Tag Archives: GFSI

Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

High False Positive Rates for Pathogen Food Safety Testing

By Thomas R. Weschler
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Thomas R. Weschler, Founder and President, Strategic Consulting, Inc (SCI)

This article looks at proficiency testing (PT) for pathogen analysis, and the recent finding by the the American Proficiency Institute (API) of a 6.6 percent false-negative rate on food safety PT samples (14-year average for the 1999-2012 period).

While at IAFP this year, I met with Heather Jordan, who directs food PT programs at API. The proficiency testing programs are used at many food labs in conjunction with lab accreditation programs. Proficiency testing is done at food plant labs (FPLs) and corporate labs, as well as at food contract testing labs (FCLs) as a way to demonstrate quality results in their food micro and chemistry testing.

More proficiency testing but less proficiency?

In fact, the use of PTs is increasing in food labs, which is probably tied in part to the push for lab accreditation by FSMA and non-government groups like GFSI. Yet it seems to me that the current use of PTs doesn’t go far enough to enable an FPL or FCL to demonstrate overall laboratory competency, and gain or maintain accreditation (ISO 17025).

In most labs, PTs are done just a few times a year. And really, they test the competency of the lab technician and protocols used in analyzing the PT samples. They are not a holistic measure of the lab and its ability to consistently generate quality results on every test run by every operator in the lab.

In a previous life I ran a group of environmental testing labs, which also are required to run PT samples during the year. From this experience, I know that lab personnel are aware that PTs are in-house: The sample-receiving group logs them in, and then alerts management. As a result, the best operators usually are assigned to run the PTs. This kid-glove treatment is not representative of day-to-day practices and processes. If we really want to validate and accredit the proficiency of an entire lab, shouldn’t every operator be tested on all protocols in use?

Plus, if labs know when they are running PT samples, and likely have their best operators running them, shouldn’t there be few, if any, false-negative or false-positive results? Surprisingly, that’s not what the API research found…

API study: Performance accuracy for food pathogens remains problematic

In a retrospective study, “Pathogen Detection in Food Microbiology Laboratories: An Analysis of Proficiency Test Performance,” API analyzed the results from 39,500 food proficiency tests conducted between 1999 and 2012 to see how U.S. labs are doing in detecting or ruling out contamination of four common food pathogens.

Over the 14-year period, “False negative results ranged from 3.3 percent to 14.0 percent for E. coli O157:H7; 1.9 percent to 10.6 percent for Salmonella spp; 3.4 percent to 11.0 percent for L. monocytogenes; and 0 percent to 19.8 percent for Campylobacter spp.” Most concerning is that while both false positive and false negative rates were down in the last year of the study, the cumulative false negative rate for the 14-year period was 6.6 percent.

As we know, false positive results (in which a sample that does not contain pathogens is incorrectly shown as positive) are a nuisance. But false negative test results—which fail to detect true pathogenic organisms in the sample—are not unacceptable.

Tom-Weschler-False-Negatives-Sep-2014

The cumulative average false positive rate was 3.1 percent, less than half of the false negative rate for the same period.

The objective of the study—and, I would think, of proficiency testing in general—is to demonstrate improvement in lab performance year over year. The results of the API report concluded to the contrary, however: “Performance accuracy for food pathogens remains problematic with the recent cumulative trend showing a slight decrease for false positive and false negative results.”

Clearly if false negatives happen in proficiency programs, they happen in the course of regular testing at food labs. I’m told that many FCLs and FPLs rely on other parts of their QA systems to make sure testing is being conducted properly. Even so, the documentation of ongoing and unacceptably high false negative rates in PT testing is a big concern for everyone. It also points to a number of follow-on questions:

  • Would the false negative and false positive results be even higher if every technician, rather than the best operator, performed the analysis?
  • PT samples are created in only a couple of sample matrices. Would results be even worse if performed on the myriad of sample matrices present in the food industry?
  • What are the performance results among all of the pathogen methods available? Are some methods better than others when measured in real world conditions? Do the more complex protocols of some pathogen diagnostic systems result in poorer PT performance results?
  • Would PT results and, even more important, lab proficiency improve if the frequency of PTs increased, and were required of every technician involved with real food samples?
  • How can proficiency testing be used to isolate problem areas, whether in the pathogen diagnostic method or the competency of lab operators and processes?
  • And finally, is the performance data different between food contract labs and food plant labs? And are all FCLs are equal, or are some more able to deliver quality results?
Dr. Jacqueline Southee, U.S. Liaison for FSSC 22000

“Make Consumer Safety and Food Safety a Hard Priority”

By Sangita Viswanathan
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Dr. Jacqueline Southee, U.S. Liaison for FSSC 22000

On September 26, Dr. Jacqueline Southee, U.S. Liaison for FSSC 22000, will present FSSC 22000 – The Road Ahead, as part of the 2014 GFSI Leadership Webcast Series presented by SafetyChain Software and FoodSafetyTech.

