FDA Director Answers "What's Next" Questions on FSMA Compliance
Source : http://www.qualityassurancemag.com/article/fda-director-answers-questions-on-fsma-compliance/
By qualityassurancemag.com (Oct 16, 2016)
With the first major compliance dates having arrived Sept. 19 for the preventive controls rules for human and animal food under FSMA, FDA published the following Q&A on the rules and "What's Next."
Some members of the food industry have expressed concern and uncertainty about enforcement measures that may accompany September 19, 2016 – the date when larger businesses had to comply with certain new standards. Human food facilities must meet preventive controls and Current Good Manufacturing Practice requirements (CGMPs); animal food facilities must meet CGMPs. (The larger animal food businesses have an additional year to meet the preventive controls standards.)
Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, addresses questions that have been raised about what the next few months will look like for human food facilities required to comply with the CGMP and preventive controls requirements and animal food facilities required to comply with the CGMP requirements.
Q. What happens next in terms of FDA enforcement of these new standards?
A. We know that this is new territory for food companies; it’s new territory for us too. For years we’ve been talking about the FSMA rulemakings and our implementation plans. Now, an important compliance date is here for some companies. As we enter this new chapter, the FDA’s primary focus will continue to be on education, training and technical assistance to help companies comply with the new requirements.
A top priority for FDA is providing the framework for industry's implementation of preventive controls and CGMP requirements. We recently issued draft guidance documents that provide more detail on how to comply with the new standards, and there are more guidances to come, about two dozen planned over the next few years. We intend to continue this dialogue and collaboration with regulated industry to ensure that everyone understands and engages in their respective roles in food safety.
This first year of compliance will affect the larger businesses, generally those with 500 or more employees. Many businesses of that size already have a HACCP (Hazard Analysis and Critical Control Points) program; we don’t expect them to need to make many changes to come into compliance. Aspects of the CGMP and preventive controls rules are similar to HACCP, a food safety system that started with industry. (The human and animal food rules have staggered compliance dates; smaller businesses have a year or more additional time to comply.)
Q. Does the focus on education mean that companies won’t really be held to these standards yet?
A. No. The FDA’s mandate is to protect public health and, when necessary, the agency will act swiftly. But keep in mind that our primary goal, not just in the first months but going forward, is to work with the food industry to create a culture of food safety, a culture of compliance with procedures, processes, and practices that we know will minimize the risk of serious illness or death.
Q. What is the best thing covered food facilities can be doing now?
A.The best thing that people in the food industry can do is take the measures required by the new rules – not just the letter of the law but what it represents in terms of transforming the food safety system. They should look at the big picture, at areas in which they could be vulnerable and proactively take action. Promptly responding to problems, even if they aren’t yet violations, can prevent them from getting to the point at which there is a concern about the safety of the food.
In addition, facilities should set up a thorough system for documenting what they do. The better the records, the more a company can demonstrate that it is meeting the legal standard. Put processes and procedures in place to prevent problems in the first place, and consider having some redundancy in the system so that if one measure fails, another can take its place.
If there is a problem, state or federal investigators will ask questions like: When problems came to your attention, what did you do? Were you proactive in looking for the problems in the first place? If you could not find a solution, did you get the right expertise? Did you educate your employees?
Q. Where can companies go wrong?
A. A company’s approach should not be: “The government was here and did our inspection. We’re safe for X amount of time.” Rather we want facilities to be confident that if FDA or the state walks in tomorrow, they’ll be able to demonstrate what they're doing to meet the new food safety requirements.
And it really is up to the management of a company to create that culture by attending to the facility and its production processes and making sure that everyone in the production chain understands what is expected and has the training and education they need to get the job done.
Q. What is the ultimate goal?
A. The purpose of these rules is to create a preventive, food safety system that is self-sustaining. Everybody in a food facility should be systematically operating in a way that complies with the law.
The preventive controls requirements fulfill the paradigm shift toward prevention that was envisioned in FSMA and, in combination with CGMPs, will help protect consumers into the future.
We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.
Salami, fermented sausage and risk in Italy
Source : http://barfblog.com/2016/10/salami-fermented-sausage-and-risk-in-italy/
By Doug Powell (Oct 16, 2016)
Sorenne loves her salami — or smallgoods as they are sometimes called in Australia.
Now its gone all artsy or artisanal but there’s still a microbiological risk.
As of the start of the 21st century, consumers have developed a growing interest in so called “traditional or artisanal” food. The renewed interest in this type of food is explained by consumers’ perception of these products. In fact, traditional food has a general positive image across Europe, and European consumers trade off the relative expense and time required for preparation of traditional food for its specific taste, quality, appearance, nutritional value, healthiness and safety (Almli et al., 2011 and Guerrero et al., 2009). Such food is often produced by small farms, and so the rural economy benefits from the increase in activity and profits through direct sales at local food markets (Berlin et al., 2009 and Carey et al., 2011).
Although the term “traditional foods” is widely used, the concept of traditional food products embraces different dimensions and there are hardly any definitions that clearly define traditional foods. In order to identify “traditional” foods, the EU legislation (EC, 2006a, EC, 2006b and EC, 2012) has defined criteria based on product designations that are linked to geographical origin or traditional production methods. In addition, the EuroFIR FP6 Network of Excellence provided a definition of traditional foods which includes statements about traditional ingredients, traditional composition and traditional type of production and/or processing method (Weichselbaum et al., 2009).
Among European countries, Italy is the lead producer of traditional foods and products such as foods with Protected Designation of Origin (PDO) or Protected Geographical Indication (PGI), followed by France, Spain, Portugal and Greece (ISMEA, 2013). Additionally, it is estimated that Italy has around 5000 traditional local food products without any certification (CIA, 2015), which could represent an important resource contributing to the development and sustainability of rural areas, providing ample variety in food choice for the consumer and a remarkable income for the economy. With its 371 typical products, Veneto Region is the fourth Italian Region according to number of traditional food products after Toscana, Campania and Lazio (Mipaaf, 2014). In addition, since 2007, Veneto Region has implemented regional legislation which defines a simplified procedure to sell small quantities of traditional food products at local level directly from the producer to the consumer (DGR, 2007 and DGR, 2008). In Veneto Region, many typical fermented sausages such as salami and soppresse are produced with traditional technologies, and so the legislation has been focused firstly on these products and subsequently on other types of meat products (poultry and rabbit meat) and products of non-animal origin (canned food; fruit juices; flour and dried vegetables; bread and bakery products; extra virgin olive oil).
In relation to fermented sausages, the legislation defines the production season, the maximum number of animals that can be reared and the minimum rearing period for pigs on the production farm as well as the minimum hygienic pre-requisites of the work areas used for processing pork meat into fermented sausages. Since these sausages are mainly produced following traditional practice in small processing units, starter cultures are not added to the minced pork meat and ripening is carried out in rooms with less temperature and relative humidity control than that used by industrial manufacturers. Therefore, deviations in temperature and/or humidity can result in insufficient fermentation-drying processes, meaning the absence of pathogens in the final products is not assured. The presence of food-borne pathogens such as Listeria monocytogenes, Escherichia coli O157, and Salmonella spp. in fermented sausages has been reported.
