Juice maker warned about HACCP, misbranding, drug claims
Source : http://www.foodsafetynews.com/2016/12/juice-maker-warned-about-haccp-misbranding-drug-claims/#.WE9QffmLSUl
BY NEWS DESK (DEC 12, 2016)
Juicer Connections Inc. makes juice products in Los Angeles that it wants consumers to believe are really good. So, for example, it suggests that by drinking them consumers will be less likely to develop Alzheimer’s disease.
In a warning letter to the owner Steven A. Mullen, the U.S. Food and Drug Administration first told Juice Connections Inc. its juices are adulterated.
It then went on to explain how, under the law, the juice company is making drug claims.
After an FDA inspection lasting from May 11 to April 2, the agency’s “investigators found serious violations of the Federal Food, Drug, and Cosmetic Act…” In the Sept. 21 warning letter that was made public in recent days, FDA said Juice Connections does not have a juice Hazard Analysis and Critical Control Point Plan (HACCP).
The company responded to FDA’s inspection observations with a “newly created HACCP plans, product formulations, a Sanitation Standard Operation Procedures (SSOP) document, and blank monitoring records.”
But FDA continues to have extensive and detailed concerns about the juice maker. In the warning letter the agency said the juice produced is not recognized as a safe and effective drug. In addition, the products are misbranded as they do not declare a net quantity on the label in addition to numerous other labeling errors.
FDA wants the many remaining issues cleared up within 15 working days.
So much for fish and chips: India’s food safety types warn against newspaper-packed foods
Source : http://barfblog.com/2016/12/so-much-for-fish-and-chips-indias-food-safety-types-warn-against-newspaper-packed-foods/
By Doug Powel (Dec 12, 2016)
Warning: food wrapped in newspapers could be slow poison.
Using newspapers to wrap, pack or serve food is a safety hazard, the Food Safety and Standards Authority of India declared this week.
Newspapers are often used by roadside vendors, small hotels and even in homes in lieu of absorbent papers. The food regulatory body has warned that cancer-causing agent and microbes could be slowly poisoning consumers of much food that has been in contact with newspapers.
Foods contaminated by newspaper ink could be dangerous because ink has multiple bioactive materials that are known to have negative health effects, the FSSAI said in its advisory on the subject. Printing inks may also contain harmful colours, pigments, binders, additives and preservatives. Newspapers could also harbor pathogenic microorganisms that could contaminate food. Newspapers, paper or cardboard boxes made of recycled paper may be contaminated with metallic contaminants, mineral oils and harmful chemicals like the phthalates which can cause digestive problems and also lead to severe toxicity.
Criminal plea hearing will likely end decade-old Peter Pan case
Source : http://www.foodsafetynews.com/2016/12/criminal-plea-hearing-will-likely-end-decade-old-peter-pan-case/#.WE9RDvmLSUl
BY DAN FLYNN (DEC 12, 2016)
The new Department of Justice’s official guidance for holding individuals responsible for corporate wrongdoing will be honored in the breach tomorrow in a federal courtroom in Albany, GA. Instead, any concern about holding individual responsible for wrongdoing will likely be swept aside with a corporate payment of the largest criminal fine ever in a U.S. food safety case.
That’s when corporate ConAgra alone is expected to enter a guilty plea to a single count of a misdemeanor violation of shipping adulterated food. The guilty plea will be formally entered by ConAgra Grocery Products Co., the ConAgra subsidiary that owns the Sylvester, GA, peanut butter processing plant that makes peanut butter, including the Peter Pan brand.
No corporate executives or company managers were charged in the criminal case brought against ConAgra over a nearly 10-year-old Salmonella outbreak that was traced to the Sylvester facility and the Peter Pan and Great Value brands it was producing. The federal Centers for Disease Control and Prevention first reported the multi-state outbreak in November 2006.
The government’s sentencing recommendations for tomorrow were submitted to the U.S. District Court for the Middle District of Georgia on Dec. 6, but have not been made public. The hearing is expected to conclude the criminal case brought against ConAgra.
In the plea agreement reached more than a year ago by ConAgra and the government, the parties agreed to ask the court to accept the record $8 million fine plus $3.2 million in forfeitures to the federal government.
Those payments, along with any restitution ordered by Judge W. Louis Sands, will end an expensive incident for ConAgra. The outbreak led to ConAgra recalling all its peanut butter production going back to 2004, removing Peter Pan from store shelves for about six months.
ConAgra also invested $275 million to fix the problems that were plaguing its Sylvester plant: leaky roofing, faulty sprinklers and an improper roasting machine. It also put new ongoing testing procedures in place. While some of the fixes were in place at the time of the outbreak, ConAgra knew of two times in 2004 when its products tested positive for Salmonella.
It was apparently on the basis of that knowledge that the government conducted its long criminal investigation. Ironically, the investigation’s existence was periodically reported over the years by ConAgra. The company made those occasional disclosures in its public reports to the Securities and Exchange Commission (SEC).
It was not until May 2015 that the government confirmed it was pursuing a criminal case in relation to the Salmonella outbreak that sickened more than 600 people in 47 states.
After the criminal case was filed, Sands ordered the government to take time to locate victims from the nearly decade old outbreak so that injured parties would have time to file for restitution with the court.
Criminal food safety prosecutions where individuals have been charged were cited last week by a top Department of Justice attorney who said government is committed to individual accountability or executives and other company employees, where possible.
Speaking to a legal conference in Washington D.C. Principal Deputy Assistant Attorney General Benjamin C. Mizer pointed to the successful prosecutions of top company officers in cases like Peanut Corporation of America and Quality Egg as examples of applying the individual accountability doctrine, where it is applicable.
A year ago, a DOJ guidance document made going after individuals in cases of corporate wrongdoing a priority. That document, known as the Yates Memo, came out after DOJ had already reached the plea agreement with ConAgra.
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Top food safety prosecutor continues accountability approach
Source : http://www.foodsafetynews.com/2016/12/top-food-safety-prosecutor-continues-accountability-approach/#.WE9RdPmLSUl
BY DAN FLYNN (DEC 8, 2016)
The Justice Department’s top food safety prosecutor says the year-old “Yates Memo,” about holding individuals at corporations accountable, is “still evolving.”
In remarks prepared for delivery Wednesday at the Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference, Principal Deputy Assistant Attorney General Benjamin C. Mizer said “the memo’s changes in emphasis are yet to be fully measured.”
He was referring to the memo written just more than a year ago by Deputy Attorney General Sally Yates for all U.S. attorneys and assistant Attorney Generals. It called for the prosecution of individuals to be the priority in all corporate misconduct investigations.
“One of the most effective ways to combat corporate misconduct is by seeking accountability from the individuals who perpetrated the wrongdoing,” she said in the so-called Yates Memo.
The memo is said to be a guidance document, not policy, with steps that should be considered in every investigation of corporate misconduct, including those involving food safety.
Yates called for the following actions:
In order to be eligible for any cooperation credit, corporations must provide to the department all relevant facts about individuals involved in corporate misconduct.
Both criminal and civil corporate investigations should focus on individuals from their inceptions.
Criminal and civil attorneys handling corporate investigations should be in routine communication with one another.
Absent extraordinary circumstances, no corporate resolution will provide protection from criminal or civil liability for any individuals.
Corporate cases should not be resolved without a clear plan to resolve related individual cases before the statute of limitations expires and declinations as to individuals in such cases must be memorialized.
Civil attorneys should consistently focus on individuals as well as the company and evaluate whether to bring suit against an individual based on considerations beyond that individual’s ability to pay.
Many corporate and defense attorneys have commented on the “Yates Memo” since it was released, some critically. Most agree it was released because the DOJ was able to charge only one individual with criminal charges after the nation’s 2008-09 financial meltdown.
Some corporate attorneys say the “Yates Memo” has since caused employees to be mistrustful of their companies.
Mizer’s remarks, however, provide a perspective from inside DOJ from someone who’s been overseeing food safety prosecutions, before, during and after the new guidance was issued.
He says corporate compliance offers have told DOJ attorneys that the memo helps focus officers and employees on best practices and higher standards.
“And that was exactly the intent,” Mizer said Wednesday. “Deterrence is better than punishment. Better for companies, better for government, and, most important, better for consumers. Every harm we avoid is a victory.”
Mizer says there is nothing new about the requirement for a corporation to fully cooperate if it’s going to get credit for cooperation. And, he said, the investigation should focus on individuals in both criminal and civil matters.
Shared enforcement between DOJ’s civil and criminal divisions, and “parallel proceedings” are “remedies to address the misconduct,” according to Mizer.
A corporate settlement will no longer include releases for individuals until they “actually participate in the settlement.” Cases against individuals must be separately solved, and claims against individuals in all civil matters must consider “all relevant matters.”
