fish eggs
Source : http://www.foodsafetynews.com/2017/01/fda-warnings-tofu-supplements-and-fish-eggs/#.WHwdrvmLSUl
BY NEWS DESK (Jan 9, 2017)
Three warning letters recently posted by the Food and Drug Administration cited food safety violations at a tofu production plant in California, a supplement company in Nebraska and a supplier of fish roe based in Peru.
Companies that receive FDA warning letters are given 15 days to respond in writing. Failure to make necessary changes can result in a variety of enforcement actions, including closure of domestic facilities and detention of foreign foods at the U.S. border.
Tofu Yu LLC, Berkely, CA
In a Dec. 22, 2016, warning letter to co-owner and president Kevin E. Strong, the FDA cited “significant violations” ranging from dirty equipment to problems with product labeling found during inspections on Oct. 11 and 25, 2016.
The Berkeley facility’s ready-to-eat tofu and tofu products, including tofu veggie wraps, are therefore considered adulterated under federal law.

In addition to dirt and old food residue on equipment, “our investigators observed uncovered tofu products on shelves were stored immediately adjacent to a path of condensate dripping from the cooler fan unit located in the walk in cooler used to store tofu,” according to the FDA warning letter.
The inspectors also observed more than 30 flies in the tofu making room, landing on walls and equipment. The October 2016 inspection wasn’t the first time the facility was cited for insects.
“Additionally, our investigator observed flying insects coming into contact with tofu processing equipment such as on the interior surface of a soybean soaking barrel containing soybeans soaking in process and on the conveyer belt area. Similar observations of flying pests were made during our previous inspections of your facility,” according to the warning letter.
Poor employee hygiene habits are also noted in the warning letter, with specific examples including an employee touching his face with his bare hands and then continuing to handle tofu wraps without washing his hands.
Rock Solid Nutrition LLC, Omaha, NE
In a Dec, 22, 2016, warning letter to co-owners Sean H. Loseke and Heath M. Murray, the FDA cited Rock Solid Nutrition for “serious violations of the Federal Food, Drug and Cosmetic Act.”
“Specifically, you have not established written procedures for quality control operations for ensuring the quality of incoming finished dietary supplement products, such as Pre-Pump, Whey Isolate, and Strength Test,” according to the warning letter.
“Your written procedures for quality control operations must ensure that reserve samples are collected and held, all established specifications are met, master manufacturing records and batch production records are reviewed and approved, the dietary supplement is packaged and labeled as specified in the master manufacturing record, and returned dietary supplements are properly handled.”
The FDA inspected the supplement company’s operation in Omaha from July 8-12, 2016. Inspectors noted the company was failing to follow the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements as detailed by federal law. The company’s response that the supplements are made by a contractor did not carry any weight with the FDA.
“Although your firm may contract out dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure the dietary supplements it places into commerce — or causes to be placed into commerce — are not adulterated for failure to comply with dietary supplement CGMP requirements,” the warning letter states.
Problems with the Rock Solid product labels are also addressed in the warning letter. Inspectors found the labels did not have accurate serving size information and failed to list all ingredients.
Blue Pacifico S.A.C. Tacna, Peru
In an Aug. 23, 2016, warning letter to company president Byeong Joon Nam, the FDA outlined “serious violations” in the handling, storing and processing of ready-to-eat frozen flying fish roe products.
During an inspection on March 28-29, 2016, FDA personnel found inadequate refrigeration of incoming fresh, raw fish roe and improper temperatures during processing.
“During our inspection, the FDA investigator observed the washing, cleaning, rubbing, sieving and sorting of the roe under unrefrigerated conditions,” according to the warning letter.
“The cumulative time for these unrefrigerated processing steps was approximately 4.5 hours. The internal temperature of the product was 71.4 degrees F.”
The Peru company also had a number of other inadequate provisions in its Hazard Analysis and Critical Control Point plan.

Technology Brings a New Age in Food Safety and Analysis
Sourc e : http://www.news-medical.net/whitepaper/20170109/Technology-brings-a-new-age-in-food-safety-and-analysis.aspx
By Pittcon (Jan 9, 2017)
Protecting consumers has long been a priority for the food industry, but modern times have changed the specific challenges producers and regulators face when it comes to food safety. Increasing globalization presents new opportunities for food fraud with the potential for billion-dollar payoffs.
Logistic and legal hurdles can also limit the ability of regulators to inspect food and impose standards when it is traveling 1000s of miles and crossing multiple borders before reaching us. In the 21st century, consumers need to be protected from accidental contamination of food and drinks, but also from deliberate economically motivated food adulteration and even bioterrorism.