Concerning L. monocytogenes, the pathogen was detected at the end of ripening in 40% of “Salsiccia Sarda” (a traditional Italian fermented sausage) with contamination levels always lower than 100 cfu/g ( Meloni et al., 2012), while a prevalence of 15% was reported in fermented sausages produced in northern Italy (De Cesare et al., 2007). Other studies conducted on traditional fermented sausages at the end of the ripening period showed a L. monocytogenes prevalence of 10% in France ( Thevenot et al., 2005), 16% in Spain (Martin et al., 2011), 42% in Greece (Gounadaki et al., 2008) and 60% in Portugal (Ferreira et al., 2007). The prevalence of Salmonella spp. in traditional fermented sausages is lower than Listeria: the presence of Salmonella was reported in two out of 38 batches of traditional Portuguese sausages (alheiras) ( Ferreira et al., 2007) and in three out of 21 (14%) batter samples of traditional Greek fermented sausages but not in the final products (ready to be sold) (Gounadaki et al., 2008). In relation to verocytotoxin-producing E. coli (VTEC), including E. coli serotype O157:H7, for which meat and meat products are considered the main source of infection for humans, an overall VTEC prevalence of 16% was found in fresh pork sausages collected in the southern part of Italy ( Villani et al., 2005).
In addition, food-borne outbreaks associated with the consumption of fermented meats are reported in the literature. In Veneto Region of Italy, in January 2004, a family outbreak of E. coli O157 infection caused by a dry-fermented traditional salami made with pork meat and produced in a local plant occurred ( Conedera et al., 2007). In Norway, an outbreak caused by E. coli O103:H25 involving 17 patients was attributed to the consumption of fermented sausages ( Sekse et al., 2009). Concerning Salmonella, an outbreak of Salmonella Typhimurium DT104A involving 63 cases associated with the consumption of traditional pork salami was reported in Lazio Region of Italy ( Luzzi et al., 2007). Another outbreak of Salmonella Typhimurium associated with the consumption of unripened salami was reported in Lombardia Region of Italy ( Pontello et al., 1998). L. monocytogenes outbreaks associated with the consumption of fermented sausages have not been reported, to our knowledge, even though L. monocytogenes has been implicated in several listeriosis outbreaks linked to the consumption of pre-sliced ready-to-eat deli meats ( Thevenot et al., 2006). The infective doses of the above-mentioned micro-organisms can vary widely according to several factors such as the strain, the susceptibility of the host, and the food matrix involved. In case of L. monocytogenes in susceptible individuals, it is unlikely that fewer than 1000 cells may cause disease ( EFSA, 2007). Concerning Salmonella the infective dose is variable but often low numbers of cells (between 10 and 1000) are sufficient to cause disease, the same for EHEC which is known for its low infective dose ( Strachan et al., 2005 and Teunis et al., 2010). The difference in dose-response relationship between the three pathogens may also, to some extent, explain the difference in stringency in surveillance. In European Regulation 2073/2005 (EC, 2005), tolerance of up to 100 cfu/g of L. monocytogenes in ready-to-eat meat products is accepted at the end of shelf life, whereas usually action limits of absence of Salmonella and EHEC per 25 g are applicable.
In order to avoid the marketing of potentially hazardous traditional fermented pork sausages (Italian salami and soppresse) produced within the Veneto region, this study was initiated by the regional competent authorities in collaboration with the small-scale producers with the following aims: a) investigate the production process of traditional salami and soppresse in Veneto Region of Italy; b) identify the microbiological hazards associated with this type of food, and finally; c) identify control measures easily applicable directly by the Food Business Operator (FBO) with the supervision and control of the regional Competent Authority (CA) in order to manage the hazards associated with this type of traditional meat product.
Artisanal Italian salami and soppresse: Identification of control strategies to manage microbiological hazards
Journal of Food Microbiology
Volume 61, February 2017, p. 5-13
Roccato, Anna. Et al.
Food Poisoning Increases Risk of Crohn’s Disease
Source : https://foodpoisoningbulletin.com/2016/food-poisoning-increases-risk-of-crohns-disease/
By Linda Larsen (Oct 15, 2016)
A new study conducted at McMaster University confirms that people who suffer from food poisoning by a particular bacteria may be at increased risk for developing Crohn’s Disease, also known as inflammatory bowel disease (IBD). In every Salmonella outbreak over the past four years, Food Poisoning Bulletin has stated that one of the long term complications from one of these illnesses is IBD.
Researchers found that infectious gastroenteritis (food poisoning) caused by a common food poisoning bacteria increases and accelerates the growth of adherent-invasive E. coli (AIEC). The scientists used a mouse model of Crohn’s Disease. Even after the mouse had cleared the food poisoning bacteria from their bodies, researchers still found increased AIEC levels in the gut. In the study, the researchers used Salmonella Typhimurium or Citrobacter rodentium.
Western societies have a much higher rate of IBD than the rest of the world. Most scientists and doctors think that bacteria in the gut participate in the development of human bowel diseases. Chronic inflammation is driven by microbial stimulation of the mucosal immune system.
AIEC are pro-inflammatory and may play a role in maintaining chronic inflammation. Acute infectious gastroenteritis creates an inflammatory environment in the gut that drives AIEC expansion.
Crohn’s disease is a debilitating illness that can lead to weight loss and malnutrition. It involves inflammation in both the small and large bowel. Symptoms of Crohn’s disease include abdominal pain, severe diarrhea, and fatigue.
People suffering from this disease have an increased risk of colorectal cancer and an increased risk of premature death, according to Dr. Brian Coombes, senior author of the study and a professor in the Department of Biochemistry and Biomedical Sciences at McMaster University. About 700,000 people in the U.S. develop Crohn’s disease every year. Most people get sick in their teens into their mid-thirties.
The strange thing about this link between Crohn’s disease and food poisoning is that Crohn’s can occur years after someone has completely recovered from food poisoning. Researchers believe that resident gut microbes perpetuate inflammatory reactions. Several factors can present a “tipping point,” creating a “sustained imbalance of intestinal homeostasis.” Genetic susceptibility is one factor; contracting a foodborne illness is another.
This environment in the gut becomes favorable to colonization by AIEC. In fact, AIEC can be found in healthy people, which confirms that food poisoning can be a risk factor for IBD. It’s also possible that food poisoning makes a person more susceptible to acquisition of AIEC through a loss of colonization resistance.
On a more hopeful note, the scientists said that the long latency period between recovery from food poisonoing and Crohn’s disease onset could create opportunities to mitigate the disease risk. Further study will be needed on this issue.
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Food Safety Talk 110: Drumsticks and Cornettos
Source : http://barfblog.com/2016/10/food-safety-talk-110-drumsticks-and-cornettos/
By Ben Chapman (Oct 13, 2016)
Food Safety Talk, a bi-weekly podcast for food safety nerds, by food safety nerds. The podcast is hosted by Ben Chapman and barfblog contributor Don Schaffner, Extension Specialist in Food Science and Professor at Rutgers University. Every two weeks or so, Ben and Don get together virtually and talk for about an hour.
They talk about what’s on their minds or in the news regarding food safety, and popular culture. They strive to be relevant, funny and informative — sometimes they succeed. You can download the audio recordings right from the website, or subscribe using iTunes.
Episode 110 can be found here and on iTunes.
This week’s episode has some audio quality issues towards the end. Listen to find out why. As usual, here are show notes so you can follow along at home.
