“Over a period of time, things have changed for the corner suite, and many CEOs and presidents of corporations understand that with the media today and the way that FDA has improved its ability to focus on contamination, something needed to happen,” said Robert Garfield, senior vice president at SQFI during the recent “SQF in the Age of FSMA” webinar. “It’s not everything that we wanted…but it’s a rule that brings the regulations up to where they need to be in this century.”
GFSI leaders will be available during the Food Safety Consortium conference. On Wednesday, November 18, don’t miss the session, “The Role of Technology in Ensuring Accessible, Actionable Data to Tackle FSMA Compliance”. LEARN MOREGarfield discussed the role of SQF certification in FSMA compliance during part one of the 2015 GFSI Leadership webcast series. Hot topics included:
Foreign supplier verification program alignment
Building a food safety plan, including HACCP to HARPC migration
Being audit ready and record keeping requirements
“Farm-to-fork” and safety controls
SQF scheme changes to align with FSMA
How SQF fills in the gaps in FSMA requirements
The next webinar takes place Friday, October 30 and covers the alignment of BRC certification with FSMA. John Kukoly, director of BRC Americas, is the featured speaker. Register here for the complimentary webinar.
If you watch the evening news or read the local newspaper, the chances are pretty good that you will read or see something about a food safety concern or incident.
While the American food supply is among the safest in the world, the Federal government estimates that there are about 48 million cases of foodborne illness annually—the equivalent of sickening 1 in 6 Americans each year, according to Foodsafety.gov. And each year these illnesses result in an estimated 128,000 hospitalizations and 3,000 deaths. Five types of organisms—Salmonella, Toxoplasma, Listeria, norovirus, and Campylobacter—account for 88% of the deaths for which the cause is known.
We watched from the sidelines when major retailers faced public scrutiny over their practices on safeguarding consumer credit card information when their websites were hacked. Today, consumer and regulatory interest in food safety are the new focus areas for the news media, especially in light of the Blue Bell Creameries Listeria and the Peanut Corporation of America (PCA) Salmonella outbreaks. Unlike consumer credit information, serious missteps in our industry can kill people, and in the case of PCA, can put you permanently out of business.
In 2008, peanut butter paste manufactured by PCA killed nine people and sickened 714 others, some critically, across 46 states and was one of the largest food recalls in American history, according to the CDC. Although still under appeal, PCA CEO Stewart Parnell was convicted and sentenced to a 28-year prison term for his role in knowingly shipping out salmonella-contaminated peanut butter. Parnell received one of the toughest punishments in U.S. history in a foodborne illness case.
In the Blue Bell case, a total of 10 people with Listeriosis related to this outbreak were reported from four states, with three deaths reported from Kansas, according to the CDC. Blue Bell pulled their products from store shelves on April 20, 2015. On May 7, the FDA released findings from inspections at the Blue Bell production facilities in Brenham, Texas, Broken Arrow, Oklahoma and Sylacauga, Alabama. The FDA reports highlighted serious problems across multiple sites.
Both cases shine a spotlight on what can happen if you don’t have an effective food safety management system (FSMS). So what makes up a good FSMS, and is it enough to keep you out of trouble? An effective FSMS is built on three elements: Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points (HACCP) and a management system. Food safety issues are avoidable, and good processes and a strong culture within an organization make them more unlikely to occur.
Implementing a FSMS does not happen in a few months; it may take up to two years to establish one. No doubt, foundational activities need to be in place for factory operations. In addition to focusing on foundational elements such as making sure equipment is cleaned properly and procedures for allergens are implemented, the leadership team needs to make it clear that it is never acceptable under any circumstances to take shortcuts that could jeopardize food safety. This policy needs to be indoctrinated throughout the organization and thus does not happen overnight.
