This week Eurofins Technologies announced a strategic partnership with Gold Standard Diagnostics (GSD), a developer and manufacturer of fully-automated diagnostic instruments and assays for various test methods. The agreement unites Gold Standard’s ELISA-based instruments and Eurofins Technologies rapidly-expanding diagnostic test kit portfolio for food, environmental and animal health testing.
Gold Standard Diagnostics will be the standard platform for Eurofins Technologies ELISA-based food testing kits including food pathogens, allergens, mycotoxins, veterinary drug residues, and animal health kits.
Eurofins Food Safety Systems and Orion Assessment Services have announced a partnership that will expand their auditing and certification services on a global scale.
“The partnership will allow Eurofins to broaden their BRC Global Standards and GFSI scheme auditing resource base and provide them additional expertise in BRC to utilize. It will also allow Orion Assessment Services to operate under the Eurofins accreditation for BRC, SQF and FSSC 22000 schemes,” according to a Eurofins news release. “As a certification body, this collaboration will enhance the standards currently offered through Orion Assessment Services’ accreditation for ISO 17065 and ISO 17021, as well as offering brand new opportunities in the various GFSI schemes, for both existing and new clients internationally.”
Food Safety Tech recently sat down with experts from Eurofins to discuss FSSC 22000. According to Kristopher Middleton, technical manager at Eurofins, and Kim Knoll, food safety systems national sales manager at the company, there are still quite a few companies (especially in North America) that are unfamiliar with the ins and outs of the certification scheme. In a Q&A with FST, Middletown and Knoll break down the basics of FSSC 2000, along with explaining some of its benefits.
Food Safety Tech: How is the trend with FSSC 22000 evolving?
Kristopher Middleton: The scheme started in 2009 based on a demand for people wanting to have an ISO-based certification within the GFSI benchmarking process. When the program came out, it trended toward larger companies that already had ISO-based certifications, mainly ISO 22000 and ISO 9001. The FSSC 22000 scheme is the fastest growing GFSI benchmarking scheme currently. It’s not just for large multinational companies; a lot of smaller suppliers are seeking certification to this scheme. The foundation continues to expand its scopes to become a true farm-to-fork certification program.
FST: Is FSSC 22000 also appropriate for a single site or for a company with fewer than 50 employees?
Middleton: The certification doesn’t discriminate based on facility size—nor footprint or number of employees. It’s ideal for any company that has a robust food safety management system and manufacture products that fall within the FSSC 22000 scope of certification. This currently includes manufacturers of perishable animal products (feed and food), perishable vegetable products, products with a long shelf life, biochemical products (i.e., food ingredients, vitamins, biocultures, etc.), manufacturers of food packaging, and primary production of animal products.
The key thing about FSSC 22000 certification is that it is not a terribly prescriptive food safety scheme, when compared to others that are available. You will be successful with FSSC 22000 certification if you are confident and knowledgeable about your own food safety management system, and you have appropriate justification or validation for the method in which your programs have been implemented, as well as validation for the controls of your food safety hazards.
FST: Are there quite a few companies that have not heard of FSSC 22000 or are not aware that it is a GFSI-recognized scheme?
Middleton: Since ISO 22000 was not terribly popular here in North America, it didn’t catch on right away. It was more so overseas that it caught on. However, within the past two years the scheme has become increasingly popular here, especially among companies that have other ISO standards already implemented (i.e. ISO 9001, 14001, 18001,etc), where it relates to occupational health and safety, environmental, and quality. The reason for that is the FSSC can easily intertwine with that entire management system program so that it all works together versus having separate programs in place.
Kim Knoll: I’m having a lot of conversations with smaller manufacturers who are brand new to GFSI. Many of them are being asked by their customers to achieve a GFSI benchmarked certification and are in the early stages of researching scheme options. Some of these companies are surprised to learn that FSSC 22000 is a viable option. Like other certification schemes, Eurofins lends support to companies planning to pursue FSSC 22000 through training courses, consulting services, pre-assessments and ultimately certification services. Even though FSSC 22000 is a newer scheme, auditor availability is not an issue.