Mizer said large criminal and civil cases involving food safety have proven to take time. He says while DOJ has “seen positive results, the (Yates) Memo’s changes in emphasis have yet to be fully measured.”
While his civil division incudes 1,300 employee and 1,000 attorneys, Mizer told the group “our resources are limited. We depend on you — everyday — to ensure compliance with laws preserving safety and security and to detect and respond to bad behavior when, and as soon as, it surfaces.”
He said cooperation with government investigations “can be part of this effort.” Among the advantages of corporations cooperating with the government, he said, is reduced disruption to legitimate business operations; shorter and less costly investigations; reductions in delays; and the accelerations in determining culpability or innocence.
“Moreover, owning up to conduct and making genuine efforts to clean house can help organizations demonstrate the responsibility necessary to participate in government programs and contracts,” Mizer added. “Genuine cooperation is often a good business decision.”
With cooperation will also come DOJ’s support for reduced monetary sanctions or penalties. And Mizer gave some examples to what such cooperation should look like.
“Cooperation should be proactive and affirmative,” he said. “Early cooperation is more valuable than late. Voluntary, material participation is more meaningful than reluctant, begrudging assistance. We are looking for meaningful, active efforts to help get to the truth.”
Mizer also predicted president-elect Trump’s Administration will continue to support holding individuals responsible for corporate wrongdoing because “it isn’t ideological, it’s good law enforcement.”
During his remarks, Mizer gave the successful prosecutions of individuals involved with Quality Egg LLC and Peanut Corporation of America as examples of recent food safety cases. He said PCA was “not representative of the food industry as a whole,” but an example of how a small number of bad actors can cause enormous harm.”
He also said the 28-year prison sentence for former PCA President Stewart Parnell “Is the longest criminal sentence ever imposed in a food safety case.”
Mizer’s remarks came in the keynote address at the two-day conference that continues today at the Mayflower Hotel in Washington, D.C.
Who is Teaching Hawaii Food Safety to Food Handlers?
Source : http://outbreaknewstoday.com/who-is-teaching-hawaii-food-safety-to-food-handlers-60966/
By Guest Author (Dec 7, 2016)
According to the CDC, from 2014-2015, Hawaii experienced 18 food borne related outbreaks, sickening over 1,000 people, causing 211 hospitalizations, and 6 deaths. In 2016, two very public food borne illness outbreaks revived an on-going discussion on food safety on the Hawaiian Islands. Safe food handling impacts everyone but Hawaii has been without regulation requiring formal training of food handlers, nor are food service operators/owners required to obtain formal training on how to safely feed the public. All that is about to change as public health officials started obligatory public hearings, just this week, introducing new initiatives to adopt the most current FDA Model Food Code, including training requirements. The new proposed Hawaii Food Safety guidelines can be read here.
Hawaii faces a few unique challenges when it comes to food safety. Let’s think about this for a bit. Hawaii imports almost all goods, 92% to be exact, meaning less money for the local economy and with food in transit for extended periods of time, this can create more opportunity for mishandling. Seafood poses an interesting challenge to the Islands and is a common culprit outbreaks recently linked to Hepatitis A, Salmonella, and even certain seafood toxins. Considering seafood is such a significant staple of the population, being it’s time-temperature sensitive nature, and often eaten raw or undercooked, it is easy to understand why. Let’s save Poi for another article, shall we?
Lack of regulation for safe food handling training leaves the training part up to the owner/operator in an industry that is already scrambling for both time and money. Consequentially, without a regulatory demand for such training, this often means a lack of access and resources to such training for those wanting to learn. With public classes seldom conducted locally, food service operators are often provided guidance only after an inspection is done or are often left to read and interpret the food code all on their own. That leaves us to ask, where can food service workers turn to find training? In an economy largely supported by the hospitality industry, including food service, who is teaching food service workers to keep our food safe?
Hawaii’s Food Safety Program
Hawaii does have a food safety program in place that is currently overseen by Dennis Loo, a 29 year veteran of the Hawaii Department of Health and fellow REHS/RS and Food Safety Education Specialist, John A. Nakashima. Even without such required training, the Hawaii Department of Health has offered classes and training to permit holders free of charge to those wanting to learn. Even with the offer of free education, many operators do not take advantage of such offerings. Shortly after the well publicized Hepatitis A outbreak earlier this year, a group of ATC Food Safety Trainers went out to Hawaii and focused on meeting with vendors and operators that were proactively training their food handlers in safe food handling practices. In interviewing various food operators, the team of trainers found that a vast majority of operators they spoke with had high praises for their food inspectors. The vast majority of those interviewed felt inspectors really went above and beyond to help them understand and comply with the code and safe food handling practices. But you don’t have to be in the industry to understand how understaffed and overwhelmed the Hawaii Department of Health has been.
ATC had the opportunity to interview Dennis Loo, back in October 2016. Check this snippet from a conversation between Robert Hemmer, an ATC Certified Food Safety Trainer, and Dennis Loo. It is very clear that Dennis and his team really do want to help operators, not just issue citations. Hawaii food safety education is his passion and it’s evident that his mission is to really get the message through to his students.
In addition to the Department of Health, there are a other few food safety trainers on the Islands but possibly, the biggest help is yet to come. ATC Food Safety, founded by April Rivas in 2012, is opening their first full time branch in downtown Honolulu this month, bringing with them decades of combined industry experience from a diverse team of local and national trainers to head up their new office and division, Aloha Food Safety! This new undertaking has been hugely supported by the collaborative efforts from KD and Associates and FNA Safety in helping move this project forward.
Campylobacter jejuni: Understanding the New Food Superbug
Source : http://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2016/campylobacter-jejuni-understanding-the-new-food-superbug/
By Joe Wanford, Julian Ketley, Ph.D., and Christopher Bayliss, Ph.D.
In previous decades, bacterial food poisoning was synonymous with the genus Salmonella. While Salmonella species are still responsible for a large number of outbreaks of foodborne disease, Campylobacter are now the most common bacteria associated with food poisoning and contamination in the European Union, the United States and, to an unknown extent, in the developing world, where detection and recording of infections is more limited. Bacterial food poisoning is particularly troublesome in impoverished countries where poor hygiene provisions correlate with a rapid spread of infection through contaminated food and water supplies. In the UK, Campylobacter infections are thought to cause more than 100 deaths per year, with many more people experiencing disease symptoms and decreased quality of life. As a result, this pathogen is thought to cost the UK economy upward of £900 million per year. That’s enough money to build a brand-new NHS (National Health Service) hospital every year if we were to eliminate Campylobacter-associated disease. While this infection rate is primarily due to the undercooking and spread of contaminated chicken throughout the household, there is also a significant contribution from high levels of Campylobacter contamination on food packaging at the retail level, a problem that further propagates the spread of Campylobacter. Novel strategies to prevent Campylobacter from entering the food chain, as well as to reduce the risk of contamination of other foodstuffs, are therefore a major priority. Progress in this area is hampered, however, by our limited understanding of the fundamental workings of this bacterial species at a genetic level.
At the University of Leicester (UoL), we have a long-standing interest in microbial sciences and, in particular, the under-recognized food superpathogen Campylobacter jejuni. In the Department of Genetics, made famous for the discovery of DNA fingerprinting by Sir Alec Jeffreys, we now have two active research groups interested in this organism. Understanding the genetics underpinning the disease-causing potential of Campylobacter is crucial. This article reviews how studies of the motility and mutability of C. jejuni at the UoL are advancing our understanding of the behavior of this bacterial species and could lead to improvements in food safety and disease prevention/control.
Campylobacter: Adapted for Survival
Campylobacter are spiral-shaped bacteria, very similar in size and structure to the gastric cancer-causing bacterium Helicobacter pylori. Campylobacter occupy several niches, which serve as bacterial reservoirs and are in direct contact with humans. This species is found in environmental niches such as riverine water sources or agricultural land as a result of treatment or contamination with fecal material from agricultural animals or wild birds (a natural host). The major sources for disease, however, are meat products from farmed animals, mainly pigs, cattle and poultry. The last of these species is the most important in the context of human disease due to the combination of high consumption and significant levels of bacterial cells in fecal excretions. Each niche mentioned above offers diverse challenges for the bacteria, with specific nutrient sources and differing physiochemical conditions. Transmission of Campylobacter between these niches exposes them to rapid fluctuations in stressful conditions. These pressures have resulted in the evolution of mechanisms in Campylobacter for the rapid generation of diversity that enables adaptation to and survival in a number of environments (Figure 1). This diversity is generated through several mechanisms, one of which (phase variation, PV) will be discussed in detail below.