?Beats by Dre
?Donald Trump Couldn’t Stop Sniffing … Again
?Official Toronto Blue Jays Website
?New York Mets – Wikipedia
?Licensed to Ill – Wikipedia
?When the Power Is Out – When to Refreeze Frozen Food and When to Throw It Out | NC State University
?Refrigerated Food and Power Outages: When to Save and When to Throw Out | FoodSafety.gov
?Produce cannot safely be salvaged in flooded areas | Food Safety News
?Safely Using Produce from Flooded Gardens, U Wisc.
?122 report illness after eating Mighty Taco refried beans
?Growth of Clostridium perfringens during cooling of refried beans. – PubMed
?Salmonella test prompts microgreens recall
?Osage Gardens Inc. Recalls Osage Gardens Organic 2oz Micro Greens Because of Possible Health Risk
?Nestlé recalls Drumstick cones after listeria test
?Nestlé USA Initiates Voluntary Recall Of Nestlé Drumstick Club 16 Count Variety and 24 Count Vanilla Pack Due to Possible Health Risk
?Nestlé Recall press release, Drumstick Variety Packs
?Three Flavours Cornetto trilogy – Wikipedia
?Super Troopers (2001)
?Star Trek Beyond
?Goodnights & Factory Restaurant
?AMolecular Evidence of Oysters as Vehicle of Norovirus GII
?Las Cruces, New Mexico – Wikipedia
?Grateful Dead – El Paso – 6-26-94 – YouTube
?I’m a Doctor. If I Drop Food on the Kitchen Floor, I Still Eat It
?Dr. Oz Asks: Is Your Poop Normal or Not?
EFSA to deepen ties with China
Source : http://www.efsa.europa.eu/en/press/news/161013a
By efsa.europa. (Oct 13, 2016)
EFSA will formalise its relationship with the China National Centre for Food Safety Risk Assessment (CFSA) during the visit of EFSA’s Executive Director to the People's Republic of China in November 2016. EFSA will also participate in the “China International Food Safety & Quality Conference + Expo 2016” and co-chair one of its seminars on future priorities in food safety.
China and the EU are increasingly working together in the area of food safety. Marking a milestone in the relationship between EFSA and the CFSA, EFSA’s Executive Director Bernhard Url and CFSA’s Acting Director General Mr Jiang Lu are to sign a Memorandum of Cooperation on 1 November 2016 in Beijing.
The agreement between EFSA and the CFSA aims at setting a legal basis to ensure cooperation programmes in the areas of capacity building, exchange of knowledge and expertise, as well as stimulating harmonisation and innovation in food safety risk assessment methods and approaches.
EFSA to co-chair seminar at international food safety conference
EFSA will also take part in the “China International Food Safety & Quality Conference + Expo 2016” in Shanghai and co-chair a seminar on “Priorities in food safety 2016-2020” on 3 November 2016.
The seminar which is jointly organised by the European Commission and EFSA will focus on future food safety challenges, and on implications for European and international risk assessors and managers. EFSA will give insights into areas of its work with global significance, such as its new guidance on applications for novel and traditional foods, and its contribution to global efforts to address antimicrobial resistance (AMR).
Cookie Dough Ingredient Recall Expands to More Popular Brands
Source : http://www.foodsafetymagazine.com/news/cookie-dough-ingredient-recall-expands-to-more-popular-brands/
By Staff (Oct 13, 2016)
Late last month, Blue Bell Creameries was hit with yet another product recall due to possible Listeria contamination. The ice cream’s cookie dough ingredient is believed to be the culprit. Now, the same recall includes one large grocery retailer, along with a popular brand of meal replacement bars and one more ice cream company.
Publix brand Premium Chocolate Chip Cookie Dough Ice Cream has been recalled in connection to the Listeria contamination.
Blue Bunny’s Hoppin’ Holidoodle Ice Cream--produced by Wells Enterprises, Inc.--was voluntarily recalled, too. The product contains snickerdoodle cookie dough pieces that may be contaminated with Listeria.
Nutrisystem Retail Division has voluntarily recalled one of their flavored diet bars containing chocolate chip cookie dough pieces due to possible Listeria contamination. The product had very limited distribution--only 455 cases were shipped to retailers in New England and along the East Coast.
Although no traces of Listeria have been found in any of the cookie dough recalled most recently, the recalls are initiated as a precaution.
The cookie dough ingredient used by Blue Bell, Publix and Blue Bunny was purchased from the same third party supplier--Aspen Hills. The supplier has said that their product tested negative for Listeria contamination before it was sent to Blue Bell production plants. One possibility, some experts say, is faulty testing. Another is that undetectable levels of Listeria could have cultivated during a 2 month holding period before Blue Bell’s Alabama plant used the ingredient.
Reports indicate that an anonymous Aspen Hills spokesperson has confirmed that Listeria was indeed found in the company’s production facility, but the source declined to identify a specific location within the facility. That person says that Aspen Hills is conducting its own investigation.
No reports of consumer illness have been reported in connection to any of the aforementioned recalls.
Another Listeria Recall for Blue Bell Ice Cream
Blue Bell Recalls All Products After Listeria Contamination
FDA Says Blue Bell Listeria Contamination Dates Back to March 2013
FDA Reports Show Blue Bell Food Safety Violations Dating Back 8 Years
First Blue Bell Plant to Resume Production After Massive Recall
Blue Bell Workers Say Production, Money Over Cleanliness at Texas Plant
DOJ Investigating Blue Bell's Listeria Outbreak
Blue Bell Issues Statement on Progress After 2015 Recall
Blue Bell Ice Cream Issues Recall for Mispackaging; Undeclared Allergens
A New Era of Food Safety Regulation Begins
Source : http://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2016/a-new-era-of-food-safety-regulation-begins/
By James F. Neale, Esq., J. Brian Jackson, Esq., and Christopher A. Ripple, Esq
This fall brings the first major compliance deadlines for rules promulgated under the Food Safety Modernization Act (FSMA), the most sweeping reform of U.S. food safety laws in over 70 years. Enacted in 2011 and now set to be implemented through seven major substantive rules—all issued within a 9-month period ending in May 2016—FSMA introduces a new era in food safety by focusing on preventing food safety risks rather than on responding to crises after they happen. As we enter the enforcement stage for the new rules, we consider the practical challenges of each rule and identify areas where enforcement may provide clarity, including in relation to one of the most difficult aspects of the final rules: regulation of the supply chain.
Each of the seven foundational rules plays a distinct role in the new integrated national food safety system, and together, they reflect the U.S. Food and Drug Administration (FDA)’s mandate to comprehensively regulate and modernize virtually all aspects of the food industry. Under this new framework, FDA requires preventive controls for food facilities and mandatory produce safety standards for a broad range of farming activities. Importers must verify that food produced on foreign farms and facilities is produced under standards at least as rigorous as those that apply to domestic food, and an accreditation program will regulate certain audits of foreign foods and foreign facilities. Regulations to minimize food safety risks during transport will apply to persons involved in the transportation of food by motor or rail carrier, including shippers, carriers, receivers, loaders and even brokers. And larger facilities will be required to protect against intentional adulteration intended to cause wide-scale public harm.