FST: What are the key differences between FSSC 22000 and the other GFSI schemes?
Middleton: Probably the most apparent difference with FSSC compared to other GFSI benchmark schemes is the fact that your certification lasts for three years, not one year. The reason for that is that it’s not a product-based certification like the others, it is a process-based certification and it uses the accreditation standard of ISO 17021 not ISO 17065. It also uses ISO 22003 for direction to the certification body for the conducting of the audit. That doesn’t mean that sites won’t be audited annually; it just means that once the certificate is granted, it’s good for three years.
Another key difference is that there is no true pass or fail within the audit. It’s a conform or not-conform audit. The decision to certify is based off the findings from the auditor and their recommendations, as well as the decision from a technical review meeting at the certification body. It requires the effective closure of a particular non-conformance or satisfactory plan being submitted for the closure of those non-conformances before the actual certificate can be granted. So that’s a bit different, because you can just submit plans for your non-conformances [instead of] actually showing that everything has been completely resolved. That being said, if a facility isn’t able to hold or get a certificate, if there’s an imminent food safety threat noted during an audit—if there’s an issue, such as a potential recall or contaminated goods, the ability to be granted that certificate is not feasible.
FST: Can you walk us through the auditing and certification process under FSSC 22000?
Middleton: Like any of the standards out there, you can get a pre-assessment, which is not necessarily part of the certification activity. The certification activity starts at a Stage 1 audit within this scheme (also known as a document audit within other schemes). It’s an evaluation of a facility’s food safety management system document to determine if they’re valid. The process does not include an entire evaluation of the implementation of the program, just simply that the programs are adequately designed and meet the requirements that are in place.
Next there’s a Stage 2 audit (sometimes referred to a facility audit) that is conducted no more than six months after the Stage 1 audit. The Stage 1 audit will identify the areas of concern—programs that might not meet exactly what the specifications required within the standard, which would become non-conformances in a Stage 2 audit (also called a facility audit or certification audit).
The Stage 2 audit is the full evaluation of the implementation of the program that was reviewed in the Stage 1 audit. Following completion of the audit, effective closure of non-conformances is required. This closure can either be [related to] major non-conformances, CAPA or root cause analysis. You have to supply evidence that the non-conformance is properly eliminated and will not recur, and this evidence must be supplied to the certification body and the auditor for review.
Any other non-conformances (also known as minor non-conformances) must have corrective action plans. Companies need to state how they plan on resolving the issue. They will be “closed” but left open for the next audit, which has to occur within one calendar year (known as a surveillance audit). The term “surveillance audit” within this standard is different from some of the other standards. Within some of the other standards, a surveillance audit is not a yearly activity—it is done within the year of certification. The surveillance audit within this standard is a yearly audit that is required to meet the requirements of GFSI. It’s also a requirement within [ISO] 17021 and [ISO] 22003 that surveillance audits are conducted. The GFSI requirement changed the surveillance audit within the ISO world because they used to do a sampling audit, which progressed to a full-blown audit. Your whole food safety management system will be evaluated, which is slightly different from ISO 22000 surveillance audits.
After that audit is conducted, you have another surveillance audit in the following calendar year. Within those surveillance audits, if any minor non-conformances or non-conformances from the previous audit are still present, they are upgraded to major non-conformances and [companies] would have to implement a full corrective action plan, root cause analysis, etc. and then determine the solution.
Once the second surveillance audit is conducted, the following year will be your recertification audit, which is simply another facility audit. It’s not a document audit—you don’t have to do Stage 1 audits after that initial one. This recertification audit occurs prior to your certificate expiring.
Several different approaches can be used to verify authenticity of food, from a heteroduplex assay to microsatellite analysis. In part II of a presentation by fruit juice and authenticity expert David Hammond, Ph.D. of Eurofins Scientific at the 2015 Food Labs Conference, learn about the DNA methodologies as well as the proactive steps that companies should be taking to prevent food fraud or economically motivated adulteration of product.