Campylobacter are potent pathogens due to their relationship with poultry and other birds. Most of our knowledge comes from studies of chickens and chicken flocks, whereas studies of wild birds are in their infancy. In many cases, the pathogens live “quietly” within chickens, causing no obvious symptoms of disease. Initial colonization of a chicken flock occurs when birds are about 2 weeks of age. Following a period of sustained growth, Campylobacter also become better adapted to colonizing these birds and spreading throughout the population. This is critical, as it shows that Campylobacter can adapt to changing environments at the genetic level, a fact that has been supported by many scientific studies. Once they then make their way into the human gut, through ingestion of contaminated food, we have a problem. In the human gut, Campylobacter have several characteristics that adapt them to cause diseases such as gastroenteritis. At the UoL, we are interested in several disease-causing strategies of this pathogen, and how these strategies permit adaptation to different environments, with the goal of improving treatment/prevention strategies and, ultimately, food safety.
Motility and Chemotaxis of Campylobacter
Like Salmonella, Campylobacter can move toward nutrients in the gut and away from chemicals that may harm them. This ability relies on two processes, motility and chemical detection. When working together, these processes are known as “chemotaxis” and allow the bacteria to move in response to their chemical environment. This is crucial for Campylobacter to cause disease. In Campylobacter, propulsion for motility is provided by rotation of two thin fibers known as flagella that extrude from both ends of the corkscrew-shaped cells. The motor for this structure is a large complex of proteins that span the cell wall and link the flagellum to the energy-providing proteins and control systems inside the cells. Campylobacter, in response to their chemical environment, redirect the rotation of their flagella through these internal systems and, subsequently, their movement. Chemotactic motility contributes to human disease by aiding high-level colonization of the avian gut and therefore increases the number of infectious cells that could make their way into our diets. Each chemical in the environment forms a chemotactic gradient, which determines the general direction of movement of the bacteria. When we observe Campylobacter moving in real time, we can see that they travel in a single direction (so-called runs) for a given period. They then randomly change direction and begin to move in another direction. So with these random changes in direction, how do Campylobacter ever migrate toward a favorable environment? The answer is that they will move further down a chemotactic gradient before changing direction than if they were moving up one (you can see a video of Campylobacter moving toward nutrients in real time on our website). This process is governed by a complex cascade of reactions at the bacterial surface, which results in direct sensing of the chemical environment. One aim of Professor Julian Ketley’s research at the UoL is to unravel the molecular signaling events involved in taking external chemical signals from the gut and translating them into bacterial motility. Gradient detection in chemotaxis involves a series of “transducer-like molecules” that Campylobacter have in their inner membrane. These molecules have been shown to be responsible for sensing and converting the extracellular, chemical environment into a change in movement of the flagella. Recently, we have shown that these molecules, while primarily affecting the chemotactic motility of Campylobacter, also diminish its ability to form clusters of cells known as biofilms when stimulated. Biofilms are involved in the persistence of the bacteria on abiotic surfaces, such as kitchen worktops or poultry waterlines, and so this chemotactic signal can switch Campylobacter cells into a motile (and hence infectious) mode, rendering them incapable of persistence on abiotic surfaces. This finding provides a platform for further understanding the ability of this pathogen to switch between a disease-causing state and one capable of persistence in the environment for long periods.
Currently, treatment for a Campylobacter infection focuses primarily on rehydration of the patient and later on antibiotic therapy in serious cases. A far more desirable approach would be to prevent colonization of the human gut by Campylobacter in the first place. In addition to motility, the Campylobacter flagellum is thought to be involved in adhesion (sticking) to the gut wall—a key initiator of infection and preceding the onset of Campylobacter-induced disease. The chemical composition of the gut is in part determined by the food ingested by poultry. It may, therefore, be possible that alterations in the poultry feed could hamper the chemotactic motility of Campylobacter. If we can disturb the chemotactic motility of this bacterium, we may be able to perturb its colonization of poultry and prevent it from ever entering our food to begin with. Novel interventions such as this are essential in improving our food safety in the future, and an understanding of the underpinning genetics is key for this development.
Motility and Phase Variation: Hiding from the Host?
While motility is a key determinant of the ability of Campylobacter to cause disease, it can also be its Achilles’ heel. As with many other surface-exposed molecules, our immune system can recognize the bacterial flagellum as a foreign target antigen and help our bodies clear Campylobacter cells before they can multiply to high levels and cause disease. Unfortunately, Campylobacter have developed ways to hide the flagellum from our immune system, enabling these bacteria to escape the immune response and remain hidden in the gut. The flagellum is covered in short carbohydrates and other structures. These molecules are possible targets for immune attack, and therefore changing the forms of these structural decorations may hide the flagellum from the immune system. In some bacteria, including Campylobacter, the DNA code responsible for the enzymes that make these structures can mutate, preventing their formation on flagella. This process is reversible, meaning that another mutation in the opposite orientation can switch expression of the flagellin modification between an on and an off state. We speculate that this switching helps Campylobacter escape the immune system by switching cells between two states, one capable of inducing the immune response and one that isn’t (Figure 2a). As we can see in the example depicted in Figure 2, when Campylobacter replicates, it produces diversity in its flagella type. When the immune system, or bacteriophages (discussed below), responds however, some cells are capable of surviving the attack and proliferating. If the immune system targets and kills cells with the modification, then other, unmodified cells in the population may survive and proliferate to potentially cause future infections and disease (Figure 2b).
One result of this reversible switching phenomenon is that populations of Campylobacter, all theoretically arising from a single bacterial cell, may have different flagellum structures expressed on the surface. This switching of expression and subsequent generation of diversity—termed “phase variation” (PV)—maximizes the chance that a population of Campylobacter cells will be able to survive in a niche and potentially cause disease. Our work at the UoL aims to better understand the role of PV in enabling Campylobacter to persist in poultry and to colonize the human gastrointestinal tract while avoiding the chicken or human immune responses.
Phase Variation: Implications for Bacteriophage Therapy
In addition to a role in motility, PV affects several other aspects of Campylobacter biology that may hamper our attempts to develop new prevention and treatment strategies. In light of the ever-looming possibility of a post-antibiotic era of medicine, scientists are constantly pursuing new avenues for the treatment of infectious disease. It is not mere chance that the use of antibiotics such as ciprofloxacin as growth promotants in poultry coincided with the evolution of antibiotic resistance. If we are to preserve the life of our current therapeutic antibiotics, we must collectively minimize this spread by lowering our antibiotic use in poultry and indeed in treatment of human disease, which in turn may require alternative treatment strategies.
One such alternative treatment option—already used in countries such as Russia and Georgia—is the use of bacteria-specific viruses, called bacteriophages, to selectively kill the infecting pathogen. These “phages” do not cause any damage to human cells, but upon contact with bacterial cells will infect them, replicate within them and cause them to burst, clearing the infection. Campylobacter are selectively preyed on by a wide array of phages, so this is in theory an entirely feasible option for either treatment of Campylobacter infection or preventive treatment of Campylobacter-infected poultry or Campylobacter-contaminated poultry products. Much like the use of antibiotics, however, this strategy is not foolproof, as Campylobacter can evolve to resist infection by bacteriophages, and one culprit is, once again, PV.
Phages infect Campylobacter by attaching to structures decorating the flagella and other similar structures on the cell surface. As a result, the sensitivity of Campylobacter to phage infection is determined by the “modification states” of these structures. The protein molecules within the bacteria responsible for these modifications are subject to PV, allowing Campylobacter to change their modification state to resist phage infection, much like they evade the immune system. This allows them to resist a variety of host pressures and persistently colonize (Figure 2c). As these different modifications, in addition to mediating phage resistance, may also play a role in the ability of Campylobacter to cause disease, there is a trade-off between phase-on and phase-off cells having different survival or disease-causing modes. Dr. Bayliss’s group is interested in fully characterizing the roles of PV in phage resistance, with the aim of optimizing future therapies. For this treatment strategy to be viable, a detailed understanding of the genetics underpinning resistance is paramount.
Potential Roles for Phase Variation in Guillain-Barré Syndrome
In rare cases (fewer than 1 in 5,000), gastroenteritis caused by C. jejuni can progress to the muscular condition Guillain-Barré syndrome (GBS), a flaccid, full-body paralysis that is fatal in roughly 2 percent of cases. GBS is an autoimmune disease in which the immune system attacks our own cells and affects particular cells of the peripheral nervous system that are heavily involved in movement. C. jejuni’s role in GBS stems from the similarity between one of its surface structures (in this case, the sugary layer surrounding the cell known as the LOS) and components of the human peripheral nerve cells. So similar are these components that exposure of the human immune system to C. jejuni cells can occasionally result in the induction of cross-reactive antibodies that target not only the bacterial cell but also nerve cells (Figure 3). This constant attack by our own immune system is responsible for the symptoms of paralysis experienced by the patient. Despite the potentially lethal nature of GBS, our understanding of the disease and the role of C. jejuni in its onset is still relatively poor.