Dr. Southee will talk about what’s new for the scheme, what changes are expected in 2015 and beyond, how these changes will affect you, and why it’s important to embrace these changes to be better prepared for upcoming food safety regulations such as FSMA. In this interview with Food Safety Tech’s Sangita Viswanathan, Dr. Southee discusses some of the topics that will be examined in more depth during the webinar – including FSSC 22000’s international food safety management certification scheme and its global integrity program.

Food Safety Tech (FST): We’re very excited to have you participate in the GFSI Leadership Webcast Series. What will you be talking about in terms of current changes with FSSC 22000?

Dr. Southee: The most striking change that FSSC 22000 is undergoing revolves around the rapid uptake of the scheme by industry and the increase in the number of certified sites which currently stand at more than 8000. This represents a 48 percent increase since mid-2013. The standard is currently operating in 146 countries, and has become a truly global scheme. We are also working to extend the scope in line with the GFSI goal to cover the entire supply chain. For instance, we have added animal feed to our scope, and will soon be adding animal farming. We are constantly making adjustments within the scheme to keep in line with GFSI requirements in terms of maintaining the highest possible scheme integrity. Overall, FSSC 22000 is creating a lot of buzz out there and we continue to work to meet the growing needs of the industry.

FST: We know that audits will be a topic of many questions. Is FSSC 22000 planning changes on the way it does audits? What are some of audit-related topics you’ll be addressing in the webinar?

FSSC 22000 LogoDr. Southee: FSSC 22000 does not do audits itself. It oversees the FSSC 22000 scheme which provides the specifications for the audit which is conducted by a qualified Certification Body. We work with 96 licensed Certification bodies and more than 1500 auditors throughout the world who conduct FSSC 22000 audits. Our goal is to ensure that these audits are conducted consistently and in line with GFSI requirements. We focus on having a global integrity program, and are in regular contact with auditors and Certified Bodies to monitor auditor competence and to ensure that both CB’s and auditors are meeting these requirements. This monitoring may require an increase in the communication that we have with our CB’s and may even result in an increase in the number of visits that we pay to them. The overall goal is to maintain the highest standard of food safety audits for FSSC 22000 certified companies.

FST: You will also be talking about the direction of FSSC 22000 in 2015 and beyond? Is there a “theme” or specific set of business drivers that are driving future changes to FSSC?

Dr. Southee: The main business drivers for FSSC 22000 are increasing transparency across the supply chain, maintaining the highest standard of consistent audits around the globe to promote a continuous improvement in food safety. As a global scheme, we are in a good position to work with many of the world’s leading food manufacturers. We work on ensuring transparency throughout the supply chain to maintain efficiency in the control of food safety, raise the confidence of the customers and the regulators in the third party certification process and to ensure the production of safe food ingredients and products for the consumer.

FST: While we all know change is important, it’s not always easy to get already-burdened food safety organizations to embrace change. What are some of the things we’ll learn in the webinar about why embracing change is critical to the ongoing success of FSSC 22000?

Dr. Southee: The global food manufacturing industry is currently under a tremendous burden with pressures coming from all sides. They must produce safe food efficiently and effectively to meet the demands of the retailers, the regulators and the consumer. What’s more in this truly digital age, where social media drives consumer preference more than anything else, they need to show their commitment to food safety. The new norm is that consumers are “involved” in what they eat. Every step industry takes is scrutinized by everyone with access to the information, and if anything slips out of compliance, it is public knowledge almost within the hour. There’s a constant demand for information, so food manufacturers need to invest in management systems such as FSSC 22000 to manage their food safety effectively, maintain transparency across the industry both for their customers and their consumers and be quick to respond to issues.

FST: We know that you’ll be providing advice on how companies can start today to prepare for tomorrow’s FSSC. Can you tell us some of the topics you’ll be addressing in this part of the webinar?

Dr. Southee: One topic I’ll be addressing is that food safety management should not be considered a cost center. In order to prepare for FSSC 22000, it is critical for senior management within an organization to recognize the need to take responsibility for food safety and that this will involve the need to have a robust food safety management program in place. Many companies now recognize the importance of investing in food safety and this is to the benefit of all. We also hear about the importance of establishing a “food safety culture” and we can talk more about what this means.

FST: It has been said that GFSI certification is a very good start to preparing for FSMA compliance. What are some of the key points you’ll be addressing when it comes to FSMA compliance and FSSC 22000?

