Tag Archives: Focus Article

David Chambliss, IBM Research
In the Food Lab

Scientific Breakthrough May Change Food Safety Forever

By David Chambliss
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David Chambliss, IBM Research

How safe is a raw diet? Could sterilizing our food actually make us more prone to sickness? Are vegans healthier than carnivores? In the last few decades, global food poisoning scares from beef to peanut butter have kept food scientists and researchers around the world asking these questions and searching for improved methods of handling and testing what we eat.

It’s been more than 150 years since Louis Pasteur introduced the idea of germ theory—that bacteria cause sickness—fundamentally changing the way we think about what makes our food safe to eat. While we’ve advanced in so many other industrial practices, we’re still using pasteurization as the standard for the global food industry today.

Although pasteurization effectively controls most organisms and keeps the food supply largely safe, we continue to have foodborne outbreaks despite additional testing and more sophisticated techniques. The potential health promise of genomics, and the gut microbiome genetics and bacterial ecosystems, could be the key to the next frontier in food safety.

The scientific community is once again at the cusp of a new era with the advent of metagenomics and its application to food safety.

What is metagenomics? Metagenomics is the study of the bacterial community using genetics by examining the entire DNA content at once. Whole genome sequencing of a single bacterium tells us about the DNA of a specific organism, whereas metagenomic testing tells us about the interaction of all the DNA of all the organisms within a sample or an environment. Think of the vast quantity of genetic material in the soil of a rice patty, a lettuce leaf, your hand, a chicken ready for cooking, or milk directly from a cow. All of them have thousands of bacteria that live together in a complex community called the microbiome that may contain bacteria that are sometimes harmful to humans—and possibly also other bacteria that help to keep the potentially harmful bacteria in check.

Metagenomics uses laboratory methods to break up cells and extract many millions of DNA molecular fragment, and sequencing instruments to measure the sequences of A’s, C’s, G’s, and T’s that represent the genetic information in each of those fragments. Then scientists use computer programs to take the information from millions or billions of fragments to determine from what bacteria they came. The process is a little like mixing up many jigsaws, grabbing some pieces from the mix, and figuring out what was in the original pictures. The “pictures” are the genomes of bacteria, which in some cases carry enough unique information to associate a given bacterium with a previously seen colony of the same species.

Genomics of single bacterial cultures, each from a single species, is well established as a way to connect samples of contaminated foods with reported cases of foodborne illnesses. With metagenomics, which essentially looks for all known species simultaneously, one hopes to do a better job of early detection and prevention. For example, if a machine malfunction causes pasteurization or cleaning to be incomplete, the metagenomics measurement will likely show compositional shifts in which bacterial phyla are abundant. This can make it possible to take remedial action even before there are signs of pathogens or spoilage that would have led to a costly recall.

Up until now, keeping food safe has meant limiting the amount of harmful bacteria in the community. That means using standard methods such as pasteurization, irradiation, sterilization, salt and cooking. To determine whether food is actually safe to eat, we test for the presence of a handful of specific dangerous organisms, including Listeria, E. coli, and Salmonella, to name a few. But what about all the “good” bacteria that is killed along with the “bad” bacteria in the process of making our food safe?

Nutritionists, doctors and food scientists understand that the human gut is well equipped to thrive unless threatened by particularly dangerous contaminants. The ability to determine the entire genetic makeup within a food could mean being able to know with certainty whether it contains any unwanted or unknown microbial hazards. Metagenomic testing of the food supply would usher in an entirely new approach to food safety—one in which we could detect the presence of all microbes in food, including previously unknown dangers. It could even mean less food processing that leaves more of the healthful bacteria intact.

More than 150 years ago, Pasteur pointed us in the right direction. Now the world’s brightest scientific minds are primed to take the food industry the next leap toward a safer food supply.

FDA

FDA Finalizes Rule on Food Facility Registration

By Food Safety Tech Staff
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FDA

As part of FSMA implementation, FDA has announced a final rule, effective today, that will better protect public health by improving accuracy of the food facility registration database. The Amendments to Registration of Food Facilities will also help the agency more efficiently use its resources to conduct inspections and aid in a faster response to food-related emergencies.