However, it is known that one of the surface structures of the bacteria responsible for inducing GBS is phase-variable. Recently, our group has measured the rate of on and off switches in expression of this surface layer, and we are now trying to determine how this switching rate influences the onset of GBS. We are also looking at how often these changes occur in poultry and humans to understand whether changes in these GBS-promoting structures are helping the bacteria survive in these organisms. Currently, only two licensed immune therapies exist for the treatment of GBS, both of which are relatively successful at halting progression of the disease. Further understanding of the potential advantages of the different GBS-linked, phase-variable states in a range of environments (e.g., chicken cecum versus human intestine), as well as the factors involved in controlling the rate of PV, could lead to improvements in treatments to retard progression of GBS, and perhaps even to new strategies to circumvent or possibly even prevent the disease.
Phasotypes and the Phasome
As discussed above, PV can contribute to the variation of individual characteristics in Campylobacter (i.e., phage resistance, immune evasion). Each character-altering state is referred to as the bacterium’s “phase state.” While studying phase states as discrete entities is helpful for understanding the contribution of specific characteristics to the disease-causing potential of a cell, it is becoming apparent that we need to study the consequences of all the different combinations of phase states of all the phase-variable genes in each cell—something we refer to as the “phasotype.” To set into context the enormous diversity generated by PV, a Campylobacter bacterium with 27 phase-variable genes can give rise to 227 independent phasotypes, which may each act differently during infection.
Here at the UoL, we are attempting to characterize changes in phasotypes in response to fluctuations in the local environment and sizes of Campylobacter populations. Studies in other bacteria have indicated that a single cell may be responsible for causing a bacterial infection. As the disease population arising from this single cell will be closely related, we refer to this as a bottleneck, which removes all the genetic variation in the population. Recently, we have discovered that imposition of a single-cell bottleneck on populations of Campylobacter can generate populations with differing phasotypes. If each of these phasotype patterns had a different outcome, say, sensitivity or resistance to immune effectors, then these small bottlenecks could produce person-to-person variations in disease outcome, something that may shift the current paradigm on treatment of infection and the use of personalized medicine.
Another key discovery arising from studying the DNA of multiple organisms is the extent of variation between different Campylobacter strains and species in the composition, number and type of phase-variable genes they contain. We refer to this variety of phase-variable genes as the “phasome,” and we have observed that phasome patterns are indicative of the evolutionary lineage of strains and the adaptation to different environmental sources of the bacteria. This latter feature implies that selective pressures may play an important role in determining the makeup of a population in differing environments and that certain phase-variable genes may be advantageous in a specific environment. In the context of food safety, an “-omics” approach to understanding variability is key, as this indicates the forces shaping the biological features of the organism and where interventions can be targeted.
Genetic Variation and Vaccine Development
In the era of modern medicine, vaccines have saved countless lives by halting the progress of infection by pathogens. Despite exhaustive research in recent years, there is not yet a licensed vaccine to prevent Campylobacter-induced disease or to reduce levels at the source (e.g., in chickens). This is due to myriad factors. Firstly, we have a poor understanding of the bacterium’s ability to cause disease. Despite its ubiquitous presence, we still have very little idea about how Campylobacter colonizes the gut, persists in the host and causes invasive disease. Secondly, as described above, Campylobacter can generate huge diversity through PV and other undiscussed genetic mechanisms. Finally, it is thought that although vaccines against Campylobacter may prevent conditions such as gastroenteritis, they may not prevent the human immune system’s reacting to the pathogen and the subsequent onset of GBS and reactive arthritis. This uncertainty only further reiterates the need for a better understanding of the biology of this highly relevant microorganism. Only through an understanding of genetic variation can we successfully inform vaccine development.
While food safety in the UK is very good, continued research into the causative pathogens will only help in reducing the serious illnesses associated with food poisoning, particularly by the big player, Campylobacter. Specifically, the success of Campylobacter as a human pathogen is owed in part to its immense ability to diversify, and as such, those developing future therapeutic strategies should consider this with great care.
For more information on the work ongoing at the UoL, email us at the addresses below or message us via Twitter: @Leicester_Micro. Alternatively, see the Virtual Genetics Education Centre11 Microbial Sciences website for resources centered on Campylobacter biology and PV.
Joe Wanford (firstname.lastname@example.org) is a Ph.D. candidate at the University of Leicester, England, investigating the genetics underpinning antibiotic treatment failure and persistence of infection.
Julian Ketley, Ph.D. (email@example.com), is a professor of bacterial genetics and the head of the Department of Genetics at the University of Leicester. He leads an active research group investigating Campylobacter.
Christopher Bayliss, Ph.D. (firstname.lastname@example.org), is a reader in bacterial genetics at the University of Leicester. He leads an active research group investigating genetic variation in Campylobacter.
3. Jones, MA et al. 2004. “Adaptation of Campylobacter jejuni NCTC11168 to High-Level Colonization of the Avian Gastrointestinal Tract.” Infect Immun 72(7):3769–3776.
5. Hartley Tassell, LE et al. 2010. “Identification and Characterization of the Aspartate Chemosensory Receptor of Campylobacter jejuni.” Mol Microbiol 75(3):710–730.
6. Wassenaar, TM et al. 1993. “Colonization of Chicks by Motility Mutants of Campylobacter jejuni Demonstrates the Importance of Flagellin A Expression.” Microbiol 139(6):1171–1175.
7. Moxon, R et al. 2006. “Bacterial Contingency Loci: The Role of Simple Sequence DNA Repeats in Bacterial Adaptation.” Annu Rev Genet 40:307–333.
8. Carrillo, CL et al. “Bacteriophage Therapy to Reduce Campylobacter jejuni Colonization of Broiler Chickens.” Appl Environ Microbiol 71(11):6554–6563.
9. Sørensen, MCH et al. 2012. “Phase Variable Expression of Capsular Polysaccharide Modifications Allows Campylobacter jejuni to Avoid Bacteriophage Infection in Chickens.” Front Cell Infect Microbiol 2: 11.
10. Bayliss, CD et al. 2012. “Phase Variable Genes of Campylobacter jejuni Exhibit High Mutation Rates and Specific Mutational Patterns but Mutability Is Not the Major Determinant of Population Structure During Host Colonization.” Nucleic Acids Res 40(13):5876–5889.
Cold plasma proving to be hottest new food safety treatment
Source : http://www.foodsafetynews.com/2016/12/cold-plasma-proving-to-be-hottest-new-food-safety-treatment/#.WE9SRfmLSUl
BY NEWS DESK (DEC 7, 2016)
Described as a “purple blow torch” by food safety scientists, cold plasma treatment can kill 99.9 percent of norovirus on blueberries without damaging the delicate fruit, giving a food safety boost to the so-called superfood.
Brendan Niemira, a microbiologist at the U.S. Department of Agriculture’s Eastern Regional Research Center in Wyndmoor, PA, and a team of scientists already demonstrated that cold plasma (CP) can kill pathogens such as Salmonella and E. coli on blueberries.
The researchers, led by Alison Lacombe, focused on blueberries with their latest project because of the increasing popularity of the fruit in recent years, attributed to its antioxidants and other nutritional benefits. They also considered the manner in which the blue fruit is grown, packed, shipped and consumed.
“… blueberries are susceptible to contamination by biological hazards from pre-harvest to post-harvest stages and are most commonly consumed raw,” according to the research results set for publication in the May 2017 edition of the journal Food Microbiology.
“Human norovirus is one of the most common etiological agents that contaminates food and causes foodborne illness.”
Another factor making blueberries prime for the research is the fragile nature of berries in general. They also have some of the shortest shelf lives in the produce aisle, adding pressure to move them through the harvest and packing process as quickly as possible.
With the cold plasma treatment tested by the USDA researchers, more than 99.9 percent of the two viruses being studied died after two minutes or less.
The process of creating plasma, which is considered the fourth state of matter after solids, liquids and gases, is created by breaking apart gas molecules and making a plume of charged electrons and ions, according to ScienceMag.org. The problem with using it as a sanitizing step is that the creation process generates heat, which is even more damaging to delicate fruits such as blueberries.
Niemira and the other scientists found by simply injecting room-temperature air into the treatment chamber the heat problem was eliminated.
“These results demonstrate that CP viral inactivation does not rely on thermal inactivation, and is therefore nonthermal in nature,” Niemira wrote in the research report.
“Currently, the preventative measures for viral outbreaks in the food supply chain primarily rely on good agricultural practices, chemical washes and increased awareness on good hygienic practices in food handling areas. However, few optimized nonthermal intervention processes are available for fresh and fresh-cut produce…
“Cold plasma is an emerging nonthermal technology that offers the advantage of being chemical- and water-free, in addition to being able to operate openly and continuously at atmospheric pressure.”