Underlying an effective FSMS are strong HACCP and GMPs, but food safety should always be the top priority for management and its employees, not share price, earnings or profit margin. Although financial performance is important, food safety must take precedence in the organization, and leadership at all levels needs to send that message loud and clear to all employees. In today’s environment, HACCP is pretty much mandatory from a regulatory standpoint and is an essential part of a FSMS. But the missing piece in many organizations is the support from the top—this is where culture becomes embedded in the organization.
The FSMS culture is the collective behavior from the organization around shared values and beliefs. The organization will follow the actions of leaders, not necessarily what they say—we all know actions speak louder than words. A good food safety culture is one where best practices are openly discussed, defined and rewarded. Food safety culture has become a buzz word and there needs to be a focus on making it come to life through a structured FSMS.
At this year’s Food Safety Consortium conference, Tim Ahn will discuss advancing food safety training and harmonization (November 19). LEARN MOREFood safety training is important not only for first line supervisors and operators, but also for senior managers and leadership, because they define the objectives and policies of the FSMS. What does it mean to conduct an effective management review? What does it mean to do an internal audit? What’s a good corrective action process? Training often misses the mark, because organizations fail to embed it correctly.
For FSMS to thrive, management must commit to the FSMS being a required way of doing things throughout the entire organization. A FSMS is most effective when it benchmarked against a proven standard and verified by an independent third party. Certification against a proven standard will reduce risk within your business.
Select your independent third-party verifier carefully. Do they have the resources and time, and do they know what they are doing? Do they add value to your organization? This is important since once you get certified, your journey starts and it doesn’t end. The value comes in two areas: Identifying risks and developing the appropriate control measures, and ensuring that the process drive continuous improvement in your organization. FSMS is focused on how continuous improvement applies to the management of risk and business operations.
The most effective way to establish an FSMS is to have leadership that recognizes its importance. The worst way is to have a recall or an incident, which draws attention to the fact that there is a problem and something needs to happen. In the case of Blue Bell, they probably understood the importance of food safety and thought they were taking the right actions. However, their management system led them to problems. FSMS must be independently verified against world-class standards to ensure effective performance.
Companies can develop blind spots where they cannot see their own bad practices, and they become institutionalized over time. Fortunately, experienced independent third-party assessors can shine a spotlight on those bad practices. That is the true value in bringing in outsiders to look at your operations and culture to uncover those blind spots.
At PCA, their poor culture and actions to the problem sealed their fate. In some ways, this criminal case presented a wake-up call to boardrooms across America and highlights how badly leadership mismanaged matters. This case came to light in the context of the public complaining to the regulators that they were not doing enough following several highly visible food poisoning cases. A FSMS would have prevented these problems because the structure would not allow such bad decisions to be made and would have been verified by an independent third party that would test and check everything. A reputable third-party verifier would not miss poor GMP/ HACCP processes.
A good assessor can help a company understand what is really important and what is not so important when it comes to findings (i.e., context). We don’t waste a client’s time with insignificant issues and that is where the experience and judgment of the auditor becomes critical. Last year I met with a client and said, “you need to be checking for Salmonella in your environment—how do you know it is not there?” I pushed them into checking because I understood the changing regulatory environment. I came back a year later, and they had confirmed that regulators were interested in their Salmonella monitoring program during a recent inspection. As an auditor, you have to be confident enough to provide advice and context to the client in a way that is understood and accepted, and that helps to build trust.
With FSMA, the government can now take specific actions against companies. If I am plant manager or CEO, how do I know for sure that I am in compliance with the requirements? How do I know that I don’t have any of these potential issues? The only way to know for sure is to have the FSMS assessed. Just like a bank or publicly traded company hires financial auditors to assure everything is done correctly, companies need to audit their FSMS to ensure compliance. Get a process audit and ensure they drill down deep into the organization—that is where we find issues and gaps. A thorough auditor will find your problems instead of looking the other way. It is important to call it the way you see it and not be too “soft” when getting an assessment.