Dr. Southee: First of all, I think that the establishment of the GFSI is an example of the food industry already regulating itself. The benchmarking approach has raised the standard of the accredited third party certification process and a company that is certified under a GFSI scheme is already meeting a high standard of food safety. A scheme such as FSSC 22000 provides additional evidence of a company’s commitment to food safety practices and management. The FSSC 22000 scheme meets many of requirements specified by the initial draft of the FSMA rules and existing data suggests that GFSI certification is a very important start to ensuring compliance with FSMA requirements.

To learn more about all of these and many more topics on FSSC 22000 – including live questions from the audience – register today for FSSC 22000 – The Road Ahead, Friday, September 26, with Dr. Jaqueline Southee.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

SQF: Where is it Going and What Does it Mean to You

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

In a recent webinar, Robert Garfield, Senior Vice President of the Safe Quality Food Institute talked about the SQF standard, changes made in 2014, what is expected in 2015, and how companies can use SQF to be better prepared to comply with rules proposed under the Food Safety Modernization Act. We present below some excerpts from the webinar, organized under the 2014 GFSI Leadership Series. The next webinar in the series will focus on FSSC 22000. Click here to register.

Where is SQF going in 2015 and beyond?

Garfield: The standard is going to be focused on enhanced compliance programs and improving the database reporting systems. For instance, if it concerns someone in the bakery or dairy industry, we would like to know how they are doing versus the industry as a whole. We are hoping that better database reporting can help with this, especially when it comes to non-compliances.

Another area we are working on is establishing Cooperative Agreements. In 2014, we finalized an agreement with the American Feed Industry Association and we are working with their food safety program. We are hoping to not just work cooperatively with the private sector, but also with various government agencies and other stakeholders.

Other areas we are growing in 2015 are expanding our language alternatives, subject matter training and developing industry specific guidance.

There are many changes proposed to food safety regulations and food safety schemes such as SQF. How will companies be affected by these changes and why is embracing these changes so important to industry?

Garfield: Embracing all these changes is critical for the food industry to do everything they possibly can to ensure that they are making and selling a safe product. At the end of the day, there is no one ‘magic bullet’ solution to food safety. Embracing these changes to food safety rules and standards will help the CEO and management team sleep better at night, knowing that they are doing what they can to protect their product, their brand name and their consumers. Also, companies need to understand that the regulatory climate will completely change in the next few years, so it’s critical for companies to start acting now to meet these new requirements that will start being in effect from October 2015.

How can companies start preparing today for tomorrow’s SQF?

Garfield: I tell companies and retailers I talk to that if they are interested in doing SQF because they want to be ‘GFSI certified,’ that’s the wrong reason to do this. To get started, management commitment and changing the culture of the entire company is critical. Starting from the CEO and going all the way to the man operating machinery on the floor, you should aim to get a commitment to food safety, where food safety management is the most important issue for the company. If you start working on that today, you can accomplish great things for the company in not just reducing recalls, but improving the overall functioning of that company.

How can SQF help prepare companies for FSMA?

Garfield: The first step is to look at the Preventive Controls and the Fresh Produce rules and see how these apply to your company. I suggest hiring an independent expert to take a look at your facility and see how your company fares against these rules and have a better understanding about where you will be when these rules are finalized by October 2015. While you will have one to three years to comply with these rules after that point, you need to get the management buy in and strong food safety management systems in place now. Start now, and don’t wait for the final rules to be announced.

Listen to this complimentary webinar today to learn more about how SQF differs from other food safety programs, unannounced audits, changes with allergen control standards, and how to become SQF certified. Click here to access the recording.

2014 GFSI Leadership Series continues with FSSC 22000: The Road Ahead. Click here to register for this informative webinar on Friday, September 26, 2014, featuring Jacqueline Southee, U.S. Liaison, FSSC 22000, who will talk about what’s new for FSSC 22000 this year, where FSSC 22000 is going in 2015 and beyond, how you will be affected by the changes, and how to start preparing today. Plus Jacqueline will take your questions live!

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Supplier Qualification and Compliance using GFSI Benchmarking

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

An efficient supply chain is very important in retail food operations. To safeguard the supply chain, a comprehensive supplier food safety program should be an integral part of retail foodservice (see my previous blog on Combating Norovirus Hazards in Retail Foodservice). This becomes even more challenging because one, retail foodservice chains don’t own their suppliers; they’re independently managed businesses, and two, the new regulatory burden placed on retailers by FDA through the proposed FSMA rule to ensure that retailers are accountable on the sources and safety of their products to continue serving safe quality foods to their customers.

Thus, continuous verification of supplier qualification and compliance is as important for food manufacturers and food processors, as it is for food retailers. To fulfill this very important business requirement, the retail Food Safety & Quality Assurance job function would usually include the following roles:

  • To conduct continuous food safety audits and monitor suppliers to ensure compliance with all FDA/USDA, State and local regulatory standards;
  • To monitor adherence to product specifications, identify deficiencies and implement corrective actions in a timely manner;
  • To perform internal and external testing to verify risk assessment and risk mitigation procedures.