To allow FDA to accomplish this sweeping mandate, FSMA provides the agency with expanded enforcement authority to compel compliance with the new rules and to respond to and contain problems when they occur. Under FSMA, FDA now has mandatory recall authority, more flexible authority to administratively detain or to deny entry to food that poses potential safety risks, the ability to suspend facility registrations and the authority to require expanded record-keeping. The enforcement penalties for noncompliance are severe. Failure to comply with the rules may result in significant civil and strict-liability criminal penalties, which means that responsible persons can be guilty of a crime without negligence or knowledge of a violation.
In some of the most challenging provisions of the new rules, FDA imposes obligations on covered parties to verify and to provide or receive documentation regarding food safety risks to other parties in their food supply and distribution chains. In some instances, these requirements even require covered entities, such as importers, to obtain verifications from entities multiple steps back in the supply chain. Given the complexity of many modern supply chains, complying with these provisions will prove challenging in practice, and the industry will be watching to determine how FDA enforces these particular regulations.
As with all new regulations, questions remain about FDA’s expectations for certain aspects of the FSMA rules, as well as how those uncertainties may impact business operations. As these deadlines approach, it is important to examine particular challenges with each of the rules and understand key considerations regarding likely implementation challenges and potential enforcement risks.
The Preventive Controls Rule
One of the cornerstones of the new FSMA regulations is the final rule regarding Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food (the Preventive Controls rule). Under the Preventive Controls rule, a facility is required to develop a written food safety plan that includes a risk-based assessment to identify hazards where preventive controls are necessary to significantly minimize or prevent hazards for any food that is manufactured, processed, packed or held at the facility. The written food safety plan must also include procedures for monitoring, corrective actions and verification of each preventive control. Raw materials or ingredients must be sourced only from approved suppliers, and manufacturers and processors must verify that their suppliers are controlling for hazards earlier in the supply chain.
Many facilities were required to comply with the Preventive Controls rule by September 19, 2016, although facilities have longer to comply with the “supply chain program” requirements, for which there are varying deadlines depending on the facility and the supplier. Here are some considerations as you make one last check that your food safety plan is in order:
Remember that the Preventive Controls Rule Is Not HACCP
Your Hazard Analysis should not be limited to the Critical Control Points (CCPs) set forth in your Hazard Analysis and Critical Control Points (HACCP) plan, if you have one. Even a world-class HACCP plan may not be sufficient. Conversely, even facilities with no CCPs might need preventive controls. The goal of the Preventive Controls rule is to identify a broader class of “hazards requiring a preventive control,” which may exist other than at CCPs.
Take a Tiered Approach to Hazard Analysis
The Preventive Controls rule refers to “hazards,” “known or reasonably foreseeable hazards” and “hazards requiring a preventive control.” Let this guide your Hazard Analysis. Out of the entire universe of hazards—that is, biological, chemical (including radiological) or physical agents likely to cause illness or injury—your Hazard Analysis should identify those that are “known or reasonably foreseeable” for each type of food manufactured, processed, packed or held at your facility. Out of this subset of hazards, you should identify those “hazards requiring a preventive control.” This is a risk-based determination, considering both the severity of illness or injury if the hazard occurs and the probability the hazard will occur in the absence of preventive controls.
Broaden Your Focus Beyond Adulteration and Reportable Risks
In identifying “hazards requiring a preventive control,” focus on hazards that are reasonably likely to cause illness or injury. Such risks might not rise to the level of “serious adverse health consequences or death to humans or animals” (a “SAHCODHA” threat), which would render a food “reportable” for the purposes of the Reportable Food Registry. But you also are not identifying every agent that could potentially render a food “adulterated” under the Federal Food, Drug, and Cosmetic Act. For example, production of food under insanitary conditions might “adulterate” a food but would not necessarily cause illness or injury. We will be watching for guidance and enforcement to clarify the severity and probability thresholds that must be reached for specific hazards to require a control.
Don’t Miss These Supply Chain Program Minimums
You do not want to miss the forest for the trees with the FSMA requirements, but there are some trees in the “supply chain program” requirements to which you must pay close attention. According to FDA, manufacturers and processors “cannot ignore published information relating to a supplier’s compliance with applicable FDA food safety regulations” when they approve suppliers or determine appropriate supplier verification activities. If you receive raw materials or ingredients from a supplier, it is a mistake not to document that you have searched FDA’s publicly available databases for warning letters and import alerts and researched publicized actions for the potential suspension of a supplier’s facility registration. Similarly, if a supply chain control is required for a SAHCODHA threat (e.g., pathogens or their toxins in ready-to-eat foods, most undeclared allergens, etc.), then an annual audit is the presumptively appropriate supplier verification activity. Refer to reports from the Reportable Food Registry for assistance in determining whether a hazard presents a SAHCODHA threat and make sure your food safety plan includes a written explanation if you decide on a verification activity other than an audit. Finally, make sure you have procedures for receiving raw materials and other ingredients, including a documented mechanism for ensuring food is received only from approved suppliers.
“We’d Like to See Your Food Safety Plan”
Be prepared to produce your written food safety plan within 24 hours. This sounds easy enough. But if your food safety plan consists of records in multiple places at a facility (although the plan must be located on-site), make sure you are not confirming its contents or its whereabouts after FDA requests a review. This is particularly important because FDA has suggested that it may rely on “two-tiered” reviews to enforce FSMA, starting first with a records request for the food safety plan before proceeding to an on-site physical inspection of a facility.
Compliance with most of the requirements for the Preventive Controls rule is now required for many facilities. With the supply chain program requirements fast approaching—as soon as March 2017 for some facilities—now is the time to reconfirm that your food safety plan is in full compliance with the Preventive Controls rule.
The Produce Safety Rule
When one considers the types of foodborne illness outbreaks that FSMA is designed to address, no other sector of the food supply more immediately comes to mind than fresh produce. Precisely because a number of recent outbreaks have involved fruits and vegetables, FSMA’s final rule regarding Standards for the Growing, Packing and Holding of Produce for Human Consumption (the Produce Safety rule) for the first time establishes science-based minimum standards that are focused entirely on “farms.”
Some of the clarity that the Produce Safety rule provides can be lost in the density of the science. The rule focuses on six areas of farm-related produce safety risks—worker training and hygiene; agricultural water practices; biological soil amendments (e.g., manure and composting methods); animal-related contamination (both wild animal intrusion and working animals); farming equipment and buildings; and special provisions focused entirely on sprouts.
This spectrum of risks reflects FDA’s effort to address and define “the realities and range of activities that farms conduct.” Under the final rule, a “farm” is an operation in one general (although not necessarily contiguous) location that is devoted to the growing or harvesting of crops or the raising of animals. You might think of this as the core of farming activity, as FDA sees it, and various farming operations branch out from that starting point. Covered farming operations also include more complex associations. For example, cooperatives and on-farm packinghouses, food aggregation and minimal “manufacturing” or “processing” activities and even off-farm packing at a “secondary activities” farm all fall within the “farm” definition.
The immediate and important practical consequence of FDA’s acknowledgement of the breadth of modern farming practices is that a greater number of food suppliers are “farms” covered by the Produce Safety rule, and not “facilities” subject to the Preventive Controls rule. Unlike the Preventive Controls rule, which requires facilities to consider biological, chemical (including radiological) or physical hazards, the Produce Safety rule focuses entirely on biological hazards. It does so by using generic Escherichia coli as a proxy for the potential threat of fecal contamination and requires that no detectable generic E. coli be present in any agricultural water used in harvest and postharvest activities, or that certain thresholds not be exceeded during direct-application growing activities. More rigorous requirements apply to sprouts because the warm, moist conditions in which they grow are conducive to growing harmful bacteria.