Additional research is needed before the CP treatment will be available for commercial-sized operations, but the researchers reported the variety of benefits it provides should make it an affordable tool for the food industry.
The researchers say their purple blow torches require only one-fifth the power needed to run a hair dryer. Niemira told ScienceMag.org his team is already working to scale up the approach: “We’re making it bigger, we’re making it faster, we’re making it more efficient.”
There is also evidence that CP treatment can extend shelf life by slowing spoilage rates.
“CP treatment was recently shown to inactivate potential spoilage microorganisms on blueberries without effecting firmness, color, or anthocyanin concentration,” according to the research report.
“In addition to improving food safety, CP technologies are environmentally friendly and sustainable, as they do not require on-site storage of supply chemicals or large volumes of processing water, either for implementation or in post-treatment rinsing.”
Data shows most American farms are still family farms
Source : http://www.foodsafetynews.com/2016/12/data-shows-most-american-farms-are-still-family-farms/#.WE9SjPmLSUl
BY NEWS DESK (DEC 7, 2016)
After all these years, agriculture in America remains overwhelmingly dominated by family farms. A new report by USDA’s Economic Research Service (ERS) shows not only just how dependent America is on family farms, but also how many are independent of government.
“Seventy-two percent of all farms received no farm-related government payments in 2015,” according to the report written by USDA’s Robert A. Hoppe and James M. MacDonald. That figure stands in contrast to the many months and even years that every Congress spends on the big “Farm Bill.”
While farms are often depicted as benefiting from “corporate welfare” as they pursue “factory farming” practices, USDA’s “America’s Diverse Family Farms: 2016 Edition” collects the facts tell a different story. Among those facts are these:
Family farms of various types together account for 99 percent of all farms, and those account for 89 percent of the production as of 2015.
About 90 percent of the farms and small farms account for 48 percent of the land under production as of 2015.
Small farms account for a large share of the production of poultry and eggs, mostly under contact, along with 52 percent of the hay production.
Overall, the large share of production is by large scale family farms, about 42 percent.
ERS has “farm typology” for grouping farms. Included are small, medium and large family farms in addition to non-family farms, which account for just 1.3 percent of all farms that are not family farms.
Since 1991, the ERS researchers say farms producing $5 million or more have increased their shre of production to 23 percent in 2015, up from 13 percent. The mid-range farms with $1 million to $4,999,999 in productio increased to 29 percent, up from19 percent.
Dairy production and specialty crops dominated that production.
Most of the million or more farms remain family farms, with only 3 percent being non-family corporations. Small farms, however, are more likely to have an operating profit margin. Farm households are generally not low income when compared with other U.S households and U.S households headed by someone who is self-employed.
Farms operating after retirement typically will report income from Social Security of other sources.
Traceability and Food Safety in Produce
Source : http://www.foodsafetymagazine.com/enewsletter/traceability-and-food-safety-in-produce/
By Javier Martinez, M.Sc. (Dec 6, 2016)
According to data from the U.S. Centers for Disease Control and Prevention, approximately 48 million people get sick each year from a foodborne illness, while another 128,000 are hospitalized. Most of the contamination, based on U.S. Food & Drug Administration (FDA) data between 1996 and 2010, likely occurred during the growing, harvesting, manufacturing, packing, holding or transportation process.
Because of the public health burden associated with these preventable outbreaks, great strides have been taken to ensure the safety of produce items in today’s food supply. While outbreaks still occur, traceability measures have been established to protect the food safety system.These include emerging technologies and standards in traceability, such as Global Trade Item Numbers and new software that promotes food safety through sustainability and traceability.
When the Food Safety Modernization Act (FSMA) was signed into law in 2011, the goal was to strengthen the U.S. food safety system. FSMA put the power into the hands of each grower to ensure their food supply was safe and traceable if an outbreak should occur. It’s important to note that there is a difference in traceability between fresh and processed fruits and vegetables, which makes the tracking of fresh produce even more important. While the produce rule does not have specific traceability standards, the enhanced tracking and tracing of food and recordkeeping has two major requirements.
First, FDA, working with the U.S. Department of Agriculture (USDA) and state agencies, must establish pilot projects in coordination with the food industry to explore and evaluate methods and appropriate technologies for rapid and effective tracking and tracing of foods. Second, FDA must publish a notice of proposed rulemaking to establish recordkeeping requirements for high risk foods to help in tracing products.
Typically, when a consumer or food service outlet buys a fresh product, they may not know where it comes from; however, a canned item will have a label with an identifying product code. While fresh produce has historically been much harder to track, the industry has proven that it can be accomplishedwith the right resources in place.
For example, through the Produce Traceability Initiative (PTI), supply chain partners can help enhance a standardized industry approach to future traceability measures. The initiative is a voluntary, industry-wide effort governed by a 34-member leadership council. Members of the initiative cover every aspect of the produce supply chain, which includes growing, storing, cooling, packing, processing and distributing operations. This is done through volunteer working groups that focus on:
• Implementation and promotion of the industry-wide adoption of GS1 standards at the foundation of the PTI, including developing best practices, identifying solutions to implementation issues, and tracking industry implementation.
• Master data issues regarding identifying product attributes, and communicating that data between trading partners.
• Industry communications to ensure two-way discussions between the initiative and industry.
• Technology forums for tech providers to collaborate to support the initiative.
Additionally, it is administered by the Canadian Produce Marketing Association, GSI US, Produce Marketing Association and the United Fresh Produce Association.
The PTI’s goal is to develop a systematic approach to help narrow the impact of potential produce recalls, foodborne illness outbreaks or other problems. However, smaller operations may have problems aligning their traceability systems with PTI, due to the complexity of the system and costs that are associated with the corresponding requirements.
To help along their initiative, the PTI has launched its 7 Milestones to PTI Implementation for case-level electronic traceability in produce. They also have launched a checklist for both growers/packers/shippers and for receivers and buyers.
To date, the industry handles more than 6 billion cases of produce each year, which makes issues such as commingling and repacking even more prevalent.
Commingling occurs when produce from separate suppliers gets mixed together and then distributed in one package to a food service establishment.This can happen on purpose, in the case of finished products that consist of mixed items, or accidentally, in the case of repacking or reworking a productin an inappropriate manner. Commingling can cause issues with traceability if a foodborne illness outbreak occurs or a recall is necessary for certain products. Products have the potential to become contaminated by coming into contact with already contaminated goods. Therefore, it’s important to be able to track each batch of produce included in the repack.
To help the supply chain establish safe commingling practices, suppliers should be able to provide batch or lot numbers for each produce item included in the repack. Additionally, a new batch number should be assigned for the repackaged bundle. The repack facility also must be required to maintain the correct documentation to link each batch back to its respective source. In the event of a recall, each lot of produce must be traced back to its original source and further analysis may be required to determine the original point of contamination.
Whether the packer determines the lot by date, grower, field, buyer or some other identification, a sanitation clean break is required between each lot to ensure the proper segregation of produce items. A clean break, which is a cleaning and sanitation process, must be completed for all food contact surfaces before production begins. It includes the execution of specific Sanitation Standard Operating Procedures followed by a pre-operational assessment to ensure that acceptable results are obtained through visual inspections and ATP testing in some cases. These surfaces include the food contact surfaces of equipment and tools used during production.
Clean breaks are important because these clearly separate a production lot from another. A lack of a “clean break,” along with other poor traceability practices, could result in recalls that have covered a whole production season due to ambiguous or incomplete lot code information. One such example is the 2012 Listeria monocytogenes melon recall from Burch Equipment LLC in 2012. The recall initially included 13,888 cases of whole cantaloupes and 581 bins (110 cantaloupes per bin) of whole cantaloupes. However, it was quickly expanded to the entire growing season’s cantaloupes and honeydew melons.
Clean breaks limit the scope of potential food safety events, establish safe cleaning and sanitation procedures for packing and repacking facilities and provide a necessary check and balance system if a recall should happen.
Overall, produce items should be traced and foodservice operators should make sure the produce they are using can be easily linked back to its source. Here are a few steps to help facilitate produce traceability:
1. Establish lots at the field level.
2. Segregate products in different lines or production shifts at the facility level.
3. Maintain finished product lot coding information throughout the distribution chain.
By following these steps, traceability can be established and the food safety of produce can be better assured.
Hawaii seeks to update food safety regs following outbreaks
Source : http://www.foodsafetynews.com/2016/12/hawaii-seeks-to-update-food-safety-regs-following-outbreaks/#.WE9VEvmLSUl
BY CORAL BEACH (DEC 6, 2016)
In the wake of two foodborne illness outbreaks, Hawaii began a week of public hearings on revisions to its food code on Monday.