How do retail folks try to tackle these important business functions, especially since most retail chains have so many domestic and international suppliers? The Global Food Safety Initiative (GFSI) benchmarking provides a common ground for farmers, manufacturers, food processors and retailers on global food safety best practices. GFSI strengthens the supply chain, eliminates multiple auditing, increases confidence in safe quality food delivery while protecting the public health.

The different GFSI schemes which include PrimusGFS, BRC, SQF, GlobalGAP and FSSC2200 are auditing entities involved with several scopes of food safety and quality assurance service standards, while others like AIB, SGS, NSF and SAIGlobal are certification bodies that perform facility audits. As a business-driven initiative, majority of food processing facilities depend on the GFSI Guidance Document for supplier qualification and compliance by using any of their benchmarking schemes. The advantages are tremendous and include less product recalls and voluntary withdrawals, enhanced traceability, clearly defined risk management and HACCP control, acceptable uniform international standards, eliminates redundancy and frees up time and resources for both food manufacturers and retailers.

Apart from supplier compliance and approval, food retail companies also want to ensure that all potential suppliers align with their corporate values and standards of ethics. GFSIschemes however do not cover these corporate needs like environmental sustainability, animal welfare, ethical sourcing, compliant labor utilization, organic and non-GMO product verification. Moreover, the auditing time frame for most GFSI schemes is only about a few days and thus gives just a snapshot of the food safety practices in these GFSI-approved facilities. Retail food companies will therefore require a more elaborate supplier monitoring and approval system to ensure that certified facilities are not just compliant within the FDA auditing time frame of about one to four days, but that their food safety culture and practices are consistent with their corporate mission to deliver safe quality food to customers.

Additionally, such continuous monitoring and verification will ensure that suppliers are also complying with company policies outside the provisions of GFSI schemes. Proper training of retail Food Safety & Quality Assurance managers on FDA/USDA inspection requirements and corporate expectations at the food processing facilities is absolutely required. The use of third party auditors to assist retailers in verifying supplier qualification and compliance is also advisable because of the often overwhelming number of suppliers involved.

Finally, as FDA begins to implement FSMA, it would be pertinent to verify FSMA readiness of the different GFSI schemes. This will ensure that GFSI certified food manufacturing and processing facilities remain in compliance with the new regulatory provisions for FSMA covered facilities. It would help to avoid costly disruptions in the supply chain and allow businesses to meet their projected growth while serving safe quality food to their customers and protecting their business brand. Overall, GFSI certification remains the gold standard that will guarantee supplier qualification and compliance at both domestic and international locations.

 

Katie Moore, Intelligent Platforms’ Global Industry Manager for Food & Beverage, GE

Big Picture Understanding for Better Food Safety

By Sangita Viswanathan
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Katie Moore, Intelligent Platforms’ Global Industry Manager for Food & Beverage, GE

Having worked in the food & beverage industry as a plant manager, Katie Moore knows just how important food safety is to a company’s brand and profits. As GE Intelligent Platforms’ Global Industry Manager for Food & Beverage, she uses today’s connected technology to help prevent food safety issues and expensive recalls.

Companies want to do the right thing and try to control what is known. They want to mitigate risks when possible. But without a clear and complete line of sight to real-time process data and information, like whether or not your HACCP processes have been followed, correctly, each and every time as stated in your HACCP Plan, how can you truly have peace of mind going to sleep every night? That’s the gap that’s plaguing food companies and managers, says Moore.

Against the backdrop of evolving food safety rules under the Food Safety Modernization Act, Moore sees manufacturers in the food and beverage industry in a wait-and-watch mode.

“Since these rules are still in the process of being finalized, everyone’s waiting to see what the final regulations will look like. This is the right time for manufacturers to educate themselves, and implement new steps and programs to assess and mitigate risk,” she explains. Moore feels larger companies are much better at addressing these changes, because of having greater resources or collaborations with industry associations, while small and medium sized companies are continuing to implement HACCP and GFSI standards, but are a step or two behind their larger counterparts.

There is a lot of risk management going on, and it all begins with HACCP, says Moore. But a gap she’s noticing is a lot of records still being paper-based.

“There is still a lot of work being done on paper. And data is not being transferred automatically. Because of this, there is no way to go back and learn from what’s going on and identify trends and issues. There is truly no electronic capture of data. This lack of learning and understanding of trends and changes is a big gap,” Moore adds.

A lot of recent recalls are due to supplier problems, so everyone focuses on that. Companies are managing the biggest risk, which is their suppliers, and there are a lot of solutions available to manage supplier compliance. “But true value can be realized when this is tied in with your manufacturing processes and specifications. How is the food handled in my line, my tanks and my processing facility…. If companies have this continuous visibility it will contribute to food safety and quality improvements growing by leaps and bounds. And also companies will be able to track and trace throughout the process, and react a lot quicker,” she describes.