Farms will need to make a proactive effort to comply with the Produce Safety rule. For example, farms are responsible for maintaining the integrity of their agricultural water sources, including by regularly inspecting those sources for conditions “reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces.” In some situations, this will require farms to consider conditions beyond their control, including uses of nearby or adjacent land and other uses of the same water source. If an event impacts the quality of a water source (e.g., discovery of a dead animal in a spring used for irrigation or changes in adjacent land use), a farm might need to take corrective measures and revise the water quality profile for the source that is required to be developed under the rule. Farms also must take measures to identify and not harvest produce that is reasonably likely to be contaminated. At a minimum, this requires inspection of all covered produce to be harvested.
Downstream manufacturers, processors and restaurants or retail food establishments should review the exemptions if they intend to source from FSMA-covered produce farms. For example, small farms with average annual produce revenue of less than $25,000 during the previous 3-year period are not covered by the Produce Safety rule. In addition, farms with average food sales of less than $500,000 per year during the previous 3-year period and that predominantly sell to “qualified end-users,” including restaurants or retail food establishments in the same state or within a 275-mile radius, are subject only to modified requirements that primarily relate to identifying the farm on the label or at the point of purchase. Entities that source produce from exempt small farms or farms subject to the modified requirements might need to do additional diligence regarding the safety practices at those farms. Finally, although produce that will be subjected to commercial processing is exempt from the rule, this applies only if the supplier discloses that the produce has not been processed and if the customer provides an annual written assurance that it is adequately processing the produce.
The Produce Safety rule covers the entire spectrum of day-to-day farming practices. Even well-advanced farming operations should review the rule carefully to make sure they are complying with the new requirements, including with respect to training and record-keeping. In addition, downstream entities, including manufacturers and processors who must verify produce suppliers as part of their preventive controls supply chain program, should consider whether farms sourcing their produce are covered by and in compliance with the Produce Safety rule.
Foreign Supplier Verification Program Rule
As part of its mandate under FSMA, FDA must implement a program to ensure that food imported from foreign suppliers is produced in compliance with processes that provide the same level of safety protection that is required of domestic facilities. Under FDA’s rule regarding Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule), “importers” must develop written plans to approve foreign food suppliers and also conduct supplier verification
The FSVP rule defines “importer” as “the U.S. owner or consignee of an article of food that is being offered for import into the United States,” and “[i]f there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under this subpart.” The rule further defines “U.S. owner or consignee” as “the person in the United States who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food.”
For facilities already required to comply with the supply chain requirements of the Preventive Controls rule (i.e., manufacturers or processors who receive raw materials or ingredients from suppliers), this language presents little challenge. If such a facility complies with the Preventive Controls rule, it will be in compliance with the FSVP rule (except for a requirement that the FSVP importer be identified at the time of entry of the food). But for facilities other than manufacturers or processors, including warehouses or distributors that only hold or pack food, identifying the appropriate FSVP “importer” is more difficult.
As the industry waits for additional guidance from FDA regarding how to identify the “importer” for the FSVP rule, facilities should focus on a few factors to guide their analysis. As an initial matter, remember that “importer” is specifically defined in the FSVP rule. FDA has emphasized that an “importer” for FSVP purposes is not necessarily either the importer of record for customs purposes or the person who submits information to comply with FDA prior notice regulations. You might be an importer for some other purpose but not for the FSVP rule.
FDA also has said that the FSVP “importer” should have “a financial interest in the food” and “knowledge and control of the food’s supply chain” at the time the food enters the United States. This could be true of multiple parties, so consider which party has a greater financial interest and knowledge and control of the supply chain at the time of entry. This will not necessarily be the direct owner of the food, in part because “entry” refers not to physical entry, but rather to the filing of certain papers with U.S. Customs and Border Protection. FDA has acknowledged “it is possible for U.S. persons to purchase or agree in writing to purchase food at the time of entry to the United States, even if they do not yet own the products at that time.”
Based on its comments to date, FDA’s promised guidance is likely to be fairly generalized to account for a variety of commercial relationships. On the one hand, this means that FDA might give the parties in a supply chain the flexibility to determine the most appropriate “importer.” In fact, FDA suggested in a presentation soon after publication of the final rule that the respective parties in the supply chain will be in the best position to identify the “importer” based on the circumstances. On the other hand, there are costs to this flexibility: Potentially covered entities will need to clarify the “importer” in each case, and it is unclear how FDA will evaluate supply chain relationships when the “importer” is not clearly identified.
The FSVP rule presents unique challenges because of the lack of clarity regarding the identification of the covered “importer” as a threshold matter. At least until FDA clarifies its position in guidance, potentially covered “importers” have no alternative but to work with other supply chain partners to identify the most appropriate FSVP “importer” based on financial interest and control of the supply chain and the particular circumstances of each situation.
Foreign Audits Rule
As part of its sweeping reforms, FSMA mandates that FDA take steps to ensure the safety of food imported from foreign sources. In a narrow, technical rule with important implications for FSMA’s overall design, the final rule regarding Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications (Foreign Audits rule) establishes a voluntary program by which foreign entities may request food safety audits and certifications from accredited third-party auditors.
The narrow focus of the Foreign Audits rule can make it difficult to discern how the rule fits into FSMA’s overall scheme. Here is how it works: FDA will start by recognizing certain accreditation bodies that will certify third-party auditors to conduct foreign food safety audits. A foreign entity, including a foreign “facility” that is required to register with FDA under Section 415 of the Food, Drug, and Cosmetic Act, can then voluntarily request that an accredited third-party auditor conduct a food safety audit or provide certifications for a food or a facility. There are two threshold takeaways: The program is voluntary, and it applies only to foreign entities.
This of course begs the question why an entity might ever want an audit under the Foreign Audits rule. There are two primary reasons. First, FDA is required to set up what is called the Voluntary Qualified Importer Program (VQIP), which, for a fee, will allow for expedited review and entry for firms with “a high level of control over the safety and security of their supply chains.” Only foreign entities that have been certified by a third-party audit under the Foreign Audits rule can participate in the VQIP. The idea is that expedited entry might incentivize foreign entities to request audits under FDA’s guidelines.
The second reason that an audit under the Foreign Audits rule might be needed is that FDA has the authority, in limited circumstances, to require certification from an accredited third-party auditor as a condition of admissibility. This authority is risk-based and is limited to circumstances in which FDA determines that a food presents a potential safety risk. (Additionally, instead of requesting certification under the Foreign Audits rule, FDA may request certification of an agency or representative of the government of the country from which the foreign food originated.) By requiring certification under the Foreign Audits rule, FDA can ensure both the competence and independence of the third-party auditor in situations involving greater potential public risk.
In addition to these two statutory-based reasons for seeking an audit under the Foreign Audits rule, a foreign entity might voluntarily seek an audit under the rule for reasons relating to the supply chain aspects of FSMA more generally. This relationship probably contributes to some of the confusion about the rule. Under the Preventive Controls rule and the FSVP rule, a receiving facility or importer, respectively, might determine that an audit of a supplier is required as a supplier verification activity under those rules. Such an audit must be conducted by a “qualified auditor,” and that auditor can be, but need not be, an accredited third-party auditor under the Foreign Audits rule.