In 2009, FDA officially recognized food fraud as an issue. Driving forces behind the problem include seeking an opportunity to make an illicit profit, a lack of premium raw materials, and a lack of supplier awareness. At the 2015 Food Labs Conference, fruit juice and authenticity expert David Hammond, Ph.D. of Eurofins Scientific offered the basics of protecting against the adulteration of fruit juices.
The collaboration aims to help manufacturers increase product shelf life while maintaining safety and quality on a wider scale.
DuPont Nutrition & Health is joining forces with Eurofins Microbiology Laboratories, Inc. to deliver tailored food protection services with advanced analytical testing services. The agreement, which is initially being launched as a pilot program in the United States, combines DuPont’s expertise in food microbial ecology and its Detect + Protect service program with Eurofins’ capabilities in microbiological testing.
The food protection program will assist manufacturers with the microbial challenges they face in their production facilities while also addressing food spoilage and waste. Introducing antimicrobials can make food products last longer, but it’s important to ensure that the quality of those products is not affected. One of the goals of the partnership is to help food manufacturers reduce spoilage and expand the shelf life of their products without making such a compromise. “Detect + Protect targets clients that are all about comprehensive [food] safety and quality,” says Marc Scantlin, vice president, US Food Division at Eurofins. “Everything has an expiration date. How can we improve the timeline of keeping whole food safe while increasing shelf life?”
According to Nathalie Brosse, global market development, BioProtection at DuPont, the company has needed more space to build its Detect + Protect offering. DuPont will be leveraging Eurofins’ extensive lab capacity to make its program more widely available, while DuPont’s international client base opens the doors for Eurofins to expand its global reach.
From a logistics perspective, the partnership will also expedite sample turnaround, as the companies take advantage of the Eurofins microbiology lab in Louisville, KY. Located in close proximity to the UPS worldwide air hub, Eurofins can receive overnight samples between 2 am and 4:30 am, providing a faster turnaround of samples by nearly six to eight hours.
DuPont and Eurofins anticipate launching the partnership in Europe but are not disclosing dates yet.
What is a Special Project? These are special testing projects that are not typically covered by laboratory testing when you run into a question that you really can’t answer, says Centrella. Special projects can be used for:
Development, validation or implementation of a new testing method;
Comparing performance of a new testing platform against a standard;
Validation of pathogen control, for instance, to check effectiveness of CCPs;
Verification of effectiveness of antimicrobials; and
Determination of whether a product requires refrigeration.
With method validation, the situation can be that you work with PCR for Salmonella, and there are certain number of matrices approved, but you want to take advantage of that method and extend the matrix. So special projects can help you answer if that method would be suitable for your product.
Another category of special projects is pathogen control. In this situation, you can see if you have a process or an ingredient that’s in your product, or simulate that intervention in a lab setting (either heat or cool step or a treatment like a wash) to check for pathogen growth. In this case, the target matrix is inoculated with high level of analyte, and the aim is to show large log reduction, or even complete elimination, once the matrix is treated with the intervention.
Shelf-life studies is another example of special projects. In this case, we simulate retail storage of the product to determine expected shelf life or determine typical storage conditions. Here, assay are prepared to assess threats to product shelf-life, microbial, chemical or nutritional in nature. Such threats could be build-up of lactic acid due to bacterial activity, or might be gas-producing microorganisms, or chemical targets that cause rancidity in oils. Often these include an organoleptic compound which could change how a product looks, or if it has an odor. It’s important to remember that often the souring of the product due to lactic acid, gas bubbles or off odors will present themselves before microbial counts become obvious.
Shelf life testing is conducted at predetermined intervals, and depending on need, we can stagger these intervals, for instance, we can do more frequent testing during the anticipated end of shelf life. The final shelf life is defined by the last acceptable result.