Mergers and acquisitions in the F&B space

These days, there is a lot of consolidation happening in the F&B space. Historically, whenever there is a merger of two food companies, there is a challenge to have in place a sound business continuity plan. For instance, Moore asks, if there’s a recall, then how do we react? If there is an issue isolated to one facility, how can we cover our bases and mitigate risks? How can we make sure our customers get our products? From an IT perspective also, there are some challenges that need to be addressed. For instance, what GFSI scheme are we using? Do we merge these two standards and our supporting IT infrastructure, or continue to work with two separate standards? The key in making this decision is to utilize big data analytics to determine which process has been working most efficiently and to factor in the cost of replacing or retrofitting the extremely expensive manufacturing equipment.

According to Moore, F&B managers need tools that can help them improve compliance to food safety, have better visualization and hence greater visibility either on the plant floor or via mobile platforms, have the ability to pull up a wide range of information and share it with people. F&B companies usually handle a wide range of project management systems, typically working on different software from different vendors.

At GE Intelligent Platforms, Moore says, the products ‘talk’ to different systems and data management software to try and address the challenge of collecting, managing and trending large amounts of data.

So are companies embracing technology solutions to better manage food safety and quality? Moore feels that a driving force is lacking.

“Once something happens and FDA has to react, the chips will start to fall. There will be a lot of recourse to technology that will be required, but right now there’s no driving force. Once FDA puts the hammer down on electronic documentation, F&B companies will start to move faster,” she sums up.

GFSI Position on Mitigating the Public Health Risk of Food Fraud

By Michael Biros
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New Food Fraud mitigation elements will be added to the next revision of the GFSI Guidance Document.

The GFSI board has decided to add two new key elements to the GFSI Guidance Document that address food fraud mitigation according to a recently published white paper. 

The additions to the Guidance Document will require a company to perform a food fraud vulnerability assessment and to have a control plan in place. The vision for the mitigation of food fraud to become an integral part of a company’s food safety management program. 

During a food safety certification audit, conducted against GFSI recognized schemes, the auditor will review the documentation related to the vulnerability assessment process and confirm that a comprehensive control plan has been developed and implemented by the company. 

Food fraud, including the subcategory of economically motivated adulteration, is not the same as food defense. Food defense protects against tampering with intent to harm whereas food fraud concerns the deception of consumers and includes substitution, unapproved enhancements, misbranding, counterfeiting, and stolen goods. The food safety risks associated with food fraud can be more dangerous and challenging to address than traditional food safety risks because the contaminants are unconventional. Some high profile food fraud incidents include the melamine tainted milk crisis, mislabeled recycled cooking oil, and knowingly shipping Salmonella contaminated peanuts. 

The new food fraud mitigation key elements will be included in the next revision of the GFSI Guidance Document (Version 7) to be released in 2016.

Food Safety and Sustainability

By Aaron G. Biros, Michael Biros
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What is sustainability and how does it relate to food safety? This article, the first in a series on the topic, introduces the concept of sustainability.

The global food industry is already feeling the destabilizing and disruptive effects of climate change. Drought and wildfire are ravaging California while flooding is inundating the Midwest. With the effects of climate change projected to amplify, companies are becoming increasingly aware of vulnerabilities to their business. In addition, current modes of food production are seen as a major driver of environmental problems such as deforestation, desertification, eutrophication and fisheries collapse. All of this is set to the backdrop of a booming world population, rapid urbanization, diminishing natural resources, and critically stressed ecosystems.

Food companies are increasingly becoming aware of these challenges and are looking for innovative ways to adapt their business models to account for them. One approach is to incorporate sustainability into business strategy and planning.

Sustainability is a conceptual framework that has the potential to mitigate business vulnerabilities while simultaneously reducing the stress that food production has on social and natural resources. In general terms, sustainability is the endurance of systems and processes. More specifically, it integrates ecology, economics, politics, and culture. Connecting environmental stewardship with a solid business plan while advancing social justice is an innovative as well as profitable approach to streamlining business operations.

There are different methods to assess sustainability, with the most common being the Triple Bottom Line and Circles of Sustainability. These methods are multi-dimensional and allow for the inclusion of complex qualitative issues. Sustainability has also been deceptively referenced in a number of marketing campaigns aimed at altering how a company is publicly perceived, not how it operates. This is a practice known as greenwashing.

In the upcoming series of articles, topics such as co-management, food waste, water conservation, agriculture, and others will be observed through an interdisciplinary lens, tying food safety with sustainability. Given the connection to the entire food production process from farm to fork, food safety professionals are poised to lead in sustainability. Many of the systems already developed to detect, prevent, and trace contamination can be retooled and applied toward sustainability. Elements of food safety programs and auditing schemes such as HACCP, GFSI, and SQF could be adapted to cover environmental and social benchmarks.