Also on Monday, state officials cleared a seaweed grower-shipper whose products were linked to one of the outbreaks to resume operations.
The Hawaii Department of Health (DOH) lifted its cease and desist order against Marine Agrifuture LLC, allowing the company to resume the sale and distribution of Kahuku Ogo, Robusta Ogo and Sea Asparagus from its Kahuku farm.
In November lab tests confirmed 14 people on Oahu had Salmonella infections. All of them developed diarrheal illness from mid- to late October. Four required hospitalization.
“The farm is located in Kahuku on Oahu. Reports of Salmonella infections on Oahu were linked to consumption of ogo (or limu) and subsequently led to the investigation of Marine Agriculture LLC on Nov. 2 and 7,” according to the health department’s Nov. 10 news release announcing the cease and desist order.
“During the investigation, testing was conducted on environmental, processing area, and ogo samples. Laboratory tests identified Salmonella bacteria in the packing and processing tanks and in the farm environment.”
As of Monday, state officials said follow-up testing showed no Salmonella.
“Laboratory test results from samples taken on Nov. 29 indicated that Marine Agrifuture’s processing areas and products were negative for Salmonella,” the department reported. “The wells, all inlets to production ponds, and the growing and rinse tanks were also free from Salmonella and levels of indicator organisms — Enterococci and Clostridium perfringens — that would signal possible environmental contamination.”
Hepatitis A outbreak count holding steady
Also on Monday, state officials began a week of public hearings regarding proposed changes to Hawaii’s food safety codes. The action comes on the heels of not only the Salmonella outbreak, but a four-month Hepatitis A outbreak traced to frozen scallops from the Philippines that were served raw by restaurants in the Genki Sushi fast food chain.
The Hepatitis A outbreak count was at 292 and holding, as of the state health department’s Nov. 30 update. The outbreak cases began June 10, with the most recent victim becoming ill on Oct. 9.
State health officials did not reference either outbreak in their announcement of the proposed food safety code revisions, but they did say they are focused on preventing foodborne illnesses.
“The department is continuing to raise the state’s food safety standards by further updating regulations to increase the focus on prevention and reduce the risk of residents and visitors contracting foodborne illness,” said Peter Oshiro, head of the DOH Food Safety program.
“Updating state requirements and fees and aligning our state with federal standards are essential for creating a world class food safety program in Hawaii.”
Training is key element of amendments
The proposed amendments include establishing a new food safety education requirement for “persons-in-charge” at all food establishments. The rule would require at least one employee on every shift be certified at the formal Food Handlers Training level.
“This will ensure a standard baseline of food safety knowledge for all establishment owners and managers,” according to the health department public hearing notice.
“Studies have shown that food establishments with properly trained persons-in-charge have a lower occurrence of critical food safety violations that are directly linked to food illnesses.
“The department is also proposing the adoption of the 2013 FDA Model Food Code. This will provide Hawaii with the most current nationally recognized food code based on the latest scientific knowledge on food safety.”
Additional proposed changes to the state’s food safety rules include:
Removing the 20 days of sale limit for homemade foods — cottage foods — that are not considered a potential public health risk;
Removing the restriction on the number of days a Special Event Temporary Food Establishment permit may be valid;
Establishing a new fee structure for Temporary Food Establishment Permits — $100 for a 20-day permit plus $5 for each additional day over 20 to a maximum of one year;
Streamlining regulations for mobile food establishments — e.g. food trucks — by incorporating the requirements into existing rules for their base operations or “brick and mortar” establishments;
Revising the fee structure for mobile units with no increase to the total amount currently paid by a mobile operator;
Allowing placarding during all inspections;
Allowing the state to refuse permit renewal for non-payment of fines or stipulated
agreements more than 30 days overdue; and
Requiring state approval for the sale of “Wild Harvested Mushrooms.”
The draft rules are available for review at http://health.hawaii.gov/opppd/proposed-changes-to- department-of-health-administrative-rules-title-11/.
Written public comments are recommended and may be submitted at the public hearings or to the Sanitation Branch at 99-945 Halawa Valley St., Aiea, Hawaii 96701 The deadline to submit comments is prior to the close of business on Dec. 16.
Remaining public hearings are scheduled for:
Tuesday, Dec. 6, from 2 p.m. – 5 p.m. for Island of Maui — UH-Maui College Community Services Building 310 Kaahumanu Ave., Bldg. #205, Kahului;
Wednesday, Dec. 7, from 2 p.m. to 5 p.m. for Island of Hawaii-Hilo — Environmental Health Building Conference Room 1582 Kamehameha Ave., Hilo;
Thursday, Dec. 8, from 2 p.m.to 5 p.m. for Island of Hawaii-Kona — West Hawaii Civic Center, Bldg. G, 74-5044 Ane Keohokalole Highway, Kailua-Kona; and
Friday, Dec. 9, from 2 p.m. to 5 p.m. for Island of Kauai — Lihue Health Center Conference Room, 3040 Umi St., Lihue.
Riverboat caterer downgraded because of filth, mold, bugs
Source : http://www.foodsafetynews.com/2016/12/riverboat-caterer-downgraded-because-of-filth-mold-bugs/#.WE9VfPmLSUl
BY NEWS DESK (DEC 5, 2016)
Federal food officials downgraded of the classification of the catering arm of BB Riverboats Inc., a riverboat cruise company operating on the Ohio River, to provisional because of multiple violations of safe food handling and holding regulations.
The director of the Food and Drug Administration’s Cincinnati district office notified the company’s president and owner, David Bernstein, of the action switching the Landing’s Galley catering operation from “approved” to “provisional” in a Nov. 23 warning letter made public in recent days.
According to the riverboat company’s website, no cruises are scheduled this week. The status of the holiday season cruises is unknown.
FDA inspected the operation on June 29-30, July 6 and July 11, including the passenger vessels, caterer, watering point and service area at BB Riverboats’ fixed base in Newport, KY.
The company’s flagship, the Belle of Cincinnati, and its River Queen boat both had multiple food safety problems including improper food handling by staff, food buildup and dirt on equipment, and red, black and pink mold on equipment and surfaces.
Employees failed to wash their hands at required points in food preparation and handling and failed to change gloves at appropriate times.
Inspectors also noted flying insects, a dead insect in a deep fryer well, leaking and standing water, food held at improper temperatures and problems with the water system on one boat.
“On the River Queen, a direct connection exists between the vessel’s potable water supply and A/C cooling and heating systems without backflow protection,” according to the warning letter.
“Based on these inspectional findings, a ‘Provisional’ classification has been assigned to your Landing’s Galley facility for a 30-day period, after which time a re-inspection will be conducted. A ‘Provisional’ classification means that the vessel, caterer, watering point, and service area may continue to operate; however, significant corrections of observed violations must be made. If significant correction is not made by the time of the next inspection, FDA will reclassify the vessel, caterer, watering point, and service area as ‘Non-Approved.’ ”
FDA warnings: Traceability, drug residues, juice hazards
Source : http://www.foodsafetynews.com/2016/12/fda-warnings-traceability-drug-residues-juice-hazards/#.WE9VtPmLSUl
BY NEWS DESK (DEC 5, 2016)
Warning letters recently posted by the Food and Drug Administration addressed a variety of violations at a food company in China, a dairy in Iowa and a juice producer in Connecticut.
Companies have 15 days to respond to FDA warning letters.
Weifang Sunwoo Foods Co. Ltd.
In a Sept. 21 warning letter, the director of the Office of Compliance for FDA’s Center for Food Safety and Applied Nutrition notified owner and general manager Zhang Fengguan that the company in Shandong Province, China, has “serious deviations from the Emergency Permit Control regulation” for its acidified foods.
Specifically, inspectors noted on April 26-28 that the company’s pickled radish products were not being processed long enough or at proper temperatures. Improper processing times and temperatures were also observed for the company’s seasoned sweet ginger and seasoned burdock, according to the warning letter.
Also, the Chinese food producer was cited for failing to have required traceability information and documents for its products.
“Your firm failed to adequately mark each container in accordance with 21 CFR Part 114.80(b). Specifically, your containers are not marked with a code identifying establishment where packed, product contained, year, date and packing period,” according to the warning letter.
“Your firm failed to maintain required records in accordance with 21 CFR Part 114.100(e) for a period of three years from the date of product manufacture. Concerning our request for temperature recording data records for a lot of Burdock manufactured on 4/13/2015, your firm replied that you keep computerized records for less than a year on a computerized file.”