If I am the CEO, I want to know where those problems exist. Independent third party assurance is the best way to find out how compliant you are with regulations. No CEO wants to deal with the inevitable lawsuits and lost business impacts. At least with an effective FSMS, you can show a level of due diligence when the regulators show up at your doorstep and the culture is such that you want to address any problems.
We have entered an important time for the food industry with FSMA implementation and other food safety regulatory requirements in the United States. These new rules place an emphasis on management accountability, risk assessment and control of supply chains. The bar for due diligence has been raised and it up to all us to show that we have done everything possible, and the best way is with an effective FSMS.
It’s that time of year again: A time when Americans, both young and old, enjoy decorating pumpkins, dressing up in outrageous costumes, visiting houses haunted with ghosts and goblins, and consuming way too much sugar. And then there’s the classic favorite, the caramel apple. I’ve never been a huge fan of the sticky treat, but many Americans just can’t get enough it.
This year’s Food Safety Consortium conference features “Preventing Listeria Workshop: A Practical Workshop on Food Safety Controls” on Tuesday, November 17. REGISTER HERE. Last year caramel apples received a huge amount of negative press as a result of a deadly Listeria outbreak that was traced back to prepackaged caramel apples from Bidart Bros (Bakersfield, CA). In February of this year, the CDC closed its investigation, and provided the final stats: 7 dead and 34 hospitalizations throughout 12 states.
Now here we are, at the height of the season for apples and sweet treats, and concerns over Listeria in caramel apples are back in the media. The good news is that industry is proceeding with caution. The Wall Street Journal reports that Kroger Co. is taking unrefrigerated caramel apples off its store shelves following a recent study that cited a higher likelihood of Listeria growth on the products when at room temperature versus under refrigeration. Published by the American Society of Microbiology, the study, “Growth of Listeria monocytogenes within a Caramel-Coated Apple Microenvironment”, found that “insertion of a stick into the apple accelerates the transfer of juice from the interior of the apple to its surface, creating a microenvironment at the apple-caramel interface where L. monocytogenes can rapidly grow to levels sufficient to cause disease when stored at room temperature”. The researchers also advise that consumers purchase refrigerated apples or eat them fresh.
Although representatives from Kroger said they think the risk of Listeria contamination is minimal, they decided to take a cautionary approach. It’s reassuring to see companies step up and take proactive tactics to mitigating risks, especially when it involves protecting consumers against another potentially deadly outbreak.
How will FDA enforce the new FSMA rules? It’s a question that has been circulating throughout industry over the past few months, and it will be answered at this year’s annual Food Safety Consortium conference next month. Michael Taylor, JD, deputy commissioner for foods and veterinary medicine at FDA will deliver the opening plenary presentation on November 18, which will be followed by an “Ask the FDA” interactive town hall meeting. During the afternoon,
Roberta Wagner, deputy director of regulatory affairs at CFSAN will discuss FSMA implementation and FDA’s strategies for gaining and maintaining industry compliance with the new rules. The agency will also be participating in several conference sessions dedicated to the FSMA rules that will be finalized by November, including:
Foreign Supplier Verification
Preventive Controls in Human Foods
Preventive Controls in Animal Foods
Voluntary Qualified Importer Program
During the event, USDA’s Food Safety and Inspection Service (FSIS) will also be answering questions related to regulatory compliance and food safety issues at a Small Plant Help Desk.
Beyond FSMA-related topics, the Food Safety Consortium conference will feature several concurrent food safety and quality assurance tracks, workshops and training programs in compliance, food manufacturing and operations, supply chain management, food labs, and foodservice and retail. Food Safety Culture is an especially hot topic right now, and the conference will address the practical ways to actually measure behavior and start taking action. Frank Yiannas, vice president of food safety at Walmart will deliver a keynote presentation, “Food Safety = Behavior” on Wednesday, November 18.