Food companies must develop more sustainable solutions in an effort to protect food safety and natural resources. Businesses, driven by C-suite oversight and stakeholder initiative, need to co-manage food quality, safety, and sustainability in a collaborative approach.  Decision making at every step in the supply chain should comprehensively approach food safety, quality, and sustainability where possible.

Andrea Moffat is the Vice President of the corporate program at Ceres, a non-profit organization that publishes findings on corporate sustainability and progress. She believes that, “Businesses need to look at sustainability and food safety as part of their core business framework in identifying risks and competitive advantages. We are beginning to see teams of executives involving sustainability issues in setting sales and revenue targets.”

By reaching across borders within a company and working toward these benchmarks, businesses can improve operations while maintaining customer loyalty and brand confidence. At the end of the day, food safety professionals are stewards of public health. Sustainability offers food safety professionals the opportunity to expand their influence on public health and safety.

Uncertainties around climate change are now threats for businesses in every sector. The food industry is witnessing the effects of climate change on vital natural resources, and thus business planning now.  Food companies are beginning to look at sustainability as an opportunity to improve business operations at the moment and in the future. The upcoming articles will focus on the interconnectedness of food safety and quality with sustainability.

Stay tuned for more articles on this topic.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Pet Food Safety: Regulations and Challenges

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

Alan Baumfalk is Pet Food Safety Specialist and food safety Auditor at Eurofins US Foods Division. After more than three decades of experience in human food production facilities, Baumfalk began inspecting and auditing pet food companies with a fresh pair of eyes and in his opinion, “pet food plants typically are very well maintained, embrace technology, are highly automated, have great productivity and are very efficient with their sanitation and production.”

In an interview with Food Safety Tech, Baumfalk talks about differences in production of human food and pet food; lessons learned from historical incidents such as melamine in pet food and contaminated chicken jerky; what are some gaps in pet food safety he’s noticing and impact of the Food Safety Modernization Act or FSMA on this sector.

Food Safety Tech (FST): What are the differences between the production of human food and pet food?
Baumfalk: In most cases, pet food facilities are dry facilities, making kibbles and similar products, and their cleaning sanitation processes are mostly sweeping and dusting, with very little water involved. When it comes to regulations covering pet food facilities, most of these fall under FDA jurisdiction, and pet food facilities need to have in place risk-based HACCP plans to ensure food safety. Some of the challenges involved in pet foods are how do you do sensory testing on dry pet food or test for taste or consistency? Pet food testers look at certain quality attributes such as color, look, smell and taste of the product. They look for data such as amount of protein in the food etc. They also need to consider if humans – especially the elderly, or children – would consume the pet food product, because this can have many food safety implications.

FST: Humans have allergic reactions to certain food ingredients. Do pets have similar concerns of allergens?
Baumfalk: We don’t know if pets suffer allergic reactions to any specific food ingredients similar to humans. Pet food manufacturers are not subject to allergens and are exempt under FDA’s allergen management regulations. However, there are strict GMPs maintained in pet food production facilities, so that known allergens are identified. Pet food manufacturers give attention to allergens though they are exempt because it’s possible that the allergens could get transferred to a human in the house who could be allergic to nuts or soy, and this could be a huge problem. In our experience, we have seen that pet food can be occasionally consumed by a child or an elderly pet owner, out of curiosity.

FST: How about pathogens such as Salmonella and E.coli, are pets susceptible to these?
Baumfalk: Pets are not typically affected by pathogens such as Salmonella or E.coli, and this goes back to their genetic background, which is, dogs coming from wolves, and cats from tigers and lions. These animals are used to eating things with pathogens, fecal matter etc. However, humans are at risk of infection by Salmonella and E.coli, so while the end consumer of pet foods are not affected by these pathogens, their handlers are. Hence, pet foods are tested for Salmonella and E.coli to make sure they are pathogen free. They have Critical Control Points (CCPs) and kill-steps just like human foods, and pet foods are diligently sampled before they are released in the market. Environmental monitoring is also strictly carried out – such as extensive swabbing of processing floor, walls etc. to test for Salmonella/ E.coli/ mycotoxins etc. If a raw material exceeds FDA guidance for mycotoxins, then they are rejected. Many manufacturers test for mycotoxin levels in finished product as well.

FST: Are there differences in auditing pet food companies versus human food manufacturers?
Baumfalk: All pet food companies are looking to get certified and audited under a GFSI-recognized scheme. SQF is probably the biggest standard though some choose BRC. Eurofins has close ties with the American Feed industry Association (AFIA) which recommends SQF, and so we follow the same standard when auditing pet food facilities. SQF has modules specific to pet food category and dry pet food products. There are a lot of similarities with requirements for human food – for instance, pest control within a pet food plant is the same as within a human plant. The commitment and requirement for compliance is the same.