The final rule adds provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of the regulation, according to an FDA update. Provisions require:

  • Email address for registration
  • Registration renewal every two years
  • Registrations must have assurance that FDA will be allowed to inspect the facility at any time

Important dates:

  • Final rule effective July 14, 2016. Registrations must contain type of activity conducted at the facility for each food product category.
  • Requirement of electronic submission of facility registrations takes effect January 4, 2020.
  • As part of registration proves, food facilities must provide unique facility identifier (UFI) beginning October 1, 2020.

Go Beyond the Classroom to Improve Employee Performance

By Maria Fontanazza
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Employee training continues to be a hot topic as companies in the food industry gear up for FSMA compliance. Many are working with a much leaner staff and have several different generations of employees, many of whom absorb information in very different ways.

In a Q&A series with Food Safety Tech, Laura Nelson, vice president of business development at Alchemy Systems, discusses how training programs that may have historically been successful are no longer an effective means to educate today’s employees. “A vast majority of employees are doing what we ask and are doing it consistently. But the reality is that we have a subset of folks [who] aren’t doing that,” says Nelson. “I don’t think you can classroom train them to the point that they get it—I think some need that coaching and demonstration; they’re the kinesthetic learners that need to see you do it and then you watch them do it.”

Food Safety Tech: Where are the gaps in how food companies conduct employee education and training today?

Laura Nelson: It can be summarized in three areas.

1. Recognizing that the legacy training programs that food companies have is not effective. Companies are acknowledging that their historical training programs are not entirely effective in driving consistent behaviors. In [a recent] global food safety training [survey], we asked: “Despite our efforts in food safety classroom training, we still have employees not following our food safety program on the plant floor”. Over 60% said they agreed—yes, we still have employees not following our food safety programs. The survey involved 1200+ food safety professionals, so that’s a large number of folks acknowledging that their food safety training programs—largely classroom training—is not delivering the desired results and reducing inherent food safety risks.

There are so many things challenging the food industry and everyone is trying to manage these expanding expectations with their lean teams. The industry is changing dramatically—[from the perspective of] employee demographics, the business itself, pervasiveness of social media and exposure that it brings, and the different regulations—so a static food safety program established two, five or ten plus years ago is not going to address these changes.  But who has the time and resources to continually update content, embrace technology and apply the latest behavioral science to the instructional design of new training content?  Because of the lack of resources and time challenges, many in the industry are still trying to operate on their legacy training program. It might be old DVDs, PowerPoints, etc. —trainers are covering food safety, workplace safety and operational topics via PowerPoints in all-day sessions, sending around a sign-up sheet and ticking off their training compliance checkbox.  Training has to be improved and enhanced for many key reasons—whether it’s considering different cultures, updating languages, engaging millennials or focusing on those critical employee behaviors that present a risk to an individual operation.

2. Understanding that training expands beyond the classroom. The industry as a whole continues to think that classroom training is their training program and that once the classroom training is complete and [the employee is] on the operations floor, that the training and education job is done. The reality is, it’s not. There’s lots more training happening beyond the classroom. Understanding that we need to formalize the extension of the classroom training and manage the ‘plant floor’ training aspect is really important. The industry is starting to embrace this [concept]. Anywhere from formal coaching and mentoring by frontline supervisors to posters and digital signage and short reminders to monthly campaigns on key critical items around food safety. Companies are starting to embrace the power of this holistic approach to training, leveraging new and emerging technology and tools to optimize employee behaviors.

3. Most people are not making the connection between training effectiveness and the ROI, the return on the investment. They think they don’t have the time to make improvements—yet, if they carved out time routinely to assess and evaluate best training practices to make training more effective and implemented these new and proven strategies, then all of a sudden the time and resource question becomes less of an issue because now you’re delivering on things like a decrease in food quality issues or reducing [employees] turnover, decreased downtime, reduced GMP non compliances, etc. It takes some time to establish those related training metrics, but once you’ve done that and have ensured that your holistic training program is current and behaviors are being exhibited consistently, you start to have fewer operational issues, enhanced customer satisfaction and motivated, engaged employees.

In part II of this Q&A series, Nelson shares her insights on training strategies based on employee demographics.