As a result, international regulators are taking steps to face up to these challenges. The US FDA recently introduced its first regulation to oppose deliberate food adulteration, requiring large food manufacturers to be much more thorough in prevention. And the EU has implemented more stringent measures to overcome fish mislabeling – a common practice that endangers consumer health and fishermen’s livelihoods.
But regulators cannot address issues in food safety by policy alone: advances in analytic technologies are helping them to combat these challenges. At Pittcon, taking place in Chicago from 5-9 March, 2017, we will hear about some of the latest advances allowing them to do just that.
Food adulteration
As a product that consumers are willing to pay a premium for, olive oil has become one of the world’s most adulterated products. Products labeled olive oil are frequently diluted or substituted with other types of oils, such as hazelnut, sunflower or soybean. The problem is widespread: a recent study that tested five leading brands of extra-virgin olive oil sold in the USA found evidence of poor-quality or adulterated products in 73% of samples.
Fortunately, technologies are emerging that can deliver rapid and cost-effective methods for testing olive oil. For example, a team from PerkinElmer, who will be presenting at Pittcon 2017, have shown that the AxION 2 time-of-flight (TOF) mass spectrometer (MS) integrated with the company’s AxION Direct Sample Analysis (DSA) system can be used to detect soybean oil contamination in olive oil samples by determining the relative quantities of fatty acids in oil samples within 30 seconds.
Another product whose contents don’t always match the label is honey. Honey can be adulterated in a number of ways, including diluting it with cheap sugar syrups or attempting to disguise its true geographic origin.
Recent research has shown how NMR profiling can be used to detect fraud in honey samples, offering a sensitive and non-targeted way to pick up adulterants. Bruker, who will be presenting their devices at this year’s Pittcon exposition, have been involved in a project called the Honey Profiling Consortium. Using the company’s FoodScreener platform, the project has brought together NMR data on 1000s of honey varieties and adulterated honeys to create a comprehensive database. Bruker offers remote data analysis of honey spectra, and will provide labs with automatically generated reports that will flag any violation of the product from its labeling.
Beverage analysis
As well as food, drinks are also subject to important regulation to protect consumer health. In particular, drinking water undergoes stringent routine testing for contamination and impurities in many countries. Ion chromatography is an ideal method for analyzing water samples as it can identify multiple components in one run from the same sample including at trace concentrations.
A team from Metrohm, another exhibitor at Pittcon 2017, developed an ion chromatographic method that is able to detect chromate contamination in water at concentration of less than 0.02 µg/L, a level well below that recommended by the EU and World Health Organization of 50 µg/L. This ability to detect such low concentrations could become very important in future as it looks likely that acceptable chromate levels will be lowered by regulators. This has already happened in the state of California, which has set a chromate limit in drinking water to 10 µg/L.
Food safety advances at Pittcon 2017
At this year’s Pittcon, taking place in Chicago March 5-7 2017, you can hear about the latest developments to for combating current challenges in food safety. Solutions presented range from the use of RF-based sensors for monitoring food quality, Raman spectroscopy to detect pathogens, and NMR for verifying food authenticity.
The conference will hear from the manufacturers who have been developing these new applications and technologies, as well as from the scientists and regulators who are putting them to use in the field.
A team from GE will discuss the development of RF sensors for food quality sensing while Steven Zbylut of General Mills will highlight the advantages of Raman spectroscopy, a technique that has undergone substantial development in recent years. The conference will also hear from the FDA on the use of NMR spectroscopy in food analysis, as well as from the UK-government affiliate FERA Science Ltd, on how recent developments in DNA sequencing are being applied to detecting and tracking food pathogens.
Furthermore, all of the major spectroscopy and analytic science companies will be in attendance at this year’s exposition, including PerkinElmer, Bruker, Renishaw, Metrohm and Wyatt Technology, making Pittcon an unmissable opportunity to see and hear the latest trends and advances in food analysis.
To find out more about food safety analytics and what’s on offer at Pittcon 2017, check out the free industry guide: “Latest Advances in Food Safety”, available to download from the Pittcon website.