Bear Creek Dairy LP
In a Nov. 21 warning letter, the director of the FDA’s Kansas City district office notified the owner, Johanes A. Boelen, that the dairy cow operation in Brooklyn, IA, violated federal law by selling an animal for slaughter as food that contained a “new animal drug that is unsafe…”
On June 14 Bear Creek Dairy sold a cow that was slaughtered the following day and then tested by the USDA’s Food Safety Inspection Service. The animal’s tissues had 0.883 parts per million (ppm) of Flunixin in the liver. FDA has established a tolerance of 0.125 ppm for residues of Flunixin in the edible tissues of cattle.
The cow’s tissues also had 0.54 ppm of Desfuroyceftiofur in the kidney. FDA has established a tolerance of 0.4 ppm for residues of Desfuroylceftiofur in the edible tissues of cattle.
In addition to the excessive drug residues, federal inspectors noted that the dairy holds “animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records. Also you failed to properly maintain an inventory system for determining quantities of drugs used to medicate your livestock. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).”
Stay Fresh Foods LLC
The director for FDA’s New England district office notified founder and managing director Amy Lawless in a Nov. 21 warning letter that inspectors found the company in violation of federal law related to juice production during an Aug. 2-12 inspection of its production facility in Meriden, CT.
“This inspection revealed serious violations of the juice Hazard Analysis and Critical Control Point (HACCP) regulation – Title 21, Code of Federal Regulations, Part 120, 21 CFR Part 120,” according to the letter.
The FDA warning states that responses from Stay Fresh Foods dated Aug. 25 and Sept. 20 were inadequate.
“(You) indicated that you will require your customers to sign a ‘quality questionnaire’ that confirms they have a HACCP plan that accounts for any appropriate hazards and that their plan is validated annually,” the FDA warning letter states.
“You also state that your firm has no responsibility for formulation or the production process of your customers. Your responses are inadequate because your firm is considered a juice processing facility subject to the requirements in 21 CFR Part 120, which includes having control measures in place to achieve a consistent 5-log reduction of the pertinent microorganism.”
The FDA warning also states that the Stay Fresh Foods process to kill the pathogen that causes botulism poisoning have not been proven effective.
“… your firm has not validated, as required by 21 CFR 120.11(b), that your processes — refrigeration and the high pressure processing (HPP) — achieve the requisite 5-log reduction to control Clostridium botulinum,” according to the warning letter.
“FDA has information to support that HPP coupled with refrigeration are not validated processes that can reduce the spores of Clostridium botulinum in low-acid juices. In fact, non-proteolytic spores of Clostridium botulinum can grow and produce toxin in low acid juice even under refrigeration temperatures.”
Feedspot: Food Safety Blogs Best 30 List – Marler Blog and Food Poison Journal Made It
Source : http://www.foodpoisonjournal.com/food-poisoning-information/feedspot-food-safety-blogs-best-30-list-marler-blog-and-food-poison-journal-made-it/#.WE9V6PmLSUl
BY BILL MARLER (DEC 3, 2016)
From Feedspot: The Best Food Safety blogs from thousands of top Food Safety blogs in our index using search and social metrics. Data will be refreshed once a week.
These blogs are ranked based on following criteria
Google reputation and Google search ranking
Influence and popularity on Facebook, twitter and other social media sites
Quality and consistency of posts.
Feedspot’s editorial team and expert review
CONGRATULATIONS to every blogger that has made this Top Food Safety blogs list! This is the most comprehensive list of best Food Safety blogs on the internet and I’m honoured to have you as part of this! I personally give you a high-five and want to thank you for your contribution to this world.
11 – www.foodpoisonjournal.com – Food Poison Journal supplements Marler Clark’s Web site www.foodborneillness.com, a site that provides information about food poisoning, and some of the most common causes of foodborne illness. Information includes the symptoms and risks of infection, testing/detection of foodborne illness, and how to prevent food poisoning outbreaks.
17 – www.marlerblog.com – Providing Commentary on Food Poisoning Outbreaks & Litigation by Bill Marler. Marler is dedicated to eliminating the need for foodborne illness litigation in this country. Until we succeed in putting ourselves out of business, we will use our experience and industry knowledge to assist consumers who have been sickened by contaminated food.
Food and Ag Science Will Shape Our Future
Source : https://medium.com/usda-results/ch11-ad478971cba7#.vism6eryn
By Tom Vilsack (Nov 1, 2016)
What if I told you a scientist had recently discovered a way to remove up to 98% of the allergens in peanuts without affecting the flavor, thereby diminishing a severe health threat to some 2.8 million Americans who suffer from peanut allergies?
Or that a small family business is working on a project that could quench the thirst of billions of people around the world with technology that’s capable of taking water from any source and making it safe to drink?
If that sounds a little like science fiction to you, you wouldn’t be alone. But both examples exist today as part of the hundreds of scientific breakthroughs made by USDA and USDA-supported scientists since the start of the Obama Administration.
When people think of USDA, they may not immediately think of cutting-edge science or discovery. But USDA is the world’s largest agricultural research force. USDA employs around 3,000 scientists, economists, statisticians and others, and funds thousands more at land-grant universities and other institutions across the country. Together, their work has helped to shape the lives of billions of people around the world.
Under the Obama Administration, USDA has made a powerful statement about the importance of scientific discovery by strengthening our institutions, building our capacity and leveraging the strengths of our outside partners to do the same. From the farm to the lab to the boardroom, we’ve increased our investment in delivering problem-driven and solutions-based science that empowers farmers, foresters, ranchers, landowners, resource managers, professors and policymakers to help manage the risks we face.
Studies have shown that every dollar invested in agricultural research now returns over $20 to our economy. For our part, since 2009, USDA has invested $19 billion in research both intramural and extramural. As a result of that investment, research conducted by USDA scientists has resulted in 883 patent applications filed, 405 patents issued and 1,151 new inventions disclosures covering a wide range of topics and discoveries since 2009.
USDA also continues to aggressively partner with private companies, universities and others to transfer technology to the marketplace to benefit consumers and businesses alike. Over the years, USDA innovations have created all manner of products Americans use every day, from cosmetics, to insect controls, leathers, shampoos and of course food products. Here is a sample of USDA’s work:
Frozen orange juice concentrate
Turf used on many NFL and other sports fields across the country
“Permanent press” cotton clothing
Almost all breeds of blueberries and cranberries currently in production
80 percent of all varieties of citrus fruits grown in the U.S. and
The mass production of penicillin during World War II
Still today, our scientists are pushing the boundaries of what’s possible and creating new miracles on behalf of the American people year after year. Their incredible dedication underscores the importance of government funding for research so that we can continue to make cutting-edge scientific breakthroughs with real potential for commercial application and growth. In recent years, some of their other discoveries include:
A new process to turn old tires into zinc fertilizer
A new kind of flour made from chardonnay grape seeds that can prevent increases in cholesterol and weight-gain
A portable method for identifying harmful bacteria in food that prevents foodborne illness and safeguards public health
A new soil nitrogen test that rapidly and inexpensively determines the total amount of nitrogen in the soil that is available to a plant. The use of this test reduces fertilizer application amounts, reduces costs for farmers, and benefits the environment
A new process for pasteurizing shelled eggs that uses radio frequency energy that is 1.5 times faster than the current pasteurization process and that does not affect the eggs’ appearance. This fast new technology should increase the number of pasteurized eggs and reduce the threat of illness from uncooked and undercooked shelled eggs
And there are many more where that came from.
Enhancing the Productivity and Sustainability of American Agriculture and Our Food Supply
USDA research has supported America’s farmers and ranchers for over 100 years, helping our agricultural sector respond rapidly and successfully to challenges as they arise. That includes working toward systems that protect long-term crop and animal health by making sure farmers are armed with knowledge and tools to make their crops and livestock more resilient to disease while keeping costs low for farmers so they can continue doing what they do best.
The 2014–2015 HPAI outbreak was the worst animal disease outbreak experienced in the United States, sweeping across 15 States and forcing officials to kill nearly 50 million birds. Consumers felt the economic impact as egg prices increased by 50.6 percent per dozen and egg shortages were seen all the way through the Midwest. Within weeks, REE scientists developed a rapid molecular test to detect the virus and quickly engineered a vaccine using a new reverse genetics technology. That’s the importance of discovery when we need it.
Our scientists and university partners have also revealed the genetic blueprints of a host of plants and animals, and used knowledge gained from the genomes of these crops to develop improved varieties. Our understanding of the genomes of apples, pigs, turkeys?—?and in particular tomatoes, beans, wheat and barley?—?are all key drivers in developing the resilience of those crops and livestock to keep a growing population well-nourished in the face of climate change.
U.S. wheat and barley, grown in 42 States, are both vital to human nutrition and to global food security. Not only that, but since 2010, the combined annual market value of wheat and barley has been estimated to be between $11 billion and $18.5 billion. When wheat and barley production in the United States was threatened by stem and stripe rusts emerging in East Africa and spreading rapidly, USDA-funded researchers worked to identify 40 new genes resistant to new strains of stem rust called Ug99. The resistant genes were identified from extensive trials in Kenya and Ethiopia over the last decade and are now being bred into U.S. grain.