This means that a successful audit under the Foreign Audits rule has significant benefits: expedited entry, coverage in the unlikely event of a risk-based FDA demand and satisfaction of a downstream supplier verification request. But here’s the other side of the coin: An accredited third-party auditor is required to perform unannounced facility audits and to notify FDA upon discovery of a condition that could cause a serious risk to public health. The third-party auditor may, but is not required to, notify the audited entity at the same time notice is given to FDA where concurrent notice is “feasible and reliable.” This notification requirement applies to “consultative” audits that are intended for internal purposes only and to “regulatory” audits that can be used to acquire certification under the Foreign Audits rule.
The Foreign Audits rule has a narrow but significant role in FSMA’s ability to minimize food safety risks from foreign sources. As the rule is implemented, the industry will be watching in particular for how significantly FDA incentivizes participation in the voluntary accreditation program by expedited entry through the VQIP. FDA has indicated that the programs under the Foreign Audits rule will be implemented once it finalizes guidance regarding model standards that will be used to accredit third-party auditors and after it finalizes a rule that will establish the user fees that will reimburse FDA for its costs in establishing and administering the program.
Sanitary Transport Rule
As part of FDA’s reform of the nation’s food safety system under FSMA, the Sanitary Transportation of Human and Animal Food Rule (Sanitary Transport rule) addresses unsafe practices that may create food safety risks during transportation by rail or motor vehicle. Applicable to shippers, carriers, loaders and receivers of food in intrastate or interstate commerce, the rule imposes vehicle and equipment standards, temperature and cross-contamination controls and training and record-keeping requirements.
Industry should take note of some important changes in the final rule. The final rule clarifies that its focus is on threats to food safety, not spoilage or quality-related defects that do not necessarily render food adulterated. In addition, the final rule clarifies that the primary responsibility for communicating safety-related shipping requirements falls on the shipper, who is best situated to make this determination and will be required to communicate any requirements in writing to the carrier. Safety-related requirements include temperature controls, although the final rule provides the parties flexibility to agree how this will be done in each case.
A carrier that takes on food safety-related obligations must ensure that its own personnel are adequately trained, and in some circumstances, a carrier might be required to demonstrate to the shipper or receiver that all safety requirements have been met. At a minimum, shippers and carriers should review their shipping contracts to make sure that safety responsibilities and liabilities are clearly and appropriately allocated and comply with the new requirements. This deference to the contracting process and the placement of the primary obligation on shippers to communicate safety requirements is a win for carriers, and probably for the industry in general.
Brokers and loaders, however, probably will not be pleased with the final rule. FDA expressly included freight brokers in the definition of “shipper” in the final rule and added “loaders” (i.e., persons who physically load food onto vehicles) as an additional category of covered parties. As a practical matter, manufacturers will need to ensure that safety-related information is provided to loaders and freight brokers, who may, in turn, demand higher rates for taking on the additional legal responsibility under the rule. The final rule allows any covered party to reassign its responsibilities to any other covered party, so brokers, loaders and manufacturers should review their contracts to make sure that responsibilities are clearly allocated. Even when this is done successfully, however, manufacturers should also review their shipping papers to ensure that sufficient safety information is provided directly to carriers. A bill of lading might be the only contract that a manufacturer has with a carrier if carriage for the shipment was arranged through a broker and the broker goes under or fails to pass on safety information or liability to a carrier. Few bills of lading currently convey such information adequately.
Notwithstanding the flexibility given to covered parties to contract around their respective obligations, covered parties should note the final rule makes clear that any shipper (including a broker), carrier, receiver or loader who becomes aware of a condition that “may” have rendered food unsafe during transport must take action to make sure the food is not sold or further distributed until a qualified individual can evaluate its safety. (This is in addition to a receiver’s obligation to assess the safety of any food requiring temperature controls.) As with all the provisions of the Sanitary Transport rule, a violation of this provision is a “prohibited act” under the Food, Drug, and Cosmetic Act and raises the risk of serious criminal penalties. All covered parties, no matter what contracts are involved, should know this provision.
The Sanitary Transport rule does not apply to transportation operations of entities with less than $500,000 in average annual revenue, to foods that are completely enclosed by a container (unless the foods require temperature controls for safety) or to transportation involving certain animal food, food contact substances, compressed food gases, live animals and food that is trans-shipped or imported for future export. Other exemptions are provided for food when it is located in facilities subject to the exclusive jurisdiction of the U.S. Department of Agriculture (this exemption does not include dual-jurisdiction establishments) and to all transportation operations conducted by a farm. Businesses with fewer than 500 full-time equivalent employees, and motor carriers that are not also shippers and receivers and having less than $27.5 million in annual receipts, must comply with the final rule by April 2018.55 All other covered businesses must comply by April 2017.
Food Defense Rule
In perhaps the most distinctive of the FSMA rules, the rule regarding Mitigation Strategies to Protect Food Against Intentional Adulteration (Food Defense rule) requires large food companies for the first time to develop and implement written “food defense” plans to assess and manage the risk of an act of intentional adulteration intended to cause wide-scale public harm. In developing food defense plans, covered entities must conduct an analysis of each facility to assess significant vulnerabilities to intentional adulteration (in particular, the risk of an “inside attacker”), as well as develop mitigation and management strategies to minimize those risks.
The Food Defense rule focuses on large companies whose food products are most likely to reach the greatest number of people. Smaller facilities and specific industry sectors are exempt. Although the rule is a first of its kind, many facilities should be able to leverage their existing food safety policies and procedures as they set out to draft their food defense plans.
A covered facility should start first by determining who will develop the food defense plan. The plan must be prepared by “one or more qualified individuals,” and facilities might find it helpful to assemble a “vulnerability assessment team.” As FDA suggested in the proposed Food Defense rule, this team could include security personnel, food safety or quality assurance specialists, human resources, members of the operations or maintenance staff or a qualified third party. Deciding who should participate in a food defense strategy will be a facility-specific determination, and facilities should document their decisions regarding who is included and why. Use this as an opportunity to demonstrate to FDA that you were deliberate from the outset.
The axis of your food defense plan will be the required written “vulnerability assessment.” FDA referred to this in a webinar as the most novel and complex part of the Food Defense rule, so give particular focus here. The goal of the vulnerability assessment is to identify “actionable process steps” at which mitigation is needed to minimize the risk of a significant vulnerability to intentional adulteration. Start by preparing a flow chart to identify “each point, step or procedure” in the production process, and then at each point, consider three factors. (Let’s call these “the three vulnerability factors.”) Specifically, at each process point, consider the potential public health impact if a contaminant were added, the degree of physical access to the product and the ability of an attacker to successfully contaminate the product if access were obtained. As you progress from process point to process point, take special note of certain “key activity types”—bulk liquid receiving and loading; liquid storage and handling; secondary ingredient handling; and mixing and similar activities. Although it is not expressly set out in the final rule, FDA previously identified these key activity types as consistently the most vulnerable in over 50 vulnerability assessments applying the three vulnerability factors. These activities most likely will be actionable process steps in all but exceptional instances at your facility.