References
Dalmia A, Perkins GL, 2013. Rapid measurement of olive oil adulteration with soybean oil with minimal sample preparation using DSA/TOF. Available at: http://www.perkinelmer.co.uk/lab-solutions/resources/docs/APP_Olive_Oil_Adult_with_Soybean_Oil.pdf
Flynn D, 2016. Food Defense Rule designed to combat intentional adulteration. Available at: http://www.foodsafetynews.com/2016/05/food-defense-rule-intended-to-combat-intentional-adulteration/#.V8ht3TWaBle
Frankel EN, Mailer RJ, Wang SC, 2011. Evaluation of extra-virgin olive oil sold in California. Available at: http://olivecenter.ucdavis.edu/research/files/report041211finalreduced.pdf
Goodwin P, 2015. Tough measures on fish fraud are working, study says. Available at: http://www.westernmorningnews.co.uk/tough-measures-fish-fraud-working-study-says/story-28274613-detail/story.html
Metrohm. Quality control in the food and beverage industry. Available at: http://partners.metrohm.com/GetDocument?action=get_dms_document&docid=692076
Schwarzinger S, Brauer F & Rösch P. Honey, what else? New Food 2015; 18 (6). Available at: https://www.bruker.com/fileadmin/user_upload/8-PDF-Docs/nf615_Bruker_bur.pdf
US Food and Drug Administration. FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration. Available at: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm378628.htm

Celebrity chefs score low on food safety practices: study
Source : http://www.safetyandhealthmagazine.com/articles/15153-celebrity-chefs-score-low-on-food-safety-practices-study
By safetyandhealthmagazine.com (Jan 9, 2017)
Manhattan, KS – Celebrity chefs who showcase their recipes on televised broadcasts often fail to follow proper food safety practices, according to a study from Kansas State University.
Researchers watched 100 cooking shows featuring 24 celebrity chefs. Eighty-eight percent of chefs were not shown washing their hands after handling uncooked meat; 23 percent licked their fingers while cooking; and 20 percent touched their hair, dirty clothing or other items before touching food again, the researchers observed. Those behaviors, as well as other food safety hazards such as failing to use a meat thermometer to check if meat has been cooked to a proper temperature, could send the wrong impression to viewers, they cautioned.
“All celebrity chefs have to do is mention these things as they go along: ‘Remember to wash your hands,’ ‘Don’t forget to change out your cutting board’ or ‘I washed my hands here’ – which some chefs did do,” Edgar Chambers IV, a professor in Kansas State’s Department of Food, Nutrition, Dietetics and Health, said in a Dec. 14 press release. “They don’t have to show it on television but they should remind viewers that there are safety issues involved in food preparation.”
About 1 out of 6 Americans is exposed to foodborne illnesses every year, researchers said.
The study was published in April in the Journal of Public Health.

E. coli O157 Outbreak Associated with Goat Dairy Farm Visits in 2016
Source : https://foodpoisoningbulletin.com/2017/e-coli-o157-outbreak-associated-with-goat-dairy-farm-visits-in-2016/
By News Desk (Jan 9, 2017)
The CDC has published a study about E. coli O157 infections that were associated with goat dairy farm visits in Connecticut in 2016 in its Morbidity and Mortality Weekly Report. A cluster of seven culture-confirmed Shiga toxin-producing Escherichia coli (STEC) infection were identified by the Connecticut Department of Public Health on March 24, 2016.
All seven patients had bloody diarrhea. Three of them were hospitalized, and two developed hemolytic uremic syndrome (HUS). Six of the seven sickened visited the same goat dairy farm in southeastern Connecticut the week before they got sick. In all, a total of 50 confirmed E. coli cases were associated with the outbreak, including 47 who had an epidemiologic link to the goat farm. Of the 50 confirmed cases, three did not have an epidemiologic link to the goat farm, and one person visited the farm but was asymptomatic.
PulseNet was used to identify the outbreak strains as STEC O157. Ill farm visitors were encouraged to contact DPH, and many were interviewed about their visit. Environmental samples were collected at the farm. Of the 61 environmental samples collected, twenty-eight, or 46%, yielded STEC 0157. And sixteen of seventeen fecal samples collected from goats at the farm yielded STEC O157. All of the environmental, fecal, and clinical isolates were indistinguishable from one another by PFGE and closely related genetically by whole genome sequencing.
Officials found that the facility design allowed visitors to come into direct contact with goats and soiled bedding. In addition, the farm did not have hand washing stations or any signs to tell visitors of potential disease risk.
About 1,500 people visited the farm during the time period of March 5 through the 24, 2016. A legal order was issued by the local health district to stop public visits to the farm.
The median age of the patients was 5 years. Eleven of the 50 patients was hospitalized, and three developed HUS. Unfortunately, young children are most likely to become seriously ill when they contract E. coli O157 infections, and are much more likely to develop HUS.

Is It Time for a “Kill Step” for Pathogens on Produce at Retail?
Source : http://www.foodsafetymagazine.com/magazine-archive1/december-2016january-2017/is-it-time-for-a-e2809ckill-stepe2809d-for-pathogens-on-produce-at-retail/
By Hal King, Ph.D., and Eric Moorman
Is It Time for a “Kill Step” for Pathogens on Produce at Retail?