In Florida, an insect carrying the bacteria causing citrus greening disease is devastating the citrus industry by decreasing marketable fruit in infected groves by more than 50 percent. To stop the bacteria from infecting new citrus trees, ARS scientists developed a molecular system to prevent the insect, known as the Asian citrus psyllid, from feeding on the citrus sap, preventing them from transmitting the bacteria from tree to tree. This antibiotic alternative can be used in conjunction with other methods to stop the spread of citrus greening.
Since 2008, USDA plant breeders and researchers have also developed and released 714 new plant varieties and enhanced germplasm lines. USDA genebanks have distributed more than 1 million samples to researchers and breeders in the United States and abroad, operating as part of a larger effort to help create new markets and enhance economic opportunities for rural America. USDA has also pioneered methods for providing researchers with open access to germplasm information through the Germplasm Resources Information Network (GRIN). Through the GRIN-Global project, USDA, in conjunction with non-governmental partners, adapted GRIN to provide an easy-to-use web-based information management system for the world’s plant genebanks to also share information on their genetic resource holdings.
When certain pollinator populations critical to the nation’s economy, food security and environmental health began to show signs of notable decline, the entire Obama Administration sprang into action. The federal-wide “National Strategy to Promote the Health of Honey Bees and Other Pollinators” was released in 2015 based upon recommendations from a task force led by USDA and the Environmental Protection Agency (EPA). For our part, USDA researchers are taking a hard look at the causes behind the stressors impacting pollinator populations, such as mites, bacteria, pesticides and management practices, and are using that vital research to work on new strategies to sustain pollinator health.
Conserving Natural Resources and Combating Climate Change
USDA is examining the potential of a suite of climate scenarios on U.S. crop production to help farmers, industry leaders and others better understand the effects of a changing climate and adopt practices that help mitigate both their agricultural production and their impacts.
In 2014, USDA established seven regional Climate Hubs and three sub-hubs. The Hubs are set up to process science and research into information that is accessible to producers, and provide them with the guidance and practices they need to help them address a region-specific set of risks due to climate variability. First established in 2014, each of the USDA Climate Hubs offer detailed vulnerability assessments for regional sensitivities and adaptation strategies for working lands. The Hubs have produced numerous decision support tools and outreach materials to help land managers make climate-informed decisions.
We’ve developed online tools aimed at providing farmers with data they can use to manage their crops. With REE support, Cornell University scientists are providing corn growers with low-cost soil assessment and greenhouse accounting tools and that also provide an evaluation of the costs and benefits of various policy incentives. Known as “Adapt-N,” the tool makes it possible to improve nitrogen use efficiency, thus improving farm profits, while reducing environmental losses.
As drought conditions continue to grip parts of the country, our scientists have begun work to develop rice and corn crops that are drought- and flood-resistant, and improved the productivity of soil. In addition, a series of satellite remote sensing tools developed by USDA will help improve agricultural drought detection, increasing our ability to reduce and prevent the impact of drought regionally and globally.
ARS researchers have also invented an automated, variable-rate, air-assisted, precision sprayer, an environmentally responsible approach that reduces average pesticide use by up to 68 percent. That also results in an annual average cost savings of $230 per acre in floral nurseries and orchards.
Improving Public Health and Fighting Obesity
USDA and USDA-supported science play a large role in building the evidence base for strong and science-based policies that keep Americans safe, healthy and well-nourished.
For example, USDA researchers have made discoveries that prove eating a protein-rich breakfast increases the brain’s level of dopamine, a chemical that helps reduce food cravings and overeating later in the day. USDA scientists recorded brain electrical activity during the performance of mental arithmetic in children and found that those who ate breakfast were more efficient at solving math problems than those who did not. Their results provide evidence for the beneficial effects of breakfast on learning in school-aged children, and provide support for policies that seek to improve school performance and slow the trend of childhood obesity through better nutrition.
Our scientists also belong to an international team that has found a way to boost the nutritional value of broccoli, tomatoes and corn, and have worked to find ways to bolster the nutritional content of other staple crops like oats and rice. USDA research has supported these efforts, showing how healthy foods can often cost less than foods that are high in saturated fat, added sugar and/or sodium.
The Food Environment Atlas is a USDA-developed online mapping tool that provides a spatial overview of a community’s ability to access healthy food and its success in doing so. Those concerned about access to healthy foods can create and print maps showing food access indicators that take into account distance to supermarkets and vehicle availability, view indicators of food access for selected subpopulations and download census-tract-level data on food access measures. This tool helps support expanding the availability of nutritious and affordable food?—?an important part of First Lady Michelle Obama’s Let’s Move! Initiative.
A team of scientists from the University of Florida at a field site in Haiti is being funded through NIFA’s Exploratory Research Grants program to determine the range of mosquito species capable of transmitting Zika virus. Because of similarities in mosquito species between Haiti and some southern U.S. states, the information generated from this research has potential to be of immediate use both there and in at-risk areas like Florida.
Strengthening Research, Institutions and Integrity
In a time of federal budgetary restraints, USDA is continuously looking at breakthrough policies that leverage federal dollars against private contributions to make the most possible of our investments. Under this Administration, the Foundation for Food and Agriculture Research (FFAR) was developed to complement USDA efforts to support science addressing today’s food and agriculture challenges and to build public-private partnerships critical to boosting America’s agricultural economy. Its creation was authorized by Congress as part of the 2014 Farm Bill, which also provided $200 million for the foundation that must be matched by non-federal funds as the Foundation identifies and approves projects.
Under the Obama Administration, USDA has restructured its science agencies to maximize effectiveness with our partners in the scientific community. In addition to the 2009 creation of USDA’s National Institute of Food and Agriculture (NIFA), which consolidates all USDA-funded extramural food and agricultural research programs, we’ve also strengthened the Office of the Chief Scientist (OCS), which identifies and prioritizes issues to be addressed by USDA scientists and researchers. USDA’s Science Council consists of scientific leaders from across USDA that advise OCS on priorities for USDA’s science agenda. In early 2015, the Department also approved the Chief Scientist’s plan to move from a largely rotating senior staff to a more permanent and consistent employment structure.
In 2011, USDA became one of the first Departments to establish a scientific integrity policy. Since then, we have revised the policy as a Departmental Regulation with additional detail and designated the full-time position of Departmental Scientific Integrity Officer as a permanent position within OCS. In 2012, OCS developed an Action Plan, which provides a foundation for prioritizing research across USDA’s agencies. It has subsequently issued action plans and progress reports for each year thereafter.
We’ve also proudly renewed our longstanding partnership with land grant universities on several fronts. In particular, USDA celebrated 150 years of partnership with Land-Grant Universities, an interactive event at the Smithsonian Folklife Festival, and 125 years with the 1890 historically black Land-Grant colleges and universities.
Recognizing the voice of youth is important, USDA plays a key role in providing positive youth development through the internationally recognized 4-H administered federally for more than a century and implemented through Cooperative Extension System partners at land-grant universities. 4-H engages youth within their communities, schools, organizations, peer groups and families to enhance their strengths and help steer more youth into the STEM professions. 4-H partners with 112 land-grant universities to provide mentoring and help, building a foundation of leadership and skills for success in their future careers.
Our work has also helped drive innovation, executing 545 new Cooperative Research and Development Agreements since 2009 with outside investigators including companies, universities and other organizations. In fiscal year 2015, USDA had 301 active Cooperative Research and Development Agreements, including 106 with small businesses.
We’re also supporting small businesses and cutting edge innovation through the Small Business Innovation Research (SBIR) Program which encourages American businesses with 500 employees or fewer to engage in high-growth research and development that has the potential for commercialization. Since 2009, USDA’s SBIR program has awarded nearly 850 research and development grants to American-owned, independently operated, for-profit businesses, allowing hundreds of small businesses to explore their technological potential, and providing an incentive to profit from the commercialization of innovative ideas. Past examples of successful SBIR projects include the sustainable water desalination and purification technology we mentioned at the outset of this chapter, as well as LLC’s research to cultivate elderberry varieties with high antioxidant levels that are now harvested and marketed for their anti-inflammatory and anti-viral properties.
The challenges facing our nation are immense. But they can be addressed with robust investment, not only in our science, research and development enterprise, but also with a focus on making sure our next generation succeeds where and when they need to. I’m proud to say that for the last eight years, and indeed long before that, USDA has served to protect, secure and improve our food, agricultural and natural resources systems through an unwavering commitment to innovation and staunch support for the amazing scientists and researchers who work everyday to make our world a better place to live.
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