Antimicrobial effectiveness is another example of special projects, and these involve products that already have an antimicrobial ingredient. In these situations, we inoculate target microorganism into the product and use assay to determine log reduction, or prevention of outgrowth. Antimicrobial effectiveness studies often include aspects of shelf life studies, where product is typically held at a given time-temp combination. These studies may use specific references such as using USP <51>, or reference could include specific microorganisms, and criteria to determine effectiveness (such as log reduction).
Another example is determination of if a product requires refrigeration. For this, we first start with the food product itself, which has a specific combination of pH and water activity to prevent growth of groups of pathogens. Once we have this information, we don’t have to look at broad range of organisms, but can look at specific organisms. The remaining potential threats become challenge organisms for the study. We store the product at room temperature and test for these challenge organisms.
The food industry has multiple levels of people involved, ranging from leadership and supervisors, all the way to line and front-end workers. Training, thus, has to not just give directions, but also provide better understanding of why we do what we are supposed to, says Gary Smith at Eurofins.
Smith, who leads the strategic development and oversight of Eurofins’ Food Safety Systems division, including auditing, certification, and training programs, says that “training for supervisors and leadership usually works well. But training workers is fraught with challenges. General training is focused more on giving directions, but not so much on providing understanding. People often skirt this rationale with the line workers, or it’s lost in translation, or missed out due to time constraints, turnover, vacation days etc. That’s where training fails.”
What would happen if we don’t spend this time address the ‘why’ behind training? People then get busy, and then miss out on steps and processes, and that causes problems, Smith replies. “It’s also critical to aim to strike a balance, for instance with line workers training – you have to ensure they understand the importance of what you are training them on, but at the same time, you cannot go too deep into the training, that would be either unnecessary or redundant.”
So what kind of training will continue to be the focus for the industry? The usual ones will continue to be important, according to Smith: Regulatory requirements for seafood, specific HACCP requirements for meat, HACCP training for employees directly responsible for food safety and quality, standards training; training for audits… For line workers, training also needs to cover specifics of their jobs, employee hygiene practices (for instance, why it’s important to wear gloves, hairnets etc.), and how to handle customer complaints.
Proposed rules under the Food Safety Modernization Act are having a positive impact on training needs, says Smith. “Everyone is now waiting for the final set of rules to be announced and implemented. A lot of good things are coming out of it, such focus on risk management and process control, understanding which products are high risk and low risk. FSMA has brought back HACCP for those industries that haven’t really had strict regulatory requirements for food safety – such as seafood, fresh produce, juice etc., or ready-to-eat products that may have escaped regulatory scrutiny in the past, such as fresh produce, and bakery products. Now the industry as a whole needs to focus on FSMA implementation, by companies helping its employees understand where the food safety risks are, how to manage them, document them, and mitigate them.
How can training help companies towards certification? When training leaders that are going to be implementing the food safety standards within their facility, it’s important to be comprehensive about understanding the specific standard. There is also the opportunity to focus on common non-conformances and say ‘this is where others have struggled and this is what you can do to avoid those non-conformances.’ Training can provide lessons, solutions and ideas to address common problems to addresses non-conformances before an audit. It can help drive continuous improvement, and help secure management commitment.
What are some of the common training themes that have resonated with Smith? He says that mostly employees bring up the issue of getting management to understand the need to focus on food safety training and procedures. “People who have attended my classes are usually struggling with getting management commitment. They are often told they need to be certified to a particular standard by end of the year, and so figure it out, but there’s no skin in the game from management. I help these trainees walk through the various steps that they can take to secure that commitment, how to talking their language in terms of more efficient production, and higher dollar savings etc.,” Smith describes.
Some challenges that he has observed in his years of training? Smith says that often times the trainers are great auditors, but poor trainers. “They will quote standards, and regulations. They are too black and white, and objective. However, training can have successful outcomes only when it’s practical and linked to real situations and ideas.”
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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