Use the three vulnerability factors to shape the rest of your food defense plan. At each actionable process step, a mitigation strategy must be implemented that is focused on the specific process step. Simplify this by focusing on the three vulnerability factors. For example, what mitigation will minimize access at this actionable process step? And how might you reduce the likelihood of successful contamination if access is obtained? (If you can accomplish both of these goals through mitigation, you also will have reduced the potential public health impact.) Locking ingredients in sealed containers in a sealed room and staging immediately prior to production might reduce access to an ingredient. Similarly, staffing sensitive areas with multiple employees or introducing downstream formulary controls might reduce the likelihood of successful contamination. Whatever mitigation is selected, you are required to support it with a written explanation, so use this opportunity to document the thoroughness of your decisions.
Stay focused on the vulnerability factors as you consider the “management” components of your food defense plan. In developing your food defense verification procedures, refer back to the written explanations you provided in support of your mitigation strategies. How effectively has each mitigation strategy minimized physical access and the potential for an inside attacker to contaminate the production process successfully? In answering these questions, you are not simply verifying your mitigation strategies—you are also verifying how well your monitoring procedures have identified deficiencies and supported effective corrective actions.
The Food Defense rule is a first-of-its-kind regulation. But by focusing on the three vulnerability factors and applying them through a step-by-step approach that is similar to a preventive controls or CCP analysis, facilities can leverage their experience in food safety issues as they address the unique challenges presented by the Food Defense rule.
While these new rules have challenging provisions, FSMA promises to introduce a new era in food safety by focusing on preventing food safety risks rather than on responding to crises after they happen. We considered the practical challenges of each rule and identified areas where enforcement may clarify how to implement the rules.
As with all new regulations, questions remain about FDA’s expectations in the coming years, as well as how those uncertainties may impact business operations. As implementation nears, it is important to examine these challenges and understand key considerations regarding likely implementation challenges and potential enforcement risks.
James F. Neale, Esq., is a partner and codeputy chair of McGuireWoods LLP’s food and beverage team. He regularly advises food manufacturers, distributors and retailers on regulatory compliance and litigation avoidance. He defends clients in food-related litigation, including cases of foodborne illness and labeling claims. He can be reached at firstname.lastname@example.org.
J. Brian Jackson, Esq., is a partner and cochair of McGuireWoods’s transportation industry team. His transportation clients span the full industry spectrum, including companies that transport food and food additive products. He tries high-exposure jury cases in jurisdictions throughout the United States. He can be reached at email@example.com.
Christopher A. Ripple, Esq., is an associate at McGuireWoods LLP. He focuses his practice on litigation and regulatory matters with an emphasis on the food and transportation industries. He advises food manufacturers, distributors and transporters on compliance with food labeling and food safety laws and counsels clients on federal transportation regulations. He can be reached at firstname.lastname@example.org.
1. Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food; Final rule, 80 Fed. Reg. 55907 (Sept. 17, 2015) (Preventive Controls rule). A similar rule, addressed to animal food, was finalized by FDA under FSMA on the same day. See Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Final rule, 80 Fed. Reg. 56169 (Sept. 17, 2015).
2. Preventive Controls rule, 80 Fed. Reg. at 56128.
3. See 21 C.F.R. § 117.3 (definitions of “hazard” and “hazard requiring a preventive control”).
4. Preventive Controls rule, 80 Fed. Reg. at 55950.
5. See 21 C.F.R. Part 117, subpart G (detailing the requirements of a supply-chain program).
6. Preventive Controls rule, 80 Fed. Reg. at 56105-56106.
7. 21 C.F.R. § 117.430(b).
8. Id. §§ 117.410, 117.415.
9. Id. §§ 117.315(c), (d); 117.320.
10. Public Meeting: FDA Food Safety Modernization Act Final Rules on Preventive Controls for Human and Animal Food, FDA-2015-N-0001, Oct. 20, 2015, Trans. at pp. 158–159.
11. Standards for the Growing, Packing and Holding of Produce for Human Consumption; Final Rule, 80 Fed. Reg. 74353 (Nov. 27, 2015) (Produce Safety rule).
12. Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Human Food; Final rule, 80 Fed. Reg. 55907, 55936 (Sept. 17, 2015) (the Preventive Controls rule) (discussing revisions to the “farm” definition in the FSMA rules).
13. 21 C.F.R. § 112.3 (definition of “farm”).
14. Produce Safety rule, 80 Fed. Reg. at 74396.
15. 21 C.F.R. § 117.130.
16. 21 C.F.R. § 112.3 (defining “known or reasonably foreseeable hazard” as “a biological hazard that is known to be or has the potential to be, associated with the farm or the food”); id. at § 112.11 (requiring farms to take appropriate measures “reasonably necessary to prevent the introduction of known or reasonably foreseeable hazards into covered produce”).
17. See id. § 112.44.
18. See 21 C.F.R. Part 112, subpart M (sprouts); see also Produce Safety rule, 80 Fed. Reg. at 74507 (describing significance of sprout conditions).
19. 21 C.F.R. § 112.42.
20. See Produce Safety rule, 80 Fed. Reg. at 74431–32; id. at 74455–56.
21. 21 C.F.R. § 112.112.
22. Id. § 112.4(a).
23. Id. § 112.5(a) (modified requirements); id. § 112.3 (definition of “qualified end-user”).
24. Id. § 112.2(b).
25. For the various compliance dates under the Produce Safety rule, see 80 Fed. Reg. at 74357.
26. See Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Final rule, 80 Fed. Reg. 74225 (Nov. 27, 2015) (FSVP rule).
27. 21 C.F.R. § 1.500 (definition of “importer”).
28. Id. (definition of “U.S. owner or consignee”).
29. Id. § 1.502(c).
30. FSVP rule, 80 Fed. Reg. 74300 (Nov. 27, 2015).
31. Id. at 74238.
32. Id. at 74240.
34. For information regarding compliance deadlines for the FSVP rule, see 80 Fed. Reg. at 74332.
35. Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications; Final rule, 80 Fed. Reg. 74569 (Nov. 27, 2015) (Foreign Audits rule).
37. 21 U.S.C. §§ 381(q) and 384d.
38. 21 C.F.R. § 117.3 (definition of “qualified auditor”); 21 C.F.R. § 1.500 (definition of “qualified auditor”).
39. 21 C.F.R. § 1.651(b)(1) (unannounced audits); id. § 1.656(c).
40. 21 C.F.R. § 1.656(e)(1).
41. Id. § 1.656(c).
43. See User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certification; Proposed rule, 80 Fed. Reg. 43987 (July 24, 2015).
44. Sanitary Transportation of Human and Animal Food; Final rule, 81 Fed. Reg. 20091 (Apr. 6, 2016) (Sanitary Transport rule).
45. Id. at 20093.
46. 21 C.F.R. § 1.908(b)(2)(5).
47. See generally id. § 1.908(e) (requirements applicable to carriers); id. § 1.910 (carrier training requirements).
48. Id. § 1.900(a) (stating that requirements apply to shippers, carriers, loaders and receivers); id. § 1.904 (defining “shipper” to include brokers).
49. Id. § 1.908(a).
50. Id. § 1.908(d).
51. Id. § 1.900(b).
52. 21 C.F.R. § 1.904 (definition of “noncovered business”).
53. 21 C.F.R. §§ 1.904 (definition of “transportation operations”), 1.900(b) (listing exemptions).
54. 21 C.F.R. §1.904 (definition of “small business”).