FST: What are some gaps or challenges in pet food safety?
Baumfalk: Most of the folks working in the pet food industry have a background in human food and are very much aware of the technical and regulatory requirements for making human food, so they end up carrying it over to pet food production. They typically follow GMPs and HACCP, and safety plans to ensure there are no food safety gaps. While most pet food companies meet, or even exceed, compliance requirements, there are always some people in the industry that don’t get the message.

FST: When we think about pet food safety, the history of melamine contamination of pet food, and tainted chicken jerky from China come to mind. What are lessons learned and how can the pet food industry be prepared for the unknown?
Baumfalk: The melamine adulteration and chicken jerky contamination incidents have taught the industry to be on guard. The industry has to make sure that they are in close alignment with their industry association which speaks for them, read technical documents, hire and train knowledgeable staff – all of which helps constantly look for the next thing that we weren’t aware of. Apart from diligently monitoring the global supply chain, it would help to have strict audit specifications for global suppliers. If something is coming from the other part of the world, where there’s a history of food safety standards not always being up to par, the pet food industry needs to make sure to buy only from a known and approved entity. Also look for lessons that can be learned from the human foods industry. Read about recalls and withdrawals and find out why that happened, if the pet food industry has similar exposure, and how this can be addressed.

FST: What will be the impact of the proposed pet food safety rule under FSMA be on this industry?
Baumfalk: FSMA is going to tighten things up, paying a lot of attention to the global supply chain and any vulnerabilities. While regulations are still being finalized, the pet food industry is already aligning itself with these proposed regulations. The technical and regulatory folks in the industry are following it; they are reading food safety journals and interacting with their associations for guidance and for making comments on the regulations. We are also updating our auditing checklists to see how we can align better with new FSMA requirements.

For more information on Eurofins, it’s pet food and auditing capabilities, click here.

Why GFSI? And How Can It Help?

By Jennifer Brusco
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The Global Food Safety Initiative or GFSI, simply explained, is a business-to-business Food Safety and Modernization Act (FSMA). It operates quietly and privately within the marketplace between the customers and their suppliers. It operates on not only a global basis, but also on a regional and local basis.

“Although people look at the [GFSI] program and see a lot of multinational corporate logos, frankly the majority of our operations are small and medium size facilities at the local level. So we welcome facilities of all natures – large, medium, and small, across the food to fork continuum,” Karil Kochenderfer, North American representative, GFSI, said during a recent webinar.

GFSI has approximately 25 benchmarked guidances, with some of the latest scope expansions include:

  • Packaging and animal conversion – August 2011;
  • Animal feed – June 2012;
  • Storage and distribution – October 2013;
  • Food brokerage/agents, retail/wholesale – early 2014; and
  • Catering, equipment manufacturing, food safety services – 2015.

Where are these guidances coming from? How can you be sure that these guidelines are science-based, risk-based, and address the issues in your plant/facility?

Why-GFSI-June2014At the very base of our efforts that are ensconced within these guidance on a sector by sector basis, are the international standards of science based within the Codex Standard on Food Hygiene. On top of that are Hazard Analysis and Critical Control Points or HACCP standards. Above HACCP are National Regulations, which includes FSMA in the U.S. and the Safe Food for Canadians Act in Canada. In Europe it’s something different, in Japan it’s something different, but all have iterative levels of science-based regulation in place to ensure the safest control of the food and management of the food. Above National Regulation is GFSI Certification.

“We go above and beyond the science of Codex, HACCP, and national regulation to perform at the highest level of industry. And our benchmarked schemes [eg. BRC Global Standards (BRC), Food Safety System Certification (FSSC 22000), International Featured Standards (IFS)] go beyond us and corporate programs go even further,” Kochenderfer highlighted.So what you have are several layers of protection that will help protect both consumers and companies.

What are some of the shared benefits for industry?

There are several benefits, which include:

  • Meet the requirements for one, meet the requirements for all;
  • Reduce duplication of audits;
  • Have comparable audit approach and outcomes;
  • Ensure the continuous improvement and customer opportunity for those GFSI-benchmarked companies;
  • Enhance trade opportunities;
  • Improve customer confidence in food safety; and
  • Gain cost efficiencies throughout the supply chain.

“We have now built confidence in third-party certification because we have reduced inefficiency in the food system. Now, it’s ‘Once Certified, Accepted Everywhere,'” stated Kochenderfer.

John Kukoly, Director of BRC in the Americas, added that companies should pursue GFSI certification for a number of reasons:

  • Customer mandate;
  • FSMA;
  • Nearly a 40 percent reduction in product non-conformance;
  • Competitiveness; and
  • Superiority in the market.