USDA Logo

FSIS to Share Food Safety Data from Slaughter and Processing Facilities

By Food Safety Tech Staff
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USDA Logo

USDA’s Food Safety and Inspection Services (FSIS) has announced a plan to share more information about food safety at domestic slaughter and processing facilities. The Establishment-Specific Data Release Strategic Plan will serve to help consumers make more informed food choices, encourage facilities to improve performance, and provide more insights into the strengths and weaknesses of practices at the facilities.

“FSIS’ food safety inspectors collect vast amounts of data at food producing facilities every day, which we analyze on an ongoing basis to detect emerging public health risks and create better policies to prevent foodborne illness,” said USDA Deputy Under Secretary for Food Safety Al Almanza in an agency release. “Consumers want more information about the foods they are purchasing, and sharing these details can give them better insight into food production and inspection, and help them make informed purchasing decisions.”

The datasets will be published quarterly on data.gov, beginning 90 days after they are published in the Federal Register. FSIS will provide information about processes used at each facility, along with facility codes to allow for the combination of future datasets by facility. The agency will also release results for Listeria monocytogenes and Salmonella in ready-to-eat and processed egg products; Shiga Toxin-producing Escherichia coli and Salmonella in raw, non-intact beef products; Salmonella and Campylobacter in young chickens and turkeys, comminuted poultry and chicken parts; testing data of routine chemical residue in meat and poultry; and advanced meat recovery test data.

FDA

Experts in Produce Safety: FDA Wants You

By Food Safety Tech Staff
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FDA

Do you have a background in science and policy? Are you interested in produce safety? Do you want to work for the FDA? If you answered ‘yes’ to these three questions, then FDA might have a job for you.

The agency is looking for eight experts to help build the Produce Safety Network, which will support implementation of the FSMA produce safety rule. These folks will be part of the first phase of new FDA hires to support compliance with the rule and will work with state public health and agricultural agencies throughout the United States.

If you’re interested in the consumer safety officer position, you’ll need to move quickly. According to the agency’s listing on usajobs.gov, the position listing closes on Friday, July 15.

Later this year FDA will hire 40 more consumer safety officers to work domestically and internationally on inspection, investigations and technical assistance.

Alert

Five Errors That Impact GFSI Compliance

By Jason Dea
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Alert

The Global Food Safety Initiative (GFSI) is a global initiative for the continuous improvement of food safety management systems. From a functional standpoint, you might be surprised to learn that one of the most challenging elements of keeping up with GFSI compliance for many food producers is sufficient document control. In fact, data compiled by SQF shows that document control-related issues are one of the most common sources of a non-conformance during GFSI-benchmarked audits. Examples of these non-conformances are associated with documentation of training requirements, business continuity planning, and corrective and preventative actions.

The Global Food Safety Initiative (GFSI) is an industry-driven initiative providing thought leadership and guidance on food safety management systems necessary for safety along the supply chain. This work is accomplished through collaboration between the world’s leading food safety experts from retail, manufacturing and food service companies, as well as international organizations, governments, academia and service providers to the global food industry. They meet together at technical working group and stakeholder meetings, conferences and regional events to share knowledge and promote a harmonized approach to managing food safety across the industry. GFSI is facilitated by The Consumer Goods Forum (CGF), a global, parity-based industry network, driven by its members.

So what exactly are some of the most common causes for document control issues as it relates to non-conformances? Keep an eye out for the following five errors that can affect compliance.

1. Lack of document control altogether

Lack of correct usage of document control in the context of GFSI compliance is a common error. This is an issue that often occurs as a result of document sprawl—specifically as it pertains to duplicate documents and supporting documents. For example, an organization might create internal reference material designed to be cheat sheets or summaries of larger policies. These could include simple charts that list key equipment set-up parameters or charts summarizing abbreviated information from product specification sheets. Many organizations fail to realize that because of the nature of the information in these files, these reference documents must also be included in their document control program to ensure that the information in them is current and universally applied.

2. Document version control

From using outdated forms to referencing outdated employee procedures, lack of proper document version control and enforcement is the most common GFSI compliance-related non-conformance. These issues can arise from operational errors (employees don’t know where to find up-to-date documentation or how to ensure that it is being used) to technical errors (the document control system is unable to properly manage document versioning, or in the case of home-grown document control software systems, they may be unable to do so altogether). To avoid these errors, it’s necessary to establish where controlled versions of documents are located and ensure that they are kept up to date. It’s also important remove obsolete versions of these documents—this is a basic principle of document control, but it’s often an area where errors compound over time. Reinforcing training so employees are made aware of document control best practices and policies is critical to keeping your compliance activities current.

3. Document revision errors

One of the most common activities and most common sources of error within any document control program involves publishing revisions to documents. These errors include:

  • Updating the contents of a document but forgetting to update information such as the version number
  • Improper tracking of revision history
  • Adding new documents to the database rather than revising or updating existing documents

4.  Inclusion of documents from external sources

If your food safety management system includes or makes use of external documents, these must be controlled in the same manner in which you control internal documents.

Some examples of external documents that may need to be included in your document control program include:

  • Sample labels provided by your chemical and pest management suppliers
  • Raw material specifications provided by your suppliers
  • Customer expectations manuals provided by your customers

5.     Improper identification of approval personnel

A best practice of document control is for the person knowledgeable about the content of a document to be assigned the responsibility of approving updates to it. In many organizations, this is interpreted to mean that all approval responsibilities are assigned to a single person across the organization. This could be the food safety coordinator or the document control administrator, despite the fact that it is not reasonable for a single person to be knowledgeable about all the procedures across the organization.

A better approach to approval responsibilities is to identify individuals who can be responsible for authorizing changes based on function or discipline. By spreading the responsibilities across more people, your document control program is more likely to be current and accurate.

When it comes to food safety compliance and best practices, particularly as they relate to GFSI, it’s often the basic principles that get overlooked once your organizations processes and systems are up and running. Setting up a process for document control and maintaining this process over time is a key to achieving and maintaining compliance. As such, it’s important to revisit your controlled document process and library regularly to ensure things are operating as designed and avoid costly compliance surprises at the same time.

USDA Logo

USDA Touts Food Safety Progress Under Obama Administration

By Food Safety Tech Staff
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USDA Logo

Between 2009 and 2015 there was a 12% reduction in foodborne illnesses associated with meat, poultry and processed egg products. “We’re better now at keeping unsafe food out of commerce, whether it’s made unsafe because of dangerous bacteria, or because of an allergen, like peanuts or wheat,” said Agriculture Secretary Tom Vilsack in a USDA release. “Over the course of [President Obama’s] Administration, we have tightened our regulatory requirements for the meat and poultry industry, enhanced consumer engagement around safe food handling practices, and made smart changes to our own operations, ultimately moving the needle on the number of foodborne illness cases attributed to products that we regulate.”

USDA’s Food Safety and Inspection Service (FSIS) has implemented a number of initiatives since 2009, including:

  1. Establishing a zero-tolerance policy for raw beef products that contain shiga-toxin producing E. coli: O26, O103, O45, O111, O121 and O145.
  2. Labeling mechanically tenderized meat. The blades or needles used to tenderize meat an introduce pathogens into the meat.
  3. First-ever pathogen reduction standards for poultry parts in order to reduce consumer exposure to Salmonella and Campylobacter. The standard is expected to prevent 50,000 cases of foodborne illness each year.
  4. Requiring that all poultry facilities create a plan to prevent contamination with Salmonella and Campylobacter, instead of addressing the problem after it occurs. Poultry companies must collect samples at two points in the production line and test them to show control of enteric pathogens.
  5. Requiring meat and poultry companies to hold all products that are undergoing lab analysis until USDA microbial and chemical tests for harmful hazards are complete.
Recall

More E. Coli Illnesses, General Mills Expands Flour Recall

By Food Safety Tech Staff
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Recall

Consumers should check their pantry. As a result of newly reported illnesses connected to raw dough or batter consumption, General Mills has expanded its recall of Gold Medal flour, Wondra flour and Signature Kitchens flour to include products made last fall. The FDA and CDC have warned consumers against eating any raw products made with flour.

According to the CDC, the multi-state outbreak of Shiga toxin-producing E. Coli O121 has sickened at least 42 consumers (with 11 hospitalizations) across 21 states. No deaths have been reported. The bacteria was isolated from samples of General Mills flour that was collected from the homes of those sickened in Arizona, Colorado and Oklahoma.

General Mills has already conducted a voluntary recall of 10 million pounds of flour (unbleached, all purpose and self rising). A full list of the products included in the recall are available on FDA’s website.

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

FSMA Preventive Controls: Are You Prepared?

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

Compliance to FSMA has presented a new and difficult challenge for industry, the public and the FDA since it passed on January 4, 2011. With compliance dates for the initial FSMA rule—Preventive Controls—coming in September 2016, food sites must establish plans now to meet the impending deadline.

Complying with the Preventive Controls Rule

The Preventive Controls Rule was published September 17, 2015, with the compliance date for registered companies (more than 500 employees) scheduled for September 19, 2016. The compliance date is one year later for companies with fewer than 500 employees, unless otherwise specified under FSMA.

Under the FSMA rules, registered food facilities must evaluate and implement preventive control provisions and meet the requirements and the approaching deadline. The most urgent concerns for companies subject to the Preventive Controls Rule include developing a Preventive Controls Program, identifying a Preventive Control Qualified Individual (PCQI), and implementing a Food Safety Plan.

The following areas are all included under the FSMA Preventive Controls Rule:

  • Hazard Analysis. Companies must identify and evaluate known and reasonably foreseeable hazards.
  • Preventive Controls. Preventive controls must be implemented to significantly minimize or prevent the occurrence of hazards.
  • Monitoring. Preventive controls must be monitored for effectiveness.
  • Corrective Actions. Procedures for addressing failures of preventive controls and prevention of affected food from entering commerce are required.
  • Verification. Facilities are required to verify that preventive controls, monitoring and corrective actions are adequate.
  • Recordkeeping. Records must be kept for two years.
  • Written Plan and Documentation. A written plan must document and describe procedures used to comply with requirements.
  • Qualified Individual. A Qualified Individual who has been adequately trained must be present at the facility to manage the preventive controls for the site and the products processed and distributed at/from the site.

Failure to implement Preventive Controls (a.k.a., Hazard Analysis and Risk-based Preventive Controls (HARPC)) for qualified sites may result in fines and possible jail sentences.

Self-Diagnostic Assessment Tool

The following self-diagnostic assessment tool can help organizations better determine their current state of planning for FSMA compliance (see Table I). To complete your own planning assessment, review your progress compared to the questions below.

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

Get Compliance-Ready

Companies must have their training, planning and development underway to comply, or face possible violations, fines, and penalties under FDA enforcement. The questions in Table I will help companies identify the areas in which they need to focus attention. Kestrel can also help answer questions, provide input on solutions, discuss how to better manage the preventive controls program—and change “No” responses into “Yes” responses that promote best practices for FSMA compliance.

Senate Deal Requires Nationwide GMO Labeling

By Food Safety Tech Staff
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The U.S. Senate Committee on Agriculture, Nutrition, and Forestry has come to an agreement on the first-of-its-kind nationwide mandatory labeling of food products that contain genetically modified organisms (GMOs).  Although the deal requires labeling on far more products than those required under the Vermont GMO labeling law (which goes into effect July 1), the way in which disclosure of genetically engineered ingredients is revealed on food products is not as straightforward as it seems.  Under the bill, disclosure methods of GMOs on labeling includes on the actual packaging; an electronic/digital link that a consumer can scan with a smartphone to retrieve more information online; or a phone number in which a consumer can call to get more information. Thus, companies are not required to include all of the information on the product label.

The Center for Food Safety estimates that 75% of processed foods contain genetically engineered ingredients.The Senate Agriculture Committee praises the bill as a “win for consumers”, but there are industry folks who disagree. “While we are pleased this proposal will finally create a national, mandatory GMO disclosure system, protects organic labels, and will cover more food than Vermont’s groundbreaking GMO labeling law, we are disappointed that the proposal will require many consumers to rely on smart-phones to learn basic information about their food.,” said Gary Hirshberg, chairman of Stonyfield Farm and advocacy group Just Label It in a release.

The National Bioengineered Food Disclosure Standard is available on the Senate Agriculture Committee’s website.