Many of you are committed to doing everything possible to prevent people from becoming ill or dying from foodborne illness, and you whole-heartedly embrace a strong food safety culture. On November 17, 2015, STOP Foodborne Illness is pleased to be hosting Food Safety Heroes, an interactive fundraising event sponsored by Chemstar Corp. and Food Safety Tech.
We are excited that Food Safety Heroes will take place during, and in conjunction with, the Food Safety Consortium Conference, which is a summit meeting for Food Safety and Quality Assurance (FSQA) industry experts and government officials. In our eyes, every guest coming to this event is a food safety hero! Each day these people contribute to the overall health of our nation, and we couldn’t be more proud to be working alongside such outstanding men and women. To be a part of efforts to increase public awareness and collaboratively seek solutions is a great honor for us.
In addition to raising much-needed funds for the important, life-saving work of STOP Foodborne Illness, we also have the great pleasure of honoring two individuals who have seen the national conversation about safe food grow from its infancy, born from tragedy, to an increasingly aware industry of food safety professionals and consumers. Their efforts have been instrumental in cultivating the food safety culture that we see today.
The 2015 Food Safety Heroes award will honor:
Nancy Donley, former spokesperson for Safe Tables Our Priority and STOP Foodborne Illness. Donley will be presented with the 2015 Legacy Tribute in recognition of her four-year-old son Alex, who died from an E. coli infection in 1993. From the time of her son’s death until her recent retirement from STOP, Donley has worked tirelessly to raise public awareness of foodborne illnesses by providing information and support for the millions of people who get sick from eating each year.
Frank Yiannas, vice president of food safety at Walmart Corp. A pioneering force in advancing the concept of a strong food safety culture, Yiannas is being celebrated as our 2015 Industry Advocate Hero. Going far beyond his role in overseeing the safety of the world’s largest food retailer, Yiannas is recognized for his commitment and dedication to building unique partnerships and participating in innovative approaches to food safety.
Please join us on November 17!
Food Safety Heroes
Time: 7–9 pm
Where: Renaissance Convention Center in Schaumburg, IL
Guests will enjoy cocktails and hors d’oeuvres, lively entertainment, a silent auction and more
With the upcoming regulations right around the corner, the good news is that FDA is still on track to meet the FSMA deadlines for August (preventive controls for human and animal food). But as industry looks to the future of FSMA and its implementation, resources and funding will be a challenge. Michael Taylor, deputy commissioner for foods and veterinary medicine at FDA, continued this message (which he declared several months ago) at the 2015 IAFP conference in Portland, OR.
“We’ve been given a brand new mandate by Congress to do things we haven’t done before,” said Taylor, as he emphasized that FDA will be in a do-more-with-less resource-challenged state. FDA would need, over the five years following the enactment of FSMA, $580 million, said Taylor. Over the first five years, FDA has received about $162 million (through 2015). “2016 is the absolute crunch year for FSMA funding,” he said. President Obama’s budget request for FY2016 would provide $109.5 million.
The issue is that there simply isn’t enough funding to get it all done, or as Taylor put it, not enough money to “maintain momentum towards comprehensive implementation of the FSMA vision.” As a result of the funding limitations, Taylor said that FDA will be making “hard choices” and will be forced to prioritize the funding that it receives. He indicated that the agency will focus on preventive controls implementation first. But this leaves a potential for disruption due to the investments needed for implementing the produce safety rule and building a strong system for imports, which may pose the biggest challenge over the next decade, Taylor warned. While trying to remain positive, the deputy commissioner also maintained that he wanted to be transparent about the situation.
FSMA will give FDA the ability and technology to act in real-time when issues occur, but it will also require new skills and training, as well as a shift in culture. In November, Taylor will be the opening plenary speaker for the Food Safety Consortium Conference and will surely have more insights, as industry will be entering the implementation phase.
Gary Nowacki, CEO of TraceGains, highlights the concerns that came out of an Ask the Expert discussion about Supplier Qualifications and Management at the 2014 Food Safety Consortium.