Right now, only a third of the industry has achieved GFSI certification, which leaves the remaining two-thirds either still at the starting line or just a few steps into their journey. How do you choose a GFSI-recognized scheme and get started?

Karil Kochenderfer shared a chart to allow users to see where they fall on the farm-to-fork continuum and further determine which scheme(s) would work for them.

Further, we have developed four GFSI checklists for the four major schemes that apply to food manufacturers, co-produced with the respective scheme owners to ensure accuracy and usability. The checklists are complimentary and may serve as a great resource on your journey toward GFSI certification.

Additional Resources:

What Constitutes a Successful FDA Audit?

By Sangita Viswanathan
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From the proposed third party accreditation rule, to GFSI audits, and needing more trained and experienced auditors, the process of auditing food facilities is undergoing a sea-change. What is the impact going to be on food companies, auditors, and the auditing process?

In a recent FSMA Fridays webinar, sponsored by SafetyChain Software, an expert team from The Acheson Group, comprised of Melanie Neumann, J.D., M.S., VP and Chief Financial Officer; Jennifer McEntire, Ph.D., VP and Chief Scientific Officer; Anne Sherod, M.S., Director of Food Safety and Valerie Scheidt, MBA, CP-FS, Director of Food Safety, answered key questions on conducting successful FDA audits. We present some excerpts below.  

How does the FSMA third party audit accreditation rule impact the audit process?

 

The purpose of the third party accreditation and certification audit is to issue a certificate for high risk foods or the voluntary qualified importer program. The main foundation of the standards that FDA is setting will come from the human preventative controls rule, the animal preventative controls rule, and the produce safety rule. Some standards may also come from the sanitary transportation rule and food defense rule. FDA will be appointing an accreditation body and this accreditation body will approve and monitor certifying bodies (CB). These CBs can be private companies or private individuals who will be authorized by the accreditation body to perform the audits and issue those certifications. 

 
Foreign governments can also be approved by FDA to act as a CB. Right now only New Zealand is approved and FDA is looking at approving Canada. We don’t anticipate any other country to be approved in the near future.;

Certifying bodies will have strict conflict of interest and reporting requirements to FDA. CBs must report to FDA within 45 days even if they’re just performing a consultative audit. They must also report to FDA if they see an issue that could lead to a Class I or Class II recall and they have to report to FDA before they report to the company that they are auditing.

 

Will a GFSI audit satisfy FSMA audit requirements?

GFSI audit requirements do not match the FSMA audit requirements, but they are not too different. Several of the schemes are very similar, and each scheme owner is making a concerted effort to become FSMA compliant. If an auditor is doing a GFSI audit, they do not need report to FDA before the company. The FSMA requirements of avoiding conflicts of interest, record keeping, and training may deter GFSI auditors from becoming Certifying bodies under FSMA. Unless FDA offers an incentive, there will be a shortage of FSMA CB auditors. 

 

What are the elements of a successful audit?

The number one goal of an audit is to identify risk. The audit needs to accurately describe the non-conformances against the audit standard to give your quality and operations team reliable and actionable data so they can mitigate that risk. The relationship between the auditor and the facility should be a partnership, add value, and build trust. The facility should learn from the auditor and the auditor should understand what the facility is doing to mitigate risk and promote food safety. Continuous improvement takes the feedback from the non-conformances and evaluates them against the organization’s goal around risk. Whether the results are from an announced, unannounced, internal, second, or third-party audit, continuous improvement is critical, and this requires commitment from management and will help the facility become audit ready. 

 

How can I ensure my auditor is up to the task?

Most audits use checklists. This goes for both the auditor and the audited. The checklist provides a standardized list of what’s expected and adds an element of order and control to the audit. It also allows for an effective way to quantify metrics. 

However, using a checklist alone can lead to minimum risk finding. The auditor needs to find a balance between being strategic and prescriptive. In order to be effective, audit protocols need to be periodically reviewed and updated. This is especially relevant with FSMA and holds true for internal and third-party audits. Check to see if the auditor’s checklist is pre-FSMA or post-FSMA. Ask the auditor when was the last time that they reviewed and updated their audit protocols. 

 

Will we have enough good auditors to meet the need?

No, we already don’t have enough good auditors. The implications of this are that we may get substandard audits from substandard auditors. The current model isn’t working and we need a new approach. Currently, most auditors have extensive prior experience working in industry and often become auditors after they retire.

We are creating auditors not through structured training. This model is not sustainable and has limited growth potential. It will not provide the level of training required for GFSI or FDA third party certification requirement. We need a training program for auditors who come right out of school. We need people to go to school for food safety and be able to become an auditor after graduation. Food safety needs to be incentivized at the university level. There should be a bachelors degree in food safety auditing. We need structured training and developmental opportunities for folks earlier in their career rather creating auditors at the end of their career.