55. Sanitary Transport rule, 80 Fed. Reg. 20160 (Apr. 6, 2016) (regarding effective and compliance dates).
56. Mitigation Strategies to Protect Food against Intentional Adulteration; Final rule, 80 Fed. Reg. 34165 (May 27, 2016) (Food Defense rule).
57. Id. at 34190.
58. 21 C.F.R. § 121.5 (exemptions).
59. Focused Mitigation Strategies to Protect Food against Intentional Adulteration; Proposed rule, 78 Fed. Reg. 78013, 78042 (Dec. 24, 2013); see also Food Defense rule, 80 Fed. Reg. at 34197.
60. See generally 21 C.F.R. § 121.130.
61. See Food Defense rule, 80 Fed. Reg. at 34197.
62. Id. at 34195–96.
63. 21 C.F.R. § 121.135.
64. See 21 C.F.R. § 121.138 (regarding “mitigation strategies management components,” including monitoring, corrective actions and verification).
How Well-Equipped is Your Facility?
Source : http://www.foodsafetymagazine.com/signature-series/how-well-equipped-is-your-facility/
By Ken Ferguson (Oct 11, 2016)
In the United States, foodborne illness accounts for a substantial amount of sicknesses, hospitalizations and deaths recorded annually. The U.S. Centers for Disease Control and Prevention estimates 3,000 deaths and 128,000 hospitalizations from foodborne pathogens each year in the U.S. alone.
Despite occurring with relative frequency, these incidents are largely avoidable. To address this public health problem, food safety laws are becoming increasingly stringent and more heavily enforced. Complying with these federal regulations is the ideal standard and should be common practice as it not only establishes trust with consumers, it also reduces the likelihood of a company becoming the subject of the next recall headline.
In addition to meeting these strict hygienic requirements and regulations, the food processing industry must adopt solutions that will maximize efficiency and minimize their operating costs. Below are examples of best practices food-processing facilities should consider in order to ensure they are up-to-date with federal food safety regulations.
Know the Regulations
Although the Food Safety Modernization Act (FSMA) was signed into law 5 years ago, the first major compliance date for large food facilities is slated for this month. Under FSMA, the U.S. Food and Drug Administration (FDA) is concentrating its efforts to prevent contamination, which is in stark contrast to the mostly reactive role the federal agency has previously occupied. While FSMA does not address food equipment standards directly, companies should factor in the new regulations when determining which equipment will most effectively enable them to meet hygiene and sanitation requirements.
Update Your Equipment
For an entire facility to be considered up to code, each and every piece of equipment must be compliant. Conveyors, for instance, are a crucial element of a food processing plant, coming into contact with every unit of product that it transports throughout the facility.
In this example, the design of the conveyor system should not leave room for water to enter or gather. The surface of the belt should be rounded or on an incline so as not to collect stagnant water, and the belts themselves must be resistant to chemicals and bacteria. Both conveyor belts and drum motors must be able to withstand frequent, wet and high-pressure wash-down applications. The latter should be constructed with stainless steel that is chemical- and rust-proof, and feature an enclosed design that is conducive to hygiene.
Ideally, equipment will be certified by multiple authorities, such as the U.S. Department of Agriculture and the FDA. Because of the sheer size of the food industry, it can be difficult for auditors to monitor whether or not equipment manufacturers are authorized to advertise certain certifications. It is imperative that purchasers perform adequate research to ascertain whether the equipment is truly compliant with current regulations.
Put Your Equipment Under the Microscope
Since equipment is typically purchased through an original equipment manufacturer, users must thoroughly examine each component’s features and specifications. However, a common mistake is to assume a piece of equipment is hygienic because it is constructed with stainless steel or it has an optimal ingress protection (IP) rating. These features do not always necessarily guarantee the equipment is hygienic, and therefore users must be prepared to probe deeper for answers.
Questions for users to consider include:
•Is each part easy to access for inspection and cleaning?
•Are there any surface areas vulnerable to water ingress or bacteria buildup?
•What IP rating does the part carry?
•Will these parts be able to perform under extended exposure to high or low temperatures?
•Are materials corrosion-resistant?
•Does the heat output from a component have the potential to affect the food quality?
Provide Specialized Training
Professional and continuing education is crucial for the success of any business and the food industry is no exception. Employees who receive training will be well versed in the federal standards, making them more confident and efficient in their work. By providing regular training in installation, proper cleaning and sanitation methods, organizations are further demonstrating their commitment to public health and best business practices.
While the impact of FSMA remains to be seen, companies cannot afford to delay implementing food safety practices. They must seek out hygienic food equipment design for their facilities and act responsibly or risk an outbreak that could cripple their business.
Ken Ferguson has more than 20 years of sales experience, specializing in automation components and motion control systems. As the U.S. sales and marketing director of Interroll, Ken is responsible for planning and implementing product development programs to achieve corporate objectives for products and services.
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 (email@example.com) 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. (firstname.lastname@example.org), 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. (email@example.com), 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.
Researchers confirm Crohn’s often follows foodborne illnesses
Source : http://www.foodsafetynews.com/2016/10/researchers-confirm-crohns-often-follows-foodborne-illnesses/#.WAQqkk6tSUl
By Dan Flynn (Oct 11, 2016)
Foodborne illnesses have long been suspected of leading to Crohn’s disease, a chronic inflammatory bowel disease (IBD).
An immune response to tissue injury has been known to causes redness, swelling and pain in the digestive or gastrointestinal (GI) tract with the potential for also threatening the mouth, esophagus, stomach, small and large intestines, and anus.
Crohn’s can affect any part of the GI tract, from the mouth to the anus, but it is more commonly found at the end of the small intestine. This is the area where the large intestine or colon begins.
New research published in the Oct. 6, 2016 edition of PLOS/Pathogens confirms that exposure to foodborne pathogens causing acute gastroenteritis does produce a long-term risk of Crohn’s disease “well into the post-infectious period but the mechanistic basis for this ongoing relationship to disease onset is unknown.”
About 700,000 people suffer from Crohn’s annually in the U.S., and its an equal opportunity disease impacting men and women at about the same rates. Symptoms range from mild to severe. And while Crohn’s can strike at any age, most people experience onset in the 15 to 35 age range. Also 20 percent of people with Crohn’s have a relative who also has the disease.
The new research entitled “Acute Infectious Gastroenteritis Potentiates a Crohn’s Disease Pathobiont to Fuel Ongoing Inflammation in the Post-Infectious Period” was funded by grants from the Canadian Institutes of Health Research and Crohn’s and Colitis Canada.
The researchers say adherent-invasive E. coli are among the bacteria that has been linked to Crohn’s, with several laboratories having reported a higher prevalence of E. coil in Crohn’s patients compared to healthy subjects.
The E. coli are said to share an “evolutionary ancestry” with extraintestinal pathogenic E coli. Crohn’s is more common in individuals exposed to infectious gastroenteritis caused by Salmonella and other enteric pathogens, “sometimes with onset times on the order of years after the infectious episode,” the researchers reported.
They found infectious gastroenteritis increases the risk of Crohn’s; that gastroenteritis causes inflammation that selectively disrupts the resident intestinal microbiota; and intestinal infections are a probable cause of relapse for inflammatory bowel disease patients.
Their work came to conclusion that E. coli colonized in the gut is a modifier to response to acute infectious gastroenteritis.
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