“A common takeaway–whether it was small, mid-size or large companies–was the frustration of having to do more audits, and the growing demand for more paperwork. A question that was often asked was that ‘my customer is asking me to subscribe to a different audit, and that defeats the promise of GFSI, that it would lead to fewer audits.’ My advice to them is to not just blindly agree, but ask the customer politely what exactly they are looking for, and see if they can address that. Another frustration related to the increase in paperwork and the time and resources consumed in filling these plethora of forms. So there was a discussion about how we can standardize these. And people are looking to get automated solutions as they are not getting more headcount.”
The Food Safety Modernization Act is the first instance of codified food defense regulations. This discussion is a hard look at the proposed food defense requirements and examining what compliance may look like.
At the upcoming Food Safety Consortium, to be held November 17-18 in Schaumburg, IL, Shannon Cooksey, MS, PMP, Senior Director, Science Program Management at the Grocery Manufacturers Association (GMA), will address the key takeaways associated with the proposed regulation.
Following this presentation, Sarah Sunday from Kraft will talk about challenges the industry will face in implementing the rule as written and how the industry currently addresses food safety.
In a chat with Food Safety Tech, Cooksey provides a sneak-peek into her presentation.
FST: How are Food Defense requirements evolving under proposed FSMA rules?
Cooksey: GMA led industry in developing comments on the proposed Food Defense rule earlier this year, specifically focusing two things: one, food defense is different from preventive controls and two, food defense cannot be prescriptive—it needs to be tied to a facility-specific risk evaluation. While FDA has not yet re-proposed new food defense language as part of the supplementals released on September 29 of this year, we have good reason to believe that FDA has shifted some of its positions in light of our comments. We also believe another opportunity to submit comments on a food defense supplemental proposal, similar to what was done with Preventive Controls, would be a valuable use of time for both the industry and the Agency as they move towards issuance of a final food defense rule in May of 2016.
FST: What are some things that companies need to keep in mind to be prepared to comply with these requirements?
Cooksey: While this is the first time food defense is being proposed as a regulation, there are already some existing training materials available to industry to begin developing food defense plans. Since the requirement to have someone specially trained in food defense will likely be part of the final rule, GMA recommends that companies start early and take advantage of the available materials already available. GMA and the GMA Science and Education Foundation are planning to release additional materials and courses in 2015.
FST: Who should attend this discussion, and how would they benefit from it?
Cooksey: Security specialists at the facility and corporate level regulatory affairs staff who oversee food defense and/or FSMA within their companies should attend. Also, food quality assurance and food safety managers will need to know how the food defense plan will work in combination with food safety plans.
Click here for more information on the Food Safety Consortium, and learn from over 75 of the Food Industry’s top food safety SMEs.
Effective training programs are the cornerstone of a high performing workplace. Providing the basic knowledge to workers and reinforcing the need to apply that learning in their daily activities are just two critically important facets of a well thought out training system.
Here are 10 concepts that need to be implemented to bring training and education full circle and to provide forward momentum in the process of developing a fully engaged highly productive workforce.
Set learning objectives – determine first what the key points or factors are that will be influenced by this knowledge exchange and how will the outcomes be measured.
Create the content – tailor the message or training information to the specific audience for maximum absorption and comprehension.
Deliver the content – ensure the set-up is conducive to learning. Keeping the message relevant to the workers level of comprehension and using real life examples that they can relate to is a best practice.
Keep training top of mind – use awareness programs as visual and audio prompts that keep the topic out in front of the organization. When everyone walks the walk and talks the talk it makes it harder for the individual leaner to forget what needs to be done and how to do it.
Verify comprehension – use testing, observation and constructive feedback to help employees apply what they have been taught. Be sure that feedback is constructive not punitive and is delivered in real time for maximum effectiveness and greater adoption by the worker.
Track and trend using metrics – Measurement of desired outcomes should be used as a yardstick to help determine if the content, delivery and application of the training is on track or needs course correction.