Outbreaks of foodborne diseases from fresh and fresh-cut produce continue to occur in the United States; historically, fresh and fresh-cut produce cause more illnesses and higher numbers of foodborne diseases than any other food commodity. In a 2015 analysis and report of data collected between 2004 and 2013 from the U.S. Centers for Disease Control and Prevention’s Foodborne Outbreak Database, the number of confirmed foodborne disease outbreaks (source identified) related to fresh and fresh-cut produce was higher than for any other single food category, including beef, poultry and seafood.[1] Only multi-ingredient, nonmeat foods registered higher, probably because they were combinations of produce commodities not confined to a single ingredient in the outbreak investigations. This same analysis showed that not only was fresh produce the most common cause of outbreaks, but also when an outbreak occurred due to fresh produce, the adulterated fresh-produce commodity also caused the largest number of illnesses in each outbreak among all the food categories (Figure 1[1]).
Of course, these data don’t truly reflect the actual number of outbreaks due to fresh produce commodities nor the number of illnesses and deaths that occurred in each outbreak, as the number of reported outbreaks generally represents only a fraction of the actual number of outbreaks in any given year.[2]
Microbial Contamination of Produce: What Is the Risk?
Because the “farm to fork” distribution of fresh (e.g., bulk whole produce) and fresh-cut (e.g., processed) produce does not routinely include a microbial elimination step (e.g., like cooking), produce naturally carries many commensal, nonharmful microorganisms. However, because of this, some produce also occasionally carries microbial pathogens that have contaminated it somewhere along the supply chain (Figure 2), sometimes with very lethal results. The microbial pathogens most commonly associated with produce-related outbreaks (Table 1[3]) are also associated with predicted, low infectious doses for human infection (i.e., numbers of microbes that one would need to ingest that would lead to an infectious disease); thus, even low levels of contamination of produce with these most common microbial pathogens often lead to a high probability of infectious disease after consumption.[3] A recent study[4] of the microbiological quality and safety of fresh produce from retail chain stores in the U.S. suggests that only a few produce commodities are occasionally contaminated with microbial pathogens over time. Only four specimens of produce from 414 samples collected over a year’s time from three chain retail establishments were positive for human pathogens (Listeria monocytogenes and Escherichia coli O157:H7 on one spinach sample each and two Salmonella spp. on one cilantro and one parsley sample each).
The variables related to the degree of microbial pathogen contamination and colonization of produce are very high,[5] but the number of microbial pathogens on any produce commodity and/or a single produce item is thought to be low unless there is an overt contamination event (e.g., transporting produce in a truck used to previously transport hogs), temperature abuse (growth of the pathogens on the produce) or cross-contamination and spreading during fresh-cut processing in a manufacturing facility or in a retail foodservice establishment (e.g., with raw chicken juice in produce sinks in a retail foodservice establishment). The continual challenges of developing, validating, implementing, monitoring and verifying preventive controls during the farming and processing of produce, and the lack of a “kill step,” will continue to make produce a high-risk food. Many validated preventive controls may reduce this risk when the Food Safety Modernization Act (FSMA) rules on produce safety[6] are implemented for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption, and when fresh-cut produce is prepared in a facility according to the FSMA Preventive Controls for Human Food rule,[7] both mandated by the U.S. Food and Drug Administration (FDA). However, much needs to be done to ensure all possible microbial hazards can be prevented by the implementation of these rules.
It is not the purpose of this article to review all the events that can lead to contamination of fresh and fresh-cut produce, which are extensively reported and continue to be discovered after each new outbreak investigation and/or recall. It is also not our purpose to discuss all the preventive controls that might avert the hazards along the supply chain. However, from our perspectives (i.e., academic and retail food business training and experience), it is the probability of the hazards associated with a commodity most often produced and harvested from the soil, the likely failure to prevent all contamination and pathogen growth events, the low infectious dose of the pathogens and the historically large number of produce foodborne disease outbreaks that led us to discuss here the need and propose options for a new set of preventive controls for produce at retail sales and retail foodservice establishments. Both represent the last opportunity to remove the microbial hazards before human consumption and prevent a foodborne illness.
Criteria for a Kill Step for Produce to Be Performed at Retail
The best means to further reduce or eliminate microbial hazards associated with produce before consumption is to implement a kill step at retail. This kill step should include defined controls that can remove and eliminate the microbial pathogens (i.e., while still attached to the produce) on all fresh produce commodities and in any wash water to prevent cross-contamination of the produce before a product is prepared and served. The kill step should be validated for efficacy against microbial pathogens by science via peer-reviewed research, and the wash/sanitizer solutions should be certified by the U.S. Environmental Protection Agency (EPA) for efficacy against the most common microbial pathogens associated with fresh-cut and fresh produce (e.g., Table 1[3]), approved for safe use on human foods by FDA, available in a format and procedure that can be executed consistently in a retail sales and foodservice establishment and provide the same quality, nutrition and flavor/sensory profile to consumers as fresh produce washed in tap water.
FDA has approved several chemical agents for use in produce wash processes that are generally recognized as safe (GRAS) in accordance with the rules of use in 21 C.F.R. 173.315, 21 C.F.R. 173.368 and 21 C.F.R. 173.300 (Table 2). These chemicals have extensive evidence for their effectiveness as produce wash agents (against dirt, waxes and microbes) and scientifically validated antimicrobial efficacy against microbial pathogens. Many of the chemicals that FDA has approved may be used only at defined concentrations and/or may not be used without a secondary rinse, and some may not be used for washing raw agricultural commodities. The definition of a raw agricultural commodity, according to 40 C.F.R. 180, includes fresh fruits, whether or not they have been washed and colored or otherwise treated in their unpeeled natural form; vegetables in their raw or natural state, whether or not they have been stripped of their outer leaves, waxed, prepared into fresh green salads, etc.; and grains, nuts, eggs, raw milk, meats and similar agricultural produce. It does not include foods that have been processed, fabricated or manufactured by cooking, freezing, dehydrating or milling.
Most of the chemicals have also been certified by EPA in some concentration and/or combination with other chemicals by manufacturers as produce wash agents or antimicrobial fruit and vegetable wash products. For example, a sodium dodecylbenzene sulfonate and lactic acid mixture has been EPA-certified for efficacy against microbial pathogens in produce wash water. However, while this fresh produce wash is not certified to effectively kill microbial pathogens attached to produce, it is an effective means to prevent recontamination of produce during washing (i.e., any pathogen numbers rinsed off the produce during treatment for the designated time will be reduced by a defined percent or log reduction).
Two additional criteria should be met to ensure the most effective kill step for microbial pathogens on produce. First, the procedure should remove and kill pathogens while attached on the produce commodity and in the wash water (as pathogens “seed” the wash water during treatment where they could recontaminate the produce). Second, the procedure should be more effective than water-washing produce alone (the current requirement at retail). Despite the degree of variance due to differences in surface characteristics of produce, time, temperature and methods of inoculation, washing fresh produce with tap water typically results in an approximate 1-log reduction in microbial load on the majority of produce items that have been evaluated. Finally, a produce wash step is probably as important as a produce sanitation step (like washing and sanitizing dishes or cleaning and then sanitizing a food contact surface), where a wash step first would remove dirt and most microbial pathogens and then a sanitation step would kill the remaining pathogens attached to the produce commodity and those in the wash water. Thus, a true validation of a produce wash-and-sanitation system should be how many bacteria, viruses, parasites and fungi are removed off the produce commodity and then how many of each are killed when in the wash water; thus, the kill step may probably be a two-step process.
Example steps in a produce wash-and-sanitation system:
RINSE—No rinse WASH—No rinse SANITIZE—PREP—SERVE
Criteria for Chemicals That Could Be Used for a Kill Step for Produce
Three sanitation technologies currently recognized by FDA for their applicability to produce sanitation include ozone (21 C.F.R. 173.368), hypochlorous acid (21 C.F.R. 173.315) and chlorine dioxide (21 C.F.R. 173.300); all three of these technologies can be generated on-site, have a short shelf life and do not leave residuals on produce, and are relatively efficacious at reducing microbial pathogens when attached to produce at concentrations that are at the highest available and allowable levels. Although each of these antimicrobial agents functions primarily through oxidation-reduction reactions, each has its own set of chemical nuances, including generation method(s) and ease thereof, regulatory limits on allowable concentrations and compulsory practices, and exposure (concentration as a gas or liquid, and contact time) required for antimicrobial efficacy on produce. EPA does not require registration of sanitizer solutions generated and used on-site. As a result, sanitation technologies capable of on-site generation must be validated by the device manufacturer. However, in our opinion, because any chemical used in direct contact with food could be abused/misused, these on-site generator systems if used in retail facilities should be physically restricted from producing concentrations above regulated limits, and any device manufacturer should have the final concentration registered with EPA (e.g., output solution with validated claims for efficacy and safety).
To evaluate which of the three chemicals would be the most feasible sanitizer solution to use in a produce wash-and-sanitation system at retail, we consolidated the findings (Tables 3[8–11] and 4[8, 9, 12–16]) of nine published research articles that evaluated the ability of each chemical to reduce E. coli O157:H7, L. monocytogenes and Salmonella spp. adhered to iceberg and romaine lettuce leaves (believed to be two of the more difficult produce commodities to sanitize). These data certainly are not a comprehensive set of evaluations of these chemicals, nor do they include all the other data published showing efficacy against pathogens on different produce commodities under other variables. We only consolidated these data to demonstrate differences and similarities of efficacy on similar produce commodities (leafy greens).
Data from these research studies utilized either a dip-inoculation method (Table 3[8–11]) or a spot-inoculation method (Table 4[8, 9, 12–16]), where the test pathogens were seeded onto the produce commodity by dipping the produce into a solution containing the pathogen (distributing the pathogen uniformly on the produce) or inoculating the test pathogen in a solution directly onto a single spot on the produce, respectively. These inoculation methods are not natural, of course, as they attempt to adhere the pathogens to the surface of the produce, allow for enumeration of the pathogen numbers before treatment and then allow for enumeration of the remaining viable pathogens after treatment. It would be difficult to mimic the exact variables of natural microbial pathogen adherence to all produce commodity types (e.g., pathogens in different types of water or directly from feces, or via irrigation water, how long the pathogens have been on the produce and at what temperature, how many of the pathogens remain on the produce initially and then grow due to temperature abuse). However, these consolidated findings in our view are the best way to determine which of the methods would probably work best as a produce sanitizer according to the criteria above.
Chlorine Dioxide
As one of several oxides of chlorine, chlorine dioxide (ClO2) is a potent and useful oxidizing agent used in water treatment and in bleaching. ClO2 is a neutral chlorine compound. It is very different from elementary chlorine, both in its chemical structure and in its behavior. One of the most important qualities of ClO2 is its high water solubility, especially in cold water. ClO2 does not hydrolyze when it enters water; it remains like a dissolved gas in solution. ClO2 is approximately 10 times more soluble in water than chlorine, and it is a compound that can decompose violently when separated from diluting substances. As a result, preparation methods that involve producing solutions of it without going through a gas phase are often preferred. Arranging safe handling is essential. ClO2 is reported to have 2.5 times the oxidation capacity of chlorine, maintains its efficacy in both aqueous and gaseous forms and is less affected by changes in pH. Therefore, this chemical should make an excellent produce sanitizer; the ability of ClO2 to reduce levels of pathogenic bacteria is well validated. However, all concentrations with the best efficacies (Tables 3[8–11] and 4[8, 9, 12–16]) are greater than the maximum concentration permissible by FDA (3 ppm). Therefore, this chemical probably would not best fit the criteria for produce sanitation in a retail facility.
Hypochlorous Acid
Hypochlorous acid is a weak acid with the chemical formula HOCl. It forms when chlorine dissolves in water and partially dissociates in water into hypochlorite and hydronium ions. HOCl and OCl- are the primary agents for disinfection when chlorine is used to disinfect water for human use. HOCl cannot be isolated in pure form due to rapid equilibration with its precursor. It is an oxidizer, and in its sodium salt form, sodium hypochlorite (NaClO), or in its calcium salt form, calcium hypochlorite [Ca(ClO)2], can be used as a bleach, a deodorant and a disinfectant. HOCl can be generated through the electrolysis of dilute brine solutions (0.1–1.0% NaCl) and is able to maintain efficacy at slightly acidic and near-neutral pH values [which differs from its sodium salt form, sodium hypochlorite (bleach), which functions at a relatively high pH]. Devices capable of on-site generation are offered by numerous manufacturers, and function using sodium chloride as the only chemical input. The method by which lettuce is contaminated with microbial pathogens greatly impacts HOCl efficacy (Tables 2 and 3[8–11]). Studies utilizing dip-inoculation methods reported 0.7- to 1.4-log reductions of E. coli O157:H7 after a 1- to 2-minute treatment with HOCl at a concentration of 50 ppm (Table 2). However, when lettuce was contaminated using the spot-inoculation method, HOCl was capable of slightly less than 4-log reductions of E. coli O157:H7, Salmonella Typhimurium and L. monocytogenes using the same concentrations and exposure times (Table 4[8, 9, 12–16]). HOCl is a promising candidate as a produce sanitizer at retail facilities, especially since these findings were obtained using concentrations lower than the allowable limit of 200 ppm.
Ozone
Ozone (O3) is a powerful oxidant and has many industrial and consumer applications related to oxidation. This same high-oxidizing potential, however, can lead O3 to damage mucous and respiratory tissues in animals and tissues in plants above concentrations of about 100 ppb. The antimicrobial properties of O3 are empirically well defined through its use in water treatment for over a century. More recently, O3 obtained GRAS status for its use on raw and minimally processed fruits and vegetables, and, as a result, is commonly employed within the produce industry to sanitize wash and flume water within packinghouse operations.[17] As seen in Table 2, levels of E. coli O157:H7 and L. monocytogenes on lettuce are typically reduced by about 1 log after treatment with O3 at industrially relevant concentrations and contact times. Interestingly, when produce is contaminated using spot-inoculation methods, larger reductions in these microbial pathogens are achieved (Table 3[8–11]).
Interestingly, pathogen reduction in all cases differed between the same chemical (e.g., HOCl), the same produce commodity (e.g., lettuce) and for the same pathogen (e.g., E. coli O157:H7) by more than 3-log units between studies using the two inoculation methods (see Table 3[8–11] vs. Table 4[8, 9, 12–16]). Overall, because of ­the regulatory restriction to use ClO2 on fresh and fresh-cut produce at concentrations above 3 ppm, the chemical HOCl would be the better sanitizer for produce when bacteria are uniformly distributed on produce leaves (mimicked by dip-inoculation, Table 3[8–11]). Likewise, HOCl may be the better sanitizer when single pathogens are spot-contaminated on leaves (Table 4[8, 9, 12–16]).
Criteria for a Produce Wash-and-Sanitation Device at Retail
Most retail sales and foodservice establishments prepare fresh produce after rinsing it with tap water as the only means to remove microbial pathogens. Although this process does remove pathogens and other microbes or soil from most produce commodities, it does not appear to prevent the majority of the foodborne disease outbreaks caused by contaminated produce. Also, when produce is rinsed or soaked by only tap water in sinks, the sinks can become sources of cross-contamination for other foods from viable pathogens rinsed off produce but not killed by the tap water.
According to FDA many produce commodities are potentially hazardous foods (raw seed sprouts, cut melons, cut leafy greens, cut tomatoes or mixtures of cut tomatoes that are not modified in a way so that they are unable to support pathogenic microorganism growth or toxin formation). We suggest that a wash-and-sanitize processing of potentially hazardous produce and produce that has the highest risk of causing outbreaks at retail sales and foodservice establishments would reduce the numbers of microbial pathogens on produce.
A more effective and valuable produce wash-and-sanitation device for retail sales and foodservice establishments could be designed that would function like a “cooking platform” as described in the FDA Food Code;[18] the raw product would be placed into the device, a process would ensue for rinse, wash and sanitation steps based on time, and when the required time to achieve the kill step for each different pathogen/produce commodity combination has occurred, the device would indicate completion for removal of the finished product. Considering the criteria for the best produce wash-and-sanitation processes above, including a wash step using, for example, sodium dodecylbenzene sulfonate or other surfactants/detergents to wash microbial pathogens off produce and then the most effective active ingredient necessary for a sanitation step to kill remaining pathogens still on the produce and in the wash water (e.g., ozone or HOCl), such a device could be developed that would be operationally feasible.
The published potential efficacy for reduction of pathogens on produce by either O3 or HOCl is encouraging for use in a produce wash-and-sanitation system, and recently published research has demonstrated enhanced efficacy of these two chemicals by increasing the concentration and adding physical methods during the sanitation process. Afari et al.[19] showed that the addition of agitation (soaking and mixing produce via forward and reverse rotation of a salad spinner at 65 rpm) to 155 ppm HOCl (pH 7.5) increased the efficacy of HOCl by 2- to 3-log reductions of E. coli O157:H7 and Salmonella Typhimurium DT 104 on romaine lettuce, iceberg lettuce and tomatoes. Likewise, the addition of increasing ultrasound raised the efficacy of HOCl by similar log reductions.[19] Ozone’s efficacy has more recently been shown to increase when used simultaneously with ultraviolet (UV) light.[16] These physical additions to chemical treatment are innovative approaches, and continued work aimed at translating these laboratory studies to industry application is feasible.
It therefore seems probable that a change in each variable of a wash solution used (e.g., surfactant that removes pathogens off fresh-cut and fresh produce, degree of physical agitation/ultrasound and time) and sanitation solution used (e.g., concentration, controlling organics dissolved in solution, pH, physical method during treatment and time) could be standardized to accommodate the maximum reduction of microbial pathogens on all high-risk produce commodities. For example, a wash-and-sanitation system device could be developed (Figure 3) that controls each of these variables based on the type of produce to be treated. The operational steps could include:
•    Remove outer leaves, if any; rinse produce with tap water spray to remove debris in rinse sink.
•    Stage produce into a removable perforated produce colander/container.
•    Insert produce colander/container into washer; fill with wash treatment solution; soak for defined time; drain.
•    Fill and soak produce for defined time with agitation, ultrasonic vibrations and/or UV light in ice-cold treatment sanitizer solution (e.g., ozone, HOCl), controlling organic load and pH by draining solution and keeping chemical concentration stable. O3 or HOCl would be generated on demand at designated concentration and pH.
•    Each produce commodity type (e.g., different leafy greens like chopped lettuce or romaine lettuce, tomatoes, berries or sprouts) would probably have a different wash time, concentration of sanitizer chemical, treatment time, and degree of agitation/ultrasonic vibration/UV light exposure to achieve a predetermined and validated log kill (e.g., to achieve a 5-log reduction standard).
•    Drain produce, rinse with sanitizer solution to remove any final remaining microbial pathogens on produce and in the colander and spin produce dry while draining to remove excess treatment solution/organics.
•    Remove produce container to dispense washed produce or label for date of expiration in covered containers and store at 41 °F until use (before its expiration time); washed and sanitized produce is a ready-to-eat food.
Such a device would not be difficult to design (similar to the design and function of a tabletop washing machine) and could ensure all high-risk produce goes through a wash-and-sanitation process that achieves a kill step for fresh and fresh-cut produce. Ultimately, any produce wash-and-sanitation device will need to be validated against a standard set of pathogens and produce commodities to ensure consistent efficacy like cooking temperatures known to kill pathogens (e.g., a 5-log reduction in these pathogens on all produce commodities). Likewise, viral and parasitic pathogens (e.g., norovirus, hepatitis A, Cryptosporidium and Cyclospora; Table 1[3]) would need to be validated to a standard that would determine function of the wash, rinse and sanitation process. Any device or equipment will need to be NSF-certified to ensure it can be cleaned and sanitized properly (e.g., will not harbor biofilms of pathogens), and then verified regularly when in use to ensure uniformity of a kill step for all defined produce commodities. Finally, such a device should enable proper execution within the typical restaurant facility and include time and chemical concentration indicators (e.g., like thermometers used to confirm temperature).
A Challenge to Stakeholders in the Produce, Retail and Device Technology Industries
A produce wash-and-sanitation device could provide value to all the stakeholders who process, buy and sell products to enhance produce safety, sales and consumption in the United States. If the device could eliminate a large amount of microbial pathogens from produce (that may be introduced at multiple steps in the produce supply chain from the farm to retail; Figure 2), it is likely such a device, if broadly used at retail, would have an impact on the reduction of produce-associated foodborne disease outbreaks by eliminating these microbial pathogens closest to the final prep before consumption. A kill step via a closed-use device (Figure 3) provided at retail would also probably have the added benefit of enhancing quality of the produce, increasing the shelf life of some produce commodities at retail and reducing cross-contamination risk in retail sales and foodservice establishments (making fresh and fresh-cut produce more like a prep of a raw to ready-to-eat process).
Because of the probability of the hazards associated with fresh and fresh-cut produce due to the continual failure to prevent all contamination and pathogen growth events, the low infectious dose of the pathogens and the historically large number of produce-associated foodborne disease outbreaks, we challenge all the stakeholders to work together and design and develop a new system of preventive controls for produce to be implemented at retail sales and retail foodservice establishments, and prevent more produce-associated foodborne disease outbreaks, the last opportunity to remove the majority of the microbial hazards before human consumption.
Benefits to Keep in Mind Going Forward
Looking ahead, the food industry should emphasize the value proposition of a produce kill step at retail to stakeholders:
•    Reduces microbial pathogens during retail prep that may have contaminated the produce anywhere along the supply chain
•    Reduces cross-contamination risk of produce that can occur during washing and preparing produce in retail sales and foodservice operations
•    Reduces produce-related foodborne disease outbreaks caused by contaminated produce from farm to retail
•    Increases the quality and likely shelf-life of produce prepared in retail sales and foodservice operations
•    Provides a kill step at retail that could reduce the risk of L. monocytogenes growth and also spoilage microbes growing on produce, even at cold temperatures during storage
•    Possibly enhances the safety of locally sourced produce from small farms
•    Provides a new value proposition for fresh and fresh-cut produce sales at retail to increase consumption by consumers
•    Increases value to the consumer of extended shelf-life of produce after purchase at retail  
Hal King, Ph.D., is president and CEO, Public Health Innovations LLC, and a member of the Editorial Advisory Board of Food Safety Magazine. He can be reached at halking@pubhealthinnovations.com.
Eric Moorman is a graduate student at North Carolina State University. He can be reached at eamoorma@ncsu.edu.
References
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17. www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ProducePlantProducts/ucm064458.htm.
18. www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodCode/.
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