Never pass up an opportunity to train – refresher training on a regular basis is needed for any program to be effective. Retraining is also very impactful when used as a corrective action or as part of an investigative process.
Keep it fun – capture the learner’s attention by using bright colorful presentations, games or game show formats, and some light humor. A little friendly competition between departments is a great way to engage the workforce while promoting the learning process.
Use positive reinforcement – those that absorb and apply need to be recognized and reinforced. Don’t just say thank you. Recognize the positive impact of their good work habits and how their application of those work habits has resulted in good outcomes.
Hold people accountable – employees that are unwilling to follow training principles need to be held accountable with appropriate consequences. Deciding in advance what the consequences are and hold all employees to the same level of accountability will drive continuous improvement and strengthen the overall training program.
These 10 basic training concepts will provide an excellent cornerstone to support programs across an organization and drive consistency, accountability and employee engagement.
Eurofins laboratories routinely test for the presence of the infectious bacterial generaSalmonella and Listeria monocytogenes in the food processing environment. While L. monocytogenes long has been known as an environmental contaminant, only recently Salmonella has been considered a persistent environmental contaminant.
At this year’s Food Safety Consortium (November 17-18, 2014, Schaumburg, IL), Dr. Douglas L. Marshall, Chief Scientific Officer – Microbiology, for Eurofins Scientific Inc. will present a workshop on Environmental Monitoring. This workshop will provide an overview of analytical methods used, a discussion of the zone approach to environmental monitoring, and a practical example of the use of microbial genetics in Eurofins’ Source Tracking Program to identify and eliminate a pathogen harborage.
Food Safety Tech (FST): How are environmental monitoring requirements changing under FSMA?
Dr. Marshall: The Food Safety Modernization Act passed by Congress contains language in SEC. 418. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS stating: ‘‘(4) the preventive controls implemented under subsection (c) are effectively and significantly minimizing or preventing the occurrence of identified hazards, including through the use of environmental and product testing programs and other appropriate means” and ‘‘(C) An environmental monitoring program to verify the effectiveness of pathogen controls in processes where a food is exposed to a potential contaminant in the environment.”
The Preventive Controls for Human Food Proposed Rule has moved environmental testing to the appendix. It is clearly FDA’s intention that firms use environmental monitoring but how this will ultimately play out in the final rule is unknown. The companies we work with are finding a substantial non-regulatory push for environmental monitoring from their customers. As a result, firms without environmental monitoring programs will find it challenging to escape criticism from inspectors, auditors, and customers.
FST: What are some broad topics you are going to be covering in your FSC presentation?
Dr. Marshall: This EMP workshop will deliver tips for an effective pathogen monitoring program. Highlights include information relevant to answering many EMP questions such as what to test for, what is the value of indicators; where to test, what methods to use, what test volumes are appropriate, how to use trending, and how to remediate an environmental problem.
FST: What are some key challenges when companies do environmental monitoring? For Salmonella, and for Listeria?
Dr. Marshall: Many companies find it difficult to start an EMP program and fail to use the program in a proactive manner as an assessment tool. Environmental monitoring is an essential tool for microbial control, but it is not a control program. Robust programs target areas in a processing plant where environmental pathogen control is critical to product safety. The pathogen of concern may differ depending on food product type and processing conditions.
FST: Why is it important for food companies to pay attention to this critical area of testing?
Dr. Marshall: Numerous recent high-profile foodborne disease outbreaks and large recalls have been traced to poor environmental controls. Lack of effective environmental monitoring by producing firms contributed to these events. As a result, inspectors, auditors, and customers are demanding the placement of environmental monitoring programs as an additional leg on the food safety control stool, adding to GMPs, SSOPs, and HACCP.
FST: What kind of technologies will you be talking about in your presentation?
Dr. Marshall: The talk will present an overview of analytical tools required for routine monitoring and give an example of the use of genetic strain typing as a source-tracking tool for